DIA 2024 Global Annual Meeting: Full Schedule

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6:00am PDT

CISCRP Medical Heroes Appreciation 5K

Component Type: Social Event

Location: 222 Marina Park Way, San Diego, CA 92101
The Center for Information and Study of Clinical Research Participation (CISCRP) will be hosting a Medical Heroes Appreciation 5K Run and Walk at 222 Marina Park Way, San Diego, CA to celebrate the volunteers who give the gift of participation in clinical research. Proceeds from the event will support education and outreach programs to patients and families interested in learning more about the clinical research process.
If you have not yet registered for the 5K, you can still do so through the CISCRP website.

Tuesday June 18, 2024 6:00am - 8:00am PDT
TBD San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Networking Opportunities, Social Event

Tags Social Event

7:00am PDT

Coffee and Light Refreshments

Component Type: Social Event

Tuesday June 18, 2024 7:00am - 8:00am PDT
Sails Pavilion San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Networking Opportunities, Social Event

Tags Social Event

8:00am PDT

#201: Considerations for Identification of Drug-Induced Liver Injury

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-556-L04-P; CME 1.00; RN 1.00

Identification of drug-induced liver injury (DILI) is hindered by the lack of a structured, standardized approach to its identification and evaluation. This leads to inefficiencies for both sponsors and regulators. Guidance related to data submission for DILI evaluation can improve the efficiency of regulatory review, for example, by reducing the number of information requests sent by the FDA to industry sponsors. Ultimately, improved strategies for DILI data gathering and submission will also improve the accuracy of DILI risk assessment. This session will provide an in-depth discussion of the challenges for reviewing clinical data and suggest potential strategies to improve the DILI identification process. Topics that will be covered include (1) regulatory guidance on structured DILI data submission, (2) how interactive data visualizations tools can enhance the ability to detect potential cases of DILI and (3) the approach to populations with elevated transaminases at baseline and why the modified eDISH (mDISH) approach has important limitations.

Learning Objectives

Describe the regulatory guidance for how to submit structured data pertaining to drug-induced liver injury (DILI) data; Discuss how to utilize interactive visualization tools to identify potential cases of DILI; Identify the challenges for detecting DILI when liver tests are abnormal at baseline.

Chair

James Buchanan, PharmD

Speaker

Regulatory Guidances for Submitting Structured DILI Data
Y. Veronica Pei, MD, MEd, MPH

Use of Interactive Visualization Tools to Identify Potential Cases of DILI
James Buchanan, PharmD

Addressing the Challenges of DILI Detection in Clinical Trials with Abnormal Baseline Liver Tests
Paul Hayashi, MD, MPH

Speakers

James Buchanan

President, Covilance LLC, United States

Dr. James Buchanan is presently an independent drug safety consultant. Dr. Buchanan began his industry career at Genentech where he worked for 9 years in the areas of medical information and drug safety. He subsequently established the drug safety departments at Gilead, Tularik and... Read More →

Paul Hayashi

Physician Lead, DILI Team, Division of Hepatology and Nutrition, OND, CDER, FDA, United States

I am Physician Lead, DILI Team, FDA. I got my BA in microbiology at UCLA and MD at UC San Diego. After residency and gastroenterology training at UC Davis, I completed a research fellowship at the NIH and a transplant fellowship at the University of Colorado. I received an MPH at... Read More →

Y. Veronica Pei

Acting Associate Director, Biomedical Informatics and Regulatory Review Science, FDA, United States

Dr. Veronica Pei is a board-certified emergency physician and a commissioned officer in the U.S. Public Health Service currently serving as Associate Director (Acting) of Biomedical Informatics and Regulatory Review Science team in the Office of New Drugs (OND), FDA. In this role... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session

Format Session
Level Intermediate
Level Intermediate
Credit Type ACPE, CME, RN
Tags Session

8:00am PDT

#202: Behavioral and Educational Strategies for Avoiding Falsified Medicine Exposure (BE SAFE)

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-557-L04-P; CME 1.00; RN 1.00

Counterfeit drugs are important public health concern that impact both developed and LMICs. The session is to understand the current landscape and global impact of these and hear from industry, regulators and others on best approaches to address this

Learning Objectives

Discuss the significance and current landscape of counterfeit (falsified) medicines; Describe the economic, socio-economic and pervasive health threats to the global population from counterfeit products; Identify the current interventions implemented by regulators, industry, policy makers to combat this; Recognize new approaches to develop more focused programs that address the root cause.

Chair

Lubna Merchant, PharmD, MS

Speaker

Academic Update
Saifuddin Ahmed, MD, PhD

WHO Update
Rutendo Kuwana, RPh

FDA Update
Sangeeta Chatterjee

Patient Perspective
Regina Mariam Kamoga, MPA

Speakers

Lubna Merchant

Director, Risk Management Center of Excellence, Pfizer Inc , United States

Lubna is a Director in the Risk Management Center of Excellence at Pfizer, Inc., where she is responsible for the strategy and implementation of risk management plans globally. Dr. Merchant provides global leadership in delivering innovative and strategic risk management excellence... Read More →

Saifuddin Ahmed

Professor, Department of Population, Family, and Reproductive Health, Johns Hopkins University, United States

Sangeeta Chatterjee

Deputy Office Director, Office of Drug Security, Integrity, Response, OC, CDER, FDA, United States

Regina Mariam Kamoga

Executive Director, Community Health And Information Network ( CHAIN), Uganda

She is passionate about patient centered healthcare and patient safety and her work puts emphasis on patient, family, community engagement and empowerment at the grassroots level. One of her key roles is as a WHO Patient Safety champion and she is a member of the WHO’s Patients... Read More →

Rutendo Kuwana

Team Lead, Incidents and Substandard/Falsified Medical Products, World Health Organization (WHO), Switzerland

Rutendo is leading the Incidents and Substandard/Falsified (ISF) medical products team at the World Health Organization (WHO) since June 2021. The ISF team is part of the Regulation and Safety (REG) Unit of the Regulation and Prequalification (RPQ) department that is within the Access... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum

Format Forum
Level Basic
Level Basic
Credit Type ACPE, CME, RN
Tags Forum

8:00am PDT

#203: Feasible Site Feasibility Assessments: Rethinking Business as Usual to Reduce Burden, Timelines, and Costs for Sustainability

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-558-L04-P; CME 1.00; RN 1.00

In 2021, recommendations to reduce site feasibility assessment burdens was released.. Current industry and CRO methods remain costly and inefficient, and delay trial start-up and patient access to clinical trials.

Learning Objectives

Describe the impact of non-standardized study feasibility assessments across the industry; Discuss opportunities and solutions around improvements to the site feasibility assessment process; Apply new methods to streamline feasibility assessments and improve study start-up timelines.

Chair

Trevor Joseph Cole, MBA, RN, PMP

Speaker

Panelist
Kristen Ballesteros, PhD, MS

Panelist
Suanna S. Bruinooge, MPH

Panelist
Ramya Thota

Speakers

Trevor Cole

Associate Director, WCG, United States

Trevor Cole is currently an Associate Director at WCG Clinical. Trevor has a bachelor’s degree in health science, an MBA in healthcare management and project management, and is a registered nurse, certified research coordinator, and certified project management professional. Trevor's... Read More →

Kristen Ballesteros

Associate Director, Feasibility Strategy, Thermo Fischer Scientific, PPD, United States

Dr. Ballesteros is an expert in feasibility strategy, with a focus in hematology and oncology over the last 7 years. Her current role encompasses data curation and analysis to support operational strategy, including a key role in site identification. As PPD's Feasibility SME for diversity... Read More →

Suanna Bruinooge

Chief and Division Director, Research Strategy and Operations Center, American Society of Clinical Oncology, United States

Suanna Bruinooge, MPH, is the Chief and Division Director of Research Strategies and Collaborations in ASCO’s Center for Research and Analytics (CENTRA). CENTRA generates and analyzes oncology data to foster innovation in research and patient care and help develop evidence related... Read More →

Ramya Thota

Associate Professor, Intermountain Medical Oncology - IMC, United States

Dr. Thota is a GI medical oncologist at Intermountain Health, Utah. She finished her subspecialty Hematology and Medical Oncology fellowship training from Vanderbilt University, Nashville, Tennessee. She receives research funding from American Cancer Society Clinician Scientist Development... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Forum

Format Forum
Level Intermediate
Level Intermediate
Credit Type ACPE, CME, RN
Tags Forum

8:00am PDT

#204: Wearable Sensors and Digital Health Technologies for Tracking Neurological and Neuromuscular Disorders

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-559-L04-P; CME 1.00; RN 1.00

Neurological disorders are complex and multifaceted, with symptoms that can vary widely. Wearable sensors and digital health technologies enable objective collection of data at the patients' home, providing unprecedented ways for tracking diseases.

This session will include presentations from several NIH-funded and Investigator-initiated studies focused on collecting digital measures of disease progression, including in patients with progressive supranuclear palsy, Parkinson disease, Alzheimer’s and ALS, and their potential impact on clinical trials and care for individuals with neurological disorders.

Learning Objectives

Demonstrate innovative wearable sensors and digital technologies capable of accurately detecting and monitoring neurological disease symptoms; Identify methods for seamlessly integrating wearable sensors with existing healthcare systems to ensure continuity of care.

Chair

Ashkan Vaziri, PhD

Speaker

NIH Update
Yuan Luo, PhD

Academic Update
Bijan Najafi, PhD, MSc

Industry Update
Sharon Tamir

Industry Update
Ashkan Vaziri, PhD

Speakers

Ashkan Vaziri

Co-founder and CEO, Biosensics LLC, United States

Dr. Vaziri is a Founder and CEO of BioSensics, a biomedical firm focused on the development of wearable sensors and digital health platforms for clinical trials and research. Dr. Vaziri’s work presents a unique combination of academic research, product development, and small business... Read More →

Yuan Luo

Program Director, AD/ADRD Biomarkers, Division of Neuroscience, National Institute on Aging, NIH, United States

Dr. Yuan Luo is a Program Director of the Clinical Interventions and Diagnostics Branch in the Division of Neuroscience at National Institute on Aging, NIH. She oversees the Division’s technology portfolio, such as using wearable, sensors technology for early detection, monitoring... Read More →

Bijan Najafi

Professor of Surgery; Director, Clinical Research, Baylor College of Medicine, United States

Dr. Bijan Najafi, Professor of Surgery at Baylor College of Medicine, specializes in digital health and biotechnologies. He's the Director of Clinical Research in Vascular Surgery and Co-Director of Center to Stream Healthcare in Place (C2SHIP). Recognized by Tucson Local Media in... Read More →

Sharon Tamir

Digital Healthcare Innovation, Business and Research Strategy, MT-Pharma, United States

Sharon Tamir, Leading the Digital Healthcare Innovation team at MT-Pharma since Jan2023. Prior to that she worked as a VP Program Leader of the Neuro-oncology and the Myelofibrosis programs at Karyopharm Therapeutics. Sharon Brings over a decade of experience in drug development... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Session

Format Session
Level Intermediate
Featured Topics Digital Technology
Level Intermediate
Feature Topics Digital Technology
Credit Type ACPE, CME, RN
Tags Session

8:00am PDT

#205: Data Standards SOS: Reducing Burnout and Navigating Through Fatigue - Part 1

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-560-L04-P; CME 1.00; RN 1.00

At the DIA 2023 a round table on data standards and harmonization discussed “standards fatigue” related to data standards, reference models, consortia, industry groups, and their impact on the industry. We intend to address this topic in a two-part workshop.

Learning Objectives

Identify various data standards and harmonization efforts across pharma and biotech industries; Discuss challenges and business impact related to the understanding, implementation, and maintenance of data standards initiatives in light of digital transformation efforts; Describe approaches to identify overlapping/competing initiatives and develop synergistic approaches to reduce fatigue.

Chair

Venkatraman Balasubramanian, PhD, MBA

Speaker

Facilitator
Sridevi Nagarajan, PhD

Facilitator
Norman Schmuff, PhD

Facilitator
Hilmar Hamann, PhD

Facilitator
Cesar Vinces

Facilitator
Vanni Carapetian, MPH

Facilitator
Heiner Oberkampf, PhD

Speakers

Venkatraman Balasubramanian

SVP and Global Head, Industry Solutions - Healthcare and Life Sciences, Orion Innovation, United States

V. “Bala” Balasubramanian is Senior Vice President and Global Head, Industry Solutions Group for Healthcare and Life Sciences at Orion, a global digital transformation products, solutions and services firm. Bala has over three decades of IT and digital transformation experience... Read More →

Vanni Carapetian

Director, Regulatory Data, Genentech, A Member of the Roche Group, United States

Vanni brings nearly 20 years of life sciences and technology expertise drawn from team and leadership roles at Roche, J&J, and Amgen. Their experience spans clinical development, manufacturing, and regulatory and their principal interest lies in setting and executing strategies that... Read More →

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands

Dr. Hilmar Hamann is the Head of Information Management at the European Medicines Agency where he focuses on transforming technology capabilities for the Network of Regulatory Agencies in the EU and its stakeholders to become an all-digital, efficient and data-driven Network of the... Read More →

Sridevi Nagarajan

Head, Digital Regulatory Strategy, AstraZeneca , United Kingdom

Bringing over two decades of experience, Sridevi Nagarajan is a seasoned strategic portfolio management professional is deeply rooted in data-driven approaches. The expertise lies in successfully steering digital transformations within the Pharmaceutical and Public Health sectors... Read More →

Heiner Oberkampf

CEO, ACCURIDS, Germany

Heiner Oberkampf is the CEO and Co-founder of ACCURIDS, which is a software for collaborative data standards implementation, that helps pharma companies, e.g., in the implementation of IDMP standards through a federated product data graph. With a group of pharma companies, he has... Read More →

Norman Schmuff

Associate Director for Science, OPMA, OPQ, FDA, United States

Norman R. Schmuff joined the FDA in 1990. For more than 20 years, he has participated in ICH as a member of several Expert Working Groups. He was the Rapporteur for the M4 CTD (eCTD) – Quality Implementation Working Group. He is involved in many FDA electronic submission initiatives... Read More →

Cesar Vinces

EU Interim and International Policy Lead, Accumulus Synergy, United States

Cesar serves as Interim EU & International Policy Lead at Accumulus Synergy within Regulatory Innovation. He engages with industry experts, national regulators, and global organizations to foster policy changes and develop strategies that enhance regulatory frameworks, promoting industry... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Workshop

Format Workshop
Level Intermediate
Featured Topics Regulatory Collaboration
Level Intermediate
Feature Topics Regulatory Collaboration
Credit Type ACPE, CME, RN
Tags Workshop

8:00am PDT

#206: Early Engagement to Enhance the Incorporation of Patient Experience Data in Drug Development Programs and Regulatory Decision-Making

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-561-L04-P; CME 1.00; RN 1.00

Integrating patient-experience data (PED) in medicines regulation for better patient-centered outcomes is a priority for medicines regulators, including the FDA and the EU network. The FDA’s program on patient-focused drug development (PFDD) has yielded 4 scientific guidelines on PED, while in the EU work is ongoing to produce a reflection paper outlining pathways for progress, marking an initial step toward smoother PED integration in medicine development. The session will present the US and EU's position in this regard and draw on the experience in applying existing guidance to date.

Learning Objectives

Describe the work done by FDA’s Patient-Focused Drug Development (PFDD) program on scientific guidelines on patient-experience data (PED), challenges and future outlook; Describe how work is progressing in the EU to foster the generation and use of patient-experience data in medicines regulatory decision-making.

Chair

Steffen Thirstrup, MD, PhD

Speaker

US Patient Representative
Karin Hoelzer, DVM, PhD

Co-Chair
Robyn Bent, MS, RN

EMA Update
Juan Garcia-Burgos, MD, PhD

EMA Update
Rosa Gonzalez-Quevedo

US Industry Representative
Maria Apostolaros, JD, PharmD, MS, RPh

Speakers

Maria Apostolaros

Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States

Dr. Maria Apostolaros is currently a Senior Director of Science and Regulatory Advocacy at PhRMA, the US industry association representing the country’s leading innovative biopharmaceutical research companies devoted to discovering and developing medicines that enable patients to... Read More →

Robyn Bent

Director, Patient Focused Drug Development, OCD, CDER, FDA, United States

Robyn Bent is the director of CDER’s Patient-Focused Drug Development (PFDD) Program, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making. Prior to joining FDA, Robyn held... Read More →

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France

Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French Medicines... Read More →

Juan Garcia-Burgos

Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands

Juan García Burgos is a Qualified Medical Doctor from Autonoma University in Madrid, specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation... Read More →

Rosa Gonzalez-Quevedo

Scientific Research Officer, European Medicines Agency, Netherlands

Karin Hoelzer

Senior Director, Policy and Regulatory Affairs, NORD, United States

Dr. Karin Hoelzer directs Policy and Regulatory Affairs for the National Organization for Rare Disorders (NORD®). She works closely with pharmaceutical and biotech partners to ensure public policy supports innovative approaches and new treatments, and adequately incorporates patient... Read More →

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Session

Format Session
Level Intermediate
Featured Topics Patient Focused, Regulator Perspectives
Level Intermediate
Feature Topics Patient Focused,Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

8:00am PDT

#208: Good Data Governance Practices: Regulatory and Industry Perspectives

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-563-L04-P; CME 1.00; RN 1.00

In this session, the speakers will emphasize the importance of involving data scientists in the identification of a critical to quality factor’s and will discuss implementation of risk proportionate processes and procedures related to these data governance procedures to address the risks to the critical to quality factors. The speakers will their perspectives related to good data governance practices and provide updates to policy related to data governance (e.g., ICH E6R3, ICH E8R1, 21 CFR part 11) and inspection case examples of clinical trials to illustrate the impact of poor data governance procedures.

Learning Objectives

Discuss the importance of good data governance practices; Identify a study’s critical to quality factors related to data governance processes and procedures; Discuss the importance of involving the data scientist in the identification of a study’s critical to quality factors; Describe inspection case examples to illustrate regulatory expectations for data governance and the use of technology in clinical trials.

Chair

Kassa Ayalew, MD, MPH

Speaker

Update from the Danish Medicines Agency
Lisbeth Bregnhoj, PhD, MPharm

Update from Industry
Prasanna Rao

Update from the FDA
Cheryl Grandinetti, PharmD

Speakers

Kassa Ayalew

Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States

Kassa Ayalew, M.D., M.P.H. is a Director of the Division Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. He is a practicing pediatric infectious disease specialist with several years of clinical and... Read More →

Lisbeth Bregnhoj

Medicines Inspector, GCP, Danish Medicines Agency (DKMA), Denmark

Lisbeth is a GCP inspector at the Danish Health and Medicines Agency. She also has experience as a clinical trial assessor, experience from a research and hospital perspective (Clinical pharmacology at a University Hospital) and from the medicinal industry as a GCP auditor. Lisbeth... Read More →

Cheryl Grandinetti

Clinical Pharmacologist, OSI, OC, CDER, FDA, United States

Dr. Grandinetti is a reviewer in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and... Read More →

Prasanna Rao

Sr. Director, Global Head, AI/ML, Clinical Data Sciences, Pfizer Inc, United States

Prasanna Rao is a distinguished AI practitioner and industry thought leader, currently serving as the Senior Director, Global Head of AI/ML, Clinical Data Sciences, Pfizer R&D. With over 30 years of experience in information technology and analytics, including more than a decade in... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

08: RD Quality-Compliance, Session

Format Session
Level Intermediate
Level Intermediate
Credit Type ACPE, CME, RN
Tags Session

8:00am PDT

#209: Leveraging New Meeting Opportunities in PDUFA VII: Experiences with Type D and INTERACT

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-564-L04-P; CME 1.00; RN 1.00

This forum will address experience to date with new meeting types included in PDUFA VII, including Type D and INTERACT. Forum participants will evaluate successes, opportunities for improvement, and discuss how learnings can be shared.

Learning Objectives

Evaluate experiences to date with Type D and INTERACT meetings included in PDUFA VII; Identify opportunities to improve implementation of new meeting types to promote innovation and optimize FDA-Sponsor Interactions.

Chair

Victoria A. Dohnal, RAC

Speaker

Industry Update
Victoria A. Dohnal, RAC

FDA Update
Christy L. Cottrell

FDA Update
Adriane Fisher, MBA, MPH

Industry Update
Alex May, MS

Speakers

Christy Cottrell

Chief, Project Management Staff, ORO, DRO-OD, CDER, FDA, United States

Christy Cottrell is a Chief Project Manager in the FDA's Office of New Drugs, Division of Regulatory Operations for Oncologic Diseases. She co-leads a team of Regulatory Project Managers who support the Division of Oncology 1 which handles the review of drugs and biologics for reproductive... Read More →

Victoria Dohnal

Director, Global Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States

Victoria Dohnal is currently Director, Global Regulatory Policy and Intelligence at Johnson and Johnson (J&J) where she is responsible for driving US regulatory intelligence and policy work related to rare diseases, patient focused drug development, cell and gene therapies, and PDUFA... Read More →

Adriane Fisher

Regulatory Project Manager, OTP, CBER, FDA, United States

Adriane Fisher joined the FDA as a Regulatory Project Manager in September 2018, where she has provided review management throughout the product life cycle, from pre-submission meetings to post-marketing submissions. As an RPM, Adriane also acts as the liaison between FDA and industry... Read More →

Alex May

North America Lead - Regulatory Science, Policy, & Intelligence, District of Columbia, United States

Alex May leads regulatory policy, science, & intelligence for North America and global regulatory policy efforts on plasma at CSL Behring. He serves as co-chair on BIO's Meetings Task Force and NORD's Regulatory Affairs Working Group. Previously, Alex was a Director of Science & Regulatory... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Format Forum
Level Intermediate
Level Intermediate
Credit Type ACPE, CME, RN
Tags Forum

8:00am PDT

#210: Digital Biomarkers as Clinical Endpoints: The Road to Regulatory Acceptability

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-565-L04-P; CME 1.00; RN 1.00

This forum will review the current regulatory paradigms for the use of digital biomarkers as endpoints in clinical trials in the US and EU. A panel of experts will discuss validation pathways and compare regulatory approaches between regions.

Learning Objectives

Describe the V3 process (verification, analytical validation, clinical validation) for validating digital health technologies as fit-for-purpose in a clinical trial; Identify validation pathways in the US and EU; Discuss outstanding challenges to the use of digital health technologies for remote data capture in clinical trials.

