Department of MedicineResearch Retreat 2/9/13

Breakout Session #4:Enhancing Industry-sponsored Research

Opportunities

Marco Costa, MD, PHDNeal Meropol, MD

AY 2011-2012 Awarded Cost by SourceCWRU Department of Medicine

$53,324,051

$192,541

$4,333,996

$3,912,515

Federal

State

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

AY 07-08 AY 08-09 AY 09-10 AY 10-11 AY 11-120

10000000

20000000

30000000

40000000

50000000

60000000

70000000

80000000

$52,515,661 $56,157,476

$69,271,446 $67,404,168

$61,763,103

Clinical Research Balance

Scientific advancementProduct development

Regulatory oversightHuman subject protections

Pre-tax cost avg. $800 million to bring a new drug to marketPre-tax cost avg. $800 million to bring a new drug to market

Timeline and Cost of Drug Development

0

3

6

12

18

Enrollment

Speed = Competitiveness & $$

CDADept. protocol reviewDept Budget reviewDept Packet preparationIRB SubmissionResearch AgreementSite 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

Benefits/Opportunities

• Partnerships on IITs• Cost-sharing

Awarded Total Cost by DivisionAY 2011-2012

$10,642,725 $446,1

35$1,227,

221$3,873,

649$313,6

00$70,22

9$12,889,141

$24,793,472

$4,907,906

$2,599,025CV Medicine

Clinical Pharm

Endocrinology

GI

Gen Med

Geriatrics

Heme-Onc/Cancer Center

ID/HIV/Medicine

Nephrology/Hyp

Pulmonary/CC/Sleep

Federal vs. Non-Federal Research FundingInstitution 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%