On Tuesday, February 26th, Dr Gigi Hirsch, Executive Director of MIT NEWDIGS, gave a presentation for the Harvard-MIT Center for Regulatory Science to a gathering of local academic, clinical, and industry leaders … Read More
Preparing Patients and the Health System for Curative Therapies in the Pipeline
American Journal of Managed Care Curative therapies represent a conundrum for healthcare. On the one hand, there is the ability to cure patients of potentially life-threatening diseases or diseases that … Read More
MIT Releases New Policy and Practice Suggestions to Make Cures Accessible and Sustainable
Innovative Therapies Will Require Innovations in Financing and Regulations WASHINGTON, DC, February 12—Today, the MIT-based Financing and Reimbursement of Cures in the US (FoCUS) consortium released a series of large-scale … Read More
“Dynamic Dossier in the Cloud” to Transform Data Sharing, Starting with Federal Regulators
New platform will redefine biopharmaceutical data sharingMIT NEWDIGS and the Harvard-MIT Center for Regulatory Science announced the Dynamic Dossier in the Cloud today, a radical new platform that promises to … Read More
Precision Financing of Durable, Potentially Curative Therapies
Pharmaceutical Executive, January 27, 2019 Trusheim, Jane Barlow Russell Teagarden Mark Gene therapies and cellular treatments create multiple financial challenges for US healthcare payers beyond price. The work of the … Read More
Precision Financing Solutions for Durable / Potentially Curative Therapies
The NEWDIGS FoCUS consortium of multiple stakeholders (payers, providers, patient advocacy organizations, pharmaceutical developers, academics and others) has been working collaboratively since 2016 to address the need for new, innovative … Read More
Incorporation of Value-Based Payment Agreements into the Calculation of Medicaid Drug Rebates
Value-Based Payment (VBP) agreements will play an important role in mitigating uncertainty in durable therapies, where it is unclear whether a large upfront payment is justified based on limited clinical … Read More
Clinical trials and investment trends for novel CAR-T and TCR therapies
Compared to small-molecule therapies, the nature of CAR-T/TCR therapies is such that they can be diversified with lower probability of failure in the clinic. Many companies and academic entities are … Read More
MIT LEAPS Design Lab Shapes Blueprint for Rheumatoid Arthritis Pilot in Massachusetts
CAMBRIDGE, MASSACHUSETTS — An international community of biomedical and healthcare innovation leaders gathered at MIT on December 12 and 13 for the second Design Lab for LEAPS (Learning Ecosystems Accelerator … Read More
Model Contracts for Innovative Oncology Therapies
When there is substantial uncertainty about a new product’s expected value, stakeholders may have strong reasons to consider performance-based contracts. One of the hardest tasks in crafting such contracts is … Read More