Key Aspects of FDA’s Expedited Drug Development and Review Programs
Friday May 12, 2017
MassBio – 300 Technology Square, 8th Floor – Cambridge, MA 02139
Registration/lunch starts at 11:00am.
Presentation starts at 11:30am to 1:00pm.


MassBio Lunch and Learn: Navigating Accelerated Approvals in Today’s Oncology Drug Development Landscape: Ensuring a Properly Tailored Approached Based on FDA Expectations and Current Trends in Drug Development

In recent years, the R&D pipeline of global biopharmaceutical companies has become increasingly enriched with products designed to address unmet medical needs in cancer, rare diseases, and other serious or life-threatening conditions. Given this trend, it is not at all surprising that the FDA’s various expedited development and data review pathways, which are designed for such products, have assumed a much higher profile in drug development.

Understanding this approach as it pertains to oncology drug development is something that is relevant and front of mind for many sponsors and is becoming an increasingly complex area to navigate. Ensuring that novel oncology compounds are successfully developed in today’s background of a rapidly changing environment involving small molecule targeted therapies, immuno-oncology compounds, and (soon) cellular therapies is becoming a challenge many sponsors face as part of their strategic development process. Creating a tailored approach necessitates an appreciation of regulatory pathways specific to each sponsors’ technology and ensuring a line of site into the elements that will allow for the most accelerated pathway from the very start.

Topics for Discussion
  • Specific requirements for FDA’s expedited designations
  • Positive effect on overall drug development time lines
  • Case studies (small molecule drug; immune checkpoint inhibitor)
Speakers
Jean Michel Gries, VP, Worldwide Head, Early Product Development, PAREXEL, will moderate a discussion among the following speakers:
  • Bruce Babbitt, Vice President, PAREXEL Consulting
  • Todd Shuster, M.D., Vice President Global Therapeutic Area Lead – Hematology/Oncology, PAREXEL
  • Alison M. O’Neill, M.D., Vice President, Clinical Development at Radius Health
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