Loading…
Attending this event?
Simple
Expanded
Grid
By Venue
Forum [clear filter]
Monday, June 17
 

11:00am PDT

#108: Risk Management in Advanced Device Technology Development
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-522-L04-P; CME 1.00; RN 1.00

This panel will discuss innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Risk management pertaining to future technologies will be critical as product become more patient centric.

Learning Objectives

Analyze latest expectations and challenges utilizing an integrated risk management approach for combination products; Discuss the importance of an integrated risk management approach to increase product understanding earlier within the product development phase.

Chair

James Wabby, MHS

Speaker

Panelist
Kimberly Trautman, MS

Panelist
Donna Rycroft, BSN

Panelist
Olivia Wong, MBA


Speakers
avatar for Kimberly Trautman

Kimberly Trautman

Managing Director, Trautman International Services, United States
Experienced Medical Devices, IVD and Combination Product Expert with over 40 years of experience, including 24 years working at the U.S. FDA CDRH. Author of the 1996 Medical Device Quality System regulation and member of the authoring group for Combination Product GMPs in Part 4... Read More →
avatar for James Wabby

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 →
avatar for Donna Rycroft

Donna Rycroft

Director, Study Risk Management, AbbVie, United States
Strategic Leader in Clinical Development with 11 years expertise in Risk-based Quality Management (RBQM) leading the development, implementation and change management of RBQM models and supporting systems at AbbVie and Allergan. Currently leading a team of Study Risk Leads supporting... Read More →
avatar for Olivia Wong

Olivia Wong

Director, Quality, Combination Products, Gilead, United States
Olivia Wong is the Director of Quality, Combination Products at Gilead Sciences in Foster City, CA. She has 22 years of industry experience in medical devices and combination products, where she has provided quality engineering expertise throughout the product lifecycle, including... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Forum |   06: TranslationalDelivery Tech-PrecMedicine, Forum

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
avatar for Vada Perkins

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 →
avatar for Ron Fitzmartin

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 →
avatar for Hilmar Hamann

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 →
avatar for Virginia Hussong

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

11:00am PDT

#110: Modernizing CDER’s New Drugs Review Program (NDRP): A Progress Update
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-524-L04-P; CME 1.00; RN 1.00

In 2017, CDER began modernizing the New Drugs Regulatory Program. This session shares progress updates and offers dialogue to enhance the program's key areas.

Learning Objectives

Describe the impetus for modernizing CDER’s Drug Regulatory Program (NDRP); Identify the NDRP strategic objectives and their associated initiatives; Discuss the progress and outcomes of two NDRP workstreams: Advisory Committees and Investigational New Drugs

Chair

Yoni Tyberg, MHA

Speaker

Panelist
Kevin Bugin, PhD, MS, RAC

Panelist
Meghana Chalasani, MHA

Panelist
Michael Monteleone, MS, RAC

Panelist
Andrew Emmett, MPH


Speakers
avatar for Kevin Bugin

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 →
avatar for Meghana Chalasani

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 →
avatar for Andrew Emmett

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 →
MM

Michael Monteleone

Associate Director for Labeling, OND, CDER, FDA, United States
Mr. Michael Monteleone is currently an Associate Director for Labeling in the Office of New Drugs at CDER, FDA. Michael has also held positions in Regulatory Affairs and Project Management throughout his 15 year tenure at the FDA.
YT

Yoni Tyberg

Associate Director of Special Programs, Office of New Drugs, CDER, FDA, United States
Yoni Tyberg is the Associate Director of Special Program Staff (SPS) at the Office of New Drugs within CDER. In this role, Yoni supports the strategic planning, project development and execution of the New Drug Regulatory Program Modernization efforts across OND and CDER. He had also... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum

11:00am PDT

#111: China Town Hall
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-525-L04-P; CME 1.00; RN 1.00

In this forum, speakers from the National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE) will present and discuss the latest information on regulation, regulatory science, and drug review and approval. Speakers will also discuss recent development in clinical research in China. Attendees will have an opportunity to discuss the issues related to drug regulation with NMPA officials.

Learning Objectives

Summarize the latest information on the National Medical Products Administration’s activities in drug regulation; Describe the recent update on the progress in drug review, approval and clinical research in China; Identify challenges in drug development and regulation in China.

Chair

Ling Su, PhD

Speaker

Opening Remarks and Introductions
Lili Cao, MS

Initiatives to Bring More New Drugs to Patients, and Faster
Zhimin Yang, MD

Recent Developments in Regulatory Science and Regulation
Jiangyong Yu

Advancing Clinical Research in China: A Clinical Oncologist’s Perspective
Shun Lu


Speakers
avatar for Ling Su

Ling Su

Research Fellow, Shenyang Pharmaceutical University, Yeehong Business School, China
Dr. Ling Su is a Research Fellow in Shengyang Pharmaceutical University Yeehong Business School and a Venture Partner in Lilly Asia Ventures (LAV). He has 30 years of experience in drug regulatory and development. He had worked in various R&D management positions in the pharma industry... Read More →
avatar for Lili Cao

Lili Cao

Deputy Director, China Center for Food and Drug International Exchange, National Medical Products, China
Lili Cao is the Deputy Director-General, China Center for Food & Drug Int’l Exchange (CCFDIE), National Medical Products Administration (NMPA). She received her bachelor degree at Nankai University, and master degree at London School of Economics and Political Science, majoring... Read More →
avatar for Shun Lu

Shun Lu

Director, Center for Clinical Medicine of Lung Cancer, Shanghai Chest Hospital,, Shanghai Jiaotong University, China
Shun Lu, MD, PhD, is a Director of the Oncology Department and Professor at Shanghai Chest Hospital. Dr. Lu serves on the International Affairs Committee of the American Society of Clinical Oncology, and Multidisciplinary Cancer Management Courses Working Group. He is also a member... Read More →
avatar for Zhimin Yang

Zhimin Yang

Deputy Director, Center for Drug Evaluation, National Medical Products Administration (NMPA), China
Dr. Yang is theDeputy Director-General ,Center for Drug Evaluation of the National Medical Products Administration. Graduated from Peking University Medical Center, majoring in clinical medicine. She used to be a known pediatrician working at Peking University People's Hospital. In... Read More →
avatar for Jiangyong Yu

Jiangyong Yu

Director, Department of Drug Registration, National Medical Products Administration (NMPA), China
Dr. Yu Jiangyong, Doctor of Science, Chief Pharmacist. Currently, he is the consultant and director of division of TCMs and Ethno-Medicines, Department of Drug Registration (Department of TCMs and Ethno-Medicines Regulation) of China's NMPA.

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum

11:00am PDT

#116: Navigating the Trusted, Responsible, and Ethical Horizon of Artificial Intelligence: Uniting Healthcare Perspectives
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-529-L04-P; CME 1.00; RN 1.00

Artificial Intelligence (AI) is making its presence known in health care, presenting unprecedented opportunities and challenges. It is crucial to devise strategies that ensure its ethical and responsible utilization for the betterment of health care and society. This imperative can only be met by harnessing the collective power of the broad Healthcare ecosystem. Join us for an engaging DIAmond session featuring esteemed panelists from technology companies, pharmaceuticals, patient advocacy groups, and academia/research to delve into how we can leverage the momentum of AI while establishing a foundation of trust. In this session, we will address the following questions: • How is the health care data landscape evolving in conjunction with AI, and what implications does it hold in terms of opportunities and concerns for our stakeholders? • What expectations do stakeholders have of us as leaders in ensuring ethical innovation? • What emerging practices, supported by real examples and lessons learned, are paving the way for the integration of ethical considerations into actionable strategies? • Where should we seek cross-sector partnerships to further propel momentum and establish standards for the ethical and responsible deployment of AI? Let us unite in paving the way towards a future where innovation is fueled by trust, driven by the responsible utilization of our burgeoning capabilities.

Learning Objectives

Define responsible innovation and ethical use of artificial intelligence (AI) in health care and life sciences; Explore the intersection of ethical considerations with technological advancements; Examine the role of cross-sector partnerships in driving trusted and responsible AI use.

Chair

Martin Hodosi, MSc

Speaker

Panelist
Junaid Bajwa, MD, MBA, MSc, FRCP

Panelist
Karla Childers, MS

Panelist
Dave deBronkart


Speakers
avatar for Martin Hodosi

Martin Hodosi

Partner, Healthcare and Life Sciences Practices, Kearney, United Kingdom
More than a decade of experience in Strategy Consulting across sectors, with 8+ years across value chains in Pharmaceuticals, MedTech and Life Sciences. Focused on helping biopharma Research & Development (R&D) leaders bring superior treatments to patients more quickly by transforming... Read More →
avatar for Junaid Bajwa

Junaid Bajwa

Practicing Physician, UK’s National Health Service; Chief Medical Scientist, Microsoft Research, United Kingdom
Junaid is the Chief Medical Scientist at Microsoft Research and a practicing physician in the UK’s National Health Service. Junaid has worked across primary care, secondary care, and public health settings in addition to acting as a payer, and policymaker within the UK, where he... Read More →
avatar for Karla Childers

Karla Childers

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States
Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →
avatar for Dave deBronkart

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 →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  14: DIAmond, 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
avatar for Pujita Vaidya

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 →
avatar for Michelle Campbell

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 →
BK

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 →
ER

Elizabeth Rosenkrands-Lange

Senior Director/ Head of US Regulatory Scientific Policy, EMD Serono, United States

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

2:15pm PDT

#140: The State of Real-World Evidence for Regulatory Decision-Making: Views from FDA, EMA, and PMDA
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-540-L04-P; CME 1.00; RN 1.00

This session will be a panel discussion with senior leaders from FDA, EMA, and PMDA who are closely involved with real-world evidence (RWE) initiatives within their respective agencies. An open Q&A with leaders in RWE from FDA, EMA, PMDA, will be included.

Learning Objectives

Describe current perspectives of regulators from several agencies on the use of real-world evidence (RWE) for regulatory decision-making; Discuss from examples of successful use of RWE in regulatory decision-making and how they can be applied; Identify current initiatives and programs regarding RWE in each regulatory agency.

Chair

Charles Lee, MBA, MS

Speaker

FDA Update
Motiur Rahman, PhD, MPharm, MS

EMA Update
Sabine Haubenreisser, PhD, MSc

PMDA Update
Yuki Ando, PhD


Speakers
avatar for Charles Lee

Charles Lee

Executive Regulatory Science Director, AstraZeneca, United States
Charles is currently Executive Regulatory Science Director at Astrazeneca. He oversees Global Regulatory science and strategy for therapeutic products in the renal, cardiovascular, diabetes, and NASH disease areas. Prior to this role, Charles was a Product Development Team Leader... Read More →
avatar for Yuki Ando

Yuki Ando

Principal Senior Scientist for Biostatistics, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yuki Ando is a Senior Scientist for Biostatistics of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. She has over 20 years' experience as Biostatistics Reviewer, and currently she is responsible for the biostatistics review and consultation in the new drug and device... Read More →
avatar for Sabine Haubenreisser

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 →
avatar for Motiur Rahman

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 →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum

2:15pm PDT

#130: Interactive Safety Graphics in the Regulatory Decision-Making Process
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-530-L04-P; CME 1.00; RN 1.00

Different visionary options may lead to a different look and feel to clincial study reports (CSRs) and submissions:
  • Broader use of interactive displays in submissions
  • Sponsor provides interactive package(s)
  • Regulators/sponsors use their own interactive package(s)


    • Let’s continue the discussion on how best to collaborate on interactive safety review strategy and development.

    Learning Objectives

    Identify the impact of interactive displays on submission content and the review process including the clinical study report (CSR) and trial data submission, use of review software, and answering information requests.

