RME Course Instructors
Director, Wake Forest Institute for Regenerative Medicine
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.
Associate Professor, Wake Forest Institute for Regenerative Medicine
Graca Almeida-Porada, MD, PhD, 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.
Chief Regulatory Science Affairs Program Officer, WFIRM
Before joining WFIRM, Dr. Bauer was Chief of the Cellular and Tissue Therapies Branch in the Division of Cellular and Gene Therapies, in the Office of Tissues and Advanced Therapies (OTAT) at the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA). Dr. Bauer has three decades of experience in regulatory science research, regulatory oversight, and policy development for regenerative medicine product development. Dr. Bauer was a member of FDA’s Senior Biomedical Research and Biomedical Product Assessment Service (SBRBPAS). As the Chief of CTTB, Dr. Bauer supervised CBER scientific staff engaged in review of cell- and gene-based biological therapies, policy development in emerging areas of cellular therapies, and research relevant to their use in clinical trials. Dr. Bauer has extensive regulatory experience with review of hundreds of regulatory submissions from all phases of product development from IND to BLAs including many novel cell, gene and tissue engineering applications. Dr. Bauer also headed FDA’s multipotent stromal cell (MSC) research consortium that published over twenty papers illustrating challenges and improvement strategies for characterization of complex MSC-based cellular and tissue engineering products. Dr. Bauer received his Ph.D. in Biochemistry from the University of Maryland in 1986. From 1986 through 1991, Dr. Bauer was a scientific member of the Basel Institute for Immunology in Basel, Switzerland. His research interests include development of strategies to improve characterization of stem-cell based therapies and to enhance our understanding of how manufacturing of regenerative medicine products influences the biological properties of these complex and heterogenous products.
Senior Director of Research
Dr. Allen Comer is a Senior Director of Research at Mallinckrodt Pharmaceuticals. In this role, he leads the company’s research and development efforts for its pipeline products, including StrataGraft®. Dr. Comer also serves as Principal Investigator of the company’s Biomedical Advanced Research and Development Authority (BARDA) contract, which supports the late-stage development of StrataGraft.
Dr. Comer has been involved in the development of StrataGraft since 2000, holding positions of increasing responsibility in the areas of research and development, quality control, and clinical development. Prior to joining Stratatech Corporation, Dr. Comer led a series of research and development and drug discovery programs in both academia and industry.
Dr. Comer received his B.S. in Biological Sciences (Biochemistry) at North Carolina State University in Raleigh, N.C. He received his Ph.D. in Genetics at the University of North Carolina at Chapel Hill in Chapel Hill, N.C. and his fellowship in molecular genetics at the University of Wisconsin in Madison, Wis. Dr. Comer’s research has been featured in 14 publications.
Associate Professor, Wake Forest Institute for Regenerative Medicine
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.
Assistant Professor and Chief Workforce Development Officer, Wake Forest Institute for Regenerative Medicine
Dr. Gary Green is assistant professor and chief workforce development officer for the Wake Forest Institute for Regenerative Medicine and chief workforce development officer for the RegenMed Development Organization. His academic interests include education and workforce development for regenerative medicine and related convergent technologies. Prior to joining WFIRM, Green was president of Forsyth Technical Community College in Winston-Salem, NC, a regional and national leader in biotechnology education. The National Center for the Biotechnology Workforce was established there under his leadership and he hosted visits to the College's biotechnology program by Presidents George W. Bush and Barack Obama. He has presented on bioscience workforce development regionally, nationally, and internationally, including White House, Department of Labor, US-EU, APEC, and US-Canada workforce conferences. Green has appeared on CNN, C-SPAN, and NPR addressing education and workforce development issues. He is an affiliate graduate faculty member at the Belk Center for Community College Leadership and Research at North Carolina State University and is co-chair of the National Industry Advisory and Leadership Council of InnovATEBio: The National Biotechnology Education Center. He also serves on the advisory board of the National Center for the Biotechnology Workforce and the board of directors of Higher Ed Works, a North Carolina educational advocacy organization. Green received his BA, MA and EdD degrees from the University of Kentucky.
Senior Vice President, R&D
Chief Scientific Officer
Cook Biotech, Inc.
Michael Hiles is 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 of Cook Biotech, which now has more than 200 hundred employees and has provided more than 6 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 two 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.
