The 2018 Regenerative Medicine Essentials course will feature prominent members of the Wake Forest Institute for Regenerative Medicine (WFIRM) faculty along with distinguished invited guests. See the list of confirmed course instructors below and click on their names to see detailed bios.
About Our Course Instructors
Anthony Atala, MD
Director, Wake Forest Institute for Regenerative Medicine
Dr. Atala is a practicing surgeon and a researcher in the area of regenerative medicine. His work focuses on growing human cells, tissues and organs. Dr. Atala works with several journals and serves in various roles, including Editor-in-Chief of: Stem Cells- Translational Medicine; Current Stem Cell Research and Therapy; Therapeutic Advances in Urology; and BioPrinting. Dr. Atala is a recipient of awards, including 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, the Samuel D. Gross Prize in Surgical Research, the Innovation Award from the Society of Manufacturing Engineers, the Rocovich Gold Medal, and the Edison Science/Medical Award for work in 3D Bioprinting. In 2011 he was elected to the Institute of Medicine of the National Academy of Sciences, and in 2014 was inducted to the National Academy of Inventors as a Charter Fellow. Dr. Atala’s ongoing work has been described in the lay press. Dr. Atala’s work was listed in 2007 as Time Magazine’s top 10 medical breakthroughs of the year, by Discover Magazine in 2007 as the Number 1 Top Science Story of the Year in the field of medicine, by Smithsonian Magazine in 2010 as one of 40 things to know about the next 40 years, by Time Magazine in 2011 as one of the top 5 medical breakthroughs of the year, by the Huffington post in 2011 as one of 18 great ideas for the future, and by Time Magazine in 2013 as one of 5 discoveries that will change the future of organ transplants. Dr. Atala was named by Scientific American in 2010 as a Medical Treatments Leader of the Year for his contributions to the fields of cell, tissue and organ regeneration, by U.S. News & World Report in 2009 in as one of 14 Pioneers of Medical Progress in the 21st Century, by the American Association of Retired Persons in 2012 as one of the 50 influential people who will make life better, and by Scientific American in 2015 as one of the world’s most influential people in biotechnology. 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 Bioengineering Consortium, the National Cancer Institute’s National Cancer Advisory Board, and was the Founder of the Regenerative Medicine Foundation. Dr. Atala heads a team of over 450 physicians and researchers. Over twelve applications of technologies developed in Dr. Atala’s laboratory have been used clinically. He is the editor of fourteen books, including Principles of Regenerative Medicine, 3D Biofabrication, Essentials of Stem Cell Biology, and Methods of Tissue Engineering. He has published more than 500 journal articles and has applied for or received over 250 national and international patents. Back to top.
Julie Allickson, PhD
Director, Regenerative Medicine Clinical Center, Wake Forest Institute for Regenerative Medicine
Dr. Allickson has more than 25 years of experience in clinical translation of cellular therapies and regenerative medicine products including business management and board directorship experience. Dr. Allickson has 8 years’ experience as an executive officer with a publicly traded company building services for cellular banking including licensure of technology with more than 30 affiliates. An experienced scientist delivering innovation, driving milestones, maintain sensitivity to financial considerations, building multidisciplinary teams, strategic planning, project management, and regulatory expertise. Dr. Allickson has a history of creating value in clinical development and translation.
Dr. Allickson heads the clinical translation team streamlining development to create a robust pipeline of products in early phase clinical trials and FDA registered products including cell therapy, tissue engineered organs and tissues, biomaterials and devices. Translation begins at Proof-of-Concept where early discussion with regulators and clinicians are critical in moving the technology from the bench to the bedside. Prior to the Institute Dr. Allickson was the Vice President of Research and Development and Laboratory Operations for Cryo-Cell International.
Dr. Allickson was part of the team to perform the first Bone Marrow Transplant at the University of Miami in 1990. She has a Doctorate in Health Sciences along with a Master’s Degree in Medical Laboratory Sciences. She is one of the founding members of the International Society of Cellular Therapy and has been a member of the American Association of Blood Banks (AABB) for 29 years. Dr. Allickson is on the Board of Directors for AABB and IWEUS Capital along with Regenerative Medicine Outcomes Foundation as a scientific advisor, Editorial board of CELLR4, Vice Chair for Cord Blood Association Quality Committee, Technical Advisory Board for Tissue Engineered Products under ICCBBA, grant reviewer for state funded initiatives such as CIRM and serves on the ISCT Commercialization Committee. Back to top.
Graca Almeida-Porada, MD, PhD
Professor, Wake Forest Institute for Regenerative Medicine
Graça Almeida-Porada, M.D., Ph.D. is a Professor of Regenerative Medicine 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. Back to top.