    Chair

    Greg Ball, PhD

    Speaker

    Panelist
    Scott Proestel, DrMed, MD

    Panelist
    Y. Veronica Pei, MD, MEd, MPH

    Panelist
    Glen Wright Colopy, PhD, MSc

    Panelist
    David Nahamya


    Speakers
    avatar for Greg Ball

    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 →
    avatar for Glen Colopy

    Glen Colopy

    Head of Data Science and Statistics, Wildfell Software, United States
    Glen Wright Colopy is the Head of Data Science & Statistics at Wildfell, a startup specializing in custom software and data science solutions for the biotech and life science industries. Glen's day-to-day work is as a hands-on full stack data science contributor, focused on helping... Read More →
    DN

    David Nahamya

    Secretary to the Authority, Uganda National Drug Authority, Uganda
    David was born in 1967 to Mr. and Mrs. Kihumuro; Ntungamo District, Western Uganda. He is known for being an influential person for positive change and leads with confidence. David is a graduate of MSc. Pharmaceutical Sciences - University of Havana; has PGD in Management - Uganda... Read More →
    avatar for Y. Veronica Pei

    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 →
    avatar for Scott Proestel

    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 →

    Monday June 17, 2024 2:15pm - 3:15pm PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      11: Statistics-Data Science, Forum |   01: ClinSafety-PV, Forum

    2:15pm PDT

    #143: Unveiling the Secrets of Success: An Executive Panel with Insights to Navigating your Career Journey
    Component Type: Forum
    Level: Basic

    This forum is designed to inspire, provide insights for robust career planning, and targeted for anyone interested in further development regardless of the stage of their career. Join industry and executive leaders as they answer your career questions.

    Learning Objectives

    Describe how to approach career planning with a focus on experiences, transferrable skills, and cross-training; Discuss how to use mentoring relationships as a career catapult; Differentiate development from promotion/advancement and use that in career planning; Identify how to mentally deal with uncertainty and benefit from lateral moves and from keeping an open mind.

    Chair

    Leslie Sam

    Speaker

    Panelist
    David Fryrear, MS

    Panelist
    Jeremy Jokinen, PhD, MS

    Panelist
    Paula Walker, MA

    Panelist
    Niam Vora, PharmD


    Speakers
    avatar for Leslie Sam

    Leslie Sam

    President, Leslie Sam and Associates, LLC, United States
    With 25 years+ of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →
    avatar for David Fryrear

    David Fryrear

    Executive Vice President and Head of Quality Assurance, Astellas, United States
    David Fryrear, M.S., is Executive Vice President and Head of Quality Assurance for Astellas. He has responsibility for providing the global vision, leadership and strategic direction for Quality Assurance, from the earliest stages of research, through clinical development and commercialization... Read More →
    avatar for Jeremy Jokinen

    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 →
    avatar for Niam Vora

    Niam Vora

    Pharmacist, Srx Health Solutions, Canada
    Niam Vora is a PharmD graduate from the University of Illinois Chicago. For the past two years, he has served as the National Student President for DIA Student Chapters across the United States. He has also completed a Schweitzer Fellowship, through which he implemented the United... Read More →
    avatar for Paula Walker

    Paula Walker

    Global Head of Risk Based Quality Management, Roche Products Ltd., United Kingdom
    Paula is the Global Head of RBQM at Roche, having started with the company with a Quality Policy focus. Formerly Head of Compliance (GCP/PV/GLP) at the MHRA and Acting Head of Inspectorate, having started in 2009 as a GCP Inspector; spending 13.5 years at the Regulator. Paula has... Read More →

    Monday June 17, 2024 2:15pm - 3:15pm PDT
    Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      13: ProfDevelopment, 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
    avatar for Ciby Abraham

    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 →
    avatar for Brooke Casselberry

    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 →
    avatar for Andrew Chang

    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 →
    avatar for Alexander Gaffney

    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 →
    avatar for Lawrence Yu

    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

    3:30pm PDT

    #149: Effective Patient / Industry Collaboration: Valuing Patient Lived Experience To Inform Trial Design
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-548-L04-P; CME 1.00; RN 1.00

    This “talk-show” style forum is driven by the patient voice to collaborate on clinical research through the eyes of patients, advocates, and caregivers. It illuminates barriers and burdens and provides solutions for industry to raise awareness, participation, and retention in clinical trials.

    Learning Objectives

    Describe how empowered patient decision making contributes to increased enrollment and engagement in clinical trials; Discuss value proposition for industry to involve patients early and give examples of metrics to quantify and measure: Idxentify unique challenges and wins in the clinical research space, including pediatric trials.

    Chair

    Aman Khera, MBA

    Speaker

    Panelist
    Stacy Hurt, MBA, MHA

    Speaker
    Mario Estevez


    Speakers
    avatar for Stacy Hurt, MBA, MHA

    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 →
    avatar for Aman Khera

    Aman Khera

    Vice President, Regulatory Science & Innovation, Worldwide Clinical Trials, Canada
    Aman Khera has earned her nickname: Rebel Regulator, a clinical research professional, with nearly 3 decades of experience in life sciences clinical research, advising biotech and pharma companies. With a deep foundation in global regulatory affairs and the life sciences industry... Read More →
    ME

    Mario Estevez

    Patient Caregiver and Project Alive, United States

    Monday June 17, 2024 3:30pm - 4:30pm PDT
    Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Forum

    3:30pm PDT

    #150: Building Trust in New Alternative Methods in Investigational New Drug Applications
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-24-549-L04-P; CME 1.00; RN 1.00

    This forum will discuss practical experiences developing investigational new drug applications (IND) applications with new alternative methods (NAMs). Panelists will share lessons learned on how to build trust in NAMs for regulatory uses.

    Learning Objectives

    Apply strategies to leverage new alternative methods (NAMs) in IND applications; Evaluate successful case studies; Identify gaps and opportunities to advance the use of NAMs for drug development.

    Chair

    Rasika Kalamegham, PhD

    Speaker

    FDA's Perspectives on the Current Use of NAMs in IND Applications
    Paul C. Brown, PhD


    Speakers
    avatar for Paul Brown

    Paul Brown

    Associate Director for Pharmacology and Toxicology, OND, CDER, FDA, United States
    Dr. Brown's responsibilities include development and implementation of guidance and policy related to the nonclinical assessment of human pharmaceuticals. He has been at the FDA since 1996 when he joined the Division of Dermatology and Dental Drug Products as a Pharmacology/Toxicology... Read More →
    avatar for Rasika Kalamegham

    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 →

    Monday June 17, 2024 3:30pm - 4:30pm PDT
    Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      06: TranslationalDelivery Tech-PrecMedicine, Forum

    3:30pm PDT

    #146: Past, Present, and Future: How Industry and FDA are Handling the Evolving Clinical Trial Diversity Regulatory Landscape
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-545-L04-P; CME 1.00; RN 1.00

    This forum will include discussion among multiple sponsors sharing their first-hand, cross-therapeutic area experience on notable trends and challenges they have faced in preparing these early diversity plan submissions. Panelists will also address how they plan to adapt to more expansive categories enumerated within diversity action plan guidance and share reflections on recently released FDA guidances on this topic (i.e. diversity action plans, post market approaches to obtain data on underrepresented populations, collection of race and ethnicity data). Additionally, panelists will discuss what policy deliverables and clarifications they would like to see reflected in the final guidances. The panel will also include FDA’s perspective and reflections from 2 years of diversity plan submissions as well as any considerations as we look to the future.

    Learning Objectives

    Describe best practices and regulatory feedback on diversity plan submissions.; Compare the perspectives of both FDA and sponsors about the current landscape of trial diversity-related guidances, including the latest diversity action plan guidance.; Discuss how by using an interactive audience feature where we seek others’ experience compiling and feedback from the FDA on diversity plan submissions.

    Chair

    Dylan Bechtle, MS

    Speaker

    Industry Update
    Andrea Doyle

    Industry Update
    Del Smith, PhD, MS

    Industry Update
    Stacy Holdsworth, PharmD

    FDA Update
    Tamy Kim, PharmD


    Speakers
    DB

    Dylan Bechtle

    Associate Director, Regulatory Policy Lead- US, Johnson & Johnson, United States
    Dylan is an Associate Director in Johnson and Johnson Innovative Medicine's Global Regulatory Policy and Intelligence (GRPI) group. Dylan leads J&J’s regulatory policy efforts around clinical trial diversity. He is interested in the intersection of novel clinical methodologies (e.g... Read More →
    AD

    Andrea Doyle

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

    Stacy Holdsworth

    Associate Vice President, US Regulatory Policy & Strategy, Eli Lilly and Company, United States
    Stacy Holdsworth is the Associate Vice President for U.S. Regulatory Policy & Strategy at Eli Lilly and Company. Her primary responsibilities are to lead a team of regulator professionals in the development and implementation of an external regulatory policy agenda that encourages... Read More →
    avatar for Tamy Kim

    Tamy Kim

    Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence, FDA, United States
    Tamy Kim is the Director for Regulatory Affairs and Policy at FDA's Oncology Center for Excellence and the Associate Director for Regulatory Affairs in the Office of Oncologic Diseases (OOD). Dr. Kim is responsible for developing policies and procedures affecting the review of products... Read More →
    avatar for Del Smith

    Del Smith

    Co-Founder and Chief Executive Officer, Acclinate Inc., United States
    Del is the co-founder and CEO of Acclinate, a trusted digital health company focused on greater health equity through inclusive research. He has built a diverse team and AI/ML platform to help the pharmaceutical and healthcare industry access and engage communities of color so that... Read More →

    Monday June 17, 2024 3:30pm - 4:30pm PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum |   02: ClinTrials -ClinOps, Forum
     
    Tuesday, June 18
     

    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
    avatar for Lubna Merchant

    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 →
    SA

    Saifuddin Ahmed

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

    Sangeeta Chatterjee

    Deputy Office Director, Office of Drug Security, Integrity, Response, OC, CDER, FDA, United States
    avatar for Regina Mariam Kamoga

    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 →
    RK

    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
    avatar for Trevor Cole

    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 →
    avatar for Kristen Ballesteros

    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 →
    avatar for Suanna Bruinooge

    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 →
    avatar for Ramya Thota

    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

    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
    avatar for Christy Cottrell

    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 →
    avatar for Victoria Dohnal

    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 →
    AF

    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 →
    AM

    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

    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
    avatar for Lina AlJuburi

    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 →
    avatar for Steve Berman

    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 →
    avatar for Gul Erdemli

    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 →
    avatar for Anindita Saha

    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 →
    avatar for Max Wegner

    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

    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
    avatar for Steven Weisman

    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 →
    avatar for Naomi Boxall

    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 →
    avatar for Vera Ehrenstein

    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 →
    avatar for Gerald Dal Pan

    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 →
    CS

    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

    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
    avatar for David Pearce

    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 →
    avatar for Philip (P.J.) Brooks

    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 →
    CW

    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

    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
    avatar for Rob Berlin

    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 →
    avatar for Rasika Kalamegham

    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 →
    avatar for Lauren Oliva

    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 →
    avatar for Jeffrey Siegel

    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 →
    JT

    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

    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
    avatar for Ellen Janssen

    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 →
    avatar for Robyn Bent

    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 →
    BH

    Brett Hauber

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

    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 →
    avatar for Bennett Levitan

    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 →
    avatar for Caroline Vass

    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

    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
    avatar for Suanna Bruinooge

    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 →
    avatar for Craig Lipset

    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 →
    avatar for Ramya Thota

    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 →
    avatar for Joseph Unger

    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

    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
    avatar for Pete Fronte

    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 →
    avatar for Karen Correa

    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 →
    avatar for James Schultz

    James Schultz

    Chief Medical Officer, Neighborhood Healthcare, United States
    MD

    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

    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
    avatar for Pamela Aung-Thin

    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.
    avatar for Alison Cave

    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 →
    avatar for Emer Cooke

    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 →
    avatar for Yasuhiro Fujiwara

    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 →
    avatar for Anthony Lawler

    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 →
    avatar for Antonio Barra Torres

    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

    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
    avatar for Brian Bradbury

    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 →
    avatar for Aaron Kamauu

    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 →
    KK

    Kajsa Kvist

    Scientific Vice President, Novo Nordisk, Denmark
    avatar for Francesco Pignatti

