1. IndianaCTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Building an Indiana Biorepository Dave A Flockhart Eric Meslin April 19 th, 2010

2. IndianaCTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Support $6 million from the Lilly Foundation $2 million to build an Informatics Portal

3. IndianaCTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Biobanks in Context Biobanks are collections of samples linked with other valuable information Biobanks can take many forms, i.e. blood, plasma, serum, urine, tumor tissues, etc. Biobanks can be as small as less than a hundred samples or can be as large as hundreds of thousands

4. IndianaCTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Examples of large Biobank linked to EMRs –Marshfield Clinic: Marshfield, WI; N=18000 (Wisconsin residents) –UK Biobank: United Kingdom; N=500,000 ages 40-60yo; collects DNA, serum, plasma and urine linked to medical records and lifestyle questionnaires –Biobank Japan: Kanagawa, Japan; N=300,000; DNA samples from individuals of 20+ –BioVU: Vanderbilt’s DNA Bank; N=75,000+; DNA samples linked to eMR –RPGEH: Kaiser Permanente Research Program on Genes, Environment, and Health; N=500,000; the completed resource will link together comprehensive electronic medical records, data on relevant behavioral and environmental factors with the DNA obtained from blood or saliva

5. IndianaCTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Technical Requirements Comprehensive Governance Structure Robotic Access and Retrieval Fast and Effective Access to Preliminary Data Fast and Effective Access to Samples User-Friendly Outcomes Data

6. IndianaCTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Principles for the Indiana Biobank Catalytic for all Indiana Researchers User-friendly Informatics and Access Regulatory compliant and ethically sound A sample repository linked to validated data, including medication data Clear, robust SOPs for collection, storage and sharing.

7. IndianaCTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Biobank Governance Issues –Consent policies and procedures Opt-in, opt-out –Public engagement strategies Building, maintaining trust Benefit-sharing –Privacy/confidentiality assurances Balancing protection and discovery –Data/sample sharing SOPs –Commercialization, IP, tech transfer –Harmonization challenges (esp. international)

8. IndianaCTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Privacy and the Need to Identify Source: Altman, (2005)

9. IndianaCTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Commercialization Varying resistance to the role of industry  The Moore objection  Commodification as a moral wrong  Source of sponsorship Human body has financial value  Tissue samples for research, esp. with rare diseases; health data linked to unique phenotypes Product development  Pharmacogenomics drugs  Tailored therapeutics  Device development

10. IndianaCTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Public Willingness to Participate in Biobanks

11. IndianaCTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Informed Consent: What Do We Know? Physicians and Nurses—Pediatric Biobanking MD and RN attitudes toward pediatric biobanks are similar Broad support for a pediatric biobank from HCP, including support for unspecified use of samples –Denne, Wolf, Meslin et al (2008) [Unpublished] Women and Pregnant Mothers 77% felt predictive health research was worthwhile Most supported consent for future use –Haas, Renbarger, Meslin, Drabiak, Flockhart (2008) IU Cancer Patients ~85% agreed that stored tissue could be used in unspecified future research 60-70% would not require re-contact each time tissues were used –Helft, Champion, Eckles, Johnson, Meslin, (2007) Parental Attitudes-—Pediatric Biobanking 68% agree/strongly agree pts should have chance to be in research 81% somewhat/very likely to permit child’s blood to in biobank 91% have fair/great deal of trust in hospitals to protect confidentiality 62% oppose/strongly oppose commercialization  Harland, Miller, Meslin, Wolf, Denne (2010)

12. IndianaCTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Administrative databases which collect: birth records, midwives' notifications, cancer registrations, inpatient hospital morbidity, in- patient and public out-patient, mental health services data and death records Used in combination with medical record audits to provide a comprehensive evaluation of health system performance. “When people in the general community were asked if they approved of their information being used in this way, they were found to be not only supportive of it, but they questioned why it was not already being done.” Source: Stanley and Meslin (2007)

13. IndianaCTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH The Future New Diagnostic Tests Biomarkers of Therapeutic Response New Targeted Therapies