Chair

Lina AlJuburi, PharmD, MSc

Speaker

Enhancing Clinical Research in Europe: Navigating the Regulatory Landscape
Max Wegner, PharmD, RPh

Panelist
Anindita Saha

Industry Perspective
Steve Berman, MPH

Industry Update
Gul Erdemli, MD, PhD

Speakers

Lina AlJuburi

Head, Global Regulatory Science and Policy - North America, Sanofi, United States

A background in pharmacy and an interest in drug development and regulation led me to the US FDA where I spent several years within CDER, Office of New Drugs. By far the hardest decision, in 2012, I transitioned to the private sector in the field of Regulatory Science and Policy... Read More →

Steve Berman

Deputy Vice President, Science and Regulatory Affairs, BIO, United States

Steve Berman serves as Deputy VP of Science and Regulatory Strategy for the Biotechnology Innovation Organization (BIO). Steve joined BIO after serving as a Director, Translational Regulatory Affairs, at AstraZeneca. Steve joined AZ after eight years at FDA, working in both CDER and... Read More →

Gul Erdemli

Global Program Regulatory Director, Novartis Pharmaceuticals Corporation, United States

Gül Erdemli is a Global Program Regulatory Director at Novartis Regulatory Affairs Early Development. She is a drug development leader with more than 15 years industry experience from target identification to clinical development. She has an MD degree from Hacettepe University, Medical... Read More →

Anindita Saha

Associate Director Strategic Initiatives, Digital Health Center of Excellence, FDA, United States

Anindita (Annie) Saha is the Associate Director for Strategic Initiatives for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA). She is leading strategic initiatives in moving care into the home, Artificial Intelligence, and international collaborations... Read More →

Max Wegner

Head Regulatory Affairs, Bayer AG, Germany

After studying pharmacy at the University of Bonn, Max Wegner commenced his PhD in pharmacology at Bayer and started in Regulatory Affairs as a Dossier Manager in 1996 in Wuppertal. Since then, Max has been employed in various functions within Product Development at Bayer and also... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Format Forum
Level Intermediate
Featured Topics Digital Technology
Level Intermediate
Feature Topics Digital Technology
Credit Type ACPE, CME, RN
Tags Forum

8:00am PDT

#211: PMDA Town Hall

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-566-L04-P; CME 1.00; RN 1.00

PMDA strives and implements various supports to promote regulatory sciences and accelerate product developments based on “4Fs” concept of priorities. In this session, PMDA will share the latest information on its policies and initiatives.

Learning Objectives

Recognize latest information on the Pharmaceuticals and Medical Devices Agency’s activity and Japanese regulations in medical products area; Describe how to develop medical products in Japan; Discuss issues on medical products regulation with senior PMDA officials.

Chair

Daisuke Tanaka, PhD

Speaker

PMDA Update
Daisuke Koga, MSc, RPh

Industry Update
Atsushi Tsukamoto, PhD, MSc

Panelist
Yoshiaki Uyama, PhD, RPh

Speakers

Daisuke Tanaka

Office Director, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Tanaka joined the Ministry of Health, Labour and Welfare (MHLW) in April 2001 and was involved in orphan drug designation and new drug approval as well as amendment of the Pharmaceutical Affairs Law. Subsequently, he worked in several organisations including European Medicines... Read More →

Daisuke Koga

Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW), Japan

Mr. Daisuke Koga is Director, Office of International Regulatory Affairs, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare (MHLW) of Japan. He started his career in 1996 at the Ministry of Health and Welfare of Japan. He worked in the areas of drugs, medical devices... Read More →

Atsushi Tsukamoto

Head is Therapeutic Area Strategies, Daiichi Sankyo, United States

Atsushi is VP of New Drug Regulatory Affairs (RA) at Daiichi Sankyo. He is also Head of Specialty Medicine RA in R&D division, to lead gobal specialty medicine regulatory strategies. As Head of Japan New Drug RA, he is responsible for leading new drug RA activities for all projects... Read More →

Yoshiaki Uyama

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science researches in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH... Read More →

Cynthia Verst

President, R&D Solutions D&DI; 2023 President, IQVIA, United States

Dr. Verst is president, Design and Delivery Innovation, Research & Development Solutions at IQVIA. She is responsible for driving innovation and transformation throughout the trial lifecycle. Having previously served as president of both clinical operations and real world and late... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Format Session
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

8:00am PDT

#212: Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-567-L04-P; CME 1.00; RN 1.00

The session will provide an update on ICMRA's Pharmaceutical Quality Knowledge Management project, including an overview of learnings from the pilots on collaborative assessment of post-approval changes and hybrid inspections by multiple authorities.

Learning Objectives

Describe the various workstreams of the ICMRA PQKM project, and their potential to support increased regulatory convergence and reliance with regards to product quality assessments and inspections; Summarise learnings arising from the ICMRA pilots on collaborative assessment of post-approval changes and hybrid inspections; Discuss potential for expansion and operationalization of the pilots.

Chair

Theresa Mullin, PhD

Speaker

Collaborative Assessment Pilot: Regulators’ Perspective
Sau L Lee, PhD

Collaborative Assessment Pilot: Regulators’ Perspective
Sean Barry, PhD

Collaborative Hybrid Inspection Pilot (CHIP): Regulator's Perspective
Stelios Tsinontides, PhD, MA

Collaborative Hybrid Inspection Pilot (CHIP): Regulator's Perspective
Brendan Cuddy, MSc

Pilot Programs: Industry's Perspective
Susanne Ausborn, PhD

Pilot Programs: Industry's Perspectives
Srivdya Srikant, MS

Panel Discussion: Pilot Programs
Evdokia Korakianiti, PhD, MSc

Panel Discussion: Pilot Programs
Yasuhiro Kishioka, PhD

Speakers

Susanne Ausborn

Global Head International Regulatory Policy, Roche, Switzerland

Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global... Read More →

Sean Barry

Senior Pharmaceutical Assessor, Health Products Regulatory Authority (HPRA), Ireland

Sean is a Senior Biologicals Assessor at the Irish health authority, HPRA, where he reviews CMC data for new product applications, scientific advices, clinical trials, and variations for mAbs, recombinant proteins, vaccines, and cell & gene therapies. Sean is chair of the Biologicals... Read More →

Brendan Cuddy

Lead Scientific Officer, European Medicines Agency, Netherlands

Brendan Cuddy joined the European Medicines Agency in October 2002. He was Head of the Manufacturing and Quality Compliance Service at the Agency from 2014 – 2020. Brendan is currently the Chairman of the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP... Read More →

Yasuhiro Kishioka

Reviewer Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Kishioka is a Review Director of the Office of Cellular and Tissue-based Products, PMDA. In this role, he is responsible for the assessment of gene therapy products and the quality of biotechnological/biological products. Since joining PMDA in 2008, Dr. Kishioka has been involved... Read More →

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands

Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →

Sau Lee

Deputy Super Office Director, OPQ, CDER, FDA, United States

Dr. Lee is currently Deputy Super Office Director for Operations who oversees research, quality surveillance, policy, quality assurance, and administrative operation functions in CDER’s Office of Pharmaceutical Quality. Dr. Lee has been with the FDA since 2005, serving as a regulatory... Read More →

Theresa Mullin

Associate Center Director - Strategic Initiatives, CDER, FDA, United States

Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →

Srivdya Srikant

Director, Global Regulatory Affairs- CMC, Gilead Sciences, United States

Srividya (Vidya) Srikant is a Director in Regulatory CMC (RA CMC) at Gilead Sciences Inc. Prior to joining Gilead Sciences, Vidya spent over 20 years with other pharmaceutical companies including Genzyme, Takeda, and GSK. She has extensive experience in CMC developing, managing, and... Read More →

Stelios Tsinontides

Office Director, OPMA, OPQ, CDER, FDA, United States

Dr. Stelios Tsinontides is the Office Director of the Office of Pharmaceutical Manufacturing Assessment (OPMA). OPMA evaluates facilities, process design, and control strategies to assess capabilities of manufacturers to produce quality pharmaceutical and biotechnology products at... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10: RegCMC-Product Quality, Session

Format Session
Level Advanced
Featured Topics Regulatory Reliance
Level Advanced
Feature Topics Regulatory Reliance
Credit Type ACPE, CME, RN
Tags Session

8:00am PDT

#213: Beyond Traditional Trials: Real-World Data for External Controls, with Focus on Cancer Drug Applications

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-568-L04-P; CME 1.00; RN 1.00

Advanced cancers pose a dilemma between evidentiary requirements and speedy access to innovative agents. We present the results of a survey with regulators and discuss factors that influence acceptability of real-world data and possible optimal submission strategies.

Learning Objectives

Describe the challenges of drug development with evidence using external controls; Discuss regulators’ attitudes about real-world evidence and opportunities for addressing the challenges; Identify strategies using real-world evidence to maximize impact on the regulatory decision.

Chair

Francesco Pignatti, MD

Speaker

Real-World Data to Support Benefit-Risk Assessment: Regulatory Perspective
Douwe Postmus, PhD, MSc

External Comparators Using Real-World Data: Results of a Simulation Study
Gerd Rippin, DrSc

The Role and Impact of Real-World Data in Cancer Drug Applications
Catherine C. Lerro, PhD, MPH

Speakers

Catherine Lerro

Senior Pharmacoepidemiologist, Oncology Center of Excellence, FDA, United States

Dr. Lerro is a senior pharmacoepidemiologist in the Oncology Center of Excellence at the US FDA. Prior to joining the FDA, she trained at the National Cancer Institute in the Division of Cancer Epidemiology and Genetics. She holds a doctorate degree and masters in public health from... Read More →

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands

Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →

Douwe Postmus

Assistant Professor & Seconded National Expert, University Medical Center Groningen & EMA, Netherlands

Dr Douwe Postmus is employed as an assistant professor at the Department of Epidemiology of the University Medical Center Groningen, The Netherlands. His research focuses on applying quantitative modeling techniques to decision making problems in health care, including regulatory... Read More →

Gerd Rippin

Senior Director, Biostatistics, Real-World Solutions, IQVIA, Germany

Dr. Gerd Rippin is a trained statistician, receiving his statistics degree in 1995 from the University of Dortmund, Germany (equivalent to BSc and MSc), and his Dr. of Sciences (equivalent to PhD) in 1999 from the University of Mainz, Germany. Dr. Rippin has worked as a medical statistician... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics-Data Science, Session

Format Session
Level Advanced
Featured Topics Regulator Perspectives, Real-World Data (RWD)- Real-World Evidence (RWE)
Level Advanced
Feature Topics Regulator Perspectives,Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags Session

8:00am PDT

#214: Unlocking Artificial Intelligence's Latest Development: Chat GPT for Beginners

Component Type: Workshop
Level: Basic

Join our beginner-friendly Chat GPT workshop! Designed to provide both an overview and hands-on experience, this session will delve into the fundamentals of ChatGPT technology. From understanding its underlying principles to practical applications, participants will gain insight into AI-driven conversations. Through interactive demonstrations and guided exercises, attendees will get firsthand experience in leveraging ChatGPT's capabilities. Whether you're new to AI or seeking practical insights, this session promises to equip you with valuable knowledge and skills

Learning Objectives

Describe the basics of artificial intelligence, large language models, and ChatGPT; Identify with using hands-on experience by interacting with ChatGPT through guided exercises; Discuss best practices for interacting with the technology as well get an overview of ethical considerations and potential limitations of ChatGPT technology; Assess the impact its already creating in pharma R&D, and what are the use cases that you can get started with.

Chair

Ankush Chandna, MSc

Speaker

Facilitator
Anjali Shah, PharmD

Facilitator
Ankush Chandna, MSc

Speakers

Ankush Chandna

Data Science Lead, Research and Development Excellence, ZS Associates , United States

Anjali Shah

Executive Director, Business Capabilities and Innovation, WWPS, Bristol-Myers Squibb Company, United States

Anjali Shah, PharmD has 15+ years experience in the biopharmaceutical industry in a variety of therapeutic, operational and leadership roles across Medical Affairs and Patient Safety. Inspired by the opportunity to enable safe and informed use of medicines, Anjali is currently involved... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

13: ProfDevelopment, Workshop

Format Workshop
Level Basic
Featured Topics Artificial Intelligence (AI), Student Programming
Level Basic
Feature Topics Artificial Intelligence (AI),Student Programming
Tags Workshop

9:00am PDT

Coffee Break

Component Type: Social Event
Meet with your colleagues to plan your day and/or discuss what you learned the previous day, all while networking with other attendees.

Tuesday June 18, 2024 9:00am - 10:00am PDT
Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Networking Opportunities, Social Event

Tags Social Event

9:00am PDT

DIA Global Annual Meeting Blood Drive

Component Type: Social Event

The drives will be held in Exhibit Hall B 1 on the following dates and times:
Monday, June 17 | 10:00am to 4:00pm; click here to schedule
Tuesday, June 18 | 9:00am to 3:00pm; click here to schedule
Wednesday, June 19 | 9:00am to 3:00pm; click here to schedule

Download Now

Tuesday June 18, 2024 9:00am - 3:00pm PDT
Exhibit Hall B 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Networking Opportunities, Social Event

Tags Social Event

9:15am PDT

#215 IT: Clario Innovation Theater: Responsibly Advancing the Use of Artificial Intelligence (AI) in Clinical Trials - Current Landscape, Common Misconceptions, and Future Opportunities

Component Type: Session

AI can help optimize operations, strengthen patient privacy, and improve data quality while reducing risks of human error in clinical trials. However, AI must be used responsibly and governed by the highest ethical principles with regard for data privacy and reducing bias in algorithm performance. Delve into the transformative role of AI in clinical trials: current industry status, common misconceptions, proactively tackling bias and navigating the evolving regulatory landscape.

Chair

Clario

Speaker

Speaker
Todd Rudo, MD

Speaker
Gaurav Josan

Speaker
Lauren Misztal

Speaker
Brian Dolan

Speakers

Clario

United States

Gaurav Josan

Senior Vice President, R&D, Clario, United States

Gaurav Josan leads the R&D team at Clario as Sr. Vice President focused on innovation and next generation technology solutions including AI capabilities. She has more than 2 decades of experience working in the Clinical Trials space leading strategic technology initiatives. She is... Read More →

Lauren Misztal

SVP, General Counsel, Clario, United States

Lauren is a business-oriented and solutions-driven legal advisor who draws on close to two decades of experience successfully resolving complex legal and regulatory issues. As Clario’s General Counsel, Lauren focuses on setting the Company’s global legal strategy and leads teams... Read More →

Todd Rudo

EVP & Chief Medical Officer, Clario, United States

Dr. Rudo provides medical and scientific leadership at Clario. He is passionate about leveraging scientific resources to support customer success with focused efforts on developing expertise across a range of therapeutic areas. His team provides expert consulting on scientific and... Read More →

Brian Dolan

Vice President Artificial Intelligence and Machine Learning, Fortrea, United States

Brian is a mathematician, inventor and cyberneticist with decades of experience building enterprise grade artificial intelligence products. Equally comfortable in product, sales and technology roles, he excels at translating complex business problems into tractable mathematical solutions... Read More →

Tuesday June 18, 2024 9:15am - 9:45am PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

9:15am PDT

#216 IT: Zelta by Merative Innovation Theater: Revolutionizing Research - The Impact of Machine Learning and Automation in eClinical Platforms

Component Type: Session

Getting the most out of AI in clinical data management means deploying it strategically with the goal of maximum, measurable outcomes. This presentation will delve into what these solutions look like when effectively scaled and applied; why traditional machine learning is more suited to driving ROI in your operations than generative AI; and how Zelta’s integrated ML models, analytics, and automation tools are helping to drive new efficiencies in clinical trials.

Chair

Merative

Speaker

Speaker
Walker Bradham

Speakers

Walker Bradham

Sr Director, Product Management & Design, Merative, United States

Walker Bradham is the Product Management Lead for Zelta, Merative’s clinical trials solutions business. He brings 20 years of experience defining, designing, and deploying web applications to the marketplace, and leads the product roadmap for all EDC/CDMS and eCOA offerings. A champion... Read More →

Merative

United States

Tuesday June 18, 2024 9:15am - 9:45am PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

9:15am PDT

#217 IT: Lokavant Innovation Theater: Prescriptive Study Planning: Optimizing Clinical Trials for Time Efficiency, Cost Savings, and Quality

Component Type: Session

Explore the power of prescriptive analytics in clinical trial planning and feasibility. Learn how Lokavant's innovative approach can prescribe the next best course of action to help refine and optimize study parameters that predict timelines, control costs, and improve quality.

Chair

Lokavant

Speaker

Speaker
Rohit Nambisan

Speakers

Lokavant

United States

Rohit Nambisan

CEO & Co-Founder, Lokavant, United States

Trained as a neuroscientist, Rohit Nambisan is a product executive with experience leading product development organizations in pharma, medical devices, personalized medicine, health IT, healthcare data and analytics, and AI. Prior to co-founding and leading Lokavant, Rohit was most... Read More →

Tuesday June 18, 2024 9:15am - 9:45am PDT
Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

10:00am PDT

#218: Long-Term Safety of Approved Medicines: Approaches for Identifying, Characterizing, and Quantifying Delayed Adverse Events

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-569-L04-P; CME 1.00; RN 1.00

This forum will hear from regulators, industry, vendors, and the academic community on how each has approached the generation of long-term safety data on a hypothetical approved medicine with a risk of delayed adverse events.

Learning Objectives

Compare strengths and weaknesses of different approaches for evaluating long-term safety particularly when delayed adverse events are a potential risk; Identify fit-for-purpose, longitudinal data sources to answer regulator research objectives for long-term follow-up studies.

Chair

Steven M. Weisman, PhD

Speaker

Panelist
Claudia A Salinas, PhD

Panelist
Naomi Boxall, PhD

Panelist
Vera Ehrenstein, DrSc, MPH

Panelist
Gerald Dal Pan, MD, MHS

Speakers

Steven Weisman

Global President, Clinical and Regulatory, Lumanity Inc, United States

Over the years, Dr. Weisman has built a stellar reputation as a regulatory and medical affairs consultant helping clients achieve productive relationships with regulatory authorities in the United States and around the world. Dr. Weisman has played a pivotal role working on important... Read More →

Naomi Boxall

General Manager, PHARMO Institute, Netherlands

Naomi is General Manager at PHARMO and INSZO and is accountable for a portfolio of RWE projects using health data from various sources to support drug development and commercialization for global life science sector. With over 20yrs experience from a breadth of epidemiology topics... Read More →

Vera Ehrenstein

Professor, Department of Clinical Medicine, Dept of Clinical Epidemiology, Aarhus University, Denmark

Vera Ehrenstein is professor of pharmacovigilance at the Department of Clinical Epidemiology, Aarhus University, Denmark. She has more than 20 years' experience as an epidemiologist, including more than 15 years' experience leading multinational postauthorisation safety studies of... Read More →

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States

Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →

Claudia Salinas

Senior Director, GPS Pharmacoepidemiology, Eli Lilly and Company, United States

Dr. Salinas is a pharmacoepidemiologist, with a doctorate in Epidemiology from the University of Washington, currently working in late stage and postmarketing clinical development at Eli Lilly and Company. She has expertise in real-world data analysis and causal inference focusing... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

10:00am PDT

#219: How to Compare FDA Medical Queries and Standardized MedDRA Queries with Interactive Graphics

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-570-L04-P; CME 1.00; RN 1.00

This workshop will discuss how to combine FDA medical queries (FMQs) and standardized MedDRA queries with study data, as well as how to compare them through interactive figures and tables. It will also discuss how to interpret the algorithmic FMQs.

Learning Objectives

Describe how to apply the FDA Medical Queries (FMQs) Excel file and the Standardized Medical Queries (SMQs)ASCII files to a given study trial by combining it with study data; Create interactive figures and tables to analyze the medical queries for a study and compare them for FMQs and SMQs.

Chair

Rebecca Lyzinski, MS

Speaker

How to Compare FDA Medical Queries and Standardized MedDRA Queries with Interactive Graphics
Rebecca Lyzinski, MS

How to Compare FDA Medical Queries and Standardized MedDRA Queries with Interactive Graphics
Scott Proestel, DrMed, MD

Speakers

Rebecca Lyzinski

Senior Software Developer, JMP Statistical Discovery, United States

Rebecca Lyzinski is a Clinical Research Developer in the JMP Life Sciences group where she develops new reports and analyses for JMP Clinical software. Before joining JMP, Rebecca worked in statistical programming for the pharmaceutical industry. She was a Manager of statistical programming... Read More →

Scott Proestel

Senior Medical Officer, ODES, OND, CDER, FDA, FDA, United States

Scott Proestel, MD, is a Senior Medical Officer on the Biomedical Informatics and Regulatory Review Science Team at the US FDA’s Center for Drug Evaluation and Research. He completed his internal medicine training at Johns Hopkins Hospital and obtained his medical degree from Columbia... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Workshop

Format Workshop
Level Intermediate
Level Intermediate
Credit Type ACPE, CME, RN
Tags Workshop

10:00am PDT

#220: Targeting Shared Molecular Etiologies to Accelerate Drug Development for Rare Diseases

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-571-L04-P; CME 1.00; RN 1.00

Many rare diseases share the same underlying molecular etiology that are therapeutically targetable. Basket trial design based on molecular etiology enables more patients to gain access to clinical trials and accelerate identification of new therpies

Learning Objectives

Recognize the potential of basket trial design in rare disease; Apply basket trial design in rare diseases with share molecular etiologies.

Chair

David Andrew Pearce, PhD

Speaker

Shared Platforms Approaches/Technologies for Rare Diseases
Philip (P.J.) Brooks, PhD

Targeting Shared Molecular Etiologies to Accelerate Drug Development for Rare Diseases
Christina Waters, PhD, MBA

Speakers

David Pearce

President of Innovation and Research/Chair International Rare Disease Research, Sanford Health, United States

David Pearce is President of Innovation & Research for Sanford Health. He completed his undergraduate Bachelor of Science Degree with honors in biological sciences at Wolverhampton Polytechnic in 1986. He gained his PhD in 1990 at the University of Bath, UK Dr. Pearce has been researching... Read More →

Philip (P.J.) Brooks

Deputy Director, Division of Rare Diseases Research Innovation, National Center for Advancing Translational Sciences (NCATS), NIH, United States

Philip J. (P.J.) Brooks is the deputy director of NCATS’ Division of Rare Diseases Research Innovation. Brooks represents NCATS in the NIH-wide Gene Therapy Working Group, the Regenerative Medicine Innovation Project and the International Rare Diseases Research Consortium (IRDiRC... Read More →

Christina Waters

Chief Executive Officer and Founder, RARE Science, Inc., United States

Dr. Christina Waters has been responsible for leading medical research in a broad range of organizations ranging from academia and disease – focused non-profits to biotech and large pharmaceutical companies. Her broad range of experience in basic, translational and clinical research... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Forum

Format Forum
Level Basic
Featured Topics Rare Disease
Level Basic
Feature Topics Rare Disease
Credit Type ACPE, CME, RN
Tags Forum

10:00am PDT

#222: External Control Arms at Scale: Multicenter, Multisource Infrastructure for External Control Arms

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-573-L04-P; CME 1.00; RN 1.00

The speakers will discuss how to enable external control arms (ECAs) at scale. The session will shed light on how to overcome the scalability and quality challenges of real-world data preparation to scale up ECAs from ad hoc projects to enterprise-level machinery for pharmaceutical clinical development function. It will also include ongoing work to create enterprise infrastructure for high-quality evidence generation using ECAs, including selected results from multicenter ECAs in several therapeutic areas.

