| ||Anthony Atala, MD|
Director, Wake Forest Institute for Regenerative Medicine
Anthony Atala, MD, is the Director of the Wake Forest Institute for Regenerative Medicine, and the W.H. Boyce Professor and Chair of the Department of Urology at Wake Forest University. Dr. Atala is a practicing surgeon and a researcher in the area of regenerative medicine. His current work focuses on growing new 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, and Therapeutic Advances in Urology; as Associate Editor of Tissue Engineering and Regenerative Medicine, Rejuvenation Research, and Gene Therapy and Regulation; as Executive Board Member or Section Editor of the International Journal of Artificial Organs, Organogenesis, and Current Urology Reports; and as Editorial Board member of Expert Opinion on Biological Therapy, Biomedical Materials, Journal of Tissue Science and Engineering, 3D Printing and Additive Manufacturing, Technology, the Journal of Urology, Recent Patents on Regenerative Medicine, BioMed Central-Urology, Urology, and Current Transplantation Reports.
Dr. Atala is a recipient of many 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, presented to individuals achieving significant and lasting progress, the Samuel D. Gross Prize, awarded every 5 years to a national leading surgical researcher by the Philadelphia Academy of Surgery, the Barringer Medal from the American Association of Genitourinary Surgeons for distinguished accomplishments, the Gold Cystoscope award from the American Urological Association for advances in the field, the Ramon Guiteras Award for pioneering research in regenerative medicine and outstanding contributions as a scholar and teacher, the Innovation Award from the Society of Manufacturing Engineers for the creation of synthetic organs, and the Rocovich Gold Medal, awarded to a distinguished scientist who has made a major impact on science toward the understanding of human disease. In 2011 he was elected to the Institute of Medicine of the National Academy of Sciences. Dr. Atala was elected to the Royal Academy for the Encouragement of the Arts in 2012, and to the National Academy of Inventors as a Charter Fellow in 2013. Dr. Atala's team received the Edison Science/Medical Award in 2013.
Dr. Atala’s work has been described in the lay press. In 2003 he was named by Scientific American as a Medical Treatments Leader of the Year for his contributions to the fields of cell, tissue and organ regeneration. Dr. Atala’s work was listed as Time Magazine’s top 10 medical breakthroughs of the year, and as Discover Magazine`s Number 1 Top Science Story of the Year in the field of medicine in 2007. In 2009 Dr. Atala was featured in U.S. News & World Report as one of 14 Pioneers of Medical Progress in the 21st Century, and his work in 2010 was listed by Smithsonian Magazine as one of 40 things to know about the next 40 years. Dr. Atala’ work was listed in the Huffington post as one of 18 great ideas of 2011, in Time Magazine as one of the top 5 medical breakthroughs of the year in 2011, by the American Association of Retired Persons as one of the 50 influential people who will make life better in 2012, and by Time Magazine as one of 5 discoveries that will change the future of organ transplants in 2013.
Dr. Atala has led or served several national professional and government committees, including the National Institutes of Health working group on Cells and Developmental Biology, the National Institutes of Health Bioengineering Consortium, and the National Cancer Institute’s Advisory Board. Dr. Atala heads a team of over 300 physicians and researchers. Over ten applications of technologies developed in Dr. Atala's laboratory have been used clinically. He is the editor of twelve books, including Essentials of Stem Cell Biology, Principles of Regenerative Medicine, Foundations of Regenerative Medicine, Methods of Tissue Engineering, and Minimally Invasive Urology. He has published more than 400 journal articles and has applied for or received over 200 national and international patents. Back to top.
| || || |
| ||Julie Allickson, PhD|
Director, Regenerative Medicine Clinical Center, Wake Forest Institute for Regenerative Medicine
Julie Allickson focuses on the translation of regenerative medicine products including cell therapy, tissue engineering, biomaterials and devices. This process begins at Proof-of-Concept where early discussion with regulators and clinicians are critical in moving the technology from the bench to the bedside. The Translational Team includes Quality Assurance, Quality Control, Regulatory Affairs, Process Development and the GMP-complaint Manufacturing Facility. Prior to joining the institute, she was an Executive Officer of the company and Vice President of Laboratory Operations and R & D at Cryo-Cell International, Inc., an AABB accredited Cord Blood Bank.
