NCATS Drug Product Development Studies 2017-2022

The National Center for Advancing Translational Sciences (NCATS) Drug Product Development Studies 2017-2022 Indefinite Delivery/Indefinite Quantity (IDIQ) contract vehicle provides comprehensive pharmaceutical development and manufacturing services for investigational drugs across various therapeutic areas. The contract supports the Division of Preclinical Innovation's mission of advancing translational research by offering contract research organizations (CROs) and contract manufacturing organizations (CMOs) capabilities for drug development, including formulation, manufacturing, and stability testing. The vehicle is designed to support drug candidates from preclinical stages through potential Phase IIB clinical studies, with a focus on developing sterile and non-sterile dosage forms for compounds targeting rare and neglected diseases, genetic conditions, and other critical research areas.

Task orders under this IDIQ have been predominantly awarded to small businesses like Societal CDMO San Diego, LLC, The University of Iowa, Purdue University, and Murty Pharmaceuticals, with contract values typically ranging from $78,600 to $2 million. The National Institutes of Health (NIH) agencies, including the National Center for Advancing Translational Sciences, National Cancer Institute, and National Institute on Drug Abuse, have been the primary funding sources. Delivery orders have covered diverse drug development activities such as dosage form development, manufacture, and stability studies for investigational compounds like metarrestin, NES-100 nasal spray, AVE-1625, and GS-441524. The task orders are predominantly firm fixed-price contracts with performance periods ranging from one to five years, typically conducted in locations such as San Diego, California, and West Lafayette, Indiana. None of the task orders reviewed utilized specific set-aside designations, indicating open competition among qualified contractors.