A PPP managed by FNIHA PPP managed by FNIHPartners are NIH, FDA, CMS, and private industryPartners are NIH, FDA, CMS, and private industry

Barbara B. Mittleman, M.D.Barbara B. Mittleman, M.D.Director, NIH PPP ProgramDirector, NIH PPP Program

Bioinformatics ForumBioinformatics ForumMarch 4, 2009March 4, 2009

Public Private Partnerships at the NIH;

The Biomarkers Consortium (BC)

BC MissionBC Mission

The Biomarkers Consortium endeavors The Biomarkers Consortium endeavors to to discoverdiscover, , developdevelop, and , and qualifyqualify biological markers (biomarkers) to biological markers (biomarkers) to support new drug development, support new drug development, preventive medicine, and medical preventive medicine, and medical diagnostics.  diagnostics. 

PrecompetitivePrecompetitive Consortium Consortium

Biomarkers Consortium PartnersBiomarkers Consortium Partners

PublicPublic NIHNIH FDAFDA CMSCMS

PrivatePrivate PhRMA / BIOPhRMA / BIO Industry/ individual companiesIndustry/ individual companies

Non-ProfitNon-Profit Patient Advocacy Groups and Patient Advocacy Groups and

Professional Societies Professional Societies UniversitiesUniversities FNIH FNIH

FNIHFNIH

FNIH : FNIH : 501(c)(3) charitable foundation501(c)(3) charitable foundation

i.e., NOT the government!i.e., NOT the government! Chartered by Congress in 1990Chartered by Congress in 1990 Incorporated in 1996Incorporated in 1996 Mission, per Congress, is to support the Mission, per Congress, is to support the

mission of the NIHmission of the NIH

Managing partner of the BCManaging partner of the BC

BC StructureBC Structure

Executive Committee

SC SC SC

project

project

project

project

project

project

project

SC

project

Governance StructureGovernance Structure Executive Committee (15 members)Executive Committee (15 members)

decision-making: advise FNIH Board on financial decision-making: advise FNIH Board on financial commitmentscommitments

3 NIH, 3 FDA, 3 pharmaceutical industry, 1 CMS, 1 3 NIH, 3 FDA, 3 pharmaceutical industry, 1 CMS, 1 biotech/diagnostics/imaging industry, 1 public, biotech/diagnostics/imaging industry, 1 public, 3 (non-voting) FNIH3 (non-voting) FNIH

Steering CommitteesSteering Committees Content area focused : Neuroscience, Metabolic Content area focused : Neuroscience, Metabolic

Diseases, Oncology, Inflammation and ImmunityDiseases, Oncology, Inflammation and Immunity Identify and oversee specific project activitiesIdentify and oversee specific project activities

Project TeamsProject Teams Implement projectsImplement projects

Intellectual PropertyIntellectual 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

Data/Sample Sharing and AccessData/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

ConfidentialityConfidentiality 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

Conflict of InterestConflict 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.

Antitrust IssuesAntitrust 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

BC Grantee/Contractor SelectionBC 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

Initial ProjectsInitial Projects

1) FDG-PET: qualification studies1) FDG-PET: qualification studies

LymphomaLymphoma

non-small cell lung cancernon-small cell lung cancer

2) Adiponectin in Type 2 Diabetes2) Adiponectin in Type 2 Diabetes

data pooling to assess utility of data pooling to assess utility of

adiponectin as a marker of PPAR against adiponectin as a marker of PPAR against

responsivenessresponsiveness

Initial ProjectsInitial Projects

3) PET ligand development: 3) PET ligand development:

developing and qualifying PET developing and qualifying PET tools tools for drug developmentfor drug development

4) Circulating Tumor Cell identification4) Circulating Tumor Cell identification

5) Other projects in development in OA,5) Other projects in development in OA, depression, etc…. depression, etc….

Important LinksImportant Links

NIH PPP ProgramNIH PPP Program http://ppp.od.nih.govhttp://ppp.od.nih.gov

FNIHFNIH

www.fnih.orgwww.fnih.org

The Biomarkers ConsortiumThe Biomarkers Consortium

www.biomarkersconsortium.orgwww.biomarkersconsortium.org