Plenary: Regulatory Research at FDA (2/14) REdI 2017 скачать в хорошем качестве

Plenary: Regulatory Research at FDA (2/14) REdI 2017

Ksenia Blinova and Alexandre J. S. Ribeiro discuss FDA in-house laboratories that conduct research to promote the understanding of emerging scientific issues. They discuss cardiotoxicity, one of the most common drug side effects that lead to withdrawal of drugs from market worldwide. Between 1988 and 2009, 14 drugs were withdrawn as a result of their potential to trigger torsade de pointes fatal ventricular tachyarrhythmia. Traditional methods to assess the risk of drug cardiotoxicity may not be the most adequate for the current needs in the field of drug evaluation. The use of animal models with non-human physiology is a common acknowledged cause for failure in predicting clinical drug effects with traditional methods. Recently the Comprehensive In Vitro Proarrhythmia Assessment initiative has deployed a series of integrated studies that will thoroughly assess the potential of induced pluripotent stem cells (iPSCs) for predicting cardiotoxicity. These human cells that can be generated from an adult patient blood or skin sample, carry donor’s genetic information and therefore also have a potential for use in Precision Medicine. This presentation will review the potential for cardiotoxicity studies, and the ability of using iPSCs for generating personalized cardiac human tissue in vitro. We also elaborate on the current technical hurdles that are keeping this alternative testing platform from replacing alternative approaches. ------------------------- FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming training and free continuing education credits: https://www.fda.gov/cdersbia CDER SBIA 2017 Playlist:    • 2017 CDER Small Business and Industry Assi...   LinkedIn:   / cder-small-business-and-industry-assistance   Training resources: https://www.fda.gov/cderbsbialearn Twitter:   / fda_drug_info   CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm... Email: CDERSBIA@fda.hhs.gov Phone: (301) 796-6707 I (866) 405-5367