Speaking Engagements (Staff, Collaborators, Strategic Partners)
2022
Mark Trusheim, Michael Ciarametaro, and Kim Caldwell for FoCUS
Mark Trusheim for FoCUS
2021
Jane Barlow and Brendan Hayes participated in the Great Lakes Hemophilia Foundation's Comprehensive Gene Therapy Symposium on November 30.
Mark Trusheim participated in the the APEC Finance Ministers' Meeting on October 28.
Mark Trusheim participated in the the McKinsey CGT Roundtable on October 22
Jane Barlow will join the AMCP Nexus 2021 in Denver, in a session "Addressing Gene Therapy Financial Challenges: A survey of emerging market solutions" with Michelle Harika on October 19.
Jane Barlow will join the Alliance for Innovation in Integrated Healthcare (AIIH) Summit in NYC: Impact of Cell and Gene Therapy panel on October 11.
Mark Trusheim participated in the Advanced Regenerative Manufacturing Institute fall meeting on October 7, presenting FoCUS's reimbursement research.
Jane Barlow discussed FoCUS emerging market solutions research at the Huron Virtual Roundtable discussion "Unlocking the Full Potential of Outcomes Based Contracting Work for CGT: Collaborate or Compete?" on September 22.
Mark Trusheim participated in the ASCGT Policy Forum panel "The Status of Medicaid Coverage and Access for Gene and Cell Therapies" on September 22, and on September 28 he led the roundtable "Preparing for 2022 regulatory change and the performance-based contracting explosion" for the Reuters Cell and Gene Therapy USA meeting. On September 30 Mark spoke in the OHE Master Class Adaptive Pathways: Generating Evidence of Value.
Mark Trusheim participated in the World Orphan Drug Congress USA 2021 on August 25–27.
Mark Trusheim participated in the BCBSA 2021 Specialty Pharmacy Conference on July 20–21.
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
On April 12 Mark Trusheim led a workshop for ISPOR, entitled “Adaptive Reimbursement: Innovating for Patient Access and Better Outcomes for All”, including Angela Banks Vice President, External Affairs, UnitedHealth Group; Ron Potts, MD; Medical Director Quality Improvement Kaiser Permanente, Chief Medical Officer, INTERLINK; and David Strutton, PhD, VP, Global Pharmaceuticals & Policy Research, Center for Observational and... Learn more
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".
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.
Mark Trusheim participated as a panelist in the BioNJ Cell & Gene Therapy Market Access Program for FoCUS
Mark Trusheim presented "Models of Paying for High-Cost Cellular Therapies" at the 2021 Meetings of the ASTCT and CIBMTR
Mark Trusheim spoke at a California Life Sciences Association briefing on January 26. The briefing was well attended, and the audience included California state legislators.
2020
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
Gigi Hirsch will present LEAPS and the RA MA Pilot
Mark Trusheim for NEWDIGS
Mark Trusheim for FoCUS
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
Mark Trusheim for FoCUS
Mark Trusheim for FoCUS
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
Mark Trusheim will represent FoCUS
Gigi Hirsch will present the research taking place through NEWDIGS
2019
Gigi Hirsch will present LEAPS
Mark Trusheim will represent NEWDIGS
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
Kay Larholt will represent NEWDIGS and LEAPS in a panel discussion titled: Getting Real: The Changing Tide on Real-World Evidence in Drug Development
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).
Mark Trusheim will represent FoCUS in a panel titled: Pricing Pressures for 2020 and Beyond
Colin Young for the FoCUS Project
Mark Trusheim will speak for FoCUS at this Duke-Margolis Center for Health Policy public workshop.
"Delve into the Evolving Reimbursement Landscape and Developments in Payer Policy"
Mark Trushiem for FoCUS
Mark Trusheim has been invited to speak.
Mark Trusheim for FoCUS
Casey Quinn will represent the FoCUS Project in a Panel titled: HTA Reimbursement and Payment of Gene Therapy for Hemophilia
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
Mark Trusheim will present:
Precision Fiancing Framework and Pilots: MIT FoCUS Consortium Findings
Jane Barlow will represent the FoCUS Project
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
Casey Quinn will present FoCUS learnings at the MIT Center for Biomedical Innovation's BioMANufacturing Program Summit
Mark Trusheim, for NEWDIGS, facilitating working sessions for this Harvard-MIT Center for Regulatory Science and BIO joint workshop.
Kimberly Freeman, for FoCUS
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.
Colin Young, FoCUS, presenting a poster on Pipeline Research
R. John Glasspool & Gigi Hirsch
Leaders in Global Healthcare & Technology
Mark Trusheim for FoCUS
Mark Trusheim for FoCUS
"Paying for the High Cost of Cures"
R. John Glasspool & Casey Quinn for FoCUS
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
(R. John Glasspool) Duke-Margolis Center for Health Policy Workshop
(Kay Larholt) Real World Evidence Discussions & Overview of Related Projects
(Gigi Hirsch) Panel: Getting What You Measure: Incentives for Collaboration
(Mark Trusheim) Adaptive Pathways and Platform Trials Discussion
(Gigi Hirsch) Panel: Real World Evidence: Hype or Reality? (John Glasspool, Moderator)
(Mark Trusheim) Panel: Gene Therapy: Commercialization Readiness & Market Access Challenges
(Gigi Hirsch) Panel: Adaptive Biomedical Innovations: The Way Forward (Stella Blackburn, Moderator)
2016
hosted by the National Cancer Policy Forum. (G.K. Raju)
“The Impact of a New Healthcare Model: What Do Payers Think of Gene Therapies?” (Mark Trusheim)
NBER Pre-Conference on Economic Dimensions of Personalized and Precision Medicine
“Europe and the US: Making Outcomes-Based Health Care Possible.” Details here. (Gigi Hirsch).
(Gigi Hirsch & Hans-Georg Eichler – Session Co-Chairs).
“Curative Therapies: Aligning Policy with Science to Ensure Patient Access” (Mark Trusheim).
“Adaptive Pathways and Biomedical Innovation in the EU, US and Japan” (Ken Oye).
“Adaptive Biomedical Innovation: Re-engineering How We Innovate” (Gigi Hirsch).
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).
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).
Panel Debate on “Earlier Access vs. Safety?” (Hans-Georg Eichler & Ken Oye).