2018 RME Course Instructors

Anthony Atala, MD Director, Wake Forest Institute for Regenerative Medicine

Dr. Anthony 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.

Julie Allickson, PhD Director, Regenerative Medicine Clinical Center, Wake Forest Institute for Regenerative Medicine

Dr. Allickson has a doctorate in health sciences along with a master’s in medical laboratory sciences. An experienced scientist with regulatory expertise, she has more than 25 years of experience in clinical translation of cellular therapies and regenerative medicine products including business management and board directorship experience. At the Institute, 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. 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.

Graca Almeida-Porada, MD, PhD Professor, Wake Forest Institute for Regenerative Medicine

Dr. Almeida-Porada received her medical degree in 1985 from ICBAS, University of Porto, Portugal, and obtained her Ph.D. in Pathology from the same University in 1995. She completed her residency in 1987, and a fellowship in Hematology/Transfusion Medicine in 1994 at Centro Hospitalar do Porto. She was a fellow at the University of Connecticut Health Center and at the University of Nevada, Reno School of Medicine. 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.

Albert Banes, PhD President and Scientific Officer, Flexcell International Corporation; Professor Emeritus, Joint Department of Biomedical Engineering, NCSU and UNC-Chapel Hill

In 1978, Albert J. Banes, Ph.D., an Assistant Professor in the Surgery Department at the University of North Carolina at Chapel Hill, received his first small grant for devising a method to apply regulated strain to cultured cells. He built prototypes of the current Flexcell® Tension System in the shop using only a timer, a simple solenoid valve to control pressure in on/off modes, and a needle valve to regulate the magnitude of the pressure. He built a baseplate with vacuum channels in Plexiglas and used natural gum rubber as the seal between the culture plate bottom and the vacuum chamber. Dr. Banes polymerized his own rubber membranes from medical grade Dow silastic components. A cast material that eventually proved satisfactory for the membrane in a 6-well, 35 mm diameter culture plate that had the well bottoms drilled out to receive the cast membranes. A Commodore Vic 20 was the first commercial microprocessor used to control the valves. The software program and a controller board were designed by Dr. Banes and a well

grounded electronics engineer, Olivier Monbureau. A Commodore 64 was the next generation computer used, followed by a Tandy computer, then IBM clones. Today, Flexcell® develops its own software and builds custom computers and controller boards and assembles them at its plant in Burlington, NC. Dr. Banes' intellectual property was awarded the first patent in the field of Cytomechanics. He believed that this technology could become important scientifically as well as medically if a market driver could be found. In his first patent describing the technology, he included the thought that cyclically stretching cells and tissues could lead to adaptation of cells to a mechanically active environment such as dermal fibroblasts cultured in vitro in a skin construct. Along with his father in Pennsylvania, G.B. Banes, J.D., they created Flexcell® Inc. The company's mission was to commercialize the technology to make it available to all scientists as well as find medically relevant uses. His first full publication (Journal of Cell Science, 1985) in the area demonstrated the utility of the system and that cyclic strain altered the expression of cytoplasmic filament proteins such as actin and tubulin in tendon cells. Continued development of the technologies behind the Flexcell® Tension and Compression Systems has taken much of Dr. Banes' time. Dr. Banes became the first university professor to be permitted to retain his academic professorship and be president of a company (Flexcell® International Corporation) by a decision of the Committee on Industrial Faculty Relations at the University of North Carolina at Chapel Hill. Dr. Banes holds three patents on the basic cell stretching technology and several more on other technologies including a DNA transfection technique using flexation of cells and a spill resistant culture plate called the SpillGuard® culture plate. He continues to develop new products for cell culture and cell stretching as

well as submit patents assigned to Flexcell® International Corporation.

George J. Christ, PhD Professor of Biomedical Engineering and Orthopaedic Surgery; Director of Basic and Translational Research, University of Virginia