Learning Objectives

Explore strategies to address the inherent challenges of real-world data (RWD) preparation at scale for external control arms (ECAs), including data scalability and quality; Describe how to transition from ad hoc ECA projects to an enterprise-level approach that ensures data quality, processing efficiency, and trustworthiness in analytical results for pharma clinical development.

Chair

Mayur Saxena, PhD

Speaker

Industry Update
Jussi Leinonen

Industry Update
Victoria Chia, PhD, MPH

Industry Update
Hongwei Wang

Industry Update
Jingyu (Julia) Luan, PhD

Speakers

Mayur Saxena

Chief Executive Officer, Droice Labs, United States

As an entrepreneur and scientist, Mayur has concentrated on advancing medicine with high-noise, big data analysis. Before founding Droice, he played key roles in several startups, including co-founding a biotechnology firm in the diabetes space. He earned his BTech at IIT Kanpur and... Read More →

Victoria Chia

Executive Director, Center for Observational Research, Amgen Inc, United States

Victoria Chia has 15+ years of experience at Amgen Inc as a pharmacoepidemiologist. She currently leads the oncology therapeutic area in the Center for Observational Research. She has worked on oncology and neurology products, supporting multiple products through the product lifecycle... Read More →

Jussi Leinonen

Strategic Project Lead, Bayer , Finland

Jingyu (Julia) Luan

Executive Regulatory Science Director, BioPharmaceuticals R&D, AstraZeneca, United States

Dr. Jingyu (Julia) Luan is a Senior Director of Global Regulatory Affairs in AstraZeneca, leading global drug development and regulatory strategies as well as innovative regulatory initiatives, eg, RWE. Prior to AstraZeneca, she worked at FDA for 13 years and held positions with increasing... Read More →

Hongwei Wang

Director/ Senior Research Fellow, AbbVie, United States

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Forum

Format Session
Level Intermediate
Featured Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Level Intermediate
Feature Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags Forum

10:00am PDT

#223: Challenges in Exceeding the Quality of Existing Endpoints and Approaches Using Digital Tools

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-574-L04-P; CME 1.00; RN 1.00

This forum will discuss how novel technologies provide the means to measure new endpoints and can assess existing endpoints in new ways. Regulatory models are needed to encourage the acceptance of these novel approaches.

Learning Objectives

Identify a clear understanding of regulatory frameworks surrounding digital endpoints; Describe the challenges that may arise when a new tool can measure endpoints more effectively than existing tools; Discuss how to build regulator confidence in novel endpoints and tools.

Chair

Rob Berlin, JD, MPH

Speaker

FDA Perspective
Jeffrey Nahum Siegel, DrMed, MD

Industry Perspective
Julie Tai, PhD

Industry Perspective
Lauren Oliva, PharmD, RPh

Industry Perspective
Rasika Kalamegham, PhD

Speakers

Rob Berlin

Head, US Regulatory Policy, GlaxoSmithKline, United States

Rob Berlin is Head of U.S. Regulatory Policy at GlaxoSmithKline (GSK). Rob leads a team focused on driving U.S. regulatory policy, advocacy, and intelligence activities, to ensure optimal advancement and lifecycle management of GSK’s product portfolio. Rob came to GSK from the FDA... Read More →

Rasika Kalamegham

Head, US Regulatory Policy, Genentech, A Member of the Roche Group, United States

Rasika Kalamegham, Ph.D, is Head of U.S. Regulatory Policy at Genentech. She oversees all FDA related policy work related to the pipeline and serves as the principal representative to Congressional and advocacy relations for regulatory policy. She plays an active role in many trade... Read More →

Lauren Oliva

US Lead, Global Regulatory Policy, Biogen, United States

Lauren Oliva is US lead for Global Regulatory Policy at Biogen. She oversees the development and execution of R&D’s policy roadmap to advance Biogen’s neuroscience and rare disease portfolio. She is passionate about patient centric drug development and the impact of multi-stakeholder... Read More →

Jeffrey Siegel

Director, Office of Drug Evaluation Sciences, OND, CDER, FDA, United States

Jeffrey Siegel is the Director of the Office of Drug Evaluation Sciences (ODES) in the Office of New Drugs (OND), CDER, FDA. ODES oversees Clinical Outcome Assessments, Biomarker Qualification, Research and Bioinformatics in OND. Dr Siegel has over 20 years of experience in research... Read More →

Julie Tai

Director, GRA, Precision Medicine and Digital Health, GlaxoSmithKline, United States

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Forum

Format Forum
Level Intermediate
Featured Topics Digital Technology
Level Intermediate
Feature Topics Digital Technology
Credit Type ACPE, CME, RN
Tags Forum

10:00am PDT

#224: Data Standards SOS: Reducing Burnout and Navigating through Fatigue - Part 2

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-575-L04-P; CME 1.00; RN 1.00

At the DIA 2023 a round table on data standards and harmonization discussed “standards fatigue” related to data standards, reference models, consortia, industry groups, and their impact on the industry. We intend to address this topic in a two-part workshop.

Learning Objectives

Identify various data standards and harmonization efforts across pharma and biotech industries; Discuss challenges and business impact related to the understanding, implementation, and maintenance of data standards initiatives in light of digital transformation efforts; Describe approaches to identify overlapping/competing initiatives and develop synergistic approaches to reduce fatigue.

Chair

Venkatraman Balasubramanian, PhD, MBA

Speaker

Facilitator
Sridevi Nagarajan, PhD

Facilitator
Heiner Oberkampf, PhD

Facilitator
Vanni Carapetian, MPH

Facilitator
Hilmar Hamann, PhD

Facilitator
Norman Schmuff, PhD

Facilitator
Cesar Vinces

Speakers

Venkatraman Balasubramanian

SVP and Global Head, Industry Solutions - Healthcare and Life Sciences, Orion Innovation, United States

Vanni Carapetian

Director, Regulatory Data, Genentech, A Member of the Roche Group, United States

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands

Sridevi Nagarajan

Head, Digital Regulatory Strategy, AstraZeneca , United Kingdom

Heiner Oberkampf

CEO, ACCURIDS, Germany

Norman Schmuff

Associate Director for Science, OPMA, OPQ, FDA, United States

Cesar Vinces

EU Interim and International Policy Lead, Accumulus Synergy, United States

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Workshop

Format Workshop
Level Intermediate
Featured Topics Regulatory Collaboration
Level Intermediate
Feature Topics Regulatory Collaboration
Credit Type ACPE, CME, RN
Tags Workshop

10:00am PDT

#225: Regulatory Guidance and Papers on Technology Innovations

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-576-L04-P; CME 1.00; RN 1.00

This session will describe and identify emerging technology innovations and health authority papers, guidance, and discussion on their use in regulatory filings and development. The session will discuss emerging artificial intelligence (AI) trends, structured content authoring, and structured data including their development, use, risks, and potential future in pharmaceutical development. Attendees will hear from industry experts on the topics and their potential implementation and impacts to the field.

Learning Objectives

Describe and identify emerging technology innovations and health authority papers, guidance, and discussion on their use in regulatory filings and development; Discuss emerging artificial intelligence (AI) trends, structured content authoring, and structured data including their development, use, risks, and potential future in pharmaceutical development; Describe potential implementation and impacts to the field.

Chair

David Meats

Speaker

AI and Technology Trends and Regulation Introduction
David Meats

Regulation Guidance and Concensus Papers
Madhavi Gidh-Jain, PhD

Regulation Guidance
Louise Lind Skov, PhD

Speakers

David Meats

Director, Regulatory Services Management, Certara, United States

David Meats is a Director of Regulatory Services and Medical Affairs at Certara. He has been a medical writer and manager for 23 years working in oncology, immuno-oncology, endocrinology, musculoskeletal, cardiac, hepatic, renal, and infectious disease therapeutic areas on nearly... Read More →

Madhavi Gidh-Jain

Global Medical Writing and Document Management Head, Sanofi, United States

Madhavi Gidh-Jain is the Global Head of Medical Writing and Document Management for all therapeutic areas and regions at Sanofi. Madhavi has more than 20 years of experience in designing, writing, and reviewing medical and regulatory documents for pharmaceuticals, biologics, devices... Read More →

Louise Lind Skov

Head of Content Digitalisation, Novo Nordisk A/S, Denmark

Louise is Head of Content Digitalisation at Novo Nordisk. In her current role at Novo Nordisk, Louise plays a pivotal role in advancing the way clinical and regulatory documents are managed and processed. Leading the digital transformation effort, she heads the development of innovative... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

04: MedAffairs-SciComm, Session

Format Session
Level Intermediate
Featured Topics Artificial Intelligence (AI), Regulator Perspectives, Digital Technology
Level Intermediate
Feature Topics Artificial Intelligence (AI),Regulator Perspectives,Digital Technology
Credit Type ACPE, CME, RN
Tags Session

10:00am PDT

#226: Effective Patient Engagement in Patient Experience Data: Practical Insights from Case Studies in Hard-to-Reach Populations

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-577-L04-P; CME 1.00; RN 1.00

This forum will describe strategies for patient engagement to help design patient experience studies (PED). Case studies will illustrate the critical impact of patient engagement on the design of PED studies.

Learning Objectives

Examine the critical role that patient engagement can have on the success of patient experience studies; Implement strategies to overcome challenges associated with patient engagement in hard-to-reach populations.

Chair

Ellen Janssen, PhD

Speaker

Lessons Learned from Publicly Funded Patient Engagement Activities
Caroline Vass, PhD

Industry-Led Case Study
Bennett Levitan, MD, PhD

Industry Update
Brett Hauber, PhD, MA

FDA Update
Robyn Bent, MS, RN

Patient Advocacy Perspective
Bellinda King-Kallimanis, PhD, MSc

Speakers

Ellen Janssen

Director, Global Epidemiology, Benefit-Risk Assessment, Janssen Research & Development LLC, United States

Ellen Janssen in a Director of Benefit-Risk Assessment/Epidemiology at Johnson and Johnson. In her work she lead structured benefit-risk assessments throughout the product lifecycle and conducts patient preferences studies to inform patient-focused decision making. Ellen is passionate... Read More →

Robyn Bent

Director, Patient Focused Drug Development, OCD, CDER, FDA, United States

Brett Hauber

Senior Director, Patient Preference Elicitation, Pfizer Inc, United States

Bellinda King-Kallimanis

Senior Director of Patient-Focused Research, Lungevity Foundation, United States

Bellinda is Senior Director of Patient-Focused Research at LUNGevity Foundation. In her work at LUNGevity she aims to ensure that patient and caregiver voices are incorporated in decision-making across a wide variety of stakeholders and has built a Citizen Scientist program to aid... Read More →

Bennett Levitan

Senior Director, Benefit-Risk Assessment, Global Epidemiology, Janssen Research & Development LLC, United States

Bennett Levitan, MD-PhD is Senior Director, Global R&D Epidemiology at Janssen R&D. He introduced state of the art patient-focused benefit-risk (B-R) assessment to Janssen and his team has led numerous clinical teams in B-R assessments and patient preference studies. He co-led development... Read More →

Caroline Vass

Senior Economist, Health Preference Assessment, RTI Health Solutions, United Kingdom

Caroline Vass, PhD, is a Senior Economist at RTI Health Solutions. Her research focuses on using stated preference methods, particularly discrete choice experiments, to elicit preferences for healthcare. She has expertise in both the qualitative and quantitative components of stated... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Forum

Format Forum
Level Intermediate
Featured Topics Patient Focused, Diversity Equity and Inclusion (DEI)
Level Intermediate
Feature Topics Patient Focused,Diversity Equity and Inclusion (DEI)
Credit Type ACPE, CME, RN
Tags Forum

10:00am PDT

#221: Improving Patient Access to Clinical Trials Through Decentralization and Flexible Design: Lessons from Oncology

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-572-L04-P; CME 1.00; RN 1.00

Improving access and minimizing burdens are critical to ensuring diverse representation in clinical trials. Panelists will discuss efforts to improve patient access to oncology clinical trials through streamlined protocols and decentralized elements.

Learning Objectives

Describe the impact of incorporating decentralized elements (DE) into oncology clinical trials (CTs) on data integrity, patient safety and regulatory approvals; Explain how DE elements increase patient access and recognize opportunities to implement DE; Identify ongoing barriers to implementing DE into CT protocols and solutions to address operational challenges in expanding access to care.

Chair

Suanna S. Bruinooge, MPH

Speaker

How Sponsors, CROs, and Sites Can Work Together
Craig H Lipset, MPH

Meta-Analysis of Trials During COVID
Joseph Unger, PhD, MS

Implementing Trials in Large Healthcare System
Ramya Thota

Speakers

Suanna Bruinooge

Chief and Division Director, Research Strategy and Operations Center, American Society of Clinical Oncology, United States

Craig Lipset

Managing Partner, Clinical Innovation Partners, United States

Craig Lipset is an advisor, educator, advocate and innovator focused on novel solutions for clinical trials and medicine development. He is the founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech and investors. Craig is Co-Chair for the... Read More →

Ramya Thota

Associate Professor, Intermountain Medical Oncology - IMC, United States

Joseph Unger

Associate Professor, Fred Hutchinson Cancer Center, United States

Dr. Joseph Unger is a biostatistician and health services researcher. He uses big data to understand more about cancer patients’ treatment outcomes and disparities, especially as they pertain to barriers to participating in clinical trials. He has been at the forefront of efforts... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Forum | 02: ClinTrials -ClinOps, Forum

Format Forum
Level Intermediate
Featured Topics Decentralized Clinical Trials (DCTs), Patient Focused
Level Intermediate
Feature Topics Decentralized Clinical Trials (DCTs),Patient Focused
Credit Type ACPE, CME, RN
Tags Forum

10:00am PDT

#227: How to Ensure Compliance in a Changing Regulatory Environment: A Regulators Perspective

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-578-L04-P; CME 1.00; RN 1.00

Hear the thoughts of regulators regarding how they see the future direction of travel for GCP Inspections. Learn about changes to compliance strategies and collaboration initiatives which are underway or in the pipeline.

Learning Objectives

Describe challenges currently faced by regulators regarding clinical trial inspections; Discuss strategies being developed by Health Authorities including future initiatives, direction of travel, and collaborative relationships.

Chair

Jason Wakelin-Smith

Speaker

FDA Update
Emily Gebbia, JD

Speakers

Emily Gebbia

Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States

Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise for OSI’s policy efforts, including the development of... Read More →

Junko Sato

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as... Read More →

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

08: RD Quality-Compliance, Session

Format Session
Level Advanced
Featured Topics Regulator Perspectives
Level Advanced
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

10:00am PDT

#228: Access Consortium and Project Orbis: Experiences from Industry and Regulatory Authorities and Recommendations for Improvement

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-579-L04-P; CME 1.00; RN 1.00

Results from international industry experience surveys on the Access Consortium and Project Orbis followed by a panel discussion, involving health authorities, to discuss recommendations and next steps to improve and promote these schemes.

Learning Objectives

Recognize the benefits and challenges of international collaborative initiatives from both the industry and regulatory authority perspectives; Discuss the recommendations to improve these schemes; Describe how to influence your own organization to adopt or increase usage of these schemes.

Chair

Sarah Powell, RAC

Speaker

Results of Industry Survey of Orbis Projects
Sarah Powell, RAC

Results of Industry Survey on Access Program
Tse Siang Kang, PhD

Speakers

Sarah Powell

President, Powell Regulatory Services, United States

Ms. Powell is the President of Powell Regulatory Services. Sarah has 30+ years of experience in pharmaceutical and related regulated industries (Clinical, Quality Control, Regulatory Affairs and Regulatory Operations). In the past 23 years as a consultant, she has assisted clients... Read More →

Tse Siang Kang

Head of Regulatory Affairs, North, East, West Asia, Global Regulatory, Pfizer Pte Ltd, Singapore

Dr. Tse Siang Kang is the Head of Regulatory Sciences in North, East and West Asia cluster, Pfizer Global Regulatory Sciences. In addition to his role in managing a diverse Asia team in Pfizer. Dr Kang also has a particular interest in publishing emerging Regulatory Sciences topics... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Format Session
Level Intermediate
Featured Topics Regulator Perspectives, Regulatory Collaboration
Level Intermediate
Feature Topics Regulator Perspectives,Regulatory Collaboration
Credit Type ACPE, CME, RN
Tags Session

10:00am PDT

#229: Clinical Trial Enrollment Diversity: Why and How to Engage Community Health Centers

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-580-L04-P; CME 1.00; RN 1.00

Minority access to clinical trials is an ongoing challenge. Community Health Centers (CHCs) can support linking these populations to studies. This session shares results from a national CHC survey that informs about needs and perceptions that can help increase participation.

Learning Objectives

Describe how to distinguish Community Health Centers (CHCs) from other types of healthcare organizations; Discuss results from a grant that surveyed 40 CHCs nationwide about their perceptions and needs related to clinical trials; Evaluate options for CHCs to be involved with supporting clinical trial and diverse enrollment.

Chair

Pete Fronte, MBA

Speaker

Industry Update
Karen Correa, PhD

Community Health Care Update
James Schultz, MD, MBA, FAAFP

Patient Update
Mario DuCre

Speakers

Pete Fronte

President and Chief Executive Officer, Altura, United States

Pete Fronte, MBA is President/CEO of Altura. During the past 30 years Mr. Fronte has been a leader in developing technology and services to expand clinical study participation for patients and building quality-based research centers within health systems and community health centers... Read More →

Karen Correa

Vice President, Head of Global Clinical Operations, Takeda, United States

Dr. Karen Correa is the Vice President, Head of Global Clinical Operations at Takeda; where she is responsible for the advancement of the portfolio and execution of global clinical trials. Her 30 years of clinical research experience cover a large range of settings and venues including... Read More →

James Schultz

Chief Medical Officer, Neighborhood Healthcare, United States

Mario DuCre

Patient, United States

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12: Value-Access, Forum

Format Forum
Level Intermediate
Featured Topics Diversity Equity and Inclusion (DEI)
Level Intermediate
Feature Topics Diversity Equity and Inclusion (DEI)
Credit Type ACPE, CME, RN
Tags Forum

10:00am PDT

#230: International Regulatory Convergence: Regulatory Science to Address Challenges Brought by Pharmaceutical Innovation

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-581-L04-P; CME 1.00; RN 1.00

Innovative approaches have the potential to create new opportunities for patients, but they also bring challenges to regulators, called to evaluate, and supervise products for which traditional regulatory approaches might not be appropriate. Global regulators will discuss how regulatory science is key to develop solutions and how regulators worldwide need to work together to overcome such challenges.

Learning Objectives

Explore how to make faster progress with translating regulatory science research outputs into practice, for accelerating and improving medicine development and use; Discuss generalizable success stories and examples with challenges to an efficient translation; Describe and critically review hurdles and success factors.

Chair

Antonio Barra Torres, MD

Speaker

Promoting International Regulatory Convergence Through Regulatory Science
Emer Cooke, MBA, MSc

Path for Future Collaboration Utilizing Regulatory Science
Yasuhiro Fujiwara, MD, PhD

ICMRA Summit 2023: Regulators Working Together Towards the Future
Anthony Lawler, MD, MBA

Panelist
Alison Cave, PhD

Panelist
Pamela Aung-Thin

Speakers

Pamela Aung-Thin

Assistant Deputy Minister of the Health Products and Food Branch, Health Canada, Canada

Pamela Aung Thin became the Assistant Deputy Minister of the Health Products and Food Branch (HPFB) on March 27, 2023.

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic... Read More →

Emer Cooke

Chair, ICMRA; Executive Director, European Medicines Agency, Netherlands

Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to... Read More →

Yasuhiro Fujiwara

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Yasuhiro Fujiwara was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National Cancer Center Hospital. He is a medical oncologist, specializing in breast cancer. Before joining NCCH, he was... Read More →

Anthony Lawler

Deputy Secretary, Health Products Regulation Group, Therapeutic Goods Administration, Australia

Professor Tony Lawler is the Head of the Australian Therapeutic Goods Administration, which works to safeguard and enhance the health of all Australians through effective, timely and risk-proportionate regulation of therapeutic goods, and the control of drug imports, exports and production... Read More →

Antonio Barra Torres

President Director, ANVISA, Brazil

Mr. Barra, President-Director of Anvisa, graduated in Medicine from Foundation Souza Marques in 1986 and had his residency in Vascular and Endovascular surgery done at Marcílio Dias Naval Hospital (HNMD) in Rio de Janeiro. MBA in Health Services Administration at Federal University... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

14: DIAmond, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives, Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives,Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

11:00am PDT

#231 CH: Quality in Focus: Diethylene and Ethylene Glycol Challenges

Component Type: Workshop
Level: Intermediate

Participants will delve into the US FDA's regulatory guidance, exploring the testing protocols for high-risk drug components and explore the essential requirements and recommended practices to ensure product safety and compliance.

Learning Objectives

Recognize key factors contributing to diethylene glycol (DEG) and ethylene glycol (EG) contamination; Examine the US FDA's regulatory guidance, delving into the testing procedures for high-risk drug components contaminated with DEG and EG; Explore requirements and recommended practices for manufacturers, repackagers, preparers, and distributors.

Chair

Chaitanya Koduri

Speakers

Chaitanya Koduri

Director, International Government and Regulatory Engagement, US Pharmacopeia, United States

Tuesday June 18, 2024 11:00am - 11:30am PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

15: Content Hubs, Workshop | 09: Regulatory, Workshop

Level Intermediate
Level Intermediate
Tags Workshop

11:00am PDT

#234 RT: Roundtable Discussion: Interactive Safety Graphics in the Regulatory Decision-Making Process

Component Type: Session

Join the Clinical Safety & Pharmacovigilance/Statistics & Data Science Community for a follow up round table discussion tied to session: Interactive Safety Graphics in the Regulatory Decision-Making Process (Monday, June 17 | 2:15PM - 3:15PM PDT). Space is limited.

Chair

Greg Ball, PhD

Speakers

Greg Ball

Safety Data Scientist, ASAPprocess, United States

Greg served in the Navy and taught HS math and physics before earning his PhD in biostatistics from the University of Texas. He co-led a crossfunctional company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded... Read More →

Tuesday June 18, 2024 11:00am - 12:00pm PDT
Ballroom 20 D/ Zone 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 01: ClinSafety-PV, Session

Tags Session

11:00am PDT

#233 RT: Roundtable Discussion: The State of Real-World Evidence for Regulatory Decision-Making - Views from FDA, EMA, and PMDA

Component Type: Session

Join the Real-World Evidence Community for a follow up round table discussion tied to session: The State of Real-World Evidence for Regulatory Decision-Making - Views from FDA, EMA, and PMDA (Monday, June 17 | 2:15pm - 3:15 PM PDT). Space is limited.

