1 / 16

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.

helmut
Télécharger la présentation

Department of Medicine Research Retreat 2/9/13

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related