    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 →
    AV

    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

    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
    avatar for Summer Starling

    Summer Starling

    Senior Project Manager, Clinical Trials Transformation Initiative (CTTI), United States
    avatar for Jennifer Miller

    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 →
    avatar for Linda Sullivan

    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

    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
    avatar for Eri Sekine

    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 →
    avatar for Leyna Mulholland

    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 →
    avatar for Toshiharu Sano

    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 →
    TS

    Toshihiro Sano

    Associate Vice President, Head of Clinical Operations, Merck Sharp & Dohme LLC , United States
    avatar for Xiaojun (Wendy) Yan

    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

    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
    avatar for Rachael Anatol

    Rachael Anatol

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

    Andrea Doyle

    Head, Global Regulatory Affairs, Neurology, Sanofi, United States
    avatar for Evdokia Korakianiti

    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 →
    MV

    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

    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
    avatar for Amanda Roache

    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 →
    avatar for Nina Cauchon

    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 →
    avatar for Connie Langer

    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 →
    SY

    Satomi Yagi

    Reviewer, Office of New Drug III, Pharmaceuticals and Medical Devices Agency (PMDA)
    avatar for Evdokia Korakianiti

    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 →
    avatar for Sau Lee

    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 →

    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

    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
    avatar for Victoria DiBiaso

    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 →
    avatar for Kenneth Getz

    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 →
    avatar for Hollie Schmidt

    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 3:15pm - 4:15pm PDT
    Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      02: ClinTrials -ClinOps, Forum

    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
    avatar for Meghana Chalasani

    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 →
    avatar for Kevin Bugin

    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 →
    avatar for Michelle Rohrer

    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 →
    avatar for Ella Balasa

    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 →
    avatar for Allison Cuff Shimooka

    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

    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
    avatar for Amanda Burkhardt

    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 →
    avatar for Terry Church

    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 →
    avatar for James Wabby

    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

    #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
    avatar for Aaron Josephson

    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 →
    avatar for Brett Howard

    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 →
    avatar for Kristin Willemsen

    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 →
    avatar for Katherine Wilson

    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

    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
    avatar for Summer Starling

    Summer Starling

    Senior Project Manager, Clinical Trials Transformation Initiative (CTTI), United States
    avatar for Jenny Chien

    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 →
    avatar for Herbert Pang

    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 →
    avatar for Karthik Venkatakrishnan

    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

    #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
    avatar for Lani Hashimoto

    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 →
    avatar for James Duhig

    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 →
    JG

    Jamie Goldfarb

    Director, Patient Recruitment Strategy, Trialbee, United States
    avatar for Eddilisa Martin

    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

    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
    avatar for Danielle Friend Economo

    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 →
    avatar for Peter Marks

    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 →
    avatar for Alexis Miller

    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 →
    avatar for Edward Neilan

    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

    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
    avatar for Antonio Barra Torres

    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 →
    avatar for Cammilla Horta Gomes

    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 →
    avatar for Patricia Oliveira Pereira Tagliari

    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 →
    avatar for Bianca Zimon

    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

    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
    avatar for Lan Mu

    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 →
    EF

    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 →
    avatar for Karthik Iyer

    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 →
    CS

    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
     
    Wednesday, June 19
     

    8:00am PDT

    #303: How Common Data Models Can Address the Challenges in the Use of Clinical Trial and Real-World Data for Evidence Generation
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-624-L04-P; CME 1.00; RN 1.00

    This panel will discuss different types of data models that exist and their strengths and weaknesses in relation to real-world data (RWD) and interoperability.

    Learning Objectives

    Recognize the different types of data models that exist and their strengths and weaknesses in relation to real-world data (RWD) and interoperability; Discuss the appropriate data models for primary and secondary data and how clinical data managers can potentially help RWD and trial data to meet the evidentiary requirements for regulatory decision-making.

    Chair

    Jesper Kjær, MS

    Speaker

    Panelist
    Davera Gabriel, RN

    Panelist
    Jonathan Stuart Chainey

    Panelist
    Stacy Tegan


    Speakers
    JC

    Jonathan Chainey

    Executive Director, Global Head, Data Standards and Governance, Data Sciences, Roche, United States
    Jonathan Chainey is an Executive Director and Global Head, Data Standards and Governance within Data Sciences, Product Development at Roche. He leads a global team accountable for the cross-functional governance and adoption of Roche’s CDISC-aligned global data standards across... Read More →
    avatar for Davera Gabriel

    Davera Gabriel

    Director of Client Success, Evidentli USA LLC, United States
    Davera Gabriel, RN FHL7 FAMIA is the Director of Client Success at Evidentli USA. Widely recognized as one of the world's leaders in accelerating the evolution of healthcare data standards in translational research. She has lead data alignment efforts in groundbreaking, multi-site... Read More →
    avatar for Jesper Kjaer

    Jesper Kjaer

    Global Director for Public, Private Partnerships, Strat Ops, Global Med Affairs, Novo Nordisk, Denmark
    Global Director for Public, Private Partnerships at Novo Nordisk, Global Medical Affaris. Former Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been... Read More →
    avatar for Stacy Tegan

    Stacy Tegan

    Program Director, Transcelerate Biopharma, Inc., United States
    Stacy Tegan is a Program Director at TransCelerate Biopharma, Inc., a non-profit organization with a mission to collaborate across the biopharmaceutical R&D community. In her current role she oversees projects to enable information sharing and harmonization across the clinical development... Read More →

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

    8:00am PDT

    #304: Synergizing Large Language Models and Digital Health Technology for Healthcare Transformation
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-625-L04-P; CME 1.00; RN 1.00

    This discussion will dive into large language models (LLMs) impact on healthcare, their integration with digital health technology, and ethical/regulatory implications.

    Learning Objectives

    Describe how digital health technologies (DHTs) and generative artificial intelliegence (AI), including large language models (LLMs) are applied to healthcare context; Examine the various integration points between LLMs and DHT and discover how these technologies can work synergistically to revolutionize patient care, telemedicine, remote, and disease progression.

    Chair

    Jagdeep Podichetty, PhD, MS

    Speaker

    Panelist
    Qi Liu, PhD

    Panelist
    Jie Shen, PhD, MBA

    Panelist
    Sakshi Sardar, PhD

    Panelist
    Emily Lewis, MS


    Speakers
    avatar for Jagdeep Podichetty

    Jagdeep Podichetty

    Senior Director of Predictive Analytics, Critical Path Institute, United States
    Dr. Jagdeep Podichetty is the Senior Director of Predictive Analytics in the Quantitative Medicine Program at the Critical Path Institute, where he is developing quantitative solutions such as disease progression models, survival models, clinical trial simulation, and artificial intelligence... Read More →
    avatar for Emily Lewis

    Emily Lewis

    Artificial Intelligence and Innovation Lead, Neurology, UCB, United States
    Emily Lewis is a trailblazing innovator and leader in the realm of digital health and AI. With nearly two decades of experience, she has made significant contributions to the development and adoption of cutting-edge digital health solutions. Her passion for using technology to improve... Read More →
    avatar for Qi Liu

    Qi Liu

    Assoc Director for Innovation and Partnerships, OCP, OTS, CDER, FDA, United States
    Dr. Qi Liu is the Associate Director for Innovation & Partnership in the Office of Clinical Pharmacology (OCP)/ Office of Translational Sciences, CDER, FDA. She has helped developing OCP’s portfolio on AI, real world evidence and digital health technologies. Qi leads OCP Innovative... Read More →
    avatar for Sakshi Sardar

    Sakshi Sardar

    Senior Director, Digital and Precision Medicine, Critical Path Institute, United States
    Sakshi Sardar is a Senior Director for Digital and Precision Medicine within Quantitative Medicine at the Critical Path Institute. Her focus is on driving the development of essential components for utilizing digital health technologies (DHTs) to meet evidentiary requirements for... Read More →
    avatar for Jie Shen

    Jie Shen

    Director, Digital Science, AbbVie, United States
    Jie Shen is a data science leader with a track record of building innovative solutions for drug discovery and development. Currently he is a Director of Digital Science at AbbVie, leading the digital health technology development, validation, and data analytics. Prior to his current... Read More →

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

    8:00am PDT

    #305: All the Ways Medical Affairs Supports Product Development: From Clinical Trials to Product Launch
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-626-L04-P; CME 1.00; RN 1.00

    Wondering what a medical affairs team does? This session will dive into some of the different roles within medical affairs, their responsibilities, and how these roles support a product over the course of its development.

    Learning Objectives

    Recognize how the medical affairs function can support a product across all stages of development; Describe different roles within medical affairs and how they connect to each other and to the broader organization.

    Chair

    Sejal Vora, PharmD

    Speaker

    All the Ways Medical Affairs Supports Product Development: Field Perspective
    Nital Patel, PharmD, MBA

    All the Ways Medical Affairs Supports Product Development: Publication Planning
    Wendy Tin, PharmD, RPh


    Speakers
    avatar for Sejal Vora

    Sejal Vora

    Director, Medical Information, BeiGene, United States
    Sejal Vora has over 20 years of industry experience within Medical Affairs, including Medical Information, Publication Planning, Investigator Initiated Research, and serving as a medical reviewer for promotional and medical review committees. She earned her PharmD at the University... Read More →
    NP

    Nital Patel

    Consultant, United States
    Nital Patel has over 12 years of experience within Medical Affairs, including Medical Training and Operations, Field Medical, and as Executive Medical Director. She earned both her PharmD and MBA at Drake University in Des Moines, Iowa. Nital completed a 2-year Regulatory Fellowship... Read More →
    avatar for Wendy Tin

    Wendy Tin

    Associate Director, HIV PrEP Scientific Publications, Gilead Sciences, United States
    Wendy Tin is a pharmacist by training with more than 6 years of experience in the pharmaceutical industry. After graduating from UC Berkeley with a BA in molecular and cell biology, Wendy attended UCSF and earned her PharmD degree. Prior to industry, Wendy worked as a pharmacist in... Read More →

    Wednesday June 19, 2024 8:00am - 9:00am PDT
    Room 7AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      04: MedAffairs-SciComm, Forum

    8:00am PDT

    #306: Which Clinical Outcome Assessment to Choose: Questionnaire or Sensor? Time to Align an Endpoint Selection Framework
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-627-L04-P; CME 1.00; RN 1.00

    Questionnaires, standardized tasks, and DHTs can measure similar outcomes which complicates endpoint selection. This forum discusses a framework to align ontologies for actively-collected and passively-monitored COAs to streamline endpoint strategy

    Learning Objectives

    Identify biomarkers from actively collected and passively-monitored COAs building upon regulatory definitions; Determine a framework to align ontologies for these measure types enabling rapid, evidence-based, and fit-for-purpose measure selection using case study examples.

