RME Course Instructors
Dr. Akey is board-certified in Internal Medicine and Integrative and Holistic Medicine, and trained in Functional and Regenerative Medicine. She has been in clinical practice for thirty years. Dr. Akey is the founding medical director of North Florida Integrative Medicine, Ageless Medical Solutions, the former Palm Beach Institute of Preventive Medicine, and co-founder of FIRRIMup™ Doctors. Her interests in other healing traditions have led her to previously teach at the Florida School of Acupuncture and Oriental Medicine. She now specializes in both the detection of chronic disease at its earliest stage, and in the slowing or reversal of its progression. Her undergraduate experience was at the University of Florida, where she was accepted on a music and five academic scholarships. She was subsequently the youngest person ever admitted to the University of Florida College of Medicine in the Junior Honors Medical Program. She taught as Assistant Clinical Professor at Yale University where she did her internal medicine residency and served as a Chief Resident. She precepts medical students and teaches them the FIRRIMup™ approach to navigating and solving complex medical problems. She is the author of the book, Fine-Tune Your Hormone Symphony (2011) which describes the FIRRIMup™ model in detail and teaches on line at FIRRIMupDoctors.com. She has co-authored the books, Kick Covid-19 to the Curb (2020) and Fine-Tune Your Immune System (2021). She is the co-editor of the highly acclaimed Fascia, Function, and Medical Applications (2021), which was nominated for a 2021 British Medical Association award and is the first textbook on fascia geared toward medical doctors. Dr. Akey is a sought-after national and international speaker at medical conferences where she has taught and presented using this model in conferences across the US, and internationally in the Caribbean, Brazil, Poland, Spain, France and Italy. She and Dr. O'Neil-Smith have a passion to educate in the FIRRIMup™ Model and the Regenology™ Pyramid and have partnered with their company FIRRIMupDoctors.com for telemedicine consults, publishing and web-based teaching directed to both consumers and physicians. She and her family reside in her hometown of Gainesville, Florida, USA.
Graca Almeida-Porada, M.D., Ph.D. is a Professor of Regenerative Medicine and the Director of the Fetal Research and Therapy Program at Wake Forest Institute for Regenerative Medicine. Dr. Almeida-Porada’s research focuses on the development of cellular and gene delivery platforms to treat genetic and immune-mediated diseases. She is particularly interested in improving the outcome of stem cell transplantation and gene therapy in fetal and neonatal patients with genetic disorders, and in developing therapies for children with immune-mediated diseases. She has been a member of several NIH study sections, she serves as an Editor, or on the Editorial Boards, of several scientific journals, she is the co-editor-in-chief of Current Stem Cell Reports. She was inducted into Phi Beta Delta in 2006. She is the co-founder of the International Fetal Transplantation and Immunology Society. Dr. Almeida-Porada holds several patents and has authored more than 200 scientific works including papers, abstracts, and book chapters.
Dr. Ameer is the Daniel Hale Williams professor of Biomedical Engineering and Surgery at Northwestern University. He is the founding director of the Center for Advanced Regenerative Engineering (CARE), director of the NIH-funded Regenerative Engineering Training Program (RE-Training), and Deputy Editor at Science Advances, a journal published by the American Association for the Advancement of Science (AAAS). He is a member of the National Academy of Medicine, the National Academy of Inventors, and the American Academy of Arts and Sciences. Dr. Ameer’s laboratory pioneered the development and tissue regeneration applications of citrate-based biomaterials, the core technology behind innovative bioresorbable orthopaedic tissue fixation devices CITRELOCK,TM CITREFIX,TM CITRESPLINE,TM CITRELOCK ACL,TM and CITRELOCK DUOTM which were recently cleared by the F.D.A for clinical use. His awards include the Key to the City of Panama, the Society for Biomaterials (SFB) Clemson Award for Contributions to the Literature, the SFB Technology Innovation and Development Award, the Tissue Engineering and Regenerative Medicine International Society-Americas the Surfaces in Biomaterials Foundation Excellence in Biomaterials Science Award, the Chinese Association for Biomaterials Global Biomaterials Leadership Award, the Bioactive Materials Lifetime Achievement Award, and the Biomedical Engineering Society Athanasiou Medal for Excellence in Translational Bioengineering. He is also a Fellow of the American Institute of Medical and Biological Engineering (AIMBE), Fellow of the Biomedical Engineering Society, Fellow of the AIChE, Fellow of the American Association for the Advancement of Science, and Fellow of the Materials Research Society. In addition to his deputy editor role at Science Advances, Dr. Ameer is an Associate Editor for the Regenerative Engineering and Translational Medicine journal, a member of the board of directors of the Regenerative Engineering Society, and past chair of the AIMBE College of Fellows.
Anthony Atala, MD, is the G. Link Professor and Director of the Wake Forest Institute for Regenerative Medicine, and the W. Boyce Professor and Chair of the Department of Urology at Wake Forest University. His work focuses on growing human cells, tissues and organs. Fifteen applications of technologies developed in Dr. Atala's laboratory have been used clinically in human patients. Dr. Atala was elected to the Institute of Medicine of the National Academies of Sciences (now the National Academy of Medicine), to the National Academy of Inventors as a Charter Fellow, and to the American Institute for Medical and Biological Engineering. Dr. Atala is a recipient of the US Congress funded Christopher Columbus Foundation Award, bestowed on a living American who is currently working on a discovery that will significantly affect society; the World Technology Award in Health and Medicine, for achieving significant and lasting progress; the Edison Science/Medical Award; the Fast Company World Changing Ideas Award; the R&D Innovator of the Year Award; and the Smithsonian Ingenuity Award. Dr. Atala’s work was listed twice as Time Magazine’s top 10 medical breakthroughs of the year, and as one of 5 discoveries that will change the future of organ transplants. Dr. Atala’s work was ranked in 2019 by the Project Management Institute as one of the top 10 most impactful biotech projects from the past 50 years. Dr. Atala was named by Scientific American as one of the world’s most influential people in biotechnology, by U.S. News & World Report as one of 14 Pioneers of Medical Progress in the 21st Century, by Life Sciences Intellectual Property Review as one of 50 key influencers in the life sciences intellectual property arena, and by Nature Biotechnology as one of the top 10 translational researchers in the world. Dr. Atala has led or served several national professional and government committees, including the National Institutes of Health working group on Cells and Developmental Biology, the National Institutes of Health Bioengineering Consortium, and the National Cancer Institute’s Advisory Board. He was a Founder of the Tissue Engineering Society, the Regenerative Medicine Society, the Regenerative Medicine Foundation, the Alliance for Regenerative Medicine, the Regenerative Medicine Development Organization, the Regenerative Medicine Manufacturing Society, and the Regenerative Medicine Manufacturing Consortium. Dr. Atala works with several journals and serves in various roles, including Editor-in-Chief of: Stem Cells Translational Medicine; Therapeutic Advances in Urology; and BioPrinting. He is the editor of 25 books, has published more than 800 journal articles and has applied for or received over 250 national and international patents.
