CiPA: A Breakthrough In Cardiac Safety
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Thursday, June 2, 2016
Bernard Fermini, Ph.D.
Global Safety Pharmacology
James Kramer, Ph.D.
Charles River Laboratories (Discovery)
Virtual Program Chair
D3D: Data, Drugs, & Diagnostics - BRC
The drug industry is on its way to accelerating the development of new therapies by building tools to assess cardiac risk earlier in the regulatory process. Through CiPA (Comprehensive in-Vitro Proarrhythmia Assay), the pharmaceutical industry aims to address certain shortcomings inherent in the existing cardiac safety paradigm. The new approach assesses the proarrhythmic risk of drug candidates through a rigorous 3-step electrophysiological validation study on such mechanisms, beyond QT and hERG studies.
Better, more relevant cardiac risk data earlier helps pharmaceutical/biotech researchers to understand the proarrhythmic potential of drugs prior to launching expensive and risky clinical trials. In addition, this approach supports evaluation of more early-stage candidates, leading to stronger compounds in the clinic, and in some cases weeding out false positive responses. It also pushes gradient labeling on drugs in order to make them available to more and more patients.
About Dr. Fermini
Dr. Fermini received a Ph.D. in Biophysics from the University of Sherbrooke (Canada), and completed post-doctoral training at Texas Tech University Health Sciences Center.
He joined Global Safety Pharmacology in 2008 and is currently Head of the Ion Channel Discipline, focusing on the development and execution of research strategies to address key issues related to the portfolio, as well as the development and validation of in vitro models for assessing the proarrhythmic potential of drug-induced QT interval changes.
Dr. Fermini is also co-chair of the CiPA Ion Channel Working group, is a member of the CiPA Steering Committee, and a member of the Board of Directors of the Safety Pharmacology Society.
About Dr. Kramer
Dr. Kramer is Principal Scientist at Charles River Laboratories (Discovery). He began his training in ion channel electrophysiology at Wright State University where he received his Ph.D. in Biomedical Sciences. This was followed by a post-doctoral fellowship at Case Western University where he studied the effects of silent subunits on the potassium ion channel, Kv2.1.
Dr. Kramer joined ChanTest Corporation in 1999 and was responsible for developing cardiac ion channel safety assays and directing studies. He has been heavily involved in the development of the Comprehensive in vitro Proarrhythmia Assay (CiPA) by serving on the Ion Channel Working Group and the Compound Selection Committee (HESI/SPS). He is currently serving as a co-leader of the High Throughput Screening (HTS) Validation Team (HESI/SPS) tasked to evaluate the CiPA approach on various HTS ion channel platforms.
About Ms. Jain
Ms. Jain most recently held the position of Laboratory Administrator at Sophion Bioscience, Inc., where her responsibilities ranged from laboratory work and office management to marketing, supply chain and finance. Prior to Sophion, she created a platform to help address the skills gap between industry and academia at BioNJ.
For the Bio-1 Initiative, she managed an internship and hiring program as part of its $5.1M federal grant to promote biotechnology in New Jersey. She continues to use her biotechnology proficiency and business aptitude, along with her project management and data analysis skills, in advancing the biotechnology industry.
A Rutgers University graduate with a degree in Biotechnology, she chairs this webinar as part of the BioPharma Research Council’s ongoing virtual programs.