Steve Hoffmann
- 1. Steve Hoffmann Scientific Program Manager The Biomarkers Consortium Inflammation and Immunity Steering Committee Strategic Public-Private Partnership with the FNIH
- 2. 2Partners 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
- 3. 3Partners for Innovation, Discovery, Health l www.fnih.org 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:
- 4. 4Partners for Innovation, Discovery, Health l www.fnih.org 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
- 5. 5Partners for Innovation, Discovery, Health l www.fnih.org 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
- 6. 6Partners for Innovation, Discovery, Health l www.fnih.org 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
- 7. 7Partners for Innovation, Discovery, Health l www.fnih.org 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, NIDCDFNIH ■ 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
- 8. 8Partners for Innovation, Discovery, Health l www.fnih.org 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
- 9. 9Partners for Innovation, Discovery, Health l www.fnih.org Project Development Process Initial Idea or Concept Approved Project Concept Project Plan Approved Project Launch 1 5432 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
- 10. 10Partners for Innovation, Discovery, Health l www.fnih.org 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
- 11. 11Partners for Innovation, Discovery, Health l www.fnih.org 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
- 12. 12Partners for Innovation, Discovery, Health l www.fnih.org 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
- 13. 13Partners for Innovation, Discovery, Health l www.fnih.org 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
- 14. 14Partners for Innovation, Discovery, Health l www.fnih.org 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
- 15. 15Partners for Innovation, Discovery, Health l www.fnih.org Contacts Cancer Sonia Pearson-White Scientific Program Manager spearson-white@fnih.org The Biomarkers Consortium (301) 402-4970 David Wholley, Director dwholley@fnih.org Metabolic Disorders Maria Vassileva Scientific Program Manager mvassileva@fnih.org Neuroscience Judy Siuciak Scientific Program Manager jsiuciak@fnih.org Inflammation & Immunity Steve Hoffmann Scientific Program Manager shoffmann@fnih.org Fundraising Asante Shakuur ashakuur@fnih.org