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.
CEO and Board Chair, Javara Research
Ms. Byrne is CEO and Board Chair of Javara, an Integrated Research Organization (IRO) that offers comprehensive clinical research services to better align population health initiatives across value-oriented healthcare systems. Her career has been devoted to leading organizations, building teams and cultivating partnerships centered on advancing the clinical research enterprise; namely to better connect patients and providers to clinical trials. Her involvement in the clinical research enterprise has been vast including collaborations with hundreds of pharma, device, Contract Research Organizations (CROs), technology, site organizations, and other research service providers. As a clinical research business leader, Jennifer thrives on building high performing teams and partnerships while navigating the complexities of the evolving healthcare and biopharmaceutical ecosystems. Jennifer is the former CEO of PMG Research and Founder of Greater Gift (501(c)3).
Jennifer was recognized as a CenterWatch Top 20 Innovator and the recipient of the Association for Clinical Research Professionals (ACRP) 2018 Innovation in Clinical Research Award. She currently serves as Board Chair for Greater Gift, a member of the Board of Trustees for ACRP, and Vice Chair for Summit School’s Board of Trustees. Additionally, she is an Advisory Board Member to CISCRP, Wake Forest Institute of Regenerative Medicine, The Dioko Fund, and The North Carolina Biotech of the Piedmont Triad. She also participates in the Leadership Advisory Board for the Avoca Quality Consortium and the Workforce Innovation Steering Committee for ACRP. Jennifer is a graduate of Texas A&M University.
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).
Professor and Department Chair, Fischell Department of Bioengineering, University of Maryland
Dr. John P. Fisher is the Fischell Family Distinguished Professor and Department Chair in the Fischell Department of Bioengineering at the University of Maryland. Dr. Fisher is also the Director of the 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.
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.
Professor, Department of Chemical & Biomolecular Engineering, Institute for Genomic Biology, University of Illinois at Urbana-Champaign
Brendan Harley is a Professor and Robert W. Schaefer Faculty Scholar in the Dept. of Chemical and Biomolecular Engineering at the University of Illinois at Urbana-Champaign. He received a B.S. in Engineering Sciences from Harvard University (2000), a Sc.D. in Mechanical Engineering from MIT (2006), and performed postdoctoral studies at the Joint Program for Transfusion Medicine at Children’s Hospital Boston.
His research group has focused on developing biomaterial systems to dynamically regulate cell behavior for applications in musculoskeletal regeneration, hematopoietic stem cell biomanufacturing, endometrial pathologies, and models of invasive brain cancer. He has received funding from the NSF, NIH, American Cancer Society, the U.S. Army, and the AO Foundation. He received an NSF CAREER award in 2013, the 2014 Young Investigator Award from the Society for Biomaterials (USA), and was elected a Fellow of the American Association for the Advancement of Science (2014) and the American Institute for Medical and Biological Engineering (2019). He also co-founded UK-based Orthomimetics, Ltd. (acquired by TiGenix, Ltd.), currently performing Phase I clinical trials on a material to repair osteochondral defects in the knee.
Assistant Professor, Dept of Cardiothoracic Surgery, Stanford University
Ngan F. Huang is an Assistant Professor in the Department of Cardiothoracic Surgery at Stanford University and Principal Investigator at the Veterans Affairs Palo Alto Health Care System. Dr. Huang completed her BS in Chemical Engineering from the Massachusetts Institute of Technology, followed by a PhD in bioengineering from the University of California Berkeley & University of California San Francisco Joint Program in Bioengineering. Prior to joining the faculty, she was a postdoctoral scholar in the Division of Cardiovascular Medicine at Stanford University. Her laboratory investigates the interactions between stem cells and extracellular matrix microenvironment for engineering cardiovascular tissues to treat cardiovascular and musculoskeletal diseases.
Dr. Huang has authored over 70 publications and patents, including reports in Nat Med, PNAS, and Nano Lett. She has received numerous honors, including a NIH K99/R00 Career Development Award, Fellow of the American Heart Association, a Young Investigator award from the Society for Vascular Medicine, a Young Investigator Award from the Tissue Engineering and Regenerative Medicine International Society-Americas, and a Rising Star award at the Cell & Molecular Bioengineering conference. Her research is funded by the NIH, NSF, Department of Defense, California Institute of Regenerative Medicine, and Department of Veteran Affairs.