As Vice President of the Laboratory Dr. Allickson was responsible for all technical aspects of Laboratory Operations along with Research and Development activities associated with adult stem cells, including the development work related to isolation of a unique stem cell harvested from menstrual blood. Prior to this position, Dr. Allickson worked for the University Of Miami School Of Medicine, Diabetes Research Institute as the Laboratory Director of the cGMP Hematopoietic Cell Processing Facility. She was responsible for the design and implementation of the State Licensed Clinical Flow Cytometry Laboratory. Dr. Allickson was the lead in Regulatory Affairs for the processing laboratory of Islet and Hematopoietic Cell products which included oversight of all Investigational New Drugs (IND) and external regulations.
Prior to working for the University of Miami she worked for the American Red Cross managing the Hematopoietic Cell Processing and Platelet Serology Laboratory. During her tenure at the American Red Cross she served as a member of the National Stem Cell Task Force and participated in the preparation of national protocols developed for Hematopoietic Cell Processing Laboratories. Dr. Allickson was part of the team to perform the very first Bone Marrow Transplant at the University of Miami in 1990.
Dr. Allickson has 25 years experience in Cellular Therapy, Cellular Processing and Regenerative Medicine. She has a Doctorate in Health Sciences along with a Master's Degree in Medical Laboratory Sciences. She is one of the founding members of the International Society of Cellular Therapy in 1992 and has been a member of the American Association of Blood Banks (AABB) for 25 years. She has presented at national and international meeting related to adult stem cells and translation. She is currently Chair of the AABB Standards Committee for Cell Therapy Product Services. Dr. Allickson is also on the Technical Advisory Board for Tissue Engineered Products under ICCBBA and the ISCT Commercialization Committee. Back to top.
| || || |
| ||Graca Almeida-Porada, MD, PhD|
Professor, Wake Forest Institute for Regenerative Medicine
Dr. Almeida-Porada was born
and raised in Portugal. She received her medical degree in 1986 from the
Instituto de Ciências Biomédicas Abel Salazar (ICBAS) of University of Porto,
Portugal. She completed her residency and fellowship in Hematology/Transfusion
Medicine at University Hospital of Santo Antonio, and obtained her Ph.D. in
Pathology from ICBAS in 1995. She was a fellow at the University of
Connecticut Health Center and at the University of Nevada, Reno School of
Medicine. She became faculty at the University of Nevada, Reno in 1999. In 2001
she joined the Department of Animal Biotechnology at the same Institution,
where she was a Professor and the Director of Graduate Studies. In 2006 she was
inducted into Phi Beta Delta. She serves on the Editorial Boards of several
scientific journals, and was an Associate Editor for Experimental Hematology.
Dr. Almeida-Porada has authored more than 90 scientific publications and
reviews, and has written chapters in several books. She joined the
faculty at WFIRM in 2011. Back to top.