Professor, Department of Neurosurgery and Brain Repair, USF Morsani College of Medicine
Cesar V. Borlongan holds the position of Distinguished Professor at USF Morsani College of Medicine’s Department of Neurosurgery and Brain Repair. His highly innovative translational “bench to clinic” research has led to 6 FDA-approved clinical trials of cell transplantation in stroke, traumatic brain injury, and cerebral palsy. He is an author of more than 550 peer-reviewed publications, lead editor of 2 books, and editor and editorial board member of many scientific journals, including Stem Cells, Stroke, Journal of Cerebral Blood Flow and Metabolism, PLoS One, and Brain Research. He is funded by NIH, DOD, VA, and several stem cell-based biotech companies. He has been a regular study section reviewer for NIH, DOD and VA, and has served over the last decade as the Scientific Chair of Maryland Stem Cell Research Foundation. He was the 2015 President-Elect of American Society for Neural Therapy and Repair, and currently the President of Italy based International Placenta Stem Cell Society. He was featured in The Lancet for Lifeline Perspectives in 2008.
His research interests include pathological examination of the role of impaired mitochondria, splenic response, and gut dysbiosis in the inflammation-plagued secondary cell death that accompanies stroke and traumatic brain injury. In addition, he probes the potential of stem cells in rescuing the mitochondria, silencing the splenic reaction, and normalizing the gut microbiome towards sequestration of both central and peripheral inflammation. Altogether, his strategy is to understand the pathological condition of CNS disorders with a focus on inflammation and its treatment with stem cell-based regenerative medicine.
Founder and CEO, Javara
Jennifer Byrne’s career has been devoted to leading teams and building relationships to transform the clinical research landscape into an integrated component of clinical care. In 2018, she founded Javara with a vision to revolutionize the industry by accelerating access to clinical trials – for patients, sponsors, and healthcare systems alike. Prior to Javara, Jennifer served as CEO for PMG Research; she is also the founder of Greater Gift (501(c)3). Jennifer has earned many industry honors during her tenure, recognized most recently as a PM360 ELITE, CenterWatch Top 20 Innovator and PharmaVOICE Woman of Influence. Jennifer is a graduate of Texas A&M University.
Dr. Tracy Criswell is currently an Associate Professor at the Wake Forest Institute for Regenerative Medicine. She received her Bachelor's of Science degree in Biology from the University of Cincinnati in 1998 (Magna Cum Laude) and her PhD in Cellular and Molecular Biology from Case Western Reserve University in 2004. Her thesis work focused on identifying the cellular effects of low dose ionizing radiation exposure on breast cancer. After the completion of her PhD, Dr. Criswell joined the laboratory of Dr. Carlos Arteaga at Vanderbilt University where her research focused on the role of TGFβ signaling in breast cancer metastases. In 2009, she joined the Wake Forest Institute for Regenerative Medicine as a senior research fellow and was subsequently promoted to a faculty position in 2012. In addition to WFIRM, Dr. Criswell has cross appointments in Integrative Physiology and Pharmacology, Molecular Medicine and Translational Science and the Virginia Tech-Wake Forest University School of Biomedical Engineering and Science. She currently serves as a liaison for Women in Medicine and Science (WIMS), serves on the Wake Forest Graduate School Council and is Co-Chair of the WFGS Committee on Race and Equity. She is actively involved in curriculum development at WFIRM, and is a mentor for high school, undergraduate and graduate student trainees.
Associate Professor, Department of Bioengineering
Bradshaw and Holzapfel Research Professor in Transformational Science and Mathematics
CEO, BMI OrganBank
Carrie DiMarzio has dedicated her career to advancing science and engineering through transformative leadership. She currently serves as CEO of BMI OrganBank®, where she leads a multidisciplinary team pioneering technologies in organ perfusion and preservation to improve transplantation outcomes and enable cutting-edge ex vivo research—efforts with the potential to save thousands of lives.
Under DiMarzio’s leadership, BMI OrganBank has established key partnerships with leading institutions including the Wake Forest Institute for Regenerative Medicine (WFIRM), Lawrence Livermore National Laboratory (LLNL), Duke Ex-Vivo Organ Laboratory (DEVOL), the Cystic Fibrosis Foundation, and the RegenMed Development Organization (ReMDO), where she also serves on the Executive Leadership Council Board. Additional strategic collaborations include Atrium Health’s Division of Abdominal Transplant, the University of North Carolina (UNC), and the Piedmont Triad Regenerative Medicine Engine (PTRME), a program funded by the National Science Foundation (NSF).
During the COVID-19 pandemic, DiMarzio led BMI OrganBank's successful emergency response efforts, guiding the development and FDA Emergency Use Authorization (EUA) approval of the SuppleVent™ ventilator in record time. She is currently steering OrganBank®, the company’s proprietary organ preservation system, through the FDA clearance process.
Before joining BMI OrganBank, DiMarzio served as CEO of Industrial Hard Carbon LLC (IHC), a precision engineering company supporting the biomedical, aerospace, and automotive industries with advanced surface coating technologies. Her experience at IHC—leading technical teams, overseeing quality systems, and cultivating strategic partnerships—laid a strong foundation for her work in biomedical innovation.
DiMarzio brings deep business insight in process and capital efficiency, strategic partnerships, and human capital development. She is recognized for her operational rigor, unwavering commitment to mission and team, and her ability to lead organizations through complex landscapes.
