For over a decade, Winston-Salem has been the premier hub for regenerative medicine. Thanks to organizations like the Wake Forest Institute for Regenerative Medicine (WFIRM), a team of 400 subject matter experts in bioprinting, tissue engineering, and cell and gene therapy working on more than 40 different tissues and organs, our city continues to solidify this legacy as a leader in the field.
Dr. Anthony Atala, considered to be the world’s foremost expert in regenerative medicine, leads WFIRM and the efforts to develop breakthrough tissue engineering technologies. He and his team are responsible for many of the basic tissue engineering and regenerative medicine principles known to the field, cutting-edge technologies and the push to speed up the availability of treatments to patients.
Dr. Atala took some time to share his thoughts on how far the regenerative medicine industry has come and what makes Winston-Salem a prime location for advancing the next evolution of medical treatments.
iQ: You have been a leader in the regenerative medicine field for some time. What makes Winston-Salem a place where you have chosen to do this work?
Dr. Atala: Both the city of Winston-Salem and the state of North Carolina are totally committed to advancing biotechnology on a global scale. Since we first came to the region, the biotech ecosystem has changed dramatically. Winston-Salem is included on Forbes’ list of “The Best Places for Business and Careers.” It has been named by U.S. News and World Report as one of the “Best Places to Live,” receiving high scores for desirability, value and quality of life. Winston-Salem also made Business Insider’s list of the 50 Best Places to live in America, citing a “bargain” cost of living, housing costs below the national average and many cultural offerings.
Innovation Quarter, located in Winston-Salem’s downtown business district and centered in the North Carolina Technology Corridor, is one of the fastest growing, urban-based districts for innovation in the country.
iQ: What are some of the most significant advances in regenerative medicine and biomanufacturing you’ve seen in the last 5 or so years?
Dr. Atala: In the U.S., we are very good at innovating when it comes to research but often not as effective at innovating in the area of manufacturing. During the 2014 Regenerative Medicine Foundation annual meeting in Berkeley, California, we were able to put together a one-day workshop on the topic of biomanufacturing. Through that workshop, a roadmap was created that focused on advancing the field of regenerative medicine biomanufacturing. The goal was to ensure that as the field continued to innovate in the research aspects of regenerative medicine, we could also innovate in the area of manufacturing by automating the production of these technologies and maintaining the establishment of these manufacturing facilities in the U.S. rather than abroad.
In the last five years, we have seen a major increase in the number of tools and technologies available specifically for the biomanufacturing of regenerative medicine products. One of the technologies that continues to advance is 3D bioprinting, which is a versatile technology. We have used the technology to bioprint tissue and organs, allowing us to scale up manufacturing while decreasing costs.
“Because the [Body-on-a-Chip] system can mimic human physiology, the organoids are a valuable pre-clinical testing platform for evaluating drug treatments and developing new therapies.”
We are also using 3D printing to create human tissue equivalents or organoids—tiny versions of human organs. We can connect the organoids with our Body-on-a-Chip system, creating an advanced 3D model of the human body using a system of chips and microfluidic devices. The Body-on-a-Chip system can be designed to fit an area smaller than the size of a matchbox. The bioprinted organoids function in a similar manner to an actual human organ. For instance, the heart beats about 60 times each minute, the lung breathes the air from the surrounding environment and the liver breaks down toxic compounds. Because the system can mimic human physiology, the organoids are a valuable pre-clinical testing platform for evaluating drug treatments and developing new therapies.
We have tested the system with drugs that made their way through extensive testing via cell culture and animal and human clinical trials with no issues and received initial FDA approval but were recalled after several years on the market. The WFIRM system was able to readily detect toxicity and replicate the damage seen in patients.
We are using patient-specific tumor organoid models to better treat cancer patients to determine the potential efficacy of drugs before testing them in patients—personalized medicine. For example, we have clinical trials with over 12 different cancers, where the patients’ own cells are obtained at the time of the diagnostic biopsy. Various treatment regimens can be tested with the “tumor-on-a-chip” to hopefully predict the best chemotherapy options before the patient starts therapy with the goal of maximizing treatment success.
“Various treatment regimens can be tested with the “tumor-on-a-chip” to hopefully predict the best chemotherapy options before the patient starts therapy with the goal of maximizing treatment success.”
Additionally, cell and gene therapies are exciting research areas because of the potential to heal diseased or damaged tissues rather than replace them. At WFIRM, for instance, we are focusing on prenatal treatment approaches for genetic disorders like hemophilia. The idea is to intervene before the baby is born by using stem cell populations and manipulating them through gene therapy or gene editing.
iQ: What’s the roadmap to making regenerative medicine something that will impact people’s lives on a regular basis? How far away are we from patients getting access to these life-changing discoveries?
Dr. Atala: We have now treated patients with 15 applications of technologies developed at WFIRM. Our current goal is to keep increasing the number of cell and tissue-based therapies that we introduce to patients and to also increase the number of patients treated with regenerative medicine therapies. We have technologies spanning all levels of development, from the pre-clinical pipeline to Phase I, II and III clinical trials and, finally, some that are now reaching the market. As the technologies move through the regulatory process, they become available to more and more patients.
iQ: Innovation Quarter’s mission is to create an environment where collaborations can happen that will potentially yield to new discoveries. How have you seen that come about being a part of the community here?
Dr. Atala: The work being conducted in the Innovation Quarter by so many people representing so many science and technology areas has created an amazing and highly collaborative environment with so much potential. The environment consists of scientists, clinicians, professors and students from many academic institutions, including the Wake Forest University School of Medicine, Wake Forest University, Forsyth Tech, Winston-Salem State University, N.C. A & T University and many others, as well as individuals from industry, such as biotechnology startups, emerging and established companies. The Innovation Quarter brings together many elements to create a vibrant ecosystem for collaboration, discovery and dissemination of new technologies.
“The environment consists of scientists, clinicians, professors and students from many academic institutions, including the Wake Forest University School of Medicine, Wake Forest University, Forsyth Tech, Winston-Salem State University, N.C. A & T University and many others, as well as individuals from industry, such as biotechnology startups, emerging and established companies.”
iQ: Why is Winston-Salem a prime place for regenerative medicine?
Dr. Atala: We have springboarded our efforts to create a sustainable regenerative medicine business landscape here with the Regenerative Medicine Hub. The Hub draws upon the resources and talent available through the Innovation Quarter and includes regenerative medicine focused entities such as the RegenMed Development Organization (ReMDO) that are dedicated to advancing the field, the national headquarters for the Regenerative Manufacturing Innovation Consortium (RegMIC), as well as a regenerative medicine test bed, innovation accelerator and workforce development program.
“Wake Forest’s academic arm within Charlotte, NC-based Atrium Health, one of the top five health care systems, creates an innovation corridor with powerhouse potential.”
A number of regenerative medicine startups and established companies already operate in the hub and the region, offering expansive resources for entrepreneurs and life science professionals. These companies are dedicated to a broad range of technologies, such as 3D printing, stem cell banking, extracellular matrices and cell and tissue therapies. Additionally, there are also business entities supporting the field in areas such as the production of reagents and diagnostics.
Wake Forest’s academic arm within Charlotte, NC-based Atrium Health, one of the top five health care systems, creates an innovation corridor with powerhouse potential.
Become a Part of the Regenerative Medicine Hub
Winston-Salem and the Innovation Quarter have become an epicenter of highly interactive science and technology that has added to the city’s growth as a result of collaborative leadership and vision. If you’re a regenerative medicine startup or company that would like to get plugged into the Innovation Quarter’s resources, please get in touch.