Regenerative Medicine in North Carolina: Q&A with Tim Bertram 

Winston-Salem is home to some unique things–like Moravian sugar cake, a baseball team named after a punctuation mark, the birthplace of some big consumer brands, and possibly the world’s largest coffee pot. Winston-Salem also happens to be home to the world’s greatest density of regenerative medicine companies.  

While the history of regenerative medicine in the area started largely with Wake Forest Institute of Regenerative Medicine (WFIRM), today, this burgeoning industry is being driven by a comprehensive partnership of academic and industrial organizations as part of the Regenerative Medicine Engine (RegenMed Engine), funded by the National Science Foundation (NSF) and based in North Carolina.

Originally, the RegenMed Engine covered 16 counties, centered around Forsyth and Guilford counties, but due to its early successes and resources available in North Carolina as a whole, the NSF asked the engine to expand its region of service to the entire state, bringing in new partners and opportunities to advance the production of regenerative medicine technologies. 

But what is the importance of all these developments? Clearly something is happening, but what exactly? And what does the continuation of the NSF Engine mean for Winston-Salem, the state of North Carolina, and the country as a whole? 

To get the full scoop, we had a conversation with Tim Bertram, PhD, the CEO for the RegenMed Engine, who shared the vision for the organization, how all the pieces are coming together to make incredible progress, and what it means for the engine to succeed in its mission to advance regenerative medicine translation and commercialization. 

Bertram has spent about 35 years in the biotechnology industry, creating eight therapeutics for some of the biggest names in the industry before getting involved in cell, gene, and tissue engineering. Bertram has started four biotechnology companies, including Pro Kidney, a company creating cellular therapies for chronic kidney disease.

About a year ago, Bertram got involved with the RegenMed Engine, helping to lead it through the early days of its mission, supported by an extensive group of more than 150 collaborating partners, including academic, industry and non-profit organizations, all dedicated to accomplishing something that’s never been done before. 

The Regenerative Medicine Industry

The field of regenerative medicine covers a lot of ground–and the research can be very complicated to understand. We asked Bertram about some of the basics of the industry.  

Q: To begin, what is regenerative medicine? 

A: Regenerative medicine uses pieces of the body as components of a medical product to heal and repair broken body parts. Healing is actually a process…a normal process, a good process. As you contrast that with a pharmaceutical or medical device, what you have is a medical product that works with the body to help normal biological processes to heal the disease condition or injury. You don’t do regenerative medicine for things like headaches that you can take a medicine for, but it addresses indications or diseases that were not addressable with a device or a pill. 

Q: What kinds of research are considered regenerative medicine?

A: An example would be burns, severe burns. We’ve got two or three companies in the ecosystem which have developed technologies that can almost completely heal and replace severe burns with nearly normal skin. 

Another example is chronic kidney disease, which has been my passion for decades. There are no therapeutics to improve the kidney and restore its function. Everything that’s available–the pills, everything else–all slow the decline, they slow the disease, but they don’t stop the disease. Regenerative technology actually may stop the disease. Regenerative medicine has this potential to restore and address diseases that are not addressable in any other way.

Q: Why did the NSF create and fund an engine in regenerative medicine?

A: In 2024, the NSF established nine engines across the country, all focused on technologies that were considered to be competitive for the United States and also contributed to national security. Regenerative medicine is the only engine that focuses in the area of medical technology, although the NSF broadly supports biotechnology. 

There is no industrial base for regenerative medicine anywhere in the world, not even in Asia or Europe. There are these smatterings, I call it a diaspora, of regenerative medicine companies around the world. The field has been largely academic in the United States with limited translation of regenerative medical technologies into commercial products. 

The RegenMed Engine was really an opportunity to take what I would say is the epicenter of regenerative medicine at WFIRM and grow it here in this region with the overall goal being to build an industrial academic base that will advance economic development in the state of North Carolina and advance regenerative medicine toward commercialization. 

Q: With such a varied science background, what brought you to Winston-Salem and RegenMed Engine?

A: About a year and a half ago, Dr. Atala [director of WFIRM] approached me about running the RegenMed Engine after WFIRM received the NSF Engine Award. He and his team had already started working with Winston-Salem State University, Forsyth Tech, and North Carolina A&T,  putting together the first ever academic center focused on bringing regenerative medicine research efforts to the market place. The first two years of the engine was a grant style, but the next eight years are supposed to be more of a business style. So they wanted someone who had business experience, had built companies, had done this kind of thing before to lead and be the CEO of the NSF Cooperative Agreement. That’s why I got involved. 

The Regenerative Medicine Engine

Since the RegenMed Engine is one-of-a-kind, Bertram provided insight into how the organization is creating an academic–industrial base, a network of academic institutions offering training and research opportunities and private-sector companies developing and commercializing regenerative medical technologies in North Carolina. With such a foundation,  many players in the field can work together toward a common goal.  

Q: What does the RegenMed Engine actually do?

A: The RegenMed Engine is an NSF sponsored Cooperative Agreement. It is designed specifically to advance technology transfer from academic institutions into companies, to create jobs and fill those jobs with skilled labor. It is economic development founded on regenerative medicine with the epicenter around WFIRM and the established academic base.   

