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Join the Biotech Clinical Strategies Workshop

Peer-to-peer interaction & a deep understanding of key topics.


LSX Clinical Strategies Workshop

Join the Clinical Strategies Workshop on FDA Modernization Act 2.0: Accelerating Drug Development and Reducing Costs taking place Thursday 4 May, 14:00

This workshop is free to attend and takes place alongside the conference sessions.

Workshops are for >40 attendees and are designed to deliver case studies and share best practice and strategy.

FDA Modernization Act 2.0: Accelerating Drug Development and Reducing Costs

President Biden of the United States of America recently signed into law the omnibus spending bill, which incorporated the FDA Modernization Act 2.0. This Act requires the FDA to consider alternatives to animal testing by amending the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act (PHSA), which applies to biosimilar drugs. This session will explore the potential advantages of the Modernization Act, including:
  • Accelerating drug development and lowering costs by using alternatives to animal models
  • Reducing or waiving animal testing requirements by leveraging in vitro, in silico and in chemico tests
  • Expanding flexibility already associated with the 505(b)(2) New Drug Application (NDA) process and creating a speedier path to market for 505(b)(1) NDAs and biosimilars
  • Identifying applications of in silico models in the clinical setting to streamline programs

William Salminen, Vice President, Nonclinical Safety and Toxicology, Premier Consulting

 William Salminen, Vice President, Nonclinical Safety and Toxicology, Premier Consulting

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