The National Center to Accelerate Cures Opens in Baltimore, Backed by $3 Million in Congressionally Directed Funding Secured by Sens. Van Hollen and Alsobrooks
BALTIMORE; TUCSON, Ariz.; and WASHINGTON, Oct. 1, 2026 — The National Center to Accelerate Cures (NCAC) today announced its official launch as a national initiative dedicated to advancing New Approach Methodologies (NAMs) toward regulatory acceptance. The Center is funded by $3 million in congressionally directed funding secured by U.S. Senators (Maryland) Chris Van Hollen and Angela Alsobrooks and is housed at Blackbird BioHub in Baltimore.
NCAC is a partnership among three nonprofit organizations: Blackbird Laboratories, Critical Path Institute® (C-Path) and the Arrowpoint Labs Foundation. Together, they give NAMs developers a national resource, a place where promising novel drug development tools can generate the regulatory-grade evidence packages the FDA requires before formally accepting them.
Bringing a new drug to market costs roughly $2.6 billion and often takes more than a decade. Over 90% of drugs that enter clinical trials never reach patients, in part because current translational tools, mainly animal models, do not always predict human biological outcomes accurately. American biomedical research also depends on imported research primates concentrated in a small number of source countries, a supply that has proven fragile to both export policy and enforcement action.
Congress took a landmark step toward addressing this issue in 2022 by authorizing NAMs, including chips lined with living human cells, computational models and other human-biology-based tools, as part of the drug development pathway. But most NAMs developers lack the dedicated infrastructure, regulatory expertise and resources to generate the validation data the FDA requires before formally accepting any new drug development tool. NCAC will serve as a critical next step towards addressing these gaps.
NCAC brings together three organizations whose combined capabilities address every dimension of the problem. Critical Path Institute, which has guided more drug development tool qualifications through the FDA than any other organization in the world, provides the regulatory science expertise and FDA relationships that developers need to navigate the qualification process. Blackbird Laboratories, a nonprofit venture studio with deep ties to the region’s venture-backed biotech community, will provide connections that help developers move their tools toward the drug companies who will adopt them and will house NCAC in its incubator facility, Blackbird BioHub. The Arrowpoint Labs Foundation provides operational expertise, program management, federal strategy and the data platform that makes NCAC’s work scalable over time.
Because all three founding partners are nonprofits, NCAC functions as a neutral, precompetitive platform for collaboration between the FDA, industry and tool developers.
“Far too many American families have experienced the distress and pain that comes with a life-changing medical diagnosis, from cancer to chronic diseases,” said Senator Van Hollen, a member of the Senate Appropriations Committee. “That’s why we must keep working to invest in the cures that will make these diagnoses a thing of the past. As Maryland leads the way in much of this research, we fought to secure this federal investment to continue to advance innovative tools that can help bring new treatments to patients faster and more efficiently.”
“Ensuring our foods, drugs and medications are well-tested before they come to the market is absolutely critical,” said Senator Alsobrooks. “But we know this process is costly and can take years. The National Center to Accelerate Cures is working for us to have more treatments, developed faster and at a lower cost, right here in Baltimore. I am proud to have partnered with Senator Van Hollen to secure $3 million for this investment.”
“NCAC strongly aligns with Blackbird Laboratories’ mission to foster industry transformation by leveraging Maryland’s unique life sciences assets and bringing together the companies, technologies and talent needed to advance drug development,” said Blackbird Laboratories CEO Matt Tremblay, Ph.D. “Through our portfolio of therapeutics companies and broader innovation ecosystem, Blackbird is uniquely positioned to catalyze meaningful connections between NCAC and first-in-class drug developers. We see NCAC as an important bridge between the innovators developing new technologies and the companies that can put those technologies to work — creating opportunities to engage with, validate and ultimately adopt the next generation of tools for drug development.”
“NCAC represents exactly the kind of collaborative infrastructure the drug development ecosystem needs to turn scientific innovation into regulatory science progress,” said C-Path CEO Klaus Romero, M.D., M.S., FCP. “Importantly, a national effort like this will succeed through the unique triangulation of Blackbird Laboratories, C-Path and the Arrowpoint Labs Foundation. NCAC connects an innovation ecosystem where promising technologies can be developed and advanced with the regulatory science expertise needed to generate evidence and pathways toward FDA endorsement and the operational, data and infrastructure required to scale those solutions nationally. This partnership is what makes NCAC uniquely powerful. Together, we can help move NAMs from promising science to trusted drug development tools — making development more predictive, reducing unnecessary repetitions and failures, and ultimately accelerating better therapies to patients.”
“Congress authorized the use of non-animal methods in 2022, but authorization is not the same as capacity,” said Arrowpoint Labs Foundation CEO Abi Kulshreshtha, Ph.D. “The developers building these tools are often small companies and academic labs and generating the evidence the FDA requires takes infrastructure that does not currently exist in a form they can access. NCAC is being built to close that gap as durable national infrastructure.”
In its first year of operations, NCAC will support regulatory submissions of its first new approach methodologies in high-priority drug development areas, publish a shared terminology framework that establishes common language across developers, regulators and industry, and release an open data standard that will bring greater consistency to how NAMs data is submitted for regulatory review.
Patients ultimately see the greatest direct payoff from this effort. Better predictive tools mean fewer late-stage failures, and late-stage failure is exactly where the cost of drug development concentrates. Securing regulatory acceptance for each new NAM directly lowers that financial hurdle. Accelerating regulatory acceptance drives a pipeline of more treatments, developed faster, at lower cost and with less dependence on foreign supply chains.
For more information, please visit acceleratecures.org.
About Blackbird Laboratories
Blackbird Laboratories is a nonprofit life sciences venture studio located in Baltimore, Maryland, founded with a $100 million philanthropic gift from The Bisciotti Family Foundation. Blackbird partners with academic institutions, including Johns Hopkins University and the University of Maryland, Baltimore, to translate research breakthroughs into life-changing therapies, and operates Blackbird BioHub, a 35,000 square foot research incubator facility on Baltimore Peninsula.
About the Critical Path Institute
Founded in 2005, as a public-private partnership in response to the FDA’s Critical Path Initiative, C-Path’s mission is to lead collaborations that advance better treatments for people worldwide. Globally recognized as a pioneer in accelerating drug development, C-Path has established numerous international consortia, programs and initiatives that currently include more than 1,600 scientists and representatives from government and regulatory agencies, academia, patient organizations, disease foundations and pharmaceutical and biotech companies. With dedicated team members located throughout the world, C-Path’s global headquarters is located in Tucson, Arizona and C-Path’s Europe subsidiary is headquartered in Amsterdam, Netherlands. For more information, visit c-path.org.
About the Arrowpoint Labs Foundation
The Arrowpoint Labs Foundation drives the development of infrastructure for technology and innovation tied directly to American regional economic growth and competitiveness, specializing in innovation ecosystem strategy and research commercialization.
For more information, please visit https://arrowpointfoundation.org/.
Media Contacts:
Roxan Triolo Olivas
C-Path
520.954.1634
rolivas@c-path.org
Kissy Black
C-Path
615.310.1894
kblack@c-path.org
