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Session 7 Track 1: Innovation Across the Regulatory Spectrum: A Call to Action for Industry
Session Chair(s)
Jake Doran
Head of Digital
Lykos Therapeutics, United States
While innovative technology in other areas of drug accelerate the capacity for organizations to do more with less or support larger product portfolios, limitations to regulatory process and technology have become an impediment. Further upstream, innovations and advanced analytics and artificial intelligence drive broader molecule evaluation through advanced modeling and simulation. How can we look to technology for similar advancements in the Regulatory environment? During this session we will have an interactive discussion around how the industry needs to embrace innovation and look to the future, while diving into details around a few important areas that can ignite and accelerate advancement.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify and understand areas that are ripe for innovation across the Regulatory spectrum
- Understand how technological advancements can be embraced to transform the submission creation and review process
- Understand how organizational needs have changed and identify design concepts for the “Regulatory Organization of the Future”
Speaker(s)
Panelist
Meredith K Sewell
Sarepta Therapeutics, United States
Vice President, Regulatory Operations
Panelist
Matt Neal, MA
Atara Biotherapuetics, United States
Senior Director, Regulatory Affairs Operations
Panelist
Daniel Chen, PhD
Veeva Systems, Canada
Senior Consultant