Chief Technology Officer, RegenMed Development Organization (ReMDO); Executive Director, Regenerative Medicine Manufacturing Society (RMMS)
Dr. Hunsberger obtained his B.A. in neuroscience from Wesleyan University and his Ph.D. in neuroscience from Yale University where his work focused on the beneficial effects of exercise in treating depression. He then did his postdoctoral work at the National Institutes of Health where he was the Julius Axelrod Post Doctoral Fellow and worked in areas of mood disorders and stroke. He then was a research fellow at the National Institutes of Health Center for Regenerative Medicine where he coordinated efforts for advancing clinical translation of stem-cell technologies. He then came to Wake Forest Institute for Regenerative Medicine where he worked on various director initiatives seeking to translate regenerative medicine technologies into the clinic to treat patients.
Dr. Hunsberger is currently chief technology officer of a non-profit organization, RegenMed Development Organization (ReMDO) that is advancing regenerative medicine manufacturing platform technologies in pre-competitive space. One of the programs focuses on development of a universal media to support clinical cell manufacturing. The other program focuses on development of a tunable bioink system for 3D bioprinting. He is also executive director of the Regenerative Medicine Manufacturing Society (RMMS) which is a professional society that has a vision of enabling the adoption of manufacturing platform technologies into standards, regulatory pathways, and commercial products by assembling a diverse network of stakeholders.
Associate 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.
Executive Vice President, Global Head of Research and Development and CMO, Caladrius Biosciences
Dr. Losordo’s career has been dedicated to patient care and to the development of novel therapeutics aimed at the reversal or repair of chronic conditions such as heart failure, critical limb ischemia, cancer, diabetes and autoimmune disease.
A native of Brooklyn, NY, he received his medical degree from the University of Vermont and completed an internship, residency and fellowship at St. Elizabeth’s Medical Center, Boston, Massachusetts.
As a member of the faculty and Professor at Tufts University and later as an endowed, tenured professor at Northwestern University he developed clinical programs in gene therapy and cell-based tissue repair including developing VEGF gene therapy for myocardial ischemia and diabetic neuropathy, CD34+ cell therapy for refractory angina, critical limb ischemia, severe claudication and coronary microvascular dysfunction. Two of these candidates advanced to phase 3.
At Caladrius Dr. Losordo has recently initiated a study of CD34 cell therapy for critical limb ischemia targeting conditional approval under the new Japanese regulatory rules governing regenerative therapies. This program achieved Sakigake designation, a breakthrough status. In the U.S. the CD34 cell therapy program for no-option refractory disabling received Regenerative Medicine Advanced Therapy designation and a pivotal clinical trial is scheduled to launch later this year.
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.
President and CEO, California Institute for Regenerative Medicine (CIRM)
Dr. Maria Millan is a physician-scientist who has devoted her career to treating and developing innovative solutions for children and adults with debilitating and life-threatening conditions. After receiving her undergraduate degree from Duke University where she first entered the arena of immunology research, she returned to her home in New Jersey where she obtained her M.D. degree and then went on to complete her surgical training and post-doctoral research in Boston at Harvard Medical School – Beth Israel Deaconess Medical Center. After a transplant surgery fellowship at Stanford University School of Medicine, she began her academic career with a busy pediatric and adult transplant surgery practice focused on technical advancements and optimization of patient outcomes. In parallel, she continued her bench research at Stanford and was promoted within 5 years to associate professor and director of the Pediatric Organ Transplant Program. She served on multiple leadership teams including the Faculty Senate and the Dean’s faculty committee at Stanford University School of Medicine and served on the Children’s Hospital operations committee. She has published in the areas of cell biology, immunology and clinical organ transplantation.
With early signals from the science that stem cell and regenerative medicine therapy was the new frontier for medicine, she ventured into the private sector in 2006 to join StemCells, Inc., one of the earliest stem cell organizations and the first to enter into an FDA-regulated clinical trial with a stem cell treatment for children with a fatal neurodegenerative disease. Dr. Millan then joined the California Institute for Regenerative Medicine (CIRM) in December 2012 where she led the formation of the Alpha Stem Cell Clinics Network, a network of California medical centers that specialize in rigorous and high-quality clinical trials and top-tier medical care for patients participating in these trials. This clinical network is successfully supporting over 45 clinical trials and was recently expanded to include 5 programs composed of 7 medical centers and their affiliated hospitals. As a key component of CIRM’s bold5-year strategic plan launched in 2016, which was designed to accelerate stem cell treatments to patients with unmet medical needs, Dr. Millan led the development of critical infrastructure, including specialized regulatory, preclinical research, manufacturing and clinical operations support for stem cell and regenerative medicine trials. In July 2017, Dr. Millan took on the role as president and CEO of CIRM, and she was formally appointed by CIRM’s board in September 2017. Under her leadership, CIRM continues to drive the mission of accelerating stem cell treatments to patients with unmet medical needs, is on track to achieve its 5-year strategic plan, has now funded a total of 45 clinical trials and is continuing to grow this robust portfolio of high-quality programs by the month.
