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Monday, June 16
 

11:00am EDT

#110: Moving Toward Pragmatism in Clinical Trials
Monday June 16, 2025 11:00am - 12:00pm EDT
151B
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-516-L04-P; CME 1.00; RN 1.00

Pragmatism in clinical trials advances modernization of clinical research. Key stakeholders including experts from the FDA will review advantages and challenges of pragmatism in clinical trials including trials in support of new labeling claims.

Learning Objectives

State the strengths and limitations of pragmatic trials and the reasons for uneven adoption among industry and regulators; Discuss the regulatory framework and FDA initiatives supporting the use of pragmatic elements in clinical trials; Identify how to determine the appropriate context-of-use for successfully deploying pragmatic trials in clinical research.

Chair

Zhanna Jumadilova, MD, MBA

Speaker

Moving Toward Pragmatism in Clinical Trials
Adrian Hernandez, MD, MHS

Moving Toward Pragmatism in Clinical Trials
Thomas Bognanno

EMA Perspective
Andrew Thomson, PhD, MA, MS

Panelist
M. Khair ElZarrad, PhD, MPH

Panelist
Kevin Bugin, PhD, MS, RAC


Speakers
avatar for Thomas Bognanno

Thomas Bognanno

Patient Representative, Alliance Practice, United States
Founder and Partner of Alliance Practice LLC, a firm dedicated to supporting select organizations in the trauma-informed care sector. Before retirement in 2023, Bognanno served as the Chief Executive Officer of Creating Healthier Communities for 17 years. Before that, he served as... Read More →
avatar for Kevin Bugin

Kevin Bugin

Head of Global Regulatory Policy and Intelligence, Amgen, United States
Dr. Kevin Bugin is the head of global regulatory affairs and intelligence at Amgen. Prior to this role, Dr. Bugin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER), where in addition, he led the creation... Read More →
avatar for Adrian Hernandez

Adrian Hernandez

Professor of Medicine; Executive Director, Duke Clinical Research Institute , United States
Adrian Hernandez, MD, MHS, is Executive Director, Duke Clinical Research Institute, and Vice Dean of the Duke University School of Medicine. Dr. Hernandez has research interests in improving cardiovascular health and accelerating clinical evidence through outcomes research, clinical... Read More →
avatar for Zhanna Jumadilova

Zhanna Jumadilova

Clinical Lead, Pfizer Inc, United States
Dr. Jumadilova is a physician scientist, pharmaceutical executive with extensive industry experience in Clinical Development, Medical Affairs, and HEOR. In her roles as a senior leader, she has led numerous development programs for small molecules and biologics. Her diverse experience... Read More →
avatar for Andrew Thomson

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
Andrew Thomson is a statistician with over 18 years in the European regulatory system. He is currently in the taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

12:10pm EDT

#115 CH: Leading Teams Through Organizational Change and Layoffs: Best Practices for Change Management
Monday June 16, 2025 12:10pm - 12:40pm EDT
L Street Bridge
Component Type: Workshop
Level: Advanced

Learn best practices for leading teams through change and layoffs with confidence and empathy. Gain strategies to communicate effectively, maintain morale, and ensure business continuity. Leave with actionable insights to navigate transition.

Learning Objectives

Identify key change management strategies to lead teams effectively through organizational change and layoffs; Demonstrate effective communication techniques to maintain trust, morale, and engagement during transitions; Develop action plans to support employees, minimize disruption, and ensure business continuity.

Chair

Vidya Narayanaswamy, MBA, MSc

Speakers
avatar for Vidya Narayanaswamy

Vidya Narayanaswamy

Senior Consultant, IPM, United States
Vidya Narayanaswamy is a Senior Consultant at IPM, bringing over 12 years of experience across the life sciences industry—from early development through late-stage programs and global regulatory submissions. She holds an MS in Biotechnology and an MBA with a focus on Leadership... Read More →
Monday June 16, 2025 12:10pm - 12:40pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   07: ProjectManagement-StrategicPlanning, Workshop

1:30pm EDT

#119 CH: Development of Regulatory Strategies for Global Evaluation of Post Approval Changes and Lifecycle Management of Drug Products
Monday June 16, 2025 1:30pm - 2:30pm EDT
L Street Bridge
Component Type: Workshop
Level: Advanced

Post-approval changes are inevitable throughout a drug product's life cycle. Due to the complex regulations in ROW countries (the rest of the world), approval of these post-approval changes usually takes several years globally.