| || || |
| || ||Tim Bertram, DVM, PhD|
President, Research and Development and Chief Scientific Officer, Tengion
Dr. Bertram has served as Tengion's Chief Scientific Officer since 2004. Prior to joining Tengion, Dr. Bertram was senior scientific executive at Pfizer, SmithKline Beecham Pharmaceuticals, and Procter & Gamble Co; a faculty member at the University of Illinois; and a visiting scientist to the National Institutes of Health. Dr. Bertram has been a leadership-mentor to scientists in government, academics, and industry. His experience includes worldwide leadership of multidisciplinary scientific teams for the pharmaceutical industry, government and private foundations focusing on resolution of challenges in pharmaceutical productivity and defining industrial applications of advanced molecular, cellular and whole organism technologies for selecting optimal therapeutic candidates with experience in discovery, development and registration of small molecules, cell-based therapies and regenerative medical products. Organizational leadership activities have included Pharmaceutical R&D sites in both the US and Europe with responsibility for developing and setting Discovery and Development strategies. Most recently, Dr. Bertram was responsible for operational oversight of large discovery and development organizations in disciplines including genomics, proteomics, discovery, development, comparative medicine and business support groups to enable therapeutic agent development. His organizations have supported new medicine portfolios that included Gastrointestinal, CNS, Cancer, Respiratory, Infectious, Immunologic, Cardiovascular, Urology, Nephrology and Metabolic diseases with the preparation of regulatory submissions for agencies in major markets around the world. Dr. Bertram holds active academic appointments and industrial advisory positions at leading national and European educational institutions, International Society of Stem Cell Research, Tissue Engineering Regenerative Medical International Society Industrial Liaison Committee, Industrial Business Advisory Board and Industrial Advisory Committee of UCLA's Bioengineering Department and industry. Dr. Bertram is a member of journal editorial boards for Tissue Engineering and, Regenerative Medicine. He has over 150 scientific communications and patents focusing on the cellular and molecular basis of diseases and tissue and organ regeneration involving the respiratory, urogenital, renal and gastrointestinal organ systems. Back to top.
| || || |
| || ||Ed Field, MBA|
President, Spine/Disc Division, Biorestorative Therapies, Inc.
Edward Field joined BioRestorative Therapies in February 2015 as President of its brtxDISC™ division. Mr. Field has over 20 years of senior leadership experience in the biotechnology industry with particular expertise in the development and commercialization of cell-based therapies and regenerative medicine products.
Previously, Mr Field served as the Executive Vice President and COO of Cytomedix, Inc. (now Nuo Therapeutics, OTCBB:NUOT) from 2012 to 2014. Mr. Field had been the President and COO of Aldagen, Inc. from 2004 to 2012 prior to its acquisition by Cytomedix in 2012. During this timeframe, Mr. Field was responsible for leading the advancement of eight cell therapy programs into early and late-stage clinical development. Mr. Field also led the building of a Phase 1/2 and a commercial cell therapy manufacturing facility. Additionally, Mr. Field led global commercial operations to support devices sold in the wound care and orthopedic market. During this timeframe, he was also involved in the regulatory efforts for 8 IND clearances, an SPA agreement, Orphan Drug Designation and two potency assays accepted for Phase 3 programs.
Previously, Mr. Field was the President/CEO of two biotechnology companies focused on the development of therapeutics in the cardiovascular, cancer and respiratory diseases areas.
Mr. Field was one of the founding members of the Alliance for Regenerative Medicine. Mr. Field served as the past Vice Chairman and Treasurer of the Alliance for Regenerative Medicine. He has also served as the Chair of its Regulatory and Reimbursement Committee and its Capital Formation Committee.
Mr. Field obtained his MBA from the Colgate Darden School of Business Administration at The University of Virginia in Charlottesville, Virginia and his B.A. from Duke University in Durham, North Carolina. Back to top.
| || || |
| ||Beth Fordham-Meier|
and Founder, NovoCreation Consulting, LLC
Principal and Founder of NovoCreation Consulting, LLC,
providing consulting services in business development and licensing,
intellectual property and portfolio optimization and alliance and project
management. Certified Licensing Professional with twenty years experience
driving business development and IP initiatives and negotiating partnering
transactions in public and private biotech and university licensing. Ten years
(2003-2013) at Targacept (NASDAQ: TRGT), culminating in the position of VP,
Licensing and Intellectual Property, fueling company and pipeline growth by
securing billion-dollar R&D and commercialization deals with global pharma
partners AstraZeneca and GlaxoSmithKline. Led cross-functional teams to advance
and out-license programs and evaluate opportunities to in-license across
multiple therapeutic areas, including CNS, immunology, GI/GU, urology and
orphan diseases. Negotiated deals to in-license assets from Cornerstone
Therapeutics, Yale University, University of South Florida and Wake Forest
University. Member, Portfolio Management Committee, piloting portfolio
investment and advancement strategies. Chaired IP Committee, driving IP
initiatives to secure Targacept's industry-leading nicotinic portfolio (>150
issued and pending patents) and directing IP due diligence. Back to top.
