Past Events


LEAPS Design Lab #6

November 17 - 18

Invitation only.

Tufts CTSI & NEWDIGS Design Lab

October 23 - 23

Invitation only.

Focus:: N-of-1 Studies

FoCUS Design Lab

October 15 - 16

Invitation only.

Tufts CTSI & NEWDIGS Design Lab

September 29 - 29

Invitation Only.

Case Study: Live Interactive Virtual Education (LIVE) Registry

LEAPS Design Lab #5

June 9 - 10

Invitation only.

FoCUS Design Lab

April 28 - 30

Invitation only

Paying for Cures Workshop

March 10 - 10
Cambridge, MA and Online

SOLD OUT - please contact to be added to the waitlist


LEAPS Design Lab #4

December 11 - 12
Cambridge, MA

These sessions will build on the strategies and tools discussed in the July 2018, December 2018, and June 2019 Design Labs under the framework of the target disease, and include reporting by all Design Teams.  Invitation only.  

FoCUS Design Lab

October 15 - 17
Boston, MA

Invitation-only Design Lab, focused on TAG reporting and next steps.  

LEAPS Virtual Design Webinar

September 25 - 25
Cambridge, MA (and online)

On September 25, LEAPS will hold a virtual design webinar to refine key features of the initial core evidence generation platforms for its pilot phase.  Here's a snapshot of the project, and a glimpse behind the curtain for this important working session.

Paying for Cures Workshop

August 7 - 7
Cambridge, MA

This intensive 1-day workshop at MIT will include:

  • An overview of cell and gene therapies’ unique and challenging characteristics
  • Insights on the financial issues and impacts of performance-based agreements for new therapies
  • A discussion of evolving policy and legistative changes
  • Interaction with sector thought leaders and MIT researchers

Click here for tickets

LEAPS Design Lab #3

June 18 - 19
Cambridge, MA

These sessions will build on the strategies and tools discussed in the July and December 2018 Design Labs under the framework of the target disease.  Invitation only.  

FoCUS Design Lab

April 23 - 24
Boston, MA

Invitation-only Design Lab to further discussions/implementation from the October 2018 Design Lab

Paying for Cures: Ensuring Patient Access and System Sustainability

February 12 - 12
Washington, DC

Learn Precision Financing solutions with innovation leaders and national policymakers at this one-day conference hosted by the MIT Center for Biomedical Innovation NEWDIGS Initiative's FoCUS Project.

Agenda, Speakers and Registration at:


LEAPS Design Lab #2

December 12 - 13
Cambridge, MA

These sessions will build on the strategies and tools discussed in the July 2018 Design Lab under the framework of the target disease.  Invitation only.

FoCUS Design Lab

October 16 - 18
Cambridge, MA

Invitation-only Design Lab to further discussions/implementation from the April 2018 Design Lab

LEAPS Design Lab

July 17 - 18
Cambridge, MA

These sessions will build on the strategies and tools discussed in the December 2017 Next Wave Forum - more details to come.

ABI Design Lab

May 7 - 8
Cambridge, MA

Co-Hosted with TIC, this Design Lab will feature E2E and EE2 - more details to come.

Financing and Reimbursement of Cures (FoCUS) Project Design Lab

April 10 - 12
Cambridge, MA

Participants will examine specific pressure-tested financing schemes through the case study methodology.


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

December 12 - 13
Massachusetts Institute of Technology

Join global biomedical research and healthcare leaders to map the future of adaptive biomedical innovation. Explore visions of integrated systems that link stakeholders, technologies, data, and practices for patient-centered and sustainable healthcare innovation.

Connect with your colleagues across the innovation ecosystem to help shape Platform Clinical Trial strategies that will change your practice, your field—and healthcare on the global scale.

Learn More

Financing and Reimbursement of Cures (FoCUS) Project Design Lab

October 18 - 20
Cambridge, MA

Participants will examine specific pressure-tested financing schemes through the case study methodology.