Chair

Jingyu (Julia) Luan, PhD

Speakers

Jingyu (Julia) Luan

Executive Regulatory Science Director, BioPharmaceuticals R&D, AstraZeneca, United States

Tuesday June 18, 2024 11:00am - 12:00pm PDT
Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 09: Regulatory, Session

Tags Session

11:00am PDT

#232 RT: Roundtable Discussion: Innovation in Manufacturing Globally

Component Type: Session

Join the Digital Acceleration/Regulatory Affairs/Statistics & Data Science Community for a follow up round table discussion tied to session: Innovation in Manufacturing Globally (Monday, June 17 | 2:15PM - 3:15PM PDT). Space is limited.

Chair

Brett Howard, JD, PhD

Speakers

Brett Howard

Senior Director, US Regulatory Policy, USP, United States

Brett Howard is a Senior Director of US Regulatory Policy at the US Pharmacopeia, where he manages USP's regulatory efforts concerning pharmaceutical quality, covering both large and small molecules. Prior to joining USP, he spent the previous decade working for chemical and pharmaceutical... Read More →

Tuesday June 18, 2024 11:00am - 12:00pm PDT
Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 10: RegCMC-Product Quality, Session

Tags Session

11:00am PDT

Luncheon Service

Component Type: Social Event

Tuesday June 18, 2024 11:00am - 1:00pm PDT
Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Networking Opportunities, Social Event

Tags Social Event

11:00am PDT

Community Networking Lunch

Component Type: Social Evt / Reception

DIA Community members - this is your dedicated space! Meet up and collaborate with fellow members, participate in roundtable discussions, and/or take a few minutes to reflect on the sessions you've attended.

Tuesday June 18, 2024 11:00am - 1:30pm PDT
TBD San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Networking Opportunities, Social Evt / Reception

Tags Social Evt / Reception

11:15am PDT

#235 IT: Deloitte Innovation Theater: Drug Safety Unfiltered - Why Isn’t the Needle Moving?

Component Type: Session

Technologies such as AI, automation and GenAI have the capability to transform the Safety function. But adoption has been uneven so far. Dive into the issues and explore the “why” behind barriers to adoption. Discover where early adoption pioneers stand now and join a Q&A around what it will take to really move the needle on transformation in Safety.

Chair

Deloitte

Speaker

Speaker
Amanda Bowles, MS

Speaker
Kelly Traverso

Speakers

Amanda Kirby Bowles

Managing Director, Deloitte, United States

Amanda helps organizations transform their business by innovating in process and technology to help protect patients, manage risk, and drive value. Amanda has in-depth experience in patient safety, pharmacovigilance, and regulatory affairs -- including operations strategy, global... Read More →

Deloitte

United States

Kelly Traverso

R&D Business Development, Deloitte, United States

Kelly has more than 20 years’ experience in the areas of Quality, Pharmacovigilance, R&D, and Regulatory Affairs with large, global Biotech and Pharmaceutical companies. She is a Subject Matter Expert on the topics of process assessment and gap analyses, governance model design... Read More →

Tuesday June 18, 2024 11:15am - 11:45am PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

11:15am PDT

#236 IT: UiPath Innovation Theater: AI Powered Automation - Reducing Time to Market for Life Sciences

Component Type: Session

As the cost, complexity and timelines for the development of new drugs and devices continues to grow, AI-powered automation is emerging as a powerful solution to reduce time to market by orchestrating clinical data, simplifying regulatory submissions, eliminating manual and paper-based processes, and automating data and solution testing. AI-powered automation allows organizations to improve time to market while reducing errors, ensuring visibility, and enabling compliance across R&D.

Chair

UiPath

Speaker

Speaker
Joe Miles

Speakers

Joe Miles

Industry Director, Life Sciences, UiPath, United States

As a global Healthcare and Life Sciences industry leader over the past several decades, I have assisted organizations in enabling digital transformation for life sciences organizations across operational, financial and compliance. Most recently, I have led the UiPath Life Sciences... Read More →

UiPath

United States

Tuesday June 18, 2024 11:15am - 11:45am PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

11:15am PDT

#237 IT: Snowflake Innovation Theater: Secure and Efficient Gen-AI to Accelerate Research and Development

Component Type: Session

In the era of AI-enabled research & development, managing and analyzing large-scale data efficiently is crucial, yet traditional systems often fall short in scalability, performance, and collaboration. Learn how Snowflake enables life sciences organizations to build a data foundation, collaborate with the ecosystem and leverage industry-leading AI models safely and cost-effectively. Demo includes use cases around: Protein Similarity & Function Prediction, Gen-AI Clinical Trial Assistant, & more.

Chair

Snowflake

Speaker

Speaker
Harini Gopalakrishnan, MS

Speaker
Lisa M. Arbogast

Speakers

Lisa Arbogast

Industry Principal, Life Sciences, Snowflake, United States

Lisa is an accomplished Life Sciences executive with over 35 years of experience in consulting, innovative business models, and global data-driven solutions that solve both technology and business challenges within biopharmaceuticals, diagnostics, and medtech. Her passion is to mobilize... Read More →

Harini Gopalakrishnan

Industry Field CTO, Life Sciences, Snowflake, United States

Harini Gopalakrishnan is the Global Field CTO for Life Sciences for Snowflake, based out of New York and works to contextualize Snowflake and partner solutions for pharma/biotech customers. She has 20 + years experience and worked in leadership roles across both tech and life sciences... Read More →

Snowflake

United States

Tuesday June 18, 2024 11:15am - 11:45am PDT
Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

11:15am PDT

#POS 2: Professional Poster Session 2

Component Type: Session

Professional and Student Posters provide an opportunity for methodology (“how to”), case study, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery, development, and lifecycle management of pharmaceuticals, biotechnology, medical devices, and healthcare-related products.

Speakers

Malak Almutairi

Researcher, Saudi Food and Drug Authority, Saudi Arabia

I am a researcher specialized in regulatory research with a master's degree in pharmacy and Pharmaceutical Sciences. I have been working in the SFDA (Saudi Food and Drug Authority) for several years now, and my focus has been on ensuring the safety and efficacy of pharmaceutical products... Read More →

Daniel Alvarez

Principal Medical Director, Health Equity and Inclusive Research (HEIR), Genentech, A Member of the Roche Group, United States

Dr. Daniel Alvarez earned his medical degree from the Institute of Medical Science of Havana, Cuba in 2002 and the University of Costa Rica in 2006. He also holds a master's degree in Science of Pharmaceutical Medicine from Hibernia College, Ireland, in 2016 and a Diploma in Pharmacoeconomics... Read More →

Celeste Amadei

Product Manager, PAK Biosolutions, United States

Cheng Chi Chen

Clinical Reviewer, Center For Drug Evaluation, Taiwan

Cheng Chi Chen, Clinical Reviewer, Division of New Drugs, CDE, Taiwan Cheng Chi Chen has been a Clinical Reviewer in Division of New Drugs at CDE Taiwan for more than 1 years. Cheng Chi Chen is a Pharmacist and holds a Master’s degree in Clinical Pharmacy from National Yang Ming... Read More →

Renata Costa

Specialist, LIBBS FARMACEUTICA, Brazil

Renata Watanabe Costa has a degree in Biomedicine, with a postgraduate degree in Research and Development of Medicines and a Master's in Sciences from the Federal University of Sao Paulo (Brazil). She has 13 years of experience in the pharmaceutical industry in the areas of Medical... Read More →

Samantha Cotter

Safety Evaluator, FDA, United States

Dr. Samantha Cotter is a pharmacist and safety evaluator in the Division of Pharmacovigilance within the Office of Surveillance and Epidemiology at the US Food and Drug Administration (FDA). Samantha has over 20 years of clinical pharmacy experience, and 12 years in research at the... Read More →

Matt D'Ambrosio

Policy Analyst, Duke-Margolis Institute For Health Policy, United States

Matt D'Ambrosio is a policy analyst with the Duke-Margolis Institute for Health Policy's Biomedical Innovation portfolio. He primarily works with the Institute's Real-World Evidence Collaborative--providing support on workstream deliverables and stakeholder engagement. Matt is based... Read More →

Tiffany Dominic

Risk Management Fellow, Pfizer, United States

Tiffany Dominic is a Post-Doctoral Risk Management Fellow at Pfizer, in conjunction with Rutgers University. She graduated with her Doctor of Pharmacy degree in May 2022 from St. John's University College of Pharmacy and Health Sciences. As a risk management fellow, she takes part... Read More →

Pierre Engel

Senior Director Business Development, Centogene Gmbh, Germany

With over 15 years of sales and delivery experience in the field of epidemiology and real world evidence (RWE), I am a passionate leader in healthcare innovation and a trusted partner for global pharma accounts. As a Senior Principal Epidemiology at CENTOGENE, I am responsible for... Read More →

Emily Epstein

Clinical Behavioral Health Specialist, Weill Cornell Medicine, United States

Emily Epstein, LMSW, is a Clinical Behavioral Health Care Specialist at Weill Cornell Medicine's Genetics and Personalized Cancer Prevention Program (GPCP). The GPCP is committed to identifying individuals living at an increased lifetime risk for cancer, conducting research, and creating... Read More →

Samuel Ewusie

Associate Director, Safety Evidence and Science, Bristol-Myers Squibb Company, United States

A registered pharmacist with a PharmD and an MS in Global Clinical and Pharmacovigilance Regulations, experienced in Clinical Drug Safety and Pharmacovigilance, Risk Management including Risk Evaluation and Mitigation Strategy (REMS), Pharmacoepidemiology and Research Data analys... Read More →

Majdi Al Gharsan

Director, Director of Medical Services, Ministry of Defence, Saudi Arabia

Yogesh Gulati

Senior Safety Physician, Soterius, India

Cheryl Hergert

University of Southern California, United States

With over 25 years of experience working with small and large companies, Cheryl is familiar with product development for medical devices, pharmaceuticals, and combination products. Her experience ranges from product feasibility testing to product launch. She has held positions in... Read More →

Hisahiro Ito

Head of Project Management Office, National Cancer Center Japan, Japan

Frank Jaeger

Independent Consultant, Nanodose Therapeutics, United States

Frank Jaeger is an accomplished C-suite leader with over 25 years of biopharmaceutical tenure from seed-stage to large global pharma, in small and large molecules, and from pre-launch to in-market experience. His career spans across R&D, Medical Affairs, Business Development, Commercial... Read More →

Sung Hoon Jung

Professor, The Catholic University of Korea, Korea, Republic of

Sung-Goo Kang

Clinical Professor., St.Vincent's Hospital, The Catholic University of Korea, Korea, Republic of

Sarah Kang

Safety Evaluator, FDA, United States

Sarah Kang is a safety evaluator in the Division of Pharmacovigilance (DPV) within the Office of Surveillance and Epidemiology at the United States Food and Drug Administration in Silver Spring, Maryland. She has over 9 years of experience as a clinical pharmacist and over 8 years... Read More →

Joseph Laudano

Medical Director, IQVIA, United States

Joseph B. Laudano BS Pharm, Pharm D – Medical Director, IQVIA Inc. Joe has over 35 years’ experience in Pharma. Before joining IQVIA, he was VP, Medical Affairs at Pharmaspectra, VP Medical Affairs at Alliqua Biomedical and Senior Director of Medical Affairs & Global Head of Publication... Read More →

Christina Mack

Chief Scientific Officer, Real-World Solutions, IQVIA, United States

Christina Mack is Chief Scientific Officer of IQVIA real world solutions. An epidemiologist and engineer by training, she is responsible for driving scientific and technical innovation that directly impacts patient health. Recognized as a 2023 PharmaVoice100 Honoree, she’s committed... Read More →

Laura Magda

Director of Clinical Trials, SRI International, United States

Andrew Marley

Senior Epidemiologist, Parexel, Spain

Hotaka Maruyama

Division of PharmacoEpidemiology, Office of Pharmacovigilance ?, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

I am a reviewer of pharmacoepidemiology division and have a few years' experience in the office of pharmacovigilance I at Pharmaceuticals and medical devices agency(PMDA).

Timothe Menard

Global Head, Quality Excellence Digital | Bioethics Coach (Data Ethics), F. Hoffmann-La Roche Ltd, Switzerland

Started in drug safety at Merck KGaA, joined Roche as a GCP/PV auditor. Transitioned to analytics; now heads Quality Excellence Digital. Focuses on digital & analytics for core quality deliverables. Co-founded the Inter coMPany quALity Analytics consortium to drive data/quality policy... Read More →

Mehdi Najafzadeh

Senior Director, Medidata AI, United States

Mehdi NajafZadeh, PhD, is Senior Director at Medidata AI. Before joining Medidata AI, he was an Assistant Professor of Medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, and the... Read More →

Raphael Pareschi

Patient Safety Lead/ Head of Pharmacovigilance Brazil, Roche, Brazil

Raphael has more than 16 years of experience in Pharmacovigilance, beginning at Sanofi Brazil, where he acted in roles of increasing responsibility within local PV organization, responsibilities including oversight of case management, PSUR management and RMP management. Raphael also... Read More →

Izabela Pedro

Clinical Research Associate, Hospital Israelita Albert Einstein, Brazil

Gerd Rippin

Senior Director, Biostatistics, Real-World Solutions, IQVIA, Germany

Bruna Sampaio

Manager, Data management, Hospital Israelita Albert Einstein, Brazil

Bruna has over 14 years of professional experience with technology and data operations. Working in clinical research for almost 10 years, she is experienced in EDC Systems (first as a system analyst and later as an end-user), data management, and data analytics. Currently, she is... Read More →

Chris Schneiderman

Epidemiologist, Abbvie, United States

Samantha Seepersad-Nayee

AD, Excision Biotherapeutics, United States

Alexandru Socolov

Senior Data Scientist, Medidata Solutions, United States

Alexandru is a Senior Data Scientist at Medidata AI focused on building advanced analytical solutions to make clinical trials safer, cheaper and faster. With the background in operations research, mathematical optimization and machine learning, Alexandru applies newest techniques... Read More →

Hiroya Taniguchi

Department of Clinical Oncology, Aichi Cancer Center Hospital, Japan

Brittin Wagner

Senior Research Scientist, PointClickCare, Canada

Brittin Wagner is Senior Research Scientist at PointClickCare. She holds a PhD is in Sociology, PhD Minor in Social Statistics from the University of Washington, with postdoctoral training in health services research & development. She has a longstanding commitment to measurement... Read More →

Matt Wampole

Director, Solution Consulting, Clarivate, United States

Matt Wampole is the Director of Solution Consulting at Clarivate where he and his team supports clients from discovery to launch of new medical interventions. His 20 years of experience covered a broad range of topics across drug discovery and optimization, clinical trial optimization... Read More →

Susan Watson

Associate Director, Bioethics, Eli Lilly and Company, United States

Susan Briggs Watson, Ph.D. is an Associate Director of Bioethics at Eli Lilly and Company. She received a PhD in clinical psychology from Indiana University-Purdue University at Indianapolis (IUPUI) and completed Georgetown University's Intensive Bioethics Course 38. She has worked... Read More →

Sam Willcox

Section Manager - Large Molecule Bioanalysis, ACM Global Laboratories, United Kingdom

Sam graduated from the University of Hull with a BSc in Human Biology in 2009. Since graduating he has worked for the last 15 years in regulated bioanalysis supporting the drug development industry. Expert in the field of bioanalysis of large molecules via ligand binding assays he... Read More →

Rebecca Williams

Senior Clinical Trials Subject Matter Expert, Essex, Part of Emmes Group, United States

Rebecca Williams, PharmD, MPH, is a Clinical Trials Subject Matter Expert with Essex, Part of Emmes Group. In this role she supports strategic policy and data initiatives with the National Cancer Institute’s Coordinating Center for Clinical Trials. Prior to this role she was the... Read More →

Xiaofeng Xiang

Sr. Medical Compliance Manager, Bayer, China

Mui Van Zandt

VP/Global Head, Data Strategy, Access and Enablement, IQVIA, United States

Feng Zhou

Medical Compliance, Bayer Healthcare Co., Ltd., China

Tuesday June 18, 2024 11:15am - 1:15pm PDT
Posters Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

18: Posters, Session

Tags Session

11:55am PDT

#238 IT: IQVIA Innovation Theater: An Ecosystem Approach to Site Tech Overload

Component Type: Session

With too many systems and not enough staff, research sites are turning down studies they find unworkable. How can we get the clinical trial ecosystem in balance so that everyone benefits, most importantly patients in need?

In this panel, leaders across the ecosystem will discuss viable strategies to make a real impact on site tech overload. Learn about One Home for Sites, an initiative that’s bringing the industry together to increase clinical trial capacity and help all stakeholders succeed.

Chair

IQVIA Technologies

Speaker

Speaker
Gareth Dabbs

Speaker
Michael Rosenblatt

Speaker
Aruna Adhikari-Thapa

Speaker
Brad Hightower

Speaker
Erik Johs

Speakers

IQVIA Technologies

United States

Gareth Dabbs

Vice President, Global Product Strategy, IQVIA, United States

Aruna Adhikari-Thapa

Senior Director, Product Strategy, IQVIA Technologies, United States

Aruna Adhikari-Thapa is a seasoned technology strategist with 20+ years of experience in software product management. She excels in leading cross-functional teams, shaping product strategies, justifying investments, and launching innovative solutions to address complex business challenges... Read More →

Brad Hightower

Chief Executive Officer, Hightower Clinical, United States

Brad has worked at the site-level in clinical research for almost 15 years and is the former Executive Director of the Oklahoma Heart Hospital Research Foundation. Brad has since started his own integrated site network, Hightower Clinical, and hosts the Note to File podcast — a... Read More →

Michael Rosenblatt

Managing Director, Greenhouse Consulting, United States

Erik Johs

Vice President, Platform Engineering, Medidata Solutions, United States

Erik Johs is the Vice President of Platform Engineering at Medidata Solutions. With over 15 years of hands-on experience, he has honed his expertise in scalable infrastructure, cloud-native architectures, and DevOps practices. Erik’s leadership is marked by a relentless focus on... Read More →

Tuesday June 18, 2024 11:55am - 12:25pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

11:55am PDT

#239 IT: Fortrea Innovation Theater: Teamwork Makes the Dream Work - How Partnering to Develop Practical Solutions that Address Site and Patient Challenges is Changing the Clinical Trial Landscape

Component Type: Session

Without patients, there are no trials. Without the sites to conduct studies, there are no trials. This simple truth drives inclusivity initiatives, and the surge in technology “solutions”. In this panel discussion, we bring together voices from across the clinical trial ecosystem and demonstrate how teamwork comprised of medical expertise, market access insight, patient voice, site advisory boards, and technology partnerships work together with developers and CROs to make teamwork the dream work.

Chair

Fortrea

Speaker

Speaker
Elizabeth Seyfert

Speaker
Jared Katz

Speaker
Stuart Cotter

Speakers

Stuart Cotter

VP, Product Strategy, Advarra, United States

Fortrea

United States

Jared Katz

Sr. Director, Development Cloud Strategy, Veeva Systems, United States

Jared is the director of strategy for Vault Connections and is responsible for defining the Vault Connections vision and strategy to drive adoption and customer success. He has over 10 years of experience in life sciences in services and strategy roles including: architecting solutions... Read More →

Elizabeth Seyfert

Head of Site Engagement and Partnership Delivery, Fortrea, United States

Elizabeth has over 18 years of industry experience and has held varying leadership positions across regulatory, start up and clinical delivery functions. Elizabeth currently oversees site partnership and relationship management at Fortrea with a primary focus on supporting clinical... Read More →

Tuesday June 18, 2024 11:55am - 12:25pm PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

11:55am PDT

#240 IT: UBC Innovation Theater: RWD Enrichment Studies - Linking Pre and Post-Trial Data to Inform Product Strategy

Component Type: Session

Capturing data on the patient’s healthcare journey prior to and following participation in a clinical trial builds a more complete understanding of their healthcare journey and increases the overall evidence yield. This presentation explores the value and challenges of tokenization and linkage to diverse secondary healthcare data as well as a case study highlighting the real-world application of this approach.

Chair

UBC

Speaker

Speaker
Irene Cosmatos, MS

Speaker
Jeff Lowry

Tuesday June 18, 2024 11:55am - 12:25pm PDT
Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

12:30pm PDT

#241 CH: Practical (and Real) AI and Advanced Automation in New Product Planning and Clinical Development

Component Type: Workshop
Level: Basic

Realizing the value of AI and Advanced Automation tools is no longer hypothetical - real value is being created by the thoughtful application of these tools. We will explore pragmatic examples and opportunities within this working session.

Learning Objectives

Create a pragmatic approach for developing and implementing AI and Advanced Automation tools within their organizations; Describe how to develop a plan, implement and calculate and measure ROI for such tools.

Chair

Bryan Katz, MBA

Speakers

Bryan Katz

Chief Strategy Officer, Propharma Group, United States

Tuesday June 18, 2024 12:30pm - 1:00pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

15: Content Hubs, Workshop | 02: ClinTrials -ClinOps, Workshop

Level Basic
Level Basic
Tags Workshop

12:35pm PDT

#241.1 IT: Flatiron Health Innovation Theater: The Time is Now - Pragmatic Approaches to Prospective Evidence Generation

Component Type: Session

Flatiron Health and the Clinical Trials Transformation Initiative (CTTI) share a bold vision for a more streamlined approach to running clinical trials. Critical to this vision is developing trials that are patient-centered, integrated into current healthcare processes, and maximally leveraging all available data, among other imperatives. Join us for a practical discussion around how to implement these streamlined practices into your trials through a combination of data, technology, and services.

Chair

Flatiron Health

Speaker

Presenter
Sara Bristol Calvert, PharmD

Presenter
Joshua Buddle

Speakers

Joshua Buddle

Director, Clinical Operations, Flatiron Health, United States

Sara Calvert

Director of Projects, Clinical Trials Transformation Initiative (CTTI), United States

Dr. Sara Bristol Calvert is currently the Director of Projects at the Clinical Trials Transformation Initiative (CTTI). Prior to this role, she was a CTTI Senior Project Manager which included leading projects in Diversity in Clinical Trials, Single IRB, Registry Trials, HABP/VABP... Read More →

Flatiron Health

United States

Tuesday June 18, 2024 12:35pm - 1:05pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

12:35pm PDT

#242 IT: PCM Trials Innovation Theater: Mastering the Logistics of Mobile Visits in Global Decentralized Trials

Component Type: Session

As the landscape of clinical trials continues to evolve, mobile visits play an increasingly crucial role in ensuring the success of global trials. With more than 80 years of combined experience in logistics and the execution of complex decentralized trials, these industry veterans will share actionable steps to overcome hurdles in distributing supplies, managing samples, and delivering compliant mobile visits to meet the logistical challenges associated with decentralized clinical trials (DCTs).

