Special sessions announced for LEAPS Design Lab

A large maze with a ladder leading out of the center for a better view
Thursday, May 28, 2020

The LEAPS Virtual Design Lab will be held online June 9–10 by invitation only. If you are interested in attending the panel session, please contact easmall@mit.edu.

New Session: Real World Platform Strategies Through the Lens of a Pandemic

The ongoing pandemic has generated a flurry of innovation as numerous industry developers, academic centers, government agencies, hospitals and provider systems all start clinical trials (1,000+) of previously approved treatments, newly developed treatments, repurposed drugs, treatment combinations and vaccines. Yet lack of coordination threatens to undermine this response.

“It’s a cacophony — it’s not an orchestra. There’s no conductor,” said Derek Angus, chair of the department of critical care medicine at University of Pittsburgh School of Medicine, who is leading a covid-19 trial that will test multiple therapies. “My heart aches over the complete chaos in the response.” Francis Collins, Director of the National Institutes of Health is concerned that “we may be unlikely to learn what we need to from such disconnected, small trials. The whole point is to replace that with a coherent, evidence-based approach.”

During our Virtual Design Lab, we will address the benefits of platform strategies for efficient and scalable real-world research designs through the lens of a global pandemic.  We will examine how a master protocol/core protocol provides structure and efficiency to the research process so that we can both “learn (clinical research) and do (clinical practice)”.  

While the treatment of rheumatoid arthritis might not have the immediacy and urgency of the treatment of COVID-19, a “coherent, evidence-based approach” is still critical for the patients and providers making important treatment decisions and the payers who are deciding on access to treatment.  The perspectives of the stakeholders towards a platform strategy will be examined especially considering the real-world constraints confronting an embedded Adaptive Point-of-Care platform as compared to individual comparative effectiveness studies.

Featured Panel Discussion: “Adaptive Reimbursement: Innovating for Patient Access & Better Outcomes for All”

An emerging Adaptive Reimbursement collaboration between MIT NEWDIGS’s FoCUS and LEAPS projects was introduced at the April FoCUS Design Lab. MIT NEWDIGS’ early work on Adaptive Licensing included the concept that patient access to therapeutics and their reimbursement should adjust over time as uncertainties regarding safety and effectiveness were reduced. 

Adaptive reimbursement combines downstream innovations that:
(1) Creatively cover and finance therapies to ensure timely, appropriate access, enhance healthcare system sustainability and reward upstream innovation; and
(2) Reward optimized treatment regimens for each patient through the generation of real-world evidence that reduces uncertainties regarding biopharmaceutical product performance.  

FoCUS has emphasized developing precision financing solutions for durable cell and gene therapies that address therapeutic performance uncertainty and actuarial risk.  LEAPS has emphasized developing a learning ecosystem that not only continuously generates real-world evidence but also directly uses that evidence to improve patient care and outcomes.  Aligning incentives through innovative payment models is envisioned as a crucial tool for LEAPS to link evidence to action. 

Together, the FoCUS and LEAPS communities will combine their efforts to extend the toolkit of innovative access models beyond durable therapies and leverage the LEAPS real-world evidence generation platforms to inform financial reimbursement design, efficiently enable  their implementation through outcomes tracking and ensure that those outcomes refine future regimen optimization.
 
The Adaptive Reimbursement collaboration will continue at the June LEAPS Design Lab with a panel that will explore current Adaptive Reimbursement examples, discuss developing future innovations, and describe approaches to overcome the significant implementation challenges.  

Panelists will be:

  • Angela Banks from United Healthcare
  • Nick Crabb from NICE
  • Ron Potts from Kaiser Permanente
  • Michael Sherman from Harvard Pilgrim Health Care
  • David Strutton from Merck & Co.  

Outputs from this panel will shape the vision and priorities for a new LEAPS Adaptive Reimbursement workstream to launch in Fall 2020.