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Wednesday, June 17
 

8:00am EDT

#600: From Breakthrough to Life: Engineered T-Cells, Patients, and the Future of Biotech
Wednesday June 17, 2026 8:00am - 9:00am EDT
114
Component Type: Session
Level: Intermediate

Following a keynote presentation by Bruce Levine on the future of genetically engineered T-cells for human therapeutics, sit down with Bruce and Brad Watts for a fireside chat. Through scientific, policy, and patient lenses, the session will examine what it takes to translate high-risk science into sustainable therapies, and what that implies for regulators, payers, sponsors, and technology partners.

Learning Objectives

Describe how advances in engineered T-cells, including CAR-T, are reshaping expectations for cancer treatment and the broader pipeline; Identify scientific, regulatory, and system conditions needed to translate high-risk engineered innovations into equitable, scalable patient benefit; Discuss how real patient and family experiences inform future strategies for regulators, payers, sponsors, researchers, and technology partners developing next-generation cell therapies.

Chair

Katie Truong

Speaker

Panelist
Bradley Watts

Plenary Presenter
Bruce Levine


Speakers
avatar for Bruce Levine

Bruce Levine

Barabara and Edward Netter Professor in Cancer Gene Therapy, Perelman School of Medicine at the University of Pennsylvania, United States
avatar for Katie Truong

Katie Truong

SVP & Managing Director, DIA Americas and Global Head of Business Operations, DIA, United States
Katie Truong is the Senior Vice President & Managing Director of DIA Americas and the Global Head of Business Operations. In her role, Katie focuses on driving growth, optimizing operations, and enhancing business performance. With experience spanning various industries, including... Read More →
avatar for Bradley Watts

Bradley Watts

Patient/Industry Advocate and Vice President, Business Development Executive, Emily Whitehead Foundation and Conner Strong & Buckelew, United States
Brad Watts is a cancer survivor and CAR-T therapy recipient, Brad is an active advocate with The Emily Whitehead Foundation and Blood Cancer United, and is a member of Act for Hope, which is working to expand patient access by collaborating across the healthcare ecosystem. Drawing... Read More →
Wednesday June 17, 2026 8:00am - 9:00am EDT
114 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session |   00: Plenary, Session |   18: Lift-Series, Session

10:15am EDT

#603: From Guidance to Practice: Regulatory and Stakeholder Views on Evaluating Risk Minimization Measures
Wednesday June 17, 2026 10:15am - 11:30am EDT
118AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-597-L04-P; CME 1.25; RN 1.25

Risk Minimization Measures (RMMs) target multiple healthcare stakeholders, and effectiveness varies by context. This session highlights guidance on their mixed-method evaluations, empirical examples, methodological advances, and insights from SmPC content analysis.

Learning Objectives

Discuss the US and EU regulatory rationale and expectations for RMM evaluations; Explain empirical examples where mixed-method evaluations altered interpretation of effectiveness compared with quantitative results alone; Discuss emerging methodological advances and data sources for meaningful patient safety outcomes.

Chair

Daniele Sartori, MSC

Speaker

Panelist
Gita Toyserkani, PHARMD, MBA

Panelist
Elaine Lippmann, JD

Panelist
Helga Gardarsdottir, FISPE

Panelist
Priya Bahri, PHD


Speakers
avatar for Priya Bahri

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
Priya Bahri, RPh, PostGradDipEpi, PhD, FISoP, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she oversees the developement of the EU Good Pharmacovigilance Practices (EU-GVP) and also instigates frameworks, research and... Read More →
avatar for Helga Gardarsdottir

Helga Gardarsdottir

Professor RWD for decision making on medicines, Utrecht University, Netherlands
Helga Gardarsdottir is professor in use of RWD for decision making on medicines at Utrecht University (NL). Since January 2025, she has also been serving as a Seconded National Expert in the Data Analytics and Methods Taskforce (RWE Workstream) at the European Medicines Agency. Her... Read More →
avatar for Elaine Lippmann

Elaine Lippmann

Principal, Leavitt Partners, United States
Elaine Lippmann, J.D., is a Principal at Leavitt Partners based on Washington, D.C., bringing more than 15 years of leadership experience at the U.S. Food and Drug Administration (FDA) and deep expertise in pharmaceutical regulatory policy to her client work. Elaine most recently... Read More →
avatar for Daniele Sartori

Daniele Sartori

Senior Pharmacovigilance Scientist, Uppsala Monitoring Centre (UMC), Sweden
Daniele is a senior pharmacovigilance scientist at Uppsala Monitoring Centre and a candidate for a DPhil in Evidence-Based Health Care at the University of Oxford. He has over 10 years of experience in pharmacovigilance, focusing on signal detection, regulatory decision-making, and... Read More →
avatar for Gita Toyserkani

Gita Toyserkani

Regulatory Strategy Lead, Perspective Pharmacovigilance, United States
Dr. Gita Toyserkani, PharmD, MBA, is Regulatory Strategy Lead at Perspective Pharmacovigilance, where she advises life sciences companies on regulatory strategy across drug safety, risk management, and benefit–risk assessment. She brings more than 20 years of experience at the U.S... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session |   10: Stats-EvidenceGeneration-RWE, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Safety & Pharmacovigilance,Biostatistics
  • Tags Session

10:15am EDT

#605: Bridging the AI Divide: Regulatory Trends, Industry Innovation, and the Future of AI in Pharma & Biotech
Wednesday June 17, 2026 10:15am - 11:30am EDT
109AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-602-L04-P; CME 1.25; RN 1.25

Artificial Intelligence is redefining pharma and biotech. This session contrasts AI-native and traditional models, examines FDA, EMA, and EU AI frameworks, and delivers strategies to ensure credible, compliant AI use in regulatory decision-making.

Learning Objectives

Differentiate between AI-native and traditional pharma/biotech models in drug development; Assess regulatory expectations for AI from FDA, EMA, and the EU AI Act; Apply strategies to establish AI model credibility for regulatory decision-making.

Chair

Mark Rutter

Speaker

Panelist
Graziella Collu, DRSC, MS, MSC

Panelist
Hussein Ezzeldin, PHD

Panelist
Donna Rivera, PHARMD, MSC, FISPE

Panelist
Megha Sinha


Speakers
GC

Graziella Collu

Vice President, Global Regulatory, AstraZeneca, Netherlands
avatar for Hussein Ezzeldin

Hussein Ezzeldin

Associate Director for Advanced Technologies, OBPV, OMP, CBER, FDA, United States
Dr. Ezzeldin is the Associate Director for Advanced Technologies in the Office of Biostatistics and Pharmacovigilance (OBPV), in the Center for Biologics Evaluation and Research (CBER). Dr. Ezzeldin supported multiple programs in previous roles, for example, leading the digital health... Read More →
avatar for Donna Rivera

Donna Rivera

Executive Vice President-Clinical Evidence Modernization, Canal Row Advisors, United States
Donna R. Rivera, PharmD., MSc., FISPE is the Associate Director for Pharmacoepidemiology in the Oncology Center of Excellence at the U.S. Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the regulatory review of Real World Data (RWD... Read More →
MR

Mark Rutter

Vice President, Regulatory Affairs, Formation Bio, United States
Mark Rutter is Vice President, Regulatory Affairs at Formation Bio, where he leads regulatory strategy across the development portfolio with a focus on innovative approaches to evidence generation. He brings extensive experience from leadership roles at Biogen, AbbVie, and Celgene... Read More →
MS

Megha Sinha

CEO, Kamet Consulting Group, United States
Wednesday June 17, 2026 10:15am - 11:30am EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Forum

10:15am EDT

#607: Preparing for the Future: From EU Legislative Reform to Digital Transformation and AI-Driven Efficiencies
Wednesday June 17, 2026 10:15am - 11:30am EDT
115AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-600-L04-P; CME 1.25; RN 1.25

This session will explore how regulators are preparing to implement the New EU Pharmaceutical Legislation turning the digital by default ambition into practice, combining legislative reforms with digital and AI strategies.

Learning Objectives

Describe the digital by default ambition of the New EU Pharmaceutical Legislation; Explain how digitalization and AI enable more agile, transparent, and patient-centered processes, that drive efficiency, productivity and innovation in regulatory science and operations; Discuss practical implementation challenges related to trust, quality, data interoperability, and organizational readiness.

Chair

Joaquim Berenguer Jornet, MS

Speaker

Panelist
Derick Mitchell

Panelist
Steffen Thirstrup, MD, PHD

Panelist
Gabriel Westman, MD, PHD, MSC


Speakers
JB

Joaquim Berenguer Jornet

AI Implementation lead, Digital Business Transformation Task Force, European Medicines Agency, Netherlands
Joaquim Berenguer is currently the AI implementation lead and supports the digital strategy of the European Medicines Agency. He is also the chair of the European Agencies Network Working Group on AI. Mathematician as background, Joaquim had led different data scientist teams during... Read More →
avatar for Jeppe G. Manuel

Jeppe G. Manuel

Data Science External Affairs & Intelligence Director, Novo Nordisk A/S, Denmark
Jeppe joined Novo Nordisk in 2015 and prior to his current role worked as a specialist in Clinical Reporting and Disclosure. He has 15+ years of experience from the pharmaceutical industry, primarily from Regulatory and Clinical working with Enterprise Content Management, Digitalisation... Read More →
DM

Derick Mitchell

Executive Director PFMD, The Synergist/Pfmd, Ireland
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 Gabriel Westman

Gabriel Westman

Head of Artificial Intelligence, Swedish Medical Products Agency, Sweden
GW is an infectious disease specialist and associate professor (MD, PhD), member of EMA/HMA Network Data Steering Group and EMA CHMP Methodology Working Party. He also has an MSc in Engineering with experience in bioinformatics, AI and big data applications within medicine and pharmaceutics... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session

10:15am EDT

#606: Enhancing Clinical Trial Oversight: Using Statistical Outlier Detection with Generative AI for Protocol Deviation Analysis
Wednesday June 17, 2026 10:15am - 11:30am EDT
107AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-601-L04-P; CME 1.25; RN 1.25

In this session, we demonstrate an integrated approach that uses bootstrap-based statistical outlier detection and generative AI to identify and characterize clinical investigator sites that underreport or overreport protocol deviations.

