Clinical Research: Phase 1 - Phase 4

Are We Trading Speed for Innovation in Approving New Drugs?

DURHAM, N.C., February 16, 2018 — Are expedited approvals of new drugs occurring at the expense of innovation? Nach Davé, Vice President of Global Regulatory Affairs at Premier Research, will explore the subject at Outsourcing in Clinical Trials West Coast 2018, February 21 in Burlingame, California.

In his presentation, Faster Approvals but Less Innovation: Trend Analysis and Future Considerations, Mr. Davé will:

  • Analyze expedited drug development pathways at the Food and Drug Administration.
  • Review the latest FDA drug development policies.
  • Examine future considerations that will affect drug development innovation.

About Premier Research

Premier Research is a leading clinical development service provider that helps highly innovative biotech, specialty pharma, and medical device companies transform breakthrough ideas into reality. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, dermatology, medical device, neuroscience, oncology, pediatrics, and rare disease. Premier Research operates in 84 countries and employs 1,100 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. They are focused on smart study design for advanced medicines that allow life-changing treatments.