Material management and standards firm ATCC has announced an indefinite delivery/indefinite quantity (IDIQ) contract award from the Biomedical Advanced Research and Development Authority, a division of the US Office of the Assistant Secretary for Preparedness and Response with the Department of Health and Human Services.
The contract has the potential to stretch out over 10 years and has a ceiling value of $250m; it reportedly complements the company’s continuing support of the US government’s pandemic response with BARDA, the National Institute of Allergy and Infectious Diseases (NIAID), Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).
Joseph Leonelli, vice president of ATCC Federal Solutions, explained to Outsourcing-Pharma that the contract covers a range of services.
“ATCC will provide the BARDA Clinical Studies Network (CSN) with a storage facility with centralized servicers for inventory management and long-term storage of biological specimens and investigational products across BARDA-supported clinical studies,” he told us. “In addition, ATCC will manage the receipt, distribution, and transport of biological specimens and investigational products for end-of-study archiving; future use; and transfer legacy biological specimens and associated inventory data currently in temporary storage at contract research organizations."
Additionally, the new initiative adds capabilities for the CSN designed to enhance continuity across the BARDA portfolio. The initiative will build on lessons learned from ATCC’s existing contracts with the National Cancer Institute (NCI).
Leonelli explained that BARDA established the CSN as a core service in 2012, then awarded IDIQ contracts to five 5 full-service clinical CROs in 2014 to form the CSN infrastructure. Over five years, the network identified key gaps in capabilities, including clinical trial planning and execution (CTPE), biological specimen and investigational product (BSIP) storage, and statistical and data coordination center (CDCC).
“BARDA selected ATCC for the BSIP in a highly competitive acquisition process based on ATCC’s ability to meet the contract requirements to provide centralized services and our past performance supporting other government agencies, including the NIAID, the NCI and the CDC; and our demonstrated best practices for the safe and secure management of biological specimens,” Leonelli said.
Raymond Cypess, ATCC’s chair and CEO, explained, “ATCC is a partner in the investigations of the academic, government, and commercial research communities to develop effective diagnostic, therapeutic, and preventive tools and reagents. We look forward to supporting BARDA and the CSN to improve the health and safety of our nation.”