DIA 2025 Global Annual Meeting: Full Schedule

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8:30am EDT

#207: Japan Town Hall

Tuesday June 17, 2025 8:30am - 9:30am EDT

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-557-L04-P; CME 1.00; RN 1.00

This session will focus on the attractiveness of developing and obtaining marketing approval of pharmaceutical products in Japan from regulatory and industry perspectives, aiming to get rid of old-fashioned ideas and views about Japan.

Learning Objectives

Discuss outdated misconceptions and “urban legends” about Japan when considering Research and Development (R&D) on new medicines in Japan; Examine the attractiveness of performing R&D in Japan, both from regulatory and industrial perspectives: attractive market, flexibility/predictability, designation for each product characters; Analyze the Roles and Prospects of the PMDA’s Overseas Offices.

Chair

Daisuke Koga, MSc, RPh

Speaker

Panelist
Eri Sekine

Panelist
Sarah Rhee

Panelist
Shinichi Noda, PhD

Speakers

Daisuke Koga

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

Mr. Daisuke Koga is the Director of the Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. He started his career in 1996 at the Ministry of Health and Welfare of Japan. He worked in the Ministry on drugs, medical devices, food... Read More →

Shinichi Noda

Division Director, Division of Planning and Management, Office of International, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

2024-present Division Director, Division of Planning and Management, Office of International Strategy and Planning, PMDA 2019-2024 Deputy Review Director, Office of Cellular and Tissue-based Products, PMDA 2015-2019 Senior Reviewer, Office of pharmacovigilance II, PMDA 2013-2015 Section... Read More →

Sarah Rhee

Vice President, Head of Global Regulatory Affairs, Alexion Pharmaceuticals, Inc, United States

Eri Sekine

Executive Vice President Data Business, CMIC Co., Ltd, Japan

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

Tuesday June 17, 2025 8:30am - 9:30am EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Regulator Perspectives, Student Programming, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulator Perspectives,Student Programming,Global Perspectives
Tags Session

8:30am EDT

#208: International Harmonization in Real-World Evidence: Recent Efforts, Barriers and Future Enablers

Tuesday June 17, 2025 8:30am - 9:30am EDT

144ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-558-L04-P; CME 1.00; RN 1.00

This session will present on recent work to harmonize RWE guidelines globally. Ongoing efforts in international collaboration on ICH M14 and the ICH reflection paper will be highlighted.

Learning Objectives

Explain recent developments in international guidelines on RWE; Discuss challenges to harmonization efforts in RWE; Recognize how to evaluate gaps in RWE harmonization needs.

Chair

Stephanie Choi, PhD

Speaker

An Overview of Emerging Regulatory Guidance & Frameworks for Developing Fit-for-Purpose Real-World Evidence: Proposed Areas for Harmonization
Rachele Hendricks-Sturrup, DrSc, MA, MSc

ICH M14: Establishment of an ICH guideline on “General principles on the plan, design, and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines”
David Moeny, MPH, RPh

Collaborative international efforts on RWD/RWE: What is coming next?
Patrice Verpillat, DrMed, MD, PhD, MPH

Opportunities for regulatory alignment? Data quality assessment and reporting
Nicole Mahoney, PhD

Speakers

Patrice Verpillat

Head of Real World Evidence, European Medicines Agency

He is a medical doctor, specialist in epidemiology. He has worked during 20 years in the pharmaceutical industry where he had positions in several international companies, always dealing with real world data (RWD) and non-interventional studies (NIS) in order to bring RWE into research... Read More →

Stephanie Choi

Director, US Global Regulatory and Scientific Policy (GRASP), EMD Serono, United States

Stephanie Choi, Ph.D. is currently a Director in Global Regulatory and Scientific Policy at EMD Serono. Her current interests relate to regulatory policy in oncology, CDx, and RWE. Prior to EMD Serono, she worked as a regulatory strategist at Jazz Pharmaceuticals supporting early... Read More →

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Institute For Health Policy, United States

Dr. Rachele Hendricks-Sturrup is the Research Director of Real-World Evidence (RWE) at the Duke-Margolis Institute for Health Policy in Washington, DC, strategically leading and managing the Institute's RWE Collaborative and RWE policy research portfolio and education. As an engagement... Read More →

Nicole Mahoney

Executive Director US Regulatory Policy & Intelligence, Novartis, 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 →

