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
The clinical benefits, ethics, and economics of stratified medicine and companion diagnostics
Drug Discovery Today, December 1, 2015Mark R. Trusheim and Ernst R. Berndt The stratified medicine companion diagnostic (CDx) cut-off decision integrates scientific, clinical, ethical, and commercial considerations, and determines its … 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
Mark Trusheim featured in Nature News Article: Financing Cures
Mark Trusheim, Director of NEWDIGS Strategic Initiatives, is quoted in the Nature News article “Promising gene therapies pose million-dollar conundrum“. He spoke at BIO on June 8th presenting on “Curative … Read More
From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients
Clinical Pharmacology & Therapeutics, March 2015H-G Eichler, Lg Baird, R Barker, B Bloechl-Daum, F Børlum-Kristensen, J Brown, R Chua, S Del Signore, U Dugan, J Ferguson, S Garner, W Goettsch, … Read More