Cleveland, Ohio (PRWEB) September 11, 2014
ChanTest will host a sponsored session entitled “The ABC’s of IND’s” at the Safety Pharmacology Society (SPS) Annual Meeting on Monday, October 20th. This session will touch on the shortcomings of the current nonclinical and clinical assays used for cardiac risk assessment, and address some solutions that will help investigators navigate successfully through the Investigational New Drug (IND) process.
Dr. Brian Roche, Director of Safety Pharmacology at WIL Research, will present “Support for an IND application: A Focus on Safety Pharmacology and Toxicology Studies.” Dr. Roche will discuss a combination of in vivo studies that focus on toxicology and safety pharmacology assessments that need to be conducted.
An overview of the FDA regulations supporting the nonclinical studies, as well as considerations for the type of molecule (small molecule, biologic, vaccine, etc.), will also be discussed. These concepts will be reviewed in light of the work by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
Dr. Jessica Brimecombe, Vice President of Operations at ChanTest, will present “Beyond hERG”, a discussion of both the current ICH S7B guideline, which focuses on the hERG assay, as an IND requirement, as well as the anticipated changes to the guideline embodied in the FDA CiPA initiative, which extends the in vitro safety testing paradigm to include multiple cardiac ion channels, stem cell assays and in silico modeling.
The annual SPS conference will run from October 19 - 22 at the home of the FDA, Washington, DC. As a world leader in ion channels, ChanTest will have a prominent presence at the conference, with particular focus on new developments.
By going beyond a typical hERG assay, ChanTest has developed a comprehensive in vitro cardiac risk assessment package, a critical component of IND applications.
Don’t miss the “The ABC’s of IND’s” at the Safety Pharmacology Society (SPS) Annual Meeting!
The ABC’s of IND’s
Monday, October 20, 2014
7:15am – 8:15am
Marriot Wardman Park Hotel
Click here for more information
About ChanTest® – The Ion Channel Expert
ChanTest’s mission is to serve the drug discovery and development needs of customers worldwide. Since its start in 1998, the Contract Research Organization has tested compounds for more than 300 global pharmaceutical and biotechnology companies. ChanTest also partners with these companies to accelerate the drug development process for the release of better, safer drugs. ChanTest offers ion channel and GPCR cell reagents, ion channel screening/profiling services, cardiac safety services and leading-edge work in cystic fibrosis assays. The company’s library of validated ion channel cell lines, and nonclinical cardiac risk assessment service portfolio, is the most comprehensive commercial library available today.
Because of ChanTest’s influential role in ion channel research, along with the company’s uncompromising commitment to quality, an independent survey has named ChanTest the “most trusted and most used fee-for-service provider” since 2006. ChanTest is based in Cleveland, Ohio.
Visit http://www.chantest.com to learn more about ChanTest.
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