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Research at the interface of industry, academia and regulatory science

Nature Biotechnology volume 28, pages 432–433 (2010)Cite this article

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A medicine is defined as 'a substance or preparation used in treating disease'. Society expects that the benefits of medicines should substantially exceed their risks, and this expectation has been translated into governmental policy around the world. Part of the mission of the US Food and Drug Administration (FDA) is to protect the public health by assuring the safety and efficacy of medicines1. The FDA has carried out its mission by relying upon the best current scientific knowledge and practice2. By definition, gaps in current scientific knowledge and practice limit the ability of regulatory agencies, such as the FDA and the European Medicines Agency (EMEA; London), to carry out their mission. Current gaps include a limited ability to extrapolate animal data to humans3,4,5, the difficulty of evaluating genetic and carcinogenic risks6,7, and our poor understanding of gender-specific responses8. It is hoped that new knowledge, technologies and tools can address these and other gaps and improve the evaluation of new drugs and medicines9,10,11,12.

In this context, the FDA has advocated a 'Critical Path Initiative'13,14 to intentionally address gaps in applied and regulatory science. The initial report and subsequent listing of specific opportunities15 called attention to research and tools needed to improve the process of drug development that extends from preclinical testing to ultimate regulatory registration. Although this area is vital for improving the development of new medicines and getting them to the public, it receives little academic, public or legislative attention and, thus, little funding. Rather, the focus of both academic research and news organizations is often on novel discoveries and/or the risks and benefits of drugs after they have reached the marketing phase. Nevertheless, a great deal of essential work must be accomplished between discovery and delivery (that is, in the critical path) to accomplish the delivery of safe and effective medicines to the public. With the goal of improving that process, the FDA has not only identified gaps in 'Critical Path Research' but also suggested that an effective approach to address these gaps would be to form consortia of industry, academic and regulatory scientists to share resources, expertise and experience toward accomplishing shared common specific objectives.

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Authors and Affiliations

  1. Critical Path Institute, Tucson, Arizona, USA

    William B Mattes, Elizabeth Gribble Walker & Raymond L Woosley

  2. European Medicines Agency, Canary Wharf, London, UK

    Eric Abadie

  3. Department of Laboratory Sciences and Investigative Toxicology, Safety Assessment, Merck Research Laboratories, West Point, Pennsylvania, USA

    Frank D Sistare

  4. Novartis, San Diego, California, USA

    Jacky Vonderscher

  5. Food and Drug Administration, Silver Spring, Maryland, USA

    Janet Woodcock

Authors
  1. William B Mattes
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  2. Elizabeth Gribble Walker
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  6. Janet Woodcock
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  7. Raymond L Woosley
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Correspondence to William B Mattes.

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Competing interests

F.D.S. is an employee of Merck and J.V. is an employee of Novartis.

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Mattes, W., Walker, E., Abadie, E. et al. Research at the interface of industry, academia and regulatory science. Nat Biotechnol 28, 432–433 (2010). https://doi.org/10.1038/nbt0510-432

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