New NAM Center Could Help Companies Strengthen Drug Development Decisions

For biotechnology companies, adopting a new testing method requires confidence that its results will support both scientific decisions and regulatory review. A newly launched initiative, the National Center to Accelerate Cures (NCAC), aims to help build that confidence by supporting the validation of New Approach Methodologies, or NAMs. 

Announced October 1, NCAC is backed by $3 million in congressionally directed funding and based at Blackbird BioHub in Baltimore. The initiative combines the capabilities of Blackbird Laboratories, Critical Path Institute, and the Arrowpoint Labs Foundation. Together, the nonprofit partners plan to provide regulatory expertise, industry connections, and operational and data support to help developers establish the reliability and usefulness of emerging drug development tools. 

NAMs encompass technologies such as human cell-based tests, organoids, organs-on-chips, and computational models. These methods can provide information about human biological responses that complements and, in appropriate circumstances, replaces evidence from animal studies. Their usefulness depends on how well each method answers a defined scientific question and whether its results are reproducible. FDA is supporting their development through guidance, consultation opportunities, and examples of their use in regulatory submissions. 

NCAC’s potential significance for companies lies in the gap between developing an interesting technology and demonstrating that others can depend on it. A testing platform may produce encouraging laboratory findings while still requiring substantial work to establish its performance, limitations, and suitability for a particular application. The center’s emphasis on validation could help technology developers address those questions and give drug sponsors a stronger basis for selecting methods. 

For therapeutic developers, better evidence could improve decisions about which candidates to advance. A validated human-based model might reveal a safety concern earlier, help explain an unexpected finding, or clarify differences between competing compounds. If those insights prevent an unproductive development program from moving forward, companies could preserve resources for more promising candidates. Such benefits remain potential outcomes; the center’s launch does not establish guaranteed savings or faster FDA approvals. 

The initiative could also create opportunities for businesses supplying research tools and services. Developers of tissue models and predictive software may benefit from stronger validation evidence when seeking pharmaceutical customers. Contract research organizations could expand capabilities in study design, method assessment, and data quality. Smaller biotechnology companies may find external expertise particularly valuable when internal resources are limited. 

Companies should nevertheless approach adoption with clear regulatory expectations. FDA’s September terminology rule recognizes NAMs without lowering evidentiary standards. The agency continues to acknowledge circumstances in which animal studies are necessary and encourages consultation about a method’s proposed use.  

Michigan companies considering these approaches should begin with a specific development question, determine what evidence would establish confidence in the method, and engage FDA early. Before pursuing a partnership, they should also clarify costs, access, confidentiality, and ownership of resulting data. Those practical details will help determine whether emerging NAM capabilities can deliver meaningful value within an individual development program.