Advancing nonclinical innovation and safety in pharmaceutical testing. Issue 2 (February 2019)

• Record Type: Journal Article
• Authors: Baker, Elizabeth J.; Beck, Nancy A.; Berg, Ellen L.; Clayton-Jeter, Helene D.; Chandrasekera, P. Charukeshi; Curley, J. Lowry; Donzanti, Bruce A.; Ewart, Lorna C.; Gunther, Jane M.; Kenna, J. Gerry; LeCluyse, Edward L.; Liebman, Michael N.; Pugh, Catherine L.; Watkins, Paul B.; Sullivan, Kristie M.
• Is Part Of: Drug discovery today. Volume 24:Issue 2(2019)
• Page Start: 624
• Page End: 628
• Publication Date: 2019-02
• Subjects: Drugs -- Design -- Periodicals; Drugs -- Research -- Periodicals; 615.1
• DOI: 10.1016/j.drudis.2018.11.011
• Languages: English
• ISSNs: 1359-6446

Abstract

Highlights: Stakeholders are collaborating to integrate human-based nonclinical tests. Regulatory and policy requirements must change from "animal" data to "nonclinical". Increased funding is needed for development and evaluation of human-based tests. Tissue recovery guidelines will increase access to quality tissues for research. New and established scientists need training and education in human-based tools. Abstract : Nonclinical tests are considered crucial for understanding the safety of investigational medicines. However, the effective translation from nonclinical to human application is limited and must be improved. Drug development stakeholders are working to advance human-based in vitro and in silico methods that may be more predictive of human efficacy and safety in vivo because they enable scientists to model the direct interaction of drugs with human cells, tissues, and biological processes. Here, we recommend test-neutral regulations; increased funding for development and integration of human-based approaches; support for existing initiatives that advance human-based approaches; evaluation of new approaches using human data; establishment of guidelines for procuring human cells and tissues for research; and additional training and educational opportunities in human-based approaches.