Dr. Christ has a broad interest in muscle physiology, intercellular communication and the role of muscle in the function and dysfunction of visceral, vascular and voluntary tissues (i.e., skeletal muscle). His research interests include physiological genomics, that is, establishing a verifiable link between changes in gene expression and alterations in cell/organ/tissue function/dysfunction, and then using this information to improve the understanding, diagnosis and treatment of smooth muscle diseases/disorders. To this end, Dr. Christ has developed a multidisciplinary approach that utilizes various visceral and vascular smooth muscle tissues/organs to attempt to establish “cause and effect” relationships between molecular/genetic alterations and measurable changes in organ function, namely, contraction and relaxation of smooth muscle cells. Animal vascular and visceral tissues are studied both in vitro and in vivo. Molecular, biochemical, electrophysiological, pharmacological, immunochemical, and whole animal techniques (rat and mouse transgenics and knockouts) are all used to study the mechanistic basis for integrative tissue physiology, as well as tissue pathophysiology, dysfunction and therapeutic repair. Parallel in vitro studies are conducted on corresponding human tissues for target validation whenever possible. The overall goal of his work is to translate scientific discoveries into technologies that can improve human health (i.e., translational research). In this regard, Dr. Christ is a co-inventor on more than 26 patents issued or applied for related to gene therapy treatments for smooth muscle disorders/diseases, and is the Co-Founder and Directing Member of Ion Channel Innovations, LLC., a development stage biotechnology company pioneering the use of gene therapy for the treatment of human smooth muscle disorders. Recently, Dr. Christ has also focused on the fields of tissue engineering and regenerative medicine. A major focus of these

efforts is to develop in vitro protocols and bioreactor systems for the accelerated maturation of engineered tissues both in vitro and in vivo; in order to further enhance their applications in regenerative medicine. In this regard, he has become extensively involved in interdisciplinary basic and translational studies directed toward muscle and vessel tissue engineering, as well as bladder regeneration, and regenerative pharmacology.

Richard Clark, MD Vice-Chair for Research and Professor of Dermatology, Professor of Biomedical Engineering, Stony Brook University; Co-Director of Skin Regeneration, Armed Forces Institute of Regenerative Medicine

Richard A.F. Clark is a dermatologist and biomedical engineer currently at the State University of New York at Stony Brook in Stony Brook, New York. Clark co-edited, with Peter M. Henson, of The Molecular and Cellular Biology of Wound Repair (Plenum Press, 1988) and is a contributor to wound repair, dermatology, and angiogenesis research. In addition, he is also a member of the board of directors of the Society for Investigative Dermatology. Clark graduated from the Massachusetts Institute of Technology and has worked at the Massachusetts General Hospital. He was previously professor at Harvard University. He is now a professor at State University of New York at Stony Brook.

Dennis Clegg, PhD Co-Director, Center for Stem Cell Biology and Engineering, and Professor, Department of Molecular, Cellular and Developmental Biology, University of California

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.

Allen Comer, PhD Director, Research and Development, Regenerative Medicine, Stratatech, a Mallinckrodt Company

Dr. Comer joined Stratatech in 2000 and currently serves as the Director for Research and Development. Dr. Comer is the Principal Investigator on numerous SBIR grants awarded to Stratatech Corporation over the past ten years. Dr. Comer has also been instrumental in developing the Quality Control department at Stratatech. Dr. Comer earned a Ph.D. in Genetics at the University of North Carolina at Chapel Hill. Prior to joining Stratatech, Dr. Comer continued his training as a post-doctoral researcher at the University of Wisconsin.

John P. Fisher, PhD Professor and Department Chair, Fischell Department of Bioengineering, University of Maryland; Director, NIH Center for Engineering Complex Tissues

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.

Joshua M. Hare, MD, FACC, FAHA Founding Director, Interdisciplinary Stem Cell Institute; Professor of Medicine, University of Miami

Dr. Joshua Hare is Chief Sciences Officer, Senior Associate Dean for Experimental and Cellular Therapeutics, Director of the Interdisciplinary Stem Cell Institute (ISCI), and Louis Lemberg Professor of Medicine at the University of Miami

Miller School of Medicine. Dr. Hare is a practicing cardiologist and an expert in cardiovascular medicine, specializing in heart failure, myocardial infarction, inflammatory diseases of the heart, and heart transplantation. He is an internationally acknowledged pioneer in the field of stem cell therapeutics for human heart disease, currently seeing and evaluating patients from all over the world for this new experimental therapy. Dr. Hare has published multiple clinical trials testing the use of mesenchymal stem cells in patients with heart or age related disorders and is the Principal Investigator of two major NHLBI programs that advance cell based therapy. He has published over 300 publications and reviews in the peer reviewed literature, holds numerous investigational new drug authorizations (INDs) from the FDA for cell therapy, and has been awarded several U.S. patents.

Nancy M. P. King, JD 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. 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; 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.

