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Monday, June 15
 

11:00am EDT

#413: Health Canada Town Hall
Monday June 15, 2026 11:00am - 12:15pm EDT
112AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-520-L04-P; CME 1.25; RN 1.25

In this session, leaders from Health Canada will provide an update on regulatory priorities for Canada. The audience will be invited to submit questions of general interest.

Learning Objectives

Describe Health Canada’s regulatory initiatives and strategic priorities; Identify opportunities for engagement with the Canadian regulator.

Chair

Alysha Croker, PHD

Speaker

Panelist
Sophie Sommerer


Speakers
avatar for Alysha Croker

Alysha Croker

Director, Strategic and Horizontal Policy, Health Canada, Canada
Dr. Alysha Croker is the Director of the Centre for Policy, Pediatrics and International Collaboration, Health Products and Food Branch, Heath Canada. In this position, Dr. Croker is responsible for developing ways to increase access to safe and effective health products for pediatric... Read More →
avatar for Sophie Sommerer

Sophie Sommerer

Director General, Marketed Health Products Directorate, Health Canada, Canada
Sophie Sommerer is the Director General of Health Canada’s Marketed Health Products Directorate. She is responsible for post-market surveillance of a range of health products, including pharmaceutical and biologic drugs, natural health products and medical devices. From 2016 to... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session |   02: ClinicalTrialOps-Innovation, Session

11:00am EDT

#414: How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Monday June 15, 2026 11:00am - 12:15pm EDT
115AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-521-L04-P; CME 1.25; RN 1.25

As FDA–industry negotiators finalize future performance goals, Congress will shape the next user-fee statute. This session examines how budget politics, workforce shifts, and innovation priorities—from AI to MAHA—may reshape FDA’s mandate.

Learning Objectives

Describe the user-fee reauthorization timeline and how Congressional “adds” can modify negotiated performance goals; Examine how budget pressures and recent reductions in force may affect FDA capacity and review predictability; Assess how leadership priorities to accelerate innovation—including review vouchers, AI, and MAHA initiatives—could influence policy riders and oversight.

Chair

Jeffrey Francer, JD, MPA

Speaker

How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Clare Paoletta

How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Barrett Tenbarge, JD


Speakers
avatar for Jeffrey Francer

Jeffrey Francer

Vice President, Head of International Regulatory Affairs and Global Policy, Eli Lilly and Company, United States
Jeff Francer serves as Vice President, Head of International Regulatory Affairs and Global Regulatory Policy for Eli Lilly and Company. In this role, Jeff leads Lilly’s interactions with regulators and submissions in the Asia-Pacific, Europe, Middle East, and Africa regions. Jeff... Read More →
CP

Clare Paoletta

Professional Staff Member, US House Committee on Energy and Commerce, United States
BT

Barrett Tenbarge

Partner, Faegre Drinker, United States
Monday June 15, 2026 11:00am - 12:15pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   06: ProfDevelop-Program-PortfolioMgmt, Forum

4:00pm EDT

#450: Medical Writing Ted Experience
Monday June 15, 2026 4:00pm - 5:00pm EDT
105AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-545-L04-P; CME 1.00; RN 1.00

Medical writing myths persist, including the assumption that “anyone can write” and “an AI can write this in 10 minutes”—even as the stakes for clarity, accuracy, and scientific integrity continue to rise. In this TED-talk–style session, three presenters will explore why medical writing expertise matters, how writers can evolve into influential cross-functional leaders, and the value and limitations of AI currently in use. Attendees will leave with practical insights to elevate the role of medical writers and adopt emerging tools responsibly to improve quality, efficiency, and credibility in drug development communication.

Learning Objectives

Examine the specialized value professional medical writers bring, including how writing expertise reduces risk, improves efficiency, and strengthens scientific credibility—beyond what generalist writing can achieve; Identify the skills and mindsets needed for “future-ready” medical writers; Describe practical ways to grow from document execution roles into strategic leadership and cross-functional influence; Assess current AI uses in medical writing, distinguishing opportunities from hype.

Chair

Monica Chiaramonte, PHD

Speaker

Panelist
Anna Whitling, PHARMD

Everyone Thinks They Can Write: Why Medical Writers Make the Difference
Monica Chiaramonte, PHD

Amid the Ballyhoo Over AI, What Are We Losing?
Steve Sibley, MS


Speakers
avatar for Monica Chiaramonte

Monica Chiaramonte

Director, Clinical Regulatory Writing, AstraZeneca, United States
Monica Chiaramonte is a Director of Clinical Regulatory Writing at AstraZeneca, with over 35 years in the scientific field and 19 years in Medical Writing across CRO and pharmaceutical settings. She brings deep expertise in authoring and leading high quality regulatory submissions... Read More →
avatar for Steve Sibley

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Certara, 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 →
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 →
AW

Anna Whitling

Senior Manager of Medical Writing, Alcon Laboratories, Inc, United States
Monday June 15, 2026 4:00pm - 5:00pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  04: MedAffairs-SciComm, Forum |   03: Data-Tech-AI, Forum

4:00pm EDT

#452: Mentorship Myth Busters: Moving Beyond Misconceptions
Monday June 15, 2026 4:00pm - 5:00pm EDT
202AB
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-547-L04-P; CME 1.00; PDU 1.00 PMI 2166DNFT53; RN 1.00

Mentorship Myth Busters uses a courtroom-style format where attendees vote on mentorship myths and learn from experts. The REAL framework guides participants toward inclusive, flexible, and sustainable mentoring practices.

Learning Objectives

Assess mentorship myths using interactive cases; Differentiate mentorship from management; Apply the REAL framework to build inclusive, flexible, lasting mentoring relationships.

Chair

Carol Morales

Speaker

Mentorship Myth Busters: The Court of REAL Mentorship
Leslie Sam

Mentorship Myth Busters: The Court of REAL Mentorship
Tywnia Brewton

panelist
Sabhorak Horn, PHARMD, MBA, RPH


Speakers
avatar for Tywnia Brewton

Tywnia Brewton

Executive Director, Human Resources, United States
Tywnia Brewton is a seasoned Human Resource Executive who established herself as an employee Advocate... Proactive Problem Solver... Leader... Effective Negotiator... Consummate HR Partner. Tywnia specializes in improving individual and organization performance. She has over 25 years... Read More →
avatar for Sabhorak Horn

Sabhorak Horn

Medical Omnichannel Education Manager, Eli Lilly and Company, United States
Sabhorak Horn is a licensed pharmacist with a dual degree from the Philadelphia College of Pharmacy. Sabo is driven by his long-term vision of leading innovation in pharma. He is passionate about medical affairs as the bridge between data, people, and real-world impact, with a growing... Read More →
avatar for Carol Morales

Carol Morales

Lead, Quality Management and Capabilities, Astellas, United States
Carol Morales is a Quality Management & Capabilities Lead with a strong focus on professional development, mentorship, and building sustainable learning cultures within the life sciences. She brings extensive experience in designing and leading development initiatives that bridge... 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 →
Monday June 15, 2026 4:00pm - 5:00pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Session

4:00pm EDT

#456: Middle East Town Hall: The Rising Global Innovation Hub - Aligning Regulations and Unlocking Fresh Opportunities
Monday June 15, 2026 4:00pm - 5:00pm EDT
112AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-549-L04-P; CME 1.00; RN 1.00

The Middle East is a fast-emerging innovation hub. Aligning with global standards, the region is opening new opportunities and incentives. Join us to discover Middle Eastern innovations and why companies should view it as a top investment destination.

Learning Objectives

Discuss how the Middle East has rapidly evolved over the past decade, benchmarking regulatory systems, achieving higher maturity levels, and accelerating cross-stakeholder collaboration.

Chair

Amira Deia Younes

Speakers
avatar for Amira Younes

Amira Younes

Director- Europe, Middle East & Africa (EMEA), Global Regulatory Policy, MSD, United Arab Emirates
Amira is Global Regulatory Policy Director for Europe, Middle East, and Africa at MSD, with over 14 years’ experience in regulatory science and policy. A recognized thought leader in regulatory reliance, work sharing, and harmonization, she builds cross-sector networks to strengthen... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum

4:00pm EDT

#455: Japan Town Hall
Monday June 15, 2026 4:00pm - 5:00pm EDT
115AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-551-L04-P; CME 1.00; RN 1.00

This session explores the benefits of drug development and approval in Japan, highlighting market size, development predictability, and regulatory support, with insights from administrative bodies and the international pharmaceutical industry.

Learning Objectives

Recognize misconceptions about Japan's drug development environment and learn the latest updates; Discuss the benefits of drug development in Japan from regulatory and industry perspectives.

Chair

Daisuke Koga, MS, MSC

Speaker

Panelist
Seiko Usami, PHD

Panelist
Yoshiaki Uyama, PHD, MS, RPH


Speakers
avatar for Daisuke Koga

Daisuke Koga

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

Seiko Usami

Pharmaceuticals and Medical Devices Agency, Japan
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Associate Executive Director, Regulatory Science Center, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science researches in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session |   02: ClinicalTrialOps-Innovation, Session
 
Tuesday, June 16
 

10:15am EDT

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

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

Learning Objectives

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

Chair

Jingyu (Julia) Luan, PHD

Speaker

Panelist
Steffen Thirstrup, MD, PHD

Panelist
Alison Cave

Panelist
Maria Vassileva, PHD

Panelist
Ayaka Kubota, RPH


Speakers
avatar for Alison Cave

Alison Cave

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

Ayaka Kubota

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

Jingyu (Julia) Luan

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

Steffen Thirstrup

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

Maria Vassileva

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

4:15pm EDT

#559: China Town Hall
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
202AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-592-L04-P; CME 1.00; RN 1.00

In this session, speakers from NMPA, Center for Drug Evaluation (CDE) and Center for Food and Drug Inspection (CFDI) will present and discuss the latest information on regulatory policy, drug review and approval, and international collaboration.

Learning Objectives

Recognize the latest information on the National Medical Products Administration (NMPA) activities in drug regulation, supporting innovation and international collaboration; Describe the recent update on the progress in drug review, inspection and approvals in China; Discuss the issues on drug regulation with NMPA officials.

Chair

Ling Su, PHD

Speaker

Panelist
Wei Zhang

Panelist
Qinghua Wang, MD

Introduction
Hui Shi

Update on Drug Regulation in China
Huijuan Zhou

Evolution of clinical trial landscape enabling early clinical development
Xiaoyuan Chen, MD


Speakers
avatar for Xiaoyuan Chen

Xiaoyuan Chen

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

Hui Shi

Director, Development Research Division, China Center for Food and Drug International Exchange, China
avatar for Ling Su

Ling Su

Research Fellow, Yeehong Business School, China
Dr. Ling Su is a Research Fellow in Shengyang Pharmaceutical University Yeehong Business School and a Venture Partner in Lilly Asia Ventures (LAV). He has 30 years of experience in drug regulatory and development. He had worked in various R&D management positions in the pharma industry... Read More →
QW

Qinghua Wang

Founder and CEO, Innogen Pharmaceuticals, China
Professor Qinghua Wang has dedicated over 30 years to translational research in metabolic diseases. He began his medical training in Shanghai, followed by graduate studies in Biochemistry in Antwerp. By 2000, he became an Assistant Professor at the University of Toronto’s Department... Read More →
avatar for Wei Zhang

Wei Zhang

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

Huijuan Zhou

Exchange Division, China Center for Food and Drug International Exchange, China
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session |   02: ClinicalTrialOps-Innovation, Session
 
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

#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

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

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

#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
 
Thursday, June 18
 

8:00am EDT

#705: Fighting Medical Disinformation (Without Actually Starting a Fight)
Thursday June 18, 2026 8:00am - 9:00am EDT
108A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-647-L04-P; CME 1.00; PDU 1.00 PMI 2166KJ1ZXS; RN 1.00

We’ll discuss whether drug development professionals have an ethical obligation to confront misinformation, effective ways to approach these conversations without confrontation, and what techniques and messages work best in different settings.

Learning Objectives

Explain the ethical principles that underlie the obligation of drug development professionals to combat disinformation; Discuss best practices for successful encounters in combatting disinformation; Distinguish the application of different practices in their most appropriate settings

Chair

Lindsay McNair, MD, MPH, MS

Speaker

Perspectives of a Science Reporter
Sydney Lupkin

Effective Messaging to Combat Scientific Mis/Disinformation
Joseph N Cappella, PHD


Speakers
JC

Joseph Cappella

Gerald R. Miller Professor Emeritus of Communication, University of Pennsylvania, United States
Joseph N. Cappella is the Gerald R. Miller Emeritus Professor of Communication at the Annenberg School for Communication. His research has resulted in more than 225 articles and four co-authored books. His research has been supported by grants from NIMH, NIDA, NSF, NCI, NHGRI, and... Read More →
SL

Sydney Lupkin

NPR Pharmaceutical Correspondent, National Public Radio (NPR), United States
Sydney Lupkin is the pharmaceuticals correspondent for NPR. Prior to NPR, she was a correspondent at Kaiser Health News, where she covered drug prices and specialized in data reporting for its enterprise team. She's reported on how tainted drugs can reach consumers, how companies... Read More →
avatar for Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States
Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In this role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →
Thursday June 18, 2026 8:00am - 9:00am EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Forum
 
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    202AB
    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
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    01: ClinSafety-PV-RM
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    02: ClinicalTrialOps-Innovation
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    Session
    Workshop
    03: Data-Tech-AI
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    Session
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    04: MedAffairs-SciComm
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    05: PersonalizedMed-ComboProd-Diagnostics
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    06: ProfDevelop-Program-PortfolioMgmt
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    Session
    Workshop
    07: RegCMC-Product Quality
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    Tutorial
    Workshop
    08: RegPolicy-Strategy-GlobalCollaboration
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    Workshop
    09: RD-Quality-Compliance
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    10: Stats-EvidenceGeneration-RWE
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    Tutorial
    11: Spark Stage
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    12: Content-Hubs
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    Workshop
    13: Community-Rounds
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    14: Posters
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    15: Networking-Opportunities
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    16: InnovationTheaters
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    17: Short-Courses
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    Tutorial
    18: Lift-Series
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    Workshop
  • Audience
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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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102AB
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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