DIA 2025 Global Annual Meeting: Full Schedule

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8:30am EDT

#201: Innovations in Signal Detection: Advancing Safety Signals with the READUS-PV Guidelines and Regulatory Updates

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

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-551-L04-P; CME 1.00; RN 1.00

This session will introduce the latest efforts to enhance the quality of safety signal generation from government, industry, and academia (e.g., recommendations, regulatory frameworks, case examples) and will conclude with a panel discussion.

Learning Objectives

Explain the latest recommendations for reporting the results of safety signal generation (transparency, completeness) and relevant case example; Examine case examples to enhance the quality of safety signal generation in industry and academia: task process and methodologies; Discuss perspectives from government, industry, and academia to enhance the quality of safety signal generation.

Chair

Judy Shin, PhD

Speaker

A New Standard in Signal Detection: Reporting and Analyzing Drug Safety Signals with the READUS-PV Guidelines and Beyond
Michele Fusaroli, DrMed, PhD

Pharmacovigilance and Signal Detection in Korea Institute Drug Safety and Risk Management
HYUN JOO JUNG, PharmD, PhD

Pharmacovigilance Innovations in Signal Detection: Bridging Safety Signals and Regulatory Decisions in Taiwan
Wei-I Huang, MS, RPh

Shaping the Future of Signal Detection: Industry Trends and Evolving Practices in Pharmacovigilance
Andrew Bate, PhD, MA

Speakers

Andrew Bate

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

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

Michele Fusaroli

Uppsala Monitoring Centre, Sweden

Michele Fusaroli, MD, PhD, serves as a Senior Pharmacovigilance Scientist at the Uppsala Monitoring Centre's Research Department. He steered the READUS_PV group, which focused on establishing reporting guidelines for disproportionality analysis. Fusaroli Michele has implemented innovative... Read More →

Wei-I Huang

Director, Division of Drug Safety, Taiwan Drug Relief Foundation, Taiwan

Ms. Wei-I Huang is a clinical pharmacist specializing in pharmacovigilance and regulatory pharmacoepidemiology. Her expertise includes drug safety signal detection, risk assessment, and regulatory compliance. As Director of the Taiwan National ADR Reporting Center, operated by the... Read More →

HYUN JOO JUNG

Departiment of Drug Safty Information, Korea Institute of Drug Safety & Risk Management, Korea, Republic of

I am currently working as the director of the office of drug safety information of department of drug safety information in Korea Institute of Drug Safety & Risk Management. Based on the Pharmaceutical Affairs Act of Korea, we collect, analyze, assess and management drug safety information... Read More →

Judy Shin

Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of

Dr. Ju-Young Shin is the Chair Professor of Biohealth Regulatory Science at the School of Pharmacy, Sungkyunkwan University (SKKU). She serves as an associate editor for SCIE journals such as Pharmacoepidemiology and Drug Safety and Epidemiology and Health. She earned her B.S. in... Read More →

Tuesday June 17, 2025 8:30am - 9:30am EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Session

Level Intermediate
Level Intermediate
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Credit Type ACPE, CME, RN
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8:30am EDT

#202: From Measuring to Modeling the Patient Burden: An Interactive Take on What Defines the Patient Experience in the AI-Age

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

206

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-552-L04-P; CME 1.00; RN 1.00

Imagine a future where AI measures patient burden from provided inputs. In this interactive workshop, participants will design input logic for AI using mock data and protocols, then present their rationale to foster collaborative learning.

Learning Objectives

Define and categorize key factors affecting patient burden in clinical trials; Analyze patient-related data to design effective AI inputs; Evaluate and justify the role of human insight in enhancing AI-driven patient burden assessments for patient-centric trial outcomes.

Chair

Mihail Tanev, DMD, PhD

Speaker

Panelist
Karen Correa, PhD

From Measuring to Modeling the Patient Burden: An Interactive Take on What Defines the Patient Experience in the AI-Age
Mihail Tanev, DMD, PhD

Speakers

Mihail Tanev

Medical Advisor, FindMeCure Ltd, Bulgaria

Dr. Mihail Tanev, DMD, PhD is a health practitioner and scientist with a doctorate in Oral Pathology Science and Photochemistry. Coming from a strong academic foundation in disease biology, diagnostics and clinical research, he brings a uniquely cross-disciplinary perspective to the... Read More →

Karen Correa

Vice President, Clinical Development Operations, Boehringer Ingelheim, United States

Dr. Karen Correa is the Vice President, Head of Global Development Operations at Boehringer Ingelheim; where she is responsible for the advancement of the portfolio and execution of global clinical trials in the US. Her 30 years of clinical research experience cover a large range... Read More →

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

02: ClinTrials-Ops, Workshop

Level Intermediate
Keyword Artificial Intelligence (AI), Patient Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI),Patient Experience
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8:30am EDT

#203: Realizing Value Through Responsible AI in Clinical Development

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

207B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-553-L04-P; CME 1.00; RN 1.00

Leveraging expertise from industry, this session will explore how responsible AI frameworks can maximize value in clinical research by ensuring ethical, transparent, and accountable AI use.

Learning Objectives

Recognize a set of responsible principles for AI in drug development; Demonstrate the ability to drive innovation and strategic advantage in AI-driven clinical trials; Propose how organizations can lead with integrity and trust in their AI applications.

Chair

Stephen Pyke, MSc

Speaker

Patient Perspectives on AI in Clinical Development
Alicia Staley, MBA, MS

Regulatory Perspectives on AI in Clinical Development
Tala Fakhouri, PhD, MPH

Industry Perspectives on AI in Clinical Development
Raja Shankar, MS

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 →

Stephen Pyke

Chief Clinical Data and Digital Officer, Parexel, United Kingdom

Stephen is responsible for leading and directing Parexel’s enterprise patient data strategy. He is also leading the development of Parexel's AI strategy. Stephen trained as a statistician, and began his career in academia (London), where he held various research and teaching positions... Read More →

Raja Shankar

Vice President, Machine Learning, IQVIA, United Kingdom

As the Vice President of Machine Learning in IQVIA’s Research and Development Solutions, Raja leads the development, selling and delivery of AI-led life sciences innovation through pilots, platforms, products and services. His current focus is on AI to augment life science R&D across... Read More →

Alicia Staley

Chief Patient Officer, Medidata, a Dassault Systèmes Company, United States

Alicia has over 20 years of experience in software design and information systems management. She has a Mechanical Engineering Degree from Syracuse University and from Boston University with a Masters of Information Systems and an MBA. At Medidata, Alicia works to infuse the patient... Read More →

Tuesday June 17, 2025 8:30am - 9:30am EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

03: Data-Tech, Session

Level Intermediate
Keyword Artificial Intelligence (AI)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI)
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8:30am EDT

#205: Revolutionizing Medical Writing: Building the Assistive Technology Ecosystem

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

151A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-555-L04-P; CME 1.00; RN 1.00

This session will explore the evaluation and implementation of assistive technology for clinical document content creation. The panelists will describe experimental design and adoption of solutions, cross-functional partnerships, and the impact to Medical Writing organizations.

Learning Objectives

Discuss and evaluate the potential benefits and challenges of implementing assistive technology, including both rule-based and AI-based solutions; Recognize the criticality of working with cross-functional teams to assess and implement technologies, ensuring successful adoption and return on investment; Discuss how AI can positively influence Medical Writing organizations.

Chair

Nancy Tam, MS

Speaker

Revolutionizing Medical Writing: Building the Assistive Technology Ecosystem
Matthew Renda, PhD, MS

Revolutionizing Medical Writing: Building the Assistive Technology Ecosystem
Aliza Nathoo

Speakers

Aliza Nathoo

Senior Director, Content Strategy, F. Hoffmann-La Roche Ltd., Canada

Aliza began her career on molecular teams and leading complex regulatory submissions. Over her 20+ years in biopharmaceuticals, she has expanded her focus into automation-assisted content authoring, generation, and management. Today, she leverages her foundation to drive content innovation... Read More →

Matthew Renda

Senior Director Medical Writing Operations, Alexion, Astrazeneca Rare Disease, United States

Matt Renda has 13 years of academic research experience focused on gene therapy and 17 years of pharmaceutical development experience providing regulatory submission management and medical writing leadership to optimize cross-functional processes, implement innovative technologies... Read More →

Nancy Tam

Head of Medical Writing, Pfizer Inc, United States

Nancy Tam is the Head of Medical Writing at Pfizer and has more than 20 years of experience as a medical writing professional in the biopharmaceutical industry. Nancy has implemented automated solutions for content creation at several sponsor companies and is working to implement... Read More →

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

04: MedAffairs-SciComm, Session

Level Intermediate
Keyword Artificial Intelligence (AI)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI)
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8:30am EDT

#207: Japan Town Hall

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

147AB

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
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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
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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

Health Authority Perspective
Julia Tierney, JD

Historic Application of Prior Knowledge
Rachel Turow, JD, MPH

Industry Perspective
Danielle Friend Economo, PhD

Speakers

Danielle Friend Economo

Senior Director, US Head Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States

Dr. Danielle Friend received her Ph.D. in neuroscience in 2013 from the University of Utah. After completing her graduate work, Danielle conducted postdoctoral research at the National Institutes of Health. In 2016, Danielle was selected as a Science and Technology Policy Fellow with... Read More →

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 Deputy Center Director for Strategy, Policy, and Legislation, CBER, 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 →

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

Alison Cave, PhD

Speaker

Panelist
James Pound

Panelist
Julian Beach

Panelist
Lawrence Tallon

Speakers

Julian Beach

Interim Executive Director of Healthcare Quality and Access (HQA), 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

Group Manager - British Pharmacopoeia & Laboratory Services, 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

8:30am EDT

#204: Real-World Data Traceability: Challenges and Solutions When Generating Real-World Evidence

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

143ABC

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-554-L04-P; CME 1.00; RN 1.00

This session will engage an expert panel in a discussion on traceability of RWD. Panelists will describe challenges and discuss potential solutions to maintain and document traceability of RWD used in regulatory submissions.