| || || |
| ||Xiaosong Gu, MD|
Director, Jiangsu Key Laboratory of Neuroregeneration of Nantong University
Professor Xiaosong Gu, M.D., is Director of Jiangsu Key Laboratory of Neuroregeneration of Nantong University, Honorary President of Chinese Society for Anatomical Sciences (CSAS) and the chief of Regenerative Medicine Branch of CSAS, the chief of Development and Regeneration Branch of Chinese Neuroscience Society (CNS), a founding member of World Society for Reconstructive Microsurgery, and a reviewing expert of National Natural Science Foundation of China.
Supported by Hi-Tech Research and Development 863 and 973 Program of China and National Natural Science Foundation, Professor Gu focuses his research on tissue engineered nerve and the molecular mechanisms underlying neural regeneration. So far, he has published 112 academic articles in SCI-indexed journals such as Brain, Biomaterials, Nucleic Acids Research, Progress in Neurobiology, Nature Cell Biology, and Stem Cell. As one of the main inventors, he has been granted several Chinese and international patents. And with the approval of CFDA, tissue engineered nerve has been applied to clinical trials. Back to top.
| || || |
| || ||Scott Guelcher, PhD|
Associate Professor of Chemical and Biomolecular Engineering, Vanderbilt University
Scott Guelcher is an Associate Professor of Chemical and Biomolecular Engineering at Vanderbilt University in Nashville, TN. Prior to his appointment at Vanderbilt, he was a Senior Associate Scientist at Bayer Corporation and an NIH/NRSA Fellow in the Department of Biomedical Engineering at Carnegie Mellon University in Pittsburgh, PA. Professor Guelcher’s research focuses on the design and development of polymeric biomaterials and delivery systems that enhance healing of tissue damaged by trauma or disease. He collaborates with biomedical scientists and clinicians to design, develop, and scale-up new materials for bone and soft tissue regeneration from the bench to the bedside. He is an author on over sixty publications and an inventor on twenty patents and published applications. Back to top.
| || || |
| ||Ben Harrison, PhD|
Associate Professor, Chief of Laboratory Operations, Wake Forest Institute for Regenerative Medicine
Dr. Benjamin Harrison was
born and raised in Pensacola, Florida. He received his B.S. Degree in chemistry
from the University of West Florida in 1998. Following that, he attended
graduate school at the University of Florida and obtained a Ph.D. in Inorganic
Chemistry in 2003. Back to top.
| || || |
| ||John Jackson, PhD|
Professor, Wake Forest Institute for Regenerative Medicine
Dr. John D. Jackson is an Associate Professor in
the Institute for Regenerative Medicine at Wake Forest School of Medicine. He
received his Ph.D. degree in Medical Sciences (Experimental Hematology) from
the University of Nebraska Medical Center. He served as Technical Director of
the Cell Processing Laboratory at the University of Nebraska Medical Center
which provided support for the bone marrow transplantation program. His research interests are in the area of
stem cell biology with particular emphasis on the use of stem cell populations
in tissue and organ regeneration. He is a member of Tissue Engineering and
Regenerative Medicine International Society (TERMIS). Back to top.
