IriSys Awarded Long Term Contract by NCI for Manufacturing Clinical Trial Materials
— Valued at Up To $3,000,000 Over Five Years –
SAN DIEGO, July 15, 2015 /PRNewswire/ – IriSys, LLC, the San Diego-based pharmaceutical contract development and manufacturing organization, today announced that it was awarded a five year contract worth up to $3,000,000 by the National Cancer Institute (NCI)’s Developmental Therapeutic Program (DTP) of the Division of Cancer Treatment and Diagnosis (DCTD) for the pharmaceutical development and production of new therapeutic agents for use in clinical trials supported by NCI.
Under this agreement, IriSys will be supplying NCI with oral, topical and injectable dosage forms to be used in NCI-sponsored and/or investigator-initiated clinical trials in humans. IriSys will be responsible for formulation studies, process optimization, manufacture of the clinical dosage forms, release testing, quality control and quality assurance.
“IriSys has a technical staff with a high number of advanced degrees that reflects our success in developing and manufacturing clinical trial materials for complex molecules. This NCI contract renewal demonstrates our ability to consistently deliver on NCI’s needs for quality clinical trials materials on a timely basis,” said Gerald Yakatan, Ph.D., chairman, CEO and founder of IriSys.
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 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 over 100 drug products from discovery to clinical development and commercialization.
Gerald Yakatan, Ph.D.
Chairman, CEO and Founder
Vice President Business Development