Chair

PCM Trials

Speaker

Speaker
Ellen Weiss

Speaker
Kevin Meek

Speaker
Mike Sweeney

Speaker
Chris Thompson

Speakers

Kevin Meek

Director, Supply Chain Operations, PCM Trials, United States

Through expert facilitation, Kevin brings together individual subject matter experts to create cross-functional teams to focus on end-to-end results. He developed these skills in the largest health payer system in the country managing dozens of partner solutions by establishing operational... Read More →

Mike Sweeney

Global Head of Strategy, CGT & DTP, QuickSTAT, France

For over three decades Mike has successfully developed and delivered customer-focused solutions in a variety of leadership and cross-functional roles within global life sciences logistics. As a trusted leader, collaborator, and personalized supply chain expert, he has driven innovative... Read More →

Chris Thompson

Senior Operations Manager, Woodley Trial Solutions, United Kingdom

In his role as Senior Operations Manager, Chris oversees all aspects of solutions and service delivery for clients. This includes rental of laboratory equipment; point-of-care testing devices; Dexcom CGM devices; high-tech connectivity products; plus ancillaries & kitting, all of... Read More →

PCM Trials

United States

Ellen Weiss

Strategy, Decentralized Trials, Emeritus, PCM Trials, United States

Ellen Weiss is an expert in connecting CROs and sponsors with right-sized hybrid and remote solutions to collect complete data. She has spoken on understanding the logistical support necessary for IMP delivery and dosing, sample collection, logistic options and best use cases. She... Read More →

Tuesday June 18, 2024 12:35pm - 1:05pm PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

12:35pm PDT

#243 IT: ProductLife Group Innovation Theater: Navigating the AI “boom” - A Methodological Framework to Create New Value Streams in your Specific Regulatory Affairs Context

Component Type: Session

The publication of Large Language Models has shed light on AI more than ever, and opened new opportunities – and risks. It has been challenging the vendor’s ecosystem. It becomes more and more complex to get a systemic view and define a strategic roadmap in this ever-changing environment. In this session, we will address such challenges by proposing and illustrating a methodological framework stemming from research in complex system engineering and design. The goal is to identify and develop AI value potential that will best fit your needs and context, in a frugal approach to avoid AI and tools “overload”.

Chair

Productlife Group

Speaker

Speaker
Gabriele Breda, PhD

Speakers

Gabriele Breda

Research & Innovation Director, ProductLife Group, France

Gabrièle Breda is the Director of Research & Innovation at ProductLife Group (PLG). Graduated from Ecole Normale Supérieure of Paris, with a PhD in Neurosciences, Gabrièle has been managing collaborative Research & Innovation in Healthcare Engineering at Altran and Capgemini Engineering... Read More →

Productlife Group

Productlife Group, France

Tuesday June 18, 2024 12:35pm - 1:05pm PDT
Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

1:15pm PDT

#244: Evidence Generation to Support Regulatory Decision-Making: Shift of the Trend over Time

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-582-L04-P; CME 1.00; RN 1.00

This session will discuss the recent shifts in evidence-based regulatory decision-making, to include types of evidence used to support decisions. Future requirements for evidence generation to support regulatory decision-making will be considered.

Learning Objectives

Describe the need for evidence generation to support regulatory decision-making; Discuss the changing evidence landscape supporting regulatory decision-making; Identify what is needed in the future.

Chair

Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP

Speaker

The Changing Trends in the Evidence Supporting Major Regulatory Decisions (Products Withdrawals) in Europe
Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP

Quantitative Measurement of the Public Health Impact of Medicines Withdrawals and Suspensions in Europe
Samantha Lane, MSc

Industry Update
Andrew Bate, PhD, MA

Industry Update
Jeremy Jokinen, PhD, MS

Speakers

Saad Shakir

Director, Drug Safety Research Unit, United Kingdom

Saad Shakir is a pharmacoepidemiologist and drug safety physician. He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international pharmaceutical industry and as the Director... Read More →

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom

Andrew is VP and Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12... Read More →

Jeremy Jokinen

Vice President and Head, Safety Evidence and Sciences, Bristol-Myers Squibb Company, United States

Jeremy Jokinen is the Vice President and Head, Safety Evidence and Sciences at Bristol Myers Squibb. In this role, he leads a global team of risk management, epidemiology, and safety science experts responsible for insights, evidence generation, and risk minimization programs ensuring... Read More →

Samantha Lane

Head of Research, Centre of Pharmacovigilance Sciences, Drug Safety Research Unit, United Kingdom

Samantha Lane is a Senior Research Fellow and the Head of Research for the Centre of Pharmacovigilance Sciences at the Drug Safety Research Unit. Samantha leads study design and statistical analysis and has experience with the CPRD electronic health records database. She has a background... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session

Format Session
Level Basic
Level Basic
Credit Type ACPE, CME, RN
Tags Session

1:15pm PDT

#252: Ensuring Inspection Readiness for Clinical Trials Using Decentralized Clinical Trial Design Features

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-590-L04-P; CME 1.00; RN 1.00

The speakers will discuss regulatory and industry perspectives on sponsor and investigator responsibilities when incorporating decentralized clinical trials features in a trial to ensure trial participant safety, data reliability and quality and inspection readiness.

Learning Objectives

Describe various design features of decentralized clinical trials (DCT), including use of digital health technologies for remote data capture; Discuss what sponsors should do upfront in the planning and during the conduct of the trial and where the risks to data integrity lie in trials incorporating DCT features; Discuss the core elements of an FDA inspection; Identify steps to ensure inspection readiness for clinical investigators and sponsors.

Chair

Cara Alfaro, PharmD

Speaker

FDA Update
Cara Alfaro, PharmD

Industry Update
Jonathan Andrus, MS

MHRA Update
Jason Wakelin-Smith

Speakers

Cara Alfaro

Senior Pharmacologist, OSI, OC, CDER, FDA, United States

Dr. Alfaro received her B.S. in pharmacy from Purdue University and her Pharm.D. from the Ohio State University. She completed a residency and research fellowship in psychiatric pharmacy at the University of Texas Health Science Center at San Antonio. In 1998, she joined NIH as a... Read More →

Jonathan Andrus

President & COO, CRIO, United States

Mr. Andrus brings over 25 years of executive management, operational, quality, and business experience to CRIO. Most recently he served as Chief Strategy Officer for Clinical Ink. Prior to that, he served as Senior Vice President for BioClinica (now Clario), where he led the e-clinical... Read More →

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Session | 08: RD Quality-Compliance, Session

Format Session
Level Intermediate
Featured Topics Decentralized Clinical Trials (DCTs), Digital Technology
Level Intermediate
Feature Topics Decentralized Clinical Trials (DCTs),Digital Technology
Credit Type ACPE, CME, RN
Tags Session

1:15pm PDT

#247: Bridging Randomized Clinical Trials and Real-World Data Utilizing Data Linkage and Tokenization

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-585-L04-P; CME 1.00; RN 1.00

Data linkage is a methodology to capture data from patients before, during, and after a clinical trial. The panel will discuss the challenges of conducting randomized clinical trials (RCTs) linked with real-world data (RWD), and will emphasize the data linkage methodologies and current needs.

Learning Objectives

Describe the methodology of data linkage, a relatively new method to collect individual patient data before, during, and after a clinical trial outside the randomized clinical trial (RCT) setting; Discuss challenges for different stakeholders involved in utilization of real-world evidence (RWE) and more specifically data linkage, including industry, regulators, and payers/HTA.

Chair

Aaron Kamauu, MD, MPH, MS

Speaker

Panelist
Francesco Pignatti, MD

Panelist
Kajsa Kvist

Panelist
Brian Bradbury, DrSc, MA

Panelist
Akshay Vashist

Speakers

Brian Bradbury

Vice President, Center for Observational Research, Amgen, United States

Brian D. Bradbury is Vice President and Head of the Center for Observational Research (CfOR) at Amgen, Inc. He leads a global team of epidemiologists, data scientists, programmers and operations professionals who generate real-world evidence (RWE) to support the development and continuous... Read More →

Aaron Kamauu

CEO, Navidence LLC, United States

Dr. Aaron Kamauu (MD, MS Biomedical Informatics, MPH, University of Utah School of Medicine) is the CEO at Navidence. He is a physician entrepreneur and an industry-leading advisor in the Real-World Data (RWD) space, specifically focusing on leveraging real-world healthcare data to... Read More →

Kajsa Kvist

Scientific Vice President, Novo Nordisk, Denmark

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands

Akshay Vashist

Exec Dir, Otsuka Pharmaceutical Development & Commercialization, United States

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Forum

Format Forum
Level Intermediate
Featured Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Level Intermediate
Feature Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags Forum

1:15pm PDT

#248: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-586-L04-P; CME 1.00; RN 1.00

This session will provide perspectives from stakeholders on successes and limitations from practical examples and discuss principles and best practices for maximizing the potential while managing the risks moving forward.

Learning Objectives

Describe the current state of the use of artificial intelligence (AI) in the medicinal product lifecycle including its opportunities and challenges; Discuss principles and best practices to maximize potential of AI while managing risks.

Chair

Hilmar Hamann, PhD

Speaker

EMA Update
Lorenzo De Angelis, PhD

Industry Update
Carlyn Crisostomo, MBA

Industry Update
Alexandra (Zan) Cha, PhD, MA

Industry Update
Timothe Menard, PharmD, MSc

Speakers

Lorenzo De Angelis

Platform Architect, European Medicines Agency, Netherlands

Lorenzo De Angelis studied Physics in Sapienza University of Rome, where he graduated cum laude in July 2014. He then moved to the Netherlands, where he obtained his physics PhD in December 2018, with a thesis entitled "The Singular Optics of Random Light". Afterwards, he joined the... Read More →

Alexandra (Zan) Cha

Principal, Chief Technology Office, Booz Allen Hamilton, United States

Zan brings 20+ years of experience in health AI / analytics, and IT /product / ops management, applied to medical devices, pharmaceuticals, supply chain, clinical trials, insurance tech, chronic disease management, and population health & wellness. She is currently focused on advancing... Read More →

Carlyn Crisostomo

Vice President, Head of R&D AI Strategy and Execution (RAISE), Amgen, United States

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands

Timothe Menard

Global Head, Quality Excellence Digital | Bioethics Coach (Data Ethics), F. Hoffmann-La Roche Ltd, Switzerland

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Session | 09: Regulatory, Session

Format Session
Level Intermediate
Featured Topics Artificial Intelligence (AI), Regulator Perspectives
Level Intermediate
Feature Topics Artificial Intelligence (AI),Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

1:15pm PDT

#249: Topics Related to the Oncology Real-Time Oncology Review Process

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-587-L04-P; CME 1.00; RN 1.00

This session focuses on the oncology real-time oncology review (RTOR) process and the considerations compared to a standard oncology submission, medical writing processes, and potential time savings.

Learning Objectives

Describe Real Time Oncology Review (RTOR) and how RTOR can impact global submission planning; Discuss lessons learned and where plans may not match reality; Define how RTOR best-practices can apply to other submissions and accelerated approval pathways.

Chair

Britta Jacobsen, PhD

Speaker

Introduction
Britta Jacobsen, PhD

Industry Update
Michael Gyulay

Industry Update
Linda Bowen, MSc, RAC

FDA Update
Jennifer J. Lee, PharmD, RAC

Speakers

Linda Bowen

Chief of Staff, Oncology Regulatory Strategy, Pfizer Inc, United States

Linda has spent the last 30 years in regulatory strategy, policy, and intelligence roles at Seagen, Sanofi, Bayer, and GSK. She most recently was Chief of Staff, Pfizer Oncology Regulatory Strategy, a role she also had at Seagen. She has also been an Assistant Adjunct Professor in... Read More →

Michael Gyulay

Director, Medical Writing, Oncology and I-Oncology, EMD Serono, United States

Michael has nearly 20 years of industry experience in Medical Writing and currently is a manager of oncology medical writing leads, leading staff to deliver high quality operational and regulatory documentation and driving best writing and review practices. Prior to his time at EMD... Read More →

Britta Jacobsen

Medical Writer and Consultant, Whitsell Innovations, Inc. , United States

Britta is a scientist and medical writer with 26 years of experience in medical research and oncology. Her postdoctoral training piqued her interest in in steroid hormone receptors and preclinical breast cancer research. The opportunity to work on efficacy testing of novel drug combinations... Read More →

Jennifer Lee

Senior Health Scientist, Oncology Center of Excellence, FDA, United States

Jennifer J. Lee, PharmD, RAC is a Sr. Health Scientist in the Oncology Center of Excellence (OCE) at the US Food & Drug Administration (FDA). In this role, she provides regulatory and strategic support for several of the OCE’s initiatives, including the Pediatric Oncology program... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

04: MedAffairs-SciComm, Session

Format Session
Level Intermediate
Level Intermediate
Credit Type ACPE, CME, RN
Tags Session

1:15pm PDT

#250: Implementable Approaches to Fully Integrating Patient Engagement Across an Entire Company: Including all Clinical Trials

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-588-L04-P; CME 1.00; RN 1.00

Increasingly, biopharmas are integrating patient engagement across their corporations in ways that address shared priorities with patient communities. Additionally, they are also increasing the transparency related to delivering on these commitments, including but not limited to, the percent of clinical trials that are informed by patients. This workshop will discuss approaches taken by various companies, the role of advocates, and their perspectives on the importance of achieving meaningful patient engagement, along with the steps necessary to achieve the goals.

Learning Objectives

Describe how to bring together key stakeholders to evaluate how, and where, patient engagement can be fully integrated to address what matters most to patients; Describe how to move beyond patients informing select clinical trials to 100% of a portfolio; Identify how to align resources, capabilities and change management needs to deliver on the vision; Discuss how to communicate and monitor the impact of engagement strategies.

Chair

Victoria DiBiaso, BSN, MPH, RN

Speaker

Implementable Approaches to Fully Integrating Patient Engagement Across an Entire Company: Including all Clinical Trials
Tracey Robertson, MBA

Patient Perspective
Hollie Schmidt, MS

Speakers

Victoria DiBiaso

Global Head, Patient Informed Development and Health Value Translation, Sanofi, France

Vicky has 25+ years of clinical research experience. She holds a Master of Public Health, is a nurse by training. Her work has been published in The Wall Street Journal, she has been recognized as one of the Top 20 Industry Innovators, through integrating patient communities into... Read More →

Tracey Robertson

Head of Patient and Site Engagement Capabilities, Boehringer Ingelheim Pharmaceuticals Inc., United States

As the global CD&O Patient & Site Engagement Capabilities Lead, Tracey's team is responsible for the development the processes, solutions and services supporting all aspects patient and site engagement. She started her career in management consulting with PricewaterhouseCoopers, working... Read More →

Hollie Schmidt

Vice President of Scientific Operations, Accelerated Cure Project, United States

Hollie Schmidt is the VP of Scientific Operations at the Accelerated Cure Project, a research-focused patient advocacy organization for MS. She has planned, developed, and directed numerous initiatives aimed at creating research resources and bridging different stakeholder communities... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Workshop

Format Workshop
Level Intermediate
Featured Topics Patient Focused
Level Intermediate
Feature Topics Patient Focused
Credit Type ACPE, CME, RN
Tags Workshop

1:15pm PDT

#246: The State of Clinical Trials in 2024: Are We Making the Grade?

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-584-L04-P; CME 1.00; RN 1.00

This forum will present metrics developed and tested to understand progress for improving trials by 2030. A panel will provide work in areas of metrics for assessing progress in improving trials and understanding the state of clinical trials in 2024.

Learning Objectives

Discuss current efforts to establish metrics for assessing progress on efforts to improve trials, including improvements to trial design quality and representativeness of trials; Identify areas of trial improvements that may be measured or assessed; Appraise metrics approaches for relevance to improving specific areas of trial operations.

Chair

Summer Starling, DrPH, MPH

Speaker

Panelist
Jennifer Miller, PhD

Panelist
Linda B Sullivan, MBA

Speakers

Summer Starling

Senior Project Manager, Clinical Trials Transformation Initiative (CTTI), United States

Jennifer Miller

Associate Professor of Medicine; Co-Director, Program for Biomedical Ethics, Yale School of Medicine, United States

Jennifer E. Miller, PhD, is an Assistant Professor in NYU School of Medicine and President of Bioethics International. She is also the Creator of the Good Pharma Scorecard, an index that ranks new drugs and pharmaceutical companies on their ethics and public health performance to... Read More →

Linda Sullivan

Senior Fellow, Tufts Center For the Study of Drug Development, United States

Ms Sullivan has more than 30 years of experience working in the Healthcare and Clinical Research industries helping organizations optimize processes to improve financial and quality outcomes. She is the founder and served as Executive Director of the Metrics Champion Consortium, an... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Forum | 02: ClinTrials -ClinOps, Forum

Format Forum
Level Intermediate
Level Intermediate
Credit Type ACPE, CME, RN
Tags Forum

1:15pm PDT

#251: Enabling Patient Access Worldwide Including Japan or Other Countries to Innovative Drugs Through Global Development Strategy

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-589-L04-P; CME 1.00; RN 1.00

This forum will present the considerations in global development strategy to approach to broader market including Japan for maximizing worldwide patient access and business opportunity. The panelists are from pharma and biotech.

Learning Objectives

Describe how to maximize the value of innovative products for the global market and benefit patients worldwide; Discuss how to apply the learnings to the clinical development strategy to expand target market effectively considering patient access to innovative drugs; Identify how to influence to regulators, industry, and trial sites to improve local environment to reduce hurdles and enhance global simultaneous development.

Chair

Eri Sekine

Speaker

Panelist
Leyna Mulholland, PharmD, PhD, MS

Panelist
Toshiharu Sano, RPh

Panelist
Xiaojun (Wendy) Yan, MD, MBA

Speakers

Eri Sekine

Executive Vice President, CMIC Group, Japan

Eri Sekine is Executive Vice President of CMIC Co., Ltd. and in charge of Data Business which includes Clinical Data Management, Biostatistics, Statistical Analysis, Pharmacovigilance, Outsourcing Management and Quality Management. Eri Sekine has over 30 years' experience in various... Read More →

Leyna Mulholland

Executive Director, Global Regulatory Affairs, Transent Group, United States

Leyna is a registered pharmacist in Japan and obtained PharmD, MS/PhD in Toxicology from the University of Michigan. Her career started in academic research focused on gene mutations and carcinogenicity in the Med School at the U of M and graduate courses teaching at Indiana University... Read More →

Toshiharu Sano

Associate Vice President, Head of Clinical Operation Area, MSD K.K., Japan

Toshiharu Sano has over 30 years of experience in pharmaceutical industry and has broad experiences in Clinical Research, R&D planning and Business Operations for Clinical Development in Japan. He also worked as several initiative’s leads and change manager through his career in... Read More →

Toshihiro Sano

Associate Vice President, Head of Clinical Operations, Merck Sharp & Dohme LLC , United States

Xiaojun (Wendy) Yan

Senior Vice President, Chief Regulatory Officer, BeiGene (Beijing) Co., Ltd., China

Wendy is a pharmacist by training, having graduated from Beijing Traditional Chinese Medicine University (China) and received an MBA from Staffordshire University (UK). She began her career in Beijing Drug Control Institute, subordinate organization of China NMPA in 1988. Since... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

07: ProjectManagement-StrategicPlanning, Forum

Format Forum
Level Intermediate
Featured Topics Diversity Equity and Inclusion (DEI), Patient Focused
Level Intermediate
Feature Topics Diversity Equity and Inclusion (DEI),Patient Focused
Credit Type ACPE, CME, RN
Tags Forum

1:15pm PDT

#253: Platform Technology Designation: Opportunities and Challenges for Implementation

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-591-L04-P; CME 1.00; RN 1.00

This forum will review the key components of the new FDA Platform Technologies Designation program. A panel of experts will provide their perspectives on the proposal and discuss opportunities and challenges related to its implementation.

Learning Objectives

Describe the key attributes of the proposed Platform Technology Designation Program as described by the anticipated FDA draft guidance; Discuss stakeholder perspectives about the new designation program; Describe anticipated opportunities and challenges related to its implementation.

Chair

Andrea Doyle

Speaker

Panelist
Rachael Anatol

Panelist
Evdokia Korakianiti, PhD, MSc

Panelist
Monica Veldman

Speakers

Rachael Anatol

Deputy Super Office Director, Office of Therapeutic Products, CBER, FDA, United States

Andrea Doyle

Head, Global Regulatory Affairs, Neurology, Sanofi, United States

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands

Monica Veldman

Director, Global Regulatory Policy, Alliance for Regenerative Medicine, United States

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Format Forum
Level Intermediate
Featured Topics Digital Technology
Level Intermediate
Feature Topics Digital Technology
Credit Type ACPE, CME, RN
Tags Forum

1:15pm PDT

#254: FDA Rare Disease Town Hall

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-593-L04-P; CME 1.00; RN 1.00

Hear from senior FDA leadership about challenges and opportunities in reviewing drugs for rare diseases. Representatives from key Agency Offices/Centers will provide updates on key trends and initiatives, then will discuss hot topic questions.

Learning Objectives

Discuss recent trends in the development and FDA review of orphan drugs; Explain new and ongoing FDA policies and initiatives to facilitate the development of drugs for rare diseases; Identify opportunities to further address the challenges associated with rare disease medical product development.

Chair

James Valentine, JD, MHS

Speaker

Panelist
Kerry Jo Lee, MD

Panelist
Peter W. Marks, MD, PhD

Speakers

James Valentine

Director, Hyman, Phelps & McNamara, PC, United States

James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →

Kerry Jo Lee

Assoc. Dir. for Rare Diseases; Program Manager, Advancing Rare Disease Cures Pro, FDA, United States

Dr. Kerry Jo Lee is a graduate of Princeton University and of the New York University School of Medicine with an honors degree conferred in microbiology. She completed residency in pediatrics at the Children’s Hospital of Los Angeles and a post-doctoral clinical fellowship in Pediatric... Read More →

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA, United States

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Format Session
Level Intermediate
Featured Topics Rare Disease, Special Populations
Level Intermediate
Feature Topics Rare Disease,Special Populations
Credit Type ACPE, CME, RN
Tags Forum

1:15pm PDT

#245: The European Clinical Trials Environment Under the Accelerating Clinical Trials (ACT EU) Initiative: Two Years On

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-583-L04-P; CME 1.00; RN 1.00

Accelerating Clinical Trials in the EU (ACT EU) and the successful launch of the clinical trial regulation have modernized the clinical trial environment. This session is focused on how Europe is embracing the change and will also present other international initiatives offering opportunities for collaboration.

Learning Objectives

Describe how ACT EU, together with other EU initiatives, is providing a platform to optimize clinical research and development, and fostering innovation through joint collaborations between member states, ethics committees, and stakeholders, bringing tangible benefits for patients, sponsors, and regulators; Discuss other international clinical trial initiatives and potential areas of collaboration.

