Monday, November 7, 2011
9:15 AM - 10:10 AM
Panel - Living and Working in the Precompetitive Space
Aled M. Edwards, Ph.D., Chief Executive, Structural Genomics Consortium
Hoyoung Huh , M.D., Ph.D. , Chairman of the Board, Geron Corporation
Daniel Laster, J.D., General Counsel, Legal Affairs, PATH
Susan Rohrer, Ph.D., Senior Director, External Scientific Affairs, Worldwide Licensing, Merck Research Laboratories
David Steinberg, Partner, PureTech Ventures
Steve Usdin, Senior Editor (Washington), BioCentury
Over the last year there has been increasing interest within the biotech and pharmaceutical industries in collaborating more across companies and sectors on pre-competitive areas of research. But the concept remains ill-defined. Where does "precompetitive" end and "competitive" begin? How should intellectual property be treated, and can it be handled in a standardized way? Can we create a "marketplace" that will help facilitate the exchange of pre-competitive information? This panel focused on the mechanics of managing collaboration in a precompetitive environment, and the pros and cons of open access.
Moderator Steve Usdin, BioCentury, set the stage by asking the panelists to help the audience understand what precompetitive means by offering an example of a precompetitive research effort in which they, or their organizations, are involved.
Aled Edwards outlined how the Structural Genomics Consortium - a public/private partnership that supports the discovery of new medicines through open access research - puts all of its research outputs into the public domain without a patent, with the goal of bringing more novel targets to proof of concept phase. The business case is there, he argued, for a "patent-free zone" explicitly for science. Edwards was especially passionate about jump-starting more collaboration in the biomedical research system to compensate for its flaws: "We have concepts being pursued in secret and in parallel. This system is a waste of brains, a waste of money and, as it were, a waste of patients."
Next, Dan Laster, of PATH's Legal Affairs, talked about the annual "enabling platform meeting" that PATH hosts for developing world vaccine manufacturers to come together and independently decide in a safe, neutral space, what information they can and will share with each other precompetitively.
PureTech Ventures' David Steinberg, an entrepreneur who starts companies based on academic technologies, noted that "precompetitive does not necessarily mean not for profit; it doesn't mean no IP; and it doesn't mean open access." He referenced Enlight Biosciences as an example, which has partnered with seven pharmaceutical companies to understand critical unmet needs within their organizations (from a platform and enabling technology perspective) and gone on to start companies in those areas with the help of leading scientific advisors.
Susan Roher of Merck, which is involved in approximately 35 precompetitive collaborations, focused her comments on two of the company's open access partnerships - the Alzheimer's Disease Neuroimaging Initiative (ADNI), and the Parkinson's Progression Markers Initiative (PPMI). These are big problems and big projects she said - working to move the field from simply treatment of symptoms to therapies that address disease progression. Merck and its partners do this by working to understand the biomarkers associated with early stages of disease, and the ways in which data is collected and analyzed.
Hoyoung Huh, Chairman of the board of directors of Geron Corporation, a public biotechnology company in oncology and stem cells, suggested that the term precompetitive is a strange one in the biotech industry. "For such large biomedical problems like stem cells, even millions are not enough to adequately address them. Efforts are too sub scale and fragmented, and we need to coordinate them. Additionally, intellectual property needs to be overhauled and change how companies are compensated." IP, he noted, was a fundamental issue preventing innovative private/public partnerships from progressing.
Steinberg stepped in to offer a solution to the IP problem: "If you start a consortium, and the organizations have to fight over the IP, they won't get anywhere. Thus, a third party developing biomedical technology can be very powerful."
The panel progressed to a debate on the issue of scale. Edwards stepped in and said, "If [the collaboration]'s too big, you can't manage it and it will fail. It needs to be small enough and adequately managed.' He continued to make the case for open access, bringing up the point that "if you make all the data available, you will be able to manage the world's issues."
Rohrer stressed the existing examples of data sharing: "Sage is collecting data from clinical trials that have been conducted and making that data available to researchers worldwide. It is happening."
Laster emphasized the importance of agreeing on the outcome of precompetitive consortiums and collaborations from the get go. Without that clarity, you are bound to failure. He also noted that "the best science is no longer occurring exclusively in the United States. It's time to adopt a global view of collaboration."