Director, Wake Forest Institute for Regenerative Medicine
Anthony Atala, MD 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.
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.
Professor, Wake Forest Institute for Regenerative MedicineDr. 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.
Dr. El Fiky is a Harvard-trained and educated clinical research expert and is currently is a full-time Medical Officer at a global regulatory and clinical research consulting firm, EMMES, headquartered in the Washington DC metropolitan region. His duties include medical monitoring, phramacovigilance, drug risk assessment/mitigation and regulatory oversight of clinical trials assessing safety and efficacy of novel drugs, vaccines and stem cell therapies. Dr. El Fiky received his medical degree from Egypt's University of Alexandria and Ph.D. in Experimental Pathology/Immunology from the University of California-Irvine. His clinical training specialized in infection control and laboratory medicine particularly molecular identification of virulence factors of endemic vector- and blood-borne pathogens. Dr. El Fiky’s PhD thesis and postdoctoral research revealed a novel signaling mechanism for type I interferon and investigated molecular signaling mechanism of cytokines in cancer, inflammation, and allergic pathogenesis. After completing his medical training and ABMM- approved fellowship, he continued postdoctoral training at the NIH’s National Cancer Institute, National Institute of Allergy and Infectious Diseases, and the FDA’s Office of Vaccine Research and Review. He completed his clinical trial training at Harvard Medical School. Dr. El Fiky co-authored peer-reviewed novel research publications in addition to a book chapter on clinical and regulatory pathway of stem cell-based therapy in the United States. Dr. El Fiky was awarded Harvard University’s clinical research scholarship, the FDA’s Commissioner Citation Award and the University of California’s William Holcomb Award for Excellence in Biomedical Research. Dr. El Fiky gave a lecture at the 2017 and the 2019 TERMIS meetings in Charlotte, NC and Orlando, FL, respectively, on the regulatory pathway for mesenchymal stromal cell-based therapy in the United States focusing on the NIH’s Production Assistance for Cell Therapy (PACT) program.
Principal Scientist, AO Research Institute Davo
Sibylle Grad is a Principal Scientist at the AO Research Institute Davos (ARI), Switzerland. Within the Regenerative Orthopaedics Program of the ARI, she is the focus area leader for intervertebral disc and cartilage research. Sibylle Grad obtained her PhD in Natural Sciences from the Department of Cell Biology of the Federal Institute of Technology in Zürich (ETHZ), Switzerland. After completing her first post-doctoral training, she joined the AO Research Institute Davos to set up a cartilage bioreactor system. She has since then acquired extensive research expertise in tissue engineering and regenerative medicine with focus on articular cartilage and intervertebral disc repair and regeneration. Her projects include whole organ culture models and bioreactors for degenerative disc disorders, cell therapy, molecular therapy, stem/progenitor cell homing, annulus fibrosus repair, circulating and tissue biomarkers; bioreactor loaded explant models for cartilage and osteochondral defects. Her expertise in advanced ex-vivo organ culture systems for studying both disease/ degeneration and repair/ regeneration in orthopedic research is widely acknowledged. Sibylle Grad is also a private docent with habilitation at the ETHZ and course leader in the graduate program of the ETH Department of Health Science and Technology. She has obtained funding from many national, European and international agencies, and has been section leader and partner of several collaborative projects. She is a co-organiser of the eCM Annual Conference and has served as Topic Chair, Spine section research chair, and program committee member of the Orthopaedic Research Society. Her publications list includes more than 100 peer-reviewed articles and 10 book chapters.
Senior Vice President, Regenerative Medicine, Stratatech Corporation a Subsidiary of Mallinckrodt, Professor, Department of Pathology and Department of Surgery, University of Wisconsin-Madison
Dr. Allen-Hoffmann received her bachelor’s degree from the University of Illinois and received her Ph.D. from Cornell University in Ithaca, New York. Dr. Allen-Hoffmann was a Damon-Runyon Walter-Winchell Postdoctoral Fellow at the Dana-Farber Cancer Institute at Harvard Medical School where she studied human keratinocyte growth and differentiation. She is a tenured, full Professor in the Departments of Pathology and Laboratory Medicine and Surgery at the UW School of Medicine and Public Health. She is internationally recognized for her innovative research and clinical development of human skin replacements including the world’s first genetically-enhanced human skin replacements. The NIKS cells, discovered in her U.W. laboratory, are a consistent source of genetically uniform, non-tumorigenic, pathogen free human keratinocytes amenable to genetic manipulation. As a result of the discovery in her laboratory, Dr. Allen-Hoffmann founded Stratatech Corporation to deliver cell-based therapies to patients with complex skin loss. She has received numerous state and national awards and is the first woman at the UW to start a biotechnology company. Dr. Allen-Hoffmann has contributed to numerous peer-reviewed publications and patents. Dr. Allen-Hoffmann’s basic and clinical research has received continuous research support, including grants from the NIH, NIST, AFIRM, BARDA, and DOD. Recently Stratatech Corporation has been one of the top 10 companies to receive SBIR and STTR funding in the United States. In 2015, BARDA released a solicitation through Project BioShield for the late stage clinical development and use of cell-based therapies for skin replacement caused by thermal burns in the event of a mass casualty event resulting from the detonation of an improvised nuclear device. Stratatech was the only academic or private sector organization in the United States to successfully compete for a BioShield award. The $247 million Project BioShield award will enable the NIKS technology to be used prior to FDA approval through the FDA’s Pre-Emergency Use Authorization mechanism. Stratatech received a 2016 Tibbitts Award which was accepted by Dr. Allen-Hoffmann at a White House ceremony. Dr. Allen-Hoffmann recently received the Hector F. DeLuca Scientific Achievement Award. Stratatech Corporation was acquired by Mallinckrodt Specialty Pharmaceuticals on August 31, 2016.
