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.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Zerlasiran Achieves Significant Sustained Reduction in Lipoprotein(a) Levels with Infrequent Dosing
November 20th 2024Zerlasiran, a novel siRNA therapy, demonstrated over 80% sustained reductions in lipoprotein(a) levels with infrequent dosing in the Phase II ALPACAR-360 trial, highlighting its potential as a safe and effective treatment for patients at high risk of cardiovascular disease.