ABI Design Lab

July 19 - 20
Cambridge, MA

These sessions will continue the series on E2E design strategies

Financing and Reimbursement of Cures (FoCUS) Project Design Lab

April 11 - 13
Cambridge, MA

Each day will feature a case study pairing a specific therapeutic area with potential financing and/or reimbursement schemes.

April 11: Gene Therapies full day

April 12: Gene Therapies 1/2 day & Common Session

April 13: Oncology full day

ABI Design Lab on Efficacy to Effectiveness (E2E) Clinical Trials

February 8 - 9
Cambridge, MA

February 8: E2E Clinical Trial Design
This session will focus on optimizing the design of a single E2E clinical trial. It is co-hosted by the Johns Hopkins-Tufts Trial Innovation Center (JHU-Tufts TIC) and the Tufts Clinical and Translational Science Institute (CTSI).

February 9: Adaptive pathway design for antibiotic
This session will build on a case (an antibiotic) analyzed in the NEWDIGS November 2016 Design Lab. It will focus on the evaluation of a proposed adaptive pathways approach to the development and delivery of the product, including a continuous E2E clinical trial design.... Learn more


Adaptive Biomedical Innovation Design Laboratory

November 10 - 11
MIT Samberg Conference Center, Cambridge, MA

A Design Lab hosted by the MIT NEWDIGS Initiative. Please note that participation is by invitation only.

FoCUS Strategic Planning Design Lab

October 27 - 27
Cambridge, MA

A Design Lab hosted by the MIT NEWDIGS Initiative. Please note that participation is by invitation only.

Adaptive Design Laboratory

June 1 - 2
EMA Offices, 30 Churchill Place, Canary Wharf London, UK

Workshop Co-hosted by ADAPT SMART, GetReal, & MIT NEWDIGS

Adaptive Design Laboratory Workshop, co-hosted by ADAPT SMART, GetReal, & MIT NEWDIGS. Please note that participation is by invitation only.

For attendees*: Event summary page


NEWDIGS Workshop

November 15 - 15
Cambridge, MA

Topic: Data Program

Better Science, Better Health: New Healthcare Models

October 27 - 28
Washington, DC

With speakers from MIT NEWDIGS and MIT, including Gigi Hirsch, Mark Trusheim and Ken Oye.

Click here to visit the conference website. 

MIT NEWDIGS Janus Program Workshop: Payer/HTA Adaptive Pathways

July 8 - 9
Cambridge, MA

Participants in this workshop will include a broad range of representatives from the global biopharmaceutical/healthcare industry including manufacturers, regulatory agencies, public and private payers and HTA officials, and academia, among others. Outputs from the workshop will be summarized and made available to all attendees.


  • Elucidate the reimbursement challenges of “Adaptive Pathways” (occasionally referred to as MAPPs or adaptive licensing”) for payers/HTAs and sponsors.
  • Refine a strategic framework for the ‘right side’ of the “Adaptive Pathways” roadmap:

NEWDIGS 2015 Data Program Workshop

January 14 - 15
Cambridge, MA

Review and discuss plan for and status update on the NEWDIGS Data Program.

Click here for full event details.
For attendees*: Agenda and presentations page


Conference on Institution Building for Accessing Korean Health Records, National Assembly

October 15 - 15

Presentation: Fostering Innovation by Improving Health Data Access and Utilization.

Ken Oye (MIT).

Invitational Symposium hosted by Sanofi

July 30 - 30
Cambridge, MA

Emerging Trends in Big Data: How can they transform pharma from discovery to commercial

Panel on Clinical Trials: Gigi Hirsch (MIT).

National Science Advisory Board on Biosecurity, Working Group

July 23 - 23
Rockville, MA

Presentation: Risk Management under Uncertainty, Complexity and Controversy: Proactive and Adaptive Strategies.

Ken Oye (MIT).

ISPOR 20th Annual International Meeting

May 16 - 20
Philadelphia, PA

Panel:  Early Access to Medicines:  What’s in it for Payers? Panelists:  Adam Heathfield (Pfizer), Mark Trusheim (MIT); Dan Ollendorf (ICER), Adrian Towse (Office of Health Economics, London).

