Clinical Pharmacology & Therapeutics, December 1, 2016A. Oye, H. G. Eichler, A. Hoos, Y. Mori, T. M. Mullin, and M. Pearson This article describes recent developments in licensing and reimbursement … 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
Health Technology Assessment in the Context of Adaptive Pathways for Medicines in Europe: Challenges and Opportunities
Clinical Pharmacology & Therapeutics, December 1, 2016C. Bouvy, P. Jonsson, C. Longson, N. Crabb, and S. Garner Adaptive pathways for medicines have gained momentum and, in Europe, adaptive pathways have … Read More
NEWDIGS convenes healthcare leaders to pioneer new pharmaceutical financing strategies
CAMBRIDGE, Mass., Oct. 27, 2016 — Patient advocates, healthcare payers, industry, and academic stakeholders gathered today at the Massachusetts Institute of Technology (MIT) to map out a new strategy for … Read More
“Threshold‐crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?
Clinical Pharmacology & Therapeutics, September 21, 2016Hans-Georg Eichler A central question in the assessment of benefit/harm of new treatments is: how does the average outcome on the new treatment (the … Read More
PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms
Clinical Pharmacology & Therapeutics, September 19, 2016Trusheim, Aa. Shrier, Z. Antonijevic, Ra. Beckman, Rk. Campbell, C. Chen, Kt. Flaherty, J. Loewy, D. Lacombe, S. Madhavan, Hp. Selker, and Lj. Esserman … Read More
Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need
Clinical Pharmacology & Therapeutics, September 14, 2016G Hirsch, M Trusheim, E Cobbs, M Bala, S Garner, D Hartman, K Isaacs, M Lumpkin, R Lim, K Oye, E Pezalla, P Saltonstall, … Read More
European Rare Diseases advocate EURORDIS joins as NEWDIGS member
International collaboration aims to improve healthcare for people living with a rare disease BOSTON, PARIS, 1 JULY 2016—MIT’s NEW Drug Development ParadIGmS (NEWDIGS) program announced today that EURORDIS-Rare Diseases Europe, … Read More
Gigi Hirsch with Alberto Grignolo on DIA Global Forum Podcast: “An Urgent Imperative Now to Learn Quickly”
Listen to a conversation between Dr. Alberto Grignolo, Deputy Editor of DIA Global Forum, and NEWDIGS Executive Director and DIA 2016 Conference Co-Chair Dr. Gigi Hirsch discuss the challenges of … Read More
Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to Implementation
Therapeutic Innovation & Regulatory Science, December 10, 2015Duane Schulthess, Lynn G. Baird, Mark Trusheim, Thomas F. Unger, Murray Lumpkin, Anton Hoos, Sarah Garner, Pamela Gavin, Michel Goldman, Nathalie Seigneuret, Magda … Read More