The LEAPS methodology begins by answering two structured questions – WHAT evidence to produce, and HOW to produce it, as outlined in this two-part Research Brief series: • Part I: … Read More
The Role of Stop-Loss Insurance and Reinsurance in Managing Performance-Based Agreements
Over the last decade, rising healthcare costs and the availability of expensive new treatment options has led to a substantial increase in the number of patients with large insurance claims. … Read More
Baking the Cake: A decision driven framework for planning fit-forpurpose evidence across stakeholders
The LEAPS methodology begins by answering two structured questions: what evidence to produce, and how to produce it, as outlined in this two-part Research Brief series: • Part I: Baking … Read More
Massachusetts Pilot Disease Selection
Rheumatoid Arthritis (RA) chosen as target for LEAPS Massachusetts (MA) Pilot (RAMA) to demonstrate the feasibility and impact of a sustainable and patient-centered healthcare learning ecosystem to optimize care regimens … Read More
Pediatric Gene Therapy Launches
Gene therapy cures for hereditary genetic conditions are likely to reach the United States market in the coming decades. Several disease areas with potential cures are orphan conditions, which affect … Read More
Patient & Caregiver Themes Survey
Patients and caregivers are key stakeholders in the development of system-wide, implementable precision financing models for durable and curative therapies. Patient and caregiver challenges are generally assumed to be primarily … Read More
Leaping Together Toward Sustainable, Patient‐Centered Innovation: The Value of a Multistakeholder Safe Haven for Accelerating System Change
Clinical Pharmacology & Therapeutics, November 2, 2018Gigi Hirsch Successfully delivering on the promise of emerging science in a world of value-driven healthcare requires that we fundamentally reengineer biomedical innovation processes … Read More
Improving Management of Gene and Cell Therapies
Pharmaceutical Executive, September 10, 2018Michael Ciarametaro, Mark Trusheim, Daniel S. Mytelka, Gregory L. Warren, and Donald Han After decades of anticipation, 2017 saw the approval of the first of a … Read More
A Benefit–Risk Analysis Approach to Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer
Clinical Pharmacology & Therapeutics, December 1, 2016K. Raju, K. Gurumurthi, R. Domike, D. Kazandjian, G. Blumenthal, R. Pazdur, and J. Woodcock Drug regulators around the world make decisions about drug … Read More
The next frontier: Fostering innovation by improving health data access and utilization
Clinical Pharmacology & Therapeutics, November 1, 2015A. Oye, G. Jain, M. Amador, R. Arnaout, J. S. Brown, W. Crown, J. Ferguson, E. Pezalla, J. A. Rassen, H. P. Selker, M. … Read More