Transcript NIH and Bayh-Dole

Public Private Partnerships at the NIH;
The Biomarkers Consortium (BC)
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
BC Mission

The Biomarkers Consortium endeavors
to discover, develop, and qualify
biological markers (biomarkers) to
support new drug development,
preventive medicine, and medical
diagnostics.

Precompetitive Consortium
Biomarkers Consortium Partners

Public




Private



NIH
FDA
CMS
PhRMA / BIO
Industry/ individual companies
Non-Profit



Patient Advocacy Groups and Professional
Societies
Universities
FNIH
FNIH

FNIH :

501(c)(3) charitable foundation

i.e., NOT the government!
Chartered by Congress in 1990
 Incorporated in 1996
 Mission, per Congress, is to support the
mission of the NIH


Managing partner of the BC
BC Structure
Executive
Committee
SC
SC
SC
project
project
project
project
project
project
project
SC
project
Governance Structure

Executive Committee (15 members)



Steering Committees



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 (non-voting) FNIH
Content area focused : Neuroscience, Metabolic
Diseases, Oncology, Inflammation and Immunity
Identify and oversee specific project activities
Project Teams

Implement projects
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
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
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
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.
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
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
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
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….
Important Links

NIH PPP Program
http://ppp.od.nih.gov

FNIH
www.fnih.org

The Biomarkers Consortium
www.biomarkersconsortium.org