Chair

Ana Zanoletty Perez

Speaker

FDA Update
Shari Targum, MD, MPH, FACC, FACP

Academic Update
Sara Bristol Calvert, PharmD

Patient Advocate Perspective
Deborah Collyar

WHO Update
Marion Laumonier, MSc

Speakers

Sara Calvert

Director of Projects, Clinical Trials Transformation Initiative (CTTI), United States

Deborah Collyar

President, Patient Advocates In Research (PAIR), United States

Deborah Collyar is founder and president of Patient Advocates in Research (PAIR), “where research meets reality.” Her leadership in patient engagement and advocacy started in the 1990s after her first cancer diagnosis. She applies business leadership, IT, communication and strategic... Read More →

Marion Laumonier

Technical Officer, Regulatory Convergence and Networks, World Health Organization (WHO), Switzerland

Marion Laumonier is currently Technical Officer in the Regulatory Convergence and Networks team at the WHO in Geneva, Switzerland. Marion Laumonier joined the WHO in 2021 and has over 20 years of experience gained in different settings, pharmaceutical industries and non-profit organizations... Read More →

Ana Zanoletty Perez

Head of Clinical Trials Transformation workstream, European Medicines Agency, Netherlands

Ana qualified as a pharmacist and following various roles managing clinical trials for the biopharmaceutical industry joined EMA in 2006. At EMA she spent her initial years coordinating initial marketing authorisation procedures, and later transitioned into the management of post-authorisation... Read More →

Shari Targum

Deputy Director, Office of Clinical Policy, OC, FDA, United States

Dr. Shari Targum has over 30 years of clinical, industry and regulatory experience. She began her FDA career in 1999 as a Medical Officer and then Team Leader in CDER's Division of Cardiovascular and Renal Products and she has held positions of increasing authority in CDER and CBER... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session | 02: ClinTrials -ClinOps, Session

Format Session
Level Intermediate
Featured Topics Ethics, Regulator Perspectives
Level Intermediate
Feature Topics Ethics,Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

1:15pm PDT

#255: International Harmonization to Support Pharmaceutical Quality and Lifecycle Management

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-594-L04-P; CME 1.00; RN 1.00

Since establishment in 1990, the International Council for Harmonisation (ICH) has expanded its global footprint to harmonize requirements for the development of medicines and to increase patient access to medicines. Importantly, ICH’s quality portfolio serves to support continual improvement and innovation in biopharmaceutical manufacturing. In 2018, ICH published its quality mission to “develop a harmonised pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science” driving the development of several new guidelines addressing topics on lifecycle management, quality risk management, continuous manufacturing, and analytical procedure development and validation. With ICH’s expansion, it has prioritized the adequate implementation and adherence of guidelines through its work to promote training and periodically conduct a survey to assess guideline implementation by ICH Members and Observers. This session will provide global regulatory and industry perspective regarding progress made on the ICH quality mission and explore future opportunities to achieve greater harmonization and encourage the global community to embrace the science and risk-based approaches. Case studies will be presented highlighting the objectives and work to facilitate a globally aligned approach to implementation of ICH guidelines.

Learning Objectives

Describe objectives of international harmonization through ICH to promote innovation and facilitate more efficient lifecycle and post-approval change management; Discuss status of key ICH Guidelines such as Q13, Q12 and Q14 and their implementation globally; Evaluate case studies and identify opportunities to advance global harmonization.

Chair

Amanda Marie Roache, MS

Speaker

Lifecycle Strategies at the Interface Between ICH Q12 and ICH Q14
Connie Langer, MSc

ICH Q14: Analytical Procedure Development and Lifecycle Management
Nina S. Cauchon, PhD

FDA Update
Sau L Lee, PhD

Update from Japan on Q12
Satomi Yagi

Speakers

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States

Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related to international regulatory policy, advocacy... Read More →

Nina Cauchon

Director Regulatory Affairs CMC, Amgen, United States

Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She has experience leading both early phase & commercial programs, including small molecules and biologics. Her areas of interest are regulatory challenges for innovative modalities and emerging technologies... Read More →

Connie Langer

Senior Director, Pfizer Inc, United States

Connie Langer is a Senior Director at Pfizer who leads a team that monitors and advises on regulatory changes and impacts. She collaborates with experts to communicate Pfizer's feedback and position to health authorities on regulations and guidance documents. She also has experience... Read More →

Satomi Yagi

Reviewer, Office of New Drug III, Pharmaceuticals and Medical Devices Agency (PMDA)

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands

Sau Lee

Deputy Super Office Director, OPQ, CDER, FDA, United States

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum | 10: RegCMC-Product Quality, Forum

Format Forum
Level Intermediate
Featured Topics ICH
Level Intermediate
Feature Topics ICH
Credit Type ACPE, CME, RN
Tags Forum

1:15pm PDT

#256: Successful Strategies for Leading and Influencing Without Authority in an Evolving Digital Landscape

Component Type: Workshop
Level: Intermediate

This workshop will discuss best practices and essential skills for leading without authority. Attendees with go through a real-world case study for leading a cross functional team through a long-term project without formal authority. This workshop will delve into essential strategies for fostering alignment, cultivating open communication, promoting agility, and successfully navigating barriers within organizations.

Learning Objectives

Discuss best practices and develop the essential skills needed for leading without authority in a cross functional team environment; Describe influencing stakeholders, negotiation tactics, and relationship building..

Chair

Mica Elizalde, RAC

Speaker

Facilitator
Connie Pascual, MSc

Speakers

Mica Elizalde

Principal Scientist, Regulatory Digital Health, Merck & Co., Inc., United States

Connie Pascual

Principal Scientist, Regulatory Digital Health, Merck & Co., Inc., United States

Connie is currently a Director of Regulatory Affairs (Digital Health) at Merck. She has worked in the medical device industry in Regulatory Affairs for over 14 years focused on digital health technologies. She has successfully managed, led, and authored domestic and international... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

13: ProfDevelopment, Workshop

Format Workshop
Level Intermediate
Featured Topics Digital Technology
Level Intermediate
Feature Topics Digital Technology
Tags Workshop

2:15pm PDT

#259 RT: Roundtable Discussion: Be Creative and Innovative - A Simple Step-by-Step Decision Science Based Process for You and Your Team

Component Type: Session
Level: Intermediate

Join the Professional Education, Training & Development/Project Management Community for a follow up round table discussion tied to session: Be Creative and Innovative - A Simple Step-by-Step Decision Science Based Process for You and Your Team (June 17 | 3:30-4:30PM PDT). Space is limited.

Learning Objectives

identify ways to apply concepts and techniques from the session

Chair

Tyler Ludlow, MBA

Speaker

Discussion
Candice Junge, PhD

Speakers

Candice Junge

Executive Director, Neurology Program and Clinical Lead, Ionis Pharmaceuticals, Inc., United States

Candice Junge is a Director in Amgen's Development Design Center working across therapeutic areas to develop novel program and clinical study design strategies. The Design Center team brings broad clinical development expertise, data modeling and analytics, and operational insights... Read More →

Tyler Ludlow

Founder and Chief Decision Scientist, Decision Skills Institute, United States

Tyler helps people turn their decision burdens into opportunities for growth. After earning a degree in applied math and an MBA, he studied decision science at Stanford. He then spent 15 years helping leaders at global 500 firms (including 18 of the top 20 pharma companies), make... Read More →

Tuesday June 18, 2024 2:15pm - 3:15pm PDT
Ballroom 20 D/ Zone 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 07: ProjectManagement-StrategicPlanning, Session | 13: ProfDevelopment, Session

Level Intermediate
Level Intermediate
Tags Session

2:15pm PDT

#257 RT: Roundtable Discussion: Good Data Governance Practices - Regulatory and Industry Perspectives

Component Type: Session

Join the Good Clinical Practices & QA Community for a follow up round table discussion tied to session: Good Data Governance Practices and the Importance of Incorporating Input from the Data Scientist in Quality by Design (Tuesday, June 18 | 8:00AM - 9:00AM PDT). Space is limited.

Chair

Terry Katz, MS

Speakers

Terry Katz

Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States

Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →

Tuesday June 18, 2024 2:15pm - 3:15pm PDT
Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 08: RD Quality-Compliance, Session

Tags Session

2:15pm PDT

#258 RT: Roundtable Discussion: Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability

Component Type: Session

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability (Tuesday, June 18 | 8:00am - 9:00AM PDT). Space is limited.

Chair

Demetra Macheras, MBA

Speakers

Demetra Macheras

Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, United States

Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S., Canada, ICH, and WHO regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and... Read More →

Tuesday June 18, 2024 2:15pm - 3:15pm PDT
Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 09: Regulatory, Session | 10: RegCMC-Product Quality, Session

Tags Session

2:15pm PDT

Refreshment Break

Component Type: Social Event

Tuesday June 18, 2024 2:15pm - 3:15pm PDT
Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Networking Opportunities, Social Event

Tags Social Event

2:30pm PDT

#259.1 IS: Arnold Venture Innovation Session: Better Drug Information for Payers, Physicians, and Patients

Component Type: Session

Shared decision-making between patients and their healthcare providers about their treatments is important, and these complex decisions can be facilitated by presenting knowledge in an intuitive manner about the benefit/risk of various therapies based on the insights learned during the clinical investigation. This session will critically consider scientific issues related to communicating drug information advances expeditiously and safely.

Chair

Arnold Ventures

Speaker

Speaker
Rita F. Redberg, MD, MSc, FACC

Speaker
Steven Woloshin

Speakers

Rita Redberg

Director, Women's Cardiovascular Services; Professor of Medicine, UCSF Medical Center, United States

Dr. Redberg is a general Cardiologist and interested in preventive cardiology. Her research interests are in our use of medical procedures and devices. She studies the regulatory process for medical devices and the strength of evidence that supports them, particularly high-risk devices... Read More →

Steven Woloshin

Professor, Dartmouth Institute, United States

Dr. Steven Woloshin is co-director of the Center for Medicine and Media at The Dartmouth Institute and a general internist. He and Lisa Schwartz co-created the drug facts box, drug-benefit and harm-data summaries shown in clinical trials to improve consumer decision-making. The FDA's... Read More →

Arnold Ventures

United States

Tuesday June 18, 2024 2:30pm - 3:00pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Networking Opportunities, Session

Tags Session

2:30pm PDT

#260 IT: Milliman IntelliScript Innovation Theater: Pre-Screening for Clinical Trials - The Revolution Starts in 3, 2, 1…

Component Type: Session

Pre-screening trial participants is tough when you don’t have access to full medical records. Instead, collect a HIPAA authorization and let Milliman IntelliScript retrieve and interpret prescription and medical data. Just upload name, zip, and DOB to access our proprietary data on most US residents. Filter by customizable inclusion and exclusion criteria in seconds for easier, more accurate pre-screening. Randomize more participants, realize more revenue, and push more trials to completion.

Chair

Milliman IntelliScript

Speaker

Speaker
Alyssa Vincze

Speakers

Milliman IntelliScript

United States

Alyssa Vincze

Principal and Director, R&D, Milliman IntelliScript

Alyssa is an actuary serving as Principal and Director of R&D with Milliman IntelliScript, a company with a long history of disruptive innovation in the life and health insurance sectors. She recently led product development for IntelliScript’s clinical trials solution, adapting... Read More →

Tuesday June 18, 2024 2:30pm - 3:00pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

2:30pm PDT

#261 IT: Parexel Innovation Theater: FSP Partnership - A Foundation for Innovation and Patient-Guided Development

Component Type: Session

Optimal outsourcing is not a one-size-fits-all approach. FSP outsourcing has evolved beyond its origins as an efficiency model to manage clinical development labor demands to provide greater control over data, processes and resource allocation. Pfizer recently transitioned from predominately full-service outsourcing to an FSP model while adopting new job roles that prioritize patients and sites. Learn how Pfizer & Parexel created resource efficiencies & agility across a global study portfolio.

Chair

Parexel

Speaker

Speaker
Liz Rogers, MSc

Speakers

Parexel

United States

Liz Rogers

Vice President, Head of Global Site and Study Operations, Pfizer Inc, United States

As Vice President and Worldwide Head of Global Site and Study Operations at Pfizer, Liz is responsible for leading the management and oversight of global investigator site planning and clinical trial execution. Global Study and Site Operations supports the delivery of the Pfizer portfolio... Read More →

Tuesday June 18, 2024 2:30pm - 3:00pm PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

2:30pm PDT

#262 IT: Weave Innovation Theater: Minutes, Not Months - How to Draft an Efficient IND

Component Type: Session

Drafting an effective IND is critical to your organization’s valuation and success. How would being able to do so in minutes rather than months free up you and your team? Learn how you can focus on other key objectives and activities by automating tedious tasks and leveraging your expertise where it matters most: getting therapies to market.

Chair

Weave AI

Speaker

Speaker
Brandon Rice

Speakers

Brandon Rice

CPO, Weave, United States

I am Brandon and I lead Product at Weave. We are building AutoIND, an AI-powered software platform to streamline every aspect of IND preparation. I am deeply committed to building products that positively impact human lives, create meaningful value for our customers, and are delightful... Read More →

Tuesday June 18, 2024 2:30pm - 3:00pm PDT
Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

3:15pm PDT

#263: Risk Management Planning- Some Twenty Years Later: Where we Started, How Far we have Come and a Modern Path Forward

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-595-L04-P; CME 1.00; RN 1.00

This session provides an opportunity to pause and reflect on how far we have come and discuss areas for future focus, innovation, and key influential drivers for change from a scientific, technological and patient-centric perspective.

Learning Objectives

Describe the evolution in the use of risk management principles in the context of patient safety; Discuss the role of real-time information and collaboration/engagement as the catalyst for action in risk management; Identify current limitations and challenges; List specific case examples from a public health and patient safety perspective; Discuss opportunities for future innovations.

Chair

Rania Mouchantaf, PhD

Speaker

FDA Update
Gerald Dal Pan, MD, MHS

MHRA Update
Alison Cave, PhD

Effectiveness of Interventions: Successes and Challenges
Yola Moride, PhD, FISPE

Industry Update
Mamiko Kasho

EMA Update
Priya Bahri, PhD, RPh

Speakers

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands

Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation... Read More →

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Mamiko Kasho

Executive Director, Global PV Management Dept., Global Safety HQs, Eisai Co., Ltd., Japan

Mamiko Kasho is Executive Director of Global Pharmacovigilance Management in Global Safety HQ of Eisai Co., Ltd, and has been involved in global PV area since she joined the company in 2007. Mamiko has been responsible for PV agreements with licensing partners for 15 years and at... Read More →

Yola Moride

President, YolaRX Consultants, Canada

Prof. Yola Moride has a strong track record of methodological expertise in pharmacoepidemiology and therapeutic risk management. She is Research Professor at Rutgers University and President of YolaRX Consultants. She received a PhD in Epidemiology from McGill University and a Post-doctoral... Read More →

Rania Mouchantaf

A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD, Health Canada, Canada

Dr. Rania Mouchantaf is A/Executive Director at the Marketed Health Products Directorate at Health Canada with over 17 years of experience in the area of pharmacovigilance. Before entering the public service she worked in the private sector, however her interest in pharmacovigilance... Read More →

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session

Format Session
Level Intermediate
Featured Topics Risk Management, Patient Focused
Level Intermediate
Feature Topics Risk Management,Patient Focused
Credit Type ACPE, CME, RN
Tags Session

3:15pm PDT

#265: Practical Approaches and Resources to Optimize Advocacy Group - Industry Collaborations: An Update on the PALADIN Consortium

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-597-L04-P; CME 1.00; RN 1.00

This session will discuss patient advocacy groups and pharmaceutical companies and the co-created the patient advocacy leaders and drug development industry network (PALADIN), a US focused pre-competitive and disease agnostic Consortium, to advance the pace of medicines development.

Learning Objectives

Describe progress made by PALADIN (patient advocacy leaders and drug development industry network), a pre-competitive alliance of 20+ organizations formed in 2023; Discuss how the Consortium was established, it’s mission and governance; Identify year one resources created to optimize collaborations; Discuss priority year two activities and long-range plans.

Chair

Victoria DiBiaso, BSN, MPH, RN

Speaker

Practical Approaches and Resources to Optimize Advocacy Group - Industry Collaborations: An Update on the PALADIN Consortium
Kenneth Getz, MBA

Patient Perspective
Hollie Schmidt, MS

Speakers

Victoria DiBiaso

Global Head, Patient Informed Development and Health Value Translation, Sanofi, France

Kenneth Getz

Tufts Center for the Study of Drug Development, Center For the Study of Drug Development, United States

Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... Read More →

Hollie Schmidt

Vice President of Scientific Operations, Accelerated Cure Project, United States

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Forum

Format Forum
Level Intermediate
Featured Topics Patient Focused, Regulatory Collaboration
Level Intermediate
Feature Topics Patient Focused,Regulatory Collaboration
Credit Type ACPE, CME, RN
Tags Forum

3:15pm PDT

#266: Exploiting Real-World Data From Social Media in Patient-Focused Drug Development

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-692-L04-P; CME 1.00; RN 1.00

Social media is an important new source of real-world data (RWD) for patient-focused drug development. This session will present a review of considerations from an industry and regulators perspectives when listening to social media from patients.

Learning Objectives

Summarize the work done by group of experts from companies’ members; Discuss the challenges and opportunities of exploiting real-world data (RWD) from social media listening for R&D purposes and regulatory submissions; Propose best practices.

Chair

Thierry H Escudier, MSc

Speaker

Industry Update
Sarah Lyons

Academic Update
Philipp Cimiano, PhD

Industry Update
Vishakha Sharma, PhD

Speakers

Philipp Cimiano

Head of Semantic Computing Group, Director, Joint AI Center, Bielefeld University, Germany

Philipp is an expert in Artificial Intelligence and Natural Language Processing. He graduated in computer science and obtained his PhD and habilitation from KIT. Since 2009, he is full professor for computer science at Bielefeld University. He leads the Semantic Computing group and... Read More →

Thierry Escudier

Chairman, Strategic Consulting, DCRIPT, France

Leader in Clinical Research, with more than 30 year’s experience in Corporate R&D pharma organizations , Thierry has been promoting patient engagement strategy across the Industry. Thierry is now acting as an independent consultant providing strategic consulting and is very much... Read More →

Sarah Lyons

Vice President, Data Transformation and AI Platforms, DTA and AI, IQVIA, Canada

Sarah Lyons is a Vice President responsible for IQVIA’s Data Transformation & AI Platforms serving healthcare and life science organizations globally with capabilities spanning privacy-enhancing technologies, natural language processing, and AI-enabled language solutions. In addition... Read More →

Vishakha Sharma

Senior Principal Data Scientist, Roche, United States

Vishakha Sharma, senior principal data scientist at Roche Diagnostics Information Solutions, leads NLP and ML initiatives, improving navify product portfolio for enhanced patient care. Vishakha has authored over 50 peer-reviewed publications and given 20+ invited talks. She serves... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Session

Level Basic
Featured Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Level Basic
Feature Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags Session

3:15pm PDT

#270: Something Borrowed Something New for Effective Project Management: Adopting Different Thinking Approaches and New Technologies in Life Science Project Management

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-602-L04-P; CME 1.00; PDU 1.00 PMI 2166XALVLX; RN 1.00

Many project management methodologies, alternative thinking approach and new technologies can be applied to life science project management and bring many benefits. In this session, the adoption of Design Thinking and Generative AI, two of the emerging topics in health care industry, into life science project management will be discussed. The session will also demonstrate, with case studies, the possibilities of implementing new thinking approach for effective project management, team leading and efficient business process development. We will also examine practical applications of Generative AI in project management from optimizing scheduling, resource planning, and risk management. Reflecting on the current adoption efforts, this session provides a platform to explore possibilities to leverage new thinking and technologies to enhance life science project management.

Learning Objectives

Critique how many project management methodologies, thinking approaches, and new technologies can be applied to life science projects, and they may bring various benefits into the practice; Implement applicable methodologies and protocol new technologies in real-world practice.

Chair

Char Leung

Speaker

Industry Update
Rune Bergendorff, MSc

Speakers

Char Leung

Director, Development Program Management, Genmab, United States

Char Leung is a Director, Development Program Management at Genmab where she leads the operationalization of drug development strategies. Prior to Genmab, Char spent 9 years at Janssen R&D managing biologics discovery and development projects with increasing responsibilities. Char... Read More →

Rune Bergendorff

Partner, International Life Sciences, Implement Consulting Group, Denmark

Rune Bergendorff, Partner at Implement Consulting, boasts two decades of consultancy experience spanning Europe and the US. Educated in IT and business, his focus is centered on delivering sustainable digital transformations that drive business impact and value. Over the past 15 years... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Session | 07: ProjectManagement-StrategicPlanning, Session

Format Session
Level Intermediate
Featured Topics Artificial Intelligence (AI)
Level Intermediate
Feature Topics Artificial Intelligence (AI)
Credit Type ACPE, CME, PMI, RN
Tags Session

3:15pm PDT

#268: Strategies to Make your Clinical Trials More Inclusive for Patients with Disabilities

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-600-L04-P; CME 1.00; RN 1.00

This workshop will assist attendees with ways to properly accommodate medically complex and/or rare disease patients through providing accessibility tools and solutions. Soft skills and “person first” language will be discussed.

Learning Objectives

Identify how to expand the definition of diversity; Describe how to have conversations with patients about disabilities; Explore solutions and recommendations for no/low-cost actions you can take to make your facility as accessible as possible for a variety of disabilities; Define resources for support and training for site staff.

Chair

Stacy Hurt, MBA, MHA

Speaker

Facilitator
Carlos Orantes, MBA

Facilitator
Cecile Gonzalez-Cerimele

Facilitator
Mindy Cameron

Speakers

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel International, United States

Stacy Hurt, MHA, MBA is an award-winning 25 year pharma executive who bridges the industry/consumer gap as a stage IV cancer survivor and 24/7 caregiver to her son with a rare disease. Her unique professional and personal experience position her as an esteemed patient advocate as... Read More →

Mindy Cameron

Patient Advocate, Advocacyworks, United States

Mindy Cameron's evolution as a rare disease patient expert started over 20 years ago when her second son was diagnosed with Duchenne muscular dystrophy. Through her work with non-profit, research, and industry organizations, Mindy has become a recognized voice for patients living... Read More →

Cecile Gonzalez-Cerimele

Executive Director Diversity and Inclusion in Clinical Trials, Eli Lilly and Company, United States

Leader with over 30 years in the pharmaceutical sector spanning discovery, New Product Planning, late-stage development, and COVID-19 Ab program. Current focus is on crafting strategies that bolster awareness, education, and availability of CTs for underrepresented groups worldwide... Read More →

Carlos Orantes

Chief Executive Officer, Alcanza Clinical Research, United States

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Workshop

Format Workshop
Level Intermediate
Featured Topics Diversity Equity and Inclusion (DEI), Rare Disease, Special Populations
Level Intermediate
Feature Topics Diversity Equity and Inclusion (DEI),Rare Disease,Special Populations
Credit Type ACPE, CME, RN
Tags Workshop

3:15pm PDT

#264: Enhancing Adoption of Innovative Approaches in Clinical Trials

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-596-L04-P; CME 1.00; RN 1.00

This forum will explore the U.S. FDA Center for Drug Evaluation and Research's portfolio of clinical trial innovation activities, including its newly established CDER Center for Clinical Trial Innovation (C3TI). C3TI serves as a central hub supporting innovative approaches to clinical trials aimed at improving the efficiency of drug development. Speakers from the FDA will elaborate on C3TI and its role in supporting innovative clinical trial designs. The FDA presenters will be joined by industry and patient speakers for a panel discussion on opportunities to enhance implementation and adoption of innovative approaches in clinical trials, aiming to ensure patient-centric trial design, improve the efficiency of clinical trials, increase the participation of diverse populations, and, in turn, accelerate the development of safe and effective new drugs.