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, Winston Salem, NC. He received his Ph.D. degree in Medical Sciences (Experimental Hematology) from the University of Nebraska Medical Center, Omaha, NE. He received post-doctoral training at DNAX Research Institute, Palo Alto, CA. At DNAX Research Institute, Dr. Jackson was involved in research directed to the study of the role of cytokines in the regulation of hematopoietic and immune systems.
In 1990, Dr. Jackson joined the Department of Pathology and Microbiology at the University of Nebraska Medical Center, Omaha, NE as an Assistant Professor. He was also appointed 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 focus during this time was directed toward the effects of cytokines and other agents on hematopoietic mobilization for transplantation as well as hematopoietic and immunological recovery following transplantation. In 2010, Dr. Jackson moved to Wake Forest School of Medicine and serves as an Associate Professor in the Institute for Regenerative Medicine. His research interests have broadened to include engineering of tissues and organs including skin, inner ear, muscle, bone, cartilage, kidney, ovary and corporal tissue.
Professor, Department of Social Sciences and Health Policy, Wake Forest School of Medicine; Professor, Wake Forest Institute for Regenerative Medicine; Co-Director, Center for Bioethics, Health and Society and Graduate Program in Bioethics, Wake Forest University
Nancy M. P. King, JD, is Professor in the Department of Social Sciences and Health Policy and Wake Forest Institute for Regenerative Medicine at Wake Forest School of Medicine, and Co-Director of the Center for Bioethics, Health, and Society and the Graduate Program in Bioethics at Wake Forest University. Her scholarship addresses a range of bioethics issues, including: informed consent, benefit, and uncertainty in health care and research; the development and use of experimental technologies; international and cross-cultural questions in human subjects research; and ethical issues in “big data” research and biobanking, gene transfer research, regenerative medicine, and other novel biotechnologies.
Professor King has published over 100 scholarly articles and book chapters, and is co-editor of The Social Medicine Reader (2nd ed., Duke University Press, 2005; 3rd ed. forthcoming), Beyond Regulations: Ethics in Human Subjects Research (UNC Press 1999), and Bioethics, Public Moral Argument, and Social Responsibility (Routledge 2012). She teaches a variety of courses in bioethics, medical humanities, and research ethics to medical students and faculty and to graduate students in bioethics and the health sciences.
Professor King has served on hospital ethics committees, IRBs, DSMBs and the NIH Recombinant DNA Advisory Committee, and has taught bioethics in national and international settings. She is a Fellow of the Hastings Center and a member of the DHHS Secretary’s Advisory Committee for Human Research Protections.
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.
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.
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.
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 coinventor 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. n 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.
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.
Evan Y. Snyder earned his M.D. and Ph.D. in neuroscience from the University of Pennsylvania (PA, USA) as a member of National Institutes of Health Medical Scientist Training Program (MSTP). He had also studied psychology and linguistics at the University of Oxford (Oxford, UK). He received all of this medical post-graduate training (in pediatrics, neurology, and neonatal-perinatal medicine) at Children's Hospital-Boston, Harvard Medical School (MA, USA) as well as a research post-doctoral fellowship in the Department of Genetics at Harvard Medical School, after which he became an attending physician in the Department of Pediatrics (Division of Newborn Medicine) and Department of Neurology at Children's Hospital-Boston, Harvard Medical School. He also established his own independent research program at Boston Children’s Hospital, Harvard Medical School and was appointed first as an instructor in neurology (neonatology) and then promoted to assistant professor where he helped launch the stem cell and regenerative medicine fields. He is regarded as one of the fathers of the stem cell and regenerative medicine fields. In 2003, after 23 years at Harvard, Dr. Snyder was recruited to Southern California, to Sanford-Burnham Prebys Medical Discovery Institute and University of California-San Diego (CA, USA) (Department of Pediatrics) as a Full Professor and Founding Director of the Center for Stem Cells & Regenerative Medicine. He then inaugurated the Stem Cell Research Center & Core Facility (serving as its founding director), initiated the Southern California Stem Cell Consortium (CA, USA), & helped found the Sanford (San Diego) Consortium for Regenerative Medicine. Dr. Snyder is a Fellow of the American Academy of Pediatrics (FAAP) and was elected to the Association of American Physicians (AAP). He was a founding member of the FDA/NIH Stem Cell Working Group to generate guidelines for human transplantation, and served nearly a decade on the FDA’s Biological Response Modifiers Advisory Committee with emphasis on stem cells, as well as serving two terms as Chair of the FDA’s Cell, Tissue, & Gene Therapy Advisory Committee. He is now Chairman of the Scientific Advisory Committee (SAC) of the Genetic Disease Biobank of the National Institute of General Medical Science (NIGMS) at NIH. He is a recent graduate of the Health Leadership Academy.