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.
Associate Professor of Cardiovascular Medicine and Genetics in the Perelman School of Medicine at the 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.
Professor, Anesthesia and Biomedical Engineering, Yale University
Dr. Niklason is the Nicholas M. Greene Professor at Yale University in Anesthesia and Biomedical Engineering, where she has been on faculty since 2006. Dr. Niklason’s research focuses primarily on regenerative strategies for cardiovascular and lung tissues. Niklason’s engineered blood vessels are being brought to the clinic by her startup company Humacyte Inc, and are the first life-sustaining engineered tissue to be studied in any Phase III clinical trial. The engineered blood vessel was the first therapy to be granted Regenerative Medicine Advanced Therapy status by the US FDA in 2017.
Niklason’s lab at Yale was one of the first to describe the engineering of whole lung tissue that could exchange gas in vivo, and this work was cited in 2010 as one of the top 50 most important inventions of the year by Time Magazine. She was inducted into the National Academy of Inventors in 2014, and was elected to the National Academy of Medicine in 2015. She was also named (along with Bill Gates and Joe Biden) as one of 34 leaders who are changing healthcare by Fortune Magazine in 2017.
Niklason received her PhD from the University of Chicago in Biophysics in 1988, and earned an AB from the University of Illinois in 1983. Niklason received her MD from the University of Michigan in 1991. Dr. Niklason completed her medical training in anesthesiology and critical care medicine at the Massachusetts General Hospital in 1996.
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.
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.
Assistant Professor, Department of Mechanical and Biomedical Engineering, Boise State University
Dr. Gunes Uzer is an Assistant Professor in the Department of Mechanical and Biomedical Engineering at Boise State University. He joined to the department in August 2016. Dr. Uzer is the director of the Mechanical Adaptations Laboratory leading a multidisciplinary research program. Dr Uzer. completed his post-doctoral training in the department of Medicine at the University of North Carolina, Chapel Hill working with Dr. Janet Rubin. Dr, Uzer obtained his Ph.D. under the direction of Dr. Stefan Judex at Stony Brook University in 2013.
Studies in Mechanical Adaptations Laboratory are towards quantifying stem cell mechanical environment within bone marrow and understand how this mechanical information regulates LINC complexes and other intranuclear organizers such as LaminA/C and actin polymerization to direct MSC mechanosignaling and fate within the context of aging and microgravity.
GM, Cell and Gene Therapy Strategy, GE Healthcare
Phil is General Manager of GE Healthcare’s Cell and Gene Therapy business development and strategy, a business formed to address the unique challenges of cell and gene therapy manufacturing and distribution.
Phil’s career has included a number of innovation, business and market development roles at Lonza, Becton Dickinson, Invitrogen, and Life Technologies, as well as two start-up biotechnology companies in the Washington, DC area. Additionally, Phil was an Instructor for Johns Hopkins University Advanced Academic Programs teaching Biotechnology Marketing.
Phil received his Ph.D. in Biochemistry and Molecular Biology from Georgetown University Medical Center and subsequently held an IRTA fellowship at the National Cancer Institute in the Laboratory of Molecular Oncology and the Hollings Cancer Center in Charleston, South Carolina.
Phil is an active board member of the Alliance for Regenerative Medicine and the ARM Foundation, as well as the Centre for Commercialization of Regenerative Medicine (CCRM) in Toronto. Additionally, Phil serves on several advisory boards in both not-for-profit and for-profit organizations and associations. Phil has published a number of industry position pieces and serves on the Editorial Board of Cell and Gene Therapy Insights.
CMC Reviewer, Division of Cellular and Gene Therapies, FDA
Prajakta Varadkar is a research biologist and CMC reviewer in the Division of Cell and Gene Therapy, Office of Tissues and Advanced Therapies at the U.S. Food and Drug Administration Center for Biologics Research and Review (CBER). She received Ph.D. in Biochemistry from the Bhabha Atomic Research Center, Mumbai, India for studies on signaling pathway modulation of radio-resistance during tumor therapies. In 2006, Dr. Varadkar moved to CBER as a staff fellow with both research and regulatory responsibilities. At FDA, she is involved in reviewing and regulating various biological products submissions including blood and blood products, cells and tissues. She has served on various FDA-CBER internal working groups and committees.
Chair and Professor, Department of Chemical Engineering, Northeastern University
Thomas J. Webster’s (H index: 86) degrees are in chemical engineering from the University of Pittsburgh (B.S., 1995) and in biomedical engineering from Rensselaer Polytechnic Institute (M.S., 1997; Ph.D., 2000). He was appointed Department Chair of Chemical Engineering at Northeastern University in 2012 in which the Department broke the record for the fastest increase in U.S. News and World Report ranking over a five year period.
