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Catalent expands the scope of the OptiForm Solution Suite to bridge gap from late-stage discovery to Phase I trials.
On July 17, 2017, Catalent Pharma Solutions announced plans to broaden the scope of its OptiForm Solution Suite platform to provide an efficient and seamless path for small and mid-size drug innovator companies from late-stage discovery to Phase I clinical trials.
The new OptiForm Solution Suite service will include 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.
The expanded service is built on Catalent’s experience in early phase development, which has supported more than 500 investigational new drugs. 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, the company reports in a statement announcing the offering.
“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,” commented Julien Meissonnier, Catalent’s vice-president, science and technology. “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.”