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Session 7, Track 2: Towards Instantaneous Approvals in 5 Years: What Would it Take to Get There?
Session Chair(s)
Cary Smithson, MBA
Managing Partner
LeapAhead Solutions, Inc., United States
Human biology is almost hopelessly intricate, making it almost miraculous that we have efficacious treatments. In contrast, the framework we use to accept evidence of safety and efficacy needs not be this complex. We believe it offers a practical and surmountable challenge to speeding up patients’ access to life saving treatment by combining better technology, and ethical and more courageous risk management. The output of this hands-on workshop will be consolidated in a multi-stakeholder framework publication.
Tony Fantana, Eli Lilly
Peter Caetano, Ipsen
Dominique Lagrave, Accumulus Synergy
Learning Objective : At the conclusion of this session, participants should be able to:- Discuss current submission and approval process
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Brainstorm opportunities to significantly shorten submissions and approval timelines
- Formulate and execute a high-level plan with interim goals that will get us closer to an 'instantaneous approval' in the appropriate circumstances
Speaker(s)
Author
Tony Fantana, PhD
Eli Lilly, United States
Senior Director
Speaker
Peter Pedro Caetano, PharmD, PhD, MBA, MPH
Ipsen, United States
Global Regulatory Affairs – Senior Director
Speaker
Dominique Lagrave, PharmD
Accumulus Synergy, United States
Senior Vice President of Regulatory Innovation
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