“Dynamic Dossier in the Cloud” to Transform Data Sharing, Starting with Federal Regulators

Eric NormanLEAPS, News

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 Solutions for Durable / Potentially Curative Therapies

Eric NormanFoCUS, Whitepapers

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

Eric NormanFoCUS, Research Briefs

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

Eric NormanFoCUS, Research Briefs

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

Eric NormanLEAPS, News

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

Eric NormanFoCUS, Research Briefs

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