july, 2014

23jul11:30 am1:30 pmThe Strategy Behind a Proof of Concept Trial


Event Details

The Strategy Behind a Proof of Concept Clinical Trial:
Balancing Science, Logistics, Economics, and the FDA

  • Reducing Trial Risk while Maximizing the Pharmacoeconomic Value of an Early Phase Compound
  • How to Secure National Institutes of Health (NIH) Funding for a Proof of Concept Trial
  • The Keys to Underwriting a Proof of Concept Trial in Light of the Current Economic Environment
  • Structuring a Study Design and Protocol to Maximize the Post-Phase 2 Value of a Compound

Who Should Attend?

  • Biotechnology CEOs, CMOs, and CFOs
  • Venture Capital
  • Private Equity
  • Angel Investors

Integrium Clinical Research, LLC

  • Founded in 1998; a foundation of 100+ employees, with CRO locations and Phase II-IV research clinics in California, New Jersey, and South Africa; 50+ bed PK Unit in California and 25+ bed PK Unit in New Jersey
  • Specialize in Proof of Concept clinical trials across a range of therapeutic indications including cardiovascular, metabolic, regenerative medicine, and orphan compounds
  • Access to 7000+ patients within varying disease states and 2500+ healthy volunteers, with regional partner CROs in South Africa, Europe, Australia, and India

Buchanan Ingersoll & Rooney

  • Founded in 1850 with 530+ attorneys in 18 offices across the U.S. Buchanan is consistently ranked as a \’powerhouse national law firm\’ by the National Law Journal, with its core service areas including: corporate and financial services; healthcare and pharmaceuticals; technology; and government relations, among others
  • Many of its attorneys have worked for the FDA, Congress or the DEA, as scientists or legal counsel


(Wednesday) 11:30 am - 1:30 pm