Clinical Pharmacology Leadership Group

The Clinical Pharmacology Leadership Group represents the disciplines of Clinical Pharmacology, Experimental Medicine and Translational Medicine within the pharmaceutical industry.  The CPLG's objectives include facilitation of interactions between industrial-, academic- and government-based clinical pharmacology organizations; strong leadership in establishing/promoting best practices for assessment of drug candidates and drug targets; constitution of Working Groups to review draft guidance and regulations; and promotion of global communication and harmonization of clinical pharmacology practices.

Recognizing that continuous advancements in scientific understanding and technology occur, the CPLG has established or is participating in several expert Working Groups to serve as knowledge centers, work with other interested parties, and provide scientific review on regulatory initiatives such as DDI and Pediatric studies. Among these are the Joint Transporters (with DMLG), Pediatrics, 4-beta Hydroxycholesterol, and Non-clinical to Clinical Translations Working Groups.  The CPLG has also established an active Guidance Committee, which leads compilation, review and consensus-building on joint submission of comments to global regulatory guidances/guidelines relevant to clinical pharmacology.

Recent Activity

The CPLG and DMLG, FDA, and the Brookings Institution recently co-developed the Improving Productivity in Pharmaceutical Research and Development meeting held in Washington, D.C. on 28 July.  There is more information about the event available in the summary here, as well as in the Pink Sheet article published about the meeting which can be accessed here.