Biomedical science is outpacing the system.
Barriers prevent patients’ access to innovations.
Are you ready to innovate how we innovate?

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
•
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

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

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.

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

Agenda

Agenda at a Glance PDF

Get the agenda at a glance PDF

December 12th morning:
Innovating how we innovate

Welcome and introduction

Panel
ABI: A vision for sustainable, patient-centered drug development, access, and value

Special Announcement

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

December 12 afternoon:
Catalyzing next generation 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

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

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?

December 13 afternoon:
Advancing from silo-driven 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

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
Forum Sponsor
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.