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
Graça 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.
Director of Research & Bioanalytics, MIMEDX Group Inc.
Heather Bara, PhD, serves as the Director of Research at MIMEDX. In this role, she oversees the scientific research investigating the regenerative properties of the company’s placental allograft products and new product concepts. At MIMEDX, she applies her broad background in bioengineering, Quality Assurance and Regulatory Affairs to develop and validate robust biological assays and thoroughly characterize the company’s tissue biologics.
Dr. Bara earned her PhD in Biomedical Engineering from Georgia Institute of Technology and Emory University with a focus of tissue engineering an autologous pancreas for the treatment of Type 1 Diabetes. She has over 10 years of experience working in and consulting for biopharma companies.
Professor, Bioengineering; Dean, Grainger College of Engineering, University of Illinois at Urbana-Champaign
Rashid Bashir, PhD is Professor of Bioengineering, the Grainger Distinguished Chair in Engineering, and is currently the Dean of Grainger College of Engineering at the University of Illinois at Urbana-Champaign. He has also been the Department Head of Bioengineering and the Director of the Holonyak Micro and Nanotechnology Laboratory at the University of Illinois at Urbana-Champaign. He was member of the core founding team and co-chair of the inaugural curriculum committee for the Carle-Illinois College of Medicine, the world’s first engineering based College of Medicine at the University of Illinois at Urbana-Champaign. He has previously been at Purdue University and at National Semiconductor Corporation as Sr. Engineering Manager. He has held a visiting Scientist position at Massachusetts General Hospital and Shriner’s Hospital for Children, and was Visiting Professor of Surgery at Harvard Medical School, Cambridge, MA. He was the recipient of the Joel and Spira teaching Award, the NSF Faculty Early Career Award and the IEEE EMBS Technical Achievement award. In 2018, he received the Pritzker Distinguished Lectureship Award from BMES.
His research group is interested in developing new diagnostic technologies for precision and personalized medicine, and in 3D bio-fabrication of cellular systems. Using bionanotechnology, BioMEMS, and lab on chip, he is working at the interface of biology and engineering from the molecular to the tissue scale, and aiming to make an impact on grand challenges in infectious disease, sepsis, cancer, and others. He has authored or co-authored over 2800 journal papers and has been granted 50 patents. He is fellow of IEEE, BMES, AIMBE, APS, IAMBE, NAI, RSC, and AAAS. Technology from his group has been licensed to BioVitesse, and Daktari, and he is co-founder of recent startups Prenosis and LabSimply.
Associate Professor, Department of Bioengineering, MIRM and CTO, Renerva
Dr. Bryan Brown is an Associate Professor in the Department of Bioengineering with secondary appointments in the Department of Obstetrics, Gynecology, and Reproductive Sciences and the Clinical and Translational Science Institute at the University of Pittsburgh. He is also a core faculty member of the McGowan Institute for Regenerative Medicine where he serves as the Director of Educational Outreach. Dr. Brown is also an Adjunct Assistant Professor of Clinical Sciences at the Cornell University College of Veterinary Medicine and Chief Technology Officer of Renerva, LLC, a Pittsburgh-based start-up company.
Dr. Brown graduated from the University of Pittsburgh with a BS in Mechanical Engineering in 2005 and a PhD in Bioengineering in 2010. He then completed postdoctoral training in the Departments of Biomedical Engineering and Clinical Sciences at Cornell University prior to joining the University of Pittsburgh as a faculty member in 2011. Dr. Brown has also served as a visiting researcher at Tsinghua University in Beijing China (2005-2006), a NSF East Asia and Pacific Summer Institutes Fellow at Tokyo Women’s Medical University Institute for Advanced Biomedical Sciences (2008), and most recently as a Building Interdisciplinary Research Careers in Women’s Health Scholar (NIH K12) at Magee Women’s Research Institute.
Dr. Brown is a member of the Biomedical Engineering Society (Member, Ethics Committee), the Society for Biomaterials, the Tissue Engineering and Regenerative Medicine International Society (Member, Membership Committee), and the American Urogynecologic Society. He has received a number of awards including the Wake Forest Institute for Regenerative Medicine Young Investigator Award, the TERMIS Educator Award, and the Carnegie Science Award. Dr. Brown has published more than 50 peer-reviewed journal articles and 5 book chapters. He has served as a reviewer on study sections for the National Science Foundation, the National Institutes of Health, and as a member of the selection committee for the Carnegie Science Awards. Dr. Brown is on the editorial board of Cells, Tissues, Organs, Current Pathobiology Reports, and the Journal of Immunology and Regenerative Medicine. He currently teaches both undergraduate and graduate level courses including “Extracellular Matrix in Tissue Biology and Bioengineering,” “Societal, Political, and Ethical Issues in Bioengineering and Biotechnology,” and “Bioengineering Thermodynamics.”
The Brown Laboratory seeks to couple a mechanistic understanding of the host inflammatory response in injury and disease with the development of context-dependent biomaterials for regenerative medicine strategies. The focus of the Brown Laboratory is upon clinical applications where few effective solutions currently exist, with increasing emphasis upon unmet clinical needs in women’s health. Since 2011, the Brown Laboratory has received research funding for these efforts from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institute on Aging, National Institute of General Medical Science, Office of Research on Women’s Health, the Wallace H. Coulter Foundation, and multiple industry partners.
Director, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research (CBER)
Wilson Bryan is a neurologist who graduated from the University of Chicago Pritzker School of Medicine. Dr. Bryan served on the neurology faculty of the University of Texas Southwestern Medical School for 13 years. He has been an investigator on clinical trials in cerebrovascular disease and neuromuscular disorders, particularly amyotrophic lateral sclerosis. Dr. Bryan joined the United States Food and Drug Administration (FDA) in 2000. Since 2016, he has served as Director of the Office of Tissues and Advanced Therapies (OTAT) in the Center for Biologics Evaluation and Research (CBER).