| || || |
| ||Peter C. Johnson, MD|
Vice President, Research and Development and Medical Affairs, Vancive Medical Technologies
Peter C. Johnson, MD is a University of Notre Dame and SUNY Upstate Medical University graduate. After General and Plastic Surgery training, Dr. Johnson practiced reconstructive surgery for ten years at U. Pittsburgh where he founded and was the first President of the Pittsburgh Tissue Engineering Initiative. Subsequent roles were co-founder/CEO of Tissue Informatics, EVP of Life Sciences, CMO and CBO of Icoria, and EVP, Entegrion, Inc. He presently serves as the VP, Research and Development and Medical and Scientific Affairs of Vancive Medical Technologies, an Avery Dennison business. He Chaired the Plastic Surgery Research Council, was President of the Pennsylvania Biotechnology Association and the Tissue Engineering Society, International and is presently the Co-Editor-in-Chief of the three-part Journal, Tissue Engineering. He serves on the Industry Committee of Tissue Engineering and Regenerative Medicine International Society (TERMIS) and on the board of the Transverse Myelitis Association. He is an Adjunct Professor of Surgery, Bioengineering and Business at the University of North Carolina at Chapel Hill, of Bioengineering at NC State and of Regenerative Medicine at Wake Forest University School of Medicine. He serves on the Board of the Transverse Myelitis Association. He is an avid cook, fly fisherman, artist and novelist. Back to top.
| || || |
| ||Nancy King, JD|
Center for Bioethics, Health and Society, Wake Forest University
Nancy M. P. King, JD, is Professor, Department
of Social Sciences and Health Policy and Wake Forest Institute for Regenerative
Medicine at Wake Forest School of Medicine, and Co-Director of the Center for
Bioethics, Health, and Society and the Graduate Program in Bioethics at Wake
Forest University. Her scholarship
addresses a range of bioethics issues, including: informed consent in health
care and research; medical decisions at the beginning and end of life; the
development and use of experimental technologies; preclinical and animal
research; international and cross-cultural questions in human subjects
research; benefit and uncertainty in human subjects research; ethical issues in
large-scale genetic research and biobanking, gene transfer research, and
regenerative medicine; and connections between science, ethics, design, and
policy in biotechnology research. She
has published over 100 scholarly articles and book chapters, and is co-editor
of The Social Medicine Reader (2nd
ed., Duke University Press, 2005), Beyond
Regulations: Ethics in Human Subjects Research (UNC Press 1999), and Bioethics, Public Moral Argument, and Social
Responsibility (Routledge 2012). She
has served on hospital ethics committees, IRBs, DSMBs and the NIH Recombinant
DNA Advisory Committee, and has taught research ethics in national and
international settings. Back to top.
| || || |
| || ||Susan Z. Kornetsky, MPH|
Director, Clinical Research Compliance, Children's Hospital Boston
Susan Kornetsky is the Director of Clinical Research Compliance at Children’s Hospital in Boston. For the past 31 years, her responsibilities include directing an IRB administrative office, educating principal investigators regarding IRB regulations, assisting investigators with protocol development, assuring institutional compliance with all federal and state regulations pertaining to human research, establishing appropriate policies and procedures and overseeing a quality improvement program for human research protections.
Her education includes a a Masters of Public Health from Boston University. In May of 2010 she completed a Medical Ethics Fellowship at Harvard Medical School.
Ms. Kornetsky is a past appointed member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) and was co-chair of the SACHRP Sub-committee on Children. She currently serves on the Subpart A subcommittee of SACHRP. She is a past member, appointed by the Secretary of HHS, of the National Human Research Protection Advisory Committee. She is a past Board member of the Association for the Accreditation of Human Research Programs (AAHRP), and also served as a site visitor. She was a member of the Institute of Medicine’s Committee on Clinical Research Involving Children.