David Moeny

Deputy Director, Office of Pharmacovigilance and Epidemiology, OSE/CDER, FDA, United States

David Moeny is a pharmacist and pharmacoepidemiologist with experience in clinical pharmacy practice, public health, drug utilization, regulatory pharmacoepidemiology, and international collaborations. At FDA, he has worked in both drug utilization and epidemiology teams and as the... Read More →

Tuesday June 17, 2025 8:30am - 9:30am EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Real-World Data (RWD) / Real-World Evidence (RWE), Regulatory Convergence and Harmonization, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE),Regulatory Convergence and Harmonization,Global Perspectives
Tags Session

8:30am EDT

#209: A Platform for Platforms? The Intersection of the Platform Tech Designation and Prior Knowledge

Tuesday June 17, 2025 8:30am - 9:30am EDT

145AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-559-L04-P; CME 1.00; RN 1.00

The Platform Technology Designation program reflects longtime practice to leverage prior knowledge to speed development through advanced regulatory science, based on what's already known. But how will this practice and policy continue to evolve?

Learning Objectives

Describe how the FDA, other Health Authorities (HAs), and sponsors have historically leveraged prior knowledge to accelerate innovative product development and review; Examine the FDA’s perspective on applying prior knowledge to enhance the platform technology designation program and other regulatory science advancements or pathways; Discuss how the FDA plans to ensure the consistent application of these policies across review divisions and Centers.

Chair

Alexis Miller, JD

Speaker

Recent Experience with Platform Technology Designation
Katherine Donigan, PhD

Health Authority Perspective
Julia Tierney, JD

Historic Application of Prior Knowledge
Rachel Turow, JD, MPH

Industry Perspective
Danielle Friend Economo, PhD

Speakers

Katherine Donigan

Executive 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 →

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 →

Alexis Miller

Head, Global Regulatory Policy, 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 →

Julia Tierney

Former FDA Chief of Staff and CBER Deputy Center Director, Tierney Strategies, United States

JULIE TIERNEY recently held several senior leadership roles at the US Food and Drug Administration, including FDA Chief of Staff in the Office of the Commissioner (2021-2023) and CBER Deputy Center Director (2024-2025). From 2015 to 2016, she was FDA’s detailee to the U.S. Senate... Read More →

Rachel Turow

Of Counsel, FDA Regulatory, Skadden, United States

A former regulatory counsel at FDA, Ms. Turow also served as in-house counsel at multinational developers and sellers of highly regulated products. Her experience spans cosmetics, dietary supplements, food, over-the-counter and prescription drugs, medical devices and combination and... Read More →

Tuesday June 17, 2025 8:30am - 9:30am EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

8:30am EDT

#210: MHRA Town Hall

Tuesday June 17, 2025 8:30am - 9:30am EDT

151B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-560-L04-P; CME 1.00; RN 1.00

In this session, senior leaders from Medicines & Healthcare products Regulatory Agency (MHRA) will provide an update on new regulatory and strategic priorities for the agency. The session will provide the opportunity for the audience to submit questions.

Learning Objectives

Describe MHRA’s regulatory initiatives and strategic priorities; Identify opportunities for engagement with MHRA regulators.

Chair

Lawrence Tallon

Speaker

Panelist
Alison Cave, PhD

Panelist
James Pound

Panelist
Julian Beach

Speakers

Julian Beach

Interim Executive Director, Healthcare Quality and Access, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

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 →

James Pound

Interim Executive Director, Innovation and Compliance, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

James Pound joined the British Pharmacopoeia in 2008. He has worked in a variety of roles within the BP including responsibility for medicinal chemicals, digital & publications and veterinary medicines. In addition to this he initiated and has led the joint BP and MHRA AQbD feasibility... Read More →

Lawrence Tallon

Chief Executive Officer, Medicines and Healthcare products Regulatory Agency, United Kingdom

Tuesday June 17, 2025 8:30am - 9:30am EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives
Tags Session

10:30am EDT

#225: Pathways to Innovation: Navigating Regulatory Expectations for AI Technologies in Drug Development

Tuesday June 17, 2025 10:30am - 11:30am EDT

147AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-572-L04-P; CME 1.00; RN 1.00

This session will explore engagement pathways with global regulators to obtain feedback on AI technologies in drug development. It will also identify effective evaluation strategies to support regulatory acceptance of novel methodologies.