    Chair

    Caprice Sassano, MPH

    Speaker

    Panelist
    Roya Sherafat-Kazemzadeh, MD, PhD

    Panelist
    Megan Parisi, MS

    Panelist
    Thomas Switzer, MEd


    Speakers
    CS

    Caprice Sassano

    Research and Data Products - Applied Sciences, HumanFirst, United States
    RS

    Roya Sherafat-Kazemzadeh

    Scientific Director, Mapi Research Trust, France
    Dr. Roya Sherafat is a trained physician and holds dual PhDs in epidemiology and health policy. Roya has over a decade experience in clinical research in the field of obesity and cardiometabolic health specifically on profiling risk factors, adverse cardiometabolic outcomes, and heterogeneity... Read More →
    avatar for Megan Parisi

    Megan Parisi

    Patient Solutions Lead, Syneos Health, United States
    Megan Parisi, MS, CCRP, is a Patient Solutions Lead at Syneos Health where she curates patient centric strategies for implementation into clinical trials across all phases of development. She innovates in patient and site focused trial design, focusing on decentralized and digital... Read More →
    avatar for Thomas Switzer

    Thomas Switzer

    Principal Digital Health Scientist, Genentech, A Member of the Roche Group, United States
    Tom is a Principal Scientist and Digital Health Lead in Genentech's Research and Early Development Informatics group.  His current focus is on developing technology platforms supporting molecule teams across the early development portfolio.  Tom has over 24 years of clinical development... Read More →

    Wednesday June 19, 2024 8:00am - 9:00am PDT
    Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Forum

    8:00am PDT

    #308: Unlocking Innovation: Implementing Future-Focused Risk-Based Quality Management Quality Briefs - A Cross-Functional Challenge
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-24-629-L04-P; CME 1.00; RN 1.00

    Join us as we delve into the cutting-edge realm of risk-based quality management (RBQM) and learn how quality briefs revolutionize compliance reporting both internally and for externally for regulators. Discover how quality briefs offer proactive transparency at the time of filing, incorporating ICH E8/E6(R3) expectations, and focusing on highest risk critical to quality (CtQ) areas. Gain insights from real-world case studies of multi-company implementations, and uncover strategies to collaborate across functions for swift product delivery while maintaining stringent quality standards. Explore how quality briefs drive a paradigm shift in quality management, moving from gatekeeping at the end of the process to proactive involvement from the start, in line with ICH E6 R3 and E8 R1 quality by design principles. Learn how to craft the GCP compliance story of your product's development, with each CtQ factor assessed for compliance status at filing, supported by evidence and data analytics insights. Dive into the 'How' of implementation, with practical guidance for companies keen on adopting this transformative approach, including updates on Health Authority engagement.

    Learning Objectives

    Critique the methodology behind implementing the outcomes-based approach of quality briefs in risk-based quality management (RBQM), illustrating how it demonstrates the compliance status of critical to quality (CtQ) factors; Design effective cross-functional communication strategies within a company to facilitate the implementation of changes required for adopting quality briefs, emphasizing collaboration; Identify the key challenges and successes derived from real-world insights.

    Chair

    Paula Walker, MA

    Speaker

    Panelist
    Cheryl Grandinetti, PharmD

    Panelist
    Jennifer Emerson, PhD, MPH, RN, PMP

    Panelist
    Jamie Bridges, MPH

    Panelist
    Alissa Mun, MS


    Speakers
    avatar for Paula Walker

    Paula Walker

    Global Head of Risk Based Quality Management, Roche Products Ltd., United Kingdom
    Paula is the Global Head of RBQM at Roche, having started with the company with a Quality Policy focus. Formerly Head of Compliance (GCP/PV/GLP) at the MHRA and Acting Head of Inspectorate, having started in 2009 as a GCP Inspector; spending 13.5 years at the Regulator. Paula has... Read More →
    avatar for Jamie Bridges

    Jamie Bridges

    Executive Director, Clinical Quality Assurance, Merck Sharp & Dohme LLC , United States
    Jamie Bridges has 26 years of pharmaceutical experience. She began her career at Pfizer and spent the past 25 years with Merck based out of West Point, PA. Her career has included leadership roles in Data Management, Epidemiology, Operational Excellence and most recently Clinical... Read More →
    avatar for Jennifer Emerson

    Jennifer Emerson

    Head Quality Analytics & Risk Management, Boehringer Ingelheim, Germany
    Clinical research professional with more than 20 years' experience in Quality Management, Project Management, Monitoring & Pharmacovigilance. PhD in Public Health - Epidemiology, Project Management Professional (PMP) Certified, ISO 9001:2015 certified Auditor. Current role: Head of... Read More →
    avatar for Cheryl Grandinetti

    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 →
    AM

    Alissa Mun

    Health Scientist Policy Analyst, OMP, CDER, FDA, United States
    Alissa Mun is a Health Scientist Policy Analyst in the Division of Clinical Trial Quality of the Office of Medical Policy in CDER/FDA. She provides scientific and technical input for ongoing policy initiatives such as risk-based monitoring, quality by design, and risk management with... Read More →

    Wednesday June 19, 2024 8:00am - 9:00am PDT
    Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      08: RD Quality-Compliance, Forum

    8:00am PDT

    #310: WHO Town Hall: Safeguarding Public Health - WHO's Vision for Global Regulatory Excellence
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-631-L04-P; CME 1.00; RN 1.00

    This session aims to delve into WHO's pivotal role in the evolving landscape of global regulatory excellence. The discussion will revolve around the transformative impact of WHO-listed Authorities on medical product regulation, emphasizing regulatory reliance as a holistic approach to enhance efficiency and accessibility. Additionally, the session will address the pressing issue of substandard/falsified medical products and their potential threats to global health.

    Learning Objectives

    Describe the significance of WHO-listed Authorities in shaping the future of medical product regulation; Examine the concept of regulatory reliance as a key strategy to enhance access and efficiency in global regulatory practices; Discuss the critical role of regulatory excellence in safeguarding public health against the threats posed by substandard/falsified medical products.

    Chair

    Samvel Azatyan, MD, PhD

    Speaker

    Elevating Regulatory Reliance: The Strategic Impact of WHO-Listed Authorities in Transforming Global Regulatory Landscapes
    Hiiti Sillo, MSc, RPh

    Securing Supply Chains: A Global Imperative
    Rutendo Kuwana, RPh

    EMA Update
    Emer Cooke, MBA, MSc

    Industry Update
    Janis Bernat, MSc

    Moderator for Panel Discussion and Q&A
    Marion Laumonier, MSc


    Speakers
    avatar for Samvel Azatyan

    Samvel Azatyan

    Team Lead, Regulatory Convergence and Networks (RCN/REG), World Health Organization (WHO), Switzerland
    Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration... Read More →
    avatar for Janis Bernat

    Janis Bernat

    Director, Scientific and Regulatory Affairs, IFPMA, Switzerland
    Janis leads cross-functional activities in regulatory science and international health policy for IFPMA, while partnering with policy experts and stakeholders to strengthen the pharmaceutical regulatory environment. She is responsible for guiding the organization’s regulatory team... Read More →
    avatar for Emer Cooke

    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 →
    RK

    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 →
    avatar for Marion Laumonier

    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 →
    avatar for Hiiti Sillo

    Hiiti Sillo

    Unit Head, Regulation and Safety, Department of Regulation and Prequalification, World Health Organization (WHO), Switzerland
    Hiiti Sillo is the Unit Head, Regulation and Safety within the WHO department of Regulation and Prequalification. Until August 2021, he was the Team Lead, Regulatory Systems Strengthening (RSS), Regulation and Safety Unit. Before joining WHO in January 2018, he was the Director General... Read More →

    Wednesday June 19, 2024 8:00am - 9:00am PDT
    Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    8:00am PDT

    #312: Revolutionizing Regulatory CMC and Advanced Manufacturing with the Power of AI: Unleashing Innovation and Efficiency
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-633-L04-P; CME 1.00; RN 1.00

    This forum session will explore the transformative potential of Artificial Intelligence (AI) in biotech RA CMC and advanced manufacturing. Discover how AI can optimize processes, improve efficiency, and ensure compliance of your data.

    Learning Objectives

    Define key concepts and principles of artificial intelligence (AI) in the context of biotech industry, regulatory CMC and advanced manufacturing; Identify the potential applications and benefits of AI including how it can automate deviation and change control processes or support strategic decision-making; Discuss the benefits, challenges and cons of AI i.e. data integrity and security.

    Chair

    Grzegorz (Greg) Podrygajlo, PhD

    Speaker

    Application of AI Tools to Support the Decision Process in Regulatory CMC
    Grzegorz (Greg) Podrygajlo, PhD

    Use of AI and ML in Pharmaceutical Manufacturing: Case Studies from the Shop Floor and Regulatory Landscape
    Gert Thurau, DrSc, PhD

    How to Use GenAI in a Smart Way for Now and for the Future
    Hubert Niewiadomski, PhD


    Speakers
    avatar for Grzegorz (Greg) Podrygajlo

    Grzegorz (Greg) Podrygajlo

    GRA CMC Director, Head of Global Manufacturing Support, CSL Behring, Switzerland
    Grzegorz (Greg) Podrygajlo, PhD is Head of Global Manufacturing Support, Global Regulatory Affairs CMC for Biologics at CSL Behring. He obtained Master in Medical Biotechnology and PhD in Neuroscience. Greg leads Global Regulatory Strategy for optimal Change Control Process and Life... Read More →
    avatar for Hubert Niewiadomski

    Hubert Niewiadomski

    Chief Executive Officer, Cledar, United States
    Hubert Niewiadomski is the CEO of Cledar, a Machine Learning and Artificial Intelligence Development company partnering with private and public sectors. Hubert has been the key contributor to more than 100 publications and has been working on neural networks for more than 20 years... Read More →
    avatar for Gert Thurau

    Gert Thurau

    Head of Manufacturing Technology Innovation in CMC Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland
    Dr. Gert Thurau leads Manufacturing Technology and Innovation Advocacy at Hoffmann-La Roche, Basel, Switzerland. He advocates for advanced technology adoption in GMP manufacturing, including continuous processing, process models, robotics, advanced analytical technology, but also... Read More →

    Wednesday June 19, 2024 8:00am - 9:00am PDT
    Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      10: RegCMC-Product Quality, Forum

    8:00am PDT

    #313: The Future of Women’s Health: Do We Really Want Innovation? Policy Ideas To Advance Innovation, Access, and Novel Approaches
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-634-L04-P; CME 1.00; RN 1.00

    There is a critical need for innovation in women’s health, particularly maternal health. What will it take to improve care in this area? How can innovative regulatory, reimbursement and access policies encourage novel approaches to women’s health?

    Learning Objectives

    Identify areas of women’s health which face barriers preventing innovation; Describe disparities in women’s/maternal health and existing regulatory, payment and access policies intended to improve outcomes; Evaluate the types of policy changes needed to encourage innovation

    Chair

    Nancy Bradish Myers, Esq, JD

    Speaker

    Panelist
    Tara Croft, MBA

    Panelist
    Sandy Milligan, JD, MD


    Speakers
    avatar for Nancy Myers

    Nancy Myers

    CEO and Founder, Catalyst Healthcare Consulting, Inc, United States
    Nancy Bradish Myers, JD, CEO & Founder, Catalyst Healthcare Consulting, is a sought-after leader with deep expertise in health law, regulation and policy. She has led a successful strategic regulatory policy consultancy for 19 years and has been active in the DC policy arena for three... Read More →
    avatar for Tara Croft

    Tara Croft

    Chief Executive Officer, Baymatob, Australia
    Tara is a passionate advocate for womens health and technology. A MedTech expert with 20 years industry experience, Tara is the CEO of Baymatob, a female-founded, female-led, early-stage business aiming to improve and save the lives of mothers and their babies, by developing an AI-enabled... Read More →
    avatar for Sandy Milligan

    Sandy Milligan

    Board of Director Member, Gossamer Bio; Principal, Innovex Strategies, United States
    Sandy Milligan is President of Aspira Women's Health, working to transform women’s gynecological health through the development and commercialization of innovative testing options. Previously, Sandy was the head of Research and Development at Organon, focused on improving the everyday... Read More →

    Wednesday June 19, 2024 8:00am - 9:00am PDT
    Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      12: Value-Access, 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?
    Sarah Vaughan

    Patient Perspective
    Christine Von Raesfeld

    Industry Perspective
    Gregory Powell, PharmD, MBA

    Academic Perspective
    Kathleen M. Giacomini, PhD


    Speakers
    avatar for Alison Cave

    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 →
    avatar for Kathleen Giacomini

    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 →
    GP

    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 →
    avatar for Christine Von Raesfeld

    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 →
    avatar for Sarah Vaughan

    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 →

    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

    10:00am PDT

    #319: Unlocking the Potential of IDMP for Global Exchange of Medicinal Products Data
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-637-L04-P; CME 1.00; RN 1.00

    This session will discuss how the ISO IDMP standards have a pivotal role in enhancing global pharmacovigilance and improving visibility in the product supply chain. The collaborative efforts of the Global IDMP Working Group reflect the need to advance this critical endeavor.

