Dr. Jennifer MacDonald’s Vision for Regenerative Manufacturing
A New Chapter in Medicine
At the 2025 NextMed Health Conference, Dr. Jennifer MacDonald, Chief Operating Officer of the Advanced Regenerative Manufacturing Institute (ARMI), delivered a keynote that transcended inspiration—it laid out a clear, actionable roadmap for bringing cell-based therapies from lab bench to bedside. In a world where chronic illness affects 60% of Americans, Dr. MacDonald offered not just hope, but a practical strategy to transform that reality.
“Discovery is not the bottleneck anymore,” she stated. “Manufacturing is. We have the science. We now need the systems to get it to people’s lives.”
Regen Valley: The Emerging Epicenter
Based in Manchester, New Hampshire, ARMI has quickly become known as Regen Valley—a national hub for biofabrication and regenerative medicine innovation. Originally the site of the world’s largest privately owned textile mill, the ARMI facility now hosts a new kind of production: living therapies, cell-based treatments, and tissue-engineered constructs.
Dr. MacDonald described how her office once served as the machine shop for repairing textile looms and now supports innovations aimed at curing chronic diseases. The transformation from industrial past to biotech future symbolized the talk’s central theme: the need to pair discovery with scalable, repeatable manufacturing.
The Unfinished Story of Regenerative Medicine
Dr. MacDonald reminded the audience that regenerative medicine has long been rich with promise. As early as 1999, it captured global headlines, and by 2015 the U.S. government was investing over $1 billion annually in the field. Yet commercialized products were rare.
Why? According to MacDonald, it wasn’t due to lack of scientific talent or discovery. “What was missing,” she explained, “was the infrastructure to carry discoveries all the way to the patient.”
Drawing on metaphors from history—the Model T, the carbon filament, the Higgins boat—she emphasized that invention alone is not enough. Manufacturing capacity and systems are essential to deliver innovation at scale.
Making the Impossible Possible
One of ARMI’s landmark achievements has been automating processes that were once entirely manual. Dr. MacDonald highlighted a fully automated production line for a bone-ligament-bone construct. Starting from cryopreserved stem cells, the line yields usable tissue constructs in 42 days—without human intervention.
“What you’re seeing on the screen,” she told the audience, “is the first of its kind in the world.”
The line is fully sensorized, measuring pH, osmolality, oxygen diffusion, and more. These real-time analytics make it possible to maintain strict quality control over living products—a challenge that has historically stymied scale-up in cell and gene therapy manufacturing.
Bridging the Valley of Death
Dr. MacDonald emphasized that ARMI is more than a facility—it’s a wraparound support system for innovators. Whether it's regulatory strategy, data systems, equipment access, or business model development, ARMI acts as a one-stop shop.
“We hear it all the time,” she said. “‘I’ve never run a company before.’ Or, ‘I can’t afford the tools I need to scale.’ And our answer is always: No problem. We can help.”
By offering these services, ARMI helps startups cross the notorious “innovation valley of death”—the stage where many promising therapies fail to reach market because of operational and regulatory barriers.
National Recognition and Global Impact
ARMI’s model is not theoretical. It has earned national recognition and demonstrated real-world success. Partner companies are already shipping standardized research-grade pancreatic islet cells across the U.S. and the U.K., developed in collaboration with Breakthrough T1D (formerly the Juvenile Diabetes Research Foundation).
“These researchers were spending months just making the raw material before they could even start their studies,” Dr. MacDonald explained. “Now, with standardized islets, they can focus on breakthroughs—not busywork.”
The Role of Government and Industry
In 2017, the U.S. Department of Defense launched ARMI with a bold goal: build a domestic regenerative manufacturing capability that could deliver therapies to soldiers and civilians alike. Through its BioFabUSA program, ARMI now connects over 200 partner organizations across government, academia, and industry.
Dr. MacDonald noted, “Yes, our acronym is ARMI—and yes, the real Army knows. And they’re proud of the work we’re doing in their name.”
This partnership between government funding and private innovation is critical. It ensures ARMI isn’t just solving technical problems, but addressing national priorities—from military readiness to supply chain resilience to health equity.
A Living Ecosystem of Innovation
Dr. MacDonald extended a warm invitation to innovators of all kinds: “Whether you’re developing a therapy, a sensor, a data analytics platform, or a next-gen AI tool—we want to work with you.”
The goal is to foster an ecosystem where pre-competitive collaboration accelerates the field as a whole. From regulatory engagement with the FDA to internship pipelines that develop a ready workforce, ARMI is building the foundations of a new industry.
“We’ve seen the light in young people’s eyes when they realize they can work on something that could save the life of someone they love,” she said.
From the Bench to the Bedside
Ultimately, ARMI’s mission is to help innovators make the leap from academic discovery to patient-ready therapy. Dr. MacDonald stressed that many scientists know how to differentiate stem cells into islet cells or create scaffolds for tissue repair—but not how to run a production line, navigate FDA protocols, or scale a supply chain.
“We’re building that bridge,” she said. “We are not just hoping. We are doing.”
One of ARMI’s member companies, Safi Biosolutions, is developing red blood cell therapies for conditions like sickle cell disease. With ARMI’s help, they’re designing a system to manufacture blood at scale—bringing the lab directly to hospitals and even forward military bases.
The Call to Action
Dr. MacDonald closed her talk with both urgency and optimism. “The story of chronic disease is not yet written,” she said. “But we can change the ending.”
She urged everyone—clinicians, scientists, investors, patients—to become part of ARMI’s growing network. “Please come visit us in Regen Valley,” she said. “Whether you're building therapies or simply hoping for a better future for someone you love, you belong in this story.”
The Moment is Now
Dr. Jennifer MacDonald’s keynote was a compelling reminder that regenerative medicine is no longer a dream deferred. Thanks to ARMI and its nationwide network, the tools, talent, and infrastructure now exist to bring cell-based therapies into mainstream care.
“Innovation without delivery is just potential,” she said. “But innovation paired with manufacturing? That’s transformation.”
At NextMed, in a room full of doctors, engineers, and patients, Dr. MacDonald didn’t just describe what’s next. She showed that it’s already happening—and invited the world to help make it real.
