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Review of the Biomedical Proposals to the 2005 Wright Centers of Innovation Award Program of the State of Ohio: Letter Report THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council April 21, 2005 Marc G. Cloutier, PhD The Vern Riffe Center Ohio Dept. of Development Technology Division-BRTT 77 S. High Street 25th Floor Columbus, OH 43215-6130 Dear Dr. Cloutier: I am writing to transmit the second of three reports from the Committee to Review Proposals to the 2005 biomedical Wright Centers of Innovation (WCI) and the 2005 Biomedical Research and Technology Transfer (BRTT) Partnership Awards program of the State of Ohio. This activity was supported by a contract of the Ohio Department of Development with the National Academy of Sciences and was performed under the auspices of the National Research Council’s Board on Life Sciences. This report provides the committee’s assessment of four proposals to the Wright Centers of Innovation (WCI) program in the biomedical sciences. As you know, applications to the WCI are limited to requests of $10-20 million for major equipment and facilities, and applicants can also request up to $8 million in operational funds to be drawn from the BRTT Partnership Award fund. This report provides an evaluation of four proposals relative to the goals, criteria and objectives of the WCI program, and identifies one proposal that stands out as having the most promising platform for launching numerous commercial products over the long term. The committee’s deliberations on the WCI submissions took place by conference call during the month of February, and during a two-day meeting in Washington, D.C. on February 16-17, 2005. Individual summary assessments of the proposals are attached as Appendix A. THE COMMITTEE AND ITS CHARGE The Wright Centers of Innovation (WCI) program is a competition intended to accelerate the pace of technology research in Ohio and enhance the efficiency with which it is commercialized. The program provides funding for facilities and equipment to
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Review of the Biomedical Proposals to the 2005 Wright Centers of Innovation Award Program of the State of Ohio: Letter Report outstanding multi-organizational collaborations of Ohio’s existing private and public organizations in the core competencies of bioscience, information technology, power and propulsion, advanced material, instruments, controls and electronics. To receive the designation of a Wright Center of Innovation, a multi-organizational collaboration must be of sufficient scale and quality to move Ohio toward a position of international leadership in a technological discipline within these areas of importance to the growth of Ohio’s economy. It must be a statewide technological resource, funded by cost shares from industry, federal grants, and other sources on the order of $30 to $60 million for an operating period of three years, with plans to scale up in the future to levels of research activity and economic development measured in the hundreds of millions of dollars. The National Academies’ National Research Council (NRC) was asked to conduct an independent review of four biomedical proposals submitted in response to the 2005 WCI program announcement. To undertake the review of the proposals, the NRC appointed a 15-member committee with collective expertise across the breadth of biomedical science and its commercial applications. In particular, the committee’s scientific expertise included molecular genetics and genomics, bioinformatics, cell biology, biochemistry, ophthalmology, nano-biotechnology, cancer research, obesity, diabetes, nutrition, biophysics, immunology, neuroscience, drug discovery, radiation and imaging technologies. The committee’s commercial competence included venture-capital investment, drug discovery, start-up formation, and technology licensing. (Appendix B contains short biographical sketches of the committee members.) Before final appointment to the committee, prospective members were screened for potential fiduciary and/or financial interests they or their immediate family members may have had in any of the organizations and institutions involved in the proposals. At the start of its February meeting, the committee held a discussion of bias and conflict of interest and reviewed its composition relative to the expertise needed for the assessment of the proposals. None of the committee members had a conflict of interest. Issues of bias were also aired, and the balance and fairness of the review committee was determined to be sound. The committee was charged with conducting a scientific review and assessment of the commercial potential of the submissions, taking into account the contribution of both the infrastructure and operational plans. The committee was requested to evaluate how well each proposal fulfilled the goals and objectives of the WCI program and to identify the proposal or proposals of greatest merit for consideration by the Ohio Office of Development (which has the authority to designate and fund Wright Centers of Innovation). REVIEW PROCESS Each proposal was assigned to one and in some cases, two committee members as its primary reviewers according to relevant expertise. The program and business plans of each proposal were also reviewed by every other member of the committee; that is, the full committee membership was assigned as secondary reviewers for all proposals. The