    Learning Objectives

    Define IDMP standards and explain their benefits when globally implemented; Describe the role of the unique global IDMP identifiers in data exchange of medicinal product information; Discuss the impact of global IDMP identifiers on different use cases in the medicinal product life cycle, for example, pharmacovigilance and drug shortages, supply chain integrity.

    Chair

    Malin Kristina Fladvad, PhD, MSc

    Speaker

    Unlocking the Potential of IDMP: Global Use Cases
    Ron Fitzmartin, PhD, MBA

    Unlocking the Potential of IDMP for Global Exchange of Medicinal Products Data
    Hilmar Hamann, PhD


    Speakers
    avatar for Malin Fladvad

    Malin Fladvad

    Portfolio Officer, Uppsala Monitoring Centre, Sweden
    Malin Fladvad is a Portfolio officer at Uppsala Monitoring Centre (UMC). In this position she is responsible for the WHODrug Product Portfolio which dictionaries and applications are used in clinical trials and safety monitoring worldwide. Malin is also engaged in various efforts... Read More →
    avatar for Ron Fitzmartin

    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 →
    avatar for Hilmar Hamann

    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 →

    Wednesday June 19, 2024 10:00am - 11:00am PDT
    Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Session |   03: Data-Tech, Session

    10:00am PDT

    #318: Defining an Inclusive Clinical Trials Approach in Europe
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-636-L04-P; CME 1.00; RN 1.00

    This forum will address industry challenges in the recruitment and retention of underserved populations in clinical research, and explores how regulators, physicians, sponsors and others can work together to develop solutions to tackle health equity.

    Learning Objectives

    Identify a proposal for addressing underrepresentation of underserved populations in Europe; Describe regulatory and industry perspectives in addressing recruitment and retention challenges for multi-regional clinical trials; Discuss best practices that can help shape inclusivity of clinical trials across borders.

    Chair

    Ambily Banerjee, PhD

    Speaker

    ACT-EU Efforts from EMA Perspective
    Ana Zanoletty Perez

    Evolving FDA Perspective Based on Learningd from DAP Submissions on What Diversity Looks Like
    M. Khair ElZarrad, PhD, MPH

    Industry Perspective of Community Engagement in Europe: A Case Study
    Monique Adams, PhD, MS

    CT Network One-Pager v2
    Nicholas Brooke, MBA


    Speakers
    avatar for Ambily Banerjee

    Ambily Banerjee

    Senior Director/Head of Diversity in Clinical Trials, Johnson and Johnson Innovative Medicine, United Kingdom
    After a decade as an academic scientist, following a Ph.D. in Molecular Biology, Ambily moved to GSK Regulatory Affairs, where she held increasingly senior roles in Global Regulatory Affairs and Internal Audit. She also led the race and ethnicity Employee Resource Group, EMBRACE... Read More →
    avatar for Monique Adams

    Monique Adams

    Executive Director, Global Head Diversity and Inclusion in Clinical Trials, Sanofi, United States
    Monique Adams is the Executive Director, Global Head of Diversity and Inclusion in Clinical Trials, or DICT, at Sanofi where she drives the pharmaceutical company’s vision, strategy, and implementation of a holistic framework for DICT. Monique has a Ph.D. in Pharmacology from the... Read More →
    avatar for Nicholas Brooke

    Nicholas Brooke

    Executive Director, Patient Focused Medicines Development (PFMD), PFMD, Belgium
    Nicholas Brooke is the Founder and Executive Director of The Synergist, an incubator and managing organization to multi-stakeholder platforms that brings key players together with the express aim of solving significant societal problems through collective actions. The Synergist also... Read More →
    avatar for M. Khair ElZarrad

    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 →
    avatar for Ana Zanoletty Perez

    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 →

    Wednesday June 19, 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

    10:00am PDT

    #322: Leveraging Testing Results Generated Within Treating Hospitals for Trials Across the Globe
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-640-L04-P; CME 1.00; RN 1.00

    Precision medicine biomarker testing can be achieved in various formats, harnessing results generated in each patient's treating hospital or in centralized laboratories. We will examine resulting regulatory and technical challenges & opportunities.

    Learning Objectives

    Demonstrate an understanding of different testing models (central vs decentralized); Identify their regulatory consequences for clinical study conduct and approval.

    Chair

    Mike Wierzba, PhD

    Speaker

    Panelist
    Oliver Stoss, PhD

    Panelist
    Amanda Baker, PharmD, PhD

    Panelist
    Ilona Reischl, PhD, MPharm

    Panelist
    Adriana Racolta, PhD, RAC

    Panelist
    Philip Kelly, PhD


    Speakers
    avatar for Mike Wierzba

    Mike Wierzba

    Director, GRA, Precision Medicine and Digital Health, GlaxoSmithKline, United States
    Mike Wierzba is a Director within the Precision Medicine & Digital Health, Global Regulatory Affairs team at GSK where he is the diagnostic regulatory lead for multiple development programs and leads efforts related to IVDR. Mike is a participant in EFPIA Precision Medicine Working... Read More →
    avatar for Amanda Baker

    Amanda Baker

    Clinical Development Lead (Director), Pathology Lab, Roche Tissue Diagnostics, United States
    Dr. Baker was a faculty member at the University of Arizona for 13 years where her research focused on the characterization of biomarkers associated with stress signaling pathways activated in response to the tumor microenvironment. She also worked for 8 years as a Research Scientist... Read More →
    PK

    Philip Kelly

    IVDR Project Manager | Assessment and Surveillance, Health Products Regulatory Authority (HPRA), Ireland
    Philip Kelly serves as the IVDR Project Manager for the HPRA. In this role Philip leads work items focused on ensuring compliance with regulatory requirements and facilitating the safe and effective use of IVDs. Recently as part of the COMBINE project Philip aided in the analysis... Read More →
    AR

    Adriana Racolta

    Director, Regulatory Affairs, Companion Diagnostics, Pfizer Inc, United States
    avatar for Ilona Reischl

    Ilona Reischl

    Biologics Quality Assessor, Austrian Medicines and Medical Devices Agency (AGES MEA), Austria
    Ilona Reischl joined the Austrian Agency in March 2006 and is currently an assessor within the clinical trials unit that is responsible for the evaluation of clinical trials with medicinal products and medical devices as well as GCP inspections. Her background is that of a quality... Read More →
    avatar for Oliver Stoss

    Oliver Stoss

    Senior Vice President of Operations, Discovery Life Sciences Biomarker Services GmbH, Germany
    Dr. Stoss is leading the clinical trial operations at Discovery Life Sciences in his function as Senior Vice President Operations. Since 2004, he served in different leadership roles in both the USA and Europe and did oversee more than 600 phase I to phase III biomarker driven clinical... Read More →

    Wednesday June 19, 2024 10:00am - 11:00am PDT
    Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      06: TranslationalDelivery Tech-PrecMedicine, Forum

    10:00am PDT

    #328: Pioneering New Frontiers: Advanced Drug Delivery Technologies and Cell/Gene Therapies in Combination Products
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-24-646-L04-P; CME 1.00; RN 1.00

    Advanced Therapies and combined advanced therapies emerging as innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Future technologies are most appealing to patients with ongoing medical conditions that require consistent treatment with daily injections or weekly procedures and unmet medical needs. Overall, the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges. When developing an advanced therapy product, there are many things to be considered – relationships between tissue, biologic, and device development as well as early establishment of regulatory and clinical strategies, understanding user needs, determining product requirements, as well as device manufacturing variation. With the dawn of a new millennium and the rapidly aging baby-boomer population, the pressure for companies to create safer and more effective treatments is growing. Advanced therapies are one of the solutions that have emerged to meet the more rigorous demands of patients. Drug-enhanced devices, including drug eluting stents and antimicrobial-coated catheters, have already proven themselves on the market. Pre-filled syringes and transdermal patches, which are novel drug delivery systems, have also been widely used treatments. However, advanced therapies and combined advanced therapies are innovative products and could provide solutions as well as cures for previously untreatable conditions, which can truly change the face of the industry. Speakers will be FDA and industry leaders and FDA illustrating hot topics and example case studies in a panel discussion for us to navigate the future regulatory framework for unmet medical needs and next generation of medical products.

    Learning Objectives

    Analyze latest regulatory expectations and challenges; Identify potential future innovation platforms; Acknowledge potential and future global convergence/harmonization initiatives for combination products; Describe the regulatory challenges and opportunities ahead.

    Chair

    James Wabby, MHS

    Speaker

    FDA Update
    Andrea Gray, PhD

    Panelist
    Rob Schulz

    Panelist
    William Daunch, PhD

    Panelist
    Michael Lehmicke, MSc


    Speakers
    avatar for James Wabby

    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 →
    avatar for William Daunch

    William Daunch

    Chief Technology Officer, Focal Medical, Inc., United States
    Professionally trained polymer scientist + analytical chemist. Began career as an industrial chemist/materials scientist in Belgium (ICI). Moved to Scotland and applied skills to helping early stage company (Aortech) develop the first fully synthetic heart valve (now commercialized... Read More →
    avatar for Andrea Gray

    Andrea Gray

    Biomedical Engineer Advisor, CBER, FDA , United States
    Andrea Gray is a Biomedical Engineer Advisor in the Regulatory Operations Branch of the Division of Regulatory Operations and Programs (DROP) in the Office of Regulatory Operations (ORO), Center for Biologics Evaluation and Research (CBER). She specializes in regulatory review of... Read More →
    ML

    Michael Lehmicke

    Senior Vice President, Science and Industry Affairs, Alliance for Regenerative Medicine, United States
    Michael has over 20 years of R&D experience in biomaterials, medical devices and regenerative medicine. He has led product development teams for class II devices, human cell and tissue-based products, and drug/device combination products. He is a creator and an inventor with multiple... Read More →
    avatar for Rob Schulz

    Rob Schulz

    President and COO, Suttons Creek, Inc., United States

    Wednesday June 19, 2024 10:00am - 11:00am PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      06: TranslationalDelivery Tech-PrecMedicine, Forum |   09: Regulatory, Forum |   14: DIAmond, Forum

    10:00am PDT

    #325: A Paradigm Shift in Global Regulatory Reviews: Has the New Normal Arrived?
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-643-L04-P; CME 1.00; RN 1.00

    Global expert presentations and in-depth panel discussion on the regulatory agilities, regulatory reliance, platform approaches, and other regulatory innovations that are pivotal during public health emergencies and necessary for future pandemic preparedness.

    Learning Objectives

    Discuss regulatory agilities, reliance and platform approaches which significantly decreased review times internationally for COVID vaccines. Discuss additional CEPI case studies that highlight regulatory innovations to address future public health emergencies, and the inherent complexities of sustaining these innovations from a health authority perspective.

    Chair

    Helen Bayes Hartman, PhD

    Speaker

    Regulatory Reliance and Platform Approaches: Has the New Normal Arrived??
    Donna Boyce, MS, RAC

    Preparedness: Challenging the Traditional Regulatory Paradigms to Address Public Health Emergencies
    Debra A Yeskey

    FDA Update
    David C. Kaslow, MD

    Moderator
    Khushboo Sharma, MBA


    Speakers
    HH

    Helen Hartman

    Director, Global Regulatory Sciences, Pfizer Inc, United States
    Helen has over 15 year of drug development experience as a global regulatory strategist and regulatory intelligence/policy professional across multiple therapeutic areas.
    avatar for Donna Boyce

    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 →
    avatar for David Kaslow

    David Kaslow

    Director, Vaccines Research and Review (OVRR), CBER, FDA, United States
    David is director of the Office of Vaccines Research and Review, CBER, US FDA, where he oversees regulation of vaccines, allergenics, live biotherapeutics and bacteriophage. His 35+ years of experience in use-inspired research, product development, and product introduction include... Read More →
    avatar for Khushboo Sharma

    Khushboo Sharma

    Chief Regulatory Innovation Officer, Accumulus Synergy, United States
    Khushboo Sharma is the Chief Regulatory Innovation Officer for Accumulus. Sharma joined Accumulus Synergy in 2022 from BIO, where she focused on major regulatory policy initiatives to build the appropriate regulatory framework. Prior to BIO, Sharma spent 11 years in various roles... Read More →
    DY

    Debra Yeskey

    Head of Regulatory Policy and Intelligence, CEPI, United States

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

    1:15pm PDT

    #344: Leveraging Point of Care Technologies for Near Real Time, Interactive Safety Surveillance: Opportunities and Challenges
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-647-L04-P; CME 1.00; RN 1.00

    Forum will summarize a study that demonstrated the ability of healthcare provides (HCPs) and pharmacovigilance (PV) staff to have near real-time adverse event communications. Panelists will discuss opportunities and challenges for extending this new, potentially transformative capability.

