1. Department of Medicine Research 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 Source CWRU 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

10. DOM Total Research Funding Trend

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

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

13. 0 3 6 12 18 Enrollment Speed = Competitiveness & $$ CDA Dept. protocol review Dept Budget review Dept Packet preparation IRB Submission Research Agreement Site Initiation 0 3 6 12 18 Enrollment 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 0 3 6 12 18 Enrollment CDA Dept. protocol review Dept Budget review Dept Packet preparation IRB Submission Research Agreement Site Initiation 0 3 6 12 18

14. Benefits/Opportunities Partnerships on IITs Cost-sharing

15. Awarded Total Cost by Division AY 2011-2012

16. Federal vs. Non-Federal Research Funding Institution Total Funding Total Federal Funding % Total Non-Fed Funding % CWRU Dept. of Medicine (FY 2011- 2012) $44.8M 70% All Federal Sources 30% Johns Hopkins SOM (FY 2011) $731M 76% All Federal Sources 24% Duke University Medicine (FY 2008)$682M 48% NIH Only 52% Washington U - St. Louis SOM (FY 2010) $596.1M 77% All Federal 23% U Penn Perelman SOM (FY 2010)$583M 70% NIH Only 30% Uof Michigan Medical School (FY 2011) $490.2M 65% NIH Only 35% Columbia College of Physicians and Surgeons (AY 2012-2013) $404M 81% All Federal Sources 19% Harvard Med School (Including HSDM) (FY 2011) $313.6M 88% All Federal Sources 12%