George Christ, PhD
Professor, Biomedical Engineering and Orthopaedic Surgery; Laboratory of Regenerative Therapeutics, University of Virginia
Dr. Christ is an internationally recognized expert in muscle physiology. He is the Past Chairman of the Division of Systems and Integrative Pharmacology of the American Society of Pharmacology and Experimental Therapeutics (ASPET), and Past President of the North Carolina Tissue Engineering and Regenerative Medicine (NCTERM) group. He was inducted into AIMBE in 2017. He currently serves on the Executive Committee of the Division for Integrative Systems, Translational and Clinical Pharmacology of ASPET. He is also on the Editorial Board of five journals and is an ad-hoc reviewer for 2 dozen others. Dr. Christ has authored more than 220 scientific publications and is co-editor of a book on integrative smooth muscle physiology and another on regenerative pharmacology. Dr. Christ has served on both national and international committees related to his expertise in muscle physiology, and on NIH study sections in the NIDDK, NICHD, NCRR, NAIAD, and NHLBI. He has chaired working groups for both the NIH and the World Health Organization. Dr. Christ is a co-inventor on more than 26 patents (national and international) that are either issued or pending, related to gene therapy for the treatment of human smooth muscle disorders and tissue engineering technologies. Dr. Christ has also been the driving scientific force behind the preclinical studies and IND approvals supporting three Phase I clinical trials for gene therapy for benign human smooth muscle disorders. This technology has been evaluated in 55 patients in the US and 21 overseas. He is also spearheading the multi-institutional development of a tissue engineered muscle repair (TEMR) technology platform for the treatment of Wounded Warriors. An IND submission for a 5 patient first-in-man pilot study is anticipated in 2018 to further develop this technology platform for treatment of cleft lip. That study is funded by DOD and will be conducted at UT-Houston. Another 5 patient pilot study has also been funded by DOD to evaluate a proprietary hydrogel for the treatment of lower extremity volumetric muscle loss injuries to the tibialis anterior muscle at UVA. An IDE application for that indication is in progress in collaboration with Keranetics LLC (W-S, NC). Back to top.
Richard A. F. Clark, MD
Professor, Biomedical Engineering, Stony Brook Univeristy; Professor and Vice-Chair for Research, Dermatology, Stony Brook University; Co-Focus Leader, Skin Regeneration, Armed Forces Institute of Regenerative Medicine (AFIRM) II
Professor Clark made many seminal observations regarding the sources and significance of fibronectin protein in wounds and wound healing. Recently he has discovered bioactive peptides within the fibronectin structure that enhance the activity of growth factors and act as survival factors for tissue cells. He has recently developed a systemic treatment to limit burn injury progression, speed healing, and reduce scarring for which he has an active IND.
Clark is founder of NeoMatrix Formulations, Inc (NMF), now NeoMatrix Therapeutics, Inc (NMT). NMT is moving novel bioactive peptides discovered in his laboratory and biopolymer composites created in his laboratory to the market place. NMF has been awarded $7M over that past 10 years from the US Army for preclinical studies on a fibronectin peptide to limit burn injury progression. These endeavors lead to the active IND mentioned above. In addition, NMF has recently garnered a US Army grant that supports the re-engineering of an ArF excimer laser for the debridement of burns that salvage underlying viable tissue and thus speed healing.
While at Stony Brook University, he has been the recipient of a 10-year National Institute of Health Merit Award, a NIAMS (RC-2 stimulus grant), and several NIH RO1 awards. Currently he is the recipient of a grant award funded by the Armed Forces Institute of Regenerative Medicine II for ways to stimulate angiogenesis and lymph-angiogenesis to accelerate the healing of burns.
Dr. Clark is Past-President of the Wound Healing Society, the Society for Investigative Dermatology, the New York Academy of Medicine Dermatology Section, and the Stony Brook School of Medicine Faculty Senate. At present he is co-Focus Leader of the Regenerative Skin Program in AFIRM II. To date he has published 235 articles in the scientific literature as well as two books, and holder of seven patents. Back to top.