Learning Objectives

Describe the inherent challenges in maintaining and documenting the traceability of Real-World Data (RWD) for regulatory purposes; Discuss potential solutions, including new and existing technologies, to enhance RWD traceability; Evaluate the strengths and weaknesses of various approaches to RWD traceability in a regulatory context.

Chair

James Browning, MPH

Speaker

Healthcare Organization Research Technology Perspective
Christopher Herrick, MBA

Traceability - Tools & Implementation Perspective
Anand Shroff, MBA, MS

Regulator Perspective
Marie C. Bradley, PhD, MPH, MPharm

Epidemiologist/Observational Researcher Perspective
Nancy Dreyer, PhD, MPH, FISPE

Speakers

Marie Bradley

Senior Advisor, Real-World Evidence Analytics, Office of Medical Policy, CDER, FDA, United States

Dr. Marie Bradley is a Senior Advisor on the Real-World Evidence Analytics team in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), FDA. Her responsibilities related to real-world evidence (RWE) include serving as program lead for the FDA Advancing Real... Read More →

James Browning

Director of Biostatistical Programming, Center for Observational Research, Amgen, United States

James Browning, MPH, is a Director of Biostatistical Programming in the Center for Observational Research (CfOR) at Amgen Inc. He has over 15 years of experience conducting observational studies in multiple therapeutic areas with the majority concentrated in oncology. He is skilled... Read More →

Nancy Dreyer

Founder, Dreyer Strategies LLC, United States

Nancy Dreyer is Chief of the Scientific Advisory Board at OM1, and brings her experience having served as Chief Scientific Officer at IQVIA Real World Solutions, Global Chief of Scientific Affairs at Outcome Sciences and Quintiles, and CEO of Epidemiology Resources Inc. Her expertise... Read More →

Christopher Herrick

VP of Research Systems and Technology, Mass General Brigham (MGB), United States

Christopher Herrick is the Vice President of Research Technology at Mass General Brigham, where he leads the strategic development of data and technology platforms that support clinical research across one of the nation’s largest academic health systems. He co-leads the Hospital... Read More →

Anand Shroff

President, Verantos, United States

Anand Shroff is a co-founder and President of Verantos, a company which specializes in rich and reliable RWD and high-validity RWE using AI. Previously, he was one of the founders of Health Fidelity (acquired by Edifecs/Francisco Partners), which focused on identifying and quantifying... Read More →

Tuesday June 17, 2025 8:30am - 9:30am EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

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

Level Intermediate
Keyword Real-World Data (RWD) / Real-World Evidence (RWE)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Forum

10:30am EDT

#215: The Need for a Multi-Stakeholder Collaboration to Modernize ICSR Management: How? Why? What?

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

150AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-562-L04-P; CME 1.00; RN 1.00

The pharmacovigilance (PV) ecosystem is fraught with noise, impeding a single source of truth for effective and timely safety surveillance of Individual Case Safety Reports (ICSRs). However, multi-stakeholder partnerships can synthesize diverse needs and requirements to pilot a modernized future state.

Learning Objectives

Recognize ICSR replication and duplication challenges to the ecosystem; Describe ways to critically appraise a proposed concept for modernizing ICSR management to address challenges, enhance safety analysis, and facilitate a real-time learning healthcare system; Identify the stakeholder perspectives, modern methods and technologies, and change management needed to design and pilot a new ICSR paradigm.

Chair

Mayur Patel, PharmD

Speaker

Panelist
Suranjan De, MBA, MS

Panelist
Andrew Bate, PhD, MA

Panelist
Phil Tregunno

Panelist
Jeremy Jokinen, PhD, MS

Speakers

Andrew Bate

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

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA, United States

Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality... Read More →

Jeremy Jokinen

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

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

Mayur Patel

Vice President, Oncology Therapy Area, Global Patient Safety, AstraZeneca, United States

Mayur Patel is an experienced drug developer and pharmacovigilance professional with over 25 years in biopharmaceutical industry. Currently, Dr. Patel is the Vice President Global Patient Safety in the Oncology Therapy Area at AstraZeneca based in the US. Over his career, he has managed... Read More →

Phil Tregunno

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

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

Tuesday June 17, 2025 10:30am - 11:30am EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Session

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

10:30am EDT

#216: The Globalization of Risk Management

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

207A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-563-L04-P; CME 1.00; RN 1.00

This session will review the key REMS and EU Risk Management guidances issued during 2024. It will review the major strategic and operational impacts of the new guidances and describe practical applications of the new approaches they describe.

Learning Objectives

Discuss the overview and intent of key risk management guidances issued by the FDA and EMA; List the key differences and similarities in the approaches outlined in the guidelines; Identify key areas of activity for organizations to align with the intent of these guidances; Evaluate the key strategic and operational impacts of the guidances on participants' organizations.

Chair

Jamie Wilkins, PharmD

Speakers

Jamie Wilkins

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

Jamie Wilkins, Pharm.D. is an experienced pharmacist and former regulator currently responsible for partnering with internal and external stakeholders on delivering innovative, strategic global safety and risk management excellence for Pfizer’s drug and biologics portfolio. Prior... Read More →

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

01: ClinSafety-PV, Session

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

10:30am EDT

#217: Case Studies of Application of AI in Risk-Based Quality Management

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

209ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-564-L04-P; CME 1.00; RN 1.00

This session will present multiple case studies illustrating the successful implementation of AI-driven RBQM solutions in real-world clinical trials. Attendees will gain insight into the practical applications of AI technologies.

Learning Objectives

Recognize the key benefits and challenges of applying AI technologies in RBQM; Identify insights into real-world examples of AI's impact on clinical trial risk management; Discuss strategies for integrating AI into existing RBQM frameworks to improve decision-making and compliance; Describe how AI enhances collaboration across clinical trial stakeholders and supports more proactive risk-based strategies.

Chair

Artem Andrianov, PhD, MBA

Speaker

Panel Discussion: AI Teammates in Trials - Elevating Risk Management and Human Insight
Brian Barnes, MA

Novo Nordisk’s Path to Integrated Quality and Risk Management with AI-Powered Study Builder
Bo Maach-Møller, MPharm

Unlocking AI Potential In RBQM: Today and Tomorrow
Cheng Su, PhD

Speakers

Artem Andrianov

CEO, Cyntegrity Germany GmbH, Germany

With over 25 years in the pharmaceutical industry, Dr. Artem Andrianov is a leading expert in clinical data quality and biostatistics. As the CEO of Cyntegrity, he specializes in data-driven risk management in clinical trials. His academic background includes a Ph.D. in Mathematical... Read More →

Brian Barnes

Director, Risk Management Strategy, Global Clinical Development Operations, BioNTech, United States

Brian is a seasoned leader in clinical research, specializing in Good Clinical Practice (GCP) process excellence, risk-based quality management (RBQM), and global clinical operations across a range of therapeutic areas. With over two decades in pharmaceutical R&D, he has held pivotal... Read More →

Bo Maach-Møller

Vice President, Risk Based Quality Management, Novo Nordisk A/S, Denmark

As a Vice President of Clinical Operations and Risk Based Quality Management, Regional Clinical Operations Director, Lean Six Sigma Black Belt, and many other Clinical Operations roles over the years, I bring an extensive and diversified experience in managing people and project initiatives... Read More →

Cheng Su

Executive Director, Data Sciences and Analytics, Biomarin Pharmaceutical, United States

Cheng is the Executive Director of Data Sciences at BioMarin, where he leads RBQM transformation, AI innovation, and statistical support for research and early development. Prior to joining BioMarin, he led the development of centralized statistical monitoring and directed the Research... Read More →

Tuesday June 17, 2025 10:30am - 11:30am EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, 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

#219: Resilient Leadership: Overcoming Isolation and Adversity

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

151A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-566-L04-P; CME 1.00; RN 1.00

In the ever-evolving pharma/biotech landscape, leaders face challenges that test their professional and personal resilience. The past year has seen a significant strain on the industry, marked by the disruption of new technologies (and expectations associated with it), the failure of promising compounds, economic pressures, and layoffs. As leaders, we are often left to shoulder the weight of these challenges, managing not only our own emotional burden but also the morale of our teams and the broader organizational impacts. This presentation, delivered by a panel of seasoned professionals in the regulatory writing space, will explore the often-unspoken loneliness of leadership in times of upheaval. We will share personal insights from our career journeys, addressing the ways in which leadership can feel isolating, especially when navigating industry setbacks. In addition, we will provide practical strategies for coping with these burdens, drawing from experiences in career pivots, reskilling/retooling, and personal resilience. We will discuss ways to maintain emotional well-being, foster collaboration, and lead with transparency, even in the face of industry-wide adversity. Attendees will leave with actionable strategies to support their teams and themselves, and insights into how to continue leading effectively in times of uncertainty.

Learning Objectives

Discuss the unique emotional and professional challenges faced by regulatory writing leaders during periods of significant change; Describe developing strategies for maintaining personal resilience and emotional well-being while leading teams through industry-wide setbacks and economic pressures; Recognize ways to implement actionable techniques for fostering skill development, reskilling, and collaboration to effectively support both individual and team growth during challenging times.

Chair

Robin Whitsell

Speaker

Panelist
Cathy Tyrrell

Panelist
Matthew Robillard, MBA

Speakers

Matthew Robillard

Senior Director, Regulatory Strategic Writing, AbbVie, United States

Matthew Robillard is a Senior Director of Strategic Medical Writing for AbbVie, based in North Chicago, IL. Matt began his career with Abbott Laboratories in 1992 in Technical Communications, and in 1996 became a Medical Writer in the Hospital Products Division. His career has progressed... Read More →

Cathy Tyrrell

Head of Medical Writing and Disclosure, CSL Seqirus, United States

Cathy has led medical writing teams and built groups in pharmaceutical companies and CROs of all sizes. Her career started in immunomodulator research that contributed to better lives for rheumatoid arthritis patients. Since then, she has played a part in the successful development... Read More →

Robin Whitsell

President, Whitsell Innovations, Inc., United States

Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 25 years of experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →

Tuesday June 17, 2025 10:30am - 11:30am EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

04: MedAffairs-SciComm, Session | 12: ProfDevelopment, Session

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

10:30am EDT

#220: Novel Framework and Case Study to Support Scientific Rigor: A New Community-Focused Model for Sustainable Clinical Trial Participation

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

202A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-567-L04-P; CME 1.00; RN 1.00

A new community-focused, multi-stakeholder, disease-agnostic framework addressing solutions to sustainably improve clinical trial participation. Learn about, and how to apply, the framework along with a case study of its initial implementation in Atlanta.

Learning Objectives

Discuss an innovative framework for multi-stakeholder, community-focused clinical trial participation developed by patient advocacy and community-based organizations, trial sites, industry sponsors, and communications partners; Recognize its practical applications, real-world experiences, and initial impact through the grassroots pilot, Reflections Atlanta.

Chair

Victoria DiBiaso, BSN, MPH, RN

Speaker

Nove Framework and Case Study to Support Scientific Rigor: A New Community-Focused Model for Sustainable Clinical Trial Participation
Ellyn Getz, MPH

Novel Framework and Case Study to Support Scientific Rigor: A New Community-Focused Model for Sustainable Clinical Trial Participation
Victoria DiBiaso, BSN, MPH, RN

Novel Framework and Case Study to Support Scientific Rigor: A New Community-Focused Model for Sustainable Clinical Trial Participation
Patricia Davidson, MPA

Novel Framework and Case Study to Support Scientific Rigor: A New Community-Focused Model for Sustainable Clinical Trial Participation
Dawn Rotellini

Speakers

Patricia Davidson

PALADIN Consortium Director, Tufts Center for the Study of Drug Development, United States

Victoria DiBiaso

Global Head, Patient Informed Development and Health Value Translation, 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 →

Ellyn Getz

Director, R&D Partnerships, CSL Behring, United States

Ellyn Getz, MPH is the Director of R&D Patient Partnerships at global biotech CSL, where she gathers input into clinical development and operations from patients, care partners, health care professionals, and researchers, and she develops strategies to support patient engagement and... Read More →

Dawn Rotellini

Chief Operating Officer, National Bleeding Disorder Foundation, United States

Dawn Rotellini has been a leader in the bleeding disorders community for 27 years. As a parent of a son with Hemophilia, she founded the Rocky Mountain Bleeding Disorders Association in Bozeman, Montana, and served as its Executive Director. After moving to Pittsburgh, PA, she served... Read More →

Tuesday June 17, 2025 10:30am - 11:30am EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

05: Patient-Impact-Product-Dev, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Diversity Equity and Inclusion (DEI)
Tags Session

10:30am EDT

#221: Participant Compensation in Clinical Trials: Exploring Today’s Landscape and Unlocking Opportunities

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

201

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-568-L04-P; CME 1.00; RN 1.00

In a rapidly evolving clinical trial landscape, breaking down financial barriers is essential to foster participant enrollment, improve retention, and ensure the success of trials.

Learning Objectives

Identify key findings from DIA’s Participant Compensation Landscape Analysis and discuss their implications to promote diversity and support clinical trial outcomes; Recognize participant-centric strategies to address financial barriers in clinical research, enhancing diversity in trial participation; Discuss collaborative approaches to further understand participant compensation practices.

Chair

Carie Pierce, MS

Speaker

Moderator
Donna Libretti Cooke, JD

Panelist
James Lovett, JD

Contributor-Industry
Karen Correa, PhD

Contributor-Academia
Kenneth Getz, MBA

Speakers

Donna Libretti Cooke

Chief Impact Officer & Owner, ImpactSphere Clinical, LLC, United States

DONNA LIBRETTI COOKE, JD Chief Impact Officer & Owner ImpactSphere Clinical, LLC A compassionate pioneer driving clinical trial solutions for a healthier world. Donna is a strategic & collaborative Life Sciences professional with a ‘dive-in’ mindset and an extensive track record... Read More →

Karen Correa

Vice President, Clinical Development Operations, Boehringer Ingelheim, United States

Kenneth Getz

Tufts Center for the Study of Drug Development, Tufts University School of Medicine, 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 →

James Lovett

CEO, Myonex, United States

James Lovett is Chief Executive Officer and Board Member of Myonex Inc., a leading clinical trial supply company with operations in US, France, Germany and UK and distribution to 80 countries. Myonex partners with pharma and biotech companies, CROs, and other pharma service providers... Read More →

Carie Pierce

Global Head of Growth & Business Development, DIA, United States

Carie serves as Global Head of Growth for DIA. She comes to DIA with over 25 years in the Medical Device, Diagnostic, and Pharmaceutical industry. She has spent much of her career with Terumo Blood and Cell Technologies in various commercial leadership roles, including responsibility... Read More →

Tuesday June 17, 2025 10:30am - 11:30am EDT
201 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

Level Intermediate
Keyword Bioethics
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Bioethics
Tags Forum

10:30am EDT

#223: Transforming the Project Management Role to Meet the Emerging Needs in Pharma: Extending Scope from R&D Focus to Launch Projects

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

151B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-570-L04-P; CME 1.00; PDU 1.00 PMI 2166B7YYGZ; RN 1.00

This pilot expanded Project Manager (PM) from R&D to encompass launch activities, enhancing cross-functional collaboration and planning, stakeholder communication and alignment with country organizations. A PM covering the entire value chain drives project success.

Learning Objectives

Assess the impact of end-to-end coverage of projects, including commercialization, on project value; Integrate critical components of launch planning, including R&D, marketing, access, and medical tactics; Develop skills to enhance cross-functional collaboration among R&D and global and local commercial teams to improve project outcomes.

Chair

Andreas Sutter, PhD, MPharm, RPh

Speaker

Industry Perspective
Jo Ann Kerwin

Industry Perspective
Stacy Hurt, MBA, MHA

Speakers

Jo Kerwin

Senior Director Strategic Planning &. Operations, Jo Ann Kerwin, United States

Experienced global pharmaceutical senior director with over 30 years of pharma experience spanning early research, clinical operations, project, program, portfolio management and medical affairs. A solutionner who provides analytical and critical thinking skills to drive innovation... Read More →

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States

Stacy is a globally recognized advocate in patient communities, ensuring patients/caregivers voice their experience & feedback at early stages to improve drug development. She promotes clinical research accessibility for people with disabilities and equal access to better treatments... Read More →

Andreas Sutter

Senior Program Management Leader, Bayer AG, Germany

Andreas Sutter is a senior program management leader in the pharmaceutical industry, with expertise spanning from early research to product launches. He focuses on implementing R&D and commercialization strategies for oncology, especially radioligand therapies. His experience includes... Read More →

Tuesday June 17, 2025 10:30am - 11:30am EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

07: ProjectManagement-StrategicPlanning, Session

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

10:30am EDT

#224: FDA, MHRA, Health Canada Views on Data Flow: The Backbone of Effective Risk Assessments in Innovative Clinical Trial Design and Conduct

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

152AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-571-L04-P; CME 1.00; RN 1.00

Effective data management and risk mitigation are crucial for ensuring data quality, safety, and reliability. This session explores strategies to uphold these standards in cutting-edge trials.

Learning Objectives

Outline regulatory requirements for data quality, traceability, and reliability in trials with decentralized elements, adaptive designs, and RWD; Discuss case studies with complex data flows to highlight the importance of understanding data flow, conducting risk conducting risk assessments, and applying effective risk mitigation strategies.

Chair

Cheryl Grandinetti, PharmD

Speaker

Industry Perspectives
Michael Torok, PhD

Health Canada Perspective
Debbi Fox

MHRA Perspective
Jason Wakelin-Smith

Speakers

Debbi Fox

Compliance and Enforcement Specialist, Health Canada, Canada

Cheryl Grandinetti

Associate Director for Clinical Policy, CDER/OC/OSI/DCCE, FDA, United States

Dr. Grandinetti is the Associate Director for Clinical Policy within the Office of Scientific Investigations’ Division of Clinical Compliance Evaluation and provides leadership and subject matter expertise on policy issues related to GCP, human subject protection, and clinical trial... Read More →

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States

Michael Torok, Ph.D. is the Global Head of Quality Assurance Programs at Genentech/Roche. He is energized and driven by the mission of positioning Quality to be an accelerant in developing new therapeutics, rather than a guardrail or "policemen". To enable this shift, cross-functional... Read More →

Jason Wakelin-Smith

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

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

Tuesday June 17, 2025 10:30am - 11:30am EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

08: RD-Quality-Compliance, Session

Level Intermediate
Keyword Clinical Trial Design, Real-World Data (RWD) / Real-World Evidence (RWE)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Clinical Trial Design,Real-World Data (RWD) / Real-World Evidence (RWE)
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

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

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

Panelist
Amy Comstock Rick, JD

Panelist
Carolyn Shore, PhD

Panelist
Victoria Gemme, MBA, MS

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 Braga 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

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

11:40am EDT

#231 CH: Using Digital Protocols to Unlock Efficiency and Accelerate Clinical Trials

Tuesday June 17, 2025 11:40am - 12:10pm EDT

TBD

Component Type: Workshop
Level: Intermediate

Digitized protocols can support more efficient workflows and help clinical operations teams accelerate trials. This interactive session will discuss the benefits of protocol digitization along with strategies and opportunities for adoption.

Learning Objectives

Learn how digital protocols can reduce the time and effort needed to manage trials from end-to-end, ultimately accelerating trials and bringing drugs to market faster; Discover how digital protocols are already driving connections and efficiencies at research sites; Understand how industry peers are addressing protocol digitization, including challenges, opportunities, and learnings.

Speakers

Denise Meade

Vice President, Life Sciences and MedTech, Verily, United States

Tuesday June 17, 2025 11:40am - 12:10pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

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

Level Intermediate
Level Intermediate
format csv
Tags Workshop

1:00pm EDT

#238 CH: Navigating AI Regulation in Pharma: Global Trends, Compliance Challenges, and Harmonization Efforts

Tuesday June 17, 2025 1:00pm - 1:30pm EDT

L Street Bridge

Component Type: Workshop
Level: Intermediate

This session explores evolving AI policies, governance frameworks, and the path toward harmonized AI regulation to ensure safe, ethical, and effective AI adoption in pharma.

Learning Objectives

Analyze key global AI regulations and their impact on pharmaceutical R&D and compliance requirements; Distinguish between different regional AI regulatory frameworks and identify strategies for harmonizing AI governance across jurisdictions; Apply best practices for AI risk management, ethics, and lifecycle monitoring in pharmaceutical AI implementation.

Chair

Christina Mack, PhD, MPH

Speaker

Navigating AI Regulation in Pharma: Global Trends, Compliance Challenges, and Harmonization Efforts
Alex Asiimwe

Speakers

Alex Asiimwe

Head of RWE Generation & Partnerships, Gilead, United Kingdom

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 →

Tuesday June 17, 2025 1:00pm - 1:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

15: Content-Hubs, Workshop | 03: Data-Tech, Workshop

Level Intermediate
Level Intermediate
format csv
Tags Workshop

1:45pm EDT

#240: Has Decentralized Trials Crashed, or Are We Just Getting Started? An Inflection Point for Clinical Operations in Oncology

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

207A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-578-L04-P; CME 1.00; RN 1.00

Our industry is still mired in failing to adopt proven technology solutions until it becomes a reg necessity or mainstay of core operations. Industry change agents will present evidence that demonstrates we typically operate with lagging efforts.

Learning Objectives

Identify emergent solutions and innovative business practices that can enhance clinical trial operations; Evaluate the impact of adopting decentralized trials in oncology using the Beat AML Master Trial as a case study; Discuss how risk-taking and cross-sector practices can accelerate clinical trial success and improve patient outcomes.

Chair

Len Rosenberg, PhD, RPh

Speaker

Panelist
Joseph Dustin

Speakers

Joseph Dustin

Founder and Managing Partner, eClinical Consulting, United States

For almost 20 years, Joe has been a vocal and visible force in the Life Sciences industry specifically in the realm of eClinical Technology starting in the eCOA space, and most recently finishing up 12 year run with Medidata. He has worked with top Pharmaceutical, Biotech and CRO... 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 →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Forum

Level Intermediate
Keyword Clinical Trial Design
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Clinical Trial Design
Tags Forum

1:45pm EDT

#241: Updating Ethics: What’s New (and why it Matters!) in the 2024 Declaration of Helsinki Revision

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

204ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-579-L04-P; CME 1.00; RN 1.00

This session will review the 2024 revision of the Declaration of Helsinki, one of the foundational codes of clinical research ethics, and the rationale and practical implications of the changes made in the current version.

Learning Objectives

Discuss the history of the Declaration of Helsinki and its relevance and importance for the healthcare industry; Recognize the changes made in the 2024 version and how they will impact the conduct of biopharma clinical trials; Discuss multi-stakeholder efforts that are working towards operationalizing ethical principles in the DOH and where more collaboration and alignment is needed.

Chair

Melissa Heidelberg, MS

Speaker

Speaker
Karla Childers, MS

Speaker
Ann Meeker-O'Connell, MS

Speakers

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 →

Melissa Heidelberg

Director, Global Bioethics and Technology Ethics Lead, Takeda, United States

I am a Bioethicist by training with more than 20 years’ experience in industry across various global roles in Research and Development and Pre-competitive Industry Collaborations. I have a passion for evolving and implementing ethical frameworks to address emerging tensions at the... Read More →

Ann Meeker-O'Connell

Director, Office of Clinical Policy, FDA, United States

Ann Meeker-O’Connell is the Director of FDA’s Office of Clinical Policy in the Office of the Commissioner. In this role, she leads an organization that develops and implements cross-cutting policy related to clinical development and research ethics. Ms. Meeker-O’Connell has... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Session

Level Intermediate
Keyword Bioethics, Student Programming, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Bioethics,Student Programming,Global Perspectives
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1:45pm EDT

#242: Not all AI is Equal: Ensuring Reliable, Responsible AI to Accelerate Adoption, Innovation, and Impact

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

150AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-580-L04-P; CME 1.00; RN 1.00

As the potential of artificial intelligence (AI) is increasingly piquing the interest of researchers, it is critical to discuss how AI works by learning from the data, and how to leverage the results. Choosing the right approach for integrating AI into the research lifecycle can have a massive impact on likelihood of success. As one example, both generalized large language models (LLMs) and purpose build LLMs have their place in the toolkit needed to curate and analyze medical record and other patient data. This presentation will explore best practices/learnings for ensuring the right AI tool for the task, including LLMs tailored to the unique needs of pharmaceutical research; the impact for pharmaceutical research and for patients this can have; and imperatives for ascertaining the reliability and trustworthiness of AI solutions for medical research, as key to promoting adoption and responsible deployment in practice.

Learning Objectives

Identify key factors to consider when selecting AI strategies and methods for use in biomedical settings and pharmaceutical research; Describe the potential impact of AI strategies on research quality and patient outcomes, using real-world use cases and examples; Apply a framework to evaluate the suitability and readiness of AI technologies, such as large language models, for specific research or clinical applications.

Chair

Sarah Lyons, MSc

Speaker

Trust and adoption: ensuring the reliability of AI for Life Sciences applications
Patrick Michael Loerch, PhD

The right AI tool for the task: real world learnings and patient impacts from deploying LLMs in healthcare
Sarah Lyons, MSc

Deploying Large Language Models in Clinical Research: Practical Considerations from Real World Examples
Troy Astorino

Speakers

Alex Asiimwe

Head of RWE Generation & Partnerships, Gilead, United Kingdom

Troy Astorino

CTO, PicnicHealth, United States

Troy Astorino is the co-founder and Chief Technology Officer of PicnicHealth, where he leads the development of AI for conducting faster, more efficient, and more reliable clinical research. His team at PicnicHealth developed LLMD, the world’s highest-performing AI model for interpreting... Read More →

Patrick Loerch

Senior Vice President, Clinical Data Science, Gilead Sciences, Inc., United States

Patrick Loerch leads the Health Informatics dept within MRL-IT; focusing on establishing strategic partnerships, providing internal & external informatics support, and closely engaging with the external health informatics landscape. Mr Loerch earned a PhD in Biostatistics from Harvard... Read More →

Sarah Lyons

Head of Operations, Applied AI Science, IQVIA, Canada

Sarah Lyons is head of operations for IQVIA’s global Applied AI Science organization, empowering healthcare and life science organizations to unleash the full potential of AI, reliably and responsibly. She leads a team delivering award-winning platforms and deep expertise to help... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

03: Data-Tech, Session

Level Intermediate
Keyword Artificial Intelligence (AI)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI)
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1:45pm EDT

#244: How Medical Writing and Regulatory Strategy Can Support Accelerating the Development of Rare Disease Therapies: Insights from the FDA’s START Program Pilot

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

151A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-582-L04-P; CME 1.00; RN 1.00

This session will explore the FDA START program for accelerating rare disease therapies. Three speakers from companies involved in the START pilot and an FDA representative will provide insights.

Learning Objectives

Explain the objectives of the FDA START Program and its role in supporting rare disease development; Discuss how the cadence of medical writing and regulatory affairs shifts for those participating in the START program.

Chair

Robin Whitsell

Speaker

Panelist
Wei Liang, PhD

Panelist
Quyen Tran, PharmD

Panelist
Paulette Robinson, PhD, RAC

Panelist
Madiha Khalid, PhD

Panelist
Jhon Cores, PhD

Speakers

Jhon Cores

Associate Director, Medical Writing, Moderna, Inc, United States

Jhon is an Associate Director of Medical Writing at Moderna Inc., where he serves as the Medical Writing lead for various rare disease an oncology programs. He has 10 years of experience in the field working in different sectors, including university startups and contract research... Read More →

Madiha Khalid

Senior Director, Medical Writing, Larimar Therapeutics, United States

Madiha is a pharmaceutical industry professional with a background in fundamental bench research. Her experience as a regulatory medical writer working with small, mid-size, and large pharmaceutical companies over the past 10 years has given her an in-depth understanding of all phases... Read More →

Wei Liang

Pharmacologist, OTAT, CBER, FDA, United States

Dr. Liang is a Pharmacology/Toxicology Reviewer in the Office of Tissues and Advanced Therapies (OTAT) in the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). She joined OTAT in 2006. Her primary focus is the review of preclinical testing... Read More →

Paulette Robinson

Senior Director, Regulatory Affairs, Neurogene Inc., United States

Paulette Robinson, PhD, RAC is the Senior Director, Regulatory Affairs at Neurogene Inc. Her regulatory affairs experience has focused on gene therapies in rare central nervous system and ophthalmic indications. She continues to lead the global regulatory strategy for the NGN-401... Read More →

Quyen Tran

Science Policy Analyst, OND, CDER, FDA, United States

Dr. Quyen Tran is a Science Policy Analyst on CDER’s Rare Diseases Team. Dr. Tran joined the FDA in 2017 and has worked in the Office of New Drugs and Office of Medical Policy, CDER. She has notable experience in rare disease drug development, policy development and implementation... Read More →

Robin Whitsell

President, Whitsell Innovations, Inc., United States

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

04: MedAffairs-SciComm, Session

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

1:45pm EDT

#245: Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, and Signal Interpretation to Drive Impact

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

202A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-583-L04-P; CME 1.00; RN 1.00

This session examines the relationship between protocol complexity, participant burden, and enrollment challenges, alongside the development and impact of participant feedback questionnaires. Patient advisors and attendees will interpret results and discuss improvements in trial performance.

Learning Objectives

Discuss patient participation burden based on protocol design characteristics and requirements; Identify design elements driving elevated levels of burden and impacting clinical trial performance; Recognize how to manipulate results into practical improvements for clinical research projects; State the value of participant feedback and compose rationale for inclusion of feedback in future studies; Describe strategies to reduce and address clinical trial and portfolio-wide participation burden.