We’re building this economic development engine not only to create jobs and fill those jobs with skilled labor, but also to solve some of the major problems associated with getting regenerative medicine products–or cell, gene and tissue engineering technologies (CGT)–-to market. 80% of the failures to make a commercial product from regenerative medicine research are linked to quality, supply chain, and manufacturing challenges.

We’re bringing in technology companies that address these challenges and keystone companies that actually manufacture and market CGT products, creating a virtuous circle of business and academic development opportunities. Building businesses creates jobs for people trained in North Carolina. So we have a twofer: we’re training people for specialized jobs, and we’re also solving the causes of failure for regenerative medicine products. So in the end, the goal is that there are more products coming out successfully, in less time, with a higher probability of success that address diseases that have no other therapeutic options.

Q: Why locate the RegenMed Engine in the iQ?

A: For about a decade, two groups were working to advance regenerative medicine in this area–WFIRM and the Regenerative Medicine Development Organization, or ReMDO. They were the catalyst, if you will, for the NSF to fund the RegenMed Engine. In addition, there’s a lot of good regenerative medicine work going on in other parts of North Carolina. 

What we have here in the Innovation Quarter is land and space for companies to build here, and it’s space that can be designed specifically for collaboration between companies. Like the grain of sand at the center of the pearl, we want to start the industrial base and grow it and create all these layers around it, which requires room and facilities for companies to build and grow. This layering ability is extremely important to building out an industrial base because you have to address manufacturing, supply chains, raw materials, and still develop the technologies, and have a common technology base for a common business objective. Being centralized helps that endeavor.  

Take Detroit or Silicon Valley, for example. To have industries where there are shared views, what you have to have is a cooperative ability–people learn, they gain know-how, they can give feedback, and they can build the industry better. What you generate in a place like this is a virtuous cycle. So the idea with Innovation Quarter is that you’re going to need specially designed space to bring companies here and help them with that collaboration, and the Innovation Quarter is positioned to build those kinds of spaces. 

Q: How does the RegenMed Engine train people to fill these new jobs? 

A: In developing the Cooperative Agreement, there were already relationships between Forsyth Tech, WFIRM, and Winston-Salem State University to provide training in medicinal chemistry and synthetic chemistry expertise for students, as well as North Carolina A&T to get engineering expertise. These linkages were brought together to train engineers, cell biologists, chemists, technicians, and technical leaders for the regenerative medicine industry.  

The Future of Regenerative Medicine

The RegenMed Engine is in year two of a 10-year funding agreement. Bertram shares what he believes to be the future of the organization and what it will mean for Winston-Salem and the state of North Carolina. 

Q: What would it look like for the RegenMed Engine to be a success? 

A: If the RegenMed Engine is a success, the engine will be gone. Our whole design is to stop this engine. The NSF is a catalyst. The perfect future means Winston-Salem, Greensboro, High Point, this whole region will be home to a vibrant group of companies that are addressing the different aspects of making and delivering a regenerative medicine product.

The academics will have a place to take their discoveries and license them to companies that are right next door, getting their ideas into the market more quickly. Industry will have a mutually collaborative environment that’s supportive, be able to partner with academics and with each other, and continue to make revenue and deliver products. 

What’s really exciting about this area is that Advocate Health, one of the largest healthcare providers in the United States, exists in this region. If you’ve got the scientists at the lab understanding and advancing research, and you’ve got companies that are developing products, and you’ve got an outlet into the market through regional healthcare systems, then everybody wins. Business, academic institutions, local, state and federal governments, patients, skilled people–everybody benefits.  

Q: What’s next for the RegenMed Engine? 

A: To build on the successes of the first two years with NSF, we will need to get the next tranche of funding, which is projected to be $45 million. What we had to show in this first year was that we could move from an academic management model to an industrial management model and that we had established a coordinated activity of bringing companies and academic centers together to advance regenerative medicine technologies.

What’s exciting is that over 90% of the metrics established by NSF were achieved within our funding window. In the first year alone, we directly created over 20 jobs, and 60% of the jobs were filled with people trained in the region–all direct outcomes of the Ecosystem Development Awards funded by the NSF Cooperative Agreement. There were a whole number of ancillary industry jobs created, as well.

The next step is really taking all the pieces and determining how we drive this so that the NSF Engine funds can go away and commercial activities can begin to occur. During this first year, we learned that there were some activities that were very, very, very successful. We’ll start bringing together those pieces into a place where the companies can prototype their processes, where they can begin to migrate through the lifecycle toward the commercialization process, and the academic centers can transfer technologies. That’s our next step: start getting very defined services that can be provided and start moving towards sustainability and revenue generation.   

Q: What part of the RegenMed Engine are you particularly excited about?

A: My passion is fulfilled when companies from around the USA and world come to our ecosystem and work together in coordination with one another and engage with the academic researchers. One exciting example is GeisterBio, which is coming to North Carolina from Austria to work very, very closely with North Carolina A&T. Another example is BMI OrganBank, which works closely with WFIRM. Companies like these are building the industrial component that will create the jobs, create the partnerships, and bring benefits for people and the economy.

Companies like these are starting to get really, really excited about the collaborations that have come out of the RegenMed Engine. We’ve already seen a number of business deals come out of this, and those are confirmational endpoints. So that’s probably what I’m excited about– seeing the companies come, create jobs, and eventually seeing university technologies be transferred and plug into the vision and mission. 

To learn more about the RegenMed Engine, visit the website or read more about the research hub developing around regenerative medicine in the iQ.