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

ABOUT THE SPONSORS
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