Professor, Department of Bioengineering, Sanford Consortium for Regenerative Medicine; Associate Dean for Faculty, Jacobs School of Engineering, University of California San Diego
Dr. Christman is a Professor in the Department of Bioengineering and the Associate Dean for Faculty Affairs and Welfare in the Jacobs School of Engineering at UC San Diego. She received her B.S. in Biomedical Engineering from Northwestern University in 2000 and her Ph.D. from the University of California San Francisco and Berkeley Joint Bioengineering Graduate Group in 2003, where she examined in situ approaches to myocardial tissue engineering. She was also a NIH postdoctoral fellow at the University of California, Los Angeles in the fields of polymer chemistry and nanotechnology. Dr. Christman joined the Department of Bioengineering in 2007 and is a member of the Institute of Engineering in Medicine at the University of California, San Diego. Her lab, which is housed in the Sanford Consortium for Regenerative Medicine, focuses on developing novel biomaterials for tissue engineering and regenerative medicine applications, and has a strong translational focus with the main goal of developing minimally invasive therapies for cardiovascular disease and women’s health. Dr. Christman is a fellow of the American Heart Association, the American Institute for Medical and Biological Engineering and the Biomedical Engineering Society, and has received several awards including the NIH Director’s New Innovator and Transformative Research Awards, the Wallace H. Coulter Foundation Early Career Translational Research Award, the American Heart Association Western States Innovative Sciences Award, the Tissue Engineering and Regenerative Medicine Society’s Young Investigator and Senior Scientist Awards, and the Society for Biomaterials Clemson Award for Applied Research. Dr. Christman is also co-founder of Ventrix, Inc. and Karios Technologies, Inc.
Professor, Biomedical Engineering; Cullen Trust for Higher Education Endowed Professorship in Engineering, The University of Texas at Austin
Elizabeth M. Cosgriff-Hernandez, PhD, is a Professor of Biomedical Engineering at The University of Texas at Austin and holder of the Cullen Trust for Higher Education Endowed Professorship in Engineering. She received a B.S. in Biomedical Engineering and Ph.D. in Macromolecular Science and Engineering from Case Western Reserve University under the guidance of Professors Anne Hiltner and Jim Anderson. She then completed a UT-TORCH Postdoctoral Fellowship with Professor Tony Mikos at Rice University with a focus in orthopaedic tissue engineering. Dr. Cosgriff-Hernandez joined the faculty of the Biomedical Engineering Department at Texas A&M University in 2007 prior to moving to The University of Texas at Austin in 2017. Her laboratory specializes in the the development of polymeric biomaterials to improve clinical outcomes of medical devices and regeneration strategies. She also serves on the scientific advisory board of ECM Biosurgery and as a consultant to several companies on biostability evaluation of medical devices. Dr. Cosgriff-Hernandez is an Associate Editor of the Journal of Materials Chemistry B and Fellow of the International Union of Societies for Biomaterials Science and Engineering, Biomedical Engineering Society, Royal Society of Chemistry, and the American Institute for Medical and Biological Engineering. She has previously served as an Associate Editor of the Journal of Biomedical Materials Research, Part B and chair of the NIH study section on Musculoskeletal Tissue Engineering.
Vice President of Therapeutics Development
Abla Creasey is the Vice President of Therapeutics Development. In this capacity, she leads all programs in Translational and Clinical development, with a focus on advancing these therapies to marketing approval. Abla has been instrumental in building and managing CIRM’S clinical portfolio of diverse therapeutic areas including oncology, neurology, ophthalmology, and others. She has led the CIRM Therapeutics Team since 2018 and delivered on a key strategic goal to identify, recruit, and develop fifty innovative clinical stage projects and manage them to success. Eight of the current 64 FDA approved projects with Regenerative Medicine Advanced Therapies Designation are among the Therapeutics grants portfolio. Abla also oversees Translation, Clinical and Marketing Approval Advisory Panels that work with grantees on all aspects of product development including preclinical, clinical, regulatory, manufacturing, project management, and strategic topics.
Abla has extensive experience in research and development, including clinical trial strategy and operations, as well as biologics process development & manufacturing, regulatory, and overall strategic product development. Prior to joining CIRM in 2016, she was at Johnson & Johnson for 12 years. While there, Abla held multiple senior level positions, including Senior Scientific Director in Pharmaceutical Development & Manufacturing Sciences (PDMS) at Janssen Therapeutics. Prior to that, she was an Executive Director, heading drug delivery, pharmacology, analytical characterization, clinical & quality at Advanced Technologies & Regenerative Medicine (ATRM), another J&J company. Prior to ATRM, Abla was Vice President of Biological Sciences at ALZA Corporation, where she headed discovery efforts in formulation, preclinical and oral drug delivery. Before joining ALZA in 2004, Abla held senior level positions in R&D, clinical development, and regulatory affairs within the biotechnology industry, including Chiron Corporation and Cetus Corporation. Abla received in 2008 the Ellis Island Medal of Honor for her biotechnology contributions. She served on the Mills College Board, Oakland, Ca, and the Dean of UC Berkeley School of Public Health Advisory Board. She has 23 patents and authored over 50 publications.
Abla received a B.S. in biology from the College of Notre Dame in Belmont, California, and earned her Ph.D. in medical microbiology from the University of California, Berkeley. She completed a post-doctoral fellowship at the Stanford University School of Medicine in infectious disease, biochemistry, and immunology.
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.
CEO, BioMedInnovations
Carrie DiMarzio was somewhat thrust into leadership at BioMedInnovations (BMI). As CEO of BMI’s sister company, Industrial Hard Carbon, a nano-technology thin-film business, with applications serving customers in the medical arena, the founders of BMI turned to Carrie to lead a now ‘17-year start-up’ to a new era of crommercial success and recognition as a world-leader in organ and tissue perfusion and preservation.
Knowing of Carrie’s ability to manage teams delivering incredible results, Carrie was initially appointed COO and, true to form, she led a multiple national award-winning public private partnership, with the Lawrence Livermore National Laboratory (LLNL), in a COVID-19 response, designing and developing an FDA Emergency Use Approved ventilator, SuppleVent™ in a breath-takingly short 9-weeks.
In light of this remarkable team achievement, Carrie was appointed CEO in July 2020 and now leads BMI’s ground-breaking efforts working with Wake Forest Institute of Regenerative Medicine’s (WFIRM’s) ReMDO Innovation Accelerator, Duke University’s ExVivo Organ Lab (DEVOL), and, similarly, in serving clients and partners as wide ranging as the Cystic Fibrosis Foundation (CFF) of America and Yale University, Neuroscience Laboratory.
Associate Vice President, Phase Holographic Imaging (PHI)
Peter Egelberg (CEO and founder of PHI, born 1963) has a career-long background in physics and computer engineering. Rather than letting the microscope lens form the image, Peter’s idea in 2000 that led to PHI was to instead record the light information a computer algorithm needs to create the image.
This approach, providing several advantages, is today known as quantitative phase imaging (QPI) and is set to fully replace the soon 100-year-old microscopy method commonly used to observe living cell cultures in regenerative medicine, conventional medical research and drug development.
