DIA 2024 Global Annual Meeting: Full Schedule

11:00am PDT

#107: Cloud-Driven Transformation: Empowering Pharma Industry and Regulators

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-521-L04-P; CME 1.00; RN 1.00

This forum will identify how cloud-based technologies may be utilized to promote interactive and collaborative regulatory review (applicant-regulator; inter-regulator) both regionally and internationally. Speakers will discuss several regulatory use cases and initiatives that are leveraging these technologies to modernize data exchange and regulatory review.

Learning Objectives

Illustrate how cloud-based technologies may promote interactive and collaborative regulatory review (applicant-regulator; inter-regulator) both regionally and internationally discussion of several regulatory and scientific use cases opportunities leveraging cloud-based solutions; Discuss relevant PDUFA VII provisions and FDA’s public-private partnerships and European Medicines Agency initiatives in advancing regulatory science through the application of cloud technology.

Chair

Vada A. Perkins, DrSc, MSc

Speaker

US FDA/Industry Regulatory Cloud Research Collaboration: Project PRISM (PrecisionFDA Regulatory Information Service Module)
Vada A. Perkins, DrSc, MSc

FDA Update
Ginny Hussong

PRISM Use Case: ICH M11 Protocol
Ron Fitzmartin, PhD, MBA

Cloud-Driven Transformation: Enabling the Ambition of a Global Pharmaceutical Quality Knowledge Management Capability
Hilmar Hamann, PhD

Speakers

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States

Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →

Ron Fitzmartin

Senior Informatics Advisor, Office of Regulatory Operations, CBER, FDA, United States

Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory... 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 →

Virginia Hussong

Branch Chief, Data Standards, CBER, FDA, United States

Ginny serves as Chief of CBER's Data Standards Branch, where she leads a multidisciplinary team that advances standards such as eCTD, CDISC, IDMP, ICSR, SPL and related terminologies. In addition, conducts technical validation of clinical study data, leads related reviewer training... Read More →

Monday June 17, 2024 11:00am - 12:00pm 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, Regulatory Collaboration
Level Intermediate
Feature Topics Digital Technology,Regulatory Collaboration
Credit Type ACPE, CME, RN
Tags Forum

2:15pm PDT

#135: Enhancing the Science of Patient Engagement and Patient Input: What's in the Future?

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-535-L04-P; CME 1.00; RN 1.00

This forum discussion focuses on current state, challenges, and opportunities to enhancing the science of patient input. Panel of experts will discuss examples of approaches with partnering with patients, enanging regulators and measuring progress.

Learning Objectives

Discuss approaches and best practices for partnering and co-creating with patients; Identify strategies to systematically incorporate patient input into decision making; Describe opportunities to enhance interactions between industry and regulators; Discuss approaches to measure progress in engaging patients and its impact to medical product development.

Chair

Pujita Vaidya, MPH

Speaker

FDA Perspective
Michelle Campbell, PhD

Industry Perspective and Case Example
Elizabeth Rosenkrands-Lange, MPH, MS

Patient Researcher Perspective
Bellinda King-Kallimanis, PhD, MSc

Speakers

Pujita Vaidya

Director, US Patient Engagement, Novartis Pharmaceuticals Corporation, United States

Pujita Vaidya serves as a Global Regulatory and R&D Policy Director at Amgen, working to develop, advocate for, and implement Amgen positions on regulatory policies (e.g., Patient Centricity, Pediatrics, and Innovative Trials). Her work includes partnering with cross-functional colleagues... Read More →

Michelle Campbell

Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER, FDA, United States

Michelle Campbell is the Associate Director for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Campbell joined FDA in 2014 and was previously... Read More →

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 →

Elizabeth Rosenkrands-Lange

Senior Director/ Head of US Regulatory Scientific Policy, EMD Serono, Part of Merck Kgaa, Darmstadt, Germany, United States

Elizabeth Rosenkrands Lange is an experienced regulatory policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 6B 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
Level Intermediate
Feature Topics Patient Focused
Credit Type ACPE, CME, RN
Tags Forum

3:30pm PDT

#147: Data and Technology Influence on ICH Initiatives: M4Q(r2)/Q12 and Global Harmonization

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-546-L04-P; CME 1.00; RN 1.00

Join industry leaders in this interactive forum to discuss the development of ICH initiatives ICH Q12 and ICH M4Q(r2), how they will impact the product approval lifecycle, and the technology that will manage these processes and the data.

