Biotech and Pharma Public-Private Partnerships

Thursday, October 25, 2007

About

With the time and costs involved in drug discovery and development, it is vital that licensing and sponsored research deals appropriately balance contributions and rewards and recognize and utilize the strengths of collaborating parties. This is especially true as the biotech and pharmaceutical industries, driving R&D at an accelerating pace, look more and more to collaborate with the government and institutional researchers for a competitive edge. However, there is a distinct culture clash between industry and academia/government that leads to wheel-spinning, which prevents agreements from being reached and important innovations from being noticed, and ultimately leads to pipeline stagnation, diminished efficiency and profitability, and competitive disadvantage.

Determining which party owns the IP in an industry-research institution deal is a persistent issue confronting these collaborations. Moreover, Bayh-Dole restrictions, which are difficult and expensive to accommodate, cause their own separate concerns about the clarity of IP positions. Government contracts can be bureaucratic and inflexible, and government-funded and university initiatives often require data sharing and publication. This is in stark contrast to companies’ vested interest in keeping their development work confidential. Institutions largely vary in their respective policies for requiring assignments of inventions and for licensing technologies. And industry remains unclear about NIH guidelines and federal tech transfer statutes, the academic/government processes for negotiation of collaborations, and the constraints and discretion of academic/government negotiators.

It is critical that you gain awareness of the prevailing culture on the other side so that a common language can be found. ACI’s publication from Biotech and Pharma Public Private Partnerships offers the Rosetta Stone in finding this common language. The publiaction brings together a distinguished faculty of leading experts from big pharma, small biotech, NIH and other government agencies, and research institutions. They provide an intensive and thorough framework for overcoming the critical issues that arise in bridging the innovation gap between industry and academia/government.

Contents & Contributors

About

With the time and costs involved in drug discovery and development, it is vital that licensing and sponsored research deals appropriately balance contributions and rewards and recognize and utilize the strengths of collaborating parties. This is especially true as the biotech and pharmaceutical industries, driving R&D at an accelerating pace, look more and more to collaborate with the government and institutional researchers for a competitive edge. However, there is a distinct culture clash between industry and academia/government that leads to wheel-spinning, which prevents agreements from being reached and important innovations from being noticed, and ultimately leads to pipeline stagnation, diminished efficiency and profitability, and competitive disadvantage.

Determining which party owns the IP in an industry-research institution deal is a persistent issue confronting these collaborations. Moreover, Bayh-Dole restrictions, which are difficult and expensive to accommodate, cause their own separate concerns about the clarity of IP positions. Government contracts can be bureaucratic and inflexible, and government-funded and university initiatives often require data sharing and publication. This is in stark contrast to companies’ vested interest in keeping their development work confidential. Institutions largely vary in their respective policies for requiring assignments of inventions and for licensing technologies. And industry remains unclear about NIH guidelines and federal tech transfer statutes, the academic/government processes for negotiation of collaborations, and the constraints and discretion of academic/government negotiators.

It is critical that you gain awareness of the prevailing culture on the other side so that a common language can be found. ACI’s publication from Biotech and Pharma Public Private Partnerships offers the Rosetta Stone in finding this common language. The publiaction brings together a distinguished faculty of leading experts from big pharma, small biotech, NIH and other government agencies, and research institutions. They provide an intensive and thorough framework for overcoming the critical issues that arise in bridging the innovation gap between industry and academia/government.

Contents & Contributors

IP TERMS IN SPONSORED RESEARCH AGREEMENTS
Merrilea J. Mayo, Ph.D, The National Academies (Washington, DC)

VALUING EARLY-STAGE OPPORTUNITIES: MANAGING UNCERTAINTY
Thomas M. Argentieri, Ph.D., Wyeth Pharmaceuticals (Collegeville, PA)

VALUING EARLY-STAGE IP IN INDUSTRY/RESEARCH INSTITUTION DEALS
Mary E. Dicig, Esq., University of Illinois at Chicago (Law Office of Mary Dicig) (Chicago, IL)