Professor; Department Chair, Fischell Department of Bioengineering, University of Maryland
Dr. John P. Fisher is the Fischell Family Distinguished Professor and Department Chair in the Fischell Department of Bioengineering at the University of Maryland. Dr. Fisher is also the Director of the NIBIB / NIH Center for Engineering Complex Tissue (CECT) that aims to create a broad community focusing on 3D printing and bioprinting for regenerative medicine applications. As the Director of the Tissue Engineering and Biomaterials Laboratory, Dr. Fisher’s group investigates biomaterials, stem cells, bioprinting, and bioreactors for the regeneration of lost tissues, particularly bone, cartilage, and cardiovascular tissues. Dr. Fisher’s laboratory has published over 200 articles, book chapters, and proceedings (9500+ citations / 53 h-index) as well as delivered over 350 invited and contributed presentations, while utilizing over $15M in financial support from NIH, NSF, FDA, NIST, DoD, and other institutions.
Dr. Fisher has been elected Fellow of the American Institute for Medical and Biological Engineering (2012), the Biomedical Engineering Society (2016), and the International Academy of Medical and Biological Engineering (2020).
Dr. Fisher has received the Clemson Award for Contributions to the Literature from the Society For Biomaterials (2020), the Senior Scientist Award from the Tissue Engineering and Regenerative Medicine International Society - Americas (TERMIS-AM) Chapter, a Fulbright Fellowship to study at the National University of Ireland, Galway (2015), the Next Power Professorship from Tsing Hua University in Taiwan (2015), the Engalitcheff Award from the Arthritis Foundation (2008), the Outstanding Graduate Alumnus Award from the Department of Bioengineering at Rice University (2007), the Arthritis Foundation’s Investigator Award (2006), and the National Science Foundation CAREER Award (2005).
Dr. Fisher is currently the Co-Editor-in-Chief of the journal Tissue Engineering, while also co-editing 6 texts in the field of tissue engineering. In 2014, Dr. Fisher was the Chair of the Tissue Engineering and Regenerative Medicine International Society - Americas (TERMIS-AM) Chapter Annual Meeting in Washington, DC. Also in 2014, Dr. Fisher was elected Chair of TERMIS-AM, and in 2018 started his three year term as Chair of the Chapter after serving three years as Chair-Elect. In 2018, Dr. Fisher was the Co-Chair of the Biomedical Engineering Society (BMES) Annual Meeting in Atlanta, GA, celebrating the 50th Anniversary of BMES.
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.
Professor, Orthopaedic Surgery, Washington University; Director of Research, St. Louis Shriners Hospitals for Children; Co-Director, Washington University Center of Regenerative Medicine
Dr. Farshid Guilak is the Mildred B. Simon Professor of Orthopaedic Surgery at Washington University, Director of Research for the St. Louis Shriners Hospitals for Children, and co-director of the Washington University Center of Regenerative Medicine. His laboratory is pursuing a multidisciplinary approach for developing new tissue engineering and stem cell-based therapies for musculoskeletal diseases, with a focus on the role of obesity in osteoarthritis. His laboratory has spearheaded the application of genome engineering and synthetic biology to stem cells, in the context of tissue engineering and regenerative medicine. He has published over 380 articles in peer-reviewed journals and has co-edited four books. He was the editor-in-chief of the Journal of Biomechanics for the past 20 years and continues to serve on numerous other journal editorial boards. He has won several national and international awards for his research, including the Kappa Delta Award for orthopaedic research 3 times, as well as 5 separate awards for mentoring. He has also worked extensively in the translation of tissue engineering technologies and he is the Founder of Cytex Therapeutics, a startup company focusing on developing new regenerative medicine therapies for musculoskeletal conditions, and co-founder of several other biotechnology-based startups.
Assistant Professor, Bioengineering, University of Oregon
Dr. Marian Hettiaratchi’s laboratory develops biomaterials for sustained protein delivery using an interdisciplinary approach that combines expertise in chemical engineering, polymer chemistry, and molecular biology. Dr. Hettiaratchi is an Assistant Professor of Bioengineering at the Phil and Penny Knight Campus for Accelerating Scientific Impact at the University of Oregon. She received her B.Sc. in chemical engineering from the University of Calgary and completed her Ph.D. at the joint biomedical engineering department of the Georgia Institute of Technology and Emory University. There she developed biomaterials to enhance bone regeneration. She then conducted post-doctoral research on engineering affinity-based biomaterials for neural regeneration at the University of Toronto. Dr. Hettiaratchi has received doctoral and postdoctoral fellowships from the Natural Sciences and Engineering Research Council of Canada. Her lab’s work is funded by the Wu Tsai Human Performance Alliance, Oregon Health & Science University (OHSU) Medical Research Foundation New Investigator Grant, and NIH R21 Trailblazer Award.
Biotechnology Instructor, Atkins Academic & Technology High School
Terry teaches Biotechnology classes at Atkins Academic & Technology High School in Winston-Salem. He has been teaching for 30 years and still enjoys it – even after the Covid pandemic. His freshman class is a hands-on class that teaches lab skills while his upper-level class provides students the opportunity to experience several molecular lab techniques. His goal is to prepare students to be scientists in biotechnology and regenerative medicine and to guide them into programs for further training.
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 Vice President, Innovation Quarter
Kaplan joined Wake Forest School of Medicine in 2012, focused primarily on academic resource support to faculty researchers and educators along with staff and students. With a passion for urban planning and design, Kaplan joined the Innovation Quarter in May 2018 to lead the operations team in real estate and property management, parking, leasing support, capital project implementation, event support and Innovation Quarter mapping and data resources. Current projects include a GIS mapping study to inventory the entire Innovation Quarter ecology and landscape and master planning for the subsequent phases of development.
Sr. Operations Research, SAS Institute
Nabaruna has been working as an Operations Research Specialist in the Analytics Center of Excellence at SAS Institute for the past few years. She works with customers from a variety of industries to help develop data-driven solutions to optimize their business operations. She has a PhD in Industrial Engineering from North Carolina State University (Go Wolfpack!) with a focus on Operations Research. Aside from classical OR techniques, she has experience in Artificial Intelligence/Machine Learning and Full-Stack Web Development.
