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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 $3,912,515 $4,333,996 $192,541 Federal State $53,324,051 Foundation Industry Basic Tenets For industry, time is $$ Patients are currency Types of Research • They come to us • We go to them • Preclinical • Clinical • Early phase • Late phase 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? 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 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 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 DOM Total Research Funding Trend 80000 $69,271 70000 $67,404 $61,763 Thousands 60000 $52,516 $56,157 50000 40000 30000 20000 10000 0 AY 07-08 AY 08-09 AY 09-10 AY 10-11 AY 11-12 Clinical Research Balance Regulatory oversight Human subject protections Scientific advancement Product development Timeline and Cost of Drug Development Pre-tax cost avg. $800 million to bring a new drug to market Speed = Competitiveness & $$ 00 33 CDA CDA CDA CDA Dept. protocol review Dept Budget Dept. protocolreview review Dept Packet preparation Dept. protocol review IRB Submission Dept Budget reviewreview Dept. protocol Research Agreement Dept Packet preparation Site Initiation Dept Budget review IRB Submission Dept Budget review Dept Packet preparation Research Agreement 66 Site Initiation Dept Packet preparation IRB Submission Enrollment 12 12 Research Agreement IRB Submission Enrollment Site Initiation Research Agreement 18 18 Enrollment Site Initiation Benefits/Opportunities • Partnerships on IITs • Cost-sharing Awarded Total Cost by Division AY 2011-2012 $4,907,906 $2,599,025 $10,642,725 $446,135 $1,227,221 CV Medicine Clinical Pharm Endocrinology GI $24,793,472 $3,873,649 $313,600 Gen Med $70,229 Geriatrics $12,889,141 Heme-Onc/Cancer Center ID/HIV/Medicine Nephrology/Hyp Pulmonary/CC/Sleep Federal vs. Non-Federal Research Funding Institution Total Funding Total Federal Funding % Total Non-Fed Funding % CWRU Dept. of Medicine (FY 20112012) $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%