Chair

Lani Hashimoto

Speaker

Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, & Signal Interpretation to Drive Impact
Sabina Kineen

Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, & Signal Interpretation to Drive Impact
Patrick Gee, SR, PhD, MS

Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, & Signal Interpretation to Drive Impact
Stephanie Manson, PhD

Addressing Participation Burden in Clinical Trials: Primary Causes, Outcomes and Mitigation Strategies and Practices
Kenneth Getz, MBA

Speakers

Patrick Gee

Chief Executive Hope Dealer & Founder, iAdvocate, United States

As a Healthcare Consultant and Professional Global Patient Activist, Patrick has received numerous accolades, such as the American Society of Nephrology President’s Medal and Celeste Castillo Lee Lectureship in 2022, and the National Kidney Foundation’s Celeste Castillo Lee Patient... Read More →

Kenneth Getz

Tufts Center for the Study of Drug Development, Tufts University School of Medicine, United States

Lani Hashimoto

Consultant, Patient Experience, Hashimoto Consulting Services, United States

Dedicated to connecting patients to research, Lani's lived experience as a trial participant & as a caregiver further inspired her professional pursuits. She credits the Cystic Fibrosis Foundation as a key influence in her passion for patient experience & the importance of patient... Read More →

Sabina Kineen

Lived Experience Expert, Rare Disease Patient Advocacy, United States

Sabina Kineen is a dedicated patient advocate and speaker with a passion for equitable access to clinical trials and healthcare. As both a patient and caregiver, she brings a unique, lived perspective that drives her work in health literacy, patient engagement, and reducing disparities... Read More →

Stephanie Manson

Founder, Trial By Patient, United States

Dr. Manson is the author of the Study Participant Feedback Questionnaire (SPFQ) which has been implemented across the Transcelerate network to collect quantitative feedback on the patient experience. She is also the founder of Trial By Patient, a structured approach to receiving patient... Read More →

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

Level Intermediate
Keyword Patient Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Patient Experience
Tags Forum

1:45pm EDT

#246: US Executive Orders: Impact on Precision Medicine and Diagnostic Development

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

146BC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-584-L04-P; CME 1.00; RN 1.00

As of April 2, 2025, President Trump signed 103 Executive Orders in 2025 (EO 14147 to EO 14249) and sweeping government actions have led to widespread change in the health and biomedical research industries. Impacts on precision the effects of many of the Orders are largely unknown and tied up in legislative process. This has created considerable uncertainty for biomedical research and subsequent development of precision medicines and diagnostics. In this session we will review the 2025 Executive Orders, the court decision striking down the LDT Final Rule, and certain organizational changes at FDA that impact precision medicine and research and will delve deeper into the global impacts that are expected as a result.

Learning Objectives

List 2025 Executive Orders affecting personalized medicine and innovation in product and diagnostics development; Summarize impacts of 2025 Executive Orders on health innovation, research, regulations including the LDT final rule and patients; Discuss potential implications of current changes in the environment on global R&D.

Chair

Courtney Granville, PhD, MPH

Speaker

Panelist
Megan Doyle, JD, MPH

Panelist
Lia Ridout

Panelist
Carly McWilliams, MBA

Panelist
Nathan Brown, JD

Speakers

Nathan Brown

Partner, Akin Gump Strauss Hauer & Feld LLP, United States

Nathan Brown leads the FDA practice at Akin LLP. Drawing upon his diverse health care industry and governmental experience, Nathan provides his clients with strategic, practical advice on cutting-edge regulatory, compliance, enforcement, and policy matters. He has worked extensively... Read More →

Megan Doyle

Associate Vice President, Assistant General Counsel - Diagnostics, Eli Lilly & Company, United States

Megan Doyle is an attorney and policy professional with 15 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public health... Read More →

Courtney Granville

Chief Scientific Officer, GO2 For Lung Cancer, United States

Courtney Granville heads the Research Team at GO2 for Lung Cancer. In this role, she oversees GO2’s community engaged and clinical research efforts, the Lung Cancer Registry, and the LungMATCH program. She identifies areas of unmet clinical research need and develops innovative... Read More →

Carly McWilliams, MBA

Head of Regulatory Policy, Roche Diagnostics, United States

Lia Ridout

Patient Advocate, N/A, United States

Lia Ridout is a passionate survivor advocate in the lung cancer community. Diagnosed with stage 3b ALK+ non-small cell lung cancer in 2017, despite having no known risk factors, she became dedicated to advocating for patients. In recent years, she has expanded her focus to include... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

06: PersonalizedMed-ComboProd-Diagnostics, Session

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

1:45pm EDT

#247: Guerrilla Strategic Delivery

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

151B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-585-L04-P; CME 1.00; PDU 1.00 PMI 2166OM1274; RN 1.00

Traditional project management methodologies often burden teams with unnecessary complexity, slowing progress and stifling innovation. Guerilla Strategic Delivery explores bold, adaptive, and pragmatic approaches to project execution that cut through the noise and deliver real results. This session will challenge outdated frameworks, offering fresh strategies that meet teams where they are—maximizing efficiency, flexibility, and impact without the bureaucratic bloat. Whether you're leading a startup, managing cross-functional teams, or driving change within a large organization, you'll leave with actionable insights to streamline delivery and achieve strategic success on your terms.

Learning Objectives

Discuss implementing adaptive strategies to enhance project delivery by prioritizing impact over rigid processes; Identify ways to optimize workflows by streamlining complexity while ensuring strategic alignment and accountability; Describe ways to facilitate team empowerment by balancing structure and support with minimal bureaucracy; Apply innovative techniques to accelerate decision-making and improve problem-solving efficiency.

Chair

Sajida Roberson, MBA, MPH

Speaker

Short-Cycle Strategy: Adaptive Execution for High-Impact Delivery
Marina Kobiashvili, MA

Breaking the Waterfall: A Pragmatic Agile Approach in Drug Development Perspective - Applying Agile Principles in a Traditionally Rigid Lifecycle
Sean Ogle

Panelist
Jennifer Trevor, PhD, MS

Speakers

Marina Kobiashvili

Independent Consultant, United States

Sean Ogle

Senior Consultant, SEI Inc., United States

Sajida Roberson

Business Transformation, Independent Consultant, United States

Meet Sajida Roberson, a dynamic consultant blending strategic leadership with hands-on expertise to drive impactful business transformations. With a proven track record in global pharmaceutical companies, Sajida seamlessly transitioned from corporate strategy roles to independent... Read More →

Jennifer Trevor

Director-Global Category Lead- Development, Astellas, United States

Jen Trevor, PhD, combines scientific expertise with business acumen, driving innovation in pharma. With a PhD in Chemistry from the University of Illinois at Chicago, Jen began her career in biosensor research at Argonne National Laboratory and as a Forensic Chemist at the DEA. She... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

07: ProjectManagement-StrategicPlanning, Session

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

1:45pm EDT

#248: Embracing ICH E6(R3) with Risk-Based Quality Management

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

152AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-586-L04-P; CME 1.00; RN 1.00

Through use cases and maturity models, this session will focus on strategies and barriers to integrating RBQM in clinical trials.

Learning Objectives

Interpret key changes in ICH E6(R3) regarding RBQM and data governance; Implement key principles, components, and change management strategies for RBQM; Assess and benchmark organizational adoption of RBQM components.

Chair

Madeleine Whitehead

Speaker

Navigating the Future of Clinical Trials: Embracing ICH E6(R3) with Risk-Based Quality Management
Nicole Stansbury

New and Expanded Assessment of Risk-Based Quality Manangemnt Adoption: Assessing Implementation Progress and Impactased
Abigail Dirks, MS

Speakers

Abigail Dirks

Data Scientist, Tufts Center for the Study of Drug Development, United States

Abigail Dirks is a Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to all aspects of industry-funded drug development performance including protocol design complexity, investigative site... Read More →

Nicole Stansbury

Senior Vice President Global Clinical Operations, Premier Research, United States

Nicole Stansbury, Senior Vice President, Global Clinical Operations, joined Premier research in April 2023 where she has responsibilities covering study start up, site management and monitoring, central monitoring and clinical trial management. Nicole has been a lead for the ACRO... Read More →

Madeleine Whitehead

RBQM CoE - Head, Roche, United Kingdom

Madeleine Whitehead is the Head of Strategic Leads in the RBQM Centre of Excellence at Roche Pharmaceuticals. During her nearly 20 year career in the industry, she has worked in both pharma and CROs as a process and Good Clinical Practice (GCP) specialist. With a robust background... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

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

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
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
Patrice Verpillat, DrMed, MD, PhD, MPH

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

A Comparative Analysis of Data Quality Frameworks
Simon Bennett, MSc

Panelist
Rachele Hendricks-Sturrup, DrSc, MA, MSc

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 →

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

#250: Pediatric Cluster Town Hall

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

209ABC

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-588-L04-P; CME 1.00; RN 1.00

Representatives from pediatric cluster health authorities will describe the common deficiencies they see in global pediatric development programs and describe best practices and what to expect for those companies that seek a common commentary.

Learning Objectives

Describe common deficiencies in global pediatric development plans; Explain the process for obtaining a common commentary; Recognize topics that are discussed at monthly pediatric cluster calls.

Chair

Melodi J McNeil, MS, RPh

Speaker

PMDA Perspective
Junko Sato, PhD

EMA Perspective
Corinne de Vries, PhD, MA, MSc

Panelist
Franca Ligas

FDA Perspective
Dionna J. Green, MD

Australia Perspective
Robyn Langham, MD, PhD

Speakers

Dionna Green

Director, Office of Pediatric Therapeutics, FDA, United States

Dr. Dionna J. Green is Director of the US Food and Drug Administration Office of Pediatric Therapeutics, a congressionally mandated office whose mission is to assure access for children to innovative, safe, and effective medical products. She leads an organization responsible for... Read More →

Robyn Langham

Chief Medical Adviser, Australia Health Products Regulation Group, Australia

Professor Langham is the Chief Medical Adviser of the Therapeutic Goods Administration, the therapeutic goods regulator in Australia. A nephrologist by training, Prof Langham has spent much of their career as a clinician researcher, in translational studies and drug development.

Franca Ligas

Scientific Officer, Paediatric Medicines Office, European Medicines Agency, Netherlands

Franca Ligas serves as a Scientific Officer at the Paediatric Medicines Office of the European Medicines Agency (EMA), overseeing Paediatric Investigation Plans, particularly in oncology. Since 2021, she has led the Paediatric cluster from the EMA's side. Franca holds a medical degree... Read More →

Melodi McNeil

Director, Regulatory Affairs (Global Regulatory Lead, Oncology Early Development, AbbVie, United States

Melodi J. McNeil, R.Ph., M.S. Ms. McNeil is currently a Director in AbbVie’s Rockville, Maryland Regulatory Policy and Intelligence office. She identifies, assesses, and comments on proposed regulatory policies, and ensures appropriate AbbVie personnel are aware of emerging and... Read More →

Junko Sato

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

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

Corinne de Vries

Head of Translational Sciences Office, European Medicines Agency, Netherlands

Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. Throughout her career, she has worked in multinational and multicultural environments... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum

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

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, PhD

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

1:45pm EDT

#252: Harnessing Opportunities Through Inspection Reliance: A Path to Greater Efficiency

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

143ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-590-L04-P; CME 1.00; RN 1.00

During this session, speakers will share insights and recent experiences regarding the implementation of Inspection Reliance from both Regulatory Authorities and Industry perspectives, including unilateral reliance and work-sharing.

Learning Objectives

Identify Recent Trends in Reliance Applications for GMP Inspections and their impact on Supply Chain Sustainability; Describe Risk-Based Approaches for GMP Inspections by National Regulatory Authorities (NRAs); Discuss the modalities and documentation required by Regulatory Authorities for Reliance in GMP Inspections.

Chair

Maria Cristina Mota Pina, MBA

Speaker

Middle East and Africa Perspectives on Inspection Reliance- Panelist
Amira Deia Younes

ANVISA Perspective
Bianca Zimon, LLM

Pathways to Inspection Reliance: A 20 Year Journey
Andrea Kurz, RPh

Speakers

Andrea Kurz

Senior Director, Lead External Advocacy Europe & Middle East, F. Hoffmann-La Roche Ltd, Switzerland

Andrea Kurz is Senior Director, Lead External Advocacy for Europe and Middle East at Roche in Basel, Switzerland. She has +20 years’ experience in the Pharmaceutical Industry holding various positions in Quality & Compliance and Regulatory Affairs. Andrea is a Pharmacist and graduated... Read More →

Maria Cristina Mota Pina

Head, Regulatory Policy for Emerging Markets -Japan and Australia, AbbVie, United States

Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for the Emerging Markets. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad... Read More →

Bianca Zimon

Health Regulation Specialist, ANVISA, Brazil

Amira Younes

Director, Europe, Middle East & Africa (EMEA) Global Regulatory Policy, MSD, United Arab Emirates

Amira is the Global Regulatory Policy Director for Europe, Middle East, and Africa at MSD, with over 14 years of experience in regulatory science and policy. She is recognized as a thought leader in reliance, work sharing, and regional harmonization. Amira has built a strong network... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

10: RegCMC-Product Quality, Session

Level Intermediate
Keyword Regulatory Reliance
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulatory Reliance
Tags Session

1:45pm EDT

#253: Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint

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

144ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-591-L04-P; CME 1.00; RN 1.00

In this session, speakers will share their insight with case studies to demonstrate how the challenges have been addressed and introduce new methods for designing appropriate wining criteria for composite endpoint in small-sized clinical trials.

Learning Objectives

Recognize the pros/cons and challenges in designing clinical trials with composite endpoints; Discuss advanced methods and strategies for analyzing composite endpoints, including the impact of winning criteria and analysis methods via win ratio, win proportion and win scores; Apply different win ratio methods by scenarios and interpret results from real case examples of small-size.

Chair

Xiaoyu Cai, PhD

Speaker

Utilizing Win Ratio Approaches and Two-Stage Enrichment Designs for Small-Sized Clinical Trials
Jialu Wang, PhD

Application of Win Statistics in Non-Malignant Hematology
Wenquan Wang, PhD

Weighted Win Score Ratio – A Generalization of Win-Ratio Approach for Composite Endpoints with Continuous Components
Qian Tang, PhD

Speakers

Xiaoyu Cai

Insmed, Inc., United States

Xiaoyu Cai is an Associate Director, Biostatistics at Insmed, Inc. Prior to joining Insmed, she served for seven years as a Mathematical Statistician at the Center for Drug Evaluation and Research, Office of Biostatistics, within the U.S. Food and Drug Administration. She earned her... Read More →

Qian Tang

University of Iowa, United States

Qian Tang is a Ph.D. candidate in Statistics at the University of Iowa, specializing in machine learning, optimization, and statistical computation. Her research focuses on developing efficient algorithms for analyzing high-dimensional data, with applications in statistical learning... Read More →

Jialu Wang

Statistician, Vertex Pharmaceuticals, United States

Jialu is a senior biostatistician at Vertex Pharmaceuticals. She closely works with health economic and research and market access teams for reimbursements and HTA submissions of multiple therapies. She also works on late Phase 3b/4 studies. Her research interests include adaptive... Read More →

Wenquan Wang

Senior Director, Pfizer, United States

Wenquan got his PhD degree in Biostatistics from the University of Iowa. He was an assistant professor at University of Alabama at Birmingham before joining the pharmaceutical industry. He has over 20 years of experience in applying statistics in translational research and phase I-IV... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

11: Statistics-Data Science, Session | 02: ClinTrials-Ops, Session

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

1:45pm EDT

#254: Charting New Courses: Reshaping Opportunities and Breaking the Expert Mold in Career Development

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

206

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-592-L04-P; CME 1.00; RN 1.00

This session outlines an approach to developing technical experts into global leaders by breaking the "expert trap" and aligning talent development with organizational growth strategy.

Learning Objectives

Identify strategies for breaking the "expert trap" and enhancing career growth for technical talent; Recognize how to align talent development with organizational growth through strategic initiatives; Identify methods to cultivate a diverse leadership pipeline in life sciences.

Chair

Amber Meriwether, JD, MA

Speaker

Industry Perspective
Elizabeth Iorns, PhD

Industry Perspective
Michael Torok, PhD

Industry Perspective
Cecilia Zvosec

Speakers

Elizabeth Iorns

Science Exchange, CEO and Co-Founder, United States

Elizabeth Iorns, Ph.D., is the CEO and co-founder of Science Exchange. Science Exchange accelerates scientific discovery by enabling instant connections to the world’s best R&D facilities through a marketplace of pre-qualified and pre-contracted scientific service providers. Science... Read More →

Amber Meriwether

Corporate Strategy, Astellas Pharma, United States

Amber Meriwether is a global leader with 20+ years in healthcare, driving initiatives that accelerate innovation and deliver measurable impact. As Director of Corporate Strategy at Astellas Pharma, she leads cross-functional teams to develop strategic capabilities and deliver key... Read More →

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States

Cecilia Zvosec

Strategy & Insights, ZS, United States

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

12: ProfDevelopment, Session

Level Intermediate
Keyword Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics 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: 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

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

#261: Advancing Premarketing Safety Analytics through FDA and Industry Partnerships

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

207A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-593-L04-P; CME 1.00; RN 1.00

We will leverage the PHUSE Safety Analytics Education library and the recent AE Groupings in Safety (AEGiS) white paper to operationalize the FDA Medical Queries and Standard Safety Tables and Figures (ST&Fs).

Learning Objectives

Discuss how to operationalize FDA Medical Queries (FMQs) and Standard Safety Tables and Figures (ST&Fs) in safety reporting; Identify ways to use the PHUSE Safety Analytics Education Library to enhance safety analytics; Describe ways to leverage the PHUSE AE Groupings in Safety (AEGiS) white paper to improve adverse event groupings in safety analysis.

Chair

Greg Ball, PhD

Speaker

PHUSE AE Groupings in Safety (AEGiS) White Paper
Robert (Mac) Gordon, MS

PHUSE Safety Analytics Education Library
William Palo, MS

FDA Medical Queries (FMQs)
Linda Jeng, MD, PhD

Standard Safety Tables and Figures (ST&Fs)
Y. Veronica Pei, MD, MEd, MPH

Speakers

Greg Ball

Safety Data Scientist, ASAPprocess, United States

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

Robert (Mac) Gordon

Director, Biostatistics, Johnson & Johnosn Innovative Medicines, United States

Mac received a Masters in Statistics and graduate certificates in Public Health, Pharmacovigilance and Pharmacoepidemiology. He has been involved in pharmacovigilance, signal detection and data visualization for most of his career, including membership in several multi-disciplinary... Read More →

Linda Jeng

Associate Director for Biomedical Informatics, FDA, United States

Dr. Linda Jeng holds an MD and PhD in Cell and Molecular Biology from the University of Pennsylvania. She completed a residency in Pediatrics and Medical Genetics at Rainbow Babies and Children's Hospital and the University Hospitals of Cleveland, followed by a fellowship in Clinical... Read More →

William Palo

Director, Safety Statistics, AbbVie, United States

Bill has an MS in Applied Statistics from the University of Iowa and has been an industry statistician for over 30 years with over half that time dedicated to product safety. He is currently the therapeutic head of safety statistics for the late-stage oncology portfolio at AbbVie... Read More →

Y. Veronica Pei

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

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

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Session

Level Intermediate
Keyword Advanced Analytics
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Advanced Analytics
Tags Session

4:00pm EDT

#262: Overcoming Site Burden: Driving Adoption of Automation and End-to-End Integration

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

202A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-594-L04-P; CME 1.00; RN 1.00

This panel will discuss the importance of end-to-end support systems that connect trial management, data collection, and patient engagement. This panel will discuss the importance of end-to-end support systems that connect trial management, data collection, and patient engagement. The session will address the challenges sites face in adopting new technologies, from budget constraints to staff resistance, and the challenge of integrating automation into existing workflows.