Learning Objectives

Identify the appropriate regulatory pathways and mechanisms for engaging with health authorities to discuss AI technologies in drug development applications; Discuss regulatory strategies, use cases, and considerations for AI model development based on context of use; Evaluate lessons learned and experiences from manufacturers, developers and health authorities.

Chair

Ryan Hoshi, PhD, MBA, MSc

Speaker

EMA Perspectives on the Use of AI in the Lifecycle of Medicines
Luis Pinheiro, PharmD, MSc

AI and Machine Learning in Pharmaceutical Manufacturing
Gert Thurau, DrSc, PhD

FDA Perspectives on the Use of AI to Support Regulatory Decision-Making for Drug and Biological Products
Tala Fakhouri, PhD, MPH

Technical and Regulatory Considerations for Streamlining Drug Development with Digital Twins: Sample-size Reduction Case Study
Aaron Smith, PhD

Speakers

Tala Fakhouri

Associate Director for Data Science and Artificial Intelligence, CDER, FDA, United States

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

Ryan Hoshi

Director, Regulatory Policy and Intelligence, AbbVie, United States

Ryan Hoshi is Director of Regulatory Policy & Intelligence at AbbVie and serves as the global policy lead for medical devices, combination products, personalized medicine, digital health, artificial intelligence, and advanced therapies. Before joining AbbVie, Ryan served as an international... Read More →

Luis Pinheiro

Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands

Luis Correia Pinheiro is a Senior Epidemiology Expert at the Data Analytics and Methods Taskforce, Real World Evidence Workstream, in the European Medicines Agency, where he designs and conducts real-world data studies and works on digital methods development. He also coordinates... Read More →

Aaron Smith

Founder, Machine Learning Scientist, Unlearn.AI, United States

Aaron is a mathematician with interests in AI, machine learning, and statistics. As a founder of Unlearn.ai, he has focused for the last 8 years on the development of digital twin models and their applications in drug development.

Gert Thurau

Head of CMC Regulatory Policy for Manufacturing Technology Innovation in, F. Hoffmann-La Roche Ltd, Switzerland

Dr. Gert Thurau is the Head of Manufacturing Technology and Innovation Advocacy in the CMC Reg PTR Policy team at Hoffmann- La Roche in Basel, Switzerland. His responsibility includes the regulatory advocacy for the adoption of advanced technologies in GMP manufacturing – covering... Read More →

Tuesday June 17, 2025 10:30am - 11:30am EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Artificial Intelligence (AI)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI)
Tags Session

10:30am EDT

#226: US and EU Orphan Drug Regulations: Shaping the Ecosystem for Rare Diseases

Tuesday June 17, 2025 10:30am - 11:30am EDT

146BC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-573-L04-P; CME 1.00; RN 1.00

The US Orphan Drug Act and the European regulatory framework have accelerated orphan medicine development, boosting investments in rare disease treatments. This session will gather key stakeholders to discuss successes a and challenges

Learning Objectives

Discuss the impact of regulatory policies on the rare disease ecosystem; Discuss the challenges and opportunities associated with orphan drug regulations; Examine the role of regulatory frameworks in fostering innovation and access to therapies for rare diseases; Explain the importance of collaboration between regulatory agencies, industry stakeholders, and patient advocacy groups.

Chair

Imran Shah, PhD

Speaker

Panelist
Amy Comstock Rick, JD

US and EU Orphan Drug Regulations: Shaping the Ecosystem for Rare Diseases
Anabela Marcal, PharmD

Panelist
Segundo Mariz, MD

Panelist
Victoria Gemme, MBA, MS

Panelist
Carolyn Shore, PhD

Speakers

Victoria Gemme

Director, Policy and Regulatory Affairs, National Organization for Rare Disorders, United States

Victoria Gemme is a research associate at the Duke-Margolis Center for Health Policy, where she works on a range of policy topics related to medical product development and regulation. Prior to Duke-Margolis, Victoria worked at the Cystic Fibrosis Foundation where she oversaw a diverse... Read More →

Imran Shah

SVP & Head, Global Regulatory, R&D Quality and Safety (RQS), EMD Serono, United States

Carolyn Shore

Director, National Academies, United States

Carolyn Shore serves as global health lead and director of the Forum on Drug Discovery, Development, and Translation at the National Academies of Sciences, Engineering, and Medicine. Before joining the National Academies, Carolyn was an officer on Pew’s antibiotic resistance project... Read More →

Segundo Mariz

European Medicines Agency, Netherlands

Amy Comstock Rick

Director of Strategic Coalitions, Rare Disease Innovation Hub, FDA, United States

https://www.fda.gov/industry/fda-rare-disease-innovation-hub/amy-comstock-rick-jd

Tuesday June 17, 2025 10:30am - 11:30am EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Rare Disease
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Rare Disease
Tags Session

10:30am EDT

#227: ANVISA Town Hall

Tuesday June 17, 2025 10:30am - 11:30am EDT

145AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-574-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

Bianca Zimon, LLM

Speaker

Panelist
Daniel Pereira

Panelist
Marcelo Moreira, MS

Panelist
Dandara Santana, MHS

Speakers

Marcelo Moreira

GENERAL MANAGER, ANVISA, Brazil

Pharmacist. At Anvisa, serving as General Manager of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs, and Advanced Therapy Products.

Daniel Pereira

ANVISA, Brazil

Director of the Second and Fifth Directorates at the Brazilian Health Regulatory Agency (Anvisa), with a Law degree and a postgraduate degree in Constitutional Law. Daniel has held various leadership roles in the Brazilian public administration, including Deputy Minister of Health... Read More →

Dandara Santana

CMC reviewer, ANVISA, Brazil

Bachelor's degree in Pharmaceutical Sciences with Clinical and Industrial qualification. Master's degree in Health Science. Professional experience as a pharmacist at the Ministry of Health in Brazil. Since 2014, working as a CMC reviewer at the National Health Surveillance Agency... Read More →

Bianca Zimon

Health Regulation Specialist, ANVISA, Brazil

Advisor to the International Affairs Office at the Brazilian Health Regulatory Agency (Anvisa). Specialist in Health Regulation and Constitutional Law, with extensive experience in health regulation and enforcement, as well as in bilateral and multilateral negotiations, international... Read More →

Tuesday June 17, 2025 10:30am - 11:30am EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Regulator Perspectives, Regulatory Collaboration, Regulatory Convergence and Harmonization, Student Programming, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulator Perspectives,Regulatory Collaboration ,Regulatory Convergence and Harmonization,Student Programming,Global Perspectives
Tags Session

10:30am EDT

#218: Innovation Reimagined: How Intelligent Automation is Redefining Research and Development Excellence

Tuesday June 17, 2025 10:30am - 11:30am EDT

207B

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-565-L04-P; CME 1.00; RN 1.00

This session will explore how Intelligent Automation (IA) and AI are transforming R&D and Regulatory Affairs by automating document-heavy processes and driving data-driven decisions. Through real-world use cases presented by industry sponsors, attendees will learn how IA and AI are being applied to improve efficiencies, reduce timelines, and optimize regulatory outcomes.

Learning Objectives

Discuss AI applications in drug discovery, clinical trials, regulatory, manufacturing, and pharmacovigilance; Explain practical use cases of AI in Regulatory Operations; Discuss advancing fit-for-purpose, risk-based frameworks for AI and global regulatory alignment.

Chair

Venkatraman Balasubramanian, PhD, MBA

Speaker

AI: Accelerating Clinical Trials Through Smarter Site Selection
Kevin Bugin, PhD, MS, RAC

Harnessing AI and Automation in Regulatory: Insights from the Recent DIA RIM Intelligent Automation Survey
Cary Smithson, MBA

Industry Perspective
Cedric Berger, PhD, MBA

AI-Driven Drug Development: Transforming Life Sciences with Data and Innovation
Sridevi Nagarajan, PhD, MS, MSc

Speakers

Venkatraman Balasubramanian

Healthcare and Life Sciences Strategic Advisor, VB Insights, LLC, United States

Bala heads VB Insights, an advisory firm for the Healthcare and Life Sciences sector. Bala brings over 35 years of experience. During his long tenure, he has been responsible for the introduction of Web, document management, global team collaboration, and regulatory information management... Read More →

Cedric Berger

Head of Knowledge Extraction and Integration, F. Hoffmann-La Roche, Switzerland

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 →

Sridevi Nagarajan

DIA Communities Lead for AI in Healthcare, Ayusarogya, United Kingdom

An influential and data-driven executive professional with a robust background in the Pharmaceutical and Public Health sectors, bringing a unique blend of expertise in leading digital transformation initiatives and leveraging data to guide corporations through complex business changes... Read More →