VALUING EARLY-STAGE IP IN INDUSTRY/RESEARCH INSTITUTION DEALS
Howard S. Schwartz, DLA Piper (Baltimore, MD)

MANAGING CRITICAL IP PROTECTION AND COMMERCIALIZATION ISSUES IN INDUSTRY/ACADEMIA COLLABORATIONS
Stephanie Hansen, J.D., Pfizer Global Research and Development (Groton, CT)
Jennifer Murphy, George Mason University (Fairfax, VA)
Tauseef R. Butt, Ph.D., Progenra, Inc. (Malvern, PA)
Jennifer S. Hsieh, Stony Brook University (Stony Brook, NY)
Jon Lourie, Edwards Angell Palmer & Dodge LLP (Boston, MA)

MANAGING CRITICAL IP: PROGENRA APPROACH
Tauseef R. Butt, Ph.D., Progenra, Inc. (Malvern, PA)

LICENSES WITH RESEARCH INSTITUTIONS AND THE GOVERNMENT: SOLVING THE KEY PROBLEMS THAT CONFRONT THE DEAL
Kai Chen, Ph.D., Iomai Corporation (Gaithersburg, MD)

SUBLICENSING & ASSIGNMENT
John Cosmopoulos, Office for Technology Licensing and Industry Collaboration, Tufts University (Boston, MA)

NIH AS A RESEARCH PARTNER: WHAT EXACTLY IS A COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT (CRADA) ANYWAY?
Claire T. Driscoll, National Human Genome Research Institute (NHGRI)
< National Institutes of Health (NIH) (Bethesda, MD)

EVERYTHING YOU NEED TO KNOW ABOUT COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENTS (CRADAS)
Charles Schlagel, Office of Technology Transfer Naval Medical Research Center (Silver Spring, MD)

INCORPORATING GOVERNMENT R&D COLLABORATIONS INTO YOUR PARTNERSHIP STRATEGY
Kathleen Sybert, Ph.D., Esq., Clinical Technology Transfer Group (McLean, VA)

“LAB TO LIFE” NIH SBIR/STTR FUNDING OPPORTU“NIH”TIES
Jo Anne Goodnight, Office of Extramural Programs OER, NIH, DHHS (Bethesda, MD)

FEDERALLY FUNDED IP: ASSESSING THE STATE OF THE USE OF IT IN GRANTS, CONTRACTS, COOPERATIVE AGREEMENTS, AND THE BAYH-DOLE ACT
Peter Leonardi, Ph.D., MBA, The NewYork-Presbyterian Hospital Columbia University Medical Center (New York, NY)

A NEW MODEL FOR ACCELERATING TRANSLATIONAL BIOSCIENCE
Russell “Rusty” Bromley, Chief Operating Officer, Myelin Repair Foundation (Saratoga, CA)

COLLABORATIONS BETWEEN INDUSTRY, ACADEMIA AND NON-PROFIT FOUNDATIONS: THE GOOD, THE BAD AND THE TRULY DIFFICULT
O. Prem Das, Ph.D., Business Development Consulting (recent former Senior VP, Praecis Pharmaceuticals) (Weston, MA)

MANAGING PARTNERSHIPS
Alex Zisson, Thomas, McNerney & Partners (Stamford, CT)

FOUNDATIONS AND INDUSTRY: MANAGING PARTNERSHIPS BETWEEN THEM AND THE SOPHISTICATION LEVEL OF THE DEAL
Laurence S. Tauber, Cohen Tauber Spievack & Wagner LLP (New York, NY)

PUBLIC PRIVATE PARTNERSHIPS AT THE NIH
Barbara B. Mittleman, M.D., Office of Science Policy/Office of Science Policy Analysis (Bethesda, MD)

PRODUCT DEVELOPMENT AND IP STRATEGIES FOR GLOBAL HEALTH PARTNERSHIPS
Sandra L. Shotwell, Ph.D., Alta Biomedical Group LLC (Portland, OR)

EXAMINING NEW FUNDING ALTERNATIVES FOR BIOPHARMACEUTICAL R&D
Jennifer L. Davis, Ph.D., Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Palo Alto, CA)



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