Dennis Clegg, PhD
Co-Director, UC Santa Barbara Center for Stem Cell Biology and Engineering
Dr. Clegg earned his BS degree in biochemistry at UC Davis and his PhD in biochemistry at UC Berkeley, where he used emerging methods in recombinant DNA to study the sensory transduction systems of bacteria. As a Jane Coffin Childs Postdoctoral Scholar at UCSF, he studied neural development and regeneration. He has continued this avenue of research since joining the UCSB faculty, with studies of extracellular matrix and integrin function in the developing eye. His current emphasis is in stem cell research, with a focus on developing therapies for ocular disease. Dr. Clegg is the recipient of the UCSB Distinguished Teaching Award in the Physical Sciences, the Pacific Coast Business Times Champions in Health Care Award, the National Eye Institute Audacious Goals award, and served as Chair of the Department of Molecular, Cellular and Developmental Biology from 2004-2009. He has been a Frontiers of Vision Research Lecturer at the National Eye Institute, a Keynote Lecturer at the Stem Cells World Congress, and a TEDx speaker. He is founder and Co-Director of the UCSB Center for Stem Cell Biology and Engineering, and has served on advisory boards for the California Institute for Regenerative Medicine and the National Institutes of Health Center for Regenerative Medicine. He is a Co-Principal Investigator of The California Project to Cure Blindness, a multi-disciplinary effort to develop a stem cell therapy for Age-Related Macular Degeneration. Back to top.
Allen Comer, PhD
Director of Research and Development, Stratatech Corporation
Dr. Comer received his bachelor’s degree in Biochemistry from North Carolina State University in 1984 and earned a PhD in Genetics from the University of North Carolina at Chapel Hill in 1993. Dr. Comer was awarded a Postdoctoral Fellowship from the Leukemia Society of America for research at the McArdle Laboratory for Cancer research at the University of Wisconsin School of Medicine where he studied cancer-related signaling pathways in Drosophila melanogaster. Dr. Comer joined Stratatech Corporation in 2000, where he has been instrumental in establishing manufacturing and quality control procedures for living skin substitutes using NIKS® cells, a consistent source of genetically uniform, non-tumorigenic, pathogen free human keratinocytes discovered at the University of Wisconsin-Madison. Dr. Comer has extensive experience with the design and conduct of clinical trials of cell-based living human skin substitutes, and has led meetings with the US Food and Drug Administration regarding chemistry, manufacturing, and control strategies for these products. As the Director of Research and Development, Dr. Comer has served as Principal Investigator on numerous Small Business Innovation Research (SBIR) grants to Stratatech for development of its portfolio of genetically-enhanced ExpressGraft™ living skin substitutes. Stratatech was awarded a Tibbets Award in 2016 in recognition of the success of its SBIR-funded programs. Dr. Comer currently manages the conduct of a $247 million Project BioShield contract from the Biomedical Advanced Research and Development Authority (BARDA), which is supporting late-stage clinical development of a cryopreserved, living human skin substitute for use as a medical countermeasure for the treatment of severe burns following a natural or man-made mass casualty thermal burn event. Back to top.
John Fisher, PhD
Professor and Department Chair of Bioengineering, University of Maryland; Director, NIH Center for Engineering Complex Tissue (CECT)
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 newly established 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. Dr. Fisher completed a B.S. in biomedical and chemical engineering at The Johns Hopkins University (1995), M.S. in chemical engineering at the University of Cincinnati (1998), Ph.D. in bioengineering at Rice University (2003), and postdoctoral fellowship in cartilage biology and engineering at the University of California Davis (2003). 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.
Overall, the laboratory has published over 140 articles, book chapters, and proceedings (5000+ citations / 40+ h-index) as well as delivered over 285 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 both the American Institute for Medical and Biological Engineering (2012) and the Biomedical Engineering Society (2016). Dr. Fisher is currently the Co-Editor-in-Chief of the journal Tissue Engineering, as well as the Chair (2018 - 2020) of the Americas Chapter of the Tissue Engineering and Regenerative Medicine International Society (TERMIS-AM). In 2018, Dr. Fisher will co-chair the Biomedical Engineering Society (BMES) Annual Meeting, celebrating the 50th Anniversary of the Society. Back to top.
Joshua Hare, MD, FACC, FAHA
Professor of Medicine, Molecular and Cellular Pharmacology, University of Miami; Director, Interdisciplinary Stem Cell Institute
Dr. Hare graduated from the University of Pennsylvania and has a medical degree from Johns Hopkins University. He did his residency at Hopkins and fellowships at Hopkins, Harvard University and The Brigham and Women’s Hospital in Boston. Dr. Hare was Professor of Medicine and Biomedical Engineering and director of cardiac transplantation at Johns Hopkins, leading their heart failure program, before he joined the faculty at University of Miami.
Dr. Hare is one of the world’s leading pioneers in the use of stem cell therapy to repair damaged hearts. He recently released findings on the first human clinical trial testing a stem-cell based treatment for heart attack patients, which showed the stem cell treated patients had lower rates of cardiac arrhythmias, and had significant improvements in heart, lung and symptom status. His work is widely published and has included recent articles in The New England Journal of Medicine, Nature, Proceedings of the National Academy of Sciences, Circulation, and Circulation Research”
Dr. Hare is the principal investigator on a National Institutes of Health Specialized Center for Cell-Therapy (SCCT) funded stem cell study for patients with congestive heart failure. Back to top.