Learning Objectives

Describe important initiatives that will have a direct impact on the pharmaceutical product approval lifecycle; Identify how the initiatives will influence changes in our industry for patient-product access and faster approvals; Discuss how technology and data has a major role in bringing these initiatives to reality.

Chair

Brooke Casselberry, MS, RAC

Speaker

Panelist
Andrew Chang, PhD

Panelist
Ciby Joseph Abraham, PhD

Panelist
Alexander Gaffney, MS, RAC

Panelist
Lawrence Yu, PhD

Speakers

Ciby Abraham

Senior Director and Group Manager, Project and Product Leadership, AstraZeneca, United States

Ciby Abraham is a Senior Director and Group Manager, Project and Product Leadership in CMC Regulatory Affairs at AstraZeneca. Prior to his role with AstraZeneca, Ciby worked at the for several years FDA as a Team Leader. In addition, Ciby worked in the industry as a formulator, analytical... Read More →

Brooke Casselberry

Vice President, Advisory and Delivery, Epista Life Sciences, United States

Brooke is known for her pivotal roles in collaborating with Sponsor Companies, Health Authorities, and Technology Developers. She has maintained focus on leveraging cutting-edge technologies as a catalyst for regulatory advancements, optimization, and collaboration for global go-to-market... Read More →

Andrew Chang

Vice President, Quality and Regulatory Compliance, Novo Nordisk, United States

Dr. Andrew Chang is a multifaceted quality and CMC leader with 28 years well-rounded medical product regulatory and industry experiences. He is a board director for CASSS-Sharing Science Solutions and PDA, respectively. Andrew has served as a member of the planning committee for DIA... Read More →

Alexander Gaffney

Executive Director, Regulatory Policy And Intelligence, AgencyIQ by POLITICO, United States

Alexander Gaffney is the Executive Director of Regulatory Policy and Intelligence for POLITICO's AgencyIQ, where he leads a team of more than a dozen regulatory intelligence professionals. Alexander has worked in regulatory for more than a decade, including at the Regulatory Affairs... Read More →

Lawrence Yu

Director, Office of New Drug Products, OPQ, CDER, FDA, United States

Lawrence X. Yu, Ph.D., is the Director, Office of New Drug Products, Food and Drug Administration and Rapporteur, ICH M4Q(R2) Expert Working Group. Dr. Yu is also an adjunct Professor at the University of Michigan. Dr. Yu is an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored... Read More →

Monday June 17, 2024 3:30pm - 4:30pm 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 ICH, Digital Technology
Level Intermediate
Feature Topics ICH,Digital Technology
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

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

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

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 →

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

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

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 →

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

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 →

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

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

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 →

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

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 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

8:00am PDT

#311: Australia, Canada, Singapore, Switzerland, and United Kingdom Consortium (Access): Re-Imagining Regulatory Collaboration

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-632-L04-P; CME 1.00; RN 1.00

Established in 2007, the Access Consortium brings together like-minded regulatory agencies to promote regulatory convergence and foster synergy to address scientific and regulatory issues. In this session, leaders from the Access Consortium will provide an update on achievements using work-sharing initiatives for timely medicines approvals for our populations, enabling industry to bring new, innovative products through Access pathways.

Learning Objectives

Discuss pathways and opportunities for industry to bring innovative products through Access; Describe new tools and methodologies to optimize regulatory collaboration under the Access Consortium to support access to medicines.

Chair

Pamela Aung-Thin

Speaker

Panelist
June Raine, MD, MSc, FRCP

Panelist
Anthony Lawler, MD, MBA

Panelist
Mimi May Ling Choong, DrMed, MD

Panelist
Jörg Schläpfer, PhD

Panelist
Eveline Trachsel

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.

