Morning session, 9am–12pm
“How an RWE Infrastructure Could Enable Payment Innovation” co-hosted by NEWDIGS & IMI’s Health Outcomes Observatory (H2O)
- Evaluate trends, gaps, and opportunities in the evolution of outcomes tracking innovations in the U.S. and Europe through the lens of several case studies.
- Explore how an RWE infrastructure could enable payment innovation in the U.S. to ensure timely and appropriate access for patients to biomedical products.
- Elucidate priorities for collective action to accelerate the evolution of sustainable, patient-centered outcomes tracking to support payment innovation.
9am
In-person Registration
10am
Welcome/Event Overview
Introduction & Welcome
Moderator: Jane Barlow, Senior Advisor, NEWDIGS
Event Overview
Gigi Hirsch, Director, Center for Biomedical System Design & NEWDIGS
H2O Overview
Meni Styliadou, Takeda & H2O Co-lead
Tanja Stamm, Medical University of Vienna & H2O Co-lead
10:30am
Panel Talks: Opening Statements
Payer Perspective
Kate Wallis, Point32Health
Developer Perspective
Greg Daniel, Eli Lilly and Company
PCORnet: National infrastructure for patient-centered clinical research
Claudia Grossman, PCORI
Real Endpoints: Multi-product market access platform
Rob O’Brien, Real Endpoints
Beekeeper AI: Next generation secure data access platform
Michael Blum, BeekeeperAI
10:55am
Panel & Group Discussion
11:55am
Closing remarks
Jane Barlow
Afternoon session, 12pm–6:30pm
LEAPS Design Lab focusing on Payment Innovation
- Explore concerns around Accelerated Approval Products (AAP) in the context of their value, appropriate patient access, and long-term performance.
- Investigate the potential for value-based contracts to address these concerns, while also contributing to the totality of AAP regulatory evidence and supporting HTA approaches.
12:00pm
Networking Lunch & Registration
1:00pm
LEAPS Design Lab Introduction
Mark Trusheim, Strategic Director, NEWDIGS
1:10pm
Methods Innovation Update
Fotios Kokkotos, Director of Data Science, NEWDIGS
1:30pm
Payment Innovation Framework Overview
Jane Barlow, Senior Advisor, NEWDIGS
1:45pm
Payment Innovation Accelerated Approval Product (AAP) Case Study presentation and clarifying questions
Ron Potts, 6 Degrees Health
Jamie Foley, Takeda Oncology
Felipe Dolz, Sanofi
2:45pm
AAP Case Study Breakout Groups Discussion
All
4:00pm
Break
4:15pm
AAP Case Study Breakout Groups Report-out and Q&A
All
5:00pm
Forward Planning
Gigi Hirsch, Director, Center for Biomedical System Design & NEWDIGS
5:30pm
Reception
Benjamin Ackerman
Quantitative Scientist
Flatiron Health
Elizabeth Apgar
Epidemiologist
NEWDIGS
Azrina Azhar
Program Operations Manager
NEWDIGS
Abbie Ba-Mancini
Head of Patient Value of Access, Hemato—oncology
Takeda Pharmaceuticals
Jane Barlow
Senior Advisor, FoCUS Project
NEWDIGS
Paul Beninger
Associate Professor
Tufts University School of Medicine
Stella Blackburn
VP, Strategic Operations
IQVIA
Mary Brophy
Director, MAVERIC
VA Boston Healthcare System
Fiona Cai
Undergraduate Researcher
MIT
Dawn Cardeiro
Director of Precision Medicine
Point32Health
Dasha Cherepanov
Director, Global Evidence and Outcomes, DSI, R&D
Takeda Pharmaceuticals
Michael Ciarametaro
VP, Research
National Pharmaceutical Council
Amita Dasmahapatra
President
AD Health Strategy, LLC
Lucas de Breed
Founder
August Care
Felipe Dolz
VP, Regulatory Science & Policy
Sanofi
John Ferguson
Head, Pharmacovigilance Sanofi SC
Sanofi
Ryan Ferguson
Director
VA Cooperative Studies Program Coordinating Center, Boston
Nathanael Fillmore
Associate Director for Machine Learning and Advanced Analytics
MAVERIC
VA Boston Healthcare System
Jamie Foley
Director of Value-Based Innovation
Takeda Oncology
Diana Frame
Founder
Frame Research LLC
Karen Geary
Senior Consultant, FoCUS Project
NEWDIGS
Ramon Hernandez Vecino
Global Head RWE Clinical Development
Sanofi
Gigi Hirsch
Executive Director
MIT Center for Biomedical Innovation
NEWDIGS
Keileen Hopps
Project Manager
NEWDIGS
Nirmal Keshava
VP - Data Science and Innovation
Cerevel Therapeutics
Fotios Kokkotos
Director of Data Science
NEWDIGS
Smita Kothari
Executive Director Outcomes Research
Merck & Co. Inc.
Kay Larholt
Retired Director of Research
NEWDIGS
Peter Loupos
Founder and General Manager
Princeton Healthcare Strategies
Mary McGowan
Chief Medical Officer
The Family Heart Foundation
Tsega Meshesha
Program Manager, FoCUS
NEWDIGS
Kelly D. Myers
Chief Technology Officer
The Family Heart Foundation
Megan O’Brien
Executive Director
Merck & Co., Inc.
Chris Pashos
Member, Board of Directors
Genesis Research
Ron Potts
Chief Medical Officer
6 Degrees Health
Lauren Ritterhouse
Associate Director, Center for Integrated Diagnostics
Massachusetts General Hospital
Gail Ryan
Director, Pharmaceutical Transformation
Point32Health
Eric Small
Senior Administrative Assistant
NEWDIGS
Asvin Srinivasan
Head of Product
Onc.AI
David Strutton
VP CORE Global Pharmaceutical, Outcomes Research
Merck & Co., Inc.
Katie Torrence
Project Coordinator, FoCUS Project
NEWDIGS
Ludovic Trinquart
Director, Center for Clinical Trials
Tufts Clinical and Translational Science Institute (CTSI)
Mark Trusheim
Strategic Director
NEWDIGS
Priscilla Velentgas
Global Lead, Safety Evidence for Regulators
IQVIA
Kate Wallis
VP Clinical Innovation
Point32Health