Learning Objectives

Discuss key challenges or barriers to implementation and adoption of innovative approaches in clinical trial design, conduct, and execution; Discuss strategies to enhance implementation and adoption of innovative approaches in clinical trial design, conduct, and execution.

Chair

Meghana Chalasani, MHA

Speaker

Panelist
Kevin Bugin, PhD, MS, RAC

Panelist
Ella Balasa

Panelist
Michelle Rohrer, PhD

Panelist
Allison Cuff Shimooka, MBA

Speakers

Meghana Chalasani

Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER, FDA, United States

Meghana Chalasani is the Associate Director for Clinical Trial Innovation in the Office of New Drugs (OND) in U.S. FDA’s Center for Drug Evaluation and Research (CDER). She is the program manager for the CDER Center for Clinical Trial Innovation and also co-leads the New Drugs Regulatory... Read More →

Kevin Bugin

Deputy Director of Operations, Office of New Drugs, CDER, FDA, United States

Dr. Kevin Bugin is the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER). In addition, he leads the CDER Center for Clinical Trial Innovation (C3TI) which aims to promote the implementation of innovative clinical... Read More →

Michelle Rohrer

Senior Vice President, Global Head of Product Development Regulatory and Policy, Genentech Roche, United States

Michelle Rohrer, PhD is Global Head of Product Development Regulatory and Policy. Michelle has worked at the company for 27 years, starting as a post-doctoral fellow. She has worked as a clinical scientist, team leader, and regulatory strategist. In 2013, Michelle was named by the... Read More →

Ella Balasa

Patient Advocate and Engagement Consultant, Balasa Consulting, United States

Ella Balasa is a patient advocate, consultant, and a person living with cystic fibrosis. She has committed her time to empowering patients and advancing healthcare strategies. She speaks publicly about the value of patient perspective and has a passion for distilling clinical information... Read More →

Allison Cuff Shimooka

Chief Operating Officer, Transcelerate Biopharma Inc, United States

Allison serves as the Chief Operating Officer of TransCelerate BioPharma Inc. In this role, Allison is responsible for translating TransCelerate’s strategic vision into operational plans in close partnership with the leadership team, member companies, and Board of Directors. She... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Forum | 09: Regulatory, Forum | 02: ClinTrials -ClinOps, Forum

Format Forum
Level Basic
Featured Topics Regulator Perspectives
Level Basic
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

3:15pm PDT

#269: For Whom the Cell Tolls: Ethics in the Era of Precision Medicine

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-601-L04-P; CME 1.00; RN 1.00

This session will discuss how precision medicine will combine medicine and technology in unique ways to maximize healthcare services and outcomes. At the heart of the issue lie ethical concerns related to privacy, informed consent, and social justice.

Learning Objectives

Analyze latest ethical expectations and challenges; Discuss potential future innovation platforms providing significant benefit to be gained from precision medicine; Recognize the bioethical challenges and opportunities ahead.

Chair

James Wabby, MHS

Speaker

Bioethics Cases and Policy Development
Terry David Church, DrSc, MA, MS

Ethical Frontiers: Navigating Transplant and Genetic Ethical Considerations in Patient Care
Amanda Burkhardt, PhD

Speakers

Amanda Burkhardt

Assistant Professor, Alfred E. Mann School of Pharmacy and Pharma Sciences, University of Southern California, United States

Prior to joining USC Mann faculty, Amanda M. Burkhardt was an adjunct assistant professor at the University of California, Irvine, in the School of Medicine, Department of Physiology & Biophysics; and lecturer in the Department of Biological Sciences at California State University... Read More →

Terry Church

Assistant Professor, Alfred E Mann School of Pharmacy and Pharma Sciences, University of Southern California, United States

Dr. Terry David Church is currently an Assistant Professor in Regulatory and Quality Sciences at the University of Southern California, Mann School of Pharmacy and Pharmaceutical Sciences. He is Assistant Director of Pharmacy Undergraduate Programs. Prof. Church's academic focus is... Read More →

James Wabby

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States

James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 22 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

06: TranslationalDelivery Tech-PrecMedicine, Forum

Format Forum
Level Basic
Featured Topics Ethics
Level Basic
Feature Topics Ethics
Credit Type ACPE, CME, RN
Tags Forum

3:15pm PDT

#271: How Will the Increasing use of Real-World Evidence for Regulatory Decision-Making Impact QA Strategies and GCP Inspections?

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-603-L04-P; CME 1.00; RN 1.00

This session will bring regulators and industry quality experts together to explore how quality management systems can be developed to meet the challenges real-world evidence presents to QA activities and regulatory inspection expectations.

Learning Objectives

Evaluate quality challenges associated with the use of real-world evidence as part of regulatory studies; Discuss how to apply proportionate risk-based quality assurance activities which meet regulatory expectations.

Chair

Andrew Gray, PhD

Speaker

FDA Update
L'Oreal Walker

FDA Update
Lee H. Pai-Scherf, MD

Industry Perspective
Abi Seifert, MBA

Speakers

Andrew Gray

Director, QA Clinical Therapeutic Area Head, Johnson & Johnson, United Kingdom

Andrew is a member of Johnson and Johnson's R&D Quality organisation where he has responsibility for risk-based audit strategies across the company’s clinical therapeutic areas. With an active interest in the use of RWE for regulatory decision making, Andrew was responsible for... Read More →

Lee Pai-Scherf

Senior Physician, GCP Assessment Branch, DCCE, OSI, OC, CDER, FDA, United States

Lee H. Pai-Scherf, MD, Senior Physician, OSI, Office of Compliance, CDER, FDA Dr. Pai-Scherf is a Senior Physician in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory... Read More →

Abi Seifert

Global Head Country Development Quality, Novartis , United States

Abi has worked in the Pharma industry for over 25 years, serving in clinical development in both QA and operational roles. Her career started in clinical study monitoring and GCP auditing and evolved into roles that defined strategy around project management, process excellence and... Read More →

L'Oreal Walker

Supervisory Consumer Safety, OBIMO, ORA, FDA, United States

L'Oreal Walker is a seasoned professional with over two decades of experience in regulatory compliance and oversight. Currently serving as a Supervisory Investigator in the Office of Bioresearch Monitoring West Division within the Office of Regulatory Affairs at the FDA, L'Oreal leads... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

08: RD Quality-Compliance, Session

Format Session
Level Intermediate
Featured Topics Risk Management, Real-World Data (RWD)- Real-World Evidence (RWE)
Level Intermediate
Feature Topics Risk Management,Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags Session

3:15pm PDT

#272: This is Your Pilot Speaking: The Journey from Regulatory Pilot Program Innovation to Routine Practice

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-604-L04-P; CME 1.00; RN 1.00

This panel will explore the blue skies of global regulatory pilot programs, including initiatives on real-world evidence (RWE), model-informed drug development (MIDD), innovative trials, and endpoints. Panelists will educate the audience on new opportunities and best practices for future pilot success.

Learning Objectives

Critique new opportunities to participate in regulatory pilot programs at FDA and globally; Outline key lessons learned from pilot program case studies and experiences; Identify best practices to increase the likelihood of success for future pilot programs.

Chair

Andrew Emmett, MPH

Speaker

Moderator
Danielle Friend Economo, PhD

PDUFA VII Rare Disease Endpoint Advancement Program
Mary Jo Salerno, MPH, MS

Industry Update
Donna Boyce, MS, RAC

Industry Update
Rasika Kalamegham, PhD

Speakers

Danielle Friend Economo

Senior Director, US Head Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States

Dr. Danielle Friend received her Ph.D. in neuroscience in 2013 from the University of Utah. After completing her graduate work, Danielle conducted postdoctoral research at the National Institutes of Health. In 2016, Danielle was selected as a Science and Technology Policy Fellow with... Read More →

Andrew Emmett

FDA Liaison | US Regulatory Policy and Global Intelligence, Pfizer Inc, United States

Andrew Emmett is Pfizer's FDA Liaison and Executive Director for U.S. Regulatory Policy & Global Intelligence. In his role, Andrew develops and advocates for Pfizer policy positions to enhance the regulatory environment for biomedical innovation. He leads key initiatives on real-world... Read More →

Donna Boyce

Head and Senior Vice President of Global Regulatory Sciences, Pfizer Inc, United States

Donna Boyce is Senior Vice President of Global Regulatory Sciences and a member of the Pfizer Research and Development (PRD) Leadership Team. She joined Pfizer in May 2013 as the Vice President, Global Regulatory Affairs, Vaccine. In her current role, Donna is responsible for the... Read More →

Rasika Kalamegham

Head, US Regulatory Policy, Genentech, A Member of the Roche Group, United States

Mary Jo Salerno

Science Policy Analyst, ORDPURM, OND, CDER, FDA, United States

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Format Session
Level Intermediate
Featured Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Level Intermediate
Feature Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags Session

3:15pm PDT

#273: How to Provide Necessary Medicinal Products to Children?

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-605-L04-P; CME 1.00; RN 1.00

In this session, speakers share the efficacy of exsiting pediatric regulation and discuss future collaboration to promote pediatric drug development worldwide

Learning Objectives

Describe the pediatric regulation of Japan and ASEAN; Discuss collaboration to promote pediatric drug development in these countries.

Chair

Junko Sato, PhD

Speaker

PMDA Update
Michiyo Sakiyama, MD

Industry Upate
Robert "Skip" Nelson, MD, PhD

FDA Update
Gerold Wharton

Speakers

Junko Sato

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Robert Nelson

Senior Director, Pediatric Drug Development (CHILD), Johnson & Johnson, United States

Robert “Skip” Nelson, MD, MDiv, PhD. is currently Senior Director, Pediatric Product Development in the Child Health Innovation Leadership Department (CHILD) at Johnson & Johnson. Previously, he was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics... Read More →

Michiyo Sakiyama

Associate Senior Scientist for Clinical Medicine, Office of Vaccines and Blood, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Michiyo Sakiyama, MD is an Associate Senior Scientist for Clinical Medicine of the office of Vaccines and Blood Products at the Pharmaceuticals and Medical Devices Agency (PMDA). She is a pediatrician and currently involved in reviewing vaccines against infectious diseases, blood... Read More →

Gerold Wharton

Program Analyst, Office of Clinical Policy and Programs, OC, FDA, United States

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Format Session
Level Intermediate
Featured Topics Special Populations
Level Intermediate
Feature Topics Special Populations
Credit Type ACPE, CME, RN
Tags Session

3:15pm PDT

#267: Evolution of Electronic Product Information in LATAM: Challenges and Opportunities to Improve the Value of Healthcare

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-599-L04-P; CME 1.00; RN 1.00

This session provides a comprehensive overview of the status/evolution of the concept of electronic product information (ePI) in LATAM from multiple perspectives, including industry, international regulatory bodies, and various stakeholders involving patients and healthcare professionals (HCPs). It also reviews some of the relevant initiatives undertaken in Low to Medium income countries and their benefits and potential.

Learning Objectives

Identify the impact of electronic product information (ePI) hybrid pilots and regulatory framework evolution in LATAM countries; Discuss relevant initiatives undertaken in Low to medium income countries; Examine industry motivations and challenges in implementing ePI pilots; Describe the evolving landscape (efforts of HA's based on international standard for ePI, regulatory advancements made to ensure an optimal experience for patients/ HCPs, implications of these challenges on healthcare.

Chair

Leonardo Semprun Semprun, RPh

Speaker

Electonic Product Information Regulatory Evolution in Brazil
Nélio Cézar de Aquino, SR, MSc

Electronic Product Information in Low to Middle Income Countries
Rutendo Kuwana, RPh

Industry Outlook in Brazil: Exploring eLabeling Perspectives
Rosana M. Mastellaro, PharmD, RPh

Considerations for Implementation and Adoption of Digital Labels
Maria Cristina Mota Pina, MBA

Speakers

Leonardo Semprun

Global Regulatory Policy Lead-LatAm, MSD, Panama

Leonardo Semprún is currently Senior Director, Global Regulatory Policy at MSD. In this role, Leonardo is responsible to define and execute a regional regulatory policy plan that addresses current and future needs, while also advocating for and anticipating regulatory change with... Read More →

Nélio Cézar de Aquino

General Manager of Medicines, ANVISA, Brazil

Nélio Cézar de Aquino is the General Manager of Medicines at the Brazilian Health Regulatory Agency (Anvisa). He has held various positions at Anvisa, including General Manager of Information Technology, Ports, Airports, Borders, and Customs Warehouses, Public Quality Control Laboratories... Read More →

Rutendo Kuwana

Team Lead, Incidents and Substandard/Falsified Medical Products, World Health Organization (WHO), Switzerland

Rosana Mastellaro

Director, Technical Regulatory Affairs and Innovation, Sindusfarma, Brazil

Pharmacist, She is currently Director of Technical Regulatory Affairs and Inovation at Sindusfarma. She has worked for 17 years in the pharmaceutical industry. Specialist in Project Management. She acts in defense of the pharmaceutical industrial sector and coordinates regulatory... Read More →

Maria Cristina Mota Pina

Head, Regulatory Policy for Emerging Markets -Japan and Australia, AbbVie, United States

Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for the Emerging Markets. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session | 03: Data-Tech, Session

Format Session
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

3:15pm PDT

#274: Regulatory Policy Roundtable: Pharmaceutical Quality, Generics, Innovative Medicines

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-606-L04-P; CME 1.00; RN 1.00

Industry leaders will discuss how regulatory and industrial policy can support delivering medicines to patients faster, how to assure pharmaceutical quality for innovative and generic medicines, and how regulatory harmonization benefits both sectors and, ultimately, patients.

Learning Objectives

Define and discuss policy and program updates from FDA's Office of Generic Drugs (OGD) and Office of Pharmaceutical Quality (OPQ); Define quality management maturity (QMM) and how the federal government may use it to improve the quality of medicines and resiliency of the supply chain; Identify policy solutions to quality challenges like nitrosamines, PFAS, and related impurities/chemicals that preserve patient access to safe medicines.

Chair

Aaron Josephson, MS

Speaker

Panelist
Katherine Wilson, JD, MA

Quality Policy Priorities of the Canadian Generic Industry
Kristin Willemsen, MS

Panelist
Brett Howard, JD, PhD

Speakers

Aaron Josephson

Senior Director, Global Regulatory Policy, Teva Pharmaceuticals, United States

Aaron develops and advocates for policies that enable more efficient and predictable regulatory systems aligned with Teva’s development programs, business objectives, and patient needs. Prior to joining Teva, Aaron worked at FDA for more than a decade in positions at CDER, CBER... Read More →

Brett Howard

Senior Director, US Regulatory Policy, USP, United States

Kristin Willemsen

Vice President, Scientific and Regulatory Affairs, Canadian Generic Pharmaceutical Association, Canada

Kristin Willemsen is the Vice President of Scientific & Regulatory Affairs for CGPA. She works with CGPA members advocating for the implementation of regulatory, policy and guidance changes to increase access to safe, effective, and affordable generic medicines for Canadians. A key... Read More →

Katherine Wilson

Head, Global Regulatory Policy and Intelligence, Viatris, United States

Katherine (Katie) Wilson, leads Global Regulatory Policy + Intelligence at Viatris, a global healthcare company committed to empowering people worldwide to live healthier at every stage of life. In her current role, Katie provides regulatory support to drive global policy initiatives... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum | 10: RegCMC-Product Quality, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

3:15pm PDT

#275: Securing the Chain: US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-607-L04-P; CME 1.00; RN 1.00

With efforts in the US and Europe to increase supply chain transparency and prevent drug shortages, this forum focuses on recent and pending regulatory updates. We examine actions taken to mitigate product shortages following an unpredicted event impacting product shortages and lack of supply predictability.

Learning Objectives

Define the impact of US and European legislation updates on supply chain integrity and efforts to promote domestic manufacturing; Recognize how regulatory actions to prevent and mitigate product shortages are aimed at improving patient access and transparency across the supply chain; Discuss a case study on how the partnership between industry and regulatory can mitigate unpredictability.

Chair

Demetra Macheras, MBA

Speaker

Industry Update
Tony Lakavage, JD

Speakers

Demetra Macheras

Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, United States

Tony Lakavage

Senior Vice President, Global External Affairs, USP, United States

Anthony Lakavage is Senior Vice President, Global External Affairs, and Secretary, USP Convention and Board of Trustees. In his role, Mr. Lakavage oversees Global Communications, U.S. and International Public Policy and Regulatory Affairs, Global Stakeholder Engagement, Board and... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10: RegCMC-Product Quality, Session

Format Session
Level Advanced
Level Advanced
Credit Type ACPE, CME, RN
Tags Session

3:15pm PDT

#276: The Promise of Disease Progression Modeling to Bring Treatments to Patients Sooner

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-608-L04-P; CME 1.00; RN 1.00

The impact of disease progression modeling (DPM) on medical product development has yet to be fully realized. This forum will describe DPM and its current applications in clinical trials and highlight the value of DPM to advance decision making and clinical development efficiency.

Learning Objectives

Describe disease progression modeling (DPM) and its current applications in clinical trials; Define the value of DPM to enhance decision making throughout the medical product development lifecycle; Discuss multi-stakeholder effort to advance clinical trial and medical product development efficiency through the increased recognition, value, and consistent use of DPM.

Chair

Summer Starling, DrPH, MPH

Speaker

Panelist
Herbert Pang, PhD, MBA

Panelist
Karthik Venkatakrishnan, PhD

Panelist
Jenny Chien, PhD

Speakers

Summer Starling

Senior Project Manager, Clinical Trials Transformation Initiative (CTTI), United States

Jenny Chien

Associate Vice President, Global PK/PD and Pharmacometrics, Eli Lilly and Company, United States

Dr. Chien is an associate VP and a scientific lead in the Global PK/PD and Pharmacometrics Department at Eli Lilly and Company. She received her Ph.D. degree in Pharmaceutical Sciences from the University of Washington, Seattle in 1997. Dr. Chien is recognized for her expertise in... Read More →

Herbert Pang

Expert Statistical Scientist, Genentech, A Member of the Roche Group, United States

Herbert (Herb) Pang is an Expert Statistical Scientist at Genentech/Roche. His research interests include real-world evidence for drug development, machine learning, biomarker discovery, -omics data, and the design and analysis of clinical trials. Herb obtained his PhD in Biostatistics... Read More →

Karthik Venkatakrishnan

Vice President, Global Head of Quantitative Pharmacology, EMD Serono, United States

Karthik Venkatakrishnan is Vice President and Global Head of Quantitative Pharmacology at EMD Serono, Inc., Billerica, MA, with accountability for leadership of Clinical Pharmacology, Translational M&S, and Pharmacometrics. Previously, he held roles in Clinical Pharmacology at Pfizer... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics-Data Science, Forum

Format Forum
Level Basic
Level Basic
Credit Type ACPE, CME, RN
Tags Forum

4:30pm PDT

#277: FDA's Approach in Harmonize Surveillance for Drugs and Biologics Safety and Quality Data

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-609-L04-P; CME 1.00; RN 1.00

This session will introduce a novel FDA approach that harmonizes surveillance for drugs and biologics safety and quality data, creating a cohesive end-to-end review and data management framework to support both safety and quality data regulated by the FDA.

Learning Objectives

Describe FDA’s harmonized surveillance process for drugs and biologics safety and quality data with an integrated database approach; Identify the significant gain in efficiencies and effectiveness in drugs and biologics safety and quality reviews at FDA for both pre-market and post-market operations.

Chair

Sri Mantha, MBA, MS

Speaker

Industry Update
Sean Darcy

Industry Update
Andrew Bate, PhD, MA

Speakers

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom

Sean Darcy

Principal, Darcy Consulting Group, United States

Sri Mantha

Director, Office of Strategic Programs, CDER, FDA, United States

Sridhar (Sri) Mantha is currently Director of the Office of Strategic Programs (OSP) at the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. As the Director of OSP, Sri leads center-wide strategic and operational planning, performance analysis, and... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session

Format Session
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

4:30pm PDT

#278: Regulatory, Pharmacoepidemiologic, and Pharmacovigilance Considerations Related to the Safety of Drugs Used During Pregnancy

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-610-L04-P; CME 1.00; RN 1.00

Pregnant individuals are underrepresented in research. This session provides an overview of how the evolving regulatory framework, pharmaco-epidemiology, and clinical trials can advance evidence generation and contribute to pregnancy labeling.

Learning Objectives

Discuss important global advances in the collection of data in drugs and biological products used during pregnancy; Identify the evolving regulatory framework, and the value of premarket and postmarketing safety data that can lead to improved labeling information for drugs and biological products used in pregnancy; Describe stakeholder efforts to include pregnant individuals in clinical trials.

Chair

Martine Dehlinger-Kremer, PhD

Speaker

Assessment of Drugs Used During Pregnancy: Current Status
Martine Dehlinger-Kremer, PhD

Safety of Drugs Used During Pregnancy: Regulatory Considerations and Updates
Lynne Yao, MD

Post-Marketing Approval Safety Studies: The Role of Pregnancy Registries
Christina Chambers, PhD, MPH

Evaluation of Drug Use During Pregnancy: Post-Marketing Surveillance and Beyond - Time for a Paradigm Shift
Laura Shaughnessy, PhD

Speakers

Martine Dehlinger-Kremer

Vice President Scientific Affairs, Pediatric Subject Matter Expert, ICON Plc, Germany

Dr. Dehlinger-Kremer’s has over 30 years experience in research industry, including 30 years of experience in global regulatory affairs, medical affairs, and pediatric leadership. Prior joining ICON, she served in executive leadership roles at global CROs, gained experience in global... Read More →

Christina Chambers

Distinguished Professor, Pediatrics, University of California San Diego, United States

Dr. Christina Chambers is a Professor in the Department of Pediatrics, School of Medicine at UC San Diego. She is Chief of the Division of Environmental Science and Health, and Co-Director of the Center for Better Beginnings. She is the principal investigator of MotherToBaby Pregnancy... Read More →

Laura Shaughnessy

Clinical Program Director, UCB Biosciences, United States

In 2012, Laura joined UCB and has dedicated more than the last decade to the Women of Childbearing Age Programs (WoCBA). This groundbreaking program presents an exceptional opportunity to enhance the quality of life and family planning for women living with severe medical conditions... Read More →

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States

Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session

Format Session
Level Intermediate
Featured Topics Special Populations
Level Intermediate
Feature Topics Special Populations
Credit Type ACPE, CME, RN
Tags Session

4:30pm PDT

#284: Collaboration in an Expanding Regulatory Landscape for Pharmacovigilance

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-616-L04-P; CME 1.00; RN 1.00

Understanding the safety of medicines and the risks imposed by their use is of interest to regulators around the world. This poses challenges for industry who are faced with meeting the regulatory requirements and expectations of multiple Healthcare Agencies from across the globe. This challenge is becoming greater still as more countries start to enter the world of PV.