John Jackson, PhD
Associate Professor, Wake Forest Institute for Regenerative Medicine
Dr. John D. Jackson is an Associate Professor in the Institute for Regenerative Medicine at Wake Forest School of Medicine. He received his Ph.D. degree in Medical Sciences (Experimental Hematology) from the University of Nebraska Medical Center. He served as Technical Director of the Cell Processing Laboratory at the University of Nebraska Medical Center which provided support for the bone marrow transplantation program. His research interests are in the area of stem cell biology with particular emphasis on the use of stem cell populations in tissue and organ regeneration. He is a member of Tissue Engineering and Regenerative Medicine International Society (TERMIS). Back to top.
Nancy King, JD
Co-Director, Center for Bioethics, Health and Society, Wake Forest University
Nancy M. P. King, JD, is Professor, 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 in health care and research; medical decisions at the beginning and end of life; the development and use of experimental technologies; preclinical and animal research; international and cross-cultural questions in human subjects research; benefit and uncertainty in human subjects research; ethical issues in large-scale genetic research and biobanking, gene transfer research, and regenerative medicine; and connections between science, ethics, design, and policy in biotechnology research. She has published over 100 scholarly articles and book chapters, and is co-editor of The Social Medicine Reader (2nd ed., Duke University Press, 2005), Beyond Regulations: Ethics in Human Subjects Research (UNC Press 1999), and Bioethics, Public Moral Argument, and Social Responsibility (Routledge 2012). She has served on hospital ethics committees, IRBs, DSMBs and the NIH Recombinant DNA Advisory Committee, and has taught research ethics in national and international settings. Back to top.
Robert Klein, JD
Chairman and President, Klein Financial Corporation; Chairman, Americans for Cures; Chairman Emeritus, California Institute for Regenerative Medicine (CIRM)
Klein authored and Chaired the campaign for Proposition 71: the California Stem Cell Research and Cures Initiative, which was approved by 7 million California voters in 2004 and established the California Institute for Regenerative Medicine (CIRM). Mr. Klein served as the Chairman of the Governing Board of the California Institute for Regenerative Medicine CIRM which manages the peer review and grant process for the $3 billion in stem cell research and human clinical trial funding authorized by the Initiative. Mr. Klein was elected Chairman Emeritus of CIRM in 2011. Klein is an accomplished philanthropist and innovator who has been named to Time Magazine’s Global “100 Most Influential People,” as well as the Scientific American’s “The Scientific American 50” as a leader shaping the future of science. Klein’s public service awards include: the Biotechnology Industry Organization’s International Conference’s “Biotech Humanitarian Award”, Research!America’s “Gordon & Llura Gund Leadership Award,”, the International Society for Stem Cell Research first ever (ISSCR) “ISSCR Public Service Award,” and multiple Resolutions of Recognition from the California Legislature and non-profit patient advocacy organizations. Klein is a currently a Member of the Board of Directors of Stand Up to Cancer Canada. He has served on the Boards of the Ontario Institute for Cancer Research, the Global Security Institute, Genome Canada, and the State of California Housing Finance Agency, and the International Board of the Juvenile Diabetes Research Foundation. Klein serves as the current Chairman and President of Klein Financial Corporation, a real estate development and investment banking company focused on multi-family housing, with an affordable component. Back to top.
Joanne Kurtzberg, MD
Director, Pediatric Blood and Marrow Transplant Program, Duke University Medical Center
Dr. Joanne Kurtzberg is an internationally renowned expert in pediatric hematology/oncology, pediatric blood and marrow transplantation, umbilical cord blood banking and transplantation, and novel applications of cord blood in the emerging fields of cellular therapies and regenerative medicine. Dr. Kurtzberg pioneered the use of umbilical cord blood as an alternative stem cell source for unrelated hematopoietic stem cell transplantation (HSCT). Over the last two decades Dr. Kurtzberg has established an internationally known pediatric transplant program at Duke which treats children with cancer, blood disorders, immune deficiencies, hemoglobinopathies and inherited metabolic diseases. In 2010, Kurtzberg established the Julian Robertson Cell and Translational Therapy Program (CT2) at Duke. CT2 focuses on translational studies from bench to bedside with a focus on bringing cellular therapies in regenerative medicine to the clinic. Recent areas of investigation in CT2 include the use of autologous cord blood in children with neonatal brain injury and cerebral palsy, as well as preclinical studies manufacturing oligodendrocyte-like cells from cord blood to treat patients with acquired and genetic brain diseases. Studies of autologous bone marrow ALDHbright cells in adults with stroke and radiation induced brain injury are also underway. Plans are ongoing to extend this work to the use of autologous cord blood in a study of young children with Autism Spectrum Disorder.
