The Next Wave in Adaptive Biomedical Innovation:
Advancing Platform Trials into End to End Rapid Learning Systems

MIT NEWDIGS logo

From siloed to ecosystem-driven innovation

Applying adaptive biomedical innovation

Scaling platform clinical trials

Connecting pre- and post-market learning

Designing disease ecosystems

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.

Snapshots of the Next Wave Forum. Credit: David Parnes Photography

Welcome

Patient advocates • Payors • Regulators • Industry • Clinicians • Academia • Investors

Breakthroughs in biomedical science are making transformative, even curative, therapies possible. But the healthcare system—patients, caregivers, regulators, payors, developers, and providers—is struggling to make them successful and sustainable.

We need to redesign the healthcare innovation system—together—to accelerate patient-centered drug development in ways that work for all stakeholders. Join other thought leaders at the Next Wave Forum and help to shape an evolving vision, and draw the roadmap, for a better system.

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.
  • 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
  • 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

Including senior thought leaders from




Cutting-edge thinking: References

Woodcock, J, LaVange, L. 
Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both
The New England Journal of Medicine. 2017;377:62-70.

Hirsch G, Trusheim M, Cobbs E, Bala M, et al.
Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need
Clinical Pharmacology & Therapeutics, special issue on Adaptive Biomedical Innovation, published 14 November 2016 DOI:10.1002

Trusheim M, Shrier A, Antonijevic Z, Beckman R, et al.
PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms
Clinical Pharmacology & Therapeutics, special issue on Adaptive Biomedical Innovation, published 14 November 2016 DOI:10.1002

Califf R, Sherman R, Slavitt A.
Knowing When and How to Use Medical Products
JAMA. 2016;316(23):2485-2486. doi:10.1001/ jama.2016.16734

Loehrer S, Feeley D, Berwick D.
10 New Rules to Accelerate Healthcare Redesign
Healthcare Executive. 2015 Nov;30(6):66-69.

 

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

Sponsored by

Sector leaders
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and Commons Hosts

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.