UI Pharmaceuticals, an Iowa-based provider of contract pharmaceutical product development and manufacturing services and a division of the University of Iowa College of Pharmacy, has been awarded a new NCATS (National Center for Advancing Translational Sciences) contract, “Dosage Form Development, Manufacture, and Stability Studies of PTH‐IA” by the Office of Logistics and Office of Administration at the National Institutes of Health (NIH). Parent IDIQ contract reference no. N01TR‐17‐2003, “CRO Support for NCATS Drug Product PTH-IA. PTH-IA is being evaluated as a candidate for Jansen metaphyseal chondrodysplasia (JMC). JMC is caused by mutations in the parathyroid hormone (PTH) receptor type 1 (PTHR1), a G protein‐coupled receptor (GPCR) that regulates critical biological processes in cells of the kidney, bone, and the growth plates. The activating mutations of JMC disrupt these processes and lead to abnormalities in bone development and mineral ion homeostasis. The goal is to use PTH‐IA as a treatment in adult patients to correct renal defects, as well as in pre‐pubertal patients to potentially correct growth plate maturation defect and improve the overall growth.
UI Pharmaceuticals is proud to have been able to support this study by preparing the investigational drug supply. We stand ready to collaborate with all our clients trying to accelerate their novel treatments into human clinical trials.
In addition to working with government agencies, UI Pharmaceuticals has a wide range of clients, partners, and collaborators that include both the U.S. and international companies, from start-up organizations to mid-tier biotech companies.
About UI Pharmaceuticals:
UI Pharmaceuticals is the largest and most experienced university-affiliated FDA-registered pharmaceutical manufacturing facility in the United States that produces both sterile and non-sterile dosage forms, we have been developing formulations, manufacturing products, and conducting analytical testing for almost 45 years. UI Pharmaceuticals can support the manufacturing and testing of preclinical, clinical, and commercial products.
For more information on the NCATS-PTH-IA project: https://govtribe.com/award/federal-vehicle/ncats-drug-product-development-studies-2017-2022