Dr. Kurtzberg established one of the largest unrelated donor cord blood bank, the Carolinas Cord Blood Bank, in the world at Duke in 1998. The bank has a current inventory of >40,000 units and has provided cord blood units to over 2,200 patients undergoing unrelated donor HSCT over the past 10 years. Dr. Kurtzberg’s lab has developed novel assays to predict cord blood potency from segments attached to cryopreserved cord blood units, and is performing translational research testing cord blood expansion, cellular targeted therapies and tissue repair and regeneration. In 2012, under the direction of Dr. Kurtzberg, the Carolinas Cord Blood Bank received FDA approval for DuCord, a stem cell product derived from umbilical cord blood, for use in transplants between unrelated donors and recipients. Dr. Kurtzberg currently holds several INDs for investigational clinical trials.
Dr. Kurtzberg has published over 300 peer-reviewed papers, multiple chapters and scientific reviews. She is a member of the American Society of Hematology, the American Association of Blood and Marrow Transplantation, the American Society of Pediatric Hematology/Oncology, the International Society of Cellular Therapies, the Pediatric Blood and Marrow Transplant Consortium (PBMTC), and other organizations. She serves on the Board of the Foundation of Accreditation of Cellular Therapies, co-chairs the National Marrow Donor Program’s Cord Blood Advisory Group and is a member of the Advisory Council of Blood Stem Cell Transplantation to Health and Human Services. Dr. Kurtzberg was awarded a Lifetime Achievement Award from the PBMTC in 2012. Back to top.
Saverio LaFrancesca, MD
Founder and CEO, Orgagen, Inc.
Dr. La Francesca is the Founder and CEO of Orgagen, a regenerative medicine company that develops bioengineered implants that induce regeneration of the patient’s own organ. Dr. La Francesca is a cardiothoracic surgeon with extensive clinical experience committed to the clinical translation of transformative medical research. He has a unique combination of experience that features over 25 years of academic clinical surgical practice and innovative research, with a foundation in the cardiovascular, thoracic transplantation, cardiac assist device and regenerative medicine fields. He is the inventor of a novel technology for a regenerative medicine combination product that harnesses the patients’ own regenerative response.
Dr. La Francesca is the former President and Chief Medical Officer of Biostage (NASDAQ: BSTG), a regenerative medicine company where he led the R&D, product development and preclinical work that allowed for the IND on the “first-in-human” FDA approved esophageal implant of a combination product for compassionate use in a cancer patient.
Experienced at different methods of raising capital like Traditional Underwritten, PIPEs, RDOs, Rights Offerings and ATM Offerings.
Prior to joining Biostage management as Chief Medical Officer, Dr. La Francesca served in the Department of Cardiovascular Surgery and Transplantation at the DeBakey Heart and Vascular Center at the Houston Methodist Hospital, where he developed the current surgical and perfusion techniques for thoracic organ procurement and preservation and where he was also the Director of the Ex-vivo Lung Perfusion Laboratory. Previously he was an attending surgeon at the Department of Cardiopulmonary Transplantation at the Texas Heart Institute in Houston, Texas and currently holds an appointment as Associate Professor of Surgery at the University of Rome "La Sapienza" in Rome, Italy. Dr. La Francesca received his medical degree from the University of Palermo, completed his residency in cardiovascular surgery at the University of Rome and his post-doctoral training with fellowships at the Texas Heart Institute in Houston under the supervision of pioneer surgeon Denton Cooley. He also served as a clinical/research fellow at McGill University in Montreal, and the Baylor College of Medicine in Houston. Dr. La Francesca holds UNOS certifications as a heart transplant surgeon and a lung transplant surgeon and is listed as co-inventor on a patent application relating to stem cell therapy in transplantation. Back to top.
Martha Lundberg, PhD
Program Director, Advanced Technologies and Surgery Branch, National Heart, Lung, and Blood Institute
Martha is a Program Director in the Advanced Technologies and Surgery Branch at the National Heart, Lung, and Blood Institute (NHLBI). Her current portfolio includes human cell-based systems for cardiovascular regenerative medicine, smart polymer systems and biodegradable matrices, and technologies for tissue engineered blood vessels, heart valves and cardiac patches. Martha has targeted and coordinated NHLBI investment in over a dozen research technology programs. Back to top.