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Review of the Biomedical Proposals to the 2005 Wright Centers of Innovation Award Program of the State of Ohio: Letter Report committee members who are venture capitalists were asked to focus specifically on the business plans. All committee members were provided with the Ohio 2005 WCI Request for Proposals (RFP), and a set of evaluation criteria based on information in the RFP. The committee was asked to score the proposal on each of the different criteria. Prior to its February meeting, the committee held a conference call to discuss the review process generally and its initial reactions to each of the WCI applications, in particular, those that did not meet the minimal criteria of the program. During the meeting, the proposals were evaluated in a multi-step process. First, the proposal scores were collated and presented to the committee. Then each proposal was presented by its primary reviewer(s) and discussed by the committee. After a final scoring process, the reports were rank ordered. EVALUATION CRITERIA Using the WCI request for proposals (RFP) for guidance, the committee was given an evaluation tool with which to develop written assessments of the proposals. The specific criteria from the RFP are: Business Partnership Criteria a) Specific Ohio industrial collaborators that will directly benefit from the research focus of the center have been engaged in the development of the center concept. Other relevant industry, professional service entities, and representatives of the private capital community are identified that will participate in the center’s activities in roles such as advisors, sponsors, and strategic partners, and are dominant in the membership of the center’s board of directors. b) The business sector has made financial commitments to support the operation of the center. c) A credible plan exists for business sector involvement in a process to continuously evaluate the commercialization potential of the center’s research activities. Research and Development Criteria a) The research and development program has the requisite scientific excellence to be competitive at an international level and the specific lines of research are scientifically sound. The research program will result in unique competitive advantage in expected fields of commercial development, and has obvious significance to building Ohio’s technology-based economy and to strengthening the competitive position of Ohio’s institutions for leveraging federal and industrial research dollars. b) Key public and private research organizations from around the state needed to establish scale and reputation in the focus area of the center are involved as collaborators. Inter-organizational collaboration, resource sharing and integration of research and commercialization capacity are meaningful and substantial.
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Review of the Biomedical Proposals to the 2005 Wright Centers of Innovation Award Program of the State of Ohio: Letter Report c) The proposal describes plans for recruiting or otherwise involving the highest quality research and technical talent available in the defined technology focus area for the center. Commercialization Criteria a) The technology focus areas of the center, structure of the organization, and personnel support the explicit purpose of creating commercial outcomes relevant to the Ohio economy. Facilities, equipment, programs, teaming arrangements, or other collaborations necessary for accelerating the pace of commercialization of the research outputs are clearly defined and well integrated into the research program. b) The commercialization plan defines realistic commercialization and business objectives that are consistent with the overall concept and structure of the center. Specific Ohio industry sectors that will benefit from the research focus of the center have been clearly identified. The expected economic impacts on these industry sectors resulting from the activities of the center have been defined and quantified. The expected Ohio economic impacts represent a reasonable return for the investment being made by the state. Organizational Criteria a) The vision and concept for the center are sound and represent an initiative that will make a significant contribution to Ohio research excellence and the growth of industry and high wage jobs. The evaluation plan for the center represents rational and measurable indicators of progress. b) The proposal appropriately integrates existing facilities, equipment and programs supported by the State of Ohio and others in designing the overall operating plan for the center. c) The budget plan meets the minimum cost share requirements and has commitments for a portion of the cost share. The budget plan supports the operational plan defined for the center. d) The continuation plan presents a credible scenario for the WCI to continue operating beyond the three-year funding period. SUMMARY ASSESSMENT The goal in establishing Wright Centers of Innovation is to maximize Ohio’s investment in research and to improve existing and emerging industries that are important to the growth of Ohio’s economy. Considering this goal and the criteria set out by the RFP, the committee identified the application for an Atrial Fibrillation Innovation Center (AFIC) (WCI05-13) as the best of the 2005 submissions to the WCI competition, and recommend that it be considered by the Ohio Department of Development for designation as a Wright Center of Innovation.
