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
Early Bird registration and special discounts
Register now for the Early Bird rate, which expires on November 12. NEWDIGS members, as well as faculty and students from any academic organization, are eligible for special discounts—just email newdigs@mit.edu for your code.
Featuring
Janet Woodcock, MD
Director, Center for Drug Evaluation and Research 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
Marcus Wilson, PharmD
Co-founder and President, HealthCore
Special Guest
to be announced
Additional esteemed speakers
Brian Alexander, MD, MPH
Disease Center Leader, 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
Founding Director, National Biomarker Development Alliance
Don Berwick, MD, MPP
President Emeritus, 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
Executive Director and Scientific Lead, Pediatric Trials Consortium, Critical Path Institute
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 Pharmaceuticals
Anne-Virginie Eggimann, MSc
Vice President, Regulatory Science, bluebird bio, Inc.
Hans-Georg Eichler, MD, MSc
Senior Medical Officer, European Medicines Agency
John Ferguson, MD
SVP, Distinguished Fellow, Shire
Keith T. Flaherty, MD
Director of Developmental Therapeutics, Massachusetts General Hospital Cancer Center
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
Denis Lacombe, MD, MSc
Director General, EORTC
Kay Larholt, ScD
Director of Integrated Knowledge Solutions, WISDOM Program, CBI, MIT
Laurice Levine, MA
Independent Medical Consultant and Patient Advocate
Robyn Lim, PhD
Senior Science Advisor, Office of Legislative and Regulatory Modernization, Health Canada
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
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, Global Clinical Oncology, Merck & Co., Inc.
Susan Schaeffer
Editor, BioCentury Publications
William E. Smoyer, MD
Director, Center for Clinical and Translational Research, Nationwide Children’s Hospital
Mark Trusheim, MS
President, Co-Bio Consulting
Luc Truyen, MD, PhD
Global Head, Development and External Affairs, Neuroscience, The Janssen Pharmaceutical Companies
Newman Yeilding, MD
Head of Immunology Development, The Janssen Pharmaceutical Companies
Including senior thought leaders from
Agenda
Day 1 morning:
Vision, Strategy, Evolution
Welcome and introduction
Panel
ABI: A vision for sustainable, patient-centered drug development, access, and value
Janet Woodcock
Roadmap to the future: From platform trials to disease-focused innovation ecosystems
Fireside Chat with Laura Esserman
Evolution in action: The iSPY story
Michael Cusumano
Outside-in learning: Insights from the evolution of industry platforms in other commercial verticals
Day 1 afternoon:
Platform trials
Panel
Advancing oncology platform trials
Panel
Translational system innovation: Platforms beyond oncology
Panel
Stakeholder perspectives on platform trials
Anna Barker
Evolution of Platform Trials: Lessons Learned So Far
Reception and poster session
Call for Poster Abstracts now open
Day 2 morning:
Data and evidence across the lifecycle
Welcome and introduction
Fireside Chat: FDA Executive (TBC) & Trent Haywood
Bridging the chasm: Connecting pre- and post-market learning
Panel
Evidence Planning in Adaptive Biomedical Innovation: Field Observations
Panel
Driving Value for Patients from Real World Evidence: Snapshots of Evolving Ecosystems
Sandy Pentland
Can technology enable data sharing, integration, and trust?
Day 2 afternoon:
From siloed to ecosystem-driven innovation
Panel
Ecosystem-Enabled Innovation: Insights from the International Neonatal Consortium
Mark Trusheim
Advancing adaptive biomedical innovation: Designing disease ecosystems
William Rouse
Innovation in Fragmented Health Ecosystems
Panel
Evolving the global ecosystem: The Adaptive Biomedical Innovation Game
Jon Gruber
The political context for biomedical and healthcare innovation
Don Berwick
Driving continuous improvement across the system
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
Early Bird registration and special discounts
Register now for the Early Bird rate, which expires on November 12. NEWDIGS members, as well as faculty and students from any academic organization, are eligible for special discounts—just email newdigs@mit.edu for your code.
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