The HHS Administration for Strategic Preparedness and Response (ASPR) Innovation and Industrial Base Expansion (IBx) program has partnered with FDA, as part of HHS efforts under the American Rescue Plan, to create an Innovative Technologies and Advanced Manufacturing Hub (I-TEAM Hub) aligned with the Agency’s strategy of FDA Leadership in Advanced manufacturing Sciences for Health (FLASH). The I-TEAM Hub will facilitate:
- Creating a configurable innovation laboratory space to provide FDA reviewers, scientists, and investigators hands-on access to innovative analytic and manufacturing technologies such as digitally enabled manufacturing and deployable manufacturing critical medicines, devices, and medical countermeasures (MCMs).
- Bringing technology and manufacturing platforms into FDA and making them available FDA-wide for investigation, evaluation, and use.
- Supporting technology modernization at FDA by supplying design models, quality management metrics, and real-world data streams to FDA and partner information systems.
The I-TEAM Hub includes research and collaboration space, remodeled from existing FDA facilities. It will contain state-of-the-art manufacturing, sensing, artificial intelligence/machine learning, and other cross-cutting technology platforms that enable the manufacture of medical products. FDA and HHS will use continued interactions with industry, academia, and other government agencies to identify technologies that may become part of the next generation in medical products manufacturing. Some of these technologies, that have broad applicability or potential to transform an industry, may be cycled into the Innovation facility.
By increasing hands-on experience and training in various novel technologies, FDA can start developing benchmarks and regulatory science metrics and tools to evaluate the technologies. Findings may lead to presentations, standards, and other publications advising industry on the best ways to communicate manufacturing process data to FDA. FDA centers can then create guidance, strategies, and policies through their innovation programs, including the CDER Emerging Technology Program (ETP) and CBER Advanced Technologies Team (CATT).
The I-TEAM Hub is part of OCET’s Advanced Manufacturing Program which supports a growing internal knowledge base of lessons learned, regulatory science, and cross-industry best practices that can be leveraged for FDA-regulated products, especially in the areas of medical countermeasures and supply chain resilience.