Steve Hoffmann

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


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:


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


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


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


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


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


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


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

http://www.biomarkersconsortium.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



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


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


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


Contacts

Cancer

Sonia Pearson-White

Scientific Program Manager

[email protected]


(301) 402-4970

David Wholley, Director

[email protected]

Metabolic Disorders

Maria Vassileva


[email protected]

Neuroscience

Judy Siuciak


[email protected]

Inflammation & Immunity

Steve Hoffmann


[email protected]

Fundraising

Asante Shakuur

[email protected]

Health & Medicine

Steve Hoffmann