Considering the Critical Path in Oncology Drug Development
In an afternoon session examining innovations in the development of anticancer medicines, speakers from the research, therapeutic, regulatory and industry perspectives discussed "Changing the Paradigm: Innovative Oncology Drug Clinical Development Programs in the Age of the Critical Path and Personalized Medicine."
In an afternoon session examining innovations in the development of anticancer medicines, speakers from the research, therapeutic, regulatory and industry perspectives discussed "Changing the Paradigm: Innovative Oncology Drug Clinical Development Programs in the Age of the Critical Path and Personalized Medicine."
Bertil Jonsson, MD, PhD, Medical Products Agency, Sweden, said that biomarkers and confirmatory studies can be an alternative measure, but added that "more data is needed." Jonsson also said that conditional approvals are viable, so long as they demonstrate "dramatic, obvious effects."
Speaking from the U.S. regulatory perspective, Robert L. Justice, MD, medical officer, CDER, said major opportunities to speed drug development include modernizing clinical trials, including adaptive trial designs and improving the problem of missing data.
"At the end of the development process, we don't know a whole lot about the drug," he lamented. Modernization solutions cited by Grant A. Williams, MD, clinical development, GlaxoSmithKline, include enrichment designs that target subgroups and focus on patient safety. One such design divides subjects into pharmacogenomic positive and negative groups, which are both subsequently randomized.
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.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.