Learning Objectives

Recognize the importance of post-approval changes in a product life cycle; Analyze the complexity of implementing post-approval changes and its impact on the commercial drug product supply; Propose the key requirements to take steps industry-wide to solve A global problem needs a global solution.

Chair

Ana Sengupta, MBA, MS, RAC

Speakers
avatar for Ana Sengupta

Ana Sengupta

Director Regulatory Affairs CMC, Mirum Pharmaceuticals, Inc., United States
Ana Sengupta, Director in Regulatory Affairs at Mirum Pharmaceuticals, Inc. She has more than 25 years of pharmaceutical industry experience and 15 years of direct experience in global regulatory affairs of drugs and biologics. Before working at Mirum Pharmaceuticals, she worked in... Read More →
Monday June 16, 2025 1:30pm - 2:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   10: RegCMC-Product Quality, Workshop

2:15pm EDT

#127: Clinical Care vs Research: Walking the Ethical Tightrope Between Advocacy and Coercion
Monday June 16, 2025 2:15pm - 3:15pm EDT
202A
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-524-L04-P; CME 1.00; RN 1.00

This session will delve into the historical and ethical context for distinguishing between clinical care and research and how the blurring poses a risk for engagement with patients. Experts in ethics and health literacy will discuss potential pitfall

Learning Objectives

Recognize the ethical and historical context for distinguishing between clinical care and research; Describe the regulatory and ethical challenges that are exposed when sponsors and investigators push patients to clinical research; Discuss how language and health literacy have the potential to impact an individual’s decision to participate in research.

Chair

Karla Childers, MS

Speaker

Bioethics Perspective
Lindsay McNair, MD, MPH, MS

Patient and Health Literacy Perspective
Catina O'Leary, PhD

IRB perspective
David Borasky, MPH


Speakers
avatar for David Borasky

David Borasky

Vice President, IRB Compliance, WCG Clinical, United States
David A. Borasky serves as Vice President of IRB Compliance for WCG IRB. Mr. Borasky has 20 years of experience in managing IRBs in settings that include global public health organizations, large academic medical centers, and independent IRBs. He has facilitated training activities... 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 Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States
Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →
avatar for Catina O'Leary

Catina O'Leary

President and Chief Executive Officer, Health Literacy Media, United States
Catina O’Leary, PhD, is President and CEO at Health Literacy Media (HLM), a St. Louis based nonprofit that develops and distributes health literate and accessible health and science communications with a wide range of global partners. Before joining HLM in 2012, Catina was Assistant... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Forum |   02: ClinTrials-Ops, Forum |   04: MedAffairs-SciComm, Forum
  • Level Advanced
  • Keyword Bioethics
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Bioethics
  • Tags Forum

2:15pm EDT

#129: Models of Collaborations to Advance Regulatory Science: Lessons Learned
Monday June 16, 2025 2:15pm - 3:15pm EDT
151B
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-526-L04-P; CME 1.00; PDU 1.00 PMI 2166X8AYYG; RN 1.00

Regulatory science is a rapidly evolving field with emerging technologies. This session explores collaborative models in drug development and highlights lessons-learned and factors for effective collaborations in advancing regulatory science.

Learning Objectives

Discuss models and management of collaborative partnerships to advance novel therapies for patients; Describe strategies to help optimize cross-functional team engagement and multidisciplinary interactions.

Chair

Huong Huynh, PhD

Speaker

Panelist
Liang Zhao, PhD

Panelist
Carla Rodriguez-Watson, PhD, MPH

Panelist
Allison Cuff Shimooka, MBA

Panelist
Meghana Chalasani, MHA


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 leads the CDER Center for Clinical Trial Innovation (C3TI) and co-leads the Advisory Committee workstream... Read More →
avatar for Huong Huynh

Huong Huynh

Director of Regulatory Science, Critical Path Institute, United States
avatar for Carla Rodriguez-Watson

Carla Rodriguez-Watson

Director of Research, Reagan-Udall Foundation for the FDA, United States
Dr. Rodriguez-Watson is focused on continuously developing and enhancing a portfolio of work that leverages real-world data and experiences to inform and conduct clinical and post-market drug safety and effectiveness studies to improve population health. Key projects bring together... Read More →
avatar for Allison Cuff Shimooka

Allison Cuff Shimooka

Chief Operating Officer, TransCelerate Biopharma Inc, United States
Allison is Chief Operating Officer of TransCelerate BioPharma Inc. In this role, Allison is responsible for shaping and delivering on TransCelerate’s strategic vision: to advance collaboration in driving efficient, effective and high-quality delivery of new medicines through the... Read More →
LZ