Robert Klein, JD Chairman and President, Klein Financial Corporation; Chairman, Americans for Cures; Board Member for Stand Up to Cancer Canada; Chairman Emeritus, California Institute for Regenerative Medicine; JDRF International Research Foundation Chancellor’s Board

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 “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,” and the International Society for Stem Cell Research first ever (ISSCR) “ISSCR Public Service Award.” 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. 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.

Joanne Kurtzberg, MD Director, Pediatric Blood and Marrow Transplant

Dr. Joanne Kurtzberg is an internationally renowned expert in pediatric

Program; Chief Scientific and Medical Officer, Robertson Clinical and Translational Cell Therapy Program; Duke University

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, which are funded by the Marcus Foundation, include the use of autologous cord blood in children with neonatal brain injury, cerebral palsy, and autism, as well as preclinical studies manufacturing microglial oligodendrocyte-like cells from cord blood to treat patients with acquired and genetic brain diseases. Studies of donor cord blood cells in adults with stroke and children with cerebral palsy and autism are also underway. Dr. Kurtzberg established one of the largest unrelated donor cord blood banks, 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 2,500 patients undergoing unrelated donor HSCT over the past 15 years. Dr. Kurtzberg’s lab has developed novel assays enumerating ALDH bright cells 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 has served on the Board of the Foundation of Accreditation of Cellular Therapies, co-chaired the National Marrow Donor Program’s Cord Blood Advisory Group and has served on 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.

Saverio LaFrancesca, MD Founder and CEO, Orgagen

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.

Martha Lundberg, PhD Program Director, Advanced Technologies and Surgery Branch, National Heart, Lung and Blood Institute (NHLBI)

Martha is a program director in the Advanced Technologies and Surgery Branch in the Division of Cardiovascular Sciences 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 developed and advanced targeted NHLBI investment in over a dozen research technology programs.

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.

Frank Marini, PhD Professor, Wake Forest Institute for Regenerative Medicine

Frank Marini is a professor at the Wake Forest Institute for Regenerative Medicine, with affiliation in the Department of Cancer Biology and the Center on Diabetes, Obesity and Metabolism at the Wake Forest School of Medicine. Marini earned his PhD at the University of Texas MD Anderson Hospital in 1998. His expertise includes molecular biology and microscopic imaging.

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 at Boston Children’s Hospital (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.

Anthony Melchiorri, PhD Associate Director, Biomaterials Lab, Rice University; Assistant Director, 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.

Michel Modo, PhD Professor, Departments of Radiology & Bioengineering, McGowan Institute for regenerative Medicine; Center for Neural Basis Cognition, University of Pittsburgh

Dr. Michel Modo is a Professor in the Department of Radiology at the University of Pittsburgh. In addition, he holds secondary appointments in the Department of Bioengineering, the McGowan Institute for Regenerative Medicine, and the Center for

Neural Basis of Cognition. Dr. Modo earned his BSc (Honors) in Psychology at Royal Holloway, University of London. He then achieved first his MSc followed by his PhD in Neurosciences from King’s College London, where he also completed his post-doctoral work in Neuroimaging. He is a fellow of the UK Higher Education Authority (HEA) and the American Society for Neural Therapy and Repair (ASNTR). He was the president of ASNTR for 2017-2018, organizing its 25thanniversary meeting (www.asntr.org). In 2013, Dr. Modo received the Bernard Sanberg Memorial Award for Brain Repair from ASNTR. Dr. Modo’s research interests include stroke, Huntington’s disease, Parkinson’s disease, cell transplantation and stem cell differentiation, implantation of biomaterials for tissue engineering, cellular and molecular MR imaging, diffusion tensor MR imaging of ex vivo tissue samples. He currently serves on the editorial boards of Brain Research Bulletin, Cell Transplantation, Current Stem Cell Research and Therapy, Journal of Cerebral Blood Flow and Metabolism, Scientific Reports, and more.

Johanna Monch, PhD Head of Nordmark Biochemicals

Sean Murphy, PhD 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.

Kiran Musunuru, MD, PhD, FAHA Associate Professor of Cardiovascular Medicine and Genetics, Perelman School of Medicine, 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.

Gail Naughton, PhD Founder and Chief Scientific Officer, Histogen, Inc.

Dr. Naughton founded Histogen, Inc. in 2007, and currently serves as Chief Scientific Officer and Chief Business Development Officer for the Company. She has spent more than 30 years extensively researching the tissue engineering process, holds more than 100 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. 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 CR Bard (NYSE: BCR), Cytori (OTC: CYTX) and several scientific advisory boards.

