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Designed to offer easier path from late-stage discovery to phase I clinical trials
July 17, 2017
By: Tim Wright
Editor-in-Chief, Contract Pharma
Catalent Pharma Solutions broadened the scope of its OptiForm Solution Suite platform to provide an efficient and seamless path from late-stage discovery to phase I clinical trials. Designed to make it easier and faster for small and mid-sized innovators to develop better treatments, the new OptiForm Solution Suite service will now include more comprehensive candidate screening tools, Absorption, Distribution, Metabolism and Excretion (ADME) considerations and in silico Drug Metabolism and Pharmacokinetic (DMPK) modeling, additional bioavailability enhancing tools, materials for cGLP intravenous and oral toxicological studies, and cGMP materials for first-in-human studies. Built on Catalent’s experience in early phase development, which has seen the company support more than 500 Investigational New Drugs (INDs), the new OptiForm Solution Suite integrates tools and services sequentially to deliver relevant data and an optimized development program to support a molecule’s progress towards the clinic. “To ensure a program’s success, formulation selection needs to be guided by a phase-appropriate model that measures and evaluates the right data at the right time,” said Julien Meissonnier, vice president, science and technology, Catalent. “The service provides innovators with a progressive, data-driven approach to maximize options that demonstrate in vivo efficacy and activity, acceptable safety margins in preclinical models, better downstream processing attributes, and optimal dose design for the intended patient group; supporting the selection of a development candidate with the best chances of success in the clinic and beyond.”
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