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NEWDIGS Design Lab

September 26-27, 2023

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Welcome to our Design Lab in Boston!


Hyatt Regency Boston Harbor
101 Harborside Drive 
Boston, MA 02128

Hello NEWDIGS Community,

We are delighted that you can join us next week for our first Design Lab of the NEWDIGS PIVOT Project, formed through the integration & extension of the NEWDIGS FoCUS and LEAPS Projects and respective communities. We look forward to gathering with you on September 26-27 at the Hyatt Regency Boston Harbor at 101 Harborside Drive, Boston, MA.

This Design Lab will build on the foundational work from both the FoCUS and LEAPS Projects, specifically:

  1. Continue to advance the work on payment innovation for cell & gene therapies (CGTs) through FoCUS as a special interest group within the PIVOT project
    • Look forward to getting your input into the evolving joint paper being developed by NEWDIGS-ICER on Innovative Payment Models in CGT
    • Continue to identify barriers to access to CGTs through a broad panel discussion and a session specifically targeting provider capacity challenges
  2. Updates on payment innovation activities that extend our work in FoCUS to a broader range of product classes, diseases, and geographies including
    • Pediatric rare diseases/Pipeline Analysis & Modeling (PAM)
    • Global/tracking the use of value-based contracts (VBCs) for CGTs
  3. Follow on efforts in Real-World Evidence (RWE) beyond LEAPS specifically focused on
    • Accelerating outcomes tracking to support value-based payment innovation
    • Exploring through a case study if value-based contracts (VBCs) can help resolve the key challenges AAP-approved products present for patient/provider access, payer value assessments, and regulatory confirmatory evidence? (Groundwork for this session was laid on our LEAPS Design Lab in June 2023.)
  4. Multi-stakeholder panel discussion exploring updates and implications of current policy developments in the US
  5. Discussing forward plans for PIVOT Project and its FoCUS special interest group, as well as more broadly, the NEWDIGS consortium.

In keeping with the environmentally friendly approach from our recent Design Labs, we will only be printing a limited selection of the pre-read materials for specific sessions. All Design Lab materials will be available on this dedicated page for easy access before and during the event, including:

  • Design Lab Objectives & Agenda
  • Attendee List with Networking Links
  • Chatham House Rule and Confidentiality Statement
  • Critical background: Accelerated Approval Case Study briefing book for Day 1 breakout group discussion session
  • Optional background: Summaries from the most recent Design Labs of FoCUS (April 2023) and LEAPS (June 2023).

Please take a moment to look through the downloadable Design Lab materials. Feel free to print and bring any of the materials with you. QR codes will be offered for quick access to the website on your devices.

For any last minute questions, please contact Keileen Hopps and Tsega Meshesha.

As always, we greatly appreciate your ongoing support and commitment. Your input is critical for our success!

Looking forward to continuing our work together.

Gigi and Mark