Dr. Elisseeff is the Morton Goldberg Professor and Director of the Translational Tissue Engineering Center at Johns Hopkins Department of Biomedical Engineering and the Wilmer Eye Institute with appointments in Chemical and Biological Engineering, Materials Science and Orthopedic Surgery. She was elected a Fellow of the American Institute of Medical and Biological Engineering, the National Academy of Inventors, a Young Global Leader by World Economic Forum. In 2018, she was elected to the National Academy of Engineering and National Academy of Medicine and in 2019 she received the NIH Directors Pioneer Award. In 2022 she was elected as a fellow of the American Academy of Arts and Sciences and in 2023 a member of the National Academy of Sciences. Jennifer received a bachelor’s degree in chemistry from Carnegie Mellon University and a PhD in Medical Engineering from the Harvard–MIT Division of Health Sciences and Technology. Later she was a Fellow at the National Institute of General Medical Sciences, Pharmacology Research Associate Program, where she worked in the National Institute of Dental and Craniofacial Research. She is committed to the translation of regenerative biomaterials and has founded several companies and participates in several industry advisory boards including appointment by the governor to the State of Maryland’s Technology Development Corporation (TEDCO).
Jennifer’s initial research efforts focused on the development of biomaterials for studying stem cells and designing regenerative medicine technologies for application in orthopedics, plastic and reconstructive surgery, and ophthalmology. Clinical results revealed the importance of the immune response in the biomaterial and regenerative medicine responses. This led to a significant shift in research efforts to biomaterials-directed regenerative immunology and leveraging the adaptive immune system to promote tissue repair. The group is now characterizing the immune and stromal environments of healing versus non-healing wounds and tumors. Biomaterials are now being applied to model and manipulate tissue environments and studying the impact of systemic and environmental factors such as aging and senescent cells, sex differences and infection/microbiome changes on tissue homeostasis and repair.
Dr. Gorantla is a tenured professor of surgery and director of the Vascularized Composite Allotransplantation (VCA) Program at Wake Forest University School of Medicine and the Wake Forest Institute for Regenerative Medicine. His clinical expertise is in hand transplantation and reconstructive transplantation with academic interests in ex vivo organ preservation, nerve regeneration, non-invasive imaging, and targeted immunomodulation. The Gorantla lab focuses on a wide range of research including organ transplantation, reconstructive microsurgery, nanomedicine, regenerative pharmacology, biosensors and point of care devices, cellular therapies, regenerative medicine applications in transplantation and the relationship between the immune system and regenerative, oncogenic and autoimmune processes.
Senior Vice President and CSO, Cook Biotech
Michael Hiles recently stepped down as the Senior Vice President for R&D and Chief Scientific Officer of Cook Biotech Inc., a medical device firm specializing in the development of extracellular matrix and resorbable biomaterial technologies for medical purposes. Cook Biotech researches, develops, and manufactures surgical implants and topical medical devices from these materials. Mike was the first employee and founder of Cook Biotech in 1995, which now has more than 250 hundred employees and has provided more than 7 million patient treatments worldwide. Prior to moving to Cook Biotech, Mike investigated these same materials for vascular grafts, ligaments, and bladder repair as an Associate Research Scholar in the Hillenbrand Biomedical Engineering Center at Purdue University. Before that, he completed his graduate education through the same Biomedical Center. He received his BS and MS degrees in Electrical Engineering from Purdue and his Ph.D. in Veterinary Physiology and Pharmacology from the Veterinary Medical School at Purdue. He has published articles on catheter-based medical instrumentation, cardiac fibrillation, pharmacological intervention in acute animal disease, biomaterials, tissue engineering, and biomechanics of soft tissues. Mike is an inventor on more than 50 issued or pending U.S. patents, serves in an advisory capacity to several industry and academic groups, lectures at multiple academic institutions, and is an Adjunct Professor in both Biomedical Engineering and Veterinary Clinical Sciences at Purdue. He lives with his wife in rural Lafayette, IN.
Chief Technology Officer, RegenMed Development Organization (ReMDO); Executive Director, Regenerative Medicine Manufacturing Society (RMMS)
Dr. Hunsberger obtained his B.A. in neuroscience from Wesleyan University and his Ph.D. in neuroscience from Yale University where his work focused on the beneficial effects of exercise in treating depression. He then did his postdoctoral work at the National Institutes of Health where he was the Julius Axelrod Post Doctoral Fellow and worked in areas of mood disorders and stroke. He then was a research fellow at the National Institutes of Health Center for Regenerative Medicine where he coordinated efforts for advancing clinical translation of stem-cell technologies. He then came to Wake Forest Institute for Regenerative Medicine where he worked on various director initiatives seeking to translate regenerative medicine technologies into the clinic to treat patients. He is currently chief technology officer of a non-profit organization, RegenMed Development Organization (ReMDO) that is advancing regenerative medicine manufacturing platform technologies in pre-competitive space. One of the programs focuses on development of a universal media to support clinical cell manufacturing. The other program focuses on development of a tunable bioink system for 3D bioprinting. He is also executive director of the Regenerative Medicine Manufacturing Society (RMMS) which is a professional society that has a vision of enabling the adoption of manufacturing platform technologies into standards, regulatory pathways, and commercial products by assembling a diverse network of stakeholders.
Associate Professor, Pharmaceutics; Founder/Co-Director, Chronic Pain Research Consortium, Duquesne University
CEO/Founder, Auxilium Biotechnologies
Dr. Koffler is an Assistant Professor of Neurosciences at UC San Diego and the co-founder and CEO of Auxilium Biotechnologies, Inc. His academic research focuses on the development of advanced bioengineering strategies to promote axonal regeneration following traumatic injuries to the peripheral nerves and spinal cord. Dr. Koffler’s interdisciplinary team integrates neural engineering, 3D bioprinting, material science, stem cell biology, conductive biomaterials, and targeted drug delivery systems to better understand regeneration mechanisms and to develop novel medical devices aimed at restoring function after nerve damage. His work has translated into pre-clinical studies using large animal models for both peripheral nerve and spinal cord injuries, as well as an ongoing clinical trial for peripheral nerve repair.