Cary Smithson

Managing Partner, LeapAhead Solutions, Inc., United States

Cary is the Managing Partner of LeapAhead Solutions and has over 30 years of experience in life sciences focused on leading strategic initiatives to drive increased business productivity, enhance regulatory compliance, and simplify information management and the use of technology... Read More →

Tuesday June 17, 2025 10:30am - 11:30am EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session | 02: ClinTrials-Ops, Session | 03: Data-Tech, Session

Level Advanced
Keyword Artificial Intelligence (AI)
Level Advanced
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI)
Tags Session

12:00pm EDT

#234 RT: Roundtable Discussion: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease

Tuesday June 17, 2025 12:00pm - 1:00pm EDT

Exhibit Hall / Zone A

Component Type: Session

Join the Advanced Therapies Community for a follow up round table discussion tied to session: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease (Monday, June 16 | 3:45pm - 4:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Carolyn Shore, PhD

Speakers

Carolyn Shore

Director, National Academies, United States

Tuesday June 17, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

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

format csv
Tags Session

1:45pm EDT

#249: Harmonizing Data Quality Frameworks: Bridging Regulatory Perspectives

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

147AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-587-L04-P; CME 1.00; RN 1.00

This session will explore the ways in which the data quality criteria within the EMA, FDA and ICH M14 guidelines converge or diverge, and propose some definitive actions for consideration to achieve harmonization of terminology.

Learning Objectives

Examine the current fragmentation in RWD/RWE data quality standards and its impact on research and regulatory decisions; Identify the key stakeholders and their varying data quality criteria within the pharmaceutical landscape; Describe potential strategies for developing a unified data quality framework to enhance consistency and reliability in data-driven research.

Chair

Elena Popa, MPharm

Speaker

Panelist
Donna Rivera, PharmD, MSc, FISPE

Harmonizing Data Quality Through an International Convergence and Applying Best Practices Through a United States Lens
Rachele Hendricks-Sturrup, DrSc, MA, MSc

A Comparative Analysis of Data Quality Frameworks
Simon Bennett, MSc

Pursuing Opportunities for Harmonization in Using Real-World Data: ICH Update
Kelly Robinson, MSc

Panelist
Patrice Verpillat, DrMed, MD, PhD, MPH

Speakers

Patrice Verpillat

Head of Real World Evidence, European Medicines Agency

Simon Bennett

Director, EU Regulatory Policy, Biogen, United Kingdom

As Director of European Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities in key areas. Simon started at Biogen in 2003 in clinical development before moving into Regulatory Sciences... Read More →

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Institute For Health Policy, United States

Elena Popa

Chief of Staff, Global Regulatory Affairs, Bayer, Switzerland

Elena is a pharmacist by training with a master in drug safety & pharmacovigilance. She is the Chief of Staff for Global Regulatory Affairs at Bayer. Elena joined Bayer as a Regulatory Policy & Innovation Lead in 2022, a role which focused on the regulatory use and acceptance of RWD/RWE... Read More →

Kelly Robinson

Director General, Pharmaceutical Drugs Directorate, Health Canada, Canada

Kelly Robinson is the Director General of the Pharmaceutical Drugs Directorate at Health Canada. In this role she leads a multidisciplinary team responsible for the authorization of innovative and generic pharmaceuticals, clinical trial evaluation, and the Special Access Program... Read More →

Donna Rivera

Associate Director for Pharmacoepidemiology, Oncology Center of Excellence, FDA, United States

Donna R. Rivera, PharmD., MSc., FISPE is the Associate Director for Pharmacoepidemiology in the Oncology Center of Excellence at the U.S. Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the regulatory review of Real World Data (RWD... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Regulatory Convergence and Harmonization, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulatory Convergence and Harmonization,Global Perspectives
Tags Session

1:45pm EDT

#251: China Town Hall

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

145AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-589-L04-P; CME 1.00; RN 1.00

In this forum, speakers from the National Medical Products Administration (NMPA) , academia and industry will present the progress in drug regulation, review China's biopharma innovation in the past decade, and discuss accelerating innovative drug approvals in China. Attendees will have an opportunity to discuss the issues related to drug development with NMPA officials, clinical researcher and industry executive.

Learning Objectives

Describe the latest information on the National Medical Products Administration’s activities in drug regulation; Describe the trend in biopharma innovation in the past decade; Discuss the strategies for accelerating innovative drug development and approval in China.

