Innovation from Academia to Industry
Dr. Paulo Fontes’ work reflects a combination of scientific/clinical expertise and entrepreneurial spirit—cultivating a supportive ecosystem bridging academia and industry.
Paulo Fontes, MD, FACS has built a career which has placed him at the forefront of efforts to solve unmet medical needs while translating innovative therapies into their first-in-human applications nurtured by effective biotech ecosystems. As a distinguished transplant surgeon, researcher and academic known for his contributions to the fields of organ transplantation and regenerative medicine—focusing on innovations that improve organ preservation and transplant outcomes—he is known for pioneering work in organ perfusion technologies, which enhances organ viability before transplantation. His research has also delved into cellular and tissue engineering, developing new protocols to support organ recovery and longevity, thus addressing critical challenges in transplantation and organ scarcity.
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Dr. Fontes was in the process of earning his PhD in Brazil at Sao Paulo Federal University when he first visited Pittsburgh in 1990. He was invited to spend a month visiting the world’s largest transplant program created by the renowned Dr. Thomas Starzl, the father of transplantation. While the experience was challenging for all of the language and cultural reasons one might expect, Fontes found himself at home in the Steel City and would go on to craft a long and successful career as researcher, educator and entrepreneur.
“My focus has always been on translating research into real-world solutions, ensuring that our discoveries in the lab actually make it to the patients who need them.”
~Dr. Paulo Fontes
In Brazil, Dr. Fontes was initially mentored by Dr. Camillo Ricordi from the University of Pittsburgh while developing the first medical device for cell isolation in South America. The collaborative project with a Brazilian medtech company was funded by a $150,000 grant from a local foundation. That was his first project as a future biotech entrepreneur—but it would not be his last. He had joined Dr. Ricordi’s Cell Transplantation Program in 1991 as a research fellow to assist in conducting their first clinical trials in pancreatic islet transplantation. After completing his training in cell transplantation and immunology, Dr. Fontes accepted a visiting assistant professor of surgery position at the University of Pittsburgh (U Pitt) as the youngest faculty member of the Pittsburgh Transplant Institute.
The new position presented many unique opportunities and he joined the medical staff at the Children’s Hospital of Pittsburgh, as principal investigator and co-investigator in clinical trials intended to treat hematologic diseases. Utilizing his continuing training and research in cell transplantation and immunology, Dr. Fontes translated cutting-edge therapies for use in organ and cell transplantation, xenografts and immune-based cancer treatments. Together with Dr. Starzl, their group spearheaded several first-in-human clinical trials—implementing new immunosuppressive therapies and donor-specific tolerance induction strategies.
In 1998 Dr. Fontes was accredited by the American Society of Transplant Surgeons and became a full-time member of the medical staff at Presbyterian Hospital, UPMC. But his additional duties as the new Director of the South & American Division of UPMC Overseas were in some ways more reflective of his professional future. The division reported to the for-profit side of UPMC and included responsibilities that extended into financial, regulatory and legal realms. While Director, Dr. Fontes was involved in 24 separate international initiatives ranging across three continents.
Continuing his academic career at U Pitt/UPMC, Dr. Fontes was the director of the Liver Transplant Program from 2001 to 2011, when more than 1,500 liver transplants were conducted—generating more than $1B in revenues. In 2002 he co-founded the UPMC Organ Referral Center (ORC). The first-of-its-kind program created new resources and opportunities to manage thousands of organ offerings from remote geographic locations and boosted UPMC’s transplant program volumes to an all-time high. For example, they performed 850 organ transplants in 2007 (five liver transplant procedures were once performed within a single 24-hour period). In a close collaboration with Dr. Ken McCurry, who led the cardiothoracic transplant program, they conducted one of the world’s largest series of combined liver/lung/heart-lung transplants. He started the Machine Perfusion Program (MPP) in 2009 at the McGowan Institute for Regenerative Medicine (MIRM), U Pitt, through a $1M philanthropic donation.
The Path to Business Enterprise
The transition to a more entrepreneurial role accelerated via collaborative efforts with both a Dutch Company for medical devices and a Boston-based company for oxygen-carrier solutions. These developments in organ and tissue preservation led to consecutive Department of Defense (DoD) awards and the inception of the first company he co-founded, VirTech Bio, in 2013. The company was initially incubated at North Shore Ventures, Beverly, MA, where they achieved back-to-back Small Business Innovation Research (SBIR) awards from the NIH and the DoD before receiving a multimillion dollar Medical Technology Enterprise Consortium (MTEC)/DoD award. Dr. Fontes remained active and connected to the MassBio ecosystem, where his company further leveraged wet lab space and additional funding from local investors.