In addition to his terrestrial research, Dr. Koffler leads a pioneering biomanufacturing initiative in space, funded by NASA. This project focuses on leveraging the unique properties of microgravity aboard the International Space Station (ISS) to 3D-print complex, high-resolution medical devices that are difficult or impossible to manufacture on Earth due to gravitational constraints. Under his leadership, Auxilium Biotechnologies deployed and operates the first digital light processing (DLP) bioprinter in space. In a groundbreaking achievement, the company has demonstrated the first large-scale production of implantable medical devices in microgravity—marking a significant step forward in the field of space-based regenerative medicine and biomanufacturing.
Professor, Wake Forest Institute for Regenerative Medicine
Dr. David Mack is an associate professor in the Department of Rehabilitation Medicine and Bioengineering, as well as an investigator in the Institute for Stem Cell and Regenerative Medicine at the University of Washington. He has a longstanding interest in how stem cells make cell fate decisions during embryonic development by coordinating their intrinsic genetic program with cues from their surrounding microenvironment. The goal of the Mack laboratory is to apply their understanding of this basic question to the development of stem cell and gene therapy treatments for neuromuscular diseases.
Dr. Mack’s expertise is rooted at the intersection of genetics, developmental biology, cancer biology and biomaterials, which resulted directly from different phases of his professional training. The foundation is a PhD in molecular genetics from the Indiana University School of Medicine, where he studied transcriptional regulation of T-cell development and how this process goes awry to cause leukemia. As a postdoctoral fellow with Dr. Gilbert Smith at the National Cancer Institute in Bethesda, he studied how tissue-specific stem cells interact with their microenvironment and how this impacts cell fate choices during mammary gland development and pregnancy. Dr. Mack then switched from cancer research to the relatively new field of regenerative medicine by accepting a senior postdoc position at the Wake Forest Institute for Regenerative Medicine. Under the leadership of Dr. Anthony Atala, his work focused on how to control embryonic and fetal stem cell differentiation by using natural and artificial scaffolds in concert with direct manipulation of the cells’ genetic program. All of these efforts have the overriding purpose of developing therapies to enhance tissue repair and regeneration following injury or disease.
Professor, Wake Forest Institute for Regenerative Medicine
Frank Marini is a professor at the Wake Forest Institute for Regenerative Medicine, with affiliation in the Department of Cancer Biology and the Center on Diabetes, Obesity and Metabolism at the Wake Forest School of Medicine. Marini earned his PhD at the University of Texas MD Anderson Hospital in 1998. His expertise includes molecular biology and microscopic imaging.
Program Director, In Space Biomanufacturing, ISSN
Before joining the ISS National Laboratory in 2022, Davide worked as a scientist at the New York Stem Cell Foundation (NYSCF). During his time at NYSCF, his research was focused on developing advanced models of neurodegenerative diseases. He achieved this by using induced pluripotent stem cell (iPSC)-derived brain organoids from patients and exploring the effects of microgravity on the development of these disease models in space. This research likely aimed to gain insights into how neurodegenerative diseases progress under altered gravity, which could also have implications for understanding these diseases on Earth. Davide's academic journey includes a B.Sc. in Molecular and Cell Biology and an M.Sc. in Biomedicine, both earned at the University of Palermo in Italy. He later pursued a Ph.D. in Molecular and Cell Biology at University College London (UK). Following his Ph.D., he conducted post-doctoral research at two prestigious institutions: the Institute of Cancer Research (UK), where he worked in drug discovery and cancer evolution, and Columbia University (NY), where his research centered on hematopoietic stem cells and aging. His background, along with his expertise in utilizing microgravity for studying biological processes, positions him as an accomplished and pioneering researcher in space biomanufacturing and life sciences.
Associate Professor, Department of Social Science and Health Policy, Wake Forest University School of Medicine
Assistant Professor, Wake Forest Institute for Regenerative Medicine (WFIRM)
Professor, Biomedical Engineering, Tulane University
Maedeh Mozneb earned her PhD in biomedical engineering from Florida International University, where she studied the application of plasmonic-based optical sensors in gathering cardiomyocyte electrophysiological information. Maedeh joined the Sharma Lab in August 2022, where she is working on cardiac organ-chips for disease modeling and drug testing application, as well as characterizing the effects of low-Earth orbit (LEO) on induced pluripotent stem cell expansion, transfection, reprogramming and differentiation.
Assistant Professor, Wake Forest Institute for Regenerative Medicine
Dr. Sean Murphy received his Bachelors degree in Molecular Biology (Honors) from the University of Western Australia in 2006 and his Ph.D. in Stem Cell Therapy in 2012. Dr. Murphy joined Wake Forest Institute for Regenerative Medicine in 2012 and is currently an Associate Professor. His research focuses on developing cell and biomaterial therapies and applying tissue engineering and regenerative medicine strategies to treat disease.
Talent Acquisition Consultant, Baylor Genetics
Internal Medicine Physician
Kathleen O’Neil-Smith, MD, FAARM is a magna cum laude graduate of Boston University School of Medicine. She completed postgraduate training in pathology at Harvard’s Massachusetts General Hospital and internal medicine at the Brigham and Women’s Hospital in Boston. She has a degree in exercise physiology and has been an athlete on the national rowing team for 40 years and a coach for six years. She has worked as an office and hospital-based internist. In 2006, she shifted to Functional and Regenerative Medicine after completing a two-year fellowship at A4M. She completed a stem cell certification through A4M and a TBI certification through AMMG. Dr. O’Neil-Smith has been teaching at many Regenerative Medicine Conferences on many topics ranging from gut health to brain health, as well as peak performance. She is a founder of the International Peptide Society and the Clinical Peptide Society. Her current focus and interest is in expanding clinicians’ understanding of the largest sensory organ in the body, fascia! She has extensive personal use of IV nutritional therapy and medicinal signaling therapies (MST) such as hormones, peptides and stem cells in her private medical practice. She also treated her only son with peptides and MST’s when told he had a severe TBI and that the prognosis was slim that he would return to normal function. He recently graduated with a math degree, two years after that TBI.
She has had a direct access practice in Functional, Integrative and Regenerative Internal Medicine in Boston for over twelve years. Dr O’Neil-Smith is an international thought leader in the clinical use of MST’s and peptide therapy. She is an innovative and compassionate doctor. Her teaching style is approachable, friendly and creative. She makes complex ideas simple, which is a testimony to her early career as a high school and college science teacher prior to going to medical school.
