Virtual Summit Program

DAY ONE: TUESDAY JULY 14, 2020

10:30 AM ET

FDA Perspective on Addressing Quality Manufacturing Capacity for Advanced Therapies

• Identify the need for quality manufacturing of advanced therapies considerations to be made at the outset of development in order to be prepared for positive clinical outcomes
  
• Hear how the FDA is collaborating with a variety of stakeholders to develop more streamlined pathways that facilitate the manufacturing of advanced therapies
  
• Understand how the availability of high quality manufacturing capacity is currently limiting the development of certain advanced therapies, and why this barrier needs to be overcome
  Q&A session to follow
  
  

Peter Marks, MD, PhD, Director, CBER, FDA

11:30 AM ET

ARM Industry Update: The Impact of the COVID-19 Pandemic on CGT Clinical Trials and Manufacturing 

• Explore the effect of the pandemic on the execution of new and ongoing clinical trials in the CGT space
• Discuss the challenges and opportunities in the manufacturing of CGT during the pandemic
• Is this a bump in the road or a transformation of the regenerative medicine industry?

Michael Lehmicke, Director, Science & Industry Affairs, Alliance for Regenerative Medicine (ARM). 

1:00 PM ET

Informal Chat: Addressing Supply Chain Challenges and Bottleneck Production for In Vivo and Ex Vivo Manufacturing To Scale
45 Min

Steve Goodman, Head of Drug Product Manufacturing, Bluebird Bio 
Craig Malzahn, VP Manufacturing and Supply Chain, Regenexbio

2:00 PM ET 

Tech Transfer,Partnering & Early Stage Considerations for Cell and Gene Therapies 

Patrick Silva, Executive Director, Clinical, Translation and Industry Collaborations, Texas A&M Health Science Center

2:45 - 5:00 PM ET 
Pre-scheduled Networking Meetings

DAY TWO: WEDNESDAY JULY 15, 2020

10:30 AM ET

Current Regulatory Initiatives and the 2020 Landscape for Manufacturers

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership dedicated to advancing biopharmaceutical manufacturing innovation and workforce development. Gain insight into current regulatory and industry efforts to support, prepare and respond to challenges presented by the COVID-19 pandemic. 30 Min

Kelvin H. Lee, Chief Executive Officer, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). 

11:00 AM ET

Fireside Chat: Moving From the Clinic to Commercial Manufacturing
Explore the strategic and risk impact for advanced therapies development in the context of the 2020 pandemic and beyond. What has changed and how are senior leaders approaching these strategies for the short and long term. Consider what it takes to make the successful transition from the clinic to commercial manufacturing mindset and learn best practices from the perspective of  strategic leadership in CGT commercialization. 

Mark Plavsic, Chief Technical Officer, Lysogene

Vlad Hogenhuis, Chief Operating Officer (fmr.) Ultragenyx

11:45 AM-12:30PM ET  BREAKOUT FOR INTERACTIVE DISCUSSION GROUPS 

Integrated Discussion Group I: Protein & Antibodies Production. 45Min   

This is an unmoderated zoom chat room for participants interested in networking and informal discussion around considerations for protein and antibodies production.

or

Integrated Discussion Group II: Viral Vector Manufacturing.  45Min

This is an unmoderated zoom chat room for participants interested in networking and informal discussion around considerations for viral vector manufacturing.

or

Integrated Discussion Group III: Manufacturing Considerations for mRNA. 45Min 

This is an unmoderated zoom chat room for participants interested in networking and informal discussion around Manufacturing Considerations for mRNA

12:30-4:30PM ET

Pre-scheduled Networking Meetings