Professor, Department of Social Sciences and Health Policy, Wake Forest School of Medicine; Professor, Wake Forest Institute for Regenerative Medicine; Co-Director, Center for Bioethics, Health and Society and Graduate Program in Bioethics, Wake Forest University
Nancy M. P. King, JD, is Professor in the Department of Social Sciences and Health Policy and Wake Forest Institute for Regenerative Medicine at Wake Forest School of Medicine, and Co-Director of the Center for Bioethics, Health, and Society and the Graduate Program in Bioethics at Wake Forest University. Her scholarship addresses a range of bioethics issues, including: informed consent, benefit, and uncertainty in health care and research; the development and use of experimental technologies; international and cross-cultural questions in human subjects research; and ethical issues in “big data” research and biobanking, gene transfer research, regenerative medicine, and other novel biotechnologies.
Professor King has published over 100 scholarly articles and book chapters, and is co-editor of The Social Medicine Reader (2nd ed., Duke University Press, 2005; 3rd ed. forthcoming), Beyond Regulations: Ethics in Human Subjects Research (UNC Press 1999), and Bioethics, Public Moral Argument, and Social Responsibility (Routledge 2012). She teaches a variety of courses in bioethics, medical humanities, and research ethics to medical students and faculty and to graduate students in bioethics and the health sciences.
Professor King has served on hospital ethics committees, IRBs, DSMBs and the NIH Recombinant DNA Advisory Committee, and has taught bioethics in national and international settings. She is a Fellow of the Hastings Center and a member of the DHHS Secretary’s Advisory Committee for Human Research Protections.
Chief, Biosystems and Biomaterials Division, National Institute of Standards and Technology
Dr. Sheng Lin-Gibson is the Chief of the NIST Biosystems and Biomaterials Division. She oversees a multidisciplinary research portfolio that includes regenerative medicine and advanced therapies, precision medicine, synthetic biology, and complex microbial systems. She leads and coordinates the development of global standards for emerging biotechnology, many of which support regenerative medicine and advanced therapy. She has coauthored over 80 peer-reviewed publications, serves on many Interagency Working Groups as well as numerous expert review panels and advisory boards. She has received two Department of Commerce Gold Medals.
Vice President Corporate Development & Strategy, Epredia; Executive Director, Global Business Development, PHC Corporation
Steven Lynum works as a catalyst in the field to create new global business opportunities for PHC business units and PHCHD subsidiary companies. Working directly with pharmaceutical companies, government agencies, academic institutions, and the investment community; providing them with Medical Device, Lifescience, and Healthcare IT solutions. Furthermore working intimately with Regenerative Medicine KOL’s, and other leading academic institutions and entities that will help grow PHC Group businesses faster organically and inorganically while achieving the corporate mission of creating healthcare solutions that have a positive impact and improve the lives of people. Immediate past president of PHC Corporation of North America.
Director, Center for Biologics Evaluation and Research, FDA
Peter Marks, PhD, 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 January 2016.
Professor, Plastic Surgery; Professor, Bioengineering; Vice Chair of Research, Plastic Surgery, University of Pittsburgh
Dr. Kacey Marra is a Professor in the Departments of Plastic Surgery (primary) and Bioengineering (secondary), as well as Vice Chair of Research in the Department of Plastic Surgery, at the University of Pittsburgh. She is also a core faculty member in the McGowan Institute for Regenerative Medicine, where she has served as a member of the Executive Committee since 2004. After earning her PhD in organic chemistry in 1996 from the University of Pittsburgh, she was a post-doctoral fellow for Elliot Chaikof at Emory University. Following four years as a research scientist at Carnegie Mellon University conducting bone tissue engineering research, she became the Director of Plastic Surgery Research at the University of Pittsburgh in 2002. She has a publication record of over 150 peer-reviewed articles and over 600 abstracts in the areas of peripheral nerve repair, adipose stem cells, bioreactors, tissue engineering, wound healing, adipose stem cells, and diabetes. Her funding includes NIH, NSF, and DoD grants in the area of regenerative medicine, (including the Armed Forces Institute for Regenerative Medicine, (AFIRM)). She was Co-Chair of the 2015 Tissue Engineering and Regenerative Medicine International Society (TERMIS) World Congress, held in Boston. Dr. Marra is also Founder and CEO of Nerve Repair Technologies, and is planning for clinical trials with a tissue-engineered nerve guide.
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. His thesis work focused on developing perinatal stem cells as a therapy for lung disease and contributed to an ongoing Phase I clinical trial for the treatment of bronchopulmonary dysplasia (BPD) in preterm infants. Dr. Murphy joined Wake Forest Institute for Regenerative Medicine in 2012 as a Postdoctoral Fellow and became an Assistant Professor in 2015.
Founder, Histogen, Inc.
Dr. Naughton founded Histogen, Inc. in 2007, is the inventor of its core technology, and served as its CEO and Chairman until March of 2017 and as Chief Scientific Officer and Chief Business Development Officer for the Company until June 1, 2021. She currently serves as a scientific advisor. She has spent more than 35 years extensively researching the tissue engineering process, holds more than 120 U.S. and foreign patents and has been extensively published in the field. She previously served as co-founder and co-inventor of Advanced Tissue Sciences, a manufacturer of human skin for wound healing and skin treatments. At ATS Dr. Naughton held a variety of key management positions, including president, chief operating officer, chief scientific officer and principal scientist. While serving as an officer and director of the Company, Dr. Naughton oversaw the design and development of the world’s first up-scaled manufacturing facility for tissue engineered products, established corporate development and marketing partnerships with companies including Smith & Nephew, Ltd., Medtronic and Inamed Corporation, was pivotal in raising over $350M from the public market and corporate partnerships, and brought four human cell-based products from concept through FDA approval and market launch. These products include TransCyte for acute burns and Dermagraft for the treatment of sever diabetic ulcers. Following ATS, Dr. Naughton served as Dean of the College of Business Administration at San Diego State University from 2002 until 2011, where she helped to make SDSU the first US campus to establish a Ph.D./MBA in life sciences. In 2000, Dr. Naughton received the 27th Annual National Inventor of the Year award by the Intellectual Property Owners Association in honor of her pioneering work in the field of tissue engineering. Dr. Naughton received her Ph.D. and M.S. from NYU Medical, and an MBA from UCLA. She currently sits on the Board of directors of Therapeutics MD (NASDAQ: TXMD), the La Jolla Institute for Immunology, and several scientific advisory boards.
