Oncology Leads Personalized Medicine
Applied Clinical Trials
Study finds that almost 75% of cancer drug candidates rely on biomarker data.
The opportunity to more precisely target and to personalize medical treatments based on biomarker data has attracted growing interest from biopharmaceutical companies. A recent study by the Tufts Center for the Study of Drug
Number of compounds in R&D that rely on biomarker data.
Development (Tufts CSDD) finds that oncology dominates personalized medicine product development in part because cancer-related illnesses are extremely complex and they receive the highest level of R&D activity. Companies involved in developing personalized medicines report that across all phases, 73% of oncology drugs now rely on biomarker data. This compares with 42% of compounds in all indications.
- Tufts CSDD
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.
FDA to Launch National Priority Voucher Program to Speed Drug Reviews for Critical Therapies
June 18th 2025Under the new initiative, companies may receive a voucher enabling FDA review to be shortened from the standard 10–12 months to just 1–2 months following final application submission if the drug addresses US national health priorities.
