steve hoffmann
DESCRIPTION
A Peek at CMO East 2013TRANSCRIPT
Steve Hoffmann Scientific Program Manager The Biomarkers Consortium
Inflammation and Immunity Steering Committee
Strategic Public-Private Partnership
with the FNIH
2 Partners for Innovation, Discovery, Health l www.fnih.org
The Biomarkers Consortium
■ Qualifies biomarkers for specific applications in diagnosing disease,
predicting therapeutic response, or improving clinical practice
■ Addresses a broad range of disease / therapeutic areas
■ Generates information useful to inform regulatory decision-making
■ Fosters the exchange of knowledge and expertise among industry,
academics, and government leaders
■ Pre-competitive; makes consortium project results broadly available to
the entire scientific community
Our Founding Partners: FDA, NIH, FNIH, PhRMA, BIO, CMS
Founded in 2006 to develop and qualify biomarkers
using new and existing technologies
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Membership Benefits
■ Facilitates discussions with key opinion leaders and regulatory
decision makers
■ Provides an integrated approach to cross-sector partnerships
■ Establishes an effective forum to generate consensus science
■ Enables sharing of data and expertise to collaboratively
address unmet medical needs
The Biomarkers Consortium:
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Contributing Members
For-Profit Companies
Amgen
AstraZeneca
Crescendo Bioscience
Daiichi Sankyo, Inc
Eisai, Inc
Eli Lilly & Company
Johnson & Johnson
Merck
Meso Scale Diagnostics
Mitsubishi Tanabe Pharma America, Inc
Myriad RBM
Pfizer, Inc
Sanofi
Takeda Pharmaceuticals USA, Inc
Non-Profit Organizations
Alzheimer’s Association
American Diabetes Association
American Orthopaedic Society for Sports Medicine
Autism Speaks
Avon Foundation
Biotechnology Industry Organization
Centre for Proteomic and Genomic Research
CHDI Foundation
Dairy Research Institute
Foundation for Health Improvement and Technology
Juvenile Diabetes Research Foundation
Pharmaceutical Research and Manufacturers of America
PROOF Centre of Excellence
Radiological Society of North America
US Pharmacopeia
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Our Strategic Approach
Our projects address high impact areas of biomarker
development and qualification
Important
Translational
Transformational
Feasible
Practical
Fundable
Unique
Collaborative
Address significant unmet scientific and medical needs
Lead to significant improvements in drug development process
Focus on critical gaps and impact on public health / patient care
Have goals that are achievable in a specific timeframe
Leverage pre-existing resources whenever possible
Capable of generating required funds and stakeholder support
Synergistic, do not duplicate other initiatives
Benefit from a multi-stakeholder approach
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Governance Structure
Executive Committee NIH / FDA / CMS / industry / FNIH
Inflammation &
Immunity Steering Committee
Neuroscience Steering Committee
Metabolic
Disorders Steering Committee
Cancer Steering Committee
Multiple Project Teams Representatives from NIH, FDA, Industry, Subject Experts from Academia
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Executive Committee
Industry ■ Paul Deutsch, Sanofi
■ Gary Herman, Merck
■ Peter Honig, AstraZeneca
■ Sara Radcliffe, BIO
FDA ■ ShaAvhrée Buckman, OTS
■ Jeffrey Shuren, CDRH
■ Janet Woodcock, CDER
CMS ■ Louis Jacques, CAG
NIH ■ Thomas Insel, NIMH
■ Douglas Lowy, NCI
■ James Battey, NIDCD FNIH ■ Garry Neil, Appletree Partners
■ Ellen Sigal, Friends of Cancer Research
Provides overall steering committee direction and final project approval
Charles Sanders (Chair) FNIH Steve Paul (Acting Chair) FNIH
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Steering Committee Co-Chairs
Four steering committees identify, develop, approve,