More information here.

Webinar: MAPPs – New Tools for Decision making

April 13 - 15

What is the current status of MAPPs in Europe and the US? Featuring

  • Luca Pani, Director General, Italian Medicines Agency
  • Gigi Hirsch, Executive Director, CBI and Program Director, NEWDIGS, MIT, USA
  • James Anderson, Head of Corporate Government Affairs, GlaxoSmithKline, UK
  • Duane Schulthess, Managing Director, Vital Transformation (moderator)

More information here.

DIA Europe 27th Annual EuroMeeting

April 13 - 15

Panel Discussion on Adaptive Licensing. James Anderson (GSK), Susanna Del-Signore (Sanofi), Hans-Georg Eichler (EMA), Gigi Hirsch (MIT)

Full program here.

MIT Media Lab

February 24 - 24

Co-sponsored by MIT Media Lab, Deloitte, & Decision Resources Group. The Future of Health Analytics. Panel Discussion on Emerging Trends, Technologies, & Opportunities, featuring Gigi Hirsch, MIT Center for BioMedical Innovation and Executive Director NEWDIGS, on the NEWDIGS Data Program.

Interdisciplinary Center for Bioethics, Institution of Social and Policy Studies

February 4 - 4
Yale University, New Haven, CT

Presentation: Adaptive Risk Management in Biotechnology: Applications to Transfats, Synthetic Biology and Pharmaceuticals.

Ken Oye (MIT).


Biogen Idec Early Payer Scientific Advice Workshop

November 20 - 20
Cambridge, MA

Panel Discussion: “Future and Emerging Trends in Early Advice and Adaptive Licensing.”

Gigi Hirsch (MIT).

Innovation in Clinical Trials

October 21 - 21
London, Royal College of Physicians

New Trial Pathways and Better Patient Data

Co-hosted by IMI, EMA, NEWDIGS, and EFPIA

“Overview the NEWDIGS Janus Initiative.”

Mark Trusheim (MIT Sloan School of Management & MIT Center for Biomedical Innovation).

NORD’s 2014 Rare & Orphan Disease Products Summit

October 21 - 22
Alexandria, VA

Keynote panel discussion: “Enterprising Breakthroughs and Catalyzing Collaboration in the Pursuit of Life-Transforming Rare Disease Treatments.”

Gigi Hirsch (MIT).

IRGC Annual Conference 2014

October 13 - 14

Improving Risk Regulation: From Crisis Response to Learning and Innovation. “Session 2.3 – Managing Uncertainty over the Life Cycle of Drug Development and Use: Enhancing Adaptability and Flexibility in Pharmaceutical Regulation.”

Ken Oye (MIT), Tony Hoos (M4P), Hans-Georg Eichler (EMA).

TOPRA Annual Symposium 2014

October 13 - 15

“Session 5: Adaptive Licensing.”

Tomas Salmonson (CHMP, MPA), Robert Hemmings (MHRA), James Anderson (GSK).

Centre for Innovation in Regulatory Science (CIRS)

October 1 - 2

Invited case study presentation: “NEWDIGS – What they have discovered as critical elements.”

Tony Hoos (Medicines 4 Patients)

DIA 2014

June 15 - 19
San Diego, CA

(1) “Adaptive, Progressive or Risk-Based Licensing Models: What Approaches Could Be Considered by Mature and Emerging Markets?”

Panel Moderator: Lawrence Liberti (CISR). Hans-Georg Eichler (EMA) – An Update on International Developments.

(2) “How Can Studies that Inform Relative Effectiveness Best Be Incorporated into Global Drug Development Plans?”

Panel Moderator: Chris Chinn (GSK). Mark Trusheim (MIT) – Overview of the NEWDIGS Janus Initiative.

Global Clinical Scholars Training Program @ Harvard Medical School

June 13 - 13
Boston, MA

“Overview of NEWDIGS & Adaptive Licensing”

Gigi Hirsch (MIT).