Frank Marini, PhD
Professor, Wake Forest Institute for Regenerative Medicine
Dr. Frank Marini, is a stem cell biologist who focuses on identifying stem cells in the development of cancer. His work involves novel non-invasive and invasive imaging techniques to track and identify cells while they participate in wound healing and tumor development. He currently heads the Center for Regenerative Imaging, and is a Professor of Regenerative Medicine and Cancer Biology at Wake Forest Institute for Regenerative Medicine. Back to top.
Peter Marks, MD, PhD
Director, 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 January 2016. Back to top.
Todd McAllister, PhD
Executive Director, Amnion Foundation
Dr. McAllister is the Executive Director at the Amnion Foundation, a public stem cell bank that is developing technology pioneered by Dr. Anthony Atala (www.amnionfoundation.org). Amnion's mission is to extend the successful model of public marrow and cord blood banking to provide immunologically matched stem cells with therapeutic capabilities beyond diseases of the blood. Prior to Amnion, Dr. McAllister was co-founder and CEO of Cytograft, a cardiovascular regenerative medicine company that developed cell-based therapies to repair and rebuild diseased tissues without using synthetic biomaterials. Dr. McAllister's was also the co-Director of the Center for Regenerative Medicine at the St. Joseph's Translational Research Institute in Atlanta, Georgia, where he oversaw a broader range of cell-based cardiovascular repair technologies. He has a B.S degree in Mechanical Engineering from the University of Washington, and a Ph.D. in Biomedical Engineering from the University of California, San Diego. With more than two decades of experience, Dr. McAllister is a well-known thought leader in the field of Regenerative Medicine. He has published his work in high impact journals including the New England Journal of Medicine, Lancet, and Nature Medicine. He is on the editorial board of the Journal of Biofabrication and on the Industry Committee for the Journal of Tissue Engineering. He is on the Executive Board for the International Cell Medicine Society, and has sat as a reviewer or external advisory board member for AFIRM, NIH, and NSF EPSCOR grants. He is well known for pioneering a novel, capital efficient business model that prioritizes capital efficiency and research focus, and has shared this knowledge on the advisory boards of several companies, including BioCardia, Lumen Therapeutics, Vault Stem Cells and others. Back to top.
Anthony J. Melchiorri, PhD
Associate Director, Biomaterials Lab, Rice University; Assistant Director, NIH Center for Engineering Complex Tissues
Anthony J Melchiorri is the Associate Director of the Biomaterials Lab at Rice University and Assistant Director of the Center for Engineering Complex Tissues. He received his B.S.E. and B.A. from University of Iowa (2011) and his Ph.D. in Bioengineering from the University of Maryland (2015). He was a postdoctoral scientist at Osiris Therapeutics in Columbia, MD before joining Rice University.
Melchiorri's recent research has investigated the role of biofabrication in regenerative medicine and medical devices both in academic and commercial settings. Previously published and ongoing research includes the development of tissue engineered vascular grafts, biomaterial coatings for cell attachment and differentiation, and 3D printing techniques for regenerative medicine.
Currently, Melchiorri directs the operations of the Biomaterials Lab. This user facility has been designed for biomaterials research and education. While assisting in the development and execution of multiple research projects related to biofabrication, Melchiorri organizes and runs group and individual training and education on biofabrication techniques and applications. Such efforts include day-to-day sessions with students and other researchers, along with workshops and lectures. He runs several programs within the Lab to encourage entrepreneurship at Rice and collaborations between Rice research groups and the rest of the Texas Medical Center community. Back to top.
Michel Modo, PhD
Professor, Departments of Radiology & Bioengineering, McGowan Institute for Regenerative Medicine; Center for Neural Basis Cognition, University of Pittsburgh
Mike Modo graduated in Psychology from Royal Holloway University of London (1997), UK, and spend 1 year as an undergraduate at the Psychology Department at McGill University (1995-1996) in Montreal, Canada. He then furthered his interests in the neural correlates underlying behavioral functions during an M.Sc. in Neuroscience (1998) at the Institute of Psychiatry at King’s College London, where he also continued his research efforts leading to a PhD in Neurosciences (2001). The main interest of Dr. Modo’s research lies in the restorative neurobiology following brain damage, predominantly focused on stroke, but also in Parkinson’s and Huntington’s disease. An interdisciplinary approach is espoused that involves the use of pharmacological approaches, stem cells, as well as biomaterials. A special focus lies on the development of magnetic resonance imaging (MRI) methods that allow us to guide and monitor in situ tissue engineering. Our aim, is to restore a functional tissue in the brain that can support behavioral recovery. In 2013, he was the recipient of the Bernhard Sanberg Memorial Award for his contribution to brain repair. Dr Modo is the president of the American Society for Neural Therapy and Repair for 2017-2018. Back to top.