This session will focus on how regulators are working together to share information and intelligence and how experienced regulatory agencies are working with nations currently establishing pharmacovigilance regulations to implement these and develop the skills and knowledge required to ensure compliance and establish accepted best practice.

Learning Objectives

Describe the challenges faced by industry from a global perspective and gain insight into how regulatory agencies are working together to combat some of these issues; Discuss information and educate countries where PV is an emerging concept; Discuss areas where processes can be improved to make global PV more aligned and less challenging for industry and regulators alike.

Chair

Sophie Radicke, MSc

Speaker

FDA Update
Carolyn A Volpe, PharmD, MS

Update from Ghana
Adela Ashie

MHRA Update
Sarah Vaughan

Speakers

Adela Ashie

Principal Regulatory Officer, Food and Drugs Authority, Ghana

Adela Ashie is a pharmacist with over 15 years of experience in Pharmacovigilance. She holds a master’s in international health (MPH IH) from the University of Nottingham, United Kingdom and is currently Head of the Vigilance Unit under the Safety Monitoring Department of the Food... Read More →

Sophie Radicke

Head of GPvP and Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Sophie is the Head of the MHRA GPvP Compliance Team and a senior pharmacovigilance inspector. She became an inspector 2018 and has since led a number of complex and technically diverse inspections. In her current role, she is responsible for ensuring the operational delivery of pharmacovigilance... Read More →

Sarah Vaughan

Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation... Read More →

Carolyn Volpe

Team Leader, OSI, OC, CDER, FDA, United States

CAPT Carolyn Volpe is a licensed pharmacist and serves as the Team Leader for the Pharmacovigilance Compliance Team in FDA’s Center of Drug Evaluation and Research Office of Compliance Office of Scientific Investigations. She has over 14 years’ experience at FDA in post-marketing... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session | 08: RD Quality-Compliance, Session

Format Session
Level Advanced
Featured Topics Regulatory Collaboration, Regulator Perspectives
Level Advanced
Feature Topics Regulatory Collaboration,Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

4:30pm PDT

#280: Innovation, Agility, and Accessibility in Trial Execution: Collaboration Among Labs, Pharmacies, and Research Enablers

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-693-L04-P; CME 1.00; RN 1.00

This forum will feature discussion on the challenges and opportunities associated with integrating health care providers in non hospital or physician office settings into the clinical research infrastructure. The forum will have case studies on successful trial execution using complimentary contributions from diagnostic providers, home care providers, pharmacies, and clinics embedded in retail settings.

Learning Objectives

Describe the opportunities related to potential trial participant engagement via alternative channels; Identify challenges and barriers to overcome in order to realize value in such innovative solutions; Define situations where optimization of research delivery can be deployed and pathways of doing so.

Chair

Earl Seltzer, MBA

Speaker

Optimizing Mobile Visits with Technology:Better Geographic, Demographic, and Sociographic Representation
Josh Rose, MBA

Supporting Decentralized Clinical Trial Delivery and Diversity in Research Through Partnerships
Irfan A. Khan, MD

How Pharmacy and Benefits Management can Support the Clinical Development Continuum
Krystyna Chmura, MPH

Exploring the Role of Diagnostic Providers in Optimizing Clinical Trial Recruitment
Kristen Andrews

Speakers

Irfan Khan

Founder and Chief Executive Officer, Circuit Clinical, United States

Dr. Khan is a cardiologist and the founder & CEO of Circuit Clinical, one of the fastest growing Integrated Research Organizations in the US. His work is focused on democratizing access to clinical trials.

Krystyna Chmura

Clinical Trials Solutions Sr. Advisor, Life Sciences Data, Evernorth Health Services, United States

Krystyna Chmura is a seasoned public health professional with experience in clinical research, drug lifecycle, pharmacy benefit management, and payer markets. At Evernorth, the health services division of The Cigna Group that serves more than 190 million people, Krystyna works with... Read More →

Earl Seltzer

Senior Director, Partnerships and Innovation, CTI, United States

Earl Seltzer has 19 years of industry experience shared across clinical investigator sites in the United States and working at CROs in the strategic planning and feasibility space. At CTI, Mr Seltzer leads the therapeutic strategy team and supports innovation in trial delivery and... Read More →

Josh Rose

Chief Executive Officer, Hawthorne Effect, United States

Josh Rose, CEO, Hawthorne Effect, is a clinical research industry veteran with more than 20 years of experience. Hawthorne Effect is pioneering the way clinical trials are delivered in the patient’s home or community to drive better study outcomes. Prior Hawthorne, Josh led the... Read More →

Kristen Andrews

Head, Research Site Enablement, Labcorp , United States

Kristen Andrews, Head of Research Site Enablement at Labcorp, has over 25 years of experience in the clinical trials industry. Starting as a clinical research coordinator, her career has progressed through increasing levels of responsibility and leadership first at research sites... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Forum

Level Intermediate
Level Intermediate
Credit Type ACPE, CME, RN
Tags Forum

4:30pm PDT

#281: Harnessing Real-World Evidence in Regulatory Decision-Making: Update on DARWIN EU, Use of Real-World Evidence in New Applications in the EU

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-613-L04-P; CME 1.00; RN 1.00

A rapidly changing landscape has led to an increased use of real-world evidence (RWE) in regulatory decision making, as a complement to randomized clinical trials (RCTs), impacting how medicines are developed and assessed. The session will present where we are and discuss the exciting future ahead.

Learning Objectives

Describe how real-world data (RWD) is being leveraged to generate real-world evidence (RWE) in support of regulatory assessment and decision-making processes in Europe; Discuss the progress of DARWIN EU, and a high-level overview of the use of RWE in recent applications in EU and see how the generation of meaningful evidence can support safer and more effective treatments for patients.

Chair

Steffen Thirstrup, MD, PhD

Speaker

EMA Update
Sabine Haubenreisser, PhD, MSc

Industry Update
Laura T. Pizzi, PharmD, MPH

Patient Update
Dave deBronkart

Industry Update
Brian Bradbury, DrSc, MA

Speakers

Brian Bradbury

Vice President, Center for Observational Research, Amgen, United States

Dave deBronkart

Patient Advocate, E-Patient Dave, LLC, United States

"e-Patient Dave" deBronkart is a cancer survivor and former high tech marketer, a founding member of the HL7 FHIR Patient Empowerment Workgroup, the BMJ patient advisory panel, and the Society for Participatory Medicine. He was the Mayo Clinic’s 2015 Visiting Professor in Internal... Read More →

Sabine Haubenreisser

Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency, Netherlands

Sabine Haubenreisser is a pharmacologist with special interest in scientific cooperation and regulatory convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators. She has held... Read More →

Laura Pizzi

Chief Science Officer, ISPOR, United States

Motiur Rahman

Senior Epidemiologist, Real World Evidence Analytics, OMP, CDER, FDA, United States

Motiur Rahman is a Senior Epidemiologist at Real-World Evidence (RWE) Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA). His responsibilities include developing guidance, improving internal Agency processes... Read More →

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Session

Format Session
Level Intermediate
Featured Topics Real-World Data (RWD)- Real-World Evidence (RWE), Regulator Perspectives
Level Intermediate
Feature Topics Real-World Data (RWD)- Real-World Evidence (RWE),Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

4:30pm PDT

#282: Shame and Blame: Our Words are a Barrier to Clinical Research are a Care Option

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-614-L04-P; CME 1.00; RN 1.00

Clinical research creates future clinical care. Let's lead in compassionate communication inviting more participation. Patient, site, and patient-focused drug development (PFDD) experts share and invite your participation in improving access through our words.

Learning Objectives

Identify the shame and blame negative words and phrases and their negative impact on patients; Recognize opportunities to improve the patient experience in clinical research as a care option through more compassionate word choice; Describe how to plan and justify optimization of protocol, informed consent, and participant communication language.

Chair

Lani Hashimoto

Speaker

Panelist
Jamie Troil Goldfarb

Panelist
Eddilisa Martin

Panelist
James Duhig, PhD

Speakers

Lani Hashimoto

Associate Director, Patient Engagement, Novartis Pharmaceuticals Corporation, United States

Lani Hashimoto is dedicated to connecting patients to research. Lani's lived experience as a clinical trial participant and caregiver further inspire her professional pursuits. She credits the Cystic Fibrosis Foundation as a key influence in her passion for patient engagement. At... Read More →

James Duhig

Global Head, Office of Health Literacy, AbbVie, United States

Dr. James (Jay) Duhig, Ph.D., is Global Head of the Office of Health Literacy for AbbVie. Dr. Duhig is an expert in the application of human factors and health literacy in the investigation of medication errors and in the development of drug and device instructional materials for... Read More →

Jamie Goldfarb

Director, Patient Recruitment Strategy, Trialbee, United States

Eddilisa Martin

Co-Founder and Chief Executive Officer, M&B Sciences Inc., United States

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Forum

Format Forum
Level Basic
Featured Topics Patient Focused, Student Programming
Level Basic
Feature Topics Patient Focused,Student Programming
Credit Type ACPE, CME, RN
Tags Forum

4:30pm PDT

#279: Accelerating Innovation Through Design: Integrating Real-World Data into Clinical Trials

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-611-L04-P; CME 1.00; RN 1.00

In this forum, speakers from regulatory, industry, and research organizations will discuss methodological considerations and evaluate various innovative use cases in different settings that integrate real-world data (RWD) in clinical designs.

Learning Objectives

Discuss global regulatory guidance, frameworks, and best practices for real-world data (RWD) in innovative hybrid study designs for regulatory purposes; Describe innovative approaches and statistical methods for integrating RWD and clinical trial data for clinical decision-making; Appraise use cases where RWD have been used in hybrid study designs to support clinical and regulatory development.

Chair

Rachele Hendricks-Sturrup, DrSc, MA, MSc

Speaker

Panelist
Mehmet Burcu, PhD, MS

Panelist
Christina Mack, PhD, MPH

Panelist
Catherine C. Lerro, PhD, MPH

Speakers

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Center for Health Policy, United States

Rachele Hendricks-Sturrup, DHSc, joins Duke-Margolis as the Research Director leading the Center’s Real-World Evidence (RWE) portfolio, including managing its RWE Collaborative. She is a scientist/researcher, health policy and industry professional, journalist, and academician within... Read More →

Mehmet Burcu

Senior Director, Epidemiology, Merck & Co., Inc., United States

Dr. Mehmet Burcu is a Senior Director in the Department of Epidemiology at Merck & Co., Inc., Rahway, NJ, United States. He currently leads a team of epidemiologists to support clinical development and regulatory decision making in Oncology. He has expertise in large, automated database... Read More →

Catherine Lerro

Senior Pharmacoepidemiologist, Oncology Center of Excellence, FDA, United States

Christina Mack

Chief Scientific Officer, Real-World Solutions, IQVIA, United States

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Forum | 03: Data-Tech, Forum | 11: Statistics-Data Science, Forum | 02: ClinTrials -ClinOps, Forum

Format Session
Level Intermediate
Featured Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Level Intermediate
Feature Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags Forum

4:30pm PDT

#285: Remote Regulatory Assessments: Examining Another Tool in the FDA Regulatory Toolbox

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-617-L04-P; CME 1.00; RN 1.00

This session will describe the evolution of remote regulatory assessments (RRA’s), FDA’s authority to conduct an RRA in lieu of an inspection, the process for conducting an RRA, and recent RRAs conducted as part of the FY23 BIMO program

Learning Objectives

Describe what a remote regulatory assessments is and FDA’s authority to conduct a remote regulatory assessment; Describe the steps taken by the agency and site before, during, and after a remote regulatory assessment is conducted; Discuss FY23 metrics including recently conducted remote regulatory assessments.

Chair

Jan Hewett, BSN, JD

Speaker

FDA Update
Kavita C. Dada, PharmD

Industry Perspective on Remote Assessments
James Riddle

Health Canada Update
Jennifer Evans

Speakers

Kavita Dada

Associate Director for Regulatory Operations, OSI, OC, CDER, FDA, United States

Jennifer Evans

Compliance Specialist, Health Canada, Canada

Jennifer Evans obtained her degree in Biochemistry from the University of Victoria, in British Columbia, Canada. She worked in the pharmaceutical and biotechnology industries in research, clinical and quality roles for 14 years prior to joining Health Canada in 2012 as a regulatory... Read More →

Jan Hewett

Regulatory Counsel for Policy, OSI, CDER, FDA, United States

Jan Hewett joined the U.S. Food and Drug Administration's Center for Drug Evaluation and Research -Office of Compliance- Office of Scientific Investigations office as Regulatory Counsel (Policy) in February 2015. Prior to joining OSI, Jan served as the Director of the Yale University... Read More →

James Riddle

Senior Vice President, Global Review Operations, Advarra, United States

JJames Riddle is the Senior Vice President of Global Review Operations at Advarra, the world’s largest provider of ethics, safety, and compliance oversight reviews services. With 25+ years’ experience providing support to the clinical research community, Riddle has operational... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Format Session
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

4:30pm PDT

#286: Recent Evolution of the Accelerated Approval Pathway: Impacts on Use and Implementation

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-618-L04-P; CME 1.00; RN 1.00

Thought leaders will be brought together in a fireside chat to discuss impacts observed due to recent changes to Accelerated Approval as well as current trends in how the pathway is being used and implemented.

Learning Objectives

Identify the changes to Accelerated Approval resulting from the passage of FDORA; Describe the benefits and challenges encountered by regulators, industry, and patient organizations when it comes to the use of Accelerated Approval; Discuss the impacts of the changes to the Accelerated Approval pathway and how it is currently being implemented.

Chair

Danielle Friend Economo, PhD

Speaker

Industry Update
Alexis Miller, JD

FDA Update
Peter W. Marks, MD, PhD

Academic Update
Edward Neilan, MD, PhD

Speakers

Danielle Friend Economo

Senior Director, US Head Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA, United States

Alexis Miller

Acting Global Lead, Global Regulatory Policy and Intelligence, Merck & Co., Inc., United States

Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping to shape the regulatory and policy environments on topics like evolution in regulatory science and policy frameworks, upholding expedited pathways, leveraging RWE and other tech opportunities, embedding... Read More →

Edward Neilan

Chief Medical and Scientific Officer, National Organization for Rare Disorders (NORD), United States

Dr. Ed Neilan is the Chief Medical and Scientific Officer at the National Organization for Rare Diseases (NORD). He is a medical geneticist with experience in both academic medicine and the pharmaceutical industry. His expertise spans laboratory research and medical practice, as well... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Format Forum
Level Intermediate
Level Intermediate
Credit Type ACPE, CME, RN
Tags Forum

4:30pm PDT

#287: ANVISA Town Hall

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-619-L04-P; CME 1.00; RN 1.00

In this forum, leaders from ANVISA will provide an update on regulatory priorities for Brazil, and inform about local trends, regulatory convergence, and collaboration initiatives. The discussion will also invite questions of general interest from the audience.

Learning Objectives

Describe ANVISA’s regulatory initiatives and strategic priorities; Discuss regulatory convergence of Brazilian regulations for medicines and medical devices to international guidelines and standards; Identify trends and opportunities for engagement with the Brazilian regulator.

Chair

Cammilla Horta Gomes, MA, MPharm

Speaker

Panelist
Antonio Barra Torres, MD

Panelist
Patricia Oliveira Pereira Tagliari, LLM, MPH

Panelist
Bianca Zimon, LLM

Speakers

Antonio Barra Torres

President Director, ANVISA, Brazil

Cammilla Horta Gomes

LATAM Regulatory Policy Lead, Roche, Brazil

Specialist in Global Health and Health Regulation, with a Master’s Degree in Development and International Cooperation. Broad experience in regulatory policy, both as regulator in ANVISA and industry, leading or contributing to bilateral and multilateral negotiations, harmonization... Read More →

Patricia Oliveira Pereira Tagliari

Associate Director, ANVISA, Brazil

Patricia Oliveira Pereira Tagliari holds a master’s degree in Public Health (Global Health and Health Diplomacy) from the National School of Public Health (2014), specializations in Health Regulation and Surveillance (2010) and Health Law (2007), both from Fiocruz, and a degree... Read More →

Bianca Zimon

Health Regulation Specialist, ANVISA, Brazil

Advisor to the International Affairs Office at the Brazilian Health Regulatory Agency (Anvisa). Specialist in Health Regulation and Constitutional Law, with extensive experience in health regulation and enforcement, as well as in bilateral and multilateral negotiations, international... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

4:30pm PDT

#289: Post-COVID cGMP Inspections by Global Regulatory Authorities

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-620-L04-P; CME 1.00; RN 1.00

Unfold real-world post-COVID inspections at global pharmaceutical manufacturing facilities, gaining insights into successes and disappointments within them. Appreciate perspectives on post-COVID inspections from FDA, EMA, Anvisa, and NMPA inspectors.

Learning Objectives

Recognize key advances and innovations that regulatory authorities and manufacturing facilities have adopted post-COVID in cGMP inspections;. Identify ongoing challenges that regulatory authorities and manufacturing facilities face in maintaining compliance and ensuring product quality in the post-COVID landscape and their implications in future pharmaceutical developments.

Chair

Lan Mu, PhD, RAC

Speaker

Industry Update
Karthik Iyer, MS

Panelist
Erica Franca Costa, RPh

Case Studies
Chiang Syin

Speakers

Lan Mu

Senior Vice President, Bio-Thera Solutions, United States

Dr. Lan Mu has over 25 years of experience in drug discovery, development, and global registration in various therapeutic areas. She was a principal research investigator at Sanofi prior to earning the Regulatory Affairs Certification (RAC). Subsequently, she held roles of increasing... Read More →

Erica Franca Costa

Health Regulation Specialist, ANVISA, Brazil

Pharmacist, Health Regulation Specialist, Senior GMP Inspector. She has been a member of the Brazilian National Health Surveillance Agency (ANVISA) since 2005, carrying out, among other activities, BPF inspections, medicine and cosmetic products registration, regulatory convergence... Read More →

Karthik Iyer

Director, Global Quality, Merck & Co., Inc., United States

Karthik is currently an associate director for Data and Analysis in the Office of Surveillance. Prior agency roles included CMC reviewer (Office of Process and Facilities), Acting Branch Chief ( Office of Surveillance) and Senior Policy Advisor (Office of Manufacturing and Product... Read More →

Chiang Syin

President, Meadows Biosolutions LLC, United States

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10: RegCMC-Product Quality, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

4:30pm PDT

#290: Charting the Biosimilars Beat Drop: The Latest Updates in the Biosimilars Landscape, Coverage, and Adoption in the US

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-621-L04-P; CME 1.00; RN 1.00

This session will provide an overview of today’s biosimilars landscape, explore trends in uptake, describe innovative programs from industry disruptors, and report perspectives from key stakeholders through their primary market research.

Learning Objectives

Summarize results of current payer and provider research on barriers to biosimilar coverage and adoption, with a focus on product interchangeability; Describe the challenges and solutions of real-world data (RWD) and real-world evidence (RWE) in decision-making; Identify a framework for operational readiness in biosimilar management.

Chair

Charlie Dragovich, RPh

Speaker

Industry Update
Chara Reid, PharmD, RPh

Industry Update
Catherine Lockhart, PharmD, PhD, MS

Speakers

Charlie Dragovich

Board of Directors, California Academy of Managed Care Pharmacy, United States

Charlie Dragovich, BSPharm, is a market access consultant currently serving on the Board of Directors on California AMCP. Mr. Dragovich previously led the development of new programs and services at the Academy of Managed Care Pharmacy (AMCP) to facilitate payer and manufacturer communication... Read More →

Catherine Lockhart

Chief Science Officer, Biologics and Biosimilars Collective Intelligence Consortium, United States

Cate Lockhart, PharmD, PhD is the Executive Director of the Biologics and Biosimilars Collective Intelligence Consortium where she is responsible for all programs of this multi-stakeholder research collaboration. She is a proven leader in health economics and outcomes research (HEOR... Read More →

Chara Reid

Director, Specialty Practice Network, Immunology, Cencora (formerly AmerisourceBergen), United States

Chara Reid is a National Sales Director for AmerisourceBergen. In this role she leads a national sales team that call on multi-specialty infusion practices. She graduated with her bachelor’s degree in biology in 1998 from Northern Illinois University. Then went on to Midwestern... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12: Value-Access, Session

Format Session
Level Intermediate
Featured Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Level Intermediate
Feature Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags Session

4:30pm PDT

#283: The Value of Project Management in Driving Drug Discovery Success: A Comparison Between Small Versus Large Pharmaceutical Companies

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-615-L04-P; CME 1.00; PDU 1.00 PMI 2166M3MMI2; RN 1.00

The session will provide an overview of projct management (PM) in discovery and early development and contrast to the application of PM skills in later stages. The session will include best practices for driving impact with discovery and early development functional areas.

Learning Objectives

Describe the value of project management (PM) on discovery teams and early in the drug development lifecycle; Compare adaptations for PM in discovery versus development in both large pharma and smaller biotech settings; Discuss best practices for driving impact with discovery and early development functional areas.

Chair

Elizabeth Somers, MS

Speaker

The Value of Project Management in Driving Drug Discovery Success - Small Company Perspective
Stuart Ince, PhD

Speakers

Elizabeth Somers

Executive Director, Global Project and Alliance Management, Merck Sharp & Dohme LLC, United States

Liz is an Executive Director in Global Project and Alliance Management at Merck focusing on Discovery PM. She manages a team focused on Discovery projects including complex collaborations which leverages her experience managing complex cross functional drug development programs and... Read More →

Stuart Ince

Vice President, Program Leadership, Accent Therapeutics, Inc, United States

Stuart Ince Ph.D. is a drug discovery and development executive with 22 years of experience in pharmaceutical R&D. He started his career in medicinal chemistry, advancing to a project lead for discovery projects in lead optimization at Bayer AG. Subsequently he progressed to drug... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

13: ProfDevelopment, Session | 07: ProjectManagement-StrategicPlanning, Session

Format Session
Level Basic
Featured Topics Student Programming
Level Basic
Feature Topics Student Programming
Credit Type ACPE, CME, PMI, RN
Tags Session