Learning Objectives

Describe the core principles of Gen AI and explain their relevance to clinical operations; Identify practical considerations for implementing AI for clinical trial oversight; Illustrate how combing a statistical bootstrap-based method with Gen AI can identify clinical investigator sites that significantly underreport or overreport clinical protocol deviations.

Chair

Ioannis Spyroglou, PHD

Speaker

Panelist
Roshan D'Souza

Bootstrapping and Simaerep: Statistical Outlier Detection in Protocol Deviation Reporting
Frederik Collin, MS

Operational Impact, Scaling, and Limitations: From Algorithm to Practice
Karin Jonczak


Speakers
FC

Frederik Collin

Senior Data Scientist, Boehringer Ingelheim, Germany
Frederik is a Data Scientist working at Boehringer Ingelheim developing advanced analytics solutions leveraging data in the GCP space. He has co-developed several statistical open-source tools and published scientific articles on quality statistics.
avatar for Roshan D'Souza

Roshan D'Souza

Head of Quality Excellence Digital, PDQ, Roche, United Kingdom
Roshan is currently the head of Quality Excellence Digital at Roche's Product Development Quality organisation. The utilisation of data analytics and digital technologies to unlock meaningful business outcomes has been a common thread since he started his career at Roche. An engineer... Read More →
avatar for Karin Jonczak

Karin Jonczak

Clinical Capabilities Lead, Director, Bristol Myers Squibb, United States
IS

Ioannis Spyroglou

Associate Director, Data Science, MSD, United States
Ioannis Spyroglou, Ph.D., is Associate Director, Data Science in QA Analytics and Digital Innovation at Merck, and is based in Prague, Czech Republic. He co-leads Generative AI initiatives and develops solutions for quality assurance across different quality functions. Previously... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   10: Stats-EvidenceGeneration-RWE, Session

10:15am EDT

#611: Future of Enhanced Product Development: Enabled Through new ICH Guidelines
Wednesday June 17, 2026 10:15am - 11:30am EDT
111AB
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-606-L04-P; CME 1.25; RN 1.25

This workshop will delve into how the science and risk-based approaches outlined in ICH Q2(2) and Q14 connect to emerging revisions in ICH Q1(R1) and Q6(R1), highlighting their combined impact on product control strategies.

Learning Objectives

Recognize how ICH guideline revisions influence analytical development in the future; Discuss the health authority view on impact that analytical measurements have on the development of the future products; Explain how to apply platform analytical procedures as a follow-up to Workshop 1.

Chair

Timothy Graul, PHD

Speaker

Shifting Analytical Procedure Development from a Reactive Activity into a Proactive, Strategic Pillar of Product Development
Margaret Ruesch, PHD

Shifting Analytical Procedure Development from a Reactive Activity into a Proactive, Strategic Pillar of Product Development
Philip Floyd, PHD

EMA Perspective on Connecting Analytical Procedure Development to Emerging Revisions in ICH Q1(R1) and Q6(R1) and Combined Impact on Product Control Strategies
Peter Richardson

ANVISA Perspective on Connecting Analytical Procedure Development to Emerging Revisions in ICH Q1(R1) and Q6(R1) and Combined Impact on Product Control Strategies
Carolina Lopes Krahn, MSC


Speakers
PF

Philip Floyd

Global Vice President, Analytical R&D, AbbVie, United States
Phil currently serves as Global VP, Analytical R&D within Development Sciences at AbbVie and previously spent 22 years at GSK with last role as Head of US Analytical Development. Phil received his PhD in Analytical Chemistry at U. of Illinois under Jonathan Sweedler, at Beckman Institute... Read More →
TG

Timothy Graul

Senior Director, Pfizer, United States
Timothy W. Graul is a Senior Director in the CMC Advisory Office at Pfizer Inc. He received his B.S. in Chemistry at James Madison University and Ph.D. in Analytical Chemistry at Florida State University. After completing studies, Tim joined Pfizer Analytical R&D and supported the... Read More →
CL

Carolina Lopes Krahn

Health Regulation Specialist, ANVISA, Brazil
Pharmaceutical professional with a degree in Industrial Clinical Pharmacy and a Master’s degree in Pharmaceutical Sciences. Has been working as Health Regulation Expert for Anvisa for over 12 years working as a drug product registration reviewer, quality management professional... Read More →
avatar for Peter Richardson

Peter Richardson

Senior Quality Specialist, European Medicines Agency, Netherlands
Dr. Richardson, a pharmacist with a Ph.D. in pharmaceutics from Queen's University Belfast, has extensive experience in formulation R&D with companies like Bristol-Myers Squibb, SmithKline Beecham, Pfizer, and Serono, focusing on drug delivery systems. He worked as a pharmaceutical... Read More →
MR

Margaret Ruesch

Vice President, Pfizer, United States
Margaret Ruesch is the Vice President of Analytical Research & Development, Biotherapeutics Pharmaceutical Sciences organization. Analytical R&D is responsible for developing in-depth product and process understanding, testing clinical trial materials, authoring investigational and... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Workshop

10:15am EDT

#614: Indonesia Town Hall 2026
Wednesday June 17, 2026 10:15am - 11:30am EDT
112AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-656-L04-P; CME 1.25; RN 1.25

Indonesia is advancing coordinated reforms across governance, regulation, and site readiness to achieve a four-months clinical trial start-up. This session highlights regulatory alignment, WHO recognition, ethics harmonization, and CRU transformation positioning Indonesia as a credible global research partner.

Learning Objectives

Describe Indonesia’s coordinated regulatory and governance reforms to accelerate clinical trial start-up; Explain the impact of WHO-Listed Authority recognition and ethics harmonization on global collaboration; Identify operational improvements at CRU level supporting trial readiness and execution.

Chair

Endang Wahjuningtyas Hoyaranda

Speaker

Panelist
Budi Gunadi Sadikin

Panelist
Taruna Ikrar, MD

INA-CRC: Harmonizing Indonesia's Clinical Research and Our Recent Achievements
Indri Rooslamiati Supriadi

Panelist
Nina Dwi Putri


Speakers
avatar for Endang Hoyaranda

Endang Hoyaranda

President, Indonesian Association For the Study of Medicinals (IASMED), Indonesia
Endang is currently the President of the Indonesian Association for the Study of Medicinals, aside from holding her responsibilities as President of Prodia Utama which is the holding company of Prodia Group, a Group of 8 healthcare companies including the largest health laboratory... Read More →
avatar for Taruna Ikrar

Taruna Ikrar

Chairperson, Indonesia Food and Drug Authority, Indonesia
Prof. dr. Taruna Ikrar, M.D., M.Biomed, Ph.D. Since August 2024, Prof. Ikrar brings exceptional expertise in pharmacology, cardiovascular science, and neuroscience to DIA's Annual Meeting. His remarkable journey spans education at Hasanuddin University, University of Indonesia, and... Read More →
avatar for Nina Dwi Putri

Nina Dwi Putri

Head of Sub-Unit Clinical Research Implementation, Clinical Research Unit Cipto Mangunkusumo Hospital, Indonesia
avatar for Budi Gunadi Sadikin

Budi Gunadi Sadikin

Minister, Ministry of Health, Indonesia
Mr. Sadikin was the Vice Minister I of State-owned Enterprises and tasked to establish market leading and globally competitive state-owned enterprises. From July 2020 until December, 22nd 2020, he lead the National Economic Recovery and Transformation Task Force amidst the COVID-19... Read More →
avatar for Indri Supriadi

Indri Supriadi

Head of BB Binomika (Parent Organization of INA-CRC), Indonesia Ministry of Health (MOH), Indonesia
Indri Rooslamiati Supriadi is Director of Indonesia’s National Center for Biomedical and Health Genomics and the Indonesia Clinical Research Center (INA-CRC) under the Ministry of Health. She leads national efforts in precision medicine and clinical research, streamlining regulations... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Regulatory
  • Tags Session

10:15am EDT

#612: Achieving Regulatory-Grade Pragmatism in Streamlined Trials Embedded in Clinical Practice
Wednesday June 17, 2026 10:15am - 11:30am EDT
102AB
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-610-L04-P; CME 1.25; RN 1.25

Randomized clinical trials embedded in routine care—when designed using Quality by Design principles—can generate regulatory-grade evidence that is scientifically rigorous, operationally feasible, and globally harmonized. This workshop will examine how pragmatic and hybrid RCTs can: Align with ICH E6(R3) expectations; Apply selective safety data collection under ICH E19; Incorporate decentralized elements consistent with FDA guidance; Advance FDA’s STEP demonstration objectives Participants will engage in a structured design exercise debating a pragmatic clinical trial in the obesity setting—contrasting a traditional “overbuilt” protocol with a streamlined, embedded alternative. Through moderated discussion, we will identify critical-to-quality factors, risk mitigation strategies, and the regulatory conversations necessary to support global implementation.

