SAN DIEGO, Aug. 3, 2017 /PRNewswire/ -- IriSys, LLC, a San Diego-based provider of contract pharmaceutical product development and manufacturing services, today announced that it has been awarded a new "CRO Support for Drug Product Development, Manufacture, and Stability Studies" contract by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). The contract ordering period runs from August 1, 2017 through July 31, 2022. The reimbursement to IriSys will be up to $14.4 million.
NCATS studies and supports translational science on a system-wide level as a scientific and operational problem, developing and supporting innovative collaborations across traditionally separate scientific disciplines and organizations. Serving as a catalyst for translational science, the Center convenes teams with diverse expertise to reduce, remove or bypass significant bottlenecks across the entire continuum of therapeutic development. Contracted organizations provide manufacturing, pharmacology, toxicology, regulatory, and clinical operations services to NCATS to assist with probe and assay development, lead selection and optimization, and Investigational New Drug - or New Drug Application/Biologic License Application-directed studies.
"IriSys is very pleased to be selected by NCATS to receive this significant contract," said Gerald Yakatan, Ph.D., Chairman, CEO and founder of the Company. "The objective of the contract is for IriSys to provide research services to support the development, manufacture, and stability studies of both oral and injectable dosage forms of experimental therapeutics. IriSys' successful track record developing and manufacturing dosage forms for therapeutic agents of all classes and physicochemical properties makes us well-suited to successfully carry out the defined activities."
This project has been funded in whole or in part with Federal funds from the National Center for Advancing Translational Sciences, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN271201700020I.
In addition to working with government agencies, IriSys has a wide range of clients, partners and collaborators that include both U.S. and international companies, from start-up organizations to mid-tier biotech companies. IriSys also offers strategic consulting related to the drug development process, including customized services for international clients.
About IriSys, LLC (www.irisys.com)
IriSys was founded in 1996 to provide contract pharmaceutical product development and manufacturing services, specializing in formulation development, cGMP manufacturing of clinical trial materials and commercial pharmaceutical products, and strategic consulting related to the drug development process. IriSys' custom approach to drug development is supported by the Company's scientific and regulatory experience in moving more than 100 drug products from discovery to clinical development and commercialization.
Rosenberg Business Communications
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SOURCE IriSys, LLC