CHAIR
:
SPEAKER
(S):
Michael Bonney, President and CEO, Cubist Pharmaceuticals
James Czaban, JD, Partner, FDA Department, WilmerHale
Alexis Borisy, AM, President and CEO, Founder, Combinatorx,Inc.
Robert Zerbe, MD, CEO, Founder, QuatRx Pharmaceuticals
Description
As biotechs and biopharmaceutical companies explore alternative means to accelerate pipeline building, previously abandoned drug candidates, or new combinations of existing drugs may be worth examining when they match an unmet medical need and fit within a therapeutic sweet spot. This panel will discuss the challenges involved (from IP protection to regulatory risk) and offer helpful lessons as well as significant cautions.
Objectives:
Outline costs/benefits to consider up front.
Discuss relevant case studies demonstrating both success and failure.
Present specific problem-solving techniques: for acquisition of external compound(s); IP; regulatory path forward.