Establishing Precompetitive Collaborations to Stimulate Genomics-Driven Product Development Workshop Summary (2011) / Chapter Skim
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The field of genomics has the potential to revolutionize our interactions with the health care system, from increasing awareness of our risk for common diseases to individualized drug design. However, even with the significant increase in basic discoveries since the sequencing of the human genome 10 years ago, there has been a troubling paucity of new disease therapeutics, diagnostics, and preventive measures based on these discoveries.
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protections and funding can be cumbersome or completely inhibitory to establishing collaborative ventures and must be overcome to facilitate this process and realize the potentially immense benefits. To explore these issues and develop potential solutions, the Roundtable on Translating Genomic-Based Research for Health held a workshop on July 22, 2010, entitled "Establishing Precompetitive Collaborations to Stimulate Genomics-Driven Drug Development" (see Appendix A for the full agenda)
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A wide variety of topics and tools are potential targets for precompetitive collaboration according to Ginsburg, including biospecimens, model systems, drug targets, probes, clinical and molecular data, preclinical models, software, and clinical trials data. IDENTIFyING NEW APPROACHES TO PRECOMPETITIvE COLLAbORATION Stephen Friend, president and chief executive officer (CEO)
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Successful collaborations may require particular inputs, recounted Friend. One likely element of success is a neutral convener that can combine the relevant stakeholder perspectives and provide a legal safe harbor for collaboration.
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Finally, effective collaborations may require the identification and prioritization of "bottleneck" knowledge gaps that can be addressed more effectively through precompetitive collaboration, the development of information "utilities" such as data standards and infrastructures, less regulatory uncertainty, and more head-to-head evaluations of collaborative models to identify key features and best practices. For example, Friend suggested that Clinical and Translational Science Awards could provide a mechanism for greater collaboration, as the institutions that have received these awards are working on ways to share data that could provide a template for many other kinds of partnerships.
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Pharmaceutical companies could use biomarkers to investigate drug targets, biological pathways, and disease mechanisms, leading to more efficient drug discovery and development, targeted therapies, and faster and less costly innovation cycles. Diagnostic companies could expand their portfolio of potential diagnostic products and reduce the risks in the discovery process.
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of Specimens Cases per Year Large tissue banks, repositories, and core facilities >2.8 million 119.6 million 390,790 Longitudinal studies >340,088 508,088 Pathology specimens >160 million >160 million >8 million Newborn screening laboratories >13.5 million >13.5 million <10,000 to >50,000 Forensic DNA banks 1.4 million 1.4 million Sperm, ovum, and embryo banks >>200 >9,900 >9,900 Umbilical cord blood banks >18,300 >18,300 Organ banks >75,500 >75,500 Blood banks ~12 million ~12 million Total >178 million >307.1 million >20.5 million SOURCE: E Eiserman and S
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and an informal survey Ginsburg conducted among colleagues before the workshop found that one major pharmaceutical company enrolls about 32,000 patients per year in clinical trials and an academic health center reported 45,000 patients in trials and registries in 2010, although each collects specimens from only a fraction of those patients. Additionally, a recent survey by Willett and colleagues (2007)
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