Professor, Department of Dermatology, Stanford University
Sr. Director, Engineering, ProKidney
Mr. Papali holds a BS in chemical engineering from Yale University and received a Six Sigma Black Belt from Xavier University. He has spent over 35 total years in manufacturing, R&D, engineering, maintenance, and facilities roles with 25+ years of experience in Pharmaceutical manufacturing including design, construction, startup, validation, operation, maintenance, and shutdown of facilities. Mr. Papali has led $350+MM in total capital investment projects with subject matter expertise in Maintenance and Calibration operations, Pharmaceutical clean room design and operation, Pharmaceutical contamination control, Structured Problem-Solving Methodologies, and Regulatory Audit Interaction/Management.
Professor, Wake Forest Institute for Regenerative Medicine
Dr. Christopher Porada received his Bachelor’s degree in Molecular Biology from Colgate University in 1991 (magna cum laude, Phi Beta Kappa) and his PhD in Cellular and Molecular Pharmacology and Physiology from the University of Nevada in 1998 (summa cum laude), focusing on fetal gene therapy for the treatment of hematologic diseases. After completing his PhD, he conducted a post-doctoral fellowship in the Department of Medicine at the VA Medical Center in Reno, focusing on stem cell biology and the immune aspects of gene delivery. In 2001, he joined the Department of Animal Biotechnology at the University of Nevada, Reno as an Assistant Professor and was subsequently promoted to an Associate Professor at the same Institution.
He has authored over 125 scientific abstracts, over 60 full-length manuscripts and has written chapters in nearly a dozen books. He serves on the Editorial Board for several international journals, and is a member of several international societies. Dr. Porada regularly serves as a reviewer for NIH, NYSTEM, several other international grant agencies and over 40 international journals focused on gene therapy, gene and drug delivery, stem cell biology, cancer and stem cell transplantation. Dr. Porada joined the faculty at WFIRM in 2011.
Consultant-Regenerative Medicine
Mahendra Rao received his MD (MBBS) from Bombay University in India and his PhD in Developmental Neurobiology from the California Institute of Technology. Mahendra Rao is internationally known for his research involving human embryonic stem cells (hESCs) and iPSC as well as other somatic stem cells and has worked in the stem cell field for more than twenty five years with stints in academia, government and regulatory affairs and industry.
Dr. Rao’s contributions have been recognized my multiple groups. He was named one of the top ten influential people in the stem cell field and was honored by the Federation of Biologists (FABA) India for his achievements in the stem cell field . He was awarded the NBRI (National Brain Research Institute) medal (India) for his contributions to neuroscience research. More recently his achievements were recognized by the Pathfinder award that is awarded annually by the Regenerative Medicine Foundation.
Until 2010 Dr. Rao led the Stem Cell and Regnerative Medicine division at LiFE Technologies and also served as the Chair of the CBER (FDA) advisory committee (CTGTAC). Dr. Rao subsequently joined the NIH under the leadership of Dr. Francis Collins to serve as the founding Director of the NIH Center of Regenerative Medicine and as the Chief of the Laboratory of Stem cell Biology at the NIH. Throughout his career Dr. Rao has provided advisory and consultancy services to Pharma, oversight committees, advisory panels on large scale projects related to stem cell biology. Advisory activities have included serving on advisory panels to the governments of the U.S., Singapore and India on hESC and iPSC policy and with the FDA and other regulatory authorities on PSC related issues most recently as the CIRM and ISSCR liaison to the ISCT.
Dr. Rao ongoing efforts are focused on translational work and he currently serves as the CSO for Vita Therapeutics and is on the Board of Directors at NKURE and Eyestem. He also is a SAB member Stellular Bio and Reprocell. Dr. Rao will continue his focus on developing low-cost technologies for use in developing countries such as India and to provide consultant and advisory services to biotechnology companies in the regenerative medicine field.
Russ has worked in the bioscience industry for over thirty - five years. Formerly he was an executive with the Burroughs Wellcome and Glaxo Wellcome companies. He was heavily involved with the commercial development of antivirals like AZT and 3TC which are mainstay treatments for HIV illness. He was CEO of the Kucera Pharmaceutical Company- a start- up bio-pharmaceutical company based in Winston-Salem. He has led a national biotechnology workforce effort for twenty years called the National Center for the Biotechnology Workforce (NCBW). The NCBW is based in Winston-Salem, a part of North Carolina’s Community College System, Forsyth Technical Community College and is a part of the college’s division of Education to Business. The NCBW focuses on achieving best practices and skill standards for the skilled technical worker. Russ leads or co- leads several NSF ATE grant initiatives including BETA Skills, Workforce Hub of InnovATEBIO, and the NSF Workforce effort for the Piedmont Triad Regenerative Medicine Engine. Russ is a Board Director for the North Carolina Life Sciences Organization.
Investigator, NIBIB; Chief, Immunoengineering, NIH
Kaitlyn Sadtler, Ph.D. joined NIBIB as an Earl Stadtman Tenure-Track Investigator and Chief of the Section for Immunoengineering in 2019. Prior to her arrival to the NIH, she completed a postdoctoral fellowship at the Massachusetts Institute of Technology with Daniel Anderson, Ph.D. and Robert Langer, Ph.D., focusing on the molecular mechanisms of medical device fibrosis. During her time at MIT, Dr. Sadtler was awarded an NRSA Ruth L Kirschstein Postdoctoral Fellowship, was listed on BioSpace’s 10 Life Science Innovators Under 40 To Watch and StemCell Tech’s Six Immunologists and Science Communicators to Follow. In 2018, she was named a TED Fellow and delivered a TED talk which was listed as one of the 25 most viewed talks in 2018. She was also elected to the 2019 Forbes 30 Under 30 List in Science, selected as a 2020 TEDMED Research Scholar, and received multiple other awards. Dr. Sadtler received her Ph.D. from the Johns Hopkins University School of Medicine where her thesis research was published in Science magazine, Nature Methods, and others. She was recently featured in the Johns Hopkins Medicine Magazine as an alumna of note. Dr. Sadtler completed her bachelor’s degree summa cum laude at the University of Maryland Baltimore County, followed by a postbaccalaureate IRTA at the Laboratory of Cellular and Molecular Immunology at NIAID.