Director, Stem Cell Program, University of California Davis School of Medicine; Director, Institute for Regenerative Cures
Jan A. Nolta, PhD, is the Director of the Stem Cell Program at University of California Davis School of Medicine and directs the Institute for Regenerative Cures and the new UC Davis Gene Therapy Center. She also serves as the Scientific Director of the large UC Davis Good Manufacturing Practice Facility, and as PI of the California State Umbilical Cord Blood Collection Program. The UC Davis stem cell program has a large number of basic, translational, and clinical scientists collaborating to work toward regenerative medicine-related cures for a spectrum of diseases and injuries. Dr. Nolta is helping UC Davis teams develop numerous clinical trials of gene and cell therapy, with 40+ stem cell/regenerative medicine therapies already in the clinic, and over twenty in the pipeline. A California Institute for Regenerative Medicine “Alpha Clinic” Award was recently granted to UC Davis to administer FDA-approved stem cell and regenerative medicine therapies.
A scientist with 30 years’ experience with human Hematopoietic and Mesenchymal stem cells, gene therapy, and clinical trial development, Dr. Nolta developed her passion for cellular therapy in the early 90’s by helping to develop and administer the first umbilical cord blood hematopoietic stem cell gene therapy trials for newborns with “bubble baby disease” with her mentor Donald Kohn at the University of Southern California.
Dr. Nolta has published over 200 peer-reviewed manuscripts in the stem cell field, with over 13,000 citations, and has authored 30+ book chapters. She has served on over 250 review panels for the National Institutes of Health and other grant-funding agencies, was editor of the Book "Genetic Engineering of Mesenchymal Stem Cells", and has been Editor-in-Chief for the Journal “Stem Cells” for the past seven years.
Dr. Nolta is a native of Northern California, trained in Los Angeles and Washington University, and has been back at UC Davis in Sacramento now for over a decade. A major driving force throughout her career has been to provide service to teams working toward novel cures, and to foster a strong sense of community and teamwork. Team training is her passion and she leads several training initiatives at UC Davis and beyond. The fields of stem cells, immunotherapy, gene therapy and regenerative medicine are poised to change the face of healthcare. The new “living medicine” preparation and delivery will be performed by large teams of experts with different expertise and backgrounds. The UC Davis Stem Cell Program is committed to fostering teamwork, training the diverse science and healthcare work force of the future, and to continuing to improve and deliver these novel cutting edge therapies for patients who currently have few other options.
Professor, Pediatrics; Definitive and Curative Medicine, Institute of Stem Cell Biology and Regenerative Medicine, Stanford
Matthew Porteus MD, PhD, is the Sutardja Chuk Professor of Definitive and Curative Medicine and a Professor in the Department of Pediatrics, Institute of Stem Cell Biology and Regenerative Medicine and Maternal-Child Health Research Institute at Stanford. His primary research focus is on developing genome editing as an approach to cure disease, particularly those of the blood (such as sickle cell disease) but also of other organ systems as well. He received his undergraduate degree at Harvard in History and Science where his honors thesis studied the recombinant DNA controversy of the 1970s. He then completed his MD and PhD training at Stanford, clinical training in Pediatric Hematology/Oncology at Boston Children’s Hospital, and post-doctoral research training with Noble Laureate David Baltimore at CalTech. He works as an attending physician on the Pediatric Hematopoietic Stem Cell Transplant service at Lucile Packard Children’s Hospital where he cares for children under going bone marrow transplantation for both malignant and non-malignant diseases. His goal is to combine his research and clinical interests to develop innovative curative therapies. He served on the 2017 National Academy Study Committee of Human Genome Editing and currently serves on the Scientific Advisory Board for WADA on Cell and Gene Doping and the NIH NexTRAC advisor committee evaluating the emergence of new technologies.
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.
Professor; Canada Research Chair in Functional Cardiovascular Tissue Engineering, University of Toronto
Dr. Milica Radisic is a Professor at the University of Toronto, Canada Research Chair in Functional Cardiovascular Tissue Engineering and a Senior Scientist at the Toronto General Research Institute. She is also Director of the NSERC CREATE Training Program in Organ-on-a-Chip Engineering & Entrepreneurship and Director of Ontario-Quebec Center for Organ-on-a-Cho Engineering. She obtained B.Eng. from McMaster University, and Ph.D. form the Massachusetts Institute of Technology. She is a Fellow of the Royal Society of Canada-Academy of Science, Canadian Academy of Engineering, the American Institute for Medical & Biological Engineering and Tissue Engineering & Regenerative Medicine Society. She received numerous awards and fellowships, including MIT Technology Review Top 35 Innovators under 35. She was a recipient of the Queen Elizabeth II Diamond Jubilee Medal in 2013, NSERC E.W.R Steacie Fellowship in 2014, YWCA Woman of Distinction Award in 2018, OPEA Research & Development Medal in 2019 and Killam Fellowship in 2020 to name a few. Her research focuses on organ-on-a-chip engineering and development of new biomaterials that promote healing and attenuate scarring. She developed new methods to mature iPSC derived cardiac tissues using electrical stimulation. Currently, she holds research funding from CIHR, NSERC, CFI, ORF, NIH, and the Heart and Stroke Foundation. She is an Associate Editor for ACS Biomaterials Science & Engineering, a member of the Editorial Board of Tissue Engineering, Advanced Drug Delivery Reviews, Regenerative Biomaterials, Advanced Biosystems, Journal of Molecular and Cellular Cardiology and eLife. She serves on review panels for Canadian Institutes of Health Research and the National Institutes of Health. She is actively involved with BMES (Cardiovascular Track Chair and TERMIS-AM (Council member, Chair of the Membership Committee). She was a co-organizer of a 2017 Keystone Symposium, “Engineered Cells and Tissues as Platforms for Discovery and Therapy”. She served on the Board of Directors for Ontario Society of Professional Engineers, Canadian Biomaterials Society and McMaster Alumni Association. Her research findings were presented in over 200 research papers, reviews and book chapters with h-index of 67 and over 16,800 citations. Her publications appeared in Cell, Nature Materials, Nature Methods, Nature Protocols, Nature Communications, PNAS etc. In 2014, she co-founded an award winning company TARA Biosystems that uses matured human engineered heart tissues in drug development. TARA raised over $20million to date and currently tests drugs for major pharmaceutical companies. In 2017, she founded Quthero Inc, a company focused on disrupting the skin regeneration and a medical esthetics market through the use of proprietary Q-gel to promote scar-free wound healing.
Professor Chief, Division of Regenerative Medicine Department of Medicine and Director, Ansary Stem Cell Institute, Weill Cornell Medicine Graduate School of Medical Sciences
Dr. Shahin Rafii, director of the Ansary Stem Cell Institute and chief of the Division of Regenerative Medicine at Weill Cornell Medicine, has received an Outstanding Investigator Award (R35) from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH), for an ambitious project to accelerate regenerative medicine technology.