    Learning Objectives

    Discuss how digital technologies can facilitate the near real time, interactive exchange of adverse drug information between healthcare providers (HCPs) and pharmacovigilance (PV) experts in a trusted, compliant, and transparent manner; Identify the opportunities and challenges with such an approach.

    Chair

    Gregory Powell, PharmD, MBA

    Speaker

    MHRA Update
    Phil Tregunno

    Patient Update
    Dave deBronkart

    Physician/EHR update
    Auren Weinberg, MD, MBA


    Speakers
    GP

    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 →
    avatar for Dave deBronkart

    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 →
    avatar for Phil Tregunno

    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 →
    AW

    Auren Weinberg

    Chief Medical Officer, Veradigm, United States

    Wednesday June 19, 2024 1:15pm - 2:15pm PDT
    Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Forum

    1:15pm PDT

    #352: Applying Machine Learning and Artificial intelligence for Predicting Product Profile Approvability (PoPPA)
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-24-655-L04-P; CME 1.00; RN 1.00

    This will be an interactive panel discussion with experts sharing examples how AI/ML can be used to create solutions for better regulatory decision-making and predicting regulatory success. Risks and benefits of using this approach will be discussed.

    Panelists will include world-renowned experts on drug development, drug regulations, decision science and data analytics.

    Learning Objectives

    Evaluate how AI/ML can be used to help with regulatory decision making; Analyze scenarios using case studies by world’s leading expert on drug development, cloud computing, and predicting regulatory success; Compare risks and benefits for using this evolving technology.

    Chair

    Romi Singh, PhD

    Speaker

    Panelist
    Kilian Weiss

    Panelist
    Subha Madhavan, PhD, FACMI

    Panelist
    Lily Li, JD


    Speakers
    avatar for Romi Singh

    Romi Singh

    Head, Regional Regulatory Sciences, Asia, Pfizer Inc, United States
    Dr. Rominder (Romi) Singh has extensive scientific and management experience at top biopharmaceutical companies--Pfizer, Amgen, Merck and GlaxoWellcome. His experience spans across drug development—drug discovery to commercialization. He is recognized as an expert on international... Read More →
    LL

    Lily Li

    Founder and President, Metaverse Law, United States
    Lily Li is the founder and president of Metaverse Law, a firm that focuses exclusively on privacy, AI, and cybersecurity law. She advises mid-sized, public, and multinational clients on a broad range of AI and data protection matters, such as the CCPA, GDPR, NIST AI Framework, Biden... Read More →
    avatar for Subha Madhavan

    Subha Madhavan

    Vice President and Head of AI/ML, Global Biometrics and Data Management, Pfizer Inc, United States
    Subha Madhavan heads up AI/ML, Quantitative and Digital Sciences within Global Product Development at Pfizer. Prior to joining Pfizer, she was Head of Data Science and AI within Oncology R&D Strategy at AstraZeneca Pharmaceuticals. She has initiated and successfully directed several... Read More →
    KW

    Kilian Weiss

    General Manager, Veeva Link, Veeva, Germany
    As general manager of Veeva Link, Kilian is responsible for the strategic direction, growth, and customer success of Veeva’s global Link Platform. He is also responsible for Veeva’s European Data business and commercial strategy. Before joining Veeva, Kilian founded Mederi, a... Read More →

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

    1:15pm PDT

    #349: Study Design for Cell and Gene Therapy Trials: Regulatory Overview, Challenges, and Updates
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-652-L04-P; CME 1.00; RN 1.00

    This forum provides a general view and challenges of the study design in cell and gene therapy trials. A panel of experts interpret FDA guidance, share their own experience for study design, and discuss the trends in this area.

    Learning Objectives

    Describe regulatory principles of the trial design for cell and gene therapy products; Identify specific design elements such as selection of study population; Discuss the selection of control, safety monitoring; Discuss challenges and new trends.

    Chair

    Yao-Yao Zhu, MD, PhD

    Speaker

    Panelist
    Katherine A. High, MD

    Panelist
    Vaishali Popat, MD, MPH

    Clinical Considerations for Oncology Cell and Gene Therapy Trials
    Ke Liu, MD, PhD


    Speakers
    avatar for Yao-Yao Zhu

    Yao-Yao Zhu

    Regulatory Affairs Director, AstraZeneca, United States
    Yao-Yao Zhu, MD, PhD, has over 15 years of regulatory experience. She is currently a Regulatory Affairs Director for cardiovascular, renal, and metabolic diseases at AstraZeneca (AZ). Prior to AZ, she was a head of Global Regulatory Affairs at Biosion for antibody products in oncology... Read More →
    avatar for Katherine High

    Katherine High

    Co-Founder and Former President, Sparks Therapeutics; Visiting Professor, Rockefeller University, United States
    Dr. Katherine High is the former President at Spark Therapeutics, a biotech company that she co-founded in 2013. Under Dr. High’s leadership, Spark received FDA approval of the first AAV gene therapy product in the US, a treatment for a rare form of congenital blindness. Dr. High... Read More →
    avatar for Ke Liu

    Ke Liu

    Chief Development Officer, Marengo Therapeutics, United States
    As Chief Development Officer of Marengo Therapeutics, Ke Liu joins Marengo with over 20 years of experience in the field of oncology, immuno-oncology, and cell and gene therapy, most recently serving as Senior Vice President and led the key regulatory activities at Sana Biotechnology... Read More →
    avatar for Vaishali Popat

    Vaishali Popat

    Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER, FDA, United States
    Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as safety analytics, staff training on the use of new review tools to make the evaluation of... Read More →

    Wednesday June 19, 2024 1:15pm - 2:15pm PDT
    Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum |   02: ClinTrials -ClinOps, Forum |   04: MedAffairs-SciComm, 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
    avatar for Ethan Chen

    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 →
    avatar for Tala Fakhouri

    Tala Fakhouri

    Associate Director for Policy Analysis, Office of Medical Policy, CDER, FDA, United States
    avatar for Hilmar Hamann

    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 →
    avatar for Nicole Mahoney

    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

    3:15pm PDT

    #359: A Safety Surveillance Plan for Serious Anticipated Events
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-659-L04-P; CME 1.00; RN 1.00

    A number of questions remain about Safety Surveillance Plans (SSPs). The proposed panel discussion will include persons from multiple sponsors who have experience with developing processes to address the FDA’s recommendations in the 2021 guidance.

    Learning Objectives

    Discuss when a safety surveillance plan (SSP) is warranted; Describe specifics on implementation of the trigger method; Evaluate a product in different patient populations and ensure study integrity; Identify clarity on roles and responsibilities to data monitoring committee members (or other entities) who are making recommendations to the sponsor regarding IND safety reporting.

    Chair

    Greg Ball, PhD

    Speaker

    Panelist
    Susan Talbot

    Panelist
    Ranjeeta Sinvhal, MD

    Panelist
    Susan Kindig, JD, MD


    Speakers
    avatar for Greg Ball

    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 →
    avatar for Susan Kindig

    Susan Kindig

    Prior Executive Director, Medical and Drug Safety, United States
    Susan most recently led the patient safety department at Halozyme and supported both the medical and regulatory functions there from March, 2022 to January, 2024. Prior to joining Halozyme, Susan spent 10 years working in Global Patient Safety at Eli Lilly. She used her clinical experience... Read More →
    avatar for Ranjeeta Sinvhal

    Ranjeeta Sinvhal

    Executive Medical Director, Medical Safety, AbbVie, United States
    Extensive experience in both post-marketing and pharmacovigilance in clinical trials for over 19 years. In-depth global filing experience as a safety lead for both small molecule and biologics. Instructor in Loyola PV Certificate Course. Co-chair of Cardiovascular Internal Safety... Read More →
    ST

    Susan Talbot

    Director Biostatistics, Amgen, United States

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

    3:15pm PDT

    #362: Streamlining Processes and Data Exchange Across R&D Functions to Improve Performance and Facilitate Automation
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-662-L04-P; CME 1.00; RN 1.00

    In this interactive forum, panelists share how they are working across R&D to improve processes and data flows, govern their data, move toward more data-driven processes, and facilitate the use of artificial intelligence (AI) and advanced technologies.

    Learning Objectives

    Identify how sponsor companies are optimizing their business processes and getting more value from their data across R&D; Discuss approaches for process optimization, data governance and standardization; Describe ways to move towards data-driven business processes and how to enable greater automation and business efficiency across product development.

    Chair

    Cary Smithson, MBA

    Speaker

    Panelist
    Linda Chong, MBA

    Panelist
    Rayna Venook, PhD


    Speakers
    avatar for Cary Smithson

    Cary Smithson

    Senior Director, Business Transformation & Systems Management, Cencora Pharmalex, United States
    Cary Smithson is the Senior Director, Business Transformation and Systems Management at PharmaLex and has over 30 years of experience helping life science Regulatory, Clinical and Quality organizations drive increased productivity, streamline information management and enhance regulatory... Read More →
    avatar for Linda Chong

    Linda Chong

    Director, Regulatory Information Management, Daiichi Sankyo, United States
    Linda Chong has overall 20 years of experience within the Pharmaceutical industry specifically Regulatory Information Management, Global Submission Management, and Data Governance including organization change management. She is currently the Director of Regulatory Information Management... Read More →
    avatar for Rayna Venook

    Rayna Venook

    Team Lead, Pharma Development Regulatory, Genentech, A Member of the Roche Group, United States
    Rayna Venook is a Team Lead within the Regulatory Information Management organization at Roche. In this capacity, she focuses on facilitating the development and delivery of solutions to enhance data interoperability to enable integrated solutions across Roche. She has 17 years of... Read More →

    Wednesday June 19, 2024 3:15pm - 4:15pm PDT
    Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Forum

    3:15pm PDT

    #365: Embedding Diversity and Inclusion into Global Clinical Research: Where Have we Been and Where are we Going?
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-665-L04-P; CME 1.00; RN 1.00

    Adequate enrollment of underrepresented groups continues to be a challenge in a complex, global regulatory and research ecosystem. Review and assess evolving expectations and processes in the US, Canada, and other regulatory systems, what has been implemented, what adjustments have been made, what has worked, and what hurdles or differences remain.

    Learning Objectives

    Describe the background and underlying requirements to FDA’s and other health authorities’ diversity and inclusion policies and guidance; Discuss how different stakeholders have implemented and reacted to implementation of new and evolving policies; Identify areas where views or expectations diverge; Discuss and describe what has worked, what has not; Identify how this area might change in future.