and manage portfolios of projects
Cancer ■ David Chang, Amgen
■ Gary Kelloff, National Cancer Institute
Neuroscience ■ Linda Brady, NIMH / NIH
■ Husseini Manji, Johnson & Johnson
Inflammation and Immunity ■ Brian Kotzin, Amgen
■ Andras Perl, SUNY Upstate Medical
Metabolic Disorders ■ Roberto Calle, Pfizer
■ Myrlene Staten, NIDDK / NIH
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Project Development Process
Initial Idea
or
Concept
Approved
Project
Concept
Project
Plan
Approved
Project Launch
1 5 4 3 2
Ideas are submitted and reviewed by Steering Committees
Projects are launched after funding is secured by FNIH
Project plans are developed by Project Teams and
reviewed by the Steering Committees and Executive Committee
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Principles and Policies
■ Key governing policies negotiated prior to launch of Biomarkers
Consortium with principals/legal counsel representing the FNIH,
NIH, FDA, PhRMA and BIO:
■ Intellectual property (IP) and data sharing
■ Antitrust
■ Selection and award of grants/contracts
■ Confidentiality
■ Conflict of interest
■ Policies, project concept submission form, and other information
available at www.biomarkersconsortium.org
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Intellectual Property and Data Sharing Policies
■ Facilitate the use of data/technologies in research efforts while ensuring:
■ Adequate incentives to commercialize biomarker technologies
■ Broad, fair distribution of discoveries to maximize public health benefit
■ Address issues with both pre-existing IP and data, and data/IP that may
be brought into a project
■ Address issues with IP and data, and data/IP generated as a result of a
project; specific treatment of IP and data access:
■ Is agreed to by PT members
■ Included in the Project Plan
■ Approved by the EC
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The Biomarkers Consortium
15 Total projects launched
5 Projects completed
3 New projects recently approved
3 FDA guidances completed with our contributions
50 Over $50 Million raised to fund projects
15 Journal articles published and mentioned in 50 others
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Project Portfolio
Cancer ■ FDG-PET in Lung Cancer
■ FDG-PET in Lymphoma
■ I-SPY 2 Trial
Metabolic Disorders Adiponectin
Carotid MRI Reproducibility
Sarcopenia Consensus Definition
■ Atherosclerosis In-Silico Modeling
■ Beta Cell Clinical Studies
Neuroscience PET Radioligand in Neuroinflammation
Alzheimer’s Plasma Proteomics
■ Alzheimer’s CSF Proteomics
■ Alzheimer’s / MCI Placebo Data Analysis
Inflammation and Immunity ■ Osteoarthritis Biomarkers
Executive Committee ■ Kidney Safety Biomarkers
■ Skin Infection and Pneumonia
Launched Projects
■ Ongoing Projects Completed Projects
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Project Pipeline
Cancer ■ Circulating Tumor Cells
■ Minimal Residual Disease
■ Qualifying Volumetric CT for Clinical Trials
Metabolic Disorders ■ Contrast-Induced Acute Kidney Injury
■ Obesity
■ Outcome Measures for Sarcopenia
■ Soluble Markers & Imaging for Bone Quality
Neuroscience ■ Arterial Spin Labeling
■ Autism Biomarkers for Drug Development
■ PET Imaging for Alzheimer’s Disease
Inflammation and Immunity ■ Ankylosing Spondylitis
■ Functional Decline in COPD
■ Lupus Working Group
■ TSPO PET Imaging for RA
Executive Committee ■ Hospital Acquired Bacterial Pneumonia
■ Ventilator Associated Bacterial Pneumonia
New Project Ideas and Concepts
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Contacts
Cancer
Sonia Pearson-White
Scientific Program Manager
The Biomarkers Consortium
(301) 402-4970
David Wholley, Director
Metabolic Disorders
Maria Vassileva
Scientific Program Manager
Neuroscience
Judy Siuciak
Scientific Program Manager
Inflammation & Immunity
Steve Hoffmann
Scientific Program Manager
Fundraising
Asante Shakuur