a ppp managed by fnih partners are nih, fda, cms, and private industry barbara b. mittleman, m.d....
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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
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