New opportunities required new skills, so he pursued consecutive career advancement training programs at the Katz Business School, University of Pittsburgh and the Kellogg Business School, Northwest University, learning the foundations of business and administration and about the commercialization of technology from academic enterprises. Subsequent training in data science and personalized medicine at the Department of Biomedical Informatics, U Pitt, and a course in AI in Pharma & Biotech via Massachusetts Institute of Technology in Boston followed. The additional 10 years of formal postgraduate education was the beginning of a journey towards professional development and the expansion of his capabilities in healthcare and life sciences.
Dr. Fontes co-founded his 2nd company, LyGenesis, in Pittsburgh in 2017—partnering with Michael Hufford, PhD, CEO and Eric Lagasse, PhD, CSO. They raised their series A at the JP Morgan Healthcare Conference in San Francisco and received their IND approval to begin their clinical applications. The company has just recently completed their first cohort of four patients treated in their phase 2a clinical trial being conducted at the Houston Methodist Hospital, Houston, TX.
In 2014 Dr. Fontes became a deputy director at the McGowan Institute for Regenerative Medicine (MIRM), U Pitt. MIRM is a research support institute with 250 interdisciplinary faculty members across the University of Pittsburgh’s campus and with other academic, industry and government partners who are driven to conceptualize, innovate, develop and commercialize regenerative medicine technologies for societal benefit. The experience led to additional opportunities to support the translation of intellectual research into monetizable investment vehicles.
Dr. Fontes was actively recruited by West Virginia University in 2018 as Professor of Surgery, Director of Research & Surgical Innovation. He analyzed 164 patents and focused on the inception of five new companies involving biologics, medical devices and digital health assets—one of which has already received Investigational Device Exemption (IDE) approval and is currently conducting initial clinical applications. He returned to direct management when he co-founded his third company, ICaPath, in 2021 in Morgantown, WV; partnering with Dr. Brock Lindsey, they developed a breakthrough technology for cancer immunotherapy. Following their IP filing, licensing process from the academic institution and a successful type B meeting with the FDA, a clear regulatory path was outlined for the technology. This company has been moved into the Baltimore-DC biotech ecosystem, and is now a proud member of the Johns Hopkins Technology Ventures—based in Baltimore, MD, and nearby Washington, DC.
Experience is often the best education and the real-life business lessons from his entrepreneur partners and associates as well as his initial involvement with the biotech ecosystems in Pittsburgh and Morgantown were invaluable. He further expanded his business/mentoring interactions within incubators, accelerators, entrepreneurs and leading investigators in large markets such as San Diego, New York and Boston and lesser known but vibrant smaller markets (Prognosis:Innovation refers to these as Incubator Cities®) such as Houston, Louisville and Cincinnati. He finally transitioned completely into a full time CMO position with LyGenesis in 2020 and is constantly pursuing new opportunities.
“The intersection of entrepreneurship and medicine is where we can truly transform patient care.”
~Dr. Paulo Fontes
Entrepreneurship Comes to the Ivory Tower
Dr. Fontes’ academic career has been marked by numerous leadership roles, including his tenure as Professor of Surgery at the University of Pittsburgh’s School of Medicine. He combined his dedication to research and education with a focus on developing innovative therapies for unmet medical needs—contributing to more than 250 publications and training more than 90 transplant surgeons. But equally important is his experience extended to evaluating and assisting in intellectual property creation, working closely with patent experts and academic innovation institutes.
Additionally, a significant aspect of Dr. Fontes’ academic journey was his success in forming interdisciplinary teams across medicine, engineering and biotechnology to tackle clinically relevant problems. This experience laid the groundwork for his transition to the biotech industry, where he applied his scientific expertise to preclinical development, CRO selection and proof-of-concept experiments—particularly in cell-based therapies, exosomes and gene therapy. His ability to navigate regulatory requirements, including IND-enabling studies and CMC processes, was instrumental in advancing drug development.
Incubator Cities® like Pittsburgh (major research hubs in smaller markets), often face challenges converting groundbreaking research into investable companies. Dr. Fontes’ story—transforming his surgical and scientific background into successful ventures in the biotech industry—highlights the critical elements required for such success: interdisciplinary collaboration, strategic industry partnerships and the ability to navigate the complexities of both academic and commercial spheres. His achievements underscore the need for policies that support not just blue-sky research, but also the infrastructure and mentorship necessary to turn academic discoveries into marketable innovations. To truly foster economic growth and technological advancement in regions like Pittsburgh, we should follow the example set by pioneers like Dr. Fontes, leveraging their experiences to shape a supportive ecosystem that bridges the gap between academia and industry.
We welcome Dr. Fontes as an expert content partner and occasional columnist. We hope you will find his reservoir of knowledge and hard-earned wisdom helpful and educational in your endeavors.