Shahin Rafii’s laboratory focuses on stem cell biology and angiogenesis uses in vivo mouse models and mouse and human genetics, tissue culture approaches, and molecular biology to model angiogenesis, cancer, and stem cell metabolic regulation. Genetic, genomics, molecular, and cell biological techniques are combined to achieve a systems-level understanding of these complex processes.
Currently, Rafii’s work is focused on identifying the molecular and cellular pathways involved in organ regeneration and tumor growth. He has established the concept that vascular endothelial cells are not just inert plumbing to deliver oxygen and nutrients, but also by the production of tissue-specific growth factors, defined as angiocrine factors, support organ regeneration, and tumor proliferation. He has shown that bone marrow endothelial cells by elaboration of angiocrine factors, such as Notch ligands, support stem cell self-renewal, and differentiation into lymphoid and myeloid progenitors. He has recently demonstrated that liver and lung endothelial cells are endowed with unique phenotypic and functional attributes and by the production of unique instructive growth factors contribute to hepatic and alveolar regeneration.
CEO, Implants Therapeutics
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 other somatic stem cells and has worked in the stem cell field for more than twenty years with stints in academia, government and regulatory affairs and industry. Dr. Rao has an extensive background teaching medical and graduate students, as well as postdoctoral fellows at institutions including The Johns Hopkins University School of Medicine, The National Centre for Biological Sciences in Bangalore, India, and the University of Utah School of Medicine. Dr. Rao has published more than 350 papers on stem cell research and is the co-founder of a neural stem cell company Q therapeutics based in Salt lake City (Utah) and more recently NxCell based in California.
Until 2010 Dr. Rao led the Stem Cell and Regenerative Medicine division at LiFE Technologies and also served as the Chair of the CBER (FDA) advisory committee (CTGTAC). Dr. Rao serves on several scientific advisory boards to Pharma, journal editorial boards and oversight committees and advisory panels on large scale projects related to stem cell biology. Dr. Rao has served and continues on the Boards of several stem cell and regenerative medicine companies such Stempeutics, CESCA, CBR and Megakaryon. Dr Rao has also served on advisory panels to the governments of the U.S., Singapore and India on hESC and iPSC policy. He continues to work with the FDA and other regulatory authorities on PSC related issues most recently as the CIRM and ISSCR liaison to the ISCT.
Dr. Rao was the founding Director of the NIH Center of Regenerative Medicine and also the Chief of the Laboratory of Stem cell Biology at the NIH. Dr. Rao ongoing efforts are focused on translational work related to Parkinsons disease and glial cell pathology. Dr. Rao is an adjunct faculty member at Wake Forest Center For Regenerative Medicine and the VP of Strategic Affairs at Q therapeutics. He also serves as a consultant on Regenerative Medicine for the New York Stem Cell Foundation and continues to provide consultant and advisory services to biotechnology companies in the regenerative medicine field. Dr. Rao was recently named one of the top ten influential people in the stem cell field and was honored recently by the Federation of Biologists (FABA) India for his achievements in the stem cell field and awarded the NBRI medal (India) for his contributions to neuroscience research.
Professor, Bioengineering and Chemical Engineering, University of Washington
Buddy Ratner is Professor, Bioengineering and Chemical Engineering, University of Washington (UW), Director-UWEB21, co-director-Center for Dialysis Innovation and Darland Chair in Technology Commercialization. Received Ph.D. 1972 (polymers) from Polytechnic Institute Brooklyn. His specializations are biomaterials, biomedical engineering. He is a fellow AIMBE, AVS, AAAS, ACS, and Society For Biomaterials (SFB). Elected to National Academy Engineering, USA (2002). Awards include AVS Welch (2002), SFB Founders (2004), the BMES Pritzker Lecturer (2008), the Acta Biomaterialia Gold Medal (2009), the Galletti Award (2011) the George Winter Award, European Society for Biomaterials (2012), UW Medicine Lifetime Innovator/Inventor Award (2014), ACS Bioelastomers Award (2021). He served as President of SFB (1998) and AIMBE (2002). He was lead editor, "Biomaterials Science: An Introduction to Materials in Medicine” (1st, 2nd and 3rd editions).
Dip. Ed, Grad. Dip. Inst. Administration, MA
Executive Director, National Center for the Biotechnology Workforce (NCBW)
Russ Read, BSc.,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 seventeen years called the National Center for the Biotechnology Workforce (NCBW). The NCBW is based in Winston-Salem is a part of North Carolina’s Community College System, Forsyth Technical Community College and is a part of the college’s division of Student Academic Success. 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 WFIRM Regen Med. Workforce and the Workforce Hub of InnovATEBIO.
Dr. Amrita Sahu is an Assistant Professor in the Department of Physical Medicine and Rehabilitation at the University of Pittsburgh School of Medicine. Dr. Sahu is also the Scientific Program Coordinator of the Alliance of Regenerative Rehabilitation Research and Training. Dr. Sahu received her B.Tech in Biomedical Engineering from Manipal University, India. She then graduated with MS in Biomedical Engineering from Carnegie Mellon University, followed by a PhD in Environmental and Occupational Health from the Graduate School of Public Health at the University of Pittsburgh. As a doctoral student, her overarching goal was to identify Klotho (an anti-aging protein) as a potential therapeutic target for enhancing the skeletal muscle healing capacity of the geriatric population by enhancing skeletal muscle mitochondrial health. Dr. Sahu joined the Department of Physical Medicine and Rehabilitation at University of Pittsburgh as a Postdoctoral Associate in 2020. She investigated the role of exercise on the molecular profile of circulating extracellular vesicles as well as the mechanisms underlying an age-related decrease in skeletal muscle regenerative capacity. As an Assistant Professor, Dr. Sahu’s long-term goal is to develop targeted rehabilitation strategies for enhancing skeletal muscle and cognitive functional capacity in a geriatric population. Recently, her research interests have taken her to explore the unexplored quantum phenomena in human body that may open several avenues into developing bio-therapeutics and precise rehabilitation strategies. Dr. Sahu’s research interests lie in aging, skeletal muscle physiology, skeletal muscle-brain axis, circulating biomarkers
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.
Head of Global Engagement and Growth, Oracle for Startups
Jane Scott is Head of Global Customer Engagement and Growth for the Oracle for Startups team. With 20 years at Oracle in different divisions, Jane is an experienced, empathetic customer advocate engaging strategically at the intersection of business strategy, customer experience and technology with a keen focus on aligning processes and policies that make it easier for our customers to do business with us.