Mimi May Ling Choong

Chief Executive Officer, Health Sciences Authority (HSA), Singapore

Dr Choong was appointed as the Chief Executive Officer of the Health Sciences Authority (HSA) of Singapore on 1 July 2014. She oversees HSA’s wide-ranging public health responsibilities, comprising health products regulation, the national blood service, the national analytical and... 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 →

June Raine

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

Dr June Raine DBE is CEO of the Medicines and Healthcare products Regulatory Agency. She trained in medicine in Oxford after completing a master’s degree by research in Pharmacology. Her interest in drug safety led to a career in medicines regulation which has spanned a number of... Read More →

Jörg Schläpfer

Head of Management Services and International Affairs, Swissmedic, Switzerland

Dr. Jörg Schläpfer, PhD is the Head of Management Services & International Affairs and Member of the Management Board of Swissmedic. He studied Veterinary Medicine at the University of Berne, completing his studies in 1991. After obtaining the title of Doctor of Veterinary Medicine... Read More →

Eveline Trachsel

Head of Medicinal Product Authorisation and Vigilance, Swissmedic, Switzerland

Eveline Trachsel PhD, eMBA has been the Head of Medicinal Product Authorisation and Vigilance at Swissmedic, the Swiss Agency for Therapeutic Products since January 2024. She is a pharmacist with a PhD from the Swiss Federal Institute of Technology in Zurich, Switzerland. In 2023... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

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

10:00am PDT

#317: Unlocking the Potential of Pharmacogenomics for Reducing the Burden of Adverse Drug Reactions

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-635-L04-P; CME 1.00; RN 1.00

This session will explore current progress in pharmacogenomics; the barriers and opportunities it represents for drug safety from the perspective of medicines regulators, industry, the scientific community, healthcare professionals, and patients.

Learning Objectives

Discuss the importance of pharmacogenomics for introducing better risk mitigation strategies; Appraise progress being made in this field internationally; Recognize opportunities for introduction of pharmacogenomic research in your organization.

Chair

Alison Cave, PhD

Speaker

From Post-Marketing Reports of Side Effects to Pharmacogenomic Research: Can we Reduce the Burden of ADRs?
Alison Cave, PhD

Patient Perspective
Christine Von Raesfeld

Industry Perspective
Gregory Powell, PharmD, MBA

Academic Perspective
Kathleen M. Giacomini, PhD

Speakers

Alison Cave

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

Kathleen Giacomini

Dean, School of Pharmacy, Professor and Principal Investigator, University of California San Francisco, United States

Kathleen M. Giacomini, Ph.D. Kathy Giacomini, a professor in the School of Pharmacy at the University of California, San Francisco, is a leader in the field of membrane transporters with a focus on genetic polymorphisms. She cloned, characterized and discovered the endogenous role... Read More →

Gregory Powell

Senior Director, Safety and Clinical Innovation, GlaxoSmithKline, United States

Greg Powell is the Senior Director of Safety and Clinical Innovation at GlaxoSmithKline. He completed his PharmD at the University of Florida, his MBA at East Carolina University, and his BS in Pharmacy at the University of North Carolina. He has over twenty years of experience practicing... Read More →

Christine Von Raesfeld

Founder/SME, Patient Experience, The Light Collective, United States

Christine is a pillar of patient advocacy and allyship in the rare and chronic disease community. She is a champion for patient voices, diversity and inclusion in clinical research, and equitable patient-sponsor partnerships. As a patient, Christine has assisted in initiatives including... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum

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

1:15pm PDT

#347: Artificial Intelligence in the Drug Development Lifecycle: Opportunities and Challenges in Regulatory Operations

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-650-L04-P; CME 1.00; RN 1.00

This panel will discuss opportunities and challenges of leveraging artificial intelligence (AI) in the drug development lifecycle, especially in regulatory operations. The panel will include representation from regulatory, and industry.

Learning Objectives

Identify the impact of artificial intelligence (AI) in the drug development lifecycle from health authorities' and, industry's perspectives; Recognize opportunities for the regulators and industry to leverage rapid advancement of AI to the drug development lifecycle; Discuss challenges to implement changes from policy, technology, standard, data security in regulatory operations.