Learning Objectives

Apply Quality by Design principles under ICH E6(R3) to pragmatic RCTs in high-impact therapeutic areas; Evaluate where selective safety data collection (ICH E19) may or may not be appropriate in long-term obesity trials; Identify operational and safety risks unique to embedding obesity trials in routine practice—and propose mitigation strategies; Debate the tradeoffs between traditional and streamlined trial designs.

Chair

Kevin Bugin, MS, RAC

Speaker

Panelist
Mary Thanh Hai, MD

Panelist
Henry Wei, MD

Panelist
Zhanna Jumadilova, MD, MBA


Speakers
avatar for Kevin Bugin

Kevin Bugin

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

Mary Thanh Hai

Deputy Director for Clinical, OND, CDER, FDA, United States
Dr. Thanh Hai is the Director of the Office of New Drugs in the Center for Drug Evaluation and Research, overseeing the drug development programs for prescription and non-prescription drugs and therapeutic biologics. She is an internist/endocrinologist. She started her career at the... Read More →
avatar for Zhanna Jumadilova

Zhanna Jumadilova

Clinical Lead, Pfizer, United States
Dr. Jumadilova is a physician scientist, pharmaceutical executive with extensive industry experience in Clinical Development, Medical Affairs, and HEOR. In her roles as a senior leader, she has led numerous development programs. Her diverse experience in both large pharmaceutical... Read More →
HW

Henry Wei

Executive Director, Data, Technology & Innovation, Regeneron Pharmaceuticals, United States
Wednesday June 17, 2026 10:15am - 11:30am EDT
102AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Workshop |   02: ClinicalTrialOps-Innovation, Workshop

10:15am EDT

#613: FDA Rare Disease Town Hall
Wednesday June 17, 2026 10:15am - 11:30am EDT
201AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-609-L04-P; CME 1.25; RN 1.25

Senior FDA leaders will discuss evolving regulatory trends in rare disease development, including accelerated approval, innovative trial designs, patient engagement, and real-world evidence, followed by open Q&A with attendees.

Learning Objectives

Identify current FDA regulatory trends and scientific approaches shaping rare disease drug development; Apply FDA expectations around accelerated approval, surrogate endpoints, and innovative trial designs; Integrate patient voice and real-world evidence into development strategies to support benefit-risk assessment.

Chair

James Valentine, JD, MHS

Speakers
VK

Vijay Kumar

Acting Director OTP/CBER, FDA, United States
avatar for James Valentine

James Valentine

Director, Hyman, Phelps & McNamara, PC, United States
James Valentine advises medical product companies and patient advocacy organizations on regulatory strategy for the development and approval of drugs and biologics, with a focus on rare diseases. He has helped secure FDA approvals, and often works in areas without well-defined regulatory... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session |   02: ClinicalTrialOps-Innovation, Session

10:15am EDT

#616: How to Accelerate Utilization of Decentralized Clinical Trial: What are Issues to Perform Decentralized Clinical Trial?
Wednesday June 17, 2026 10:15am - 11:30am EDT
117
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-611-L04-P; CME 1.25; RN 1.25

Share the gap of Decentralized Clinical Trial (DCT) regulation in the EU, US and Japan. The speakers also touch how to overcome them. The session is helpful for sponsor which plan the trials.

Learning Objectives

Explain DCT regulations in Japan, the US, and Europe and how to overcome their differences.

Chair

Junko Sato, PHD

Speaker

DCT in Japan
Ruri Matsumoto, RPH

Experiences and expactation to DCT
Rasmus Enggaard, MPHARM, MSC


Speakers
RE

Rasmus Enggaard

Therapy Area Head, CardioRenal/Liver/RareD, Novo Nordisk A/S, United States
Rasmus Enggaard is the Therapy Area Head for CardioRenal, Liver, and Rare Diseases in U.S. Clinical Development & Operations at Novo Nordisk, where he is responsible for execution of a broad and complex clinical trial portfolio. His work focuses on operational excellence, scalable... Read More →
RM

Ruri Matsumoto

Office of Non-clinical and Clinical Compliance I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
avatar for Junko Sato

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 →
Wednesday June 17, 2026 10:15am - 11:30am EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Session |   02: ClinicalTrialOps-Innovation, Session

11:40am EDT

#618 CH: Regulatory Excellence as an Enabler for Sustainable Manufacturing in Africa
Wednesday June 17, 2026 11:40am - 12:10pm EDT
Content Hub
Component Type: Workshop
Level: Intermediate

This session will explore how regulatory system strengthening and harmonization can act as a catalyst for regional pharmaceutical manufacturing in Africa, ensuring access to quality-assured medicines and building a resilient health ecosystem.

Learning Objectives

1. Discuss the role of regional regulatory harmonization initiatives in reducing duplication, and improving patient access 2. Examine how collaboration between manufacturers and regulators can streamline product development, improve compliance, and reduce time-to-market for essential medicines 3. Share lessons learned to inform future efforts and actions to support supply chain resilience

Wednesday June 17, 2026 11:40am - 12:10pm EDT
Content Hub The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  12: Content-Hubs, Workshop

12:20pm EDT

#619 CH: The End of the Static Protocol: How Digital Blueprints Will Orchestrate the Next Generation of Clinical Trials
Wednesday June 17, 2026 12:20pm - 12:50pm EDT
Content Hub
Component Type: Workshop
Level: Intermediate

What if protocols weren’t documents - but executable trial blueprints? Learn how protocol digitization into structured USDM content, combined with clinical operational data, enables orchestration across systems to streamline and improve trials.

Learning Objectives

Identify how digital protocols and structured USDM models improve clinical operations and accelerate trial timelines through ecosystem orchestration. Evaluate how site operational data generates insights that streamline execution and improve protocol design. Learn how industry peers are approaching protocol digitization, including key challenges and lessons learned.

Wednesday June 17, 2026 12:20pm - 12:50pm EDT
Content Hub The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  12: Content-Hubs, Workshop

12:30pm EDT

#620 RT: Roundtable Discussion: Can You Complete Your Submission in 10 weeks?
Wednesday June 17, 2026 12:30pm - 1:30pm EDT
Zone B
Component Type: Session
Level: Intermediate

Join the Medical Writing Community for a follow up round table discussion tied to session: Can You Complete Your Submission in 10 weeks? (Wednesday, June 17 | 12:30pm - 1:30pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Steve Sibley, MS
Sharon Wolfe-Schwartz, MS

Speakers
avatar for Steve Sibley

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Veristat LLC, United States
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →
Wednesday June 17, 2026 12:30pm - 1:30pm EDT
Zone B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

12:30pm EDT

#621 RT: Roundtable Discussion: International Regulatory Cooperation with the African Medicines Agency
Wednesday June 17, 2026 12:30pm - 1:30pm EDT
Zone A
Component Type: Session
Level: Intermediate

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: International Regulatory Cooperation with the African Medicines Agency Wednesday, June 17 | 12:30pm -1:30pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Chaitanya Koduri, DDS, MHS

Wednesday June 17, 2026 12:30pm - 1:30pm EDT
Zone A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

1:45pm EDT

#622: Pharmacovigilance to Strengthen Vaccine Confidence and Address Hesitancy: Lessons from Brazil and Beyond
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
118AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-612-L04-P; CME 1.00; RN 1.00

This forum will explore how pharmacovigilance strengthens vaccine confidence and reduces hesitancy through safety monitoring, transparent communication, and healthcare professional training, with lessons from Brazil and international perspectives.

Learning Objectives

Describe how pharmacovigilance can strengthen vaccine confidence and address hesitancy; Identify strategies to empower healthcare professionals to improve safety data reporting; Discuss global and national approaches to transparent risk–benefit communication in immunization.

Chair

Mayra Martho Moura Oliveira, BSN

Speaker

Pharmacovigilance as a Trust-Building Tool: From Surveillance to Confidence
Patrícia Mouta Nunes Oliveira, MD

The role of healthcare professionals: how training and information dissemination transform trust in vaccines.
Vera Lúcia Gattás, PHD


Speakers
avatar for Vera Gattás

Vera Gattás

QPPV, Instituto Butantan , Brazil
Graduated in Nursing from Escola Paulista de Medicina - Depto. Nursing (1979); Master in Public Health from the Faculty of Public Health of the University of São Paulo - USP (1996) and PhD in Tropical Diseases and International Health from the Institute of Tropical Medicine at USP... Read More →
avatar for Patricia Mouta

Patricia Mouta

Pharmacovigilance specialist, Biomanguinhos/Fiocruz, Brazil
Dr. Patrícia Mouta is a Medical Doctor and Patient Safety specialist with extensive experience in pharmacovigilance and vaccine safety. Since 2011, she has worked as a Safety Physician at Bio-Manguinhos/Fiocruz, a leading public manufacturer of vaccines and biopharmaceuticals in... Read More →
avatar for Mayra Oliveira

Mayra Oliveira

pharmacovigilance manager, Instituto Butantan, Brazil
Since graduating as a nurse in 2007, I have built a solid career in immunization, working across different areas including vaccination clinics, clinical research coordination, and clinical operations management. Over the years, I progressed into vaccine safety and currently serve... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Safety & Pharmacovigilance
  • Tags Session

1:45pm EDT

#624: Optimizing Protocol Data Collection to Reduce Site and Patient Participation Burden
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
108B
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-613-L04-P; CME 1.00; RN 1.00

This session presents results of a recent TransCelerate–Tufts CSDD study highlighting trends, benchmarking protocol data collection practices, and offering new, practical strategies to simplify protocol designs and reduce participant and site burden.

Learning Objectives

Analyze new benchmarks on the distribution of protocol data across core, standard, and non-core endpoints; Identify procedures associated with non-core and non-essential endpoints and their contribution to patient and site burden; Discuss strategies to evaluate protocol data collection, simplify design and lower participation burden.

Chair

Kenneth Getz, MBA

Speaker

New Benchmarks on Clinical Trial Data Collection Practices and their Impact
Kenneth Getz, MBA

Frameworks and Tools Guiding Optimization of Protocol Data Collection
Jackie Cole, MS


Speakers
JC

Jackie Cole

Director, Design and Innovation, Clinical Operations, Gilead Sciences, United States
Jackie Cole is a clinical development innovator with more than two decades of experience across clinical operations and site engagement. At Gilead, she serves as Director of Design & Innovation, driving enterprise-wide innovation strategies that reshape how trials are designed and... Read More →
avatar for Kenneth Getz

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 →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session |   03: Data-Tech-AI, Session |   04: MedAffairs-SciComm, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Development & Operations,Data Management & Data Standards
  • Tags Session

1:45pm EDT

#623: Designing the Future: Emulation of Clinical Trials Using Real-World Data
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
108A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-614-L04-P; CME 1.00; RN 1.00

Panelists that conduct trial emulation with real-world data to design better trials will present work from oncology and COPD/asthma. Presentations followed by discussion on data-driven trial design and its challenges.

Learning Objectives

Explain how trial emulation using real-world data can be used to enhance design of future clinical trials; Discuss the need for clinical trials design to take a data-driven approach and how this can lead to larger patient pools and trials that are more generalizable to clinical practice; Discuss the challenges of emulating trial endpoints, eligibility criteria, and other design elements.

Chair

Leo Russo, MS

Speaker

Panelist
Jingchuan Serena Guo, MD, PHD

Panelist
Donna Rivera, PHARMD, MSC, FISPE


Speakers
JS

Jingchuan Serena Guo

Associate Professor, Purdue University, United States
avatar for Donna Rivera

Donna Rivera

Executive Vice President-Clinical Evidence Modernization, Canal Row Advisors, United States
Donna R. Rivera, PharmD., MSc., FISPE is the Associate Director for Pharmacoepidemiology in the Oncology Center of Excellence at the U.S. Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the regulatory review of Real World Data (RWD... Read More →
avatar for Leo Russo

Leo Russo

Advisor, Get Real Institute, United States
I bridge the gap between clinical trials and real-world outcomes, ensuring breakthrough therapies deliver on their promise to patients. Leading teams across pharmaceutical development for 25+ years, I've pioneered trial emulation, AI analytics, and pragmatic designs that generate... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Forum |   10: Stats-EvidenceGeneration-RWE, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Biostatistics
  • Tags Forum

1:45pm EDT

#625: Building AI Governance Frameworks: Classification, Validation and Regulatory Alignment in Life Sciences
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
109AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-618-L04-P; CME 1.00; RN 1.00

This session presents AI consortium working group assessments on regulatory frameworks, use case classification, and validation approaches. Participants engage with practical tools while demystifying real AI deployments and regulatory requirements.

Learning Objectives

Apply standardized AI use case classification frameworks to drug development and research-related scenarios; Recognize risk-based, practical assessment, governance and validation approaches for AI systems across regulatory contexts and use cases; Demonstrate utilizing aligned terminology for cross-jurisdictional AI discussions.

Chair

Sridevi Nagarajan, PHD

Speaker

Panelist
Carrie Nielson, MPH

Panelist
Michael Lingzhi Li, PHD

Panelist
Joaquim Berenguer Jornet, MS

Panelist
Venkatraman Balasubramanian, MBA

Panelist
Leon Rozenblit, JD, PHD

Panelist
Christina Mack, MPH


Speakers
JB

Joaquim Berenguer Jornet

AI Implementation lead, Digital Business Transformation Task Force, European Medicines Agency, Netherlands
Joaquim Berenguer is currently the AI implementation lead and supports the digital strategy of the European Medicines Agency. He is also the chair of the European Agencies Network Working Group on AI. Mathematician as background, Joaquim had led different data scientist teams during... Read More →
ML

Michael Lingzhi Li

Assistant Professor, Harvard Business School, United States
Michael Lingzhi Li is an Assistant Professor in the Technology and Operations Management unit at Harvard Business School. His research focuses on the end-to-end development of decision algorithms based on machine learning, causal inference and operations research. He examines the... Read More →
avatar for Christina Mack

Christina Mack

CSO RWE and SVP AAIS, IQVIA, United States
Christina Mack, Ph.D. is senior vice president of Applied AI Science within the AI and Technology Solutions (ATS) business, where she is responsible for driving scientific and technical innovation across the organization that has direct impact on patient health. Dr. Mack also leads... Read More →
avatar for Sridevi Nagarajan

Sridevi Nagarajan

DIA Communities Chair for AI in Healthcare, Ayusarogya, United Kingdom
An influential and data-driven executive professional with a robust background in the Pharmaceutical and Public Health sectors, bringing a unique blend of expertise in leading digital transformation initiatives and leveraging data to guide corporations through complex business changes... Read More →
avatar for Carrie Nielson

Carrie Nielson

Director of Epidemiology, Gilead Sciences, United States
Carrie Nielson is a Director of Epidemiology at Gilead Sciences, where she focuses on regulatory policy for RWE and on rigorous observational research methods that support reliable evidence generation. She collaborates with industry, academic, and regulatory colleagues, including... Read More →
LR

Leon Rozenblit

Executive Director, Q.E.D. Institute, United States
Leon Rozenblit is a nationally recognized thought leader at the intersection of clinical research informatics and AI governance. As Co-Founder and Executive Committee member of the DCI Network at Beth Israel Deaconess Medical Center, Harvard Medical School, he has co-organized two... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Forum

1:45pm EDT

#630: Streamlining Regulatory Frameworks for Complex Generic Development: Global Extractables and Leachables Harmonization
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
112AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-620-L04-P; CME 1.00; RN 1.00

Examine evolving extractables and leachables (E&L) regulatory guidance focusing on ICH harmonization efforts to support complex generic development through aligned risk management approaches and streamlined global regulatory frameworks.

Learning Objectives

Evaluate current global regulatory frameworks for E&L assessment in complex generic products; Analyze risk-based approaches for leachable impurity control across different jurisdictions; Synthesize harmonization opportunities to streamline product development and regulatory submissions.

Chair

Allison Radwick

Speaker

Panelist
Chaitanya Koduri, DDS, MHS

Panelist
Karthik Balasubramanian, PHD, MS

Panelist
James Wabby, MHS

Panelist
Ji Guo, PHD


Speakers
avatar for Karthik Balasubramanian

Karthik Balasubramanian

Dir Project/Program Management, External Manufacturing, Teva Pharmaceuticals, United States
Dr. Karthik Balasubramanian, Ph.D is Director, Program and Project Management at Teva Pharmaceuticals. He has over 20 years of experience in all phases of medical device and combination product development, from R&D to Technical Operations. Prior to joining Teva, he has worked in... Read More →
JG

Ji Guo

Chemist, OPQ, CDER, FDA, United States
Dr. Ji Guo is a chemist in the Office of Policy for Pharmaceutical Quality (OPPQ) within the Office of Pharmaceutical Quality (OPQ) at the FDA's Center for Drug Evaluation and Research (CDER). Her work encompasses scientific review of drug quality issues, policy analysis, and collaboration... Read More →
avatar for Chaitanya Koduri

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 →
AR

Allison Radwick

Senior Regulatory and Policy Communications Manager, U.S. Pharmacopeia, United States
Allison is accomplished in combining communications, regulatory affairs, policy and science with demonstrated success driving public engagement initiatives, implementing integrated outreach plans and liaising across executive and functional levels. Skills include building awareness... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session

1:45pm EDT

#629: Inside the Biotech Breakthroughs: How Investors and Founders Build Winning Companies
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
103A
Component Type: Session
Level: Intermediate

This candid panel looks inside notable biotech breakthroughs to explore what “success” really takes beyond the headlines. Through case studies from leading venture groups and founders, speakers will unpack key decisions, near misses, pivots, and partnership strategies, translating them into practical lessons for emerging companies and their partners.

Learning Objectives

Describe the strategic and operational decisions that shape successful biotech trajectories from idea to inflection point; Analyze real-world case studies to identify patterns in pivots, near misses, financing, and partnership strategies; Translate investor and founder perspectives into practical lessons for emerging companies and their partners.

Chair

Robert Tepper

Speaker

Panelist
Abbie Celniker, PHD

Panelist
Gabriela Apiou, PHD


Speakers
avatar for Gabriela Apiou

Gabriela Apiou

Investigator, Assitant Professor (M), Massachusetts General Hospital, United States
Gabriela Apiou, PhD, is an Assistant Professor of Dermatology at Massachusetts General Hospital (MGH) and Harvard Medical School, the inaugural Endowed MGH Research Institute Chair in Translational Sciences, and Director of the MGH Wellman Center for Photomedicine’s Translational... Read More →
AC

Abbie Celniker

Partner, Third Rock Ventures, United States
avatar for Robert Tepper

Robert Tepper

Co-founder and Partner, Third Rock Ventures, United States
Bob Tepper is a co-founder and Partner of Third Rock Ventures and a distinguished physician-scientist with more than 30 years of experience building and operating leading research and development organizations in the biotech industry. Bob focuses on the formation, development, and... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session |   18: Lift-Series, Session

1:45pm EDT

#631: Bold Leadership: Embolden Your Team for Smart Risk-Taking
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
202AB
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-621-L04-P; CME 1.00; PDU 1.00 PMI 21663K6JS3; RN 1.00

This workshop helps break through habitual thinking and guide teams toward inventive, high-impact strategies. Participants will engage in activities to encourage team engagement, uncover hidden constraints, and practice leading with confidence.

Learning Objectives

Analyze psychological and organizational factors that inhibit idea generation; Explain how to adopt techniques for leading scenario exploration.

Chair

Larissa Wilsie, MBA, MS, PMP

Speaker

Workshop Exercise 2
Nathan Kreischer, MS, PMP

Workshop Exercise 1
Amanda Adamek, MBA, PMP


Speakers
AA

Amanda Adamek

Organon, United States
avatar for Nathan Kreischer

Nathan Kreischer

Director, Global Project & Alliance Management, Merck & Co., Inc., United States
Nathan is a Director within Global Project & Alliance Management at Merck. He has almost 20 years of experience in the Pharmaceutical industry spanning Basic Research, Sales, Clinical Research and Project/Program Management. He has successfully lead teams through strategy development... Read More →
avatar for Larissa Wilsie

Larissa Wilsie

Sr. Director, PPM Business Development, GlaxoSmithKline, United States
A cell biologist by training, Larissa moved into project management in 2013 and has worked across therapeutic areas, supporting programs from early stage development through post-approval activities. She has been able to apply PM skills in a variety of settings beyond drug development... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Workshop

1:45pm EDT

#632: Program Manager: Jack of All Trades, Master of None?
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
203AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-622-L04-P; CME 1.00; PDU 1.00 PMI 21668R8O1J ; RN 1.00

The program manager role can be found within many functional areas, including discovery research, manufacturing, regulatory, and, the ultimate jack of all trades, the global program manager.

Learning Objectives

Recognize the diversity of PM role with respect to technical expertise and background required; Describe the importance of explicit roles and responsibilities and recognize the importance of not leaving anything unspoken or assume anything.

Chair

Rosa Tarng, MA

Speaker

Panelist
Simina Grigoriu, PHD


Speakers
avatar for Simina Grigoriu

Simina Grigoriu

Director, R&D Operations, Accent Therapuetics, United States
Simina is an early-stage clinical program manager who draws on over a decade of experience spanning the continuum from drug discovery to early clinical development. Trained in structural biology and protein sciences, she led Protein & Structural Sciences teams before moving into program... Read More →
avatar for Rosa Tarng

Rosa Tarng

Early Development Leader, GSK, United States
Rosa Tarng is a drug development professional with over 20 years of industry experience. Rosa is currently an Early Development Leader at GSK. Prior experience includes leading Research and Translational program management teams as well as managing drug development programs and portfolios... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Session

1:45pm EDT

#633: Advancing Biosimilar Development: The EU Tailored Clinical Approach and Global Harmonization Efforts
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
118C
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-672-L04-P; CME 1.00; RN 1.00

EU’s Reflection Paper introduces a tailored clinical approach for biosimilars, driving an optimised and efficient development programme by reducing unnecessary studies, as regulators and industry discuss opportunities for patient access and global harmonization.

Learning Objectives

Describe the scientific basis and regulatory rationale behind the EU’s tailored clinical approach for biosimilar development; Discuss how enhanced analytical similarity assessments can support leaner clinical development programs; Explain circumstances under which comparative clinical efficacy studies may be reduced or waived.

Chair

Peter Richardson

Speaker

Panelist
Steffen Thirstrup, MD, PHD


Speakers
avatar for Peter Richardson

Peter Richardson

Senior Quality Specialist, European Medicines Agency, Netherlands
Dr. Richardson, a pharmacist with a Ph.D. in pharmaceutics from Queen's University Belfast, has extensive experience in formulation R&D with companies like Bristol-Myers Squibb, SmithKline Beecham, Pfizer, and Serono, focusing on drug delivery systems. He worked as a pharmaceutical... 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 →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session

1:45pm EDT

#635: MHRA Town Hall
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
119AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-626-L04-P; CME 1.00; RN 1.00

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

Learning Objectives

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

Chair

Lawrence Tallon

Speaker

Panelist
Alison Cave

Panelist
Julian Beach, MBA


Speakers
avatar for Julian Beach

Julian Beach

Interim Executive Director, Healthcare Quality and Access, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Julian oversees the portfolio that is designed to ensure the quality and access of products to the UK market - this includes scientific advice, licensing assessment, marketing authorisations for all innovative and established medicines. A committed professional with over 15 years... Read More →
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 Lawrence Tallon

Lawrence Tallon

Chief Executive Officer, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
119AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session

1:45pm EDT

#636: The Next Frontier: Autoimmune Cell and Gene Therapy, Regulation, and Patient Access
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
201AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-625-L04-P; CME 1.00; RN 1.00

This panel will explore how patient advocacy can shape regulatory strategy, trial design, and access planning for autoimmune cell and gene therapies as they move toward future approvals.

Learning Objectives

Identify how patient advocacy can shape regulatory strategy and access for future autoimmune CGTs; Describe approaches to incorporating patient priorities such as quality of life and treatment burden into trial design; Discuss strategies to ensure equitable and sustainable patient access.

Chair

Samantha Roberts, PHD

Speaker

Perspectives from the Myositis Community
Paula Eichenbrenner, MBA

Patient Perspective
Joy Buie, BSN, PHD, MS, RN

Patient advocacy perspective
Brian Kennedy

FDA perspective
Vijay Kumar


Speakers
JB

Joy Buie

Vice President of Research, Lupus Foundation of America, United States
Dr. Joy Buie is a nurse-scientist and leader advancing patient-centered innovation in autoimmune disease, particularly lupus. She leads strategic research initiatives that integrate real-world and patient experience data into clinical development, regulatory decision-making, and therapeutic... Read More →
PE

Paula Eichenbrenner

Executive Director, The Myositis Association, United States
BK

Brian Kennedy

Executive Director, Global Alliance for Patient Access, United States
VK

Vijay Kumar

Acting Director OTP/CBER, FDA, United States
avatar for Samantha Roberts

Samantha Roberts

Senior Director, Regulatory Intelligence, AstraZeneca, United States
Samantha Roberts leads Respiratory & Immunology Regulatory Intelligence and Portfolio Policy at AstraZeneca. Previously she was in Genentech’s US Regulatory Policy team where she focused on topics including patient-focused drug development, innovative trials, diversity and inclusion... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum

1:45pm EDT

#634: Access Unlocked: Collaborative Strategies for Navigating Regulatory and Payor Landscapes
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
115AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-623-L04-P; CME 1.00; RN 1.00

Aligning regulatory and payor expectations is critical in the evolving healthcare landscape. Regulatory Affairs, Medical Affairs, and Market Access functions are collaborating within this complex ecosystem to ensure sustained patient access to medicines.

Learning Objectives

Examine the dynamic collaboration between Regulatory Affairs, Medical Affairs, and Market Access to effectively address current regulatory and payor requirements; Describe advancements in drug development that ensure clinical trials align with regulatory frameworks and coverage decisions.

Chair

Alison Maloney, MBA, MS

Speaker

An Academic Perspective
Sean D. Sullivan, PHD

A Medical Perspective
Emma Lee

A Regulatory Perspective
Todd Paporello, PHARMD, MBA


Speakers
EL

Emma Lee

Executive Director and Head, US Medical Affairs Patient Access and Quality, Gilead Sciences, United States
avatar for Alison Maloney

Alison Maloney

Head of Regulatory Affairs North America, Bayer , United States
Alison Maloney is currently Head of Regulatory Affairs North America for Bayer Pharmaceuticals. Prior to this role, she was the Head of Regulatory Affairs for Bayer Radiology and Consumer Health North America. Alison has also held Canadian positions as the Head of Regulatory Affairs... Read More →
avatar for Todd Paporello

Todd Paporello

Vice President, Global Head of Regulatory Affairs, Specialty Care, Sanofi, United States
Todd Paporello is the Vice President & Global Head of Regulatory Affairs Specialty Care at Sanofi. Before joining Sanofi, he held leadership positions of increasing responsibility within regulatory affairs at Bayer, Roche, Genentech, Merck, and Schering-Plough. Todd holds pharmacy... Read More →
SS

Sean Sullivan

Prof. of Pharmacy, Public Hlth, University of Washington, United States
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session |   04: MedAffairs-SciComm, Session

1:45pm EDT

#637: Destigmatizing 483 Observations
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
117
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-627-L04-P; CME 1.00; RN 1.00

Hear from regulators and industry on the challenges and opportunities in supporting sponsors through 483 observations. Panelists will discuss their impact on monitoring strategies and the role that centralized monitoring plays in mitigating violations.

Learning Objectives

Discuss the impact of 483 observations on Risk-Based Quality Management (RBQM) strategies; Describe how perceptions about the criticality of 483 observations are influencing clinical monitoring strategy decisions; Identify opportunities to mitigate anxiety related to 483 observations and to support cohesion between sponsors, CROs, and regulatory agencies to enable future adoption of centralized monitoring strategies.

Chair

Erin Brown, MPH

Speaker

Panelist
Cris McDavid, MS

Panelist
Nicole Stansbury

Panelist
David C. Burrow, JD, PHARMD

Panelist
Tracy Vanderslice


Speakers
avatar for Erin Brown

Erin Brown

Director, Industry Intelligence and Messaging, Association of Clinical Research Organizations (ACRO), United States
Erin Brown is the Director of Industry Intelligence and Messaging for the Association of Clinical Research Organizations (ACRO), where she leads survey development, collection, and analysis related to risk-based quality management (RBQM) adoption, FDA regulatory trends, and other... Read More →
avatar for David Burrow

David Burrow

Director, Office of Scientific Investigations, OC, CDER, FDA, United States
David Burrow is the Director of the Office of Scientific Investigations (OSI) within the Office of Compliance in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). He leads CDER's Bioresearch Monitoring (BIMO) program, overseeing clinical... Read More →
avatar for Cris McDavid

Cris McDavid

Senior Director, GCDO, Parexel International, United States
Cris McDavid is a seasoned clinical research leader with over 20 years of global clinical trial delivery experience. Cris leads Parexel Risk-Based Quality Management (RBQM) operations and Integrated Data Delivery (IDD), driving strategic process and technology implementation across... Read More →
avatar for Nicole Stansbury

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 →
avatar for Tracy Vanderslice

Tracy Vanderslice

Vice President, Clinical Operations, Gilead Sciences, United States
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC
  • Tags Session

1:45pm EDT

#638: Real World Evidence Throughout the Product Life Cycle: Case Studies and Real-Life Examples
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
116
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-628-L04-P; CME 1.00; RN 1.00

Use of Real-World Evidence (RWE) in regulatory assessments has increased in recent years with use cases spanning across the development, initial authorisation and post-marketing monitoring of medicines. Examples across lifecycle and therapeutic areas will be discussed.

Learning Objectives

Discuss the use of RWE to support regulatory decisions; Identify use cases based on regulatory assessment, stage of lifecycle and therapeutic area; Examine real-world examples of RWE use to identify effective practices and apply insights to future evidence-generation strategies.

Chair

Denise Umuhire, MBA, MSC

Speaker

Panelist
Patricia Furlong, BSN

Panelist
Rohini Hernandez, PHD, MPH

Panelist
Motiur Rahman, PHD, MPHARM, MS


Speakers
avatar for Patricia Furlong

Patricia Furlong

Founding President and Chief Executive Officer, Parent Project Muscular Dystrophy, United States
Pat Furlong is the Founding President and CEO of Parent Project Muscular Dystrophy (PPMD), the largest nonprofit organization in the United States solely focused on Duchenne muscular dystrophy (Duchenne). Their mission is to end Duchenne. They accelerate research, raise their voices... Read More →
avatar for Rohini Hernandez

Rohini Hernandez

Director, Center for Observational Research, Amgen, United States
Rohini Hernandez, PhD, MPH, is a Director of Observational Research in the Center for Observational Research at Amgen. She leads a Pharmacovigilance Epidemiology team focused on leveraging real world data to support benefit/risk assessments globally and across therapeutic areas. Prior... Read More →
avatar for Motiur Rahman

Motiur Rahman

Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States
Dr. Motiur Rahman is a Senior Epidemiologist and Policy Advisor in Real-World Evidence (RWE) Analytics within the Office of Medical Policy at CDER, FDA. He leads the consult service for reviewing RWD study submissions, leads international regulatory collaborations including ICH initiatives... Read More →
DU

Denise Umuhire

Pharmacoepidemiologist and Real-World Evidence Specialist, European Medicines Agency, Netherlands
I am a pharmacoepidemiologist & RWE specialist within the Data Analytics and Method Taskforce at the Europea Medicine Agency (EMA). I am part of the RWE workstream that provides support on RWE related matters to different evaluation committees, delivering rapid analyses of RWD to... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Session

3:00pm EDT

#629.2 RT: Roundtable Discussion: Insights Regarding Implementation of the ASAP Process
Wednesday June 17, 2026 3:00pm - 3:45pm EDT
TBD
Component Type: Session
Level: Intermediate

Join the Clinical Safety and Pharmacovigilance Community for a follow up round table discussion tied to session: Insights Regarding Implementation of the ASAP Process (Wednesday, June 17 | 2:45pm - 3:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Greg Ball, PHD

Wednesday June 17, 2026 3:00pm - 3:45pm EDT
TBD The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

3:00pm EDT

Roundtable Discussion: Building AI Governance Frameworks: Classification, Validation and Regulatory Alignment in Life Sciences
Wednesday June 17, 2026 3:00pm - 3:45pm EDT
TBD
Component Type: Session
Level: Intermediate

Join the AI in Healthcare Community for a follow up round table discussion tied to session: Building AI Governance Frameworks: Classification, Validation and Regulatory Alignment in Life Sciences (Wednesday, June 17 | 2:45pm - 3:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Sridevi Nagarajan, PHD

Speaker

Speaker
Stephanie Rosner, MA, PMP


Wednesday June 17, 2026 3:00pm - 3:45pm EDT
TBD The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

4:00pm EDT

#643: Utilizing Signal Detection Methodologies: A Toolkit for Diverse Product Types
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
118AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-629-L04-P; CME 1.00; RN 1.00

This session will share insights into signal detection approaches across different product types, exploring how regulators, industry, and academia are leveraging new technologies and data sources to address current challenges and advance pharmacovigilance practices.

Learning Objectives

Describe challenges in performing signal detection activities across a range of healthcare product types, including devices, combination products, and advanced therapies; Discuss novel approaches and data sources to enhance signal detection; and identify opportunities to incorporate emerging signal detection approaches into your organization's vigilance activities.

Chair

Monica Munoz, PHARMD, PHD

Speaker

Panelist
Judith Maro, MS

Panelist
Jeffery L Painter, JR, JD, MSC


Speakers
avatar for Judith Maro

Judith Maro

Associate Professor, Department of Population Medicine, Harvard Medical School, United States
Dr. Maro is an Associate Professor in the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. She received her doctorate in Engineering Systems at the Massachusetts Institute of Technology (MIT). She is a site principal investigator... Read More →
avatar for Monica Munoz

Monica Munoz

Division Director, Division of Pharmacovigilance-I, OSE, CDER, FDA, United States
CAPT Monica Muñoz is the Director of the Division of Pharmacovigilance-I within US FDA’s Center for Drug Evaluation and Research. Since joining FDA in 2010, she has served as a safety reviewer, managed review teams, and provided oversight for pharmacovigilance initiatives. Her... Read More →
avatar for Jeffery Painter

Jeffery Painter

Senior Director, Quantitative Leader for Safety Innovation & Analytics, GlaxoSmithKline, United States
Jeffery Painter is the Quantitative Leader for Safety Innovation and Analytics at GSK, advancing pharmacovigilance through Bayesian methods, semantic similarity, and ontology-driven analytics. He is the author of PVLens, a drug safety reference database derived from regulatory labeling... Read More →
avatar for Sarah Vaughan

Sarah Vaughan

Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Sarah has worked in pharmacovigilance at the MHRA for the past 20 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Development & Operations
  • Tags Session

4:00pm EDT

#644: 50,000 Participants, Two Countries, One DCT: Oversight That Worked
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
108A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-630-L04-P; CME 1.00; RN 1.00

50,000 participants across two African countries created oversight challenges no checklist could handle. Learn how operational design and informal KRIs shaped oversight—and dual perspectives from operations and quality.

Learning Objectives

Differentiate traditional monitoring from risk-proportionate oversight in mega-scale DCTs; Analyze how operational practices reflected RBQM and QbD principles without labels; Design fit-for-purpose monitoring approaches informed by informal KRIs and real-time signals.

Chair

Leslie Sam

Speaker

Panelist
Lisa Collins


Speakers
LC

Lisa Collins

Founder - Head Clinical Operations, Innomas Clinical Research (Africa), Nigeria
Lisa Ursella Collins is Co-Founder and CEO of Innomas Clinical Research and a global clinical operations and program leader. She works at the intersection of clinical execution, quality, and operational risk—translating development strategy into disciplined delivery. Through Innomas... Read More →
avatar for Leslie Sam

Leslie Sam

President, Leslie Sam and Associates, LLC, United States
With 30 years of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session |   09: RD-Quality-Compliance, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC
  • Tags Session

4:00pm EDT

#647: Not Can, but Should: How do we WANT AI/ML to Transform Clinical Development?
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
111AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-632-L04-P; CME 1.00; RN 1.00

Visionary leaders will debate three options for the ideal AI-transformed future state of the clinical trials enterprise. Attendees will appraise these big ideas, consider market implications, and reflect on their roles in getting us there.

Learning Objectives

Evaluate three “big goals" for AI transformation of clinical development (eg, 10xing drugs reaching the market, eliminating human trial participants); Discuss the infrastructure implications of each goal (eg., with more drug candidates advancing, how will the system need to adapt?); Identify necessary, accompanying regulatory changes (eg, how will we meet increased demand for reviews?)

Chair

Morgan Hanger, MPA

Speaker

Panelist
Tala Fakhouri, PHD, MPH

Panelist
Henry Wei, MD

Panelist
Gabriel Westman, MD, PHD, MSC


Speakers
avatar for Tala Fakhouri

Tala Fakhouri

Vice President, AI & Digital Policy, Real-World Research, Parexel International, 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 →
avatar for Morgan Hanger

Morgan Hanger

Executive Director, Clinical Trials Transformation Initiative (CTTI), United States
Morgan Hanger is the Executive Director of the Clinical Trials Transformation Initiative (CTTI), a public-private partnership between Duke University and the U.S. FDA. She brings extensive experience in convening diverse stakeholders to tackle complex challenges in evidence generation... Read More →
HW

Henry Wei

Executive Director, Data, Technology & Innovation, Regeneron Pharmaceuticals, United States
avatar for Gabriel Westman

Gabriel Westman

Head of Artificial Intelligence, Swedish Medical Products Agency, Sweden
GW is an infectious disease specialist and associate professor (MD, PhD), member of EMA/HMA Network Data Steering Group and EMA CHMP Methodology Working Party. He also has an MSc in Engineering with experience in bioinformatics, AI and big data applications within medicine and pharmaceutics... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Forum |   02: ClinicalTrialOps-Innovation, Forum
  • Audience Intermediate
  • Area Artificial Intelligence
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Health Technology & AI,Clinical Development & Operations
  • Feature Topics Artificial Intelligence
  • Tags Forum

4:00pm EDT

#648: Medical Affairs: Drivers of Scientific Impact and Strategic Value in Healthcare
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
105AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-634-L04-P; CME 1.00; RN 1.00

Discover how Medical Affairs drives strategic value across the drug lifecycle through scientific leadership, data-driven insights, and digital fluency to improve patient outcomes.

Learning Objectives

Discuss Medical Affairs’ evolving role in driving scientific credibility and impact; Describe how digital fluency, data analytics, and AI transform it into a tech-enabled function; Identify best practices and leadership insights for advancing capabilities in a patient-centric, data-driven ecosystem.

Chair

Ranjini Prithviraj, PMP

Speaker

Panelist
Donna A. Holder, PHARMD

Panelist
Alexander Condoleon

Panelist
Sarah Jarvis, MBA


Speakers
AC

Alexander Condoleon

Chief Medical Affairs Officer, Medical Engagements & Impact, Pfizer, United States
avatar for Donna Holder

Donna Holder

Principal, HDMA Advisory, United States
Donna Holder has over 30+ yrs experience in the pharma. She now serves as an advisor to Medical Affairs organizations within the pharmaceutical industry. She was recently the Executive Director & Head of Digital Strategy and Innovation in Global Oncology Medical Affairs at Daiichi... Read More →
avatar for Sarah Jarvis

Sarah Jarvis

Global Medical & Evidence Lead, ZS Associates, United States
Sarah Jarvis leads our Global Medical & Evidence consulting space at ZS. Based now in San Francisco, California, Sarah has worked in the lifesciences industry for over 25 years and has focused exclusively on working with medical affairs clients for the past 20+ years at ZS. ZS has... Read More →
RP

Ranjini Prithviraj

Director, Global Medical Affairs, Publication Management, Regeneron Pharmaceuticals, United States
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  04: MedAffairs-SciComm, Session

4:00pm EDT

#651: Regulatory CMC and Product Quality Hot Topics Discussion
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
118C
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-636-L04-P; CME 1.00; RN 1.00

This interactive forum will bring together senior industry experts to discuss their perspectives on critical hot topics impacting Regulatory CMC and Product Quality.

Learning Objectives

Discuss current regulatory CMC challenges, including the use of AI, digitization, and emerging technologies in pharmaceutical quality systems; Examine how to analyze strategies for managing global regulatory complexity, supply chain resiliency, and international harmonization.

Chair

Celeste Frankenfeld Lamm

Speaker

Panelist
Peter Richardson

Panelist
Mahesh R. Ramanadham, PHARMD, MBA

Panelist
Kevin Fitzpatrick, RPH

Panelist
Yoshihiro Matsuda, DrMed


Speakers
avatar for Kevin Fitzpatrick

Kevin Fitzpatrick

Senior Vice President, Quality Assurance, AbbVie, United States
Kevin Fitzpatrick is Senior Vice President of Quality Assurance at AbbVie. Kevin was appointed to his current role in June 2025 after serving as Vice President, Quality Assurance, Biologics. Kevin has been with AbbVie/Abbot for 26 years, supporting CMC strategy and execution of AbbVie’s... Read More →
avatar for Celeste Frankenfeld Lamm

Celeste Frankenfeld Lamm

Senior Director, Global Quality and Reg CMC Policy, Merck & Co., Inc., United States
Celeste Frankenfeld Lamm, Ph.D., is a Senior Director of Quality and Reg CMC Policy at Merck & Co., where she leads a team of policy professionals who work to capture and align subject matter expertise around manufacturing quality and regulatory science, and translate it into meaningful... Read More →
avatar for Yoshihiro Matsuda

Yoshihiro Matsuda

Senior Scientist (for Quality), Pharmacist, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Matsuda is a pharmacist and a Principal Senior Scientist for Quality at the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. He received his Bachelor of Pharmaceutical Sciences from Toho University in 1997 and his Master’s degree from Toyama Medical and Pharmaceutical... Read More →
avatar for Mahesh Ramanadham

Mahesh Ramanadham

Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA, United States
Acting Director for the Division of Inspection Assessment within OPQ/OPF. His division is primarily responsible for the center level discipline review of facilities and inspections in support of drug applications. He joined the Agency in November 2009 after graduating with his PharmD... Read More →
avatar for Peter Richardson

Peter Richardson

Senior Quality Specialist, European Medicines Agency, Netherlands
Dr. Richardson, a pharmacist with a Ph.D. in pharmaceutics from Queen's University Belfast, has extensive experience in formulation R&D with companies like Bristol-Myers Squibb, SmithKline Beecham, Pfizer, and Serono, focusing on drug delivery systems. He worked as a pharmaceutical... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Forum |   03: Data-Tech-AI, Forum

4:00pm EDT

#652: Anvisa Townhall - From Backlogs to Breakthroughs: Building a Smarter Regulatory Future
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
107AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-666-L04-P; CME 1.00; RN 1.00

This town hall will present Anvisa’s strategy to reduce backlogs, modernize regulatory processes, and integrate innovation and AI into decision-making. The session will explore how Brazil is building a more agile, risk-based, and globally connected regulatory system.

Learning Objectives

Describe Brazilian Health Regulatory Agency (Anvisa)’s strategy to reduce regulatory backlogs and modernize processes; Discuss how innovation, digital tools, and AI are being integrated into regulatory decision-making; Identify how Brazil is advancing a more agile, risk-based, and globally connected regulatory system.

Chair

Diogo Penha Soares

Speaker

Panelist
Ana Carolina Moreira Marino Araujo

Panelist
Maira Ribeiro de Souza, DRSC, PHARMD

Panelist
Adriane Alves de Oliveira, MSC

Panelist
Daniel R. Coradi de Freitas, DRSC


Speakers
avatar for Ana Carolina Moreira Marino Araujo

Ana Carolina Moreira Marino Araujo

Head, International Affairs Office, ANVISA, Brazil
Ana Carolina Marino is Head of the International Affairs Office at ANVISA. Holds a permanent position at ANVISA as goverment employe, Health Regulatory Expert, since March 2007. Has experience in both technical and management roles: Advisor at the Fourth Directorate/ANVISA; Head for... Read More →
avatar for Daniel R. Coradi de Freitas

Daniel R. Coradi de Freitas

GENERAL MANAGER, ANVISA, Brazil
Biologist, MSc in Genetics and Molecular Biology, PhD in Epidemiology, with continuous work in health surveillance since 2000 in technical and senior management roles. Former FETP (2004–2006), joined Anvisa in 2005, working in blood, tissues, cells and organs, cell therapy, health... Read More →
avatar for Adriane Alves de Oliveira

Adriane Alves de Oliveira

Deputy Head, Clinical Trials Office, ANVISA, Brazil
Health Regulation Expert with over 12 years of experience in the regulatory evaluation and oversight of non-clinical and clinical development of drugs and biological products. She is currently the Deputy Head of the Clinical Trials Office at Anvisa and a Good Clinical Practice (GCP... Read More →
DP

Diogo Penha Soares

Deputy Director, ANVISA, Brazil
MR

Maira Ribeiro de Souza

Expert, Division of Safety and Efficacy Assessment, ANVISA, Brazil
Industrial pharmacist with a degree from the Federal University of Ouro Preto, Master of Pharmaceutical Sciences from the Federal University of Ouro Preto (2012), and Ph.D. in Pharmaceutical Sciences from the Federal University of Rio Grande do Sul (2022). Currently, works as a Specialist... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Regulatory
  • Tags Session

4:00pm EDT

#655: Navigating the New US and EU Rare Disease Regulatory Framework and Global Harmonization Efforts
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
201AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-640-L04-P; CME 1.00; RN 1.00

This session will assess the evolving global rare disease regulatory landscape and examine global harmonization efforts. Panelists will include leaders from FDA, EMA, NORD, Global Genes and they will discuss how get medicines to patients faster.

Learning Objectives

Describe the evolving US and EU regulatory policy landscape; Examine how to advance global harmonization efforts for rare disease drug development; Discuss the opportunities and challenges on how to get rare disease medicines to patients faster.

Chair

Emel Mashaki Ceyhan

Speaker

Panelist
Corinne de Vries, PHD, MA, MSC

Panelist
Steffen Thirstrup, MD, PHD


Speakers
EM

Emel Mashaki Ceyhan

SVP & Head, Regulatory, Quality & Clinical Reporting (RQC), R&D, Novo Nordisk, Turkey
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 Corinne de Vries

Corinne de Vries

EMA liaison official to the US FDA, 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. At EMA, she has headed the offices of Risk Management, Science and Innovation... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Rare Disease & Special Populations,Regulatory
  • Tags Forum

4:00pm EDT

#656: Singapore Town Hall
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
112AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-668-L04-P; CME 1.00; RN 1.00

The Singapore Town Hall will show case how Singapore's world-class regulatory environment creates compelling business value, showcasing innovative pathways, digital transformation initiatives, and strategic advantages that make Health Sciences Authority (HSA) registration essential for Asia-Pacific success.

Learning Objectives

Evaluate HSA's innovative regulatory frameworks and fast-track pathways that accelerate time-to-market for pharmaceutical products, clinical trials to adoption; Identify strategic advantages of Singapore registration for companies seeking Asia-Pacific market expansion and regional manufacturing hubs; Discuss how to apply HSA's regulatory processes and collaborative approaches to optimize product development and approval strategies.

Chair

Raymond S.B. Chua, MD, MBA, MPH, FRCP

Speaker

Panelist
Wan Yee Goh


Speakers
avatar for Raymond Chua

Raymond Chua

Deputy Director of Medical Services, Health Regulation Group, Ministry of Health, Singapore
Adj A/Prof (Dr) Raymond Chua is a Registered Medical Practitioner and Public Health Specialist. He is currently the Deputy Director of Medical Services, Health Regulation Group to oversee the regulations of healthcare services and premises in Singapore, so as to safeguard public health... Read More →
WY

Wan Yee Goh

Senior Vice President and Head, Healthcare, Singapore Economic Development Board, Singapore
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Regulatory
  • Tags Session

4:00pm EDT

#654: India Town Hall: India’s Evolving Regulatory Landscape - Policy Reforms and Digital Systems Accelerating Innovation
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
116
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-639-L04-P; CME 1.00; RN 1.00

India’s recent regulatory, policy, and digital reforms are accelerating innovation, quality, and global collaboration. This town hall will highlight key updates shaping clinical research, medtech growth, and patient safety, and India’s rising global role.

Learning Objectives

Identify key regulatory, policy, and digital reforms transforming India’s healthcare and innovation ecosystem; Evaluate how updates in clinical trial rules, medical device policy, GMP standards, and data privacy impact global development; Identify opportunities for global collaboration and regulatory convergence enabled by India’s evolving frameworks.

Chair

Vivek Ahuja, MD

Speaker

Panelist
Marc Franklin

Panelist
Shahin Fesharaki

Panelist
Rajeev Singh Raghuvanshi


Speakers
SF

Shahin Fesharaki

Chief Scientific Officer, Lupin, United States
MF

Marc Franklin

CEO - North America, Cipla, United States
avatar for Vivek Ahuja, MD

Vivek Ahuja, MD

Program Chair, Executive Vice President, Pharmacovigilance, EVERSANA, India
Dr. Vivek Ahuja is a physician-turned pharmaceutical leader with 25 years of experience across pharmacovigilance, clinical research, public health, and technology. In 2005 he pioneered pharmacovigilance in India by establishing the first global PV unit at Ranbaxy. He is Executive... Read More →
RS

Rajeev Singh Raghuvanshi

Drug Controller General, Central Drugs Standard Control Organization, India
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   02: ClinicalTrialOps-Innovation, Forum |   07: RegCMC-Product Quality, Forum

4:00pm EDT

#659: Real World Evidence in Regulatory Decision-Making: Challenges, Innovations, and Impact
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
203AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-642-L04-P; CME 1.00; RN 1.00

This session highlights innovative Real World Data (RWD) methods, including AI, for enhancing Real World Evidence (RWE) for regulatory decisions. Through case studies and discussion, it will examine practical integration strategies for these innovations.

Learning Objectives

Define the key challenges and limitations in the use of real-world evidence (RWE) for regulatory decision-making; Illustrate how innovative methodologies can be integrated into study design and analysis to enhance the robustness and credibility of RWE; Describe practical insights, informed by multi-stakeholder perspectives, for developing a framework of regulatory acceptability of RWE.

Chair

Alison Cave

Speaker

Advancing Real-World Evidence for Regulatory Decision-Making: Academic perspective
Olaf Klungel, FISPE

Advancing Real-World Evidence for Regulatory Decision-Making: industry perspective
Gracy G Crane, MS

Advancing Real-World Evidence for Regulatory Decision-Making: FDA perspective
Motiur Rahman, PHD, MPHARM, MS


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 Gracy Crane

Gracy Crane

Policy Lead, Roche, United Kingdom
Gracy holds a Ph.D. in Molecular Oncology from King’s College Hospital, an M.Sc. in Biomedical Research from King’s College. She did her postdoctoral training at Oxford (UK) and at MIT (USA). Gracy brings broad experience in clinical research, medical affairs and health outcomes... Read More →
OK

Olaf Klungel

Professor of Pharmacoepidemiologic Methods, Utrecht University, Netherlands
Olaf Klungel is Professor of Pharmacoepidemiologic Methods, chair of the division of Pharmacoepidemiology & Clinical Pharmacology and the scientific director of the Utrecht Institute for Pharmaceutical Sciences (UIPS) at Utrecht University. He is also member of the Methodology working... Read More →
avatar for Motiur Rahman

Motiur Rahman

Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States
Dr. Motiur Rahman is a Senior Epidemiologist and Policy Advisor in Real-World Evidence (RWE) Analytics within the Office of Medical Policy at CDER, FDA. He leads the consult service for reviewing RWD study submissions, leads international regulatory collaborations including ICH initiatives... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Session

4:00pm EDT

#657: Great Science Isn’t Enough: Building Value Early in Emerging Biotech
Wednesday June 17, 2026 4:00pm - 5:15pm EDT
103A
Component Type: Session
Level: Intermediate

As a closing session, this discussion brings together key themes from the day to examine how innovators can better connect science to market realities. It will highlight practical ways to optimize product value for investors, payers, and regulators

Learning Objectives

Understand the factors that shape product value; Identify critical early decisions (indication, endpoints, evidence) that influence downstream access and partnering outcomes; Define opportunities to better align development strategy with payer, provider, and investor expectations.

Chair

Mark Twyman

Speaker

Panelist
Michael Kuchenreuther


Speakers
MK

Michael Kuchenreuther

Director Research & Analytics, Numerof & Associates, United States
MT

Mark Twyman

Senior Consultant & Engagement Manager, Numerof & Associates, United States
Wednesday June 17, 2026 4:00pm - 5:15pm EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Session |   18: Lift-Series, Session
 
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    203AB
    204AB
    Ballroom AB
    Content Hub
    Exchange
    Innovation Theater 1
    Innovation Theater 2
    Innovation Theater 3
    Spark Stage
    TBD
    Zone A
    Zone B
  • Filter By Type
    00: Plenary
    All
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    01: ClinSafety-PV-RM
    All
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    Session
    02: ClinicalTrialOps-Innovation
    All
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    Session
    Workshop
    03: Data-Tech-AI
    All
    Forum
    Session
    Workshop
    04: MedAffairs-SciComm
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    Workshop
    05: PersonalizedMed-ComboProd-Diagnostics
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    Forum
    Session
    Workshop
    06: ProfDevelop-Program-PortfolioMgmt
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    Forum
    Session
    Workshop
    07: RegCMC-Product Quality
    All
    Forum
    Session
    Tutorial
    Workshop
    08: RegPolicy-Strategy-GlobalCollaboration
    All
    Forum
    Session
    Workshop
    09: RD-Quality-Compliance
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    Forum
    Session
    10: Stats-EvidenceGeneration-RWE
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    Forum
    Session
    Tutorial
    11: Spark Stage
    All
    Session
    12: Content-Hubs
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    Workshop
    13: Community-Rounds
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    Session
    14: Posters
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    Session
    15: Networking-Opportunities
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    Session
    16: InnovationTheaters
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    Session
    17: Short-Courses
    All
    Tutorial
    18: Lift-Series
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    Session
    Workshop
  • Audience
    Advanced
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  • Area
    Artificial Intelligence
    Biotech-ClinTech-Pathway
    Cross-Functional Collaboration
    Digital Enablement and Modernization
    Ethics
    Evidence Innovation
    Global Alignment in Practice
    Patient-Centered Design and Experience
    Student and Early Career Pathway
    Therapeutic Pathways
    Trust and Responsible Innovation
  • Timezone
DIA 2026 Global Annual Meeting
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Monday, June 8
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102AB
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110A
111AB
112AB
114
115AB
115C
116
117
118AB
118C
119AB
201AB
202AB
203AB
204AB
Ballroom AB
Content Hub
Exchange
Innovation Theater 1
Innovation Theater 2
Innovation Theater 3
Spark Stage
TBD
Zone A
Zone B
  • 00: Plenary
  • 01: ClinSafety-PV-RM
  • 02: ClinicalTrialOps-Innovation
  • 03: Data-Tech-AI
  • 04: MedAffairs-SciComm
  • 05: PersonalizedMed-ComboProd-Diagnostics
  • 06: ProfDevelop-Program-PortfolioMgmt
  • 07: RegCMC-Product Quality
  • 08: RegPolicy-Strategy-GlobalCollaboration
  • 09: RD-Quality-Compliance
  • 10: Stats-EvidenceGeneration-RWE
  • 11: Spark Stage
  • 12: Content-Hubs
  • 13: Community-Rounds
  • 14: Posters
  • 15: Networking-Opportunities
  • 16: InnovationTheaters
  • 17: Short-Courses
  • 18: Lift-Series
  • Audience
  • Advanced
  • Basic
  • Intermediate
  • Area
  • Artificial Intelligence
  • Biotech-ClinTech-Pathway
  • Cross-Functional Collaboration
  • Digital Enablement and Modernization
  • Ethics
  • Evidence Innovation
  • Global Alignment in Practice
  • Patient-Centered Design and Experience
  • Student and Early Career Pathway
  • Therapeutic Pathways
  • Trust and Responsible Innovation