Learning Objectives

Explain how automation and integration reduce site burden and improve trial efficiency; Identify compliance challenges in implementing automated systems; Discuss best practices for overcoming barriers to technology adoption.

Chair

Denise N Bronner, PhD

Speaker

Strategic Implementation of Automation
Amber Michelle Hill, PhD

Overcoming Resistance & Driving Adoption
Kimberly Tableman, MSc

Seamless Data Integration and Compliance
Cal Collins

Speakers

Denise Bronner

Founder & CEO, Empactful Ventures, United States

Denise N Bronner, Ph.D. has roughly 15 years of organizational thought leadership experience within the global healthcare space and has held various roles in academia, consulting, pharma, and venture capital. During her career, she has specialized in health equity, data-driven global... Read More →

Cal Collins

Chief Technology Officer, OpenClinica, LLC, United States

Cal co-founded OpenClinica with colleague Ben Baumann in 2006. He co-led a collaboration with an OpenClinica client and the FDA that won Bio-IT World’s 2022 Innovative Practice Awards for their work on the OneSource initiative integrating EHR and EDC systems. He has been active... Read More →

Amber Hill

Founder & CEO, R.grid, United Kingdom

Kimberly Tableman

Founder & CEO, Espero, United States

With a robust background in clinical development and a sharp focus on digital health, my journey has led me to found ESPERO, where we're revolutionizing drug development through insight-driven protocol design. At the helm of ESPERO, my team and I are committed to enhancing operational... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Forum

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

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
Maria Apostolaros, JD, PharmD, MS, RPh

Industry Perspective
Lesley Maloney, PharmD

Industry Perspective
Elizabeth Rosenkrands-Lange, MPH, MS

Speakers

Maria Apostolaros

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

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

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 →

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

#266: Opportunities for Innovation Under Fragmented Regulatory Framework for Clinical Development of Medicines and Diagnostics

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

204ABC

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-598-L04-P; CME 1.00; RN 1.00

This session will focus on evaluating key global regulatory challenges in combined clinical trials and harmonization of clinical practices to support medical research innovation.

Learning Objectives

Evaluate the challenges of conducting clinical studies in the US and Europe within a fragmented regulatory landscape; Describe how to analyze specific clinical trial challenges at the intersection of IVDR and CTR; Explain key solutions proposed by COMBINE project recommendations and outlining forward-looking strategies for successful implementation.

Chair

Adriana Racolta, PhD, RAC

Speaker

Pharma Industry Approaches to Harmonize Conduct of Trials Under Fragmented Global Regulatory Frameworks
Lauren Tobe, JD

Diagnostic Industry Perspective and Experience: Innovative Regulatory Approaches for Implementing Diagnostic Testing in Clinical Development of Medicines
Jennifer Tucker, MA

EMA Perspective
Stiina Aarum

Speakers

Stiina Aarum

Senior Scientific Specialist, Scientific Advice, Product Development Scientific, European Medicines Agency, Netherlands

Adriana Racolta

Director, Regulatory Affairs, Companion Diagnostics, Pfizer Inc, United States

Adriana Racolta, PhD is an industry professional with 12 years of experience in the field. As a Director of Regulatory Affairs at Pfizer Inc., she spearheads the company's efforts to implement diagnostic regulatory requirements in support of precision medicine development. In this... Read More →

Lauren Tobe

Director, Regulatory Policy and Strategy, Eli Lilly and Company, United States

Lauren Tobe serves as the Director of Regulatory Policy at Eli Lilly and Company where she focuses on advancing digital health technologies, artificial intelligence, and medical devices. Her role involves collaborating with industry leaders, regulators and other important stakeholders... Read More →

Jennifer Tucker

Global Head of Regulatory Affairs, Pathology Lab, Roche Diagnostics, United States

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

06: PersonalizedMed-ComboProd-Diagnostics, Forum | 09: Regulatory, Forum | 02: ClinTrials-Ops, Forum

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

4:00pm EDT

#267: Delivering Effective Business Transformations and How to Apply them to Drug Development

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

151B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-599-L04-P; CME 1.00; PDU 1.00 PMI 2166K30VP9; RN 1.00

Significant business transformations can be critical to achieve organizational vision and goals in an evolving landscape. In this session we will discuss how to effectively plan, execute and monitor significant business transformations.

Learning Objectives

Discuss the importance of business transformations in defining future-states and driving organizations forward; Explain how to effectively plan, execute and monitor business transformations; Describe how to apply business transformations to drug development.

Chair

Ashar Choudhry, MBA

Speaker

Delivering Effective Business Transformations and How to Apply them to Drug Development
Jason Eisfelder

Speakers

Ashar Choudhry

Executive Director, Enterprise Program Leadership & Operational Excellence, Bristol Myers Squibb, United States

Ashar Choudhry has over 25 years of experience within the BioPharma industry in leading transformational changes across a variety of major divisions and at the enterprise level. He is highly experienced in strategy development, business operations, operational excellence/process improvement... Read More →

Jason Eisfelder

DSO Practitioner, Bayer, United States

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

07: ProjectManagement-StrategicPlanning, Session

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

4:00pm EDT

#268: New Data and Insights on the Vendor Qualification Process in Drug Development

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

150AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-600-L04-P; CME 1.00; RN 1.00

Review and panel discussion of the results from a new Tufts Center for the Study of Drug Development (TCSDD) Working Group study assessing the vendor qualification and selection process

Learning Objectives

Discuss the prevailing approaches to vendor qualification in small, mid and large pharma organizations including the level of effort required and time taken; Describe the impact on drug development timelines; Recognize the point of view of clinical service providers from a time and cost standpoint; Identify how pharma companies and CROs are addressing qualification challenges.

Chair

Kenneth Getz, MBA

Speaker

Panelist
Neil McCullough

Panelist
Patty Leuchten

Panelist
Shyard Wong, DrMed

Panelist
Tran V. Huynh

Speakers

Kenneth Getz

Tufts Center for the Study of Drug Development, Tufts University School of Medicine, United States

Tran Huynh

Director, Clinical Vendor Strategy, Fortrea, United States

Patty Leuchten

Founder and CEO, Diligent Pharma, United States

Patricia Leuchten is the Founder and CEO of Diligent Pharma, a quality and compliance organization with tech-enabled service offerings that help mitigate risk in clinical trials. Leuchten has over 30 years of experience as a business owner and entrepreneur in the pharmaceutical industry... Read More →

Neil McCullough

Executive Vice President, Clinical Quality and Compliance, IQVIA, United States

Dr. McCullough has vast experience leading global quality and compliance teams within the industry. His expertise in quality assurance, regulatory affairs, risk-based auditing, continuous improvement, and project management are relied upon by PPD and its clients to achieve high quality... Read More →

Shyard Wong

Global Head, Clinical Quality and Continuous Improvement, Sanofi, France

A physician by training who graduated from the National University of Singapore in 1991, Shyard Wong rotated through a series of clinical postings in both the public and private healthcare sectors in Singapore and then undertook a career switch to become a full time healthcare administrator... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

08: RD-Quality-Compliance, Forum

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

4:00pm EDT

#269: Pharmacovigilance Inspections Fireside Chat

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

152AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-601-L04-P; CME 1.00; RN 1.00

A rare opportunity to hear inspectors from three global regulators and a European industry association compare and contrast common compliance trends, hot topics, legislative updates, future conduct of inspections, and global collaboration efforts. It is well recognized that pharmacovigilance is a global activity; however, the regulation of pharmacovigilance (PV) still occurs very much at a country-specific level. Regulation is enforced by inspectors in each country which results in organizations being inspected frequently by multiple regulators. Inspectors from three global world-renowned regulatory agencies (US FDA, Health Canada, UK MHRA) will come together in this fireside chat in a rare opportunity to hear inspectors’ perspectives and how they can envision working together to ensure the systems in place are adequately capturing safety issues. The regulator perspective will be complemented by industry views from the European Federation of Pharmaceutical Industries and Associations (EFPIA). Discussions will focus on differences and similarities in inspection styles and requirements across the three regulators, including inspector expectations and conduct of inspections. You will have the opportunity to hear from inspectors about key emerging issues. Common inspection trends will be discussed highlighting areas where inspectors see compliance issues across all three regulators. There will be a chance to hear from the panel discussing the future of inspections, including hot topics such as AI and new initiatives in each of the respective regions . Discussions will also focus on collaboration efforts, such as efforts to reduce burden on industry and looking into the future about upcoming best practices in pharmacovigilance. The audience will have a chance to pose questions to panel members to gain simultaneous insights from regulators and industry.

Learning Objectives

Distinguish commonalities and differences between pharmacovigilance regulations and inspections undertaken by three global regulators and understand their impact on industry; Discuss common trends from inspection deficiencies identified by the three regulators and gain tips on improving compliance; Define areas of future direction for inspections and collaboration efforts in pharmacovigilance inspections globally.