Chair

Ethan Chen, MBA, MS, PMP

Speaker

The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle
Hilmar Hamann, PhD

Panelist
Tala Fakhouri, PhD, MPH

Panelist
Nicole Mahoney, PhD

Speakers

Ethan Chen

Director, Division of Data Management Services and Solutions, OBI, OSP, CDER, FDA, United States

Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led several critical initiatives as the CDER Informatics... Read More →

Tala Fakhouri

Associate Director for Data Science and Artificial Intelligence, Office of Medic, FDA, United States

Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing... Read More →

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands

Nicole Mahoney

Executive Director US Regulatory Policy & Intelligence, Novartis Pharmaceuticals Corporation, United States

Nicole Mahoney is an Executive Director for Regulatory Policy at Novartis, and global regulatory policy lead for data and digital technologies, including real-world evidence and artificial intelligence. Prior to Novartis, she led Regulatory Policy at Flatiron Health, helping support... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

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

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

3:15pm PDT

#360: More than Meets the Eye: AI’s Potential to Identify Skin Manifestations of Internal Disease in Patients of Color

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-660-L04-P; CME 1.00; RN 1.00

Unlocking AI's potential to facilitate diversity in clinical trials demands inclusive images capturing skin manifestations of internal diseases across races and ethnicities. Join our panel to learn more about inclusive innovation in AI solutions.

Learning Objectives

Discuss the importance of photographs and images in AI algorithms to identify internal diseases impacting patients of color and how that supports clinical trial enrollment; Identify the questions to ask of AI solution providers to ensure imagery is inclusive; Describe what’s being done to improve imagery in AI learning to drive clinical trial diversity.

Chair

Pamela Simpkins, MBA

Speaker

Patient Update
Tricha Shivas, MS

Industry Update
Lionel Phillips, MBA

Industry Update
Brian H Johnson

Speakers

Pamela Simpkins

Managing Partner, Mezzopointe. LLC, United States

Biopharma R&D executive with 26+ years in the industry and nearly a decade as an institutional investor. Expert in R&D Finance with a proven track record in accelerating development of key pipeline assets to achieve regulatory approval and market authorization. Built, led and sold... Read More →

Brian Johnson

Vice President, R&D Technology, Takeda, United States

Lionel Phillips

President, Inside Edge Consulting, United States

Tricha Shivas

Chief of Staff and Strategy, Foundation For Sarcoidosis Research, United States

Tricha Shivas joined the Foundation for Sarcoidosis Research (FSR) in December of 2020. As the Chief of Staff and Strategy, she works with various stakeholders including individuals living with sarcoidosis. Through her career she has built strong stakeholder relations, created comprehensive... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Session | 11: Statistics-Data Science, Session | 02: ClinTrials -ClinOps, Session

Format Session
Level Basic
Featured Topics Artificial Intelligence (AI), Decentralized Clinical Trials (DCTs)
Level Basic
Feature Topics Artificial Intelligence (AI),Decentralized Clinical Trials (DCTs)
Credit Type ACPE, CME, RN
Tags Session

4:30pm PDT

#370: Critical Appraisal of Artificial Intelligence Solutions for Pharmacovigilance

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-669-L04-P; CME 1.00; RN 1.00

Artificial intelligence solutions may support and enhance human decision-making and information processing throughout pharmacovigilance. This session aims to outline best practices and potential pitfalls in their use.

Learning Objectives

Recognize key challenges in assessing artificial intelligence solutions and interpreting evaluations of their performance; Describe some best practices for critical appraisal of artificial intelligence solutions; Identify the need for consideration of human computer interactions.

