1. A PPP managed by FNIH Partners are NIH, FDA, CMS, and private industry Barbara B. Mittleman, M.D. Director, NIH PPP Program Bioinformatics Forum March 4, 2009 Public Private Partnerships at the NIH; The Biomarkers Consortium (BC)

2. BC Mission The Biomarkers Consortium endeavors to discover, develop, and qualify biological markers (biomarkers) to support new drug development, preventive medicine, and medical diagnostics. The Biomarkers Consortium endeavors to discover, develop, and qualify biological markers (biomarkers) to support new drug development, preventive medicine, and medical diagnostics. Precompetitive Consortium Precompetitive Consortium

3. Biomarkers Consortium Partners Public Public NIH NIH FDA FDA CMS CMS Private Private PhRMA / BIO PhRMA / BIO Industry/ individual companies Industry/ individual companies Non-Profit Non-Profit Patient Advocacy Groups and Professional Societies Patient Advocacy Groups and Professional Societies Universities Universities FNIH FNIH

4. FNIH FNIH : FNIH : 501(c)(3) charitable foundation 501(c)(3) charitable foundation i.e., NOT the government! i.e., NOT the government! Chartered by Congress in 1990 Chartered by Congress in 1990 Incorporated in 1996 Incorporated in 1996 Mission, per Congress, is to support the mission of the NIH Mission, per Congress, is to support the mission of the NIH Managing partner of the BC Managing partner of the BC

5. BC Structure Executive Committee SC project SC project SC project SC project

6. Governance Structure Executive Committee (15 members) Executive Committee (15 members) decision-making: advise FNIH Board on financial commitments decision-making: advise FNIH Board on financial commitments 3 NIH, 3 FDA, 3 pharmaceutical industry, 1 CMS, 1 biotech/diagnostics/imaging industry, 1 public, 3 NIH, 3 FDA, 3 pharmaceutical industry, 1 CMS, 1 biotech/diagnostics/imaging industry, 1 public, 3 (non-voting) FNIH Steering Committees Steering Committees Content area focused : Neuroscience, Metabolic Diseases, Oncology, Inflammation and Immunity Content area focused : Neuroscience, Metabolic Diseases, Oncology, Inflammation and Immunity Identify and oversee specific project activities Identify and oversee specific project activities Project Teams Project Teams Implement projects Implement projects

7. Intellectual Property Pre-competitive focus: BC strives not to generate new IP, although it might happen Existing IP coming into PPPs will be protected New IP will be handled in accordance with Federal law and BC/PT specific agreements

8. Data/Sample Sharing and Access Must comply with human subjects protections Informed consents must be consistent with the BC activities if samples are to be used or distributed Precompetitive structure  broad public availability of data and samples, generation of public resources

9. Confidentiality Pre-existing data, samples, and activities contributed to BC activities will be considered to be confidential if the donor requests (subject to antitrust review) Confidentiality Agreements will be executed, as needed No more than the minimum needed for Consortium activities should be shared with project Aim is to maximize public availability, in accordance with the project plan

10. Conflict of Interest FNIH is not NIH For NIH employees, these are official duty activities FNIH rules require disclosure and reporting Intention is to optimize fairness and openness.

11. Antitrust Issues Industry collaborations with more than a single company may expose participants to antitrust liability The Federal government is not liable Partnering with the government does not immunize private partners against antitrust liability BC rules comply with Federal antitrust law

12. BC Grantee/Contractor Selection FNIH is not NIH Awards are FNIH awards, not NIH awards FNIH/BC Conflict of Interest and Confidentiality policies apply Solicitation and independent scientific review conducted by FNIH Responders, awardees, and reviewers may be BC members or not

13. Initial Projects 1) FDG-PET: qualification studies Lymphoma non-small cell lung cancer 2) Adiponectin in Type 2 Diabetes data pooling to assess utility of adiponectin as a marker of PPAR against responsiveness

14. Initial Projects 3) PET ligand development: developing and qualifying PET tools for drug development 4) Circulating Tumor Cell identification 5) Other projects in development in OA, depression, etc….

15. Important Links NIH PPP Program NIH PPP Program http://ppp.od.nih.gov FNIH FNIH www.fnih.org The Biomarkers Consortium The Biomarkers Consortium www.biomarkersconsortium.org