NORD Corporate Council Meeting

May 8 - 8
Washington, DC

“Overview of NEWDIGS-Adaptive Licensing”

Thomas Unger (Pfizer).

DIA Euro Meeting 2014

March 26 - 26

“Creating an Adaptive Pathway for Medicines to Patients–Could this Be An Approach That Fulfills the Needs of All Decision-Makers? A Roundtable Discussion.”

Moderator: Andrzej Rys (European Commission, Belgium); Hans-Georg Eichler (EMA); Jurgen Windeler (IQWiG, Germany); Tomas Salmonson (CHMP/EMA); Carole Longson (NICE); Chris James (Motor Neurone Disease Association, United Kingdom); Anton Hoos (GSK).

21st International Molecular Medicine Tri-Conference, Leaders in Precision Medicine Symposium

February 13 - 14
San Francisco, CA

“Adaptive Licensing as an Enabler for Precision Medicine”

Panel: Hans-Georg Eichler (EMA), Kenneth Oye (MIT), Ed Pezalla (Aetna), Mark Trusheim (MIT), & Thomas Unger (Pfizer).


The Next Act

July 9 - 9
Cambridge, MA

What’s Needed to Make Orphan Drugs Readily Available to People with Rare Diseases

Co-hosted by NORD, LFE and NEWDIGS

NEWDIGS Quarterly Workshop

June 4 - 5
Cambridge, MA

Global Updates on Accelerated Access to Innovative Medicines for Patients in Need

April 2 - 3
Cambridge, MA

Workshop Co-hosted by EMA, IMI, EFPIA, & MIT


NEWDIGS Q4 Working Sessions

December 5 - 6
Cambridge, MA

NEWDIGS Q3 Working Sessions

September 16 - 17
Cambridge, MA

NEWDIGS Q2 Working Sessions

June 20 - 21
Cambridge, MA

NEWDIGS Q1 Working Sessions

February 26 - 27
Cambridge, MA


Alzheimer’s Disease and Dementia Initiative

November 6 - 7
New York, NY

New York Academy of Sciences.

Panel: Public Private Partnerships. Panelist: Gigi Hirsch

FasterCures 5th Annual Partnering for Cures

November 3 - 5
New York, NY

The Art and Science of Multi-stakeholder Collaboration

Panelist: Gigi Hirsch.

International Conference on Rare Diseases and Orphan Drugs (ICORD)

November 1 - 2
St. Petersburg

Controlled Early Access for Medicines to Patients with High Medical Need: What Can Adaptive Licensing Offer for Patients Suffering from Rare Diseases?

(Abstract submitted by Tony Hoos/GSK).

IOM Roundtable on Value and Science-Driven Healthcare

September 26 - 26
Washington, DC

Regulatory Science & Practice: Overview of Adaptive Licensing.

Ed Pezalla (Aetna).

Special Executive Briefing on NEWDIGS/Adaptive Licensing Program (regulators-only)

September 19 - 19
Washington, DC

Session Co-Leads: Gigi Hirsch and Ken Oye (MIT)

CancerRX Conference

June 17 - 18
Cambridge, MA

(Chaired by Prof. Andrew Lo).

Panel Discussants: New Business Models/NEWDIGS Gigi Hirsch (MIT) and Thomas Unger (Pfizer)


June 5 - 5

“Progressive Patient Access (adaptive licensing) How could pilots look taking the new EU-PV legislation into account?”

Dr. Anton (Tony) Hoos (GlaxoSmithKline)

11th Annual FEI: Front End Innovation

May 6 - 8
Boston, MA


Panel Discussants: Gigi Hirsch (MIT), Ed Pezalla (Aetna), and Thomas Unger (Pfizer).

EFPIA/IMI planning session for Task Force on Progressive Patient Access

April 29 - 29

Gigi Hirsch and Lynn Baird (MIT)

Healthcare Ecosystem @MIT

April 25 - 25
Cambridge, MA

Keynote speakers: Gigi Hirsch (MIT) and Robert Langer (MIT).

