New Report from Tufts CSDD on R&D Models
A management report from Tufts CSDD, based on an executive roundtable, found that drug companies and their development partners are incorporating business planning earlier in clinical development
A management report from Tufts CSDD, based on an executive roundtable, found that drug companies and their development partners are incorporating business planning earlier in clinical development, as well other strategies, to help increase the clinical success rate of new drug candidates. The roundtable also discussed how using a more rigorous use of risk-adjusted net present value calculations earlier in clinical development can improve decision making on how to structure clinical trials.
Read the full release here.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