Chair

Sophie Radicke, MSc

Speaker

Industry Perspective
Carrie Scott

FDA Perspective
Namita Kothary, PharmD, RAC

Health Canada Perspective
Stephane Berard, MS

Speakers

Stephane Berard

Interim Supervisor-Health Product Compliance East Unit, Health Canada, Canada

Stéphane is acting supervisor for the Health Product Compliance East Unit at Health Canada since 2022. He joined the organization in 2012 as an inspector and he had been involved in various compliance and enforcement activities for drugs and natural health products. In 2016, he became... Read More →

Namita Kothary

Associate Director, DEPS, OSI, OC, CDER, FDA, United States

Namita Kothary, PharmD, RAC (US) currently serves as Associate Director of Scientific Affairs within FDA-CDER's Office of Scientific Investigations - Division of Enforcement and Postmarketing Safety, where she develops and executes strategies for international collaborations and outreach... Read More →

Sophie Radicke

Head of GPvP and Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Sophie is the Head of the MHRA GPvP Compliance Team and a senior pharmacovigilance inspector. She became an inspector 2018 and has since led a number of complex and technically diverse inspections. In her current role, she is responsible for ensuring the operational delivery of pharmacovigilance... Read More →

Carrie Scott

Head, Global PV Compliance and Policy, Pharmacovigilance and Patient Safety, AbbVie Ltd, Portugal

Responsibility to lead the strategic positioning & direction of Pharmacovigilance (PV) quality & compliance across AbbVie's global PV QMS. Act as an expert in critical assessment & interpretation of PV compliance regulations, and consequential internal PV policy and process determination... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

08: RD-Quality-Compliance, Forum | 01: ClinSafety-PV, Forum

Level Intermediate
Keyword Regulator Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulator Perspectives
Tags Forum

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
Julia Djonova

Panelist
Dianliang Lei

Panelist
Yasuhiro Kishioka, PhD

Panelist
Caroline Pothet, PharmD, RPh, RAC

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 →

Dianliang Lei

Scientist of Technology, Standard and Norm, World Health Organization (WHO), Switzerland

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

Sr. Dir, 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

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

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

4:00pm EDT

#273: Regulatory Cooperation Between US and Japan

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

Salon C

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-678-L04-P; CME 1.00; RN 1.00

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Washington, D.C. Office in November, 2024 for one of the purposes of strengthening regulatory cooperation between U.S. and Japan. After the establishment of the Office, direct communication and practical cooperation at D.C. time make possible, and it is also possible to make the foundation of regulatory cooperation. This session will explore the purpose behind the establishment of PMDA’s Washington, D.C. Office and its role in strengthening U.S.-Japan regulatory cooperation. Representatives from PMDA and FDA will share their perspectives on collaborative opportunities, followed by a panel discussion on how this initiative can enhance global regulatory alignment and communication.

Learning Objectives

Analyze the strategic purpose behind the establishment of PMDA’s Washington, DC Office and evaluate its role in enhancing regulatory cooperation between the US and Japan; Engage in a panel discussion to identify and propose opportunities for collaborative initiatives between PMDA and FDA that support global regulatory alignment and improved international communication.

Chair

Naoyuki Yasuda, MSc

Speaker

Panelist
Richard Pazdur, MD

Panelist
Akihiro Ishiguro, PhD

Panelist
Mark Abdoo

Panelist
Yasuhiro Fujiwara, MD, PhD

Speakers

Naoyuki Yasuda

Pharmaceuticals and Medical Devices Agency, Japan

Mr. Naoyuki Yasuda graduated from Osaka University in 1991. He careered industrial policy, industrial chemicals assessment, medical devices revaluation, international cooperation on narcotics and psychotropics, blood/blood product safety and vaccine supply and overall pharmaceuticals... Read More →

Yasuhiro Fujiwara

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

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

Akihiro Ishiguro

Head of PMDA, Washington D.C. Office, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Akihiro Ishiguro, PhD is the Head of Pharmaceuticals and Medical Devices Agency (PMDA) Washington D.C. Office. His work at PMDA began in 2004 when PMDA was established, allowing him to experience the contribution of post marketing drug safety, new drug review, review management... Read More →

Mark Abdoo

Associate Commissioner for Global Policy and Strategy, FDA, United States

Richard Pazdur

Director, Oncology Center of Excellence, CDER, FDA, United States

Richard Pazdur, MD, is founding director of the FDA Oncology Center of Excellence since 2017. He joined FDA in 1999 as director of the Division of Oncology Drug Products and led consolidation of cancer drug review divisions in 2005. He earned a BS from Northwestern University (1973... Read More →

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

09: Regulatory, Forum

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

4:00pm EDT

#274: Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk

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

143ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-605-L04-P; CME 1.00; RN 1.00

The pharmaceutical industry faces challenges due to global regulations. Structured data and cloud platforms can facilitate global collaborations. Visualizing the control strategy can enhance understanding of patient benefit-risk.

Learning Objectives

Recognize how CMC structured data enhances collaboration between industry and health authorities via cloud-based platforms; Discuss the concepts of IDMP and PQ/CMC and their roles in product quality discussions; Illustrate how an overall control strategy supports efficient product quality communication.

Chair

Ciby Joseph Abraham, PhD

Speaker

Panelist
Katie Duncan, PhD

Panelist
David Sidney Ross, MBA, MSc, PMP, RAC

Panelist
Vada Perkins, DrSc, MSc

Panelist
Omar Serang

Speakers

Ciby Abraham

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

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

Katie Duncan

Director, CMC Policy and Advocacy, GSK, United States

Katie Duncan is a Director of CMC Policy and Advocacy with Global Regulatory Affairs/CMC Excellence. Prior to joining GSK, Katie was a senior pharmaceutical quality assessor with the Office of Pharmaceutical Quality at the US Food and Drug Administration. She previously worked in... Read More →

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 →

David Ross

Senior Director, Regulatory Data and Submissions, AstraZeneca, United States

David Ross (Senior Director, Regulatory Data and Submissions, AZ) has undergraduate degrees in Chemical Engineering, and Biochemistry with an MBA and Engineering Management graduate degrees. He led global complex Business Transformation projects in the Pharmaceutical and Biologics... Read More →

Omar Serang

Chief Cloud Officer, DNAnexus, United States

General Manager and Lead Architect for DNAnexus' Regulatory Solutions. Expertise working at the intersection of cloud technology, genomic science, and regulatory science. Leading the vision and formation of Trusted Regulatory Spaces (TRS) in the cloud for global regulatory stakeholder... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

10: RegCMC-Product Quality, Session

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

4:00pm EDT

#275: Externally Controlled Trials in Clinical Development: Challenges and Mitigation Strategies

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

144ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-606-L04-P; CME 1.00; RN 1.00

Externally controlled clinical trials emerges as a viable alternative to traditional RCTs but come with risks such as confounding and bias. This session will focus on discussing these challenges and how to mitigate them via design and analysis.

Learning Objectives

Identify and describe various sources of bias in externally controlled clinical trials, and illustrate their impact on causal effect estimation; Explain statistical methods developed to estimate causal treatment effect from externally controlled trials; Discuss regulatory perspectives on the use of external controls for drug development and registration.

Chair

Xiang Zhang, PhD

Speaker

Externally Controlled Trials in Oncology: Regulatory Considerations and a Case Example
Arup Sinha, PhD

Panelist
Charles Lee, MBA, MS

An EU Regulatory Perspective on External Controls
Andrew Thomson, PhD, MA, MS

Uncovering the Challenges of Utilizing RWE in Regulatory Decision Making: Barriers, Mitigations and Future Directions
Ran Duan, PhD

Speakers

Ran Duan

Director Biometrics, Vertex Pharmaceuticals, United States

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 →

Jingyu (Julia) Luan

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

Dr. Jingyu (Julia) Luan is an Executive Regulatory Science Director in AstraZeneca, overseeing the global regulatory strategy and supporting the research, development and commercialization of CVRM products. She is a core member of CVRM Regulatory Leadership Team. Prior to AZ, she... Read More →

Arup Sinha

Statistician, OTS, CDER, FDA, United States

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 →

Xiang Zhang

Head of Medical Affairs and HTA Statistics/Co-lead FORExcellence, CSL Behring, United States

Xiang Zhang is the Head of Medical Affairs and HTA Statistics and a co-lead of the Forum for Observational Research Excellence at CSL. He leads a team of statisticians, epidemiologists, and RWE scientists to support RWE generation across drug life cycle including clinical development... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

11: Statistics-Data Science, Session | 02: ClinTrials-Ops, Session

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

4:00pm EDT

#277: Getting the Work of Medicines Development and Manufacturing Done by Hook or by Crook: Attracting, Retaining and Developing Key Talent in the New World of Work

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

201

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-608-L04-P; CME 1.00; RN 1.00

This session will present two contrasting approaches to workforce development which address the challenges in attracting and retaining the ideal talent. First, what can pharma learn from other industries who have developed a remote, agile and on-demand talent base responsive to changing needs. Second a case study in meeting the challenge of extraordinary growth in product pipeline and expansion by implementing an integrated, multi-faceted, workforce development ecosystem in collaboration with academic institutions and other manufacturing companies that also builds and sustains the local economy.

Learning Objectives

Discuss how to maximize agility and attract the best talent to get the critical work of drug development and manufacturing done; Identify novel approaches to developing and retaining a skilled workforce capable of meeting the needs of a highly regulated industry; Recognize how the organization can achieve unprecedented agility by embracing the Future of Work tools and methodologies.

Chair

Denyse Baker, RAC

Speaker

Far Beyond Remote Work: NASA, The Ford Motor Company, and The New World of Work - Opportunities for Pharma
Sheila Mahoney Jewels, MBA

Transforming Talent: Leveraging Partnerships for Biopharma Success
Dedric Day

Speakers

Denyse Baker

Assoc. Vice President Global Quality Compliance, Eli Lilly and Company, United States

Denyse Baker is Associate Vice President of Global Quality Compliance with Lilly. She has more than 35 years of experience in the pharmaceutical industry including leadership roles with AstraZeneca, US FDA and PDA. Denyse’s expertise includes policy development, external engagement... Read More →

Dedric Day

Senior Director- Strategic Talent Partnerships, Eli Lilly and Company, United States

Dedric Day has worked at Eli Lilly and Company for 22 years since graduating with a bachelor’s degree in chemical engineering from Rose-Hulman Institute of Technology. He has held leadership roles in engineering, operations, and technical services/manufacturing sciences in manufacturing... Read More →

Sheila Mahoney Jewels

Drug Development Multi-Functionalist, LifeSciHub , United States

Life sciences R&D Ecosystem Expert, Independent Small Business and Workforce Advocate, Software Platform Developer and Investor. Focus areas include: Regulatory and Clinical Operations, Strategic Patient Engagement, CMC, Real World Evidence, Pharmacovigilance, and Biometrics, Medical... Read More →

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

12: ProfDevelopment, Session

Level Intermediate
Keyword Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Student Programming
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