ATCC, the world’s premier biological materials management and standards organization, today announced a five-year, $87 million award from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to support the development of next-generation medical countermeasures (MCMs) to protect Americans from public health security threats such as coronaviruses.
Through Project NextGen, BARDA is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID), as well as the private sector, to enable decreased cost, accelerated production, increased efficacy and improved access, strengthen a diverse pipeline of next-generation, innovative vaccines through clinical trials, and support the development of next-generation therapeutics. ATCC will provide cold-chain and lifecycle management of biological specimens from Project NextGen clinical studies.
“With this award, we remain steadfast in our commitment to BARDA and its efforts to develop new vaccines and therapeutics to address current SARS-CoV-2 viral strains better and prepare for future ones. Protecting the public’s health against multiple coronavirus variants with effective and longer lasting vaccines, as well as more resilient treatments, is critical. By working together, we can help find innovative solutions to this challenge.”
Raymond H. Cypess, DVM, PhD, Chairman and CEO, ATCC
Under the Project NextGen initiative, ATCC will provide centralized and standardized services for receipt, processing, storage, protection, retrieval, packaging, shipping, tracking, and distribution of clinical specimens collected from participants across several clinical trials, including Phase IIb efficacy trials. Samples generated during these clinical trials may support downstream assay development, characterization of SARS-CoV-2 variants, or identify and establish vaccines that correlate with protection.
This further expands ATCC’s operation of BARDA’s Medical Countermeasures Clinical Studies Network (CSN) Biological Specimen and Investigational Product (BSIP) storage facility, which also provides centralized services, storage, and distribution of its clinical samples and investigational products across BARDA-supported studies.
“Throughout the public health crisis, ATCC has been engaged with BARDA and NIAID through the U.S. Department of Health and Human Services’ SARS-CoV-2 Interagency Group, which works to identify and monitor emerging variants and their potential impact on vaccines, therapeutics, and diagnostics,” said Rebecca Bradford, MBA, MS, PMP, vice president of Government Programs within ATCC Federal Solutions. “We have actively been participating in pandemic preparedness and the government’s global response to health emergencies such as complex infectious diseases for years and will continue to do so as our mission is to improve global public health through advancements in science.”
This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50120D00013/75A50121F33005/P00008.