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Regulatory Frameworks: How Can Regulators Facilitate Disruptive Innovation?
Session Chair(s)
Nancy Bradish Myers, JD
CEO and Founder
Catalyst Healthcare Consulting, United States
This forum will provide an overview of the regulatory context for the coming surge of disruptive innovation. We will discuss the challenges involved and explore how FDA and others could collaborate to develop new approaches to facilitate this innovation. We will describe the steps FDA has already begun taking to prepare, as well as lay out where the agency could go further.
Learning Objective : Explain how disruptive innovations will challenge regulatory frameworks; describe how FDA, companies and patients may approach collaborating to facilitate disruptive innovations such as gene therapy, combination products and microbiome exploration; Explain how regulatory approaches may change in order to accommodate this innovation
Speaker(s)
Panelist
Richard Moscicki, MD
PhRMA, United States
Chief Medical Officer and Executive Vice President, Science and Regulatory
Gene Therapy Cures: How Will They Break the Mold?
Anne-Virginie L. Eggimann, MS
bluebird bio, Inc., United States
Chief Regulatory Offcer
Panelist
Tal Zaks, MD, PHD
OrbiMed, United States
Venture Partner