1:30pm Chair Introduction

Ohad Karnieli, Chief Executive Officer, Adva Biotechnology 

1:35pm Presentation: Cell Culture Media: Myths, Realities, and the Importance of Ownership

David Sheehan, President & Chief Executive Officer, Nucleus Biologics

1:50pm Presentation: Lessons Learned From Manufacturing The First Gene Therapy Approved in Both The US and EU

• Eric Hacherl, Vice President of Manufacturing at Spark Therapeutics, will share the key lessons learned from manufacturing Luxturna, the first gene therapy approved in both the US and EU
• From investing early to automation, scaling and planning for analytical, Hacherl will share the five lessons that Spark continues to utilize and benefit from in manufacturing today
• Hacherl will also cover the unique challenges of gene therapy, from development to commercialization, and how Spark leveraged it’s culture and values to launch and then continue to manufacture Luxturna for patients around the world

Eric Hacherl, Vice President, Head of Manufacturing, Spark Therapeutics

2:05pm Presentation: The Product is the Product: The Challenge and Obligation

• Responsible characterization
• Refining the definition of drug safety
• Embracing a future manufacturing standard

J Kelly Ganjei, President and Chief Executive Officer, Amplify Bio

2:20pm  Closing Panel with Q&A

With all session participants joined by: 

Lesley Chan, Director of Cellular Process Development, bluebird bio