FDA has issued a sources sought related to its Biologics Effectiveness and Safety (BEST) Initiative.
In September 2017, FDA/CBER awarded two separate, one-year contracts to IMS Government Solutions, Inc to launch a new pilot initiative within the CBER Sentinel Program called the Biologics Effectiveness and Safety (BEST) Initiative.
“CBER plans to continue to develop additional active post-market risk identification and analysis systems as part of the Biologics Effectiveness and Safety (BEST) Initiative in the Sentinel Program by using new data sources, enhanced capabilities and expanded infrastructure with the goal of providing deliverables in a more cost-effective, efficient, and timely manner for all biologic products. CBER’s BEST Initiative will build additional capacity for: 1) Data, tools and infrastructure for surveillance of biologics; and, 2) New, innovative approaches to conduct automated adverse event reporting for biologic products to include approaches and applications such as machine learning, artificial intelligence, natural language processing and others…”
“The primary goal of the future contract is to expand and enhance the current CBER capabilities with respect to data sources, infrastructure, methods, and tools and to conduct surveillance and epidemiologic studies that promote CBER’s Office of Biostatistics and Epidemiology’s (OBE) mission to assure the safety and effectiveness of biologic products including vaccines, blood and blood products, tissues and advanced therapeutics. This contract builds and expands upon activities undertaken as part of previous FDA collaborative studies for biologic product safety and effectiveness such as the Sentinel contract awarded to the HPHCI in 2014 and the contract awarded to IQVIA (formerly known as QuintilesIMS) in 2017…”
It is anticipated that this requirement will result in the award of an Indefinite Delivery/ Indefinite Quantity (IDIQ) contract.
Responses are due by February 14, 2018.
