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Tuesday, October 29 • 11:00am - 11:45am
Leverage Innovative Regulatory Pathways to Expedite Drug Development

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  • Outline major regulatory incentive programs available in the U.S., EU, and beyond, and how these pathways can be leveraged across the development life cycle
  • Understand the financial and commercial benefits for each of the different pathways
  • Consider how a regulatory strategy can align with a company’s corporate strategy to achieve future business success

Speakers
avatar for Kim Raymer

Kim Raymer

Vice President, Regulatory Affairs, HALLORAN CONSULTING GROUP
Kim Raymer has more than 24 years of professional experience in regulatory affairs, with deep expertise in chemistry, manufacturing, and controls (CMC). Kim has extensive experience with the regulatory CMC aspects of investigational and marketed drug products for both small molecules... Read More →
avatar for L. Mary Smith, Ph.D.

L. Mary Smith, Ph.D.

Senior Vice President, Clinical Research and Development, SPRINGWORKS THERAPEUTICS
Dr. Mary Smith is responsible for designing and running the clinical development programs. Prior to joining SpringWorks Therapeutics Mary was the executive vice president of gene therapy at Bamboo Therapeutics, a wholly owned subsidiary of Pfizer where she led several key gene transfer... Read More →
avatar for Matthew Boyd

Matthew Boyd

Vice President, Regulatory Affairs, North America, SOBI

Tuesday October 29, 2019 11:00am - 11:45am PDT
  Product Development Strategy