Past 2017 NEWDIGS Events

April 11–13, 2017
Cambridge, MA

Financing and Reimbursement of Cures (FoCUS) Project Design Lab

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

February 8–9, 2017
Cambridge, MA

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

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.

Past 2016 NEWDIGS Events

November 28, 2016
Cambridge, MA

Address by Gerald J. Dal Pan, MD, MHS

The FDA’s Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research will deliver the address, “Assessing the Impact of Postmarketing Regulatory Programs and Actions.” Please note that participation is by invitation only.

November 10-11, 2016
MIT Samberg Conference Center, Cambridge, MA

Adaptive Biomedical Innovation Design Laboratory

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

October 27, 2016
Cambridge, MA

FoCUS Strategic Planning Design Lab

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

June 1-2, 2016
EMA Offices, 30 Churchill Place, Canary Wharf London, UK

Adaptive Design Laboratory

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

May 3, 2016
MIT Samberg Conference Center, Cambridge, MA

Adaptive Financing & Reimbursement of Cures in the US

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

For attendees*: Event summary page

 

*Attendees, if you are unable to access the page with your log-in information, please contact wijtmans@mit.edu.

2015 NEWDIGS Events

November
Cambridge, MA

NEWDIGS Workshop

Topic: Data Program

October 27-28
Washington D.C.

Better Science, Better Health: New Healthcare Models

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

Click here to visit the conference website. 

July 8-9
Cambridge, MA

MIT NEWDIGS Janus Program Workshop: Payer/HTA Adaptive Pathways

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:
    • Creative coverage and reimbursement under clinical utility uncertainty;
    • Role of real world data for evidence development;
    • Expanding scope of HTAs: social value, patient preference, combination treatments;
    • Accounting for variability in clinical practice, patient preference and treatment regimen adherence in HTA analysis and payer schemes;
    • The challenges of orphan size populations and combination treatments;
    • Beyond product affordability: impact on system.
  • Describe elements, factors and findings to include in Janus quantified simulations.
  • Articulate findings into a call-to-action publication(s) designed to increase awareness and catalyze collaborative and financial support.

Please note that participation is ‘by invitation only.’

March 23
MIT

Invitational Forum on Health Data, Topics: Advanced Analytic Methods in Pharmaceutical Innovation.

January 14-15
Cambridge, MA

NEWDIGS 2015 Data Program Workshop

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

2015 NEWDIGS Presentations

October
Seoul

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

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

Ken Oye (MIT).

July 30
Cambridge, MA

Invitational Symposium hosted by Sanofi

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

Panel on Clinical Trials: Gigi Hirsch (MIT).

July 23
Rockville, MA

National Science Advisory Board on Biosecurity, Working Group

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

Ken Oye (MIT).

May 16-20
Philadelphia, PA

 ISPOR 20th Annual International Meeting

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.

April 13 – 15
Paris

Webinar: MAPPs – New Tools for Decision making

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.

April 13 – 15
Paris

DIA Europe 27th Annual EuroMeeting

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

Full program here.

February 24
MIT

MIT Media Lab

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.

February 4
Yale University, New Haven

Interdisciplinary Center for Bioethics, Institution of Social and Policy Studies

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

Ken Oye (MIT).

 

*Attendees, if you are unable to access the page with your log-in information, please contact wijtmans@mit.edu.

2014 NEWDIGS Events

July 9
Cambridge, MA

The Next Act

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

Co-hosted by NORD, LFE and NEWDIGS

June 4-5
Cambridge, MA

NEWDIGS Quarterly Workshop

April 2-3
London

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

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

2014 NEWDIGS Presentations

November 20
Cambridge, MA

Biogen Idec Early Payer Scientific Advice Workshop

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

Gigi Hirsch (MIT).

October 21
London, Royal College of Physicians

Innovation in Clinical Trials

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).

October 21-22
Alexandria, VA

NORD’s 2014 Rare & Orphan Disease Products Summit

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

Gigi Hirsch (MIT).

October 13-15
Brussels

TOPRA Annual Symposium 2014

“Session 5: Adaptive Licensing.”

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

October 13-14
Paris

IRGC Annual Conference 2014

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).

October 1-2
London

Centre for Innovation in Regulatory Science (CIRS)

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

Tony Hoos (Medicines 4 Patients)

June 15-19
San Diego

DIA 2014

(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.

June 13
Boston

Global Clinical Scholars Training Program @ Harvard Medical School

“Overview of NEWDIGS & Adaptive Licensing”

Gigi Hirsch (MIT).

May 8
Washington DC

NORD Corporate Council Meeting

“Overview of NEWDIGS-Adaptive Licensing”

Thomas Unger (Pfizer).

March 26
Vienna

DIA Euro Meeting 2014

“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).

February 13-14
San Francisco

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

“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).

2013 NEWDIGS Events

December 5-6

NEWDIGS Q4 Working Sessions

September 16-17

NEWDIGS Q3 Working Sessions

June 20-21

NEWDIGS Q2 Working Sessions

February 26-27

NEWDIGS Q1 Working Sessions

2013 NEWDIGS Presentations

November 6-7
New York

Alzheimer’s Disease and Dementia Initiative

New York Academy of Sciences.

Panel: Public Private Partnerships. Panelist: Gigi Hirsch

November 3-5
New York

FasterCures 5th Annual Partnering for Cures

The Art and Science of Multi-stakeholder Collaboration

Panelist: Gigi Hirsch.

November 1-2
St. Petersburg

International Conference on Rare Diseases and Orphan Drugs (ICORD)

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).

September 26
Washington DC

IOM Roundtable on Value and Science-Driven Healthcare

Regulatory Science & Practice: Overview of Adaptive Licensing.

Ed Pezalla (Aetna).

September 19
Washington DC

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

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

June 17-18
Cambridge, MA

CancerRX Conference

(Chaired by Prof. Andrew Lo).

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

June 5
London

DIA

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

Dr. Anton (Tony) Hoos (GlaxoSmithKline)

May 6-8
Boston

11th Annual FEI: Front End Innovation

NEWDIGS

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

April 29
London

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

Gigi Hirsch and Lynn Baird (MIT)

April 25
Cambridge, MA

Healthcare Ecosystem @MIT

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

April 22-25
Chicago

BIO 2013

“Adaptive Development Strategies for Managed Entry of New Medicines”

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

March 25
Brussels

Progressive development and patient access

IMI project development meeting

Gigi Hirsch (MIT) and Thomas Unger (Pfizer)

February 21
London

Multi stakeholder meeting on Adaptive Licensing

Could AL become an IMI call topic?

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

February 11
Washington DC

IOM

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

Hans-Georg Eichler (European Medicines Agency)

February
Washington DC

IOM

“Accelerating innovation through partnerships: the NEWDIGS example”

Hans-Georg Eichler (European Medicines Agency)

January 24
Washington DC

Institute of Medicine, Committee

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

Invited Discussant: Gigi Hirsch (MIT).

January 14
Seoul

(1) Korean Advanced Institute of Science & Technology (KAIST)

(2) Korean Institute of Industrial Economics & Trade (KIET)

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

January 10
Beijing

From Crisis Management to Risk Governance

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).

2012 NEWDIGS Events

September 10-11

NEWDIGS Q3 Working Sessions

June 18-19

NEWDIGS Q2 Working Sessions

April 3
London

Legal Foundations of Adaptive Licensing Roundtable Forum

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

March 12-13

NEWDIGS Q1 Working Sessions

January 27

NEWDIGS Strategic Planning and Implementation Retreat

2012 NEWDIGS Presentations

November 29-30
London, UK

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

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

October 15-16
New York, N.Y.

Wired Health Conference

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

Invited Speaker: Dr. Gigi Hirsch (MIT)

September 13-14
Amsterdam, Netherlands

3rd DIA Health Technology Assessment (HTA) Forum

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)

June 24-28
Philadelphia, PA

DIA 2012 Annual Meeting

“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)

April 2012

Creating a Collaborative Environment in an Academic Setting

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

March 26-28
Copenhagen, Denmark

DIA EuroMeeting 2012

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

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

March 26-27

2012 MassBio Annual Meeting

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

Panelist – Dr. Gigi Hirsch (MIT)

2011 NEWDIGS Events

December 14-15

Adaptive Licensing Scenario Design Workshop

November 16

NEWDIGS Research Seminar Series

“New Approaches to Drug Approval”

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

November 8

Coverage with Evidence Development and Adaptive licensing workshop

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

Workshop Summary

October 25

NEWDIGS Research Seminar Series

“Healthcare Intelligence”

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

September 21

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

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

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

September 12-14

Advancing Active Surveillance: Focus on Singapore

August 17

Demonstration Project Planning

August 16

Adaptive Licensing Anti-Infective Scenario Design Workshop

May 16

Critical Questions Mapping: Oncology

May 9

Scenario Design Workshop: Adaptive Licensing

April 27

Critical Questions Mapping: Adaptive Licensing

January 7

Leveraging NEWDIGS to Transform Cancer Care