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Drug Repurposing and Repositioning Workshop Summary (2014) / Chapter Skim
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5 Policy Approaches and Legal Framework
Pages 39-48

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From page 39...
... However, the biotechnology and pharmaceutical industries have been resistant to collaborative research because intellectual property is so important in this sector, said Arti Rai, Elvin R Latty Professor at Duke University.
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From page 40...
... Programs undertaken by NIH in the United States and the MRC in the United Kingdom have been developed to foster innovation in drug repurposing and to increase the understanding of disease mechanisms by promoting collaborations between pharmaceutical companies and academic researchers, Rai said. OVERCOMING BARRIERS TO DRUG REPURPOSING AT NCATS The mission of NCATS is "to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions,"1 said Christine Colvis, director of extramural therapeutics discovery at NCATS.
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From page 41...
... NIH provides template collaborative research agreements, confidential disclosure agreements, mechanisms for peer review, funding, and oversight of the program. The pharmaceutical partners provide therapeutic compounds and relevant drug data along with in-kind support.
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From page 42...
... After peer review, the top-rated applicants were put in contact with the company for the first time. At this point the partners could make a joint decision about whether or not to go forward and execute collaborative research agreements and confidential disclosure agreements.
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From page 43...
... The overall strategy is to ensure that the science it supports is of relevance to human health. Under the Mechanisms of Disease Initiative, the MRC has been working with AstraZeneca to provide academic researchers access to compounds that AstraZeneca has deprioritized and is therefore no longer developing (Wadman, 2012)
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From page 44...
... NCATS and MRC both have detailed provisions for publication, and both draw a distinction between background, including existing intellectual property protections, and the research results that could emerge from the collaboration. The programs being conducted by the two agencies differ in several key ways, however, said Rai.
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From page 45...
... In particular, the use of a template known as the Model Industry Collaborative Research Agreement, which has been approved by a wide range of stakeholders, made it possible for the research agreements to be signed within 4 months of the announcement of funding decisions. COMPOUND AVAILABILITY A smaller and less formal program for investigators who need a small amount of a compound to do a quick cell culture or animal experiment would be very helpful, Dietz said.
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From page 46...
... Confidentiality agreements were necessary among all partners in order to allow for the protection of some of the more detailed information, the sharing of information necessary for choosing the right molecules, the protection of the intellectual property of potential applicants, and the assuring of confidentiality from the peer reviewers, Watkins said. AstraZeneca retains the intellectual property on its molecules, Watkins said, while any intellectual property resulting from the research is to be retained by the research organizations.
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From page 47...
... If the compound is not being marketed, a method-of-use patent provides more exclusivity, though the level of exclusivity depends on the strength of the method-of-use patent. An alternative intellectual property approach may be needed, given that the patent system is not now working optimally for the biopharmaceutical industry, Rai said.
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Key Terms

  • research agreements
  • academic researchers
  • template agreements
  • cures act
  • disease mechanisms

  • template collaborative
  • human disease
  • potential therapeutic
  • pharmaceutical partners
  • human diseases

  • disclosure agreements
  • clinical trial
  • therapeutic interventions
  • property protections
  • ceutical industry

  • partners provide
  • validate targets
  • overcoming barriers
  • confidential disclosure
  • moddern cures

  • drug data
  • research councils
  • existing intellectual
  • relevant drug
  • alternative intellectual

  • provide academic
  • disease biology
  • drug information
  • drug indications
  • research proposals


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