Johanna Mönch, PhD
Head of Nordmark Biochemicals Division, Nordmark Arzneimittel GmbH & Co. KG
Johanna Mönch, PhD, leads the Nordmark Biochemicals Division at Nordmark Arzneimittel GmbH & Co. KG, a pharmaceutical company located in Germany. Nordmark is the world's largest manufacturer of collagenase.
After more than 10 years of research work in the field of genetically modified organisms, Dr. Mönch started at Nordmark as Product Manager, developing collagenases suitable for individual requirements of different cell type isolations.
Initially her main focus was on the development of enzyme preparations including collagenase for the isolation of islet cells intended for transplantation to treat patients with Type 1 diabetes. Several collaborations with experts in that field contributed valuable input to the knowledge about the impact of collagenase in the digestion of human tissue.
In recent years, Dr. Mönch's focus has moved to new areas as the application of collagenase in the field of stem cell therapy and regenerative medicine has become more and more important. In particular, this involves combining her experience with tissue dissociation and pharmaceutical production standards with knowledge of the challenging regulatory framework to provide collagenase users with the resulting comprehensive support. Back to top.
Kiran Musunuru, MD, PhD, MPH, FAHA
Associate Professor, Cardiovascular Medicine and Genetics, University of Pennsylvania
Kiran Musunuru, MD, PhD, MPH, FAHA, is Associate Professor of Cardiovascular Medicine and Genetics in the Perelman School of Medicine at the University of Pennsylvania. Dr. Musunuru received his medical degree from Weill Cornell Medical College, his PhD from The Rockefeller University, and his Master of Public Health from Johns Hopkins Bloomberg School of Public Health. He trained in Internal Medicine at Brigham and Women's Hospital and Cardiovascular Medicine at Johns Hopkins Hospital, followed by postdoctoral work at Massachusetts General Hospital and the Broad Institute of MIT and Harvard. Dr. Musunuru's research focuses on the genetics of cardiovascular and metabolic diseases and seeks to identify naturally occurring genetic variants that predispose to or protect against disease and can be used to develop therapies to protect the entire population. His expertise includes the use of human pluripotent stem cells as a platform for disease modeling and the use of genome-editing tools such as CRISPR-Cas9 for research and therapeutic applications. In 2016, he received the Presidential Early Career Award for Scientists and Engineers from the White House, as well as the American Heart Association's Award for Meritorious Achievement. Back to top.
Gail Naughton, PhD
Founder and Chief Scientific Officer, Histogen, Inc.
Gail K. Naughton, Ph.D., has been in tissue engineering research for 30 years, holds over 105 patents, and founded two regenerative medicine companies. Her current venture, Histogen, is focused on novel products from hypoxia induced stem cells. She is the Company's CSO/CBDO and invented its core technology. She was the founder/co-inventor at Advanced Tissue Sciences, oversaw the design and development of the world's first up-scaled manufacturing facility for tissue engineered products, established major corporate development partnerships, raised over $350M, and brought four products from concept through market launch. At Histogen Dr. Naughton developed a new skin care product, ReGenica, which was recently acquired by Allergan. Dr. Naughton has been extensively published and a frequent speaker in the field of tissue engineering. 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 regenerative medicine. She served as the Dean of the SDSU College of Business Administration from 2002-2011. Back to top.
Chris Porada, PhD
Associate Professor, Wake Forest Institute for Regenerative Medicine
Dr. Christopher Porada received his Bachelor’s in Molecular Biology from Colgate University in 1991 and his PhD in Cellular and Molecular Pharmacology and Physiology from the University of Nevada in 1998. After completing his PhD, he served as an Assistant and then Associate Professor in the Department of Animal Biotechnology at the University of Nevada, Reno. He has authored over 65 scientific publications and reviews, has written over a dozen book chapters, and serves on the Editorial Board for several international journals. He is a member of several international societies including the American Society of Gene and Cell Therapy, the Radiation Research Society, and the American Society for Gravitational and Space Research, and he regularly reviews for over 40 international journals focused on gene therapy, gene and drug delivery, stem cell biology, and stem cell transplantation. Dr. Porada joined the faculty at WFIRM in 2011. Back to top.
Bernie Siegel, JD
Executive Director, Regenerative Medicine Foundation
Bernard Siegel, J.D., is the Executive Director of the nonprofit Regenerative Medicine Foundation (RMF), with a mission of accelerating regenerative medicine to improve health and deliver cures. He founded and co-chairs the annual World Stem Cell Summit, founded and serves as co- editor-in-chief of the World Stem Cell Report (AlphaMed Press) and is the editor of the Regenerative Medicine Foundation newsletter. Back to top.