Liang Zhao

Professor and Director for Center of Global Regulatory Science and Innovation, University of California San Francisco, United States
Dr. Liang Zhao is currently a professor and establishing the Center for Global Regulatory Science and Innovation at the School of Pharmacy, University of California San Francisco (UCSF). Prior to joining UCSF, he had served as the Director of Division of Quantitative Methods and Modeling... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Session
  • Level Advanced
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, PMI, RN
  • Tags Session

2:15pm EDT

#134: Building a Regulatory Landscape to Support CMC Innovation
Monday June 16, 2025 2:15pm - 3:15pm EDT
143ABC
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-531-L04-P; CME 1.00; RN 1.00

Senior leaders from industry and regulatory agencies will discuss the role of cooperation across regulatory bodies to facilitate innovation in the CMC/product quality sector. Senior leaders will discuss how, despite various internal and external pressures, an agile path forward can be found to advance innovative and high quality medicines.

Learning Objectives

Describe initiatives to streamline regulatory assessment/inspection; Recognize how regulatory initiatives can facilitate innovation in CMC; State comparing perspectives from senior leaders regarding regulatory initiatives and regulatory advancements.

Chair

Demetra Macheras, MBA

Speaker

Panelist
Evdokia Korakianiti, PhD, MSc

Panelist
Ingrid Markovic, PhD

Panelist
Leanne Hickman

Panelist
Jennifer McCafferty, PhD

Panelist
Sean Barry, PhD


Speakers
avatar for Demetra Macheras

Demetra Macheras

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

Jennifer McCafferty

Senior Vice President, Regulatory CMC and Quality Assurance, Merck, United States
Jennifer McCafferty is Senior Vice President, Quality Assurance and Regulatory CMC in Merck Research Laboratories. Jennifer’s more than 25-year career includes leadership positions across analytical sciences, factory and CMO operations, quality systems, quality control, CMC regulatory... Read More →
avatar for Sean Barry

Sean Barry

Senior Pharmaceutical Assessor, Health Products Regulatory Authority (HPRA), Ireland
Sean is a Senior Biologicals Assessor at the Irish health authority, HPRA, where he reviews CMC data for new product applications, scientific advices, clinical trials, and variations for mAbs, recombinant proteins, vaccines, and cell & gene therapies. Sean is chair of the Biologicals... Read More →
avatar for Leanne Hickman

Leanne Hickman

Senior Vice President, Global Quality Analytical Sciences & QC Operations, Eli Lilly and Company, United States
Leanne Hickman, Sr. VP of Global Quality Analytical Sciences and QC Strategy, leads efforts to standardize and transform QC labs across the manufacturing network. She oversees analytical methods, systems, and technologies to support testing for current and pipeline molecules. Her... Read More →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which includes Quality, GxP Compliance, Referrals and PhV. She is the EMA lead of the EU Network's strategic priority to facilitate the uptake of advanced manufacturing approaches. She... Read More →
avatar for Ingrid Markovic

Ingrid Markovic

United States
Ingrid Markovic, Ph.D. is Senior Science Advisor for CMC at the FDA's Center for Biologics where she spearheads CMC policy activities partnering with internal and external stakeholders to ensure consistent application of CMC policies and programs. She led FDA efforts for modernization... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

2:15pm EDT

#136.1: Ushering in a New Era of Africa Healthcare
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-534-L04-P; CME 1.00; RN 1.00

Crossing 1.5 billion population in 2024, Africa's demographic boom is urging new models of development and innovation. In this fireside chat, four pioneers (from leading U.S. medical centers to Top 10 pharma to big-name philanthropies) will share their ground-breaking journey in advancing Africa healthcare and R&D capabilities, and ambitious plans ahead. The panelists will be joined by DIA's incoming and past Board Chairs to help unlock our community's collective energy and creativity on this worthy front and explore win-win collaborations.

Learning Objectives

Discuss the significant social progress and momentum in the world's fastest growing continent, as well as implications for healthcare development, patient needs and opportunities, and life science innovations. Recognize the vision, achievements, lessons learned, and future goals shared by this cross-section of global and on-the-ground change makers.