Chair

Ling Su, PhD

Speaker

Brief Introduction from the NMPA
Feng Zhu

The Progress of China's Drug Review and Approval Reform
Jianwu Zhang, PhD

Accelerating the Development and Approval of Innovative Drugs in China: Industry's Perspective
Wei Zhang

The Past Decade of China's Biopharma Innovation
Xiaoyuan Chen, MD

Building a World-Class Hub for Biomedical Innovation - Case Study of Suzhou Industrial Park (SIP)
Gina Zhang

Speakers

Xiaoyuan Chen

Professor, Tsinghua University, China

Researcher Chen Xiaoyuan graduated with a bachelor's degree in clinical medicine in 1996 and a master's degree in clinical pharmacology in 2002. In 2010, he received a doctorate in pharmacology from Shanghai Jiaotong University. In 2002, he joined the drug evaluation center of the... Read More →

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 →

Wei Zhang

SVP, Head of Medicine, Greater China, Boehringer Ingelheim, China

Jianwu Zhang

Division Director, Drug Registration Department, National Medical Products Administration, China

Feng Zhu

Director, Cooperation Department, China Center for Food and Drug International Exchange (CCFDIE), China

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

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

Level Intermediate
Keyword Global Perspectives, Regulator Perspectives, Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives,Regulator Perspectives,Student Programming
Tags Session

2:55pm EDT

#255 RT: Roundtable Discussion: International Regulatory Harmonization for Development of Medicines - A Look at How far We’ve Come and Where We Go From Here

Tuesday June 17, 2025 2:55pm - 3:55pm EDT

Exhibit Hall / Zone A

Component Type: Session
Level: Intermediate

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: International Regulatory Harmonization for Development of Medicines: A Look at How Far We’ve Come and Where We Go From Here (Monday, June 16 | 2:15pm – 3:15pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session,

Chair

Chaitanya Koduri, DDS, MHS

Speakers

Chaitanya Koduri

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

Dr. Chaitanya Koduri serves as the Director of International Government and Regulatory Engagement in the Global External Affairs division of the United States Pharmacopeia. In this capacity, Dr. Koduri oversees international regulatory partnerships involving the United States Pharmacopeia... Read More →

Tuesday June 17, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

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

Level Intermediate
Level Intermediate
format csv
Tags Session

4:00pm EDT

#270: Patient Engagement in Trial Design and the Evolving Landscape of FDA, EMA and Country Authority Guidance

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

146BC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-602-L04-P; CME 1.00; RN 1.00

With several regulatory and ethics authority initiatives to encourage patient input to trial design, how should sponsors communicate this information in submissions and how can authorities provide aligned review, guidance and expectations towards these activities?

Learning Objectives

Discuss US and EU initiatives for systematic conduct and documentation of patient input to trial design; Explain learnings from survey on sponsor submission/advice experience and guidance needs; Identify gaps and opportunities for authority (regulatory and ethics committee) harmonization in expectations and guidance

Chair

Melissa Herman, MSc

Speaker

Industry Perspective
James Valentine, JD, MHS

Industry Perspective
Lesley Maloney, PharmD

Industry Perspective
Elizabeth Rosenkrands-Lange, MPH, MS

Speakers

Melissa Pauline Herman

Senior Specialist, Patient Insights, Lundbeck A/S, Denmark

Melissa Herman is a Senior Specialist in the H. Lundbeck A/S Global Patient Insights team, working to systematically integrate patient experience data and patient engagement across neurology and neuro-rare development programs.

Lesley Maloney

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

Lesley R. Maloney, Pharm.D., is Regulatory Policy Leader at Genentech, a member of the Roche Group. She is responsible for shaping the external regulatory environment in the US and globally on topics including patient-focused drug development, digital health technologies, and artificial... Read More →

Elizabeth Rosenkrands-Lange

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

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

James Valentine

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

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

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

05: Patient-Impact-Product-Dev, Session | 09: Regulatory, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Keyword Global Perspectives, Clinical Trial Design, Patient Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives,Clinical Trial Design,Patient Experience
Tags Session

4:00pm EDT

#271: Enhancing Global Access to Innovative Therapies: Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

147AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-603-L04-P; CME 1.00; RN 1.00

Global key initiatives towards harmonization, convergence and collaborative efforts in advancing the development and accessibility of advanced therapy medicinal products (ATMPs) will be explored, with a special focus on supporting MICs.