BIO 2013

April 22 - 25
Chicago, IL

“Adaptive Development Strategies for Managed Entry of New Medicines”

Panel Discussants: Robyn Lim (Health Canada), Kenneth Oye (MIT), and Thomas Unger (Pfizer).

Progressive development and patient access

March 25 - 25

IMI project development meeting

Gigi Hirsch (MIT) and Thomas Unger (Pfizer)

Multi stakeholder meeting on Adaptive Licensing

February 21 - 21

Could AL become an IMI call topic?

Gigi Hirsch (MIT) and Thomas Unger (Pfizer).


February 11 - 11
Washington, DC

“International Perspective: NEWDIGS Initiative, MIT Center for Biomedical Innovation”

Hans-Georg Eichler (European Medicines Agency)


February 5 - 5
Washington, DC

“Accelerating innovation through partnerships: the NEWDIGS example”

Hans-Georg Eichler (European Medicines Agency)

Institute of Medicine, Committee

January 24 - 24
Washington, DC

To Review the Clinical and Translational Science Awards (CTSA) Programs at the National Center for Advancing Science (NCATS).

Invited Discussant: Gigi Hirsch (MIT).

(1) Korean Advanced Institute of Science & Technology (KAIST) (2) Korean Institute of Industrial Economics & Trade (KIET)

January 14 - 14

Panelists: Robyn Lim (Health Canada), Kenneth Oye (MIT), & Thomas Unger (Pfizer).

From Crisis Management to Risk Governance

January 10 - 10

Ministry of Science & Technology of the PRC, the State Council of the PRC, Tsinghua University School of Policy & Management, and the International Risk Governance Council

Panelists: Robyn Lim (Health Canada), Kenneth Oye (MIT), & Thomas Unger (Pfizer).


The Annual European Medicines Agency Review of the Year and Outlook for 2013

November 29 - 30
London, UK

Program session “Adaptive licensing/NEWDIGS & HTA”, EMA Annual Review of the Year and Outlook for 2013, TOPRA, Regulatory Rapporteur, 19.

Wired Health Conference

October 15 - 16
New York, NY

In partnership with the Robert Wood Johnson Foundation’s Pioneer Portfolio

Invited Speaker: Dr. Gigi Hirsch (MIT)

3rd DIA Health Technology Assessment (HTA) Forum

September 13 - 14

Regulatory and HTA Interface Developments; “Ensuring Patient Access to Innovative Medicines through MIT NEWDIGS: A multi-stakeholder initiative to catalyse the evolution of adaptive licensing”

Speaker: Dr. Tony Hoos (GlaxoSmithKline)

DIA 2012 Annual Meeting

June 24 - 28
Philadelphia, PA

“Adaptive Licensing: Bane or Boon for Drug Development?”

Chair: Dr. Hans-Georg Eichler (European Medicines Agency) and panelists – Dr. Thomas Unger (Pfizer), Dr. Kenneth Oye (MIT) and Dr. Robyn Lim (Health Canada)

Creating a Collaborative Environment in an Academic Setting

April 26 - 26
Cambridge, MA

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development Workshop Summary, 57-60.

Olson and A. Claiborne.

DIA EuroMeeting 2012

March 26 - 28
Copenhagen, Denmark

“Adaptive Licensing: A useful concept for introducing drugs?”

Chair: Dr. Eric Abadie (CHMP) and Presenter: Dr. Hans-Georg Eichler (EMA)

2012 MassBio Annual Meeting

March 26 - 27
Cambridge, MA

“The Business of Science: Re-catalyzing innovation in the industry”

Panelist – Dr. Gigi Hirsch (MIT)


NEWDIGS Q3 Working Sessions

September 10 - 11
Cambridge, MA

NEWDIGS Q2 Working Sessions

June 18 - 19
Cambridge, MA

Legal Foundations of Adaptive Licensing Roundtable Forum

April 3 - 3

Jointly organized with the European Medicines Agency (EMA), London, United Kingdom

NEWDIGS Q1 Working Sessions

March 12 - 13
Cambridge, MA