    Chair

    Alexis Miller, JD

    Speaker

    FDA Update
    Karen Hicks, DrMed

    Health Canada Update
    Alysha Croker, PhD

    UK Update
    Naho Yamazaki, PhD

    Patient Update
    Loriana Hernandez-Aldama


    Speakers
    avatar for Alexis Miller

    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 →
    avatar for Alysha Croker

    Alysha Croker

    Director, Centre for Policy, Pediatrics and International Collaboration, BRDD, Health Canada, Canada
    Dr. Alysha Croker is the Director of the Centre for Policy, Pediatrics and International Collaboration, Health Products and Food Branch, Heath Canada. In this position, Dr. Croker is responsible for developing ways to increase access to safe and effective health products for pediatric... Read More →
    avatar for Loriana Hernandez-Aldama

    Loriana Hernandez-Aldama

    Patient Advocate|2x Survivor| Founder, ArmorUp for Life, Armorup For Life, United States
    Loriana is a 2x cancer survivor, international motivational speaker, award-winning journalist, podcast host, and author of "Becoming the Story: The Power of Prehab." Bold, transparent, and honest, Loriana has emerged as a game-changer in healthcare, advocating globally for transformative... Read More →
    avatar for Karen Hicks

    Karen Hicks

    Deputy Director, Office of Medical Policy, CDER, FDA, United States
    Dr. Hicks is the Deputy Director of the Office of Medical Policy in the Center for Drug Evaluation and Research (CDER) at the United States Food and Drug Administration (FDA). She oversees regulation and policy development for CDER and participates in cross-cutting agency initiatives... Read More →
    avatar for Naho Yamazaki

    Naho Yamazaki

    Deputy Director, Policy and Partnerships, Health Research Authority, United Kingdom
    Naho is Deputy Director, Policy and Partnerships at the Health Research Authority (HRA), where she is leading on a range of policy and engagement initiatives for the HRA to make it easy to do research that people can trust. This includes pushing for change to increase diversity and... Read More →

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

    3:15pm PDT

    #367: EMA Town Hall
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-667-L04-P; CME 1.00; RN 1.00

    The European Forum will explain our various platforms and ways to engage to support innovation, illustrated on an example of an Advanced Therapy Medicinal Product (ATMP).

    Learning Objectives

    Describe the assessment procedure and the role of CHMP and rappoteur; Describe platforms to support developers; Discuss a successful submission of an ATMP.

    Chair

    Steffen Thirstrup, MD, PhD

    Speaker

    Panelist
    Sabine Haubenreisser, PhD, MSc

    Panelist
    Anabela Marcal, PharmD

    Panelist
    Evdokia Korakianiti, PhD, MSc


    Speakers
    avatar for Sabine Haubenreisser

    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 →
    avatar for Evdokia Korakianiti

    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 →
    avatar for Anabela Marcal

    Anabela Marcal

    EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
    Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →
    avatar for Steffen Thirstrup

    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 →

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

    4:30pm PDT

    #374: Updated Status of Multiregional Clinical Trials Based on ICH E17 Guideline: 5 Years After the Implementation
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-673-L04-P; CME 1.00; RN 1.00

    The forum will consist of regulators and industry experts who were the authors of the ICH E17 guidelines. As regulators and sponsors, they will provide first-hand narrative on their experiences in implementing the ICH E17 guidelines.

    Learning Objectives

    Discuss the status of adoption of ICH E17 guidelines on conduct of multiregional clinical trials (MRCT) by the regulators and industry. • Identify reasons behind slow uptake of the ICH E17 guidelines. • Discuss points for increasing usage of E17 for conduct of MRCT and simultaneous global development.

    Chair

    Yoshiaki Uyama, PhD, RPh

    Speaker

    PMDA Perspective
    Yoko Aoi, PhD

    Pharmaceutical Industry Perspective
    Romi Singh, PhD

    FDA Update
    Douglas Pratt

    Taiwan Perspective
    I-Chun Lai, MD, MS

    China Perspective
    Yangfeng Wu, MD, PhD


    Speakers
    avatar for Yoshiaki Uyama

    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 →
    avatar for Yoko Aoi

    Yoko Aoi

    Deputy Review Director, Office of New Drug V, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    Dr. Yoko Aoi is a deputy review director of Office of New Drug V responsible for review and scientific advice on oncology drugs. After joining PMDA, Dr. Aoi was involved in review and scientific advice on new drugs for rheumatoid arthritis, asthma, COPD etc. (2011-2016) and planning... Read More →
    avatar for I-Chun Lai

    I-Chun Lai

    Director, Consultation Division, Center for Drug Evaluation, Taiwan
    Dr. I-Chun Lai graduated with her medical degree from Taipei Medical University in Taiwan in 2001 and worked as a physician until 2007, when she joined the Center for Drug Evaluation (CDE) in Taiwan. In 2013, she received her Master of Science from the Institute of Health Policy and... Read More →
    DP

    Douglas Pratt

    Supervisory Medical Officer, OVRR, CBER, FDA , United States
    avatar for Romi Singh

    Romi Singh

    Head, Regional Regulatory Sciences, Asia, Pfizer Inc, United States
    Dr. Rominder (Romi) Singh has extensive scientific and management experience at top biopharmaceutical companies--Pfizer, Amgen, Merck and GlaxoWellcome. His experience spans across drug development—drug discovery to commercialization. He is recognized as an expert on international... Read More →
    YW

    Yangfeng Wu

    Executive Director, Peking University Clinical Research Institute, China
    Professor Wu is the Executive Director of Peking University Clinical Research Institute. He has been principal investigators of tens of research projects sponsored by national and international founding agencies including China Ministry of Science and Technology, China Natural Science... Read More →

    Wednesday June 19, 2024 4:30pm - 5:30pm PDT
    Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      02: ClinTrials -ClinOps, Forum |   09: Regulatory, Forum
    • Format Forum
    • Level Intermediate
    • Featured Topics ICH
    • Level Intermediate
    • Feature Topics ICH
    • Credit Type ACPE, CME, RN
    • Tags Forum

    4:30pm PDT

    #372: Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence: An Industry and Regulatory Agency Experience
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-671-L04-P; CME 1.00; RN 1.00

    This forum will discuss regulatory activities and technology to enable global convergence and reliance for post-approval changes (PAC). Diverse panelists will share examples of efficient collaboration and information exchange to reduce the PAC process cycle times.

    Learning Objectives

    Recognize the importance of global collaboration to support sovereign decision making; Discuss how building in reliance practices into cloud-based solutions could accelerate the post-approve changes (PAC) process globally; Explain how cloud solutions support transparency, trust, regulatory convergence, and information exchange, and collaboration to increase patient access to therapies.

    Chair

    Dominique Lagrave, PharmD

    Speaker

    Panelist
    Samvel Azatyan, MD, PhD

    Panelist
    David Mukanga, PhD, MPH

    Panelist
    Susanne Ausborn, PhD

    Panelist
    Cynthia Ban


    Speakers
    avatar for Dominique Lagrave

    Dominique Lagrave

    Senior Vice President of Regulatory Innovation, Accumulus Synergy, United States
    Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as SVP of Regulatory... Read More →
    avatar for Susanne Ausborn

    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 →
    avatar for Samvel Azatyan

    Samvel Azatyan

    Team Lead, Regulatory Convergence and Networks (RCN/REG), World Health Organization (WHO), Switzerland
    Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration... Read More →
    avatar for Cynthia Ban

    Cynthia Ban

    Global Head, Regulatory Affairs CMC, Vaccines, Sanofi, Canada
    Cynthia Ban is the Global Head Regulatory CMC & Devices for Vaccines at Sanofi. Senior Global Leader in the pharmaceutical industry specializing in Regulatory Affairs. Worked for small biotech and large multinational companies. Led and developed teams across multiple geographies and... Read More →
    avatar for David Mukanga

    David Mukanga

    Deputy Director, Africa Regulatory Systems, Bill & Melinda Gates Foundation, United States
    Dr. David Mukanga is Deputy Director Africa Regulatory Systems at the Bill & Melinda Gates Foundation, where he leads the foundation’s Africa regulatory systems optimization portfolio, and the linkage between regulatory systems and health care services. In this role, David supports... Read More →

    Wednesday June 19, 2024 4:30pm - 5:30pm PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Forum

    4:30pm PDT

    #375: Sustainability of Rare Disease Drug Development
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-674-L04-P; CME 1.00; RN 1.00

    Panelists will reflect on the past forty years of the orphan drug act including advancements and impediments. The panel will discuss what is needed in the future to continue to advance rare disease drug development to treat as many patients as possible.

    Learning Objectives

    Discuss the outcomes, challenges, and opportunities in the next forty years of the Orphan Drug Act; Identify policy advancements that need to be made to continue innovative rare disease drug development.

    Chair

    Darcy Frear, PhD

    Speaker

    Panelist
    Katherine Donigan, PhD

    Panelist
    Patroula Smpokou, MD

    Panelist
    Karin Hoelzer, DVM, PhD

    Panelist
    Julia Tierney, JD


    Speakers
    avatar for Darcy Frear

    Darcy Frear

    Associate Director, Bridgebio, United States
    Dr. Darcy Frear is currently the associate director for Regulatory Policy and Intelligence at BridgeBio. Prior to joining BridgeBio in 2022, Darcy began her regulatory career at Genentech supporting program management in oncology and US regulatory policy. Subsequently, she joined... Read More →
    KD

    Katherine Donigan

    Senior Director, Science and Regulatory Policy, Sarepta, United States
    Dr. Katherine Donigan is currently a Senior Director of Science and Regulatory Policy at Sarepta Therapeutics. Prior to joining Sarepta, Dr. Donigan was a Senior Director of Science and Regulatory at Biotechnology Innovation Organization (BIO) and spent 7 years in regulatory policy... Read More →
    KH

    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 →
    avatar for Patroula Smpokou

    Patroula Smpokou

    Lead Physician, Division of Rare Diseases/Medical Genetics, OND, CDER, FDA, United States
    Patroula Smpokou, MD, is a board-certified pediatric clinical geneticist working in the Division of Rare Diseases and Medical Genetics at CDER. Her work involves the clinical review and regulation of products intended for rare genetic diseases. Prior to joining FDA, she was a practicing... Read More →
    avatar for Julia Tierney

    Julia Tierney

    Deputy Center Director for Strategy, Policy, and Legislation, CBER, FDA, United States
    JULIE TIERNEY is the Deputy Center Director for Strategy, Policy and Legislation for the Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER). Ms. Tierney has held several senior roles in the Office of the Commissioner and CBER during her... Read More →

    Wednesday June 19, 2024 4:30pm - 5:30pm PDT
    Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum
     
    Thursday, June 20
     

    8:00am PDT

    #404: Meeting in the Middle: Best Practices for Collaboration Between Medical Affairs and Clinical Development
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-24-680-L04-P; CME 1.00; RN 1.00

    Medical affairs and clinical development enhance the scientific credibility of the company (and its products) with established and emerging clinical investigators These collaborations may also improve study recruitment techniques.

    Learning Objectives

    Design new activities which require participation from both medical affairs and clinical development; Demonstrate how the medical affairs team can provide real-world data to help inform study designs and execution; Critique case studies of successful collaborations.

    Chair

    J. Lynn Bass, PharmD, RPh

    Speaker

    Industry Update
    J. Lynn Bass, PharmD, RPh

    Industry Update
    Rebecca A. Vermeulen, RPh

    Industry Update
    Sonja Wesley Hokett, PharmD, MS, MSc


    Speakers
    avatar for J. Lynn Bass

    J. Lynn Bass

    Senior Director, Medical Science Liaisons, BridgeBio, United States
    In her 25+ years of industry experience, Lynn has served in both individual and leadership positions within Medical Affairs at both large and start-up companies. She is currently Sr. Director, Medical Science Liaisons at BridgeBio, where she is building and leading a field medical... Read More →
    avatar for Sonja Hokett

    Sonja Hokett

    Executive Director/Head of Medical Managed Care, BioXcel Therapeutics, United States
    Residing in Branson, Missouri, Sonja holds PharmD degree from the University of Louisiana Monroe, Master of Science degree in Hospital Pharmacy Administration from the University of Houston, and Executive Master's degree Health Economics, Policy & Management from the London School... Read More →
    avatar for Rebecca Vermeulen

    Rebecca Vermeulen

    Vice President, Global Patient Networks | PD Medical Affairs, Genentech, A Member of the Roche Group, United States
    Rebecca Vermeulen, RPh, brings a variety of experiences to her role as VP of Strategy for Patients and Society, Product Development, at Hoffman La Roche. She has served in numerous functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science... Read More →

    Thursday June 20, 2024 8:00am - 9:00am PDT
    Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      02: ClinTrials -ClinOps, Forum |   04: MedAffairs-SciComm, Forum

    8:00am PDT

    #403: Achieving Diversity in Clinical Research Using Digital Health Technologies
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-24-679-L04-P; CME 1.00; RN 1.00

    This session will explore, from three complementary perspectives, how to improve diversity in clinical research by actively addressing accessibility, equity, and inclusion throughout the design and implementation of digital health technologies.