Christopher Porada, PhD Associate 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.

Adrienne Bell-Cors Shapiro Founder and Science Administrator, Axis Advocacy Foundation; Ambassador, American for Cures Foundation

Adrienne Bell-Cors Shapiro is a Sickle Cell Disease and stem cell Patient Advocate, the Founder and Science Administrator of the Axis Advocacy foundation, and a fifth generation mother of a child with Sickle Cell Disease. She is a recipient of the highest honor in the regenerative medicine community, the 2018 Stem Cell and Regenerative Medicine Action Inspiration Award. Her experience includes attending educational conferences and seminars, as well as meeting with lawmakers to promote support for the Sickle Cell Education Act. She was one of the first supporters of the work done by UCLA’S Dr. Don Kohn in bone marrow and later stem cell transplants. As a firm believer that stem cell science will cure Sickle Cell Disease, she has dedicated a large portion of her life to improving the lives and overall healthcare of those living with the disease. In the past three years Ms. Shapiro has found her voice as a stem cell activist, speaking at multiple forums in support of the funding for clinical trails through the California Institute for Regenerative Medicine (CIRM) and her role as an ambassador for the Americans for Cures Foundation. As a stem cell advocate, Adrienne, is passionate about the role of stem cells in medicine, including its potential for drug discovery of more effective treatments in mental illness and addiction.

Bernie Siegel, JD Executive Director, Regenerative Medicine Foundation

Bernard Siegel is the executive director of the nonprofit Regenerative Medicine Foundation (RMF), with a mission of accelerating regenerative medicine to improve health and deliver cures. Bernie founded and co-chairs the annual World Stem Cell Summit and RegMed Capital Conference, founded and serves editor–in–chief of the peer-reviewed “World Stem Cell Report” (AlphaMed Press). In 2002, he filed the first court case relating to reproductive cloning and is widely credited for debunking the claim of the group claiming that they cloned the first baby. As a recognized advocacy and policy expert in the fields of stem cell research, regenerative medicine and related subjects, Bernie works with the leading scientists

and patient advocates, raising public awareness and educating lawmakers, the media and public. He is a frequent conference panelist and keynote speaker.

Aleksander Skardal, PhD Assistant Professor, Wake Forest Institute for Regenerative Medicine

Dr. Skardal received his B.Sc. degree in Biomedical Engineering from Johns Hopkins University in 2005. Following that, he received his Ph.D in Bioengineering from the University of Utah in 2010. Dr. Skardal joined the Wake Forest Institute for Regenerative Medicine in 2010 as a postdoctoral research fellow and is now an Assistant Professor.

Julie Watson, JD Special Counsel, Marshall, Gerstein & Borun, LLP; Intellectual Property Director and Legal Counsel, Wake Forest Institute for Regenerative Medicine

Julie M. Watson 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 of experience structuring complex intellectual property transactions in-house, Ms. Watson has a deep appreciation of client needs and knows how to deliver strategic solutions. Prior to joining the Firm as special counsel, Ms. Watson was Director of Intellectual Property and Legal Counsel at the Wake Forest Institute for Regenerative Medicine; the Director of Intellectual Property Services at the American Medical Association; and a client of the Firm while Vice President of the Advanced Research & Technology Institute, the technology transfer arm of Indiana University. 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 United States Patent and Trademark Office. She also holds an MA in biopsychology from Johns Hopkins University and completed advanced graduate work in neuroscience at Northwestern University. She is a Certified Licensing Professional™ (CLP), a credential issued by the Licensing Executives Society (LES) (USA and Canada), Inc. to recognize licensing professionals who are committed to professional development and the attainment of the skills and knowledge necessary to perform at the highest level of quality.

Nick Willett, PhD Assistant Professor, Orthopaedics, Emory University

Nick Willett, PhD is an assistant professor in orthopaedics at Emory university School of Medicine. He graduated from University of Colorado in Boulder, Colorado with a BS in Mechanical Engineering in 2005 and a PhD in Biomedical Engineering from the Georgia Institute of Technology and Emory University in Atlanta, Georgia in 2010. He completed his postdoctoral training at the Georgia Institute of Technology in Atlanta 2010-2013 in bioengineering. His research focus includes the musculoskeletal disease and regenerative engineering.

David F. Williams, DSc Professor and Director of International Affairs, Wake Forest Institute for Regenerative Medicine

Professor Williams has had 50 years 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.

James Yoo, MD, PhD Associate Director, 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.