Director, Process Development of Cell and Gene Therapy, Charles River Laboratories
Alex Sargent – better known as “Sarge” – is currently the Director of Process Development of Cell and Gene Therapy at Charles River Laboratories. He obtained his PhD from Case Western Reserve University in Cleveland Ohio, where he studied the challenges and promises of stem cell biology, neuroimmunology, and Cleveland sports teams. He then went on to the Lerner Research Institute at the Cleveland Clinic Foundation to continue his research in stem cell biology and neural regeneration. Since joining the biotech industry, he has worked at several large companies on drug discovery and the research and development of groundbreaking cell and gene therapies. These include Lonza Inc., where he patented new technologies for cell therapy manufacturing and CRISPR gene editing, and AstraZeneca, where he worked to bring new chimeric antigen receptor (CAR) T-cell therapies into clinical trials. He is passionate about the challenge of curing cancer, working on cell and gene therapy process and analytical development from discovery, through regulatory submission, manufacturing, and clinical trials. He wakes up each day excited to help advance cell and gene therapy to treat and cure disease, with the steadfast goal of improving human lives.
Stephen Sawyer graduated from the Virginia Military Institute in 2005, followed by University of South Carolina in 2009 and Syracuse University in 2018. After graduating from Syracuse, Dr. Sawyer was a ORISE Fellow at the FDA for 5 years working on various aspects of bioprinting and characterization of stem cells.
Chief Education Program Officer, Wake Forest Institute for Regenerative Medicine
Joan’s work is focused on providing high quality educational programming within the field of tissue engineering and regenerative medicine. In her role, she also works to increase awareness of the Institute’s leadership role within the field of biomedicine. Joan's professional background includes more than 20 years of specialized experience in administration, education, research, fund raising, collaborative team building, program development and direct care/services delivery within the university, community and non-profit, public health and education setting. Throughout her career, she has recognized the importance of education and the need to develop collaborative, multidisciplinary education and research training across formal and informal educational environments.
Former Chief Commercial Officer, Humacyte
Mr. William (B.J.) Scheessele is a commercial leader with over 25 years of experience creating and growing businesses in the vascular and regenerative medicine markets. He is responsible for providing leadership, direction, and strategic vision to drive the commercial launch of the Acellular Tissue Engineered Vessel (ATEV™) in its initial vascular indications and follow-on market expansion.
Mr. Scheessele has served as Chief Commercial Officer, at Humacyte since August 2021. He served as Executive Vice President, of Global Marketing for Quest Medical Imaging Inc. from 2018 to 2021. Previously, Mr. Scheessele served as Vice President, Marketing at Sientra, Inc., a medical device company, from 2017 to 2018. Prior to that, he served as Vice President of North America Marketing and Canada Country Manager, among other roles in sales and marketing, at LifeCell Corporation, a regenerative medicine company, from 2007 to 2016, and as Vice President, North American Marketing and Reimbursement at Allergan plc, a global biopharmaceutical company. From 2016 to 2017, after its acquisition of LifeCell Corporation. Earlier in his career, Mr. Scheessele worked in business development and product management with Cordis Corporation, a medical device company and subsidiary of Johnson & Johnson, from 1998 to 2007. Mr. Scheessele earned a BSE in biomedical engineering and economics and an M.B.A. from Duke University.
Founder & President, Durendal AI Inc.
Jim is a Founder, President, and Vice-Chair of Durendal AI Inc. He is a technology executive and AI strategist with a proven record of building and scaling ventures at the intersection of artificial intelligence, healthcare, and enterprise systems. Over the course of his career, Jim has played a founding role in four startups—spanning advanced technology and healthcare services—all of which have achieved successful outcomes, including acquisition or continued independent growth.
With more than 25 years of leadership experience, Jim has held senior roles at Oracle, IBM, Roche, and Genentech, where he led large-scale initiatives in AI innovation, health informatics, and cloud architecture. He has directed international software development teams spanning Europe, Israel, India, China, and Australia, and worked closely with globally distributed business development and solution delivery teams across the Americas, EMEA, and Asia-Pacific regions. At both IBM and Oracle, Jim was instrumental in enterprise transformations for institutions such as Mount Sinai, Mayo Clinic, and MD Anderson, driving integration of AI, analytics, and data platforms into high-stakes clinical environments.
Earlier in his career, Jim served as a Staff Scientist at Lawrence Berkeley National Laboratory, contributing to a NASA-funded program studying the biological effects of high-energy charged particle radiation. He also advanced multi-modal medical image reconstruction using Bayesian and maximum likelihood approaches.
Jim earned his PhD in Biophysics from the University of California, Berkeley.
Assistant Professor, Bioengineering; Basic Science and Engineering (BASE) Initiative at the Betty Irene Moore Children’s Heart Center
Mark received his B.A. and M.Eng in Engineering at Cambridge University (Sidney Sussex College) in the UK in 2007. Under the supervision of Professor Mehmet Fatih Yanik at MIT from 2007-2012, Mark’s Ph.D. in Medical and Electrical Engineering involved the creation of new methods to use femtosecond lasers to print protein structures in 2D and 3D to direct neural and endothelial cell development. After his Ph.D., Mark had a brief foray into the startup world at Formlabs, where he developed and tested 3D printer resins for the Form 1 stereolithography printer. Mark performed his postdoctoral research from 2013-2020 with Jennifer Lewis at Harvard, where he developed new methods of manufacturing vascularized biological tissues, organoids, soft robotics, and metals. Mark is now a member of Stanford’s Basic Science and Engineering (BASE) Initiative of the Children’s Heart Center, where he aims to develop integrative strategies for billion- and trillion-cell bioprinting towards therapeutic scale and whole-organ biomanufacturing.
