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Tuesday, June 16
 

10:15am EDT

#513: Advancing Chronic Disease Development: Insights from FDA, EMA, PMDA, and MHRA
Tuesday June 16, 2026 10:15am - 11:30am EDT
201AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-565-L04-P; CME 1.25; RN 1.25

Chronic Disease Town Hall spotlights emerging programs and global initiatives for chronic disease drug development, outlines the current landscape, explores opportunities and challenges, and assesses strategies to boost efficiency and accelerate therapeutic innovation.

Learning Objectives

Discuss the present landscape, opportunities, and challenges of chronic disease drug development; Describe emerging programs and global initiatives designed to facilitate development of chronic disease drugs; Assess various considerations and strategies to enhance the efficiency of chronic disease drug development.

Chair

Jingyu (Julia) Luan, PHD

Speaker

Panelist
Steffen Thirstrup, MD, PHD

Panelist
Alison Cave

Panelist
Maria Vassileva, PHD

Panelist
Ayaka Kubota, RPH


Speakers
avatar for Alison Cave

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Dr Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA), with responsibility for the safety of medicines and medical devices in the UK. She holds a BSc (Hons) and PhD from the University of London and has extensive academic and regulatory... Read More →
avatar for Ayaka Kubota

Ayaka Kubota

Office of Safty II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
She is a reviewer at the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. She is involved in the scientific review of pharmaceuticals, primarily focusing on cardiovascular drugs and treatments for Alzheimer’s disease, with an emphasis on clinical evaluation and regulatory... Read More →
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

Executive Regulatory Science Director, AstraZeneca, United States
Dr. Luan is currently the Executive Regulatory Science Director at AstraZeneca (AZ), where she oversees all regulatory aspects of obesity and diabetes drug development and supports the research, development, and commercialization efforts in these disease areas. She also leads the... Read More →
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s... Read More →
avatar for Maria Vassileva

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States
Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session

10:15am EDT

#512: Enhanced Analytical Procedure Development: Principles, Prior Knowledge, and Change Management
Tuesday June 16, 2026 10:15am - 11:30am EDT
202AB
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-562-L04-P; CME 1.25; RN 1.25

This workshop will focus on the principles of enhanced analytical procedure development, and use of prior knowledge in creating robust methods. It will include industry case studies, a regulator’s perspective, and a debate-style panel. Part 2 of this workshop is Future of Enhanced Product Development: Enabled through new ICH guidelines scheduled for Wednesday, June 17 at 10:15AM ET.

Learning Objectives

Describe ICH Q14 and the principles of analytical procedure development and lifecycle management; Apply enhanced approaches to analytical procedure development through the use of prior knowledge; Discuss health authority expectations for submission of information regarding enhanced analytical procedure development and lifecycle management.

Chair

Bryan Castle, PHD

Speaker

Exploring the Principles of Enhanced Analytical Procedure Development Emphasizing the Role of Prior Knowledge in Designing Robust Methods
Nina S. Cauchon, PHD

Panelist
Julie Armitstead

Panelist
Gary McGeorge


Speakers
JA

Julie Armitstead

Principal Scientist, Pfizer, United States
avatar for Bryan Castle

Bryan Castle

Associate Vice President, Synthetic Molecule Design & Development, Eli Lilly and Company, United States
Dr. Castle is a technical leader in Eli Lilly & Company's Synthetic Molecule Design and Development organization. He has been part of the Lilly team for over 25 years and has held many different roles in drug substance and drug product analytical development. He currently is engaged... Read More →
avatar for Nina Cauchon

Nina Cauchon

Director Regulatory Affairs CMC, Amgen, United States
Nina S. Cauchon, PhD, leads external engagement and advocacy for RA-CMC at Amgen Inc. She has experience leading both early phase & commercial programs, including small molecules and biologics. Her areas of interest are regulatory harmonization including collaboration, regulatory... Read More →
GM

Gary McGeorge

Director for PAT, Bristol Myers Squibb, United States
Tuesday June 16, 2026 10:15am - 11:30am EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Workshop

1:45pm EDT

#533: Is Your AI Ready to Scale? Build the Governance Backbone for Reliable Innovation and Trust
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
111AB
Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-573-L04-P; CME 1.25; RN 1.25

AI pilots are everywhere; enterprise impact is rare. Governance separates AI that works once from AI that works reliably. Join pharma, regulator, and tech leaders to explore how data ownership, content models, and process controls enable trustworthy AI.

Learning Objectives

Explain why scalable AI requires foundational data, content, and process governance; Design governance mechanisms that align data standards (IDMP, CDISC) with structured content management principles; Evaluate regulatory expectations and industry hurdles related to data integrity, reliance, and trust in AI-driven or assisted processes; Assess and address organizational gaps that limit AI deployment.

Chair

Vanni Carapetian, MPH

Speaker

Industry Perspectives on AI + Governance: Policy
Andrew Robertson, JD, PHD

Industry Perspectives on AI + Governance: Tech
Jeff Steinke

Industry Perspectives on AI + Governance
Vada Perkins, MS


Speakers
avatar for Vanni Carapetian

Vanni Carapetian

Senior Director, Regulatory Data, Genentech, A Member of the Roche Group, United States
Vanni brings nearly 20 years of life sciences and technology expertise drawn from team and leadership roles at Roche, J&J, and Amgen. Their experience spans clinical development, manufacturing, and regulatory and their principal interest lies in setting and executing strategies that... Read More →
avatar for Vanni Carapetian

Vanni Carapetian

CMC RA, Strategy and Operations, Executive Director, Gilead Sciences, Inc, United States
Vanni brings nearly 20 years of life sciences and technology expertise drawn from team and leadership roles at Roche, J&J, and Amgen. Their experience spans clinical development, manufacturing, and regulatory and their principal interest lies in setting and executing strategies that... Read More →
avatar for Vada Perkins

Vada Perkins

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

Andrew Robertson

Vice President, Head of Global Regulatory Policy and Innovation, Takeda, United States
Andrew Robertson, PhD, JD, is Vice President and Head of Global Regulatory Policy & Innovation at Takeda. He leads Takeda’s global regulatory science and policy agenda, shaping engagement with FDA, EMA, PMDA, WHO, and other authorities, and guiding strategy on initiatives such as... Read More →
JS

Jeff Steinke

Founder, TE Digital Limited, United Kingdom
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session

1:45pm EDT

#540: Regulators Approach to Address Drug Shortages
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
115C
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-578-L04-P; CME 1.25; RN 1.25

Drug shortages are difficult to measure across healthcare systems and complex pharmaceutical supply chains. At this session, the FDA and their international regulatory counterparts will address the key aspects of drug shortages in their region and how real-world data are used to inform on shortages and their impact on patients.

Learning Objectives

Discuss recent regulatory updates related to drug shortages in the United States; Recognize how real-world data can be used to inform the identification, mitigation, and resolution of shortages; Describe how recent international collaboration efforts are helping to combat drug shortages.

Chair

Sema Hashemi, MS

Speaker

Panelist
Emily T. Thakur, RPH

Panelist
Grace Chai, PHARMD

Panelist
Gerald Dal Pan, MD, MHS


Speakers
avatar for Grace Chai

Grace Chai

Associate Director for Special Initiatives, OSE, CDER, FDA, United States
avatar for Sema Hashemi

Sema Hashemi

Senior International Policy Advisor, FDA, United States
Ms. Sema Hashemi is a Senior International Policy Advisor in the Office of Global Policy and Strategy (OGPS) within FDA’s Office of the Commissioner. Her portfolio focuses on bilateral and regional engagements with Canada, East Asia, the Pacific, Middle East and North Africa. Sema... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →
ET

Emily Thakur

Team Leader, Drug Shortage Staff, Office of the Center Director, CDER, FDA, United States
CDR Emily Thakur has been working with the Drug Shortage Program since February 2011. She joined the FDA in 1999, working in the Office of Generic Drugs. She then joined the Office of Regulatory Policy in 2005. She received her Bachelor of Science degree from Rutgers College of Pharmacy... Read More →
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
115C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum

1:45pm EDT

#543: Global Regulatory Perspectives on Bayesian Design and Analysis Informing Regulatory Decision Making
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
116
Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-581-L04-P; CME 1.25; RN 1.25

Bayesian statistical methods are gaining increasing importance in drug development, with growing regulatory recognition across major global health authorities. Recent developments highlight this momentum: the U.S. Food and Drug Administration (FDA) released a draft guidance in early 2026 on the use of Bayesian methodology in clinical trials, while China’s Center for Drug Evaluation (CDE) issued a draft guidance in 2026 focused on Bayesian approaches for external data borrowing. In parallel, the European Medicines Agency (EMA) has published a concept paper and is currently seeking public consultation (Q1–Q2 2026) as a first step toward developing formal guidance. This session brings together key contributors to these regulatory initiatives to provide a unique, cross-regional perspective on the evolving role of Bayesian design and analysis in informing regulatory decision-making. Speakers will present the scope, principles, and current thinking reflected in their respective documents, as well as discuss areas of alignment, divergence, and ongoing uncertainty across regions. Given that all three agencies are actively shaping their positions, this session offers a timely opportunity for dialogue between regulators and industry. Through case examples and panel discussion, participants will gain insight into how Bayesian methods are being evaluated in practice, including considerations for trial design, external data integration, and evidentiary standards. The session will also highlight opportunities for stakeholder engagement, particularly in the context of EMA’s ongoing public consultation. Attendees will leave with a clearer understanding of global regulatory expectations and practical strategies for incorporating Bayesian approaches into drug development programs in a rapidly evolving regulatory landscape.

Learning Objectives

Summarize key elements of recent FDA (2026) and CDE (2026) draft guidances and EMA concept paper on Bayesian methods; Compare regulatory perspectives and areas of alignment and divergence across regions; Explain applications of Bayesian approaches in clinical trial design, analysis, and regulatory decision-making; Identify current expectations, implementation challenges, and opportunities for industry engagement in shaping future guidance.

Chair

May F Mo, MBA, MS

Speaker

Panelist
Juan Jose Abellan

Panelist
Andrew Thomson, PHD, MA, MSC


Speakers
JJ

Juan Jose Abellan

Statistician, Data Analytics and Methods Task Force, European Medicines Agency, Netherlands
avatar for May Mo

May Mo

Associate Vice President, Biostatistics, Amgen, United States
May Mo is an Associate Vice President of Biostatistics and the Head of Design and Innovation (D&I) group within the Center of Design and Analysis (CfDA) at Amgen. In her role, she leads an internal platform organization with specialized statistical expertise in areas such as Innovative... Read More →
AT

Andrew Thomson

Consultant, Regnitio, Netherlands
Dr Thomson is a consultant providing expert advice on clinical trial design, analysis and interpretation. He spent over 18 years as a regulator in the EU system, where he held a variety of quantitative roles, initially at the UK regulator, MHRA and subsequently at EMA. In his time... Read More →
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Forum |   02: ClinicalTrialOps-Innovation, Forum
  • Audience Advanced
  • Area Global Alignment in Practice
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Development & Operations
  • Feature Topics Global Alignment in Practice
  • Tags Forum

4:15pm EDT

#553: Latest in Combination Product Industry Trends: Development and Submission Strategies for Success
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
203AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-588-L04-P; CME 1.00; RN 1.00

Explore the latest combination product trends, sustainability in design, recent FDA/global guidelines, post-approval device changes, and emerging submission practices to help navigate the evolving regulatory landscape and achieve development success.

Learning Objectives

Discuss recent FDA and global guidelines (ICH Q1, ICH Q6, ICH M4Q) that inform effective control strategies & stability programs; Recognize how to manage post-approval changes for device constituents and focusing on best practices; State recent IND and submission trends (e.g., Human Factors, design verification, stability) and successful health authority interactions to accelerate therapies to patients.

Chair

Rumi Raquel Young, MS

Speaker

Panelist
Alan Stevens, MS

Panelist
James Bertram, PHD, MS, RAC

Panelist
Chelsea O'Connell, MS, RAC

Panelist
Katie Duncan, PHD


Speakers
avatar for James Bertram

James Bertram

Director, Office of Combination Products, OC, FDA, United States
James Bertram is currently the Director of the Office of Combination Products (OCP) in the United States Food and Drug Administration (FDA). OCP is responsible for the assignment of combination products to FDA’s medical product centers for review, helps coordinate timely, effective... Read More →
KD

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 →
avatar for Chelsea O'Connell

Chelsea O'Connell

Director, Global Regulatory Policy & Intelligence, Amgen, United States
Chelsea O’Connell, MS, RAC, joined Amgen in 2011 and is currently US Lead, Global Regulatory Policy & Intelligence, where she advances strategic regulatory policy goals by engaging with health authorities, industry, professional associations, and other stakeholders across various... Read More →
AS

Alan Stevens

Global Head, Complex Devices and Drug Delivery Systems, Abbvie, United States
Alan joined AbbVie as Global Head of Complex Devices and Drug Delivery Systems for RA Devices in October 2023. Prior to joining AbbVie, Alan worked at FDA/CDRH for 20 years as an expert in drug delivery devices and combination products. While at FDA, he led guidance development for... Read More →
avatar for Rumi Young

Rumi Young

Director, Regulatory Policy, Novo Nordisk A/S, United States
Rumi Young is the Director of Regulatory Policy at Novo Nordisk, ensuring future growth and innovation by promoting effective biopharmaceutical policies. Previously, she led BD’s Global Regulatory Policy team to shape future policies for medical devices, diagnostics, and combination... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session

4:15pm EDT

#557: Advancing Global Regulatory Harmonization for Cell and Gene Therapies: Enhancing Access and Innovation
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
115AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-591-L04-P; CME 1.00; RN 1.00

This session will explore scientific and regulatory considerations unique to cell and gene therapies (CGTs), emphasizing the urgent need for harmonization among health authorities globally. Participants will discuss regulatory challenges and examine opportunities for regulatory collaboration, including harmonization efforts led by the ICH Cell and Gene Therapy Discussion Group. The session will also cover recent efforts by regulatory authorities to streamline expectations for CGT manufacturing, showcasing best practices and flexible regulatory strategies that support faster development. Attendees will gain an understanding of current collaborative efforts and policy innovations shaping the future of CGTs worldwide.

Learning Objectives

Analyze global regulatory considerations and opportunities posed by current frameworks for cell and gene therapy products to drive innovation and increase patient access to medicines; Discuss work under international organizations, such as ICH, to align regulatory expectations and harmonize technical requirements; Evaluate recent regulatory approaches and best practices designed to streamline CGT manufacturing, and recognize policy initiatives shaping the advancement of CGTs.

Chair

Akanksha Kaushal, MS

Speaker

EMA’s role in Transforming CGT Innovation and Access
Patrick Celis, PHD

Industry Perspective on Driving Regulatory Alignment: Analyzing Regulatory Challenges and Identifying Needs and Opportunities for Convergence
D. Allen Callaway, II, MBA, MS

ICH Harmonization Efforts- The Cell and Gene Therapy Discussion Group
Lesbeth Caridad Rodriguez, MS

FDA Initiatives to Streamline CGT Manufacturing to Accelerate Development
Andrew Byrnes, PHD


Speakers
avatar for Andrew Byrnes

Andrew Byrnes

Director, Division of Gene Therapy 1, CBER, FDA, United States
Andrew P. Byrnes, PhD, is the Director of the Division of Gene Therapy 1 at FDA’s Center for Biologics Evaluation and Research. The Division of Gene Therapy 1 reviews manufacturing of gene therapy vectors, microbial vectors, cancer vaccines, oncolytic viruses, in vivo genome editing... Read More →
DA

D. Allen Callaway

Associate Director - Global Regulatory Affairs CMC, Johnson and Johnson, United States
avatar for Patrick Celis

Patrick Celis

Scientific Administrator, European Medicines Agency, Netherlands
Patrick Celis joined the European Medicines Agency (EMA) in 1997. He holds a degree in Pharmacy and a PhD in Pharmaceutical Sciences. P Celis is Lead Scientific officer in EMA’s ATMP Office and since December 2008, he is responsible for the Scientific Secretariat of the Committee... Read More →
avatar for Akanksha Kaushal

Akanksha Kaushal

Director, Science and Regulatory Advocacy, PhRMA, United States
Akanksha Kaushal, MS, is Director, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). She supports PhRMA’s work under the International Council for Harmonisation (ICH) as well as other global quality and manufacturing initiatives... Read More →
avatar for Lesbeth Rodriguez

Lesbeth Rodriguez

Director, Regulatory Affairs Policy and Science, Bayer, United States
Lesbeth Rodriguez is director of Regulatory Affairs, Policy and Science at Bayer. She leads Bayer’s global regulatory policy strategies for Cell & Gene Therapy. Ms. Rodriguez represented PhRMA in ICH working groups—including the Q13 Implementation Working Group and the Cell and... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session
 
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