Building Consortia for Enhanced Predictive, Diagnostic, and Therapeutic Care: The Example of the Biomarkers Consortium Best Practices for Personalized Medicine Vancouver, BC March 9, 2011
Building Consortia for Enhanced Predictive, Diagnostic, and Therapeutic Care • The ultimate deliverable:translation of personalized medicine to the clinic and patient Dr. Daniel Bednarik, Director, Genomics and Bioinformatics, Cardiome Pharma • Strategies and barriers to deliver personalization to the point of care Dr Brad Popovich, Chief Scientific Officer, Genome BC • ASK for confident decisions: harnessing the power of semantics Dr. Erich Gombocz, Vice-President and Chief Scientific Officer, IO Informatics 2
Conv onver ergen ence of e of mul ultiple fac actor ors has has l led ed to o the em he emer erge genc nce of of publ public- pr private par partne nerships in n bi biom omedi edicine Declining productivity in biopharma R&D → Decline in government Escalating complexity of health research budgets “externalization” of biomedical science and → funding gap research technologies Increased Need for Public- Private Partnerships Emergence of viable Regulatory challenges → Expansion of “pre- collaborative models → competitive” field increasing complexity, e.g., SNP Consortium, limited budgets Gates Foundation 3
Biom omar arker ers have m have many uses any uses • Clinic Clin ical Practice – Diagno agnose or or ident dentify risk for or di diseas ease – Strati tify fy p patients ts – Assess sev ever erity/di diseas ase pr progr ogression on – Predi edict pr prognos ognosis – Gui uide de treat eatment Personalization – Assess res espon ponse t e to o treat eatment • Drug ug Dev evel elopm pment – Assess rol ole e of of dr drug ug tar arge get in n di diseas ease pr proc oces ess – Assess how how a a dr drug ug candi andida date int nter eracts with h a a tar arge get rec ecep eptor or, enz enzyme, or or prot pr otei ein – Tox oxicol ology gy – PK, PD, dos dosing ng – In n clini nical dev devel elop opmen ent, as asses essing w g whet hether her a a dr drug ug is saf afe e and and ef effec ective • Drug ug Qual ualification – Inf nform regul egulatory dec decision on-mak aking ng 4
Out of 1,261 putative cancer protein or peptide biomarkers described in the literature*, only 9 are FDA approved as “tumor associated antigens” • Fewer than 1 per year have been approved by the FDA since 1998 • This high percentage of un-validated biomarkers is generalizable to other diseases • This “biomarker barrier” in which candidate biomarkers have not been validated needs to be overcome * Polanski and Anderson (2006). A List of Candidate Cancer Biomarkers for Targeted Proteomics. Biomarker Insights 2:1– 48 5
Biomarker qualification: the value of collaboration • Biomarkers require extensive testing and qualification for practical use – Multiple studies to ensure integrity, reproducibility of results • Qualification is challenging, expensive, and time-consuming – Can require large amounts of data: literature, observational studies, clinical trials • Qualification is based on consensus among the scientific community – Deep understanding of and agreement on disease risk, natural history, outcomes • Qualification is a pre-competitive activity • Qualification is difficult to accomplish this in a single institutional setting ➜ Requi uires es partner nershi hips ps and and a a strat ateg egic appr proac oach 6
As a result, a number of PPPs in biomarker discovery and development have emerged in recent years Some examples: • ADNI • Critical Path Institute (PSTC, CAMD) • Serious Adverse Events Consortium • Innovative Medicines Initiative (Europe) • PROOF Centre • The Biomarkers Consortium 7
Founda Foundation on f for or NIH Over erview • Established by Congress in 1990; incorporated in 1996 • Supports the NIH mission • Close relationships with NIH • 501(c)(3) non-profit organization – Raised over $560M since 1996 – 50+ projects • Non-governmental – Directly solicits contributions – Flexible donor relationships – Creates open, inclusive, objective governance mechanisms – Timely, effective grants/contracts/project management 8
Goal oals of of The B The Biom omar arkers Cons onsor ortium • Facilitate the development and standardization of biomarkers using new and existing technologies • Help qualify these biomarkers for specific applications in diagnosing disease, predicting therapeutic response, or improving clinical practice • Generate information useful to inform regulatory decision-making • Make consortium project results broadly available to the entire scientific community 9
Cont ontribu buting ng M Mem ember bers ( (62) 62) For-Prof Fo ofit C Compan panies ( (28) Non on-Profit O Organi nizat ation ons ( (34) Academy of Molecular Imaging Abbott Laboratories Advanced Medical Technology Association Amgen Alliance for Aging Research Amylin Alzheimer ’ s Association AstraZeneca American Association for Cancer Research American College of Neuropsychopharmacology Banyan Biomarkers American Diabetes Association BG Medicine American Health Assistance Foundation Boehringer-Ingelheim American Society of Clinical Oncology Bristol-Myers Squibb American Society for Clinical Pharmacology and Therapeutics Celgene Corporation American Society for Therapeutic Radiology and Oncology Arthritis Foundation Daiichi Sankyo Association of Clinical Research Organizations Eisai, Inc. Autism Speaks Genstruct, Inc. Avon Foundation GlaxoSmithKline Battelle Memorial Institute InfraReDx, Inc. Biotechnology Industry Organization CHDI Foundation Johnson & Johnson Cystic Fibrosis Foundation Therapeutics Eli Lilly and Company Federation of Clinical Immunology Societies Merck and Co., Inc. The Hamner Institutes for Health Sciences Meso Scale Discovery The Immune Tolerance Institute, Inc. Metabolon, Inc. International Society of Biological Therapy of Cancer Juvenile Diabetes Research Foundation NextGen Sciences Kidney Cancer Association Orasi Medical, Inc. The Leukemia and Lymphoma Society Pfizer Inc. Michael J. Fox Foundation for Parkinson ’ s Research F. Hoffmann-La Roche Ontario Cancer Biomarker Network RareCyte, Inc. Osteoarthritis Research Society International Pharmaceutical Research and Manufacturers of America Scout Diagnostics PROOF Centre of Excellence Sepracor Radiological Society of North America Takeda Pharmaceuticals Society for Nuclear Medicine XOMA, Ltd. University of Illinois 10
Govern ernance ance Executive Committee NIH / FDA / Industry / Foundation for NIH CMS / Public-Patient Representative Steering Cancer Inflammation & Metabolic Neuroscience Committees Immunity Disorders Project 6 Project 2 Project Teams Project 4 Project 1 Project 3 Project 5 11
The B e Biomar arker ers Consor nsortium um Executiv ive C Commit ittee FDA DA Chai hairman an ShaAvhree Buckman, Office of Charles Sanders, Foundation for Translational Science NIH Jeffrey Shuren, Center for Devices and Radiological Health NI NIH Janet Woodcock, Center for Drug Thomas Insel, National Institute of Evaluation and Research Mental Health Douglas Lowy, National Cancer Indus ndustry Institute Stephen Eck, Eli Lilly & Co. James Battey , National Institute Gary Herman, Merck & Co., Inc. on Deafness and Other Garry Neil, Johnson & Johnson Communication Disorders Sara Radcliffe, BIO CM CMS Found oundation on for or NIH Boar oard Barry Straube Steve Paul, ex-Eli Lilly & Co. Ellen Sigal, Friends of Cancer Research Publ ublic Mem ember ber Mary Woolley, Research!America 12
Projec ect D Developm opment ent Proces ess Steering EC/ SC, Executive Com m ittee/ RFA/ RFP or Steering Com m ittee Project Team Project External Com m ittee I ni ( and Funders) Team Subm ission tia App 2 1 4 3 5 l rov Ap Pro I d ed pro La ject ea Proj ved un Pla ect or Pro ch n Co Con jec • Protocol • Scientific m erit nc cep • Final QA/ QC t • Contracts • Resources • Pre-com petitive • Funding ep t • Project • I ntellectual • Feasibility m anagem ent property t • Data sharing and distribution • Tim elines and m ilestones • Budget I nitial funding • Hum an subjects FNI H initiates scan • Privacy form al funding • Legal review requests 13
Ac Accompl plishm shment ents t to Date • 11 11 launc aunche hed proj projects (1 (1 com compl pleted) – 1 1 com compl pleted proj project (A (Adi dipone ponectin); 4 4 proj projec ects will com compl plete e in n 2011 2011 – 3 3 new new proj projects i in n 2011 pi 2011 pipel peline (i (inf nfectious disease, ease, OA, A, atheroscl rosclerosi erosis) s) • Trend rending t tow owar ards m more ore indus ndustry- and F and FDA-based based subm submission ons, m more ore qual qualification proj projects • Incr creased m eased membershi ship b p base/operat operations c ons core • Inc ncre reasingly seen seen as as a a model odel publ public-pri rivat ate e partner part ershi hip 14
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