Chief Commercial Officer, HUMACYTE, Inc.
Mr. Scheessele is responsible for the commercial launch of the HAV (Human Acellular Vessel) in its initial vascular indications and follow-on market expansion. Prior to joining Humacyte, Mr. Scheessele served as Executive Vice President of Global Marketing for Quest Medical Imaging Inc., an Olympus Corporation acquisition. Previously, Mr. Scheessele spent 10 years at LifeCell Corporation, a leader in the Regenerative Medicine market, where he held roles of increasing responsibility in sales and marketing, culminating in Vice President of North America Marketing and Canada Country Manager. Earlier in his career, he worked in business development and product management with Cordis Corporation, a Johnson & Johnson Company. Mr. Scheessele earned a BSE in biomedical engineering and economics and an MBA from Duke University.
Chief Scientific Officer, TurtleTree Labs
Aletta C. Schnitzler, PhD, recently joined TurtleTree as Chief Scientific Officer, leading the R&D teams and spearheading an innovation roadmap to bring nutritious cell-based dairy and meat alternatives to market. Previous to joining TurtleTree, Aletta co-founded Merck KGaA’s Cultured Meat Innovation program and directed technology development to advance platforms enabling rapid development, validation and manufacture of cell-based meat products. Focus areas included formulating cost-effective cell culture media, understanding cell line requirements, and envisioning new process templates for biomass generation and structured products. Additionally, Aletta was Head of Cell Therapy Bioprocess R&D at MilliporeSigma, honing expertise in media optimization and single-use bioreactor systems for use in a complex regulatory environment. She also held technical and marketing roles supporting small-scale chromatography devices and cell culture products for monoclonal antibody production. Aletta received her PhD in 2007 from Boston University School of Medicine in the fields of immunology and neuroscience, and is an editorial board member of Stem Cells Translational Medicine.
University Professor and Michael E. Charles Chair in Chemical Engineering; Associate Chair, Graduate Studies, Chemical Engineering & Applied Chemistry, Donnelly Centre, University of Toronto
Professor Molly Shoichet is University Professor, a distinction held by less than 2% of the faculty, at the University of Toronto. She served as Ontario’s first Chief Scientist in 2018 where she worked to enhance the culture of science. Dr. Shoichet has published over 650 papers, patents and abstracts and has given over 420 lectures worldwide. She currently leads a laboratory of 30 and has graduated 220 researchers. Her research is focused on drug and cell delivery strategies in the central nervous system (brain, spinal cord, retina) and 3D hydrogel culture systems to model cancer. Dr. Shoichet co-founded four spin-off companies, is actively engaged in translational research and science outreach. Dr. Shoichet is the recipient of many prestigious distinctions and the only person to be inducted into all three of Canada’s National Academies of Science of the Royal Society of Canada, Engineering and Health Sciences. In 2018, Professor Shoichet was inducted as an Officer of the Order of Canada and in 2011, she was awarded the Order of Ontario. Dr. Shoichet was the L’Oreal-UNESCO For Women in Science Laureate for North America in 2015, elected Foreign Member of the US National Academy of Engineering in 2016, won the Killam Prize in Engineering in 2017 and elected to the Royal Society (UK) in 2019. In 2020, Dr. Shoichet was awarded the NSERC Herzberg Gold Medal and won the Margolese National Brain Disorders Prize. Dr. Shoichet received her SB from the Massachusetts Institute of Technology (1987) and her PhD from the University of Massachusetts, Amherst in Polymer Science and Engineering (1992).
Professor, Wake Forest Institute for Regenerative Medicine
Shay Soker, PhD, 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.
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.
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.
Commercial Innovation Strategy Lead, Axiom Space
Jana Stoudemire, PhD, is helping to create the commercial space economy in low-Earth orbit for biomedical and technology in-space manufacturing applications on the world's first commercial space station. In addition to a strong technical background, Jana has a career history marked by successful identification of new business opportunities for private and public healthcare companies, along with product development and global commercialization of some of the most innovative healthcare technologies. 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.
Assistant Professor, Department of Biomedical Engineering; Orthopaedics & Rehabilitation, Pennsylvania State University
Dr. Szczesny is an Assistant Professor at the Pennsylvania State University with a joint appointment in the Departments of Biomedical Engineering and Orthopaedics & Rehabilitation. He completed his postdoctoral training in 2017 as an NIH NRSA F32 Fellow and obtained a PhD in bioengineering in 2015 at the University of Pennsylvania. Prior to his doctorate, Dr. Szczesny developed medical implants as a design engineer for Aesculap Implant Systems and as a research assistant at the Helmholtz Institute for Biomedical Technology in Aachen, Germany. He obtained a MS in mechanical engineering at the Massachusetts Institute of Technology in 2005 and a BS in mechanical engineering at the University of Pennsylvania in 2003. Dr. Szczesny’s current research examines how cells in tendon sense the mechanics of their local microenvironment (e.g., strains, stiffness) and how their response drives changes in tissue mechanical properties during tendon degeneration, repair, and development, which is supported by the National Institutes of Health, National Science Foundation, Congressionally Directed Medical Research Program, and other non-profit organizations. His contributions to the field of tendon biomechanics and mechanobiology have been recognized by a 2022 NSF CAREER Award, 2022 CMBE Rising Star Award, 2016 ORS New Investigator Recognition Award (NIRA) finalist, 2015 Acta Student Award, and two-time winner of the SB3C PhD competition. Dr. Szczesny is also committed to improving diversity, equity, and inclusion within engineering. To that end, he serves as the Diversity Chair for the 2022 Summer Biomechanics, Bioengineering, and Biotransport Conference (SB3C). He is also a member of the Diversity, Equity, and Inclusivity Committee for the Orthopaedic Research Society and the Department of Biomedical Engineering at Penn State. Finally, he is a co-chair of the Race and Marginalized Populations Workgroup for the State College Area School District.
Associate Professor of Regenerative Bioscience, Regenerative Bioscience Center, University of Georgia
Dr. Franklin West is a world leading expert in stem cell biology with a focus on the development of therapies for stroke and traumatic brain injury (TBI). His transformative research has demonstrated how neural stem cells and extracellular vesicles can reduce brain injury, lead to faster, and improved recovery in stroke and TBI. In addition, he has produced the first live chimeric pigs from induced pluripotent stem cells and has developed novel stem cell to germ cell culture systems to study infertility. Dr. West was named one of the nation's top scholars under 40 by Georgia Trends and Diverse: Issues in Higher Education magazines and has been featured on NPR, CNN and FOX News for his breakthrough research. Dr. West received a Bachelor of Science in biology from Morehouse College where he was a David and Lucille Packard Research Fellow and a MARC U-Star Research Fellow. He received his doctorate in stem cell biology from the University of Georgia, where he is now an associate professor in the regenerative bioscience center. Dr. West has published in numerous international scientific peer-reviewed journals including Cell, Stem Cells, and Neurotrauma and written many book chapters covering topics from developing transgenic animals to cell therapies. His research has been supported by the NIH, DoD, NSF, the Bill and Melinda Gates Foundation, and many other industry partners.