Following many years as an active member as well as President of ARENA, PRIM&R’s membership program, Ms. Kornetsky was elected to PRIM&R’s Board of Directors in 2001. She is currently Vice Chair of the Board . She was an initial member on the Council for Certification of IRB Professionals (CCIP) and served as a Council co-chair. She is one of the co-chair of the 2012 and 2013 PRIMR annual IRB national conferences. She is a member of a Stakeholder Advisory Group for a Healthcare System Research Collaboratory
She lectures at many national meetings and international most recently teaching clinical research ethics in Turkey and Portugal. She has served as a consultant on an Office of Protection from Research Risks (OPRR) site visit team. She has developed a course IRB administrator 101 and teaches IRB members at many universities , hospital and medical schools. She also lectures on research ethics and IRB regulations for multiple courses offered to new investigators and fellows through Harvard Medical School. Some of her areas of interest are research ethics related to pediatric research, boundaries between research and innovation, biobanking and the obligation to return research results to subjects, She is also a current member of the Massachusetts Down Syndrome Congress Medical and Scientific Advisory Council. Back to top.
| || || |
| ||Joanne Kurtzberg, MD|
Pediatric Blood and Marrow Transplant Program, Duke University Medical Center
Joanne Kurtzberg is an internationally renowned expert in pediatric
hematology/oncology, pediatric blood and marrow transplantation, umbilical cord
blood banking and transplantation, and novel applications of cord blood in the
emerging fields of cellular therapies and regenerative medicine. Dr. Kurtzberg
pioneered the use of umbilical cord blood as an alternative stem cell source
for unrelated hematopoietic stem cell transplantation (HSCT). Over the last two
decades Dr. Kurtzberg has established an internationally known pediatric
transplant program at Duke which treats children with cancer, blood disorders,
immune deficiencies, hemoglobinopathies and inherited metabolic diseases. In
2010, Kurtzberg established the Julian Robertson Cell and Translational Therapy
Program (CT2) at Duke. CT2 focuses on
translational studies from bench to bedside with a focus on bringing cellular
therapies in regenerative medicine to the clinic. Recent areas of investigation
in CT2 include the use of autologous cord blood in children with neonatal brain
injury and cerebral palsy, as well as preclinical studies manufacturing
oligodendrocyte-like cells from cord blood to treat patients with acquired and
genetic brain diseases. Studies of autologous bone marrow ALDHbright cells in
adults with stroke and radiation induced brain injury are also underway. Plans are ongoing to extend this work to the
use of autologous cord blood in a study of young children with Autism Spectrum
Kurtzberg established one of the largest unrelated donor cord blood bank, the
Carolinas Cord Blood Bank, in the world at Duke in 1998. The bank has a current inventory of
>40,000 units and has provided cord blood units to over 2,200 patients
undergoing unrelated donor HSCT over the past 10 years. Dr. Kurtzberg’s lab has developed novel assays to predict cord blood
potency from segments attached to cryopreserved cord blood units, and is
performing translational research testing cord blood expansion, cellular
targeted therapies and tissue repair and regeneration. In 2012, under the
direction of Dr. Kurtzberg, the Carolinas Cord Blood Bank received FDA approval
for DuCord, a stem cell product derived from umbilical cord blood, for use in
transplants between unrelated donors and recipients. Dr. Kurtzberg currently
holds several INDs for investigational clinical trials.
Dr. Kurtzberg has published over 300 peer-reviewed papers, multiple
chapters and scientific reviews. She is
a member of the American Society of Hematology, the American Association of
Blood and Marrow Transplantation, the American Society of Pediatric
Hematology/Oncology, the International Society of Cellular Therapies, the
Pediatric Blood and Marrow Transplant Consortium (PBMTC), and other
organizations. She serves on the Board
of the Foundation of Accreditation of Cellular Therapies, co-chairs the
National Marrow Donor Program’s Cord Blood Advisory Group and is a member of
the Advisory Council of Blood Stem Cell Transplantation to Health and Human
Services. Dr. Kurtzberg was awarded a
Lifetime Achievement Award from the PBMTC in 2012. Back to top.
