11:00am
Chair Introduction

Serene Forte, Senior Vice President, Head of Genetic Medicine, RELIEF Therapeutics

11:05am Presentation: Lost in Translation: Anticipating Hurdles to Expedite the Transition to Commercialization

Discover how to design a customized and innovative strategy to overcome every barrier on the commercialization journey

• Supply chain hurdles from pre-clinical to commercial
• Market access challenges
• Patient support: how to design unique programs that meet patient needs

Lung-I Cheng, Vice President, Cell & Gene Therapy, AmerisourceBergen

11:20am Presentation: Key Learnings from Pathology Studies in Muscle Gene Therapy

• Discuss the process of identifying treatment relevant tissue endpoints when translating pre-clinical studies to the human clinical trial stage
• How can we use those endpoints to make assessments of efficacy in animal and human studies, and how well do animals predict human responses
• What have our animal-to-human translations taught us about factors impacting efficacy, particularly issues that are unrelated to manufacturing (such as age at treatment or the time of biopsy following treatment)

Michael Lawlor, Professor of Pathology, Medical College of Wisconsin

11:35am Presentation: Integrated Solutions for Global Viral Vector Manufacturing

• Summarizing viral vector experiences focusing on select challenges presented from various viral vectors
• Opportunities for external manufacturers and biotech companies to merge ideas, development and manufacturing approaches
• Integrating single-use manufacturing strategies within a global network

Ian Goodwin, Director, Global Program Design, FUJIFILM Diosynth Biotechnologies

11:05am Closing Panel with Q&A

With all session participants, joined by:

Lisa Deschamps, Chief Executive Officer, AviadoBio

Emily Chee, General Manager, Americas, Novartis Gene Therapies