Assistant Professor, Wake Forest Institute for Regenerative Medicine
Dr. Victoria Weis, PhD, 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.
Professor and Director of International Affairs, Wake Forest Institute for Regenerative Medicine
Professor David Williams, DSc, has had 50 years of experience in biomaterials, medical device and tissue engineering. During his career he has published over 35 books and 430 papers: his latest book, 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 for 15 years. He has received the major awards from the US, European and Indian societies of biomaterials including the Founders Award of the US Society for Biomaterials in 2007, and received the prestigious Acta Biomaterialia Gold Medal in 2012. In 1999 he was elected as a Fellow of the Royal Academy of Engineering, UK, and is a Foreign Fellow of the Indian National Academy of Engineering and a Fellow of the American Institute of Medical and Biological Engineering, all in recognition of his contributions to engineering in medicine. He was global President of the Tissue Engineering & Regenerative Medicine International Society between 2012 and 2015.
Professor Williams left the University of Liverpool, UK, in 2007, where he had been Head of Clinical Engineering, Director of the UK Centre for Tissue Engineering and Pro Vice Chancellor of the University. While retaining the title of Emeritus Professor at Liverpool, he is currently Professor and Director of International Affairs, Wake Forest Institute of Regenerative Medicine, North Carolina, USA. In addition, he is a Visiting Professor in the Christiaan Barnard Department of Cardiothoracic Surgery, Cape Town, South Africa, a Visiting Professorial Fellow at the Graduate School of Biomedical Engineering, University of New South Wales, Australia, and a Guest Professor, at Tsinghua Universities, Beijing, and Advisory Professor at Shanghai Jiao Tong University, China. In Cape Town, along with Professor Peter Zilla, the current Chris Barnard Professor of Surgery, he formed a company that will produce low cost but high technology medical devices that can be used with minimally invasive procedures to treat young adults in sub-Sarah Africa, who currently have no therapies available to them. After 8 years work, and raising the equivalent of $30 million within Africa, his team successfully used their non-occlusive delivery system in a First-in-Man experience in January 2019, the first in the world.
Director, Stanford Cardiovascular Institute; Professor, Medicine & Radiology, Stanford University School of Medicine
Joseph C. Wu, MD, PhD, is Director of Stanford Cardiovascular Institute and Simon H. Stertzer, MD, Professor of Medicine and Radiology at Stanford University. Dr. Wu received his MD from Yale University and PhD (Molecular & Medical Pharmacology) at UCLA. He is board certified in cardiology.
His lab works on cardiovascular genomics and induced pluripotent stem cells (iPSCs). The main goals are to (i) understand basic disease mechanisms, (ii) accelerate drug discovery and screening, (iii) develop “clinical trial in a dish” concept, and (iv) implement precision medicine for patients. Dr. Wu has published >450 manuscripts with H-index of 112 on Google scholar. He is listed as top 1% of highly cited researchers by Web of Science for past 4 years (2018, 2019, 2020, 2021).
Dr. Wu has received NIH Director’s New Innovator Award, NIH Roadmap Transformative Award, Presidential Early Career Award for Scientists and Engineers (PECASE) given out by President Obama at the White House, American Heart Association (AHA) Distinguished Scientist Award, and Burroughs Wellcome Foundation Innovation in Regulatory Science Award. He serves on the FDA Cellular, Tissue, and Gene Therapies Advisory Committee.
Dr. Wu is an elected member of Association of University Cardiologists (AUC), American Institute for Medical and Biological Engineering (AIMBE), American Association for the Advancement of Science (AAAS), American Association of Physicians (AAP), and National Academy of Medicine (NAM).
CEO, BioSpherix Medical, div. of BioSpherix, Ltd.
Randy Yerden, B.S., was educated as a cell biologist/biochemist at Syracuse University and the University of Rochester. He was cloning stem cells in 1976 when he developed an incubator enhancement that radically improved the growth and robustness of the cells. Yerden went on to develop dozens of other tools and instruments for leading cell biologists over the following 40 years, all to better meet the needs of their cells. From this vantage point he saw a common theme, and defined a set of Cytocentric Principles that are becoming recognized as fundamental quality concepts for live cells. His company, BioSpherix, is the exclusive source for a unique equipment platform and new SOPs that enable anyone anywhere in the new live cell industry to practice these principles with the critical cell process parameters temperature, CO2, and O2 universal for all cells. These are foundational for all other additional critical process parameters necessary to maximize live cell quality.
University of Toledo
Dr. Yildirim-Ayan is an Associate Professor in the Department of Bioengineering at the University of Toledo. She is a director of Engineered Biosystem Laboratory. Her research group focuses on understanding how mechanical loading can be used to modulate innate immune cell response, fibroblast-to-myofibroblast differentiation, and mesenchymal stem cell differentiation using three-dimensional tissue analogs (in vitro) and ex-vivo organ culture models for mechanome-guided musculoskeletal tissue healing.
Associate Professor, Director of Research, UTHealth, School of Dentistry
Dr. Simon Young, DDS, MD, PhD, FACS, is a board-certified oral & maxillofacial surgeon and scientist whose research efforts include the synthesis and characterization of implantable biomaterials designed to elicit in situ cell recruitment and programming. His work includes the use of materials able to simultaneously deliver multiple bioactive factors with distinct release profiles. These constructs have been used in a diverse set of applications such as the promotion of craniofacial bone regeneration and cancer immunotherapy. Current work in the Young lab seeks to develop novel material-based immunotherapies for the treatment of head and neck cancer and explore mechanisms of how this approach may synergize with chemo/radiation therapy. The paradigm of in situ cell programming using biomaterials is also being utilized in separate collaborative tissue engineering research projects exploring the use of semiconductor-based materials to enhance craniofacial bone regeneration and multidomain peptide hydrogels for nerve regeneration.
Chief Operations Program Officer, Wake Forest Institute for Regenerative Medicine
Dr. James Yoo, MD, PhD, 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.