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Review of the Biomedical Proposals to the 2005 Wright Centers of Innovation Award Program of the State of Ohio: Letter Report The submission was put forward by the Cleveland Clinic Foundation with the collaboration of Case Western Reserve University, the University of Cincinnati, AtriCure, Inc, Philips Medical Systems, Sinus Rhythm Technology, Inc. and Symphony Medical. The proposed Center addresses a distinct area of opportunity – the need for alternatives to drug therapies to address Atrial Fibrillation (AF). The operational plan lays out a logical set of projects aimed at producing multiple commercial products to address AF and the infrastructure request is appropriate to proposed research. Based on the scientists and companies involved in the research and development and the straightforward nature of the research plan, the likelihood appears great that such a Center would be successful. In the committee’s view, some elements of the application require clarification. For example, the proposal budget indicates that there are commitments of more than a cost share of 1:1 to support the operational aspects of the project, but less than the 2:1 cost share required for the capital request. The role of key industry players in supporting the AFIC directly (versus Symphony Medical alone) should also be better defined, and plans for the long-term success of the Center should be addressed. Nevertheless, the proposal is an exciting opportunity for Ohio, which stands to further capitalize on its existing strengths in cardiology research and care. The three other applications submitted to the 2005 WCI competition presented less-compelling and/or less-focused proposals for centers. The Center for Systems Medicine (WCI05-23) proposes to renovate space to build a facility for functional genomics, proteomics, and bioinformatics associated with the Genome Research Institute (GRI). While the reputation of the GRI and its leadership is excellent, the committee’s difficulty with the proposal lies in what seems to be a “disconnect” between the broad ambitions of the Center and the focus of the obesity demonstration project to uncover fundamental mechanisms of the disease in model organisms. The application’s lengthy discussion of each technology was not an adequate substitute for more specifics on what the new proposed Center would be doing. In the end, the capital improvements requested by the submission did not correlate well with the demonstration project. The Ohio Neuromodulation and Neurostimulation Center (WCI05-20) fell short because the proposal did not connect a well-supported scientific plan with the infrastructure request. For example, it is proposed that the supercomputer facility will be able to model the effects of neurostimulation, yet the proposal did not make the case that such a facility is required, since the effects of stimulation on CNS elements can be modeled with less powerful computers. Although the scientists involved in this venture have excellent reputations, and there is potential industry involvement, (from inside and some outside Ohio), it was the uncertainty of the science that gave the committee pause. It is not clear if the scientific premise of the proposed technology is developed enough to consider dedicating a large sum of money and facility to the proposed projects. As the proposal mentions, the state has invested in two BRTT grants as essentially pilot projects in this field of research. Those activities are just getting off the ground and their outcomes might provide a clearer picture of where the science and technology are headed. Finally, the committee was uncertain if the Center of Innovation in Particle Therapy (WCI05-21) actually met the definitional criteria for inclusion in the biomedical sciences focus of the WCI competition. The timeframe for the implementation of the
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Review of the Biomedical Proposals to the 2005 Wright Centers of Innovation Award Program of the State of Ohio: Letter Report initial goals of the proposal are not consistent with WCI award. There did not seem to be the appropriate level of expertise leading this effort. The application also could have been better written. ADDITIONAL COMMENTS It is troublesome that in many cases potential industrial collaborators seem to be standing by waiting to commercialize what might come out of a Center, but are less likely to be true collaborators from the start. The Centers would all be stronger, and achieve Ohio’s larger goals, with the proactive participation of industry partners. At the Department of Development’s request, the committee would be pleased to send a subgroup to Ohio meet with representatives of the leading application to further explore the plans for the proposed Center and its prospects for success. The committee will present findings from that management review meeting in a final report and provide Ohio with additional guidance as it makes funding decisions related to the WCI awards. Sincerely, Barbara Hansen Chairwoman Committee to Review Biomedical Proposals to the 2005 Wright Centers of Innovation cc: Warren Muir Frances Sharples Appendixes: A. Individual Summary Evaluations B. Committee Biosketches
Representative terms from entire chapter: