Speaking Engagements (Staff, Collaborators, Strategic Partners)
2021
June 17 - 17, 2021
Online
Precision therapies are often approved based on small trials, in specialized settings, and using biomarkers as endpoints. Thus, despite their potential high cost, the evidence of value is lacking which makes real-world evidence crucial. Join Schaeffer Center Director of Research Darius Lakdawalla in discussion with MIT NEWDIGS Director of Research Kay Larholt and Merck Center for Observational and Real-World Evidence Executive Director Megan O’Brien for a discussion about how we should measure and leverage real-world data to assess the value of precision medicines.
... Learn more
February 26 - 26, 2021
Online
NEWDIGS Executive Director Gigi Hirsch moderated the midday keynote fireside chat at the MIT Sloan 2021 Healthcare and Bioinnovations Conference, on the topic "The Value of Downstream Innovation - Improving Patient Access to Groundbreaking Therapies".
February 22 - 22, 2021
Online
Mark Trusheim spoke at on the panel "Collecting & Utilizing Data to Support Gene Therapy Market Access" at the 4th Annual Gene Therapy for Rare Disorders conference representing FoCUS.
February 17 - 17, 2021
Online
Mark Trusheim participated as a panelist in the BioNJ Cell & Gene Therapy Market Access Program for FoCUS
February 9 - 9, 2021
Online
Mark Trusheim presented "Models of Paying for High-Cost Cellular Therapies" at the 2021 Meetings of the ASTCT and CIBMTR
2020
June 23 - 23, 2020
Online: https://www.fiercevirtual.com
Kay Larholt will represent NEWDIGS in a panel:
Real-world evidence: Another "gold standard" for drugmakers?
June 23 at 1 p.m. ET
In their hunt for new approvals, biopharma companies spend billions of dollars every year on clinical trials. In recent years, though, real-world studies as sources of practice-informing data––and even as the basis for new indications––have multiplied. but clinical trials remain the gold standard.
In a post-pandemic future, will clinical trials ever look the same again? Could real-world data help fill in the gaps? In this session, we will discuss the role real-world... Learn more
June 20 - 20, 2020
Online
Gigi Hirsch will present LEAPS and the RA MA Pilot
April 7 - 9, 2020
Los Angeles, CA
Mark Trusheim for NEWDIGS
March 30 - 2, 2020
Boston, MA
Mark Trusheim for FoCUS
February 28 - 28, 2020
MIT, Cambridge, MA
12:45PM:
Lunch Fireside Chat:
- Noubar Afeyan, PhD, Founder & CEO, Flagship Pioneering
- Gigi Hirsch, MD, Executive Director, Center for Biomedical Innovation, Massachusetts Institute of Technology
February 21 - 21, 2020
Orlando, FL
Mark Trusheim for FoCUS
February 13 - 13, 2020
Washington, DC
Mark Trusheim for FoCUS
February 7 - 7, 2020
Orlando, FL
Danielle Rollmann will represent FoCUS in a panel titled: Guiding the Future of Pharmacy Benefits: Adapting to Gene Therapy and Ultra High-Cost Drugs to Make Leading-edge Care Affordable
February 6 - 7, 2020
Washington, DC
Mark Trusheim will represent FoCUS
January 31 - 31, 2020
Tufts Clinical and Translational Science Institute, Boston, MA
Gigi Hirsch will present the research taking place through NEWDIGS
2019
November 15 - 15, 2019
Cambridge, MA
Gigi Hirsch will present LEAPS
October 29 - 30, 2019
Bethesda, MD
Mark Trusheim will represent NEWDIGS
October 29 - 29, 2019
Washington, DC
Gigi Hirsch will present LEAPS in a panel entitled Flipping the Script: Designing the System to Deliver for Patients.
- Livestreamed panels can be viewed here. The panel is scheduled for 3:45-4:45pm
October 29 - 29, 2019
Boston, MA
Kay Larholt will represent NEWDIGS and LEAPS in a panel discussion titled: Getting Real: The Changing Tide on Real-World Evidence in Drug Development
October 23 - 23, 2019
Washington, DC
Gigi Hirsch and Kay Larholt have been invited to present Learning Ecosystems Accelerator for Patient-Centered, Sustainable Innovation (LEAPS) Project in a closed forum meeting.
The 30-minute presentation will be followed by a 45-minute informal discussion with the Forum membership moderated by the Forum co-chairs (Rob Califf and Greg Simon).
September 26 - 26, 2019
New York City, NY
Mark Trusheim will represent FoCUS in a panel titled: Pricing Pressures for 2020 and Beyond
September 17 - 17, 2019
Cambridge, MA
Colin Young for the FoCUS Project
September 11 - 11, 2019
Washington, DC
Mark Trusheim will speak for FoCUS at this Duke-Margolis Center for Health Policy public workshop.
June 14 - 14, 2019
Boston, MA
"Delve into the Evolving Reimbursement Landscape and Developments in Payer Policy"
Mark Trushiem for FoCUS
May 10 - 10, 2019
Rockville, MD
Mark Trusheim has been invited to speak.
May 4 - 4, 2019
New Orleans, LA
Mark Trusheim for FoCUS
April 4 - 4, 2019
Montreal, Ontario, Canada
Casey Quinn will represent the FoCUS Project in a Panel titled: HTA Reimbursement and Payment of Gene Therapy for Hemophilia
April 2 - 2, 2019
Cambridge, MA
12:00 PM Panel: Towards an “Agile” Regulatory Framework (45 mins)
Chaired by Gigi Hirsch, Massachusetts Institute of Technology
Paul Howard, Food and Drug Administration
Anne-Virginie Eggimann, bluebird bio
Ed Pezalla, Enlightenment Bioconsult
John Ferguson, Sanofi
March 27 - 27, 2019
Boston, MA
Mark Trusheim will present:
Precision Fiancing Framework and Pilots: MIT FoCUS Consortium Findings
March 25 - 28, 2019
San Diego, CA
Jane Barlow will represent the FoCUS Project
February 26 - 26, 2019
Cambridge, MA
Gigi Hirsch presented LEAPS:
From Bigger Data to Smarter Evidence
As health data increasingly scale and go digital, the prevailing attitude has been a big data approach, where whoever has the most data wins. However, the creation of vast amounts of data has not translated to useful evidence in many cases, particularly as biopharmaceutical innovation and healthcare systems evolve toward precision medicine, patient-centered innovation, and value-based reimbursement models where reliable, targeted, and fit-for-purpose evidence is key to matching the appropriate treatments to patients. NEWDIGS is leading a... Learn more
2018
December 12 - 12, 2018
Cambridge, MA
Casey Quinn will present FoCUS learnings at the MIT Center for Biomedical Innovation's BioMANufacturing Program Summit
November 7 - 7, 2018
Boston, MA
Mark Trusheim, for NEWDIGS, facilitating working sessions for this Harvard-MIT Center for Regulatory Science and BIO joint workshop.
October 30 - 31, 2018
New York, NY
Kimberly Freeman, for FoCUS
October 29 - 29, 2018
Silver Spring, MD
Mark Trusheim, for NEWDIGS
The FDA Oncology Center of Excellence, in collaboration with theUCSF-Stanford Centers of Excellence in Regulatory Science and Innovation (CERSI) will hold a public workshop to explore clinical trial designs and innovations that will aid in ioptimizing outcomes in early breast cancer.
October 3 - 5, 2018
La Jolla, CA
Colin Young, FoCUS, presenting a poster on Pipeline Research
May 8 - 9, 2018
Stanford, CA
R. John Glasspool & Gigi Hirsch
Leaders in Global Healthcare & Technology
May 5 - 5, 2018
Chicago, IL
Mark Trusheim for FoCUS
May 2 - 2, 2018
Beverly Hills, CA
Mark Trusheim for FoCUS
"Paying for the High Cost of Cures"
March 26 - 26, 2018
Paris, France
R. John Glasspool & Casey Quinn for FoCUS
March 21 - 22, 2018
Budapest, Hungary
Ariel Stern and Mark Trusheim will facilitate a day of interactive discussions on MAPPS and the Adapt Smart consortium using NEWDIGS Scenario Design Lab methodology
2017
November 14 - 14, 2017
Washington, DC
(R. John Glasspool) Duke-Margolis Center for Health Policy Workshop
October 24 - 25, 2017
Washington, DC
(Kay Larholt) Real World Evidence Discussions & Overview of Related Projects
July 12 - 12, 2017
Boston, MA
(Gigi Hirsch) Panel: Getting What You Measure: Incentives for Collaboration
May 24 - 24, 2017
Boston, MA
(Mark Trusheim) Adaptive Pathways and Platform Trials Discussion
May 10 - 11, 2017
Palo Alto, CA
(Gigi Hirsch) Panel: Real World Evidence: Hype or Reality? (John Glasspool, Moderator)
April 27 - 27, 2017
Boston, MA
(Mark Trusheim) Panel: Gene Therapy: Commercialization Readiness & Market Access Challenges
January 23 - 23, 2017
Washington, DC
(Gigi Hirsch) Panel: Adaptive Biomedical Innovations: The Way Forward (Stella Blackburn, Moderator)
2016
December 12 - 12, 2016
Washington, DC
hosted by the National Cancer Policy Forum. (G.K. Raju)
October 5 - 5, 2016
La Jolla, CA
“The Impact of a New Healthcare Model: What Do Payers Think of Gene Therapies?” (Mark Trusheim)
September 21 - 21, 2016
New York, NY
NBER Pre-Conference on Economic Dimensions of Personalized and Precision Medicine
June 29 - 29, 2016
Philadelphia, PA
“Europe and the US: Making Outcomes-Based Health Care Possible.” Details here. (Gigi Hirsch).
June 26 - 30, 2016
Philadelphia, PA
(Gigi Hirsch & Hans-Georg Eichler – Session Co-Chairs).
June 8 - 8, 2016
San Francisco, CA
“Curative Therapies: Aligning Policy with Science to Ensure Patient Access” (Mark Trusheim).
April 21 - 22, 2016
Duke University, Durham, NC
“Adaptive Pathways and Biomedical Innovation in the EU, US and Japan” (Ken Oye).
April 21 - 22, 2016
Amsterdam
April 21 - 22, 2016
Washington, DC
“Adaptive Biomedical Innovation: Re-engineering How We Innovate” (Gigi Hirsch).
March 21 - 22, 2016
San Francisco, CA
co-sponsored by Silicon Valley Executive Network (SVEN), Decision Resources Group, and MIT Media Lab. “Adaptive Biomedical Innovation: Transforming Big Data Hype into Patient Value” (Tom Unger).
March 17 - 18, 2016
Amsterdam
Belgian Healthcare Knowledge Center (HKC) & WHO jointly sponsored Drug Pricing Scenarios Project (Report to be presented to Dutch EU Presidency in June 2016) – Part 1 (Mark Trusheim).
January 27 - 29, 2016
Washington, DC
Panel Debate on “Earlier Access vs. Safety?” (Hans-Georg Eichler & Ken Oye).