Aleksander Skardal, PhD
Assistant Professor, Wake Forest Institute for Regenerative Medicine
Aleksander Skardal received his B.Sc. from Johns Hopkins University in 2005 and his Ph.D. from the University of Utah in 2010. He joined the Wake Forest Institute for Regenerative Medicine in 2010 initially focusing on the application of hydrogel biomaterials for wound healing cell therapies and fabrication of environments for modulating stem cell behaviors and primary cell viability and function in vitro. His current research continues to apply hydrogel biomaterials within the framework of several areas including: biofabrication of microtissue "organoids" for diagnostics (aka "Body-on-a-Chip"), host tissue organoids for in vitro modeling of metastasis phenomena and mechanisms, integration with microfluidic systems, and naturally-derived hydrogels for cell-free wound healing therapies. Back to top.
Julie Watson, JD
Special Counsel, Marshall, Gerstein & Borun, LLP; Intellectual Property Director and Legal Counsel, WFIRM
Julie M. Watson, special counsel at Marshall Gerstein & Borun LLP, concentrates on counseling related to intellectual property transactions with a particular emphasis in technology startups and university technology transfer. A licensing professional with over 25 years experience structuring complex intellectual property transactions in-house, Ms. Watson has a deep appreciation of clients’ needs and knows how to deliver strategic solutions. Ms. Watson manages the intellectual property program for the Wake Forest Institute for Regenerative Medicine, where she served as director of intellectual property and legal counsel prior to joining Marshall Gerstein & Borun. Ms. Watson holds a J.D., cum laude, from Wake Forest University Law School and is admitted to practice law in Illinois, North Carolina and before the USPTO. She holds an MA from Johns Hopkins University and is a Certified Licensing Professional™ (CLP), a credential issued by the Licensing Executives Society (LES) (USA and Canada), Inc. Ms. Watson is a frequent speaker and active participant in professional licensing organizations and has authored more than 50 national presentations and publications including peer-reviewed articles. Back to top.
Nick Willett, PhD
Assistant Professor, Department of Orthpaedics, Emory University
In the musculoskeletal field, a limiting factor in addressing unmet clinical needs has been that the musculoskeletal system is often studied and treated as independent tissues rather than functionally integrated units. The overall research of the Willett Lab focuses on a systems integration approach to musculoskeletal disease and regenerative engineering by applying novel imaging and engineering approaches to mechanistic biology problems. Our current work has three main thrusts: (i) cell and biologic therapies for the healing of large bone and muscle defects, (ii) multi-scale mechanical regulation of regenerative therapies, (iii) intra-articular therapeutic delivery for post-traumatic osteoarthritis. Combining backgrounds in mechanical engineering, vascular biology and musculoskeletal tissue regeneration, our research integrates mechanics principles and analytical tools with molecular biology techniques to uniquely address challenges of musculoskeletal disease and regeneration.
Nick Willett is an Assistant Professor in the Department of Orthopaedics at Emory University and runs a research lab with a focus on engineering strategies for musculoskeletal regeneration and rehabilitation. Nick has a secondary appointment in the joint Biomedical Engineering Department between Emory University and Georgia Institute of Technology as well as an appointment in the Research Division at the Atlanta VA Medical Center. Nick performed his postdoctoral training at the Georgia Institute of Technology working with Prof. Robert Guldberg in Mechanical Engineering. He received his Ph.D. (2010) in Biomedical Engineering from the joint program between Georgia Institute of Technology and Emory University. Prior to his graduate work he received his B.S. (2005) in Mechanical Engineering from the University of Colorado at Boulder. Back to top.
David Williams, DSc
Professor and Director of International Affairs, Wake Forest Institute for Regenerative Medicine
Professor Williams has had 45 years experience in biomaterials, medical device and tissue engineering. During his career he has published over 30 books and 400 papers: his latest book, Essential Biomaterials Science will be published by Cambridge University Press in June 2014. He has been Editor-in-Chief of Biomaterials, the world’s leading journal in this field since 2000. 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 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 is currently global President of the Tissue Engineering & Regenerative Medicine International Society.
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. He is Visiting Chair Professor of Biomedical Materials, Taipei Medical University, Taiwan. In Cape Town, along with Professor Peter Zilla, the current Chris Barnard Professor of Surgery, he has 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. Back to top.
James J. Yoo, MD, PhD
Associate Director and Chief Scientific Officer, WFIRM
Dr. Yoo is a surgeon and researcher. He is currently a faculty member at the Wake Forest Institute for Regenerative Medicine and is cross-appointed to the Department of Urology, Physiology and Pharmacology, and Biomedical Engineering. Dr. Yoo received his Bachelor’s Degree in biology from the University of Illinois in 1984. Back to top.