Professor and Associate Director of Research Excellence, School of Biological and Health Systems Engineering, Arizona State University
Dr. Sarah Stabenfeldt is a Professor at Arizona State University's School of Biological and Health Systems Engineering. She received her B.S. in Biomedical Engineering from Saint Louis University and her Ph.D. in Bioengineering from Georgia Institute of Technology. Her current research projects span from nanoparticle delivery after brain injury to neural injury biomarker discovery to neural tissue engineering/regenerative medicine. Dr. Stabenfeldt's research is funded via federal (NIH, NSF), state (ABRC), and private foundation/clinical sources (Flinn Foundation, Phoenix Children's Hospital, Mayo Clinic). Dr. Stabenfeldt has received a number of prestigious awards including NIH Director's New Innovator Award (2014), NSF CAREER Award (2015), and Arizona Biomedical Research Centre Early Stage Investigator Award (2015). Additional honors include the Society for Biomaterials Mid-Career Award (2021), Fellow of American Institute for Medical and Biological Engineering (AIMBE, 2022), and Fellow of Biomedical Engineering Society (BMES, 2023). Dr. Stabenfeldt recently served as President of the Society for Biomaterials (SFB, 2024-2025).
CEO and Founder, Eascra Biotech
Heading Eascra Biotech, Mari Anne Snow’s focus is on developing groundbreaking nanotechnologies that promise to revolutionize therapeutic delivery and regenerative medicine. With a knack for innovation, her team's efforts have yielded promising in-vivo results, showcasing our DNA-inspired nanotubes' potential in cutting-edge medical treatments. Their approach is not only effective but also scalable and cost-efficient, aligning with the company's mission to offer super biocompatible solutions for therapeutic delivery that overcomes the current functional limitations of the available delivery options.
At Sophaya, Snow’s leadership extends to redefining remote work paradigms, providing resources and mentorship for organizations to thrive in distributed environments. Known for her book on remote team management, "The Remote Work Handbook," she leverages her expertise to help businesses implement resilient and effective virtual work programs. Her work with the Remote Nation Institute further cemented her role as a thought leader in operationalizing remote work strategies that foster engagement and productivity.
In Space Manufacturing Lead, NSF PTRME; Axiom Space
As part of the In-Space Solutions team for Axiom Space, Jana is helping to create new market sectors in the commercial space economy for in-space manufacturing of biomedical and advanced material applications on the world's first commercial space station. She transitioned from pharma to lead life science research in microgravity as part of the team managing the International Space Station U.S. National Laboratory (ISS-NL), then joined Space Tango where she successfully established the initial foundational partnerships that are helping to define an emerging biomedical market on orbit. Jana is a member of the National Academies of Sciences, Engineering, and Medicine Committee on Biological and Physical Sciences in Space, Regenerative Medicine Manufacturing Society member, a WOMEN In Advanced Therapies leadership mentor, National Stem Cell Foundation International Space Station Program Advisor, United Mitochondrial Disease Foundation Board of Trustees Member, and past New Organ Alliance Oversight Committee Member and co-chair of the Microgravity Enabling Technology Committee. Jana also served as co-editor of the book entitled, In-Space Manufacturing and Resources: Earth and Planetary Exploration Applications published in 2022 (Wiley, ISBN: 978-3-527-34853-4).
Senior Clinician, Transfusion Medicine Department, NIH
Dr. Stroncek completed his undergraduate and medical school degrees, an internal medicine residency, and a hematology/oncology fellowship at the University of Minnesota. He then joined the faculty of the University of Minnesota Medical School, Laboratory Medicine and Pathology Department, and later became medical director of the blood bank. He came to the NIH Clinical Center Department of Transfusion Medicine in 1996 as Chief of the Laboratory Service Section.
Executive Director of the Textile Technology Center at Gaston College
Jasmine Cox Wade serves as the Executive Director of the Textile Technology Center at Gaston College in Belmont, NC. Prior to her role as Executive Director, Jasmine has served in various roles including director of Textile Technology Programs, Physical Testing Laboratory Technician, and Process Coordinator. Originally, from Raleigh, NC Jasmine obtained her bachelor’s and master’s degree in Textile Technology from the NC State Wilson College of Textiles. She is currently pursuing her doctoral studies in Textile Technology Management at the NC State Wilson College of Textiles.
Beyond her professional endeavors, Jasmine is actively involved in leadership roles and volunteerism within the textile community, serving on various boards and councils.
President and CEO, LambdaVision
Dr. Nicole Wagner obtained her PhD in Molecular and Cell Biology from the University of Connecticut under the advising of Dr. Robert Birge, a pioneer in the field of light-sensitive proteins. Nicole entered the graduate program in 2007 and spent the majority of her graduate career working on optimizing retinal-containing proteins for application in devices. During the course of her PhD research, she played a critical role in the proof-of-concept experiments which helped to found LambdaVision. Through the use of site-directed mutagenesis, site-specific saturation mutagenesis, and directed evolution, Nicole was able to genetically engineer the protein, bacteriorhodopsin, for a variety of device applications, including protein-based holographic and 3-dimensional memories, a chemical detection sensor, and, most recently, a protein-based artificial retina.
Nicole is an accomplished scientist and entrepreneur with numerous peer-reviewed publications, and has presented her research at both national and International meetings. In 2012, she received the Connecticut Technology Council’s Women of Innovation “Collegian Innovation and Leadership Award” for her work with LambdaVision, and in 2015, was listed as one of CT Magazine’s 40 under 40. Nicole currently serves as LambdaVision’s president and CEO. Since taking on the role of CEO, Nicole has been successful in securing over $8M in local, state, and government funding to accelerate the research, development, and commercialization of LambdaVision’s artificial retina.
Jordan Family Director, Blood & Marrow Transplant Program, BCH-Oak; Chief, Hematology Division; Professor, Pediatrics/Hematology; University of California
The over-arching goal of Dr. Walters’ research career has been to develop and expand curative therapies for hemoglobin disorders in particular and non-malignant hematopoietic disorders more broadly. He focused on genome editing approaches most recently, which rely upon modification of autologous hematopoietic cells to elicit a curative effect. In collaboration with colleagues at UC Berkeley, BCHO and UCLA, Dr. Walters’ team is pursuing genomic editing of the sickle mutation in hematopoietic stem cells using the CRSPR/Cas9 ribonucleoprotein system. He has a long track record of experience in cellular therapies for pediatric acquired and hereditary conditions and in bone marrow transplantation.
