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Department of Medicine Research Retreat 2/9/13

Department of Medicine Research Retreat 2/9/13. Breakout Session #4: Enhancing Industry-sponsored Research Opportunities Marco Costa, MD, PHD Neal Meropol, MD. AY 2011-2012 Awarded Cost by Source CWRU Department of Medicine. Basic Tenets. For industry, time is $$ Patients are currency.

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Department of Medicine Research Retreat 2/9/13

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  1. Department of MedicineResearch Retreat 2/9/13 Breakout Session #4: Enhancing Industry-sponsored Research Opportunities Marco Costa, MD, PHD Neal Meropol, MD

  2. AY 2011-2012 Awarded Cost by SourceCWRU Department of Medicine

  3. Basic Tenets For industry, time is $$ Patients are currency

  4. Types of Research • They come to us • We go to them • Preclinical • Clinical • Early phase • Late phase

  5. Discussion Points • What types of research can industry support? • What are the pros and cons of industry- vs. other types of support? • What challenges are present at the national level regarding industry support of research? • What challenges are present at the local level (department, hospital, SOM, University) regarding industry support of research? • How can we increase investigator-initiated clinical research? • How can we address the local challenges? What is needed?

  6. Challenges • External • Regulatory complexity • Decreased availability of funds for IITs • Incomplete funding of IITs • Local • Institution not viewed as “go-to” place for industry • Institutional risk aversion • Timelines: budgets – contracts – activation • Lack of investigator awareness of opportunities

  7. Solutions: Investigator-Level • Market our strengths: e.g. patients, infrastructure, efficiency, specialized knowledge • Create unique areas of excellence, capabilities (e.g. health services), resources (e.g. administrative databases) • Expand health services/CER/behavioral science • Become aware of opportunities (also institutional solution) • Increase lab investigators interactions with MDs who can identify/facilitate contacts • Recognize preclinical opportunities, e.g. mechanistic studies of marketed agents • Pitch ideas at all opportunities

  8. Solutions: Institutional level • Themes: • Function more like business • Service orientation • Current lack of awareness of CCRT structure/function/resource – educate faculty – be proactive • Improve efficiency (e.g. Budgets, contracts, IRB) • Establish accountability for timelines • Be cost-competitive (e.g. indirects, clinical tests, research cores) • Expand core support (e.g. stats); run like businesses • Need medical/scientific leadership/oversight of infrastructure: evolve point of view towards service of research • Cost-sharing of academia/industry partnerships – must define ROI • Recognize value of research to national reputation – attracts patients and funding • Develop long-term as well as short-term view vis a vis ROI

  9. DOM Total Research Funding Trend

  10. Clinical Research Balance Regulatory oversight Human subject protections Scientific advancement Product development

  11. Timeline and Cost of Drug Development Pre-tax cost avg. $800 million to bring a new drug to market

  12. Speed = Competitiveness & $$ 0 3 6 12 18 • CDA • Dept. protocol review • Dept Budget review • Dept Packet preparation • IRB Submission • Research Agreement • Site Initiation 0 3 6 12 18 • CDA • Dept. protocol review • Dept Budget review • Dept Packet preparation • IRB Submission • Research Agreement • Site Initiation 0 3 6 12 18 0 3 6 12 18 • CDA • Dept. protocol review • Dept Budget review • Dept Packet preparation • IRB Submission • Research Agreement • Site Initiation • CDA • Dept. protocol review • Dept Budget review • Dept Packet preparation • IRB Submission • Research Agreement • Site Initiation • Enrollment • Enrollment • Enrollment

  13. Benefits/Opportunities • Partnerships on IITs • Cost-sharing

  14. Awarded Total Cost by DivisionAY 2011-2012

  15. Federal vs. Non-Federal Research Funding

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