The Next Wave in Adaptive Biomedical Innovation:
Advancing Platform Trials into End to End Rapid Learning Systems
Hosted by the NEWDIGS Initiative at the MIT Center for Biomedical Innovation
From siloed to ecosystem-driven innovation
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Applying adaptive biomedical innovation
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Scaling platform clinical trials
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Connecting pre- and post-market learning
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Designing disease ecosystems
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Driving sustainable, patient-centered innovation
December 12–13, 2017
Massachusetts Institute of Technology
Next Wave Forum video playlist
Dr Don Berwick, President Emeritus and Senior Fellow, Institute for Healthcare Improvement, could not join the Forum in person, but his recorded remarks perfectly summarized the challenges and importance of creating a learning system for biomedical innovation.
Featuring
- Janet Woodcock, MD Director, Center for Drug Evaluation and Research at FDA
- Gerald Dal Pan, MD, MHS Director, Office of Surveillance and Epidemiology at FDA
- Laura Esserman, MD, MBA Director, UCSF Carol Franc Buck Breast Care Center
- Jonathan Gruber, PhD Ford Professor of Economics, MIT
- Trent Haywood, MD, JD Chief Medical Officer, Office of Clinical Affairs, Blue Cross Blue Shield Association
- Sandy Pentland, PhD Director, MIT Human Dynamics Laboratory
- Sebastian Schneeweiss, MD, ScD Professor of Medicine and Epidemiology, Harvard Medical School
- Mark Cziraky, PharmD Co-founder and Vice President of Research, HealthCore, Inc.
Additional esteemed speakers
- Brian Alexander, MD, MPH Disease Center Leader, Radiation Oncology, Center for Neuro Oncology, Dana-Farber Cancer Institute
- Derek C. Angus, MD, MPH, FRCP Chair, Department of Critical Care Medicine, University of Pittsburgh
- Naomi Aronson, PhD Executive Director of Clinical Evaluation, Innovation, and Policy, Blue Cross and Blue Shield Association
- Anna D. Barker, PhD Co-Director, Complex Adaptive Systems Professor, School of Life Sciences Director, National Biomarker Development Alliance (NBDA) Arizona State University
- Don Berwick, MD, MPP President Emeritus and Senior Fellow, Institute for Healthcare Improvement
- Mathieu Boudes, PhD Operations and Projects Manager, EURORDIS
- Nick Crabb, PhD Programme Director, Scientific Affairs at NICE
- Edward Connor, MD, MBE, FAAP Chairman and President, Institute for Advanced Clinical Trials for Children
- Michael A. Cusumano, PhD Sloan Management Review Distinguished Professor of Management, MIT
- Jonathan M. Davis, MD Director of the CTSA Trial Innovation Network Center at the CTSA Hub Tufts CTSI; Floating Hospital for Children at Tufts Medical Center
- Kourtney Davis, PhD, MSPH Global Head of Real World Data and Analytics, GlaxoSmithKline
- Anne-Virginie Eggimann, MSc Vice President, Regulatory Science, bluebird bio, Inc.
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Hans-Georg Eichler, MD, MSc
Senior Medical Officer, European Medicines Agency - John Ferguson, MD Head, Genzyme PV Unit Global Pharmacovigilance and Epidemiology Sanofi US
- R. John Glasspool Financing and Reimbursement of Cures in the US (FoCUS) Project Senior Advisor, CBI, MIT
- Gigi Hirsch, MD Executive Director, Center for Biomedical Innovation, MIT
- Eric Klopfer, PhD Director, Scheller Teacher Education Program & The Education Arcade, MIT
- Peter Kolchinsky, PhD Portfolio Manager & Managing Director, RA Capital Management, LLC
- Marina Kozak, PhD Project Officer, OS/ASPR/BARDA, U.S. Department of Health and Human Services
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Denis Lacombe, MD, MSc
Director General, EORTC - Kay Larholt, ScD Director of Integrated Knowledge Solutions, WISDOM Program, CBI, MIT
- Laurice Levine, MA Patient Advocate and Independent Medical Consultant
- Robyn Lim, PhD Senior Science Advisor, Health Products and Food Branch, Health Canada
- Victoria Manax, MD Chief Medical Officer, Pancreatic Cancer Action Network
- Hilary M. Malone, PhD Chief Regulatory Officer, Sanofi
- Newell McElwee, PharmD, MSPH Vice President, Health Economics and Outcomes Research, Boehringer-Ingelheim
- Carole Mitnick, ScD Associate Professor of Global Health and Social Medicine, Harvard Medical School
- Jane Perlmutter, PhD, MBA President and Founder, Gemini Group
- Eleanor Perfetto, PhD, MS Senior VP, Strategic Initiatives, National Health Council & Professor of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy
- Edmund Pezalla, MD, MPH Independent consultant; formerly Aetna
- William B Rouse, PhD Alexander Crombie Humphreys Chair in Economics of Engineering, Stevens Institute of Technology
- Eric Rubin, MD Vice President, Therapeutic Area Head, Oncology Early Development, Merck & Co., Inc.
- Susan Schaeffer Editor, BioCentury
- William E. Smoyer, MD Director, Center for Clinical and Translational Research, Nationwide Children’s Hospital
- Richard S. Strauss, MD Senior Director, Clinical Research, The Janssen Pharmaceutical Companies
- Mark Trusheim, MS President, Co-Bio Consulting
- Luc Truyen, MD, PhD Global Head, Development and External Affairs, Neuroscience, The Janssen Pharmaceutical Companies
December 12th morning:
Innovating how we innovate
Michael Cusumano
Outside-in learning: Insights from the evolution of industry platforms in other commercial verticals
December 12 afternoon:
Catalyzing next generation platform trials
Reception and poster session
December 13 morning:
Connecting data and evidence across the product lifecycle
Welcome and introduction
Fireside Chat: Gerald Dal Pan, Trent Haywood and Hilary Malone, Moderated by Hans-Georg Eichler
Bridging the chasm: Connecting pre- and post-market learning
December 13 afternoon:
Advancing from silo-driven to ecosystem-driven innovation
William Rouse
Innovation in Fragmented Health Ecosystems
Gigi Hirsch
Action Plan
Details and Registration
The Next Wave in Adaptive Biomedical Innovation:
Advancing Platform Trials into End-to-End Rapid Learning Systems
December 12–13, 2017
Boston Marriott Cambridge
Cambridge, Massachusetts
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Hosted by the MIT Center for Biomedical Innovation
The MIT Center for Biomedical Innovation integrates the Institute’s technical, scientific, and management expertise to solve complex biopharmaceutical challenges and improve the impact of biomedical innovation on society.
Cross-stakeholder collaboration drives CBI activity. Cutting-edge MIT research is complemented by expertise from industry, public agencies, and patient advocacy to develop scalable and sustainable solutions for problems in biopharmaceutical r&d, manufacturing, safety, and financing.
The Center advances practice through new knowledge and through real-world initiatives like NEW Drug Development ParaDIGmS (NEWDIGS) and The Biomanufacturing Project (BioMAN). Altogether, these activities bring parties together for mutual advantage and create system-scale healthcare impact.