A public-private collaboration model for clinical innovation

Abstract

Launched in May 2012 as part of the New Therapeutic Uses program, the National Center for Advancing Translational Sciences (NCATS)' National Institutes of Health (NIH)-Industry Partnerships initiative fostered collaboration between pharmaceutical companies and the biomedical research community to advance therapeutic development. Over the 10-year life of the initiative, the industry partners included: AstraZeneca; AbbVie (formerly Abbott); Bristol-Myers Squibb; Eli Lilly and Company; GlaxoSmithKline; Janssen Pharmaceutical Research & Development, L.L.C.; Pfizer; Sanofi; and Mereo (out licensed assets). The initiative provided researchers at academic medical centers with a rare opportunity to propose clinical trials to test ideas for new therapeutic uses for a selection of clinic-ready and often previously proprietary experimental pharmaceutical assets that were provided by industry partners. Here, we describe the process by which collaborations between pharmaceutical companies with viable experimental assets and academic researchers with ideas for new uses of those assets were established; and how NCATS/NIH funding supported not only phase I and II clinical trials as well as any nonclinical studies needed before testing in a new patient population, it also provided an opportunity for testing innovative outcome measures for proof-of-concept trials. Although the program did not demonstrate improved success rates for phase II clinical trials, this collaboration model leverages the strengths of each party and with a focus toward evaluating an innovative outcome measure, could be used to reduce patient burden and trial costs, and improve patient engagement.

FIGURE 1

Industry‐based standard drug development timeline versus drug repurposing. Represented in the graphic are typical timelines and pharmaceutical company costs for drug development at each stage in the drug development process. IND, Investigative New Drug; NDA, new drug application.

FIGURE 2

Three‐way partnership model. This infographic depicts the three‐way partnership between academia, government, and pharmaceutical partners and the responsibilities of each party. This partnership brought together specific compound information, formulation, and clinical design expertise from pharmaceutical companies and disease experts in academic medical centers that had access to new patient populations. NCATS, National Center for Advancing Translational Sciences; NIH, National Institutes of Health.

FIGURE 3

This figure depicts the process steps and time needed for three‐way partnerships among academic medical centers, the National Institutes of Health (NIH), and pharmaceutical partners.

FIGURE 4

This figure depicts the process for an academic medical center and a pharmaceutical partner to establish a collaboration after top tier pre‐applications are identified and put in contact with a pharmaceutical partner. CDA, Confidential Disclosure Agreements; CRA, Collaborative Research Agreements.