Chair

Jim Barrett, PhD, MSc

Speaker

MHRA Update
Phil Tregunno

FDA Update
Monica Munoz, PharmD, PhD

Industry Update
Andrew Bate, PhD, MA

Speakers

Jim Barrett

Senior Data Scientist, Uppsala Monitoring Centre (UMC), Sweden

Jim is a senior data scientist at Uppsala Monitoring Centre (UMC), where he has worked for the past 4 years. In that time, Jim has worked on several projects including advanced signal detection methods, tools to facilitate analysis of large case series and NLP methods for mining structured... 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 →

Monica Munoz

Division Director, Division of Pharmacovigilance-I, OSE, CDER, FDA, United States

CAPT Monica Muñoz is the Director of the Division of Pharmacovigilance-I within US FDA’s Center for Drug Evaluation and Research. Since joining FDA in 2010, she has served as a safety reviewer, managed review teams, and provided oversight for pharmacovigilance initiatives. Her... Read More →

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm 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 Artificial Intelligence (AI)
Level Intermediate
Feature Topics Artificial Intelligence (AI)
Credit Type ACPE, CME, RN
Tags Session

8:00am PDT

#406: More Nuanced Clinical Outcomes from Person-Generated Health Data: The New Frontier

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-682-L04-P; CME 1.00; RN 1.00

Person-generated data offers nuanced effectiveness measures for clinical and regulatory decision-making for new medical products, like the wearable-derived digital clinical outcome assessment for Duchenne muscular dystrophy. What's next?

Learning Objectives

Describe practical applications of person-generated health data, and key business and regulatory perspectives on opportunities and challenges; Explain the value of this type of information to patients, clinicians, and colleagues to help inform decision-making.

Chair

Nancy A Dreyer, PhD, MPH, FISPE

Speaker

Panelist
Christina Mack, PhD, MPH

Panelist
Paul Strijbos, PhD

Panelist
Jeffrey Nahum Siegel, DrMed, MD

Panelist
Martha Azer, PharmD, RPh

Speakers

Nancy Dreyer

Founder, Dreyer Strategies LLC, United States

Nancy Dreyer is Chief Scientific Advisor to Picnic Health and Adjunct Professor of Epidemiology at the University of North Carolina. Recently retired from full-time employment as Chief Scientific Officer at IQVIA Real World Solutions, she maintains an active career consulting, publishing... 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 →

Paul Strijbos

Senior Principal Neurotech Innovation Leader, F. Hoffmann-La Roche Ltd, Switzerland

Paul is a PhD neuroscientist with over 25 years of clinical development experience across the product lifecycle. He works as Neurotechnology Innovation Leader in the late stage Neuroscience organization of F. Hoffmann-La Roche in Basel and focusses on the development, validation and... Read More →

Martha Azer

Associate Director, Global Regulatory Policy & Intelligence, Johnson & Johnson, United States

Martha Azer is an Associate Director of Global Regulatory Policy and Intelligence at Johnson & Johnson. She leads the US policy work on Digital Health and Artificial Intelligence & Machine Learning as well as Precision Medicine to help shape the regulatory policy landscape to provide... Read More →

Jeffrey Siegel

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

Thursday June 20, 2024 8:00am - 9:00am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

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

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

9:15am PDT

#414: Regulatory Affairs of the Future: Is Now

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-689-L04-P; CME 1.00; RN 1.00

Global regulatory affairs is a critical function at the key interface between the innovation from our pipelines and patients. The world around us is changing very rapidly leading to implications and opportunities for regulatory affairs. We must evolve. But how?

Learning Objectives

Identify what global changes are leading to an evolved regulatory affairs organization; Discuss what skillset global regulatory affairs professionals of the future will need.

Chair

Lina AlJuburi, PharmD, MSc

Speaker

FDA Update
M. Khair ElZarrad, PhD, MPH

Academic Update
Maria Florez, MA

Industry Update
Nicole Mahoney, PhD

Speakers

Lina AlJuburi

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

M. Khair ElZarrad

Director, Office of Medical Policy, CDER, FDA, United States

Dr. ElZarrad is the Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple... Read More →

Maria Florez

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

Maria Florez studies the practices, strategies, attitudes, and incentives driving innovation in the pharmaceutical R&D process, as well as the impact of digital transformation in clinical research. Maria has been a researcher, consultant, and advisor in the healthcare sector for over... Read More →

Nicole Mahoney

Executive Director US Regulatory Policy & Intelligence, Novartis Pharmaceuticals Corporation, United States

Thursday June 20, 2024 9:15am - 10:15am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

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