McAdam Family Foundation Professor of Heart Assist Technology, Cornell University
Yadong Wang obtained his Ph.D. degree at Stanford University in 1999, performed his postdoctoral studies at MIT, and joined the Georgia Institute of Technology in 2003 as an assistant professor. He was recruited to Pittsburgh in 2008. He has published high-impact articles at every stage of his academic career in journals including Science, Nature Biotechnology, Nature Medicine, and PNAS. Several of his inventions are licensed, one polymer he invented is now commercially available and approved for clinical use. He co-founded two companies to translate the technologies developed in his laboratory. His research focuses on creating biomaterials that will solve key challenges in the cardiovascular, nervous and musculoskeletal systems. His team enjoys collaboration with others who share the same passion for translational research.
The Wang Lab’s most mature project is artery tissue engineering. We use a biodegradable elastomer to guide cells to make living arterial tissues as the polymer degrades. The unique design of the polymer allows the synthesis of a substantial amount of elastin quickly in the engineered arterial tissue, which had been a key challenge in tissue engineering. In order to facilitate clinical translation, we refined our approach to eliminate the need of cell seeding prior to the implantation of the arterial graft. Now the transformation from a synthetic polymeric tube into an elastic artery-like tissue occurs completely in the recipient body within a few months after implantation. This broke new grounds in tissue engineering and was reported in Nature Medicine in 2012. Science Translational Medicine called the work “a departure from traditional tissue engineering”. We are testing this in ovine and porcine models for application in peripheral arterial diseases, dialysis access and eventually coronary artery diseases.
Our project on controlled drug delivery focuses on protein drugs. The only successful protein drugs are those of long half-lives, such as insulin and growth hormones. Growth factors are potent molecules that guides the essential cell functions including proliferation, differentiation, and migration. However, their short half-lives have limited their clinical use over the last few decades. Heparin binds many growth factors and greatly extends their half-lives in vivo. However, [heparin:growth factor] complexes are soluble in water and will spread throughout the body inducing significant side effects. We designed a biocompatible polycation that conjugate heparin and induce phase separation (termed complex coacervation) of the [heparin:growth factor] complex. The resultant precipitate enables spatial and temporal control of the release of the growth factors, increasing the efficacy while reducing the side effects.
We have recently embarked on a project in regenerative extracellular matrix (ECM). With the strong developmental biology expertise at Cornell, my lab will expand beyond synthetic polymeric biomaterials. Many evolutionarily simpler species have amazing regeneration capabilities. A well-known example is the limb regeneration of newt. Cells are undoubtedly important for this regeneration. However, in many cases, cell fate is controlled by the ECM. ECM has been investigated in regeneration medicine for decades. However, the focus of the field is on mammalian ECM. Many target organs in regenerative medicine, such as the heart and central nerve, do not regenerate in mammals. Instead, mammalian default repair mechanism in these organs is fibrosis. I believe it is possible to harvest the regenerative capability of primitive species using their ECM. When properly decellularized, the ECM will keep many of the signaling molecules that controls cell function. Thus using a healing ECM from a primitive species will likely help mammalian tissues to regenerate.
Moving forward, I would like to initiate a project in collaboration with the computation experts at Cornell. With the presence of a very strong polymer science community at Cornell, I envision that close collaborations with polymer scientists will create biomaterials with more precise control over properties and more diverse functions. Clear guiding principles in biomaterials design and development are still elusive. A strong materiomics project that couples computation and experiments will advance this aspect of biomaterials science. I believe collectively biomaterials field has sufficient data on materials-biology interfaces that computational models will provide useful guidance on materials design.
Dr. Victoria Weis is currently an Assistant Professor at the Wake Forest Institute for Regenerative Medicine (WFIRM). Dr. Weis is formally trained in gastrointestinal cell biology and pathophysiology and has expertise in disease modeling in gastrointestinal tissues. Following her Bachelor’s Degree in Biology from Washington University in St. Louis, she began her research career as a research technician studying the homeostasis of the stomach epithelium. In 2013, she earned her PhD in Cell and Developmental Biology from Vanderbilt University. Her thesis work focused on disease progression in gastric metaplasia to understand the pathophysiology and identify potential biomarkers. She continued her early postdoctoral studies at Vanderbilt University supported by a competitive T32 training grant. In this work, she investigated the molecular mechanisms of diarrheal disease in the rare pediatric congenital disorder Microvillus Inclusion Disease (MVID). In 2017, Dr. Weis joined WFIRM as a senior research fellow and promoted to a faculty position in 2021. At WFIRM, she is currently investigating a stem cell-based therapy for Necrotizing Enterocolitis, a life-threatening intestinal disease in premature infants. She has recently earned a NIDDK K01 and American Gastroenterological Association Research Scholar Award for this work.
Dr. Pamela C. Yelick, PhD, is a tenured full professor in the Department of Orthodontics at the Tufts University School of Dental Medicine, Boston MA, where she Directs the Division of Craniofacial and Molecular Genetics. Dr. Yelick also Directors the Genetics Program at the Tufts University Graduate School of Biomedical Sciences and holds adjunct appointments in the Tufts Biomedical Engineering and Developmental, Molecular and Cellular Biology Departments. Dr. Yelick is an internationally recognized leader in dental tissue engineering and craniofacial development and disease, with ~125 peer-reviewed basic research publications, more than two dozen reviews, and over 400 abstracts since the year 2000. She has received national and international acclaim for her research on dental tissue and whole tooth tissue engineering and has participated in over 300 Invited Speaker Lectureships. Dr. Yelick is the Cofounder and Chief Scientific Officer of RegendoDent Inc., along with cofounder and Chief Medical Officer Luiz Bertassoni, President and Chief Executive Officer Scott Olson, and Project Manager Anissa Bartolome. Their product, RegendoGel, is a first-generation regenerative endodontic product that revitalizes teeth by inducing natural dental pulp and dentin regeneration. Dr. Yelick was recently elected Vice President of the International Association for Dental Research, a four-year term of VP, President Elect, President, and Immediate Past President. Dr. Yelick has received many awards including the IADCR Distinguished Scientist Award in 2017 and 2019, was elected as a 2022 AAAS Fellow in recognition of her sustained contributions to the field of Craniomaxillofacial development, disease and regeneration.
Dr. Yoo is a surgeon and researcher. He is currently a faculty member at the Wake Forest Institute for Regenerative Medicine and is cross-appointed to the Department of Urology, Physiology and Pharmacology, and Biomedical Engineering. Dr. Yoo received his Bachelor’s Degree in biology from the University of Illinois in 1984.