| || || |
| ||Jeanne F. Loring, PhD|
Director, Center for Regenerative Medicine at The Scripps Research Institute
Jeanne Loring, Ph.D., is a Professor and the founding Director of the Center for Regenerative Medicine at The Scripps Research Institute in La Jolla. Her research team focuses on large-scale analysis of genomics and epigenetics of human pluripotent stem cells (hPSCs) and their derivatives, in order to ensure the quality and safety of these cells for clinical use. The lab's translational projects include development of cell therapies for Parkinson’s disease, multiple sclerosis, and Alzheimer disease, and epigenetic modeling of autism. The team is also producing an ethnically diverse library of iPSC (induced pluripotent stem cell) lines for use in pharmacogenomic analysis. In addition, her lab is developing a "zoo" of induced pluripotent stem cells from endangered species to aid in their conservation.
In addition to her scientific research, Dr. Loring is committed to educating both scientists and the public. She has trained more than 400 scientists over the last 10 years in intensive laboratory courses in human ES and iPSC biology, She is frequently quoted in major newspapers, and gives numerous public lectures and interviews to inform the public about biological and societal issues associated with stem cell research. She is particularly concerned with the ethics of stem cell generation and clinical use, the legal implications of stem cell patents, and the dangers of unregulated stem cell treatments (“stem cell tourism”). Dr. Loring serves on both bioethics and scientific advisory boards. Back to top.
| || || |
| ||Frank Marini, PhD|
Wake Forest Institute for Regenerative Medicine
Frank Marini, is a stem cell biologist who focuses on identifying
stem cells in the development of cancer. His work involves novel non-invasive
and invasive imaging techniques to track and identify cells while they
participate in wound healing and tumor development. He currently heads the
Center for Regenerative Imaging, and is a Professor of Regenerative
Medicine and Cancer Biology at Wake Forest Institute for Regenerative Medicine. Back to top.
| || || |
| ||Todd McAllister, PhD|
Co-Founder and CEO, Cytograft Tissue Engineering, Inc.
Dr. McAllister is the co-founder and CEO of Cytograft Tissue Engineering, Inc., a regenerative medicine company developing cell-based therapies to repair and rebuild diseased tissues and organs without using synthetic biomaterials. 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. Dr. McAllister pioneered a novel business strategy that prioritized capital efficiency and research focus. Over the span of 6 years, Cytograft was able to transition from inception to Phase II clinical trials, and is moving programs forward based on its proprietary platform, “TESA™,” Tissue Engineering by Self Assembly™. Cytograft is now one of the few Regenerative Medicine companies pursuing Phase IIb/III clinical trials. The Company has a broad platform of therapeutic indications with vascular grafts, valve leaflets, covered stents, and dermal fillers that are under development.
With more than two decades of experience, Dr. McAllister is a well-known thought leader in the field of Regenerative Medicine. He is a frequent reviewer and contributor for high impact journals and 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. Dr. McAllister has also sat as a reviewer or external advisory board member for AFIRM, NIH, and NSF EPSCOR grants. He has sat on the advisory boards of several companies, including BioCardia, Lumen Therapeutics, Wolf Biosciences and others. 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 repair technologies. Back to top.
| || || |
| ||C. Randal Mills, PhD|
and Chief Executive Officer, California Institute for Regenerative Medicine
C. Randal Mills, Ph.D. is the President and Chief Executive Officer of the California Institute for Regenerative Medicine (CIRM), the state’s $3 billion stem cell agency. With nearly 300 programs in its portfolio, including over a dozen in or entering clinical trials, the agency is the world’s largest entity dedicated to the advancement of stem cell therapies and regenerative medicines. As a strong advocate for patients throughout his career, Dr. Mills’ mission at CIRM is to speed up the development of new treatments and cures by finding real-time solutions for the regulatory, clinical, manufacturing, and business problems that often slow down novel therapies.
Previously, Dr. Mills served as the CEO of Osiris Therapeutics, the world's first profitable stem cell company. In 2005 Osