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thought leadership

1

Advanced Therapy – What Is It?
Date: Monday, September 14 at 12:00 PM – 1:30 PM ET

Moderated by: Kirsten Messmer, PhD, RAC, Principal Regulatory Affairs Specialist (PPD)

Speakers:
– Tobias Fleischmann, Dr. rer. nat., Dipl. Biol., Principal Regulatory Affairs Specialist (PPD)
– Kamali Chance, PhD, MPH, RAC, Chief Regulatory Office, BioSciences Corporation
– Ana Hidalgo-Simon, MD, PhD, European Medicines Agency

2

Cannabis and Plant Derived Products as Pharmaceutical Products: Challenges and Harmonization

Date: Monday, September 14 at 2:05 PM – 3:00 PM

Moderated by: Ahmed Abouelnour, MSc., RAC, Senior Specialist, Regulatory Affairs, Medicago

Speakers:
– John Joines, RPh, RAC, Senior Manager, Regulatory Affairs (PPD)
– Michael Craig, BSc Pharm, Principal Consultant, PARAXEL International

3

Technology and Innovation Case Studies in Regulatory Affairs
Date: Monday, September 14 at 2:05 PM – 3:00 PM

Speakers:
– Brian Wellins, MBA, Senior Director, Pharmacovigilance and Regulatory Affairs (PPD)
– Rob Connelly, MBA, Product Management, Certara

4

Regulatory-Grade Evidence: Is There Global Consensus On Existing Real-World Evidence (RWE) Frameworks?
Date: Tuesday, September 15 at 11:00 AM – 12:30 PM

Moderated by: Ilker Oztop, PhD, Director, Data Science Portfolio Management, Janssen Pharmaceuticals

Speakers:
– Eric Faulker, MPH, Vice President, Real-World Value and Strategy (Evidera)
– Dharmi Shah, PharmD, Post-Doctoral Fellow, Global Regulatory Affairs – Labeling, Sanofi
– Xavier Kurz, MD, MSc, PhD, Head of Surveillance & Epidemiology, European Medicines Agency

5

Gene Editing – Where are We Now?
Date: Tuesday, September 15 at 1:00 PM – 2:30 PM

Moderated by: Kirsten Messmer, PhD, RAC, Principal, Regulatory Affairs (PPD)

Speakers:
– Daniel O’Connell, PhD, Associate Director, Intellia Therapeutics, Inc
– Aron Stein, PhD, Vice President, Global Regulatory Affairs, Sangamo Therapeutics, Inc.
– James Valentine, JD, Associate, Hyman, Phelps & McNamara PC

6

Introduction to Advanced Therapies: Focusing on Regulatory Considerations for the Development of CAR-T Cell Immunotherapy Products
Date: Wednesday, September 16 at 12:05 PM – 1:00 PM

Moderated by: Kirsten Messmer, PhD, RAC, Principal, Regulatory Affairs (PPD)

Speakers:
– Richard Dennett, PhD, Senior Director, Regulatory Affairs (PPD)
– Ana Hidalgo-Simon, MD, PhD, European Medicines Agency

7

Companion Diagnostics in an Evolving Global Regulatory Landscape: Alignment of Co-Development Strategies for Diagnostics and Targeted Therapies
Date: Wednesday, September 16 at 10:35 AM – 11:30 AM

Moderated by: Kenneth Butz, Associate Director, Regulatory Affairs (PPD)

Speakers: Armin Ritzhaupt, PhD, MPH, European Medicines Agency

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