    Learning Objectives

    Summarize the current state and define industry goals related to diversity, equity, and inclusion (DEI) in clinical research; Outline the role of digital solutions in achieving these diversity, equity, and inclusion goals in clinical research; Apply core principles for digital design and implementation with case studies.

    Chair

    Lindsay Hughes, PhD, MS

    Speaker

    Panelist
    Silas Buchanan


    Speakers
    LH

    Lindsay Hughes

    Principal, Patient Experience Solutions and Patient Centered Solutions, IQVIA, United States
    Dr. Hughes is a scientist and leader with nearly 20 years of experience in behavioral and life sciences, focusing particularly on the role of access to information in human behavior and health outcomes. She is a former advisor to national governments on stigma in healthcare and clinical... Read More →
    SB

    Silas Buchanan

    Chief Executive Officer, Institute for eHealth Equity, United States

    Thursday June 20, 2024 8:00am - 9:00am PDT
    Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Forum |   03: Data-Tech, Forum

    8:00am PDT

    #405: The FDA's Commitment to Patient-Centric Research: Key Themes from Decentralized Trial Draft Guidance
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-681-L04-P; CME 1.00; RN 1.00

    This interactive forum will explore the key themes and industry feedback from the decentralized trials alliance members’ response to the FDA draft guidance on decentralized clinical trials.

    Learning Objectives

    Examine how the FDA draft guidance reflects a commitment to patient-centric decentralized clinical trials; Identify key themes and industry feedback provided in the alliance's response to the draft guidance; Discuss the next steps needed to enable adoption of decentralized trials under the draft framework.

    Chair

    Rasika Kalamegham, PhD

    Speaker

    Collaboration Perspective
    Jane Elizabeth Myles, MSc

    FDA Perspective
    M. Khair ElZarrad, PhD, MPH

    Industry Perspective
    Dylan Bechtle, MS


    Speakers
    DB

    Dylan Bechtle

    Associate Director, Regulatory Policy Lead- US, Johnson & Johnson, United States
    Dylan is an Associate Director in Johnson and Johnson Innovative Medicine's Global Regulatory Policy and Intelligence (GRPI) group. Dylan leads J&J’s regulatory policy efforts around clinical trial diversity. He is interested in the intersection of novel clinical methodologies (e.g... Read More →
    avatar for M. Khair ElZarrad

    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 →
    avatar for Rasika Kalamegham

    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 →
    avatar for Jane Myles

    Jane Myles

    Program Director, Decentralized Trials and Research Alliance (DTRA), United States
    Jane has over 25 years of experience improving clinical trials and patient experiences. She has focused on driving innovation in trial design and execution to accelerate getting medicines to patients. Jane transitioned from molecule focus to portfolio focus about 14 years ago, first... Read More →

    Thursday June 20, 2024 8:00am - 9:00am 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

    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
    avatar for Nancy Dreyer

    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 →
    avatar for Christina Mack

    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 →
    avatar for Paul Strijbos

    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 →
    avatar for Martha Azer

    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 →
    avatar for Jeffrey Siegel

    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 →

    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

    8:00am PDT

    #409: Dive into the Power of Diversity: Leveraging Transferable Skills from Regulated Industries to Regulatory Agencies in Medicines Development
    Component Type: Forum
    Level: Intermediate

    Curious about who shapes the decisions behind medicines approval and inspection? Wondering about the diversity in backgrounds and perspectives within regulatory agencies? Join us for an insightful session delving into the critical role of diversity in medicines development and regulatory decision-making. Ever pondered if your skills could transition you from being regulated to a regulator, or vice versa? Explore how transferable skills can bridge the gap between industry and regulatory roles, fostering diverse thinking essential for patient-centric outcomes. Discover career pathways in both sectors and learn how breadth of experience in seemingly unrelated roles can enrich regulatory processes, including patient advocacy. Don't miss this opportunity to uncover the less trodden path between regulators, the regulated, and patient advocacy. Join us to pave the way for a more inclusive and impactful medicines development landscape.

    Learning Objectives

    Recognize transferable skills from industry to regulatory roles, fostering diversity crucial for innovation; Assess the panelists' career trajectories transitioning between sectors, gaining strategies for professional growth; Identify the patient advocacy's role, understand how similar transferable skills are utilized to support patient-centric approaches.

    Chair

    Paula Walker, MA

    Speaker

    Panelist
    Sophie Radicke, MSc

    Panelist
    Patroula Smpokou, MD


    Speakers
    avatar for Paula Walker

    Paula Walker

    Global Head of Risk Based Quality Management, Roche Products Ltd., United Kingdom
    Paula is the Global Head of RBQM at Roche, having started with the company with a Quality Policy focus. Formerly Head of Compliance (GCP/PV/GLP) at the MHRA and Acting Head of Inspectorate, having started in 2009 as a GCP Inspector; spending 13.5 years at the Regulator. Paula has... Read More →
    avatar for Sophie Radicke

    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 →
    avatar for Patroula Smpokou

    Patroula Smpokou

    Lead Physician, Division of Rare Diseases/Medical Genetics, OND, CDER, FDA, United States
    Patroula Smpokou, MD, is a board-certified pediatric clinical geneticist working in the Division of Rare Diseases and Medical Genetics at CDER. Her work involves the clinical review and regulation of products intended for rare genetic diseases. Prior to joining FDA, she was a practicing... Read More →

    Thursday June 20, 2024 8:00am - 9:00am PDT
    Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Forum |   13: ProfDevelopment, 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
    avatar for Lina AlJuburi

    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 →
    avatar for M. Khair ElZarrad

    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 →
    avatar for Maria Florez

    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 →
    avatar for Nicole Mahoney

    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 →

    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

    9:15am PDT

    #415: EMA-FDA Question Time
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-690-L04-P; CME 1.00; RN 1.00

    In this interactive forum experts from EMA and FDA will address questions from the audience and share their experiences of collaboration in specific areas as well as on how both Agencies collaborate in addressing current regulatory, scientific, and communication challenges.

    Learning Objectives

    Identify an overall understanding of the regulatory and scientific collaboration between EMA and FDA; Describe experience and explore specific areas of collaboration between the two Agencies; Examine how EMA and FDA are addressing regulatory and scientific challenges in new areas.

    Chair

    Anabela Marcal, PharmD
    Katherine Tyner, PhD

    Speaker

    Panelist
    Kerry Jo Lee, MD

    Panelist
    Adam C Fisher, PhD

    Panelist
    R. Angelo De Claro, MD

    Panelist
    Evdokia Korakianiti, PhD, MSc

    Panelist
    Steffen Thirstrup, MD, PhD

    Panelist
    Francesco Pignatti, MD


    Speakers
    avatar for Anabela Marcal

    Anabela Marcal

    EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
    Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →
    avatar for Katherine Tyner

    Katherine Tyner

    FDA Liaison to the EMA, Office of Global Policy and Strategy, OC, FDA, United States
    Dr. Katherine Tyner is the FDA liaison to the EMA. Dr. Tyner joined FDA in 2007 and has held numerous positions within CDER to advance the quality, safety, and efficacy of complex drug products. In her most recent role as the Associate Director for Science in the Office of Pharmaceutical... Read More →
    avatar for R. Angelo De Claro

    R. Angelo De Claro

    Associate Director for Global Clinical Sciences, Oncology Center of Excellence, FDA, United States
    Dr. de Claro is the Division Director for Division of Hematologic Malignancies I with Office of Oncologic Diseases. He provides leadership and scientific direction to staff engaged in the review and evaluation of applications for investigational new drugs and drug approvals. Dr. de... Read More →
    avatar for Kerry Jo Lee

    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 →
    AF

    Adam Fisher

    Director, Enterprise Project Staff, OQA, OPQ, CDER, FDA, United States
    Adam Fisher, PhD., is the Director of Enterprise Project Staff in the Office of Pharmaceutical Quality and lead of the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative at the U.S. FDA. He has been a primary and secondary reviewer of generic drug applications... Read More →
    avatar for Francesco Pignatti

    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 →
    avatar for Steffen Thirstrup

    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 →
    avatar for Evdokia Korakianiti

    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 →

    Thursday June 20, 2024 9:15am - 10:15am PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum |   14: DIAmond, Forum

    10:45am PDT

    #416: FDA Town Hall
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-24-691-L04-P; CME 1.25; RN 1.25

    The FDA Town Hall is the forum to hear from FDA leadership about Center priorities. The audience will be invited to submit questions of general interest.

    Learning Objectives

    Discuss FDA Center priorities.

    Chair

    Kim Quaintance-Lunn

    Speaker

    Panelist
    Kevin Bugin, PhD, MS, RAC

    Panelist
    Julia Tierney, JD

    Panelist
    Anindita Saha

    Panelist
    Tamy Kim, PharmD


    Speakers
    avatar for Kim Quaintance-Lunn

    Kim Quaintance-Lunn

    Vice President, Regulatory Affairs Americas, Bayer AG, United States
    Kim Quaintance-Lunn is the Vice President, Regulatory Affairs Americas and a Distinguished Science Fellow at Bayer, a Director at Large for the FDA Alumni Association, and Chair of DIA's Americas Regional Advisory Council. At Bayer, Kim serves in a leadership capacity for US Regulatory... Read More →
    avatar for Kevin Bugin

    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 →
    avatar for Julia Tierney

    Julia Tierney

    Deputy Center Director for Strategy, Policy, and Legislation, CBER, FDA, United States
    JULIE TIERNEY is the Deputy Center Director for Strategy, Policy and Legislation for the Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER). Ms. Tierney has held several senior roles in the Office of the Commissioner and CBER during her... Read More →
    avatar for Anindita Saha

    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 →
    avatar for Tamy Kim

    Tamy Kim

    Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence, FDA, United States
    Tamy Kim is the Director for Regulatory Affairs and Policy at FDA's Oncology Center for Excellence and the Associate Director for Regulatory Affairs in the Office of Oncologic Diseases (OOD). Dr. Kim is responsible for developing policies and procedures affecting the review of products... Read More →

    Thursday June 20, 2024 10:45am - 12:00pm PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum |   14: DIAmond, Forum
     
    Filter sessions
    Apply filters to sessions.
    Sunday, June 16
    Monday, June 17
    Tuesday, June 18
    Wednesday, June 19
    Thursday, June 20
    Ballroom
    Ballroom 20 A/ Zone 1
    Ballroom 20 BC/ Zone 2
    Ballroom 20 D/ Zone 3
    Ballroom 20 Lobby
    Ballroom 6 Lobby
    Content Hub Sails Pav
    Exhibit Hall
    Exhibit Hall B 1
    Exhibit Hall Theater #1
    Exhibit Hall Theater #2
    Exhibit Hall Theater #3
    Posters Exhibit Hall
    Room 11AB
    Room 14AB
    Room 15AB
    Room 16AB
    Room 17AB
    Room 1AB
    Room 2
    Room 5AB
    Room 6A
    Room 6B
    Room 6C
    Room 6D
    Room 6E
    Room 6F
    Room 7AB
    Room 8
    Sails Pavilion
    TBD
    USS Midway
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Focused Drug Dev
  • 06: TranslationalDelivery Tech-PrecMedicine
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Short Courses
  • Format
  • Forum
  • Session
  • Tutorial
  • Workshop
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Featured Topics
  • Artificial Intelligence (AI)
  • Cell and Gene Therapy
  • Decentralized Clinical Trials (DCTs)
  • Digital Technology
  • Diversity Equity and Inclusion (DEI)
  • Ethics
  • ICH
  • Patient Focused
  • Rare Disease
  • Real-World Data (RWD)- Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Reliance
  • Risk Management
  • Special Populations
  • Student Programming