Patsy and Alan Dorris Chair in Pediatric Technology, Associate Chair for Translational Research & Professor, Wallace A. Coulter Department of Biomedical Engineering; Director, Center for 3D Medical Fabrication; Director, Tissue Engineering & Mechanics Laboratory, Georgia Institute of Technology and Emory University
Dr. Hollister is the Patsy and Alan Dorris Chair in Pediatric Technology and Professor of Biomedical Engineering at the Georgia Institute of Technology. He directs the Center for 3D Medical Fabrication as well as the Tissue Engineering and Mechanics Laboratory at Georgia Tech. Dr. Hollister’s research focuses on the computational design, 3D printing fabrication and characterization of biomaterial devices and scaffolds for tissue reconstruction. He was co-inventor of an airway splint in both resorbable and permanent versions that to date has been implanted and saved the lives of 25 children with Tracheobronchomalacia. This work has been featured in a number of mainstream media outlets including The Today Show, NPR, CNN, the New Yorker, the Doctors Show, CBS Morning News and USA Today. He was awarded the 2013 Popular Mechanics Breakthrough Innovation award for the airway splint together with Dr. Glenn Green.
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.
Director, Center for Regenerative Medicine, Dept. of Molecular Medicine
Dr. Loring is an internationally recognized pioneer in human pluripotent stem cell research, having begun her work on these cells more than 20 years ago. She has extensive experience in both academia and industry, and is currently Professor emeritus at Scripps Research in La Jolla, CA, and advisor to Aspen Neuroscience, the company she founded to develop a cell replacement therapy for Parkinson’s disease, using dopamine neurons derived from autologous induced pluripotent stem cells. Her publications include landmark studies of the genomics and epigenetics of pluripotent stem cells, with a focus on safety and efficacy of cell therapies. Dr. Loring serves on scientific journal editorial boards, grant review committees, scientific advisory and ethics boards, and the BOD for a patient advocacy foundation. She is the recent recipient of a Stem Cell Pioneer award and a Rosalind Franklin Award. She is a American Institute for Medical and Biological Engineering (AIMBE) Fellow and was named as one of the 11 Most Influential Women in Advanced Therapies. She is interested in development of broad applications of pluripotent stem cells, including for rescue of endangered species and for investigating the effects of space flight on the nervous system. In the press, she has been called a “stem cell evangelist” and the “godmother of stem cells”.
Wake Forest Institute for Regenerative Medicine (WFIRM)
Josh Maxwell is an Assistant Professor at WFIRM. He graduated from Allegheny College in 2004 with a bachelor’s degree in Biology. Josh then received his Ph.D. in Cell and Molecular Physiology in 2010 from Loyola University Medical Center in the Department of Cell and Molecular Physiology studying the IP3 receptor in cardiac tissues. Dr. Maxwell then went on to post-doc with Dr. Lothar Blatter at Rush University Medical Center studying intracellular calcium handling, heart failure, and arrhythmogenesis. He then moved to Emory University in 2014 where he began studying cardiac regenerative medicine. Josh recently moved to WFIRM in August 2021 where he continues his pioneering work developing stem cell-based approaches for heart failure.
Center for Biologics Evaluation and Research, FDA
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in 2016.
Associate 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.
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.
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.
Professor, Wake Forest Institute for Regenerative Medicine
Dr. Soker, is a Professor of Regenerative Medicine, Biomedical Engineering and Cancer Biology and the Chief Science Program Officer at the Wake Forest Institute for Regenerative Medicine (WFIRM). Dr. Soker received his PhD from the Technion-Israel Institute for Technology, followed by a postdoctoral fellowship at the Children’s Hospital Boston and Harvard Medical School. He was then recruited to the Laboratory for Tissue Engineering and Cellular Therapies as Assistant Professor of Surgery at the Harvard Medical School.
Research Interests: Dr. Soker’s research focuses on multiple aspects of regenerative medicine including identification of new sources of cells and scaffolds for tissue engineering, tissue neovascularization and real-time imaging technologies. Some of his research projects have been translated into clinical applications in patients including the use of cells, biomaterials and bioengineered tissues to repair muscles, skin wounds and damages urological tissues. In parallel, Dr. Soker has been making bioengineered tissue models of human development and disease. This technology enables screening of existing drugs on a personalized basis and development of new drugs and test them on cells derived from individual patients. Based his work, a new Wake Forest Organoid Research Center (WFORCE) was recently established, on which he serves as the scientific director.
Other Scientific Activities: During his scientific career, Dr. Soker won numerous prizes for his research projects and publications and had obtained funding for his research from different sources including NIH (NCI, NIBIB, etc.), DoD, the state of North Carolina, private foundations and industry. Dr. Soker is an inventor of patents in the area of regenerative medicine and regenerative medicine. Some served as the foundation for biotech companies he founded along with others at WFIRM and others have been licensed to companies.
CEO, Organamet Bio, Inc.