Professor Webster has graduated/supervised over 189 visiting faculty, clinical fellows, post-doctoral students, and thesis completing BS, MS, and PhD students. To date, his lab group has generated over 13 textbooks, 68 book chapters, 276 invited presentations, at least 583 peer-reviewed literature articles and/or conference proceedings, at least 867 conference presentations, and 42 provisional or full patents. He is the founding editor-in-chief of the International Journal of Nanomedicine (pioneering the open-access format).
Professor Webster currently directs or co-directs several centers in the area of biomaterials: The Center for Natural and Tropical Biomaterials (Medellin, Colombia), The Center for Pico and Nanomedicine (Wenzhou China), and The International Materials Research Center (Soochow, China).
Professor Webster has received numerous honors including but not limited to: 2012, Fellow, American Institute for Medical and Biological Engineering (AIMBE, representing the top 2% of all medical and biological engineers); 2013, Fellow, Biomedical Engineering Society; 2015, Wenzhou 580 Award; 2015, Zheijang 1000 Talent Program; 2016, International Materials Research Chinese Academy of Science Lee-Hsun Lecture Award; 2016, International College of Fellows, Biomaterials Science and Engineering; 2016, Acta Biomaterialia Silver Award; 2018, Fellow, National Academy of Inventors; and 2019, Overseas Fellow, Royal Society of Medicine (UK). He also served as the President of the U.S. Society For Biomaterials. He has appeared on BBC, NBC, ABC, Fox News, the Weather Channel, the Discovery Channel, and the recent special ‘Year Million’ TV series on National Geographic talking about the future of medicine and science.
Director, Stanford Institute for Stem Cell Biology and Regenerative Medicine; Director, Ludwig Center for Cancer Stem Cell Research, Professor of Pathology and Developmental Biology, Stanford University
Dr. Weissman is the Founder and Director of the Stanford institute for stem cell biology and regenerative medicine (SCBRM) since 2002, the Director of the Stanford Ludwig Center for Cancer Stem Cell Research, and the former director of the Stanford cancer center. To develop new therapies based on scientific discoveries from his group including, Weissman co-founded SyStemix 1988-1996, StemCells in 1996-2017, and Cellerant in 2001-9. In 2015He founded Forty Seven Inc. for clinical development of immunutherapies and is the Director of the Company. Additionally, Dr. Weissman was a member of the founding Scientific Advisory Boards of Amgen (1981-1989), DNAX (1981-1992), and T-Cell Sciences (1988-1992).
His research on hematopoiesis, hematologic malignancies and solid tumors has led to several discoveries and the development of new therapies. These include the isolation and transplantation of pure hematopoietic stem cells (HSCs) and the demonstration that, upon transplantation, pure HSCs can regenerate the entire blood and immune system in a host without causing graft vs. host disease. At SyStemix he co-discovered the human hematopoetic stem cell and at StemCells, he co-discovered a human central nervous system stem cell. With SyStemix, he led clinical trials in the 90s that demonstrated the therapeutic potential and beneficial outcomes of transplanted purified, cancer-free HSC for women with metastatic breast cancer who received high dose chemotherapy.
Those earlier studies on HSCs and hematopoiesis served as a foundation for the biological definition and prospective isolation of human leukemia stem cells [LSC]. Next, by comparing LSC to HSC, Weissman discovered CD47 as a ‘don’t eat me’ signal used by leukemias and all other human cancers to evade innate immunity. Binding of CD47 to SIRP, its receptor on macrophages, inhibits phagocytosis, and blocking this interaction with anti CD47 antibodies unleashes phagocytosis of cancer cells by macrophages. Weissman then led the clinical development of CD47 blockade as a new cancer immunotherapy and to the establishment of forty seven inc. In phase-I clinical trials significant therapeutic anti-cancer effects were achieved, remarkably complete remissions were observed with a combination therapy of anti CD47 and Rituximab in lymphoma patients who failed all other therapies. The results were published in the New England Journal of Medicine (NEJM) in 2018.
Professor Weissman is a member of the National Academy of Sciences, the Institute of Medicine at the National Academy, and the American Association of Arts and Sciences. He has received many awards, including the Kaiser Award for Excellence in Preclinical Teaching, the Pasarow Award in Cancer Research, the California Scientist of the Year, the De Villiers International Achievement Award of the Leukemia Society of America, the Robert Koch Award, the Rosenstiel Award, The max Delbruck Medal,and the Jessie Stevenson Kovalenko Award of the National Academy of Sciences. He is also the 2004 New York Academy of Medicine Award for distinguished contributions to biomedical research, and has several honorary doctorates.
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.
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.