Schedule

Creating a Coordinated Path Forward: Biomarkers in Drug Discovery and Clinical Practice

Mar 28, 2017
Track 1
11:20 AM - 12:10 PM

The use of biomarkers in pharmaceutical development and early-phase clinical trials has increased dramatically since the sequencing of the human genome, but particularly over the last few years, with a growing consensus that biomarkers have the potential to speed and improve drug development.

In fact, last spring, the Biotechnology Innovation Organization, in partnership with Biomedtracker and Amplion, released the largest study ever of clinical development success rates that, for the first time, quantified the benefit of using selection biomarkers in drug development — the findings showed that the likelihood of approval from Phase I increased to one in four with the use of selection biomarkers compared to less than one in 10 without. This real data, impressive on its own, makes a clear statement about where the future of drug development is headed and how it could transform the precision medicine landscape.

This panel will address, among other topics:

  • The overall use of biomarkers in drug development and the clinical space from a variety of stakeholder perspectives
  • Biomarker strategies as a business model component and driver for both corporate and industry growth
  • Suggestions for accelerated approval pathways that focus on biomarker development
  • Key business issues to understand and address prior to entering into a cross-industry product development partnership
  • How the FDA is approaching biomarkers and other 21st-century technologies, including its involvement in pre-competitive partnerships and academic projects across the industry to develop science and infrastructure that everyone can benefit from

 

Speakers

Mark Frasier, PhD, Senior Vice President, Research Programs, The Michael J. Fox Foundation for Parkinson's Research

Pamela Garzone, PhD, Vice President, Early Oncology Development and Clinical Research, Pfizer

Sally A. Howard, JD, Head of Regulatory Affairs and Policy, Human Longevity, Inc.

David Litwack, PhD, Personalized Medicine Staff, Center for Devices and Radiological Health, FDA

MODERATOR: Christine Meda, Chief Business Officer, IncellDx