FierceBiotech Drug Development Forum 2019

Tue, Oct 29th 2019

Leverage Innovative Regulatory Pathways to Expedite Drug Development

Tuesday, October 29th, 2019 11:00 a.m. - 11:45 a.m.

Join Kim Raymer, Halloran's VP of Regulatory Affairs, (among other speakers) for an informative session that will:

  • 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

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 →

Dr. Mary Smith, 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 →

Matthew Boyd, Vice President, Regulatory Affairs, North America, SOBI