Dr. Doris Taylor is a revolutionary innovator, scientist, entrepreneur, and global thought leader in regenerative medicine and biomanufacturing. Passionate to create cures for heart disease, which kills more people than any other disease and has an economic impact of 219 billion dollars annually, Doris lives her motto: “Build the future today – and do it with Heart”. Founder of Organamet Bio Inc., with a mission to cure heart disease and reduce healthcare costs, Taylor’s goal is to bioengineer safe, effective personalized replacement hearts that are available fairly and equitably (www.organametbio.com [organametbio.com]).
In 1998 Taylor pioneered the first functional repair of an injured heart with stem cells. In 2008 she developed perfusion decellularization, recognized as one of the “Top 10 Research Advances” by the American Heart Association, which transforms un-transplantable organs into a scaffold for building new organs using stem cells. After being nominated as one of the “100 most influential people in the world” by Time magazine Taylor turned to disease prevention and is developing “cellular signatures” of heart disease and aging.
Dr. Taylor proudly grew up in Mississippi, deeply impacted by ordinary people doing extraordinary things to change the world. She earned a B.S. from Mississippi University for Women (MUW) and a Ph.D. from UT Southwestern Medical Center (Dallas). Taylor is a Fellow of the American Heart Association, American College of Cardiology, and European Society for Cardiology, was awarded an honorary Doctor of Science degree by MUW, and the national Distinguished Alumnus Award by the American Association of State Colleges and Universities. In 2019 she was elected as a Senior member of the National Academy of Inventors and, in 2020, as a fellow to the American Institute for Medical and Biological Engineering.
Taylor has sat on numerous think tanks and international scientific committees including at the NIH the FDA, AABB, the Alliance for Regenerative Medicine and the Advanced Regenerative Manufacturing Institute (ARMI). She sat for almost 2 decades on the jury for the Institut de France LeFoulon-Delalande Foundation Grand Prix, awarded annually to individuals making worldwide contributions to cardiovascular medicine. Dr. Taylor appears as an expert on cell therapy, women’s health, cardiac repair and organ transplantation in the public media and her work is recognized and featured in most worldwide media outlets.
Chairman and Director, Strait Access Technologies, South Africa
Emeritus Professor, Wake Forest Institute for Regenerative Medicine
Professor Williams, who studied metallurgy at the University of Birmingham (UK) in the 1960s, has had 55 years-experience in biomaterials, medical device technology and tissue engineering, mostly at the University of Liverpool, where he was Professor of Clinical Engineering, Director of the UK Centre for Tissue Engineering and Pro-Vice Chancellor. He was Professor of Biomaterials and Director of International Affairs at Wake Forest Institute of Regenerative Medicine, North Carolina, USA until 2022; he has the title of Emeritus Professor from both Liverpool and Wake Forest. He has published over 35 books and 440 papers: his textbook, Essential Biomaterials Science, was published by Cambridge University Press in 2014. He was Editor-in-Chief of Biomaterials, the world’s leading journal in this field between 2000 and 2014. He was elected as Fellow of the Royal Academy of Engineering in 1999 and as Fellow of the Learned Society of Wales in 2021; he has received major awards from the US and European societies of biomaterials. He was scientific advisor to the European Commission and wrote several opinions on risk management in health technologies and nanotechnologies, upon which several regulations were based. In South Africa, he is the Founding Director and Chairman of a company, Strait Access Technologies, that has developed low cost, high technology medical devices that can be used with minimally invasive procedures to treat young adults in sub-Sarah Africa who are suffering from rheumatic heart disease but currently have no therapies available to them.
Associate Professor, Dept. of Microbiology, Immunology & Molecular Genetics, University of California, Los Angeles (UCLA)
Dr. Lili Yang received her Ph.D. degree in Biology from the California Institute of Technology (Caltech) in 2004, studying with Dr. David Baltimore. She then stayed at Caltech and led a multi-institutional Engineering Immunity Program from 2004 to 2012, developing gene- and cell-based immunotherapies for cancer and HIV/AIDS. She joined the University of California, Los Angeles (UCLA) as an Assistant Professor in 2013. Her laboratory at UCLA studies tumor immunology and cancer immunotherapy, with a special focus on stem cell-engineered immunotherapy for cancer. So far her work has resulted in over 60 publications, 20 patents, 2 clinical trials, and 2 biotech startups.
In recognition of her scientific achievements, Dr. Lili Yang has received multiple prestigious awards, including a TR35 (Innovators Under 35) Award from the MIT Technology Review Magazine , a Forbeck Scholar Award, a Director’s New Innovator Award from the National Institute of Health (NIH), a Translational Research Award from the California Institute for Regenerative Medicine (CIRM), a Young Investigator Award from the American Association of Immunologists (AAI), and an Outstanding New Investigator Award from the American Society of Gene & Cell Therapy (ASGCT). In year 2022, Dr. Lili Yang was recognized as Women in Biopharma (20 of the Top women leaders in Biopharma R&D) by the Endpoints News.