Director, McGowan Institute for Regenerative Medicines; Professor of Surgery, Chemical Engineering
Dr. Wagner is Director of the McGowan Institute for Regenerative Medicine as well as a Professor of Surgery, Chemical Engineering, and Bioengineering at the University of Pittsburgh. He serves as Scientific Director of the NSF Engineering Research Center on “Revolutionizing Metallic Biomaterials” and Chief Science Officer for the Armed Forces Institute of Regenerative Medicine. He holds a B.S. (Johns Hopkins Univ.) and Ph.D. (Univ. of Texas) in Chemical Engineering. Professor Wagner is the Founding Editor and Editor-in-Chief of one of the leading biomaterials journals, Acta Biomaterialia. He is past-president of the American Society for Artificial Internal Organs (ASAIO) and is past chairman and current council member of the Tissue Engineering and Regenerative Medicine International Society (TERMIS) Americas region. He is a fellow and former vice president of the American Institute for Medical and Biological Engineering (AIMBE) and has also been elected a fellow of the Biomedical Engineering Society, the International Union of Societies for Biomaterials Science and Engineering, TERMIS, and the American Heart Association. In 2006 he was selected to the “Scientific American 50”, the magazine’s annual list recognizing leaders in science and technology from the research, business and policy fields. His research has generated numerous patents and patent filings that have resulted in licensing activity, the formation of a company that began clinical trials in 2014, and University of Pittsburgh Innovator Awards 2007, 2008, 2009, 2010, and 2014. In recent years he has been awarded the Society for Biomaterials Clemson Award for Applied Research, the Chancellor’s Distinguished Research Award by the University of Pittsburgh, and the Senior Investigator Award by TERMIS-Americas. In 2017 he was inducted into the National Academy of Inventors and in 2018 he was named Inventor of the Year by the Pittsburgh Intellectual Property Law Association. In 2019 Dr. Wagner was promoted to the rank of Distinguished Professor, and in 2020, he was selected as one of Pittsburgh Business Times “Power 100” for leadership in regenerative medicine which has resulted in more than 30 spin-out companies. Dr. Wagner's research interests are in cardiovascular engineering with projects that address medical device biocompatibility and design, biomaterial development, and tissue engineering.
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.
Field Application Scientist, RoosterBio Inc.
Dr. Xuan Xu is a Field Application Scientist (FAS) at RoosterBio Inc. Her role as a FAS is mainly to provide technical support to the commercial team, as well as manage customer product/technical inquires, including performing laboratory demonstrations at customer sites. Besides this, she also travels actively to conferences or customer centers to give talks or training sessions. Her educational background includes a Ph.D. in Molecular Medicine from the University of Texas Health Science Center at San Antonio (UTHSCSA), and a B.A. in Life Sciences from Fudan University in Shanghai, China. Dr. Xu conducted postdoctoral research at NCI/NIH prior to joining RoosterBio. Her Ph.D. focus was to investigate the function and regulation of the multiprotein Mediator of transcription in human disease including Alzheimer’s disease (AD), X-linked mental retardation, colorectal cancer, etc. and the identification of a Mediator subunit Med12, as a potential therapeutic target in AD. Her post-doctoral study involved the study of TGFb signaling in early embryonic development using an embryonic stem cell/epiblast stem cell system and in tumorigenesis using a cancer cell system. Her research work has been published in top journals including Mol. Cell, PNAS, EMBO Rep, PLoS Biol, etc..
Dr. Michael Yaszemski is the Krehbiel Family Endowed Professor of Orthopedic Surgery and Biomedical Engineering at Mayo Clinic and director of its Polymeric Biomaterials and Tissue Engineering Laboratory. He is a retired USAF Brigadier General. He has served as the president of the Mayo medical staff. He received both bachelor’s and master’s degrees in chemical engineering from Lehigh University in 1977 and 1978, an M.D. from Georgetown University in 1983 and a Ph.D. in chemical engineering from Massachusetts Institute of Technology in 1995. He served as a member of the Lehigh University Board of Trustees.
Associate Director, Wake Forest Institute for Regenerative Medicine
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.