Past Events

Events

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

Events

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

Events

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.

Objectives 

  • 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

Presentations

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

October 15 - 15
Seoul

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
Paris

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
Paris

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
MIT

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).

Presentations

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
Paris

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
Brussels

“Session 5: Adaptive Licensing.”

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

Centre for Innovation in Regulatory Science (CIRS)

October 1 - 2
London

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
Vienna

“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).

Events

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

Events

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

Presentations

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)

DIA

June 5 - 5
London

“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

NEWDIGS

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
London

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
Brussels

IMI project development meeting

Gigi Hirsch (MIT) and Thomas Unger (Pfizer)

Multi stakeholder meeting on Adaptive Licensing

February 21 - 21
London

Could AL become an IMI call topic?

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

IOM

February 11 - 11
Washington, DC

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

Hans-Georg Eichler (European Medicines Agency)

IOM

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
Seoul

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

From Crisis Management to Risk Governance

January 10 - 10
Beijing

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).

Presentations

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.

http://www.europeanregulatory.com/docs/regulatory-rapporteur-jul-aug-2012.pdf

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
Amsterdam

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.

http://books.nap.edu/openbook.php?record_id=13283&page=R1

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)

Events

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
London

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

NEWDIGS Q1 Working Sessions

March 12 - 13
Cambridge, MA

Events

Adaptive Licensing Scenario Design Workshop

December 14 - 15
Cambridge, MA

NEWDIGS Research Seminar Series

November 16 - 16
Cambridge, MA

“New Approaches to Drug Approval”

Cliff Rosen, MD, Director of Clinical and Translational Research and, Senior Scientist at Maine Medical Center’s Research Institute

Coverage with Evidence Development and Adaptive licensing workshop

November 8 - 8
Cambridge, MA

Hosted by CMTP and NEWDIGS at World Trade Center Baltimore, MD Coverage with Evidence Development & Adaptive Licensing

Workshop Summary

NEWDIGS Research Seminar Series

October 25 - 25
Cambridge, MA

“Healthcare Intelligence”

Luis Perez-Breva, PhD, Lecturer and Research Scientist, School of Engineering, Innovation Teams (Joint with Sloan), MIT

“Collaborative Models and New Paradigms for Supporting Regulatory Science Research and Practice”

September 21 - 21
Cambridge, MA

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

Gigi Hirsch, MD, Institute of Medicine of the National Academy of Sciences, Washington, DC

Advancing Active Surveillance: Focus on Singapore

September 12 - 14
Cambridge, MA

Demonstration Project Planning

August 17 - 17
Cambridge, MA

Critical Questions Mapping: Oncology

May 16 - 16
Cambridge, MA

Leveraging NEWDIGS to Transform Cancer Care

January 7 - 7
Cambridge, MA