Learning Objectives

Outline global efforts on collaboration and harmonization initiatives for ATMPs; Identify and discuss efforts to build regulatory capacity, provide technical assistance, and facilitate access to ATMPs in middle-income countries (MICs); Discuss strategies for achieving convergence and harmonization for ATMPs.

Chair

Maria Antonieta Roman, MPharm

Speaker

Global Efforts to Build Regulatory Capacity and Facilitate Access to ATMPs in Middle-Income Countries
Kowid Ho, PharmD

Panelist
Yasuhiro Kishioka, PhD

Panelist
Caroline Pothet, PharmD, RPh, RAC

Panelist
Julia Djonova

Panelist
Renata Miranda Parca, AHIP

Speakers

Julia Djonova

Head Division ATMP, Swissmedic, Switzerland

Kowid Ho

Pharma Technical Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland

Kowid Ho has been working at F. Hoffmann-La Roche Ltd.’s Global Pharma Technical (CMC) Regulatory Policy in Basel, Switzerland for >10 years. He was previously a quality assessor for biological products at Agence nationale de sécurité du médicament et des produits santé (ANSM... Read More →

Yasuhiro Kishioka

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

Dr. Kishioka is a Review Director of the Office of Cellular and Tissue-based Products, PMDA. In this role, he is responsible for the assessment of regenerative medical products (gene/cell therapy products). Since joining PMDA in 2008, Dr. Kishioka has been involved in various international... Read More →

Renata Parca

Health regulatory specialist, ANVISA, Brazil

I hold a degree in Biology from the University of Brasília, where I also completed my master’s degree. I work as a health specialist at Anvisa since 2005, in the office of blood, tissues, cells, and advanced therapy medicinal products.

Caroline Pothet

Head of advanced therapies and haemato-oncology, European Medicines Agency, Netherlands

Caroline Pothet is head of the office for advanced therapies and haemato-oncology at the European Medicines Agency. Caroline joined EMA in 2020; prior to this, Caroline worked in the Industry for 20 years in a variety of sectors such as regulatory policy, regulatory science and drug... Read More →

Maria Antonieta Roman

Head Regulatory Policy LaCan, Novartis, Mexico

Degree in Pharmacy, Master of Science (pharmacy) UNAM; Diploma in Clinical development and regulatory affairs, Universidad Anahuac; diploma in public health by the Swiss School of Public Health. 32 years of experience in various areas in the Pharmaceutical industry like R&D, quality... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Regulatory Collaboration, Regulatory Convergence and Harmonization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulatory Collaboration ,Regulatory Convergence and Harmonization
Tags Session

4:00pm EDT

#272: Towards Instantaneous Regulatory Decisions and Better Predictability

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

145AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-604-L04-P; CME 1.00; RN 1.00

An interactive sesion to reimagine regulatory frameworks and streamline product approvals globally. This session will focus on focus on data transparency, collaboration, process optimization and technology to accelerate medicine development and patient access.

Learning Objectives

Recognize the power of data to accelerate submissions; Initiate pilot projects aiming at sharing data, not documents, and lay the groundwork for dynamic reviews; Create better pre-competitive collaborations to share more safety data and endpoints.

Chair

Dominique Lagrave, PharmD

Speaker

Panelist
Debra Yeskey

Panelist
Len Rosenberg, PhD, RPh

Panelist
Tony Fantana, PhD

Speakers

Tony Fantana

Senior Director, Eli Lilly, United States

Tony Fantana is the Global Regulatory Affairs Innovation and Technology Lead at Eli Lilly. He is passionate about creatively solving unmet medical needs through innovative technology solutions. Trained at Harvard Medical School, Tony held roles of increasing responsibility driving... Read More →

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 →

Len Rosenberg

Head of Clinical Operations, Beat AML, a division of The Leukemia and Lymphoma Society, United States

Len Rosenberg is an executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, CRO and eClinical sectors - diverse background includes executive management, clinical and regulatory operations, business development and... Read More →

Debra Yeskey

Head of Regulatory Policy and Intelligence, CEPI, United States

Debra Yeskey, Pharm.D., is the Head of Regulatory Policy and Intelligence for the Coalition for Epidemic Preparedness Innovations (CEPI). She has been with CEPI since December 2018, and was instrumental in the creation of the Regulatory Affairs Group under COVAX that is co-led by... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session