Guest Column | July 3, 2012

Getting To Proof-Of-Concept In Early Stage Clinical Research

By Sy Pretorius, Corporate Vice President and World-wide Head of Early Phase, PAREXEL International Corporation

Every biopharmaceutical company today is striving to arrive at the Proof-of-Concept decision point for new treatments as quickly and cheaply as possible. Management is looking to identify potential winners and avoid costly late stage failures.

These business imperatives are driving the necessity to transform approaches to early stage clinical development research so that decisions made in this phase allow companies to manage development costs, accelerate development timelines and obtain an earlier path from First-in-Human to successful Proof-of-Concept.

One framework is to break these transformational approaches into three key areas. First, develop a laser-like focus on the data necessary for Proof-of-Concept. Next, determine how to obtain the data as fast and efficiently as possible. Finally, determine whether and how a collaboration or strategic partnership with a contract research organization, academic institution, competitor or open innovation network will allow you to achieve your end result faster and/or cheaper.