OR WAIT null SECS
© 2023 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
Applied Clinical Trials
Cohen addresses the three-pronged parts of drug development process or clinical trials
Quintiles released the written remarks, its Senior Vice President and Global Head of Early Clinical Development, Oren Cohen, MD, will make today October 9, to a Congressional Roundtable being held in Research Triangle Park, NC. The roundtable is an outgrowth of the U.S. House Energy & Commerce Committee’s 21st Century Cures Initiative and will focus on the discovery, development, and delivery of vaccines.
In these remarks, again specific to vaccines, Cohen addresses the three-pronged parts of drug development process or clinical trials; pathways or regulatory alternatives to minimize clinical development times, and preparedness for development of vaccines.
Under clinical trials or process, interestingly, Cohen targets ECs and IRB inefficiencies, promotes eSource Data Capture and the enforced use of common data standards, such as those created by CDISC.
Under pathways, Cohen believes an adaptive licensing approach similar to the EMA pilots now underway, would be helpful for FDA in regard to vaccine development.
Dr. Cohen is an infectious diseases expert and head’s Quintiles’ Phase I Clinical Research division, which includes world-class facilities in Overland Park, Kansas (US) and London.
Read the full release here.
The following infographic was sent with the press release. (Click to enlarge).