Featured event – San Diego Symposium

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Please Contact Michael Loftus for questions or to reserve your seat.

Michael Loftus, MPA
(909) 295-4578

Mike.Loftus@Integrium.com

Integrium Clinical Research, LLC cordially invites you
to a Lunch and Learn

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

About the Presenters

Dr. Joel Neutel

Medical Director, Integrium Clinical Research, LLC

• Principal, Founder, and Medical Director of Integrium Clinical Research, Orange County Research Center, and Memorial Care Medical Research, with locations in California, New Jersey, and South Africa
• Over 25 years of extensive experience in Proof of Concept clinical trials, serving the biopharmaceutical, Venture Capital, and Private Equity Industries
• Conducted over 250 trials among 6,500 sites and 50,000 subjects; designated as a Specialist in Clinical Hypertension by ASH; and author of numerous publications in pharmacology and a member of several specialty organizations

Dr. Joana Rosario

Senior Medical Advisor, Whitemarsh Capital, LLC

• Former Deputy Director at BSP, DAIDS, National Institutes of Health (NIH); and has facilitated hundreds of investigators access to funding through the NIH
• Over 35 years of experience and internationally recognized as a researcher, educator, government official, and entrepreneur
• Published over 50 peer-reviewed publications and received recognition awards from a list of prominent universities and organizations

Barbara A. Binzak Blumenfeld

Ph.D., Counsel, Buchanan Ingersoll & Rooney PC

• Focuses her practice on clients whose products are subject to Food and Drug Administration (FDA) regulations, including drugs, foods, dietary supplements, medical foods, cosmetics, and medical devices.
• Advises clients on numerous issues such as investigational new drug application (IND) and biologics license application (BLA) requirements for biologic products, such as stem cells.
• Has co-authored a book chapter entitled Pioneer and Generic Drugs: Balance Between Product Life Cycle Extension and Anticompetitive Behavior.

About the Sponsors

Integrium Clinical Research, LLC

• Integrium is a foundation of trusted advisors and clinical Proof of Concept experts across a range of therapeutic indications including cardiovascular, metabolic, regenerative medicine, and orphan compounds
• Founded in 1998; 100+ employees with locations and Phase I-IV research clinics in California, New Jersey, and South Africa; 50+ bed PK Unit in California and 25+ bed PK Unit in New Jersey.
• Access to 7000+ patients within varying disease states and 2500+ healthy volunteers in the US. In addition, access to 10,000+ patients within varying disease states in South Africa, with CRO partners 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

Whitemarsh Capital, LLC

• Whitemarsh Capital has earned a reputation for successfully initiating, negotiating, structuring, and closing middle-market mergers, acquisitions, divestitures licensing and joint ventures.

Our Sponsors