The US FDA has selected the first participants for its new pilot inspection programme, FDA PreCheck.
The FDA PreCheck Pilot Program is a new initiative resulting from a Presidential executive order, which the organisation says is designed to "boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the US drug supply chain".
HHS Secretary, Robert F. Kennedy Jr, stressed that one of the main outcomes of the programme should be "self-reliance".
The regulator has chosen seven participants for this trial:
- Amneal Pharmaceutical: Amneal’s facility in Long Island, NY will manufacture small molecule sterile liquid products for pain management, respiratory and ophthalmic diseases.
- Cellares Corp: Cellares’s facility in Bridgewater, NJ will manufacture cell-based gene therapy products for oncology and hematology diseases.
- Eli Lilly and Company: Eli Lilly’s facility in Lebanon, IN will manufacture drug substance (active pharmaceutical ingredients) in support of the company’s existing and future medicines.
- FUJIFILM Biotechnologies: FUJIFILM's facility in Holly Springs, NC will support commercial-scale cell culture biomanufacturing.
- Kriya Therapeutics: Kriya’s facility in Durham, NC will manufacture AAV-based gene therapy products to address chronic disease conditions.
- Kyowa Kirin: Kyowa’s facility in Sanford, NC will manufacture biotechnology drug substance for rare diseases.
- Regeneron Pharmaceuticals: Regeneron’s facility in Saratoga Springs, NY will manufacture biotechnology drug substance, sterile injectables, and novel protein therapeutics for multiple diseases.
Responding to their selection, participants were enthusiastic.
Eric Fulmer, Senior VP of Global Quality at Cellares, said: ""Manufacturing and facility risks are usually the ones no one considers until a pre-approval inspection or a complete response letter, long after a sponsor has filed. PreCheck moves that conversation up by several years, to a time before a facility is even in operation, which is taking it off the critical path."
Fulmer said that for the sponsors building and commercialising on Cellares’ platform, manufacturing is the one thing that won't stand between their therapy and regulatory approval.
Kriya says they look forward to working with the FDA on the programme. "Selection for the FDA PreCheck Pilot Program is an important recognition of our investments to build manufacturing as a core internal strategic capability,” said Shankar Ramaswamy, CEO and co-founder.
Manufacturing and facility risks are usually the ones no one considers until a pre-approval inspection or a complete response letter - Eric Fulmer, Senior VP of Global Quality at Cellares
How will FDA PreCheck work?
Selected participants will engage with FDA under the two-phase PreCheck model.
In Phase 1 (Facility Readiness), participants will receive early technical guidance from the FDA before the facility becomes operational, including reviews of facility information submitted through a facility-specific Drug Master File (DMF). This allows the FDA to assess and help enhance facility readiness before a drug or biologics application is submitted.
In Phase 2 (Application Submission), participants will have opportunities for enhanced engagement with the FDA through facility-focused pre-submission meetings, which are intended to support expedited facility evaluation and enable inspections earlier in the review cycle.
The FDA says that this programme enhances FDA-industry engagement by facilitating earlier interactions to minimise uncertainty associated with manufacturing readiness. The PreCheck model enables FDA expertise and feedback to inform the acceleration of the facility development process from the outset, while allowing the FDA to identify potential facility issues before they result in deficiencies that could delay or prevent application approval.
The regulator says that it will continue to evaluate implementation of the PreCheck Pilot Program and assess opportunities to inform future programme development.