Speaker

Panelist
Huwaida Bulhan, MD, MPH

Panelist
Tariro Makadzange, MD, PhD

Panelist
Katherine Van Loon

Panelist
Rebecca Vermeulen, RPh

Panelist
David Mukanga, PhD, MPH


Speakers
avatar for Huwaida Bulhan

Huwaida Bulhan

Senior Clinical Research Operations Lead Area Africa, Roche Kenya Limited, Kenya
avatar for Katherine Van Loon

Katherine Van Loon

Director, Global Cancer Program, UCSF Helen Diller Family Comprehensive Cancer Center, United States
avatar for Tariro Makadzange

Tariro Makadzange

Executive Director, Founder, Zimbabwe Clinical Research Center, United States
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 →
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 →
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  13: Spotlight, Forum |   13: Spotlight, Forum

3:45pm EDT

#150: Prior Knowledge - How Experience of the Past Can Drive the Future: Patient-Centric Specs ICH Q6, Predictive Stability, Modeling ICH Q1/5C
Monday June 16, 2025 3:45pm - 4:45pm EDT
143ABC
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-548-L04-P; CME 1.00; RN 1.00

This session will delve into how prior knowledge can be used to support decision making and development in the CMC dossier. Specifically, how prior knowledge can support patient centric specifications and predictive stability will be explored.

Learning Objectives

Describe what prior knowledge may be meaningful in supporting patient centric specifications and predictive stability; Discuss how prior knowledge may reduce regulatory burden.

Chair

Celeste Frankenfeld Lamm

Speaker

Industry Perspective: Prior knowledge to Inform Specifications and Control Strategy
Sarah Demmon, MS

Overview of ICH Q6
Andrew Chang, PhD

Industry Perspective: Prior Knowledge, Advanced Kinetic Modeling for Stability, and ICH Q1/5C
Warren Roche


Speakers
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 Sarah Demmon

Sarah Demmon

Vice President, Eli Lilly, United States
Sarah Demmon, M.S., is Vice President at Eli Lilly and Company. With 28 years in biopharmaceutical development, she specializes in late phase development and commercialization of fusion proteins and monoclonal antibodies. She started as an analytical chemist developing methods for... Read More →
avatar for Celeste Frankenfeld Lamm

Celeste Frankenfeld Lamm

Senior Director, Global Regulatory Affairs – CMC, Merck Sharp & Dohme LLC , United States
Celeste Frankenfeld Lamm, Ph.D., is a seasoned industry professional with 18 years of experience in the field. As a Senior Director of Global Regulatory Affairs – CMC at Merck & Co., she spearheads the company's global CMC policy efforts. In this role, Celeste engages externally... Read More →
WR

Warren Roche

Statistician, Sanofi, Ireland
Monday June 16, 2025 3:45pm - 4:45pm EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session
  • Level Advanced
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Session

3:45pm EDT

#152: AI in Patient Care: Aspirations and Considerations
Monday June 16, 2025 3:45pm - 4:45pm EDT
201
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-550-L04-P; CME 1.00; RN 1.00

We will discuss potential applications of AI in making diagnoses and treatment decisions, the appropriate ethical and regulatory boundaries, and how to progress forward balancing patient benefits against the potential risks.

Learning Objectives

Recognize the potential impact, ethical considerations, and evolving regulations related to the use of artificial intelligence in making diagnoses and treatment decisions; Discuss ways to formulate plans to bring artificial intelligence solutions to market and shape regulations.

Chair

Eli Weinberg, PhD, MS

Speaker

Panelist
Isaac Kohane, MD, PhD

Panelist
Shweta Maniar

Panelist
Subha Madhavan, PhD, FACMI


Speakers
avatar for Isaac Kohane

Isaac Kohane

Chair, Department of Biomedical Informatics, Harvard Medical School, United States
Isaac Kohane, MD, PhD, is the chair of Harvard Medical School’s Department of Biomedical Informatics, whose mission is to develop methods and tools for a new generation of scientists and doctors to move biomedicine rapidly forward with the insight and precision offered by big data... 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 →
avatar for Shweta Maniar

Shweta Maniar

Director, Healthcare and Life Sciences Solutions, Google Cloud, United States
Shweta is the strategy and market leader responsible for Healthcare and Life Sciences. Shweta has quickly risen through the ranks as a well-known innovator, game-changer, and relationship ambassador. With 18+ years’ experience in clinical research, Healthcare and Bio Tech, she has... Read More →
avatar for Eli Weinberg

Eli Weinberg

Partner, Bain & Co., United States
Eli Weinberg is a leader in Bain's Life Sciences and Private Equity practices. He is an advisor and thought partner to life science innovators in biopharma, diagnostics, and medtech, as well as investors active in those areas. He is keenly interested in commercialization, value creation... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  13: Spotlight, Session |   09: Regulatory, Session
 
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143ABC
144ABC
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146ABC
146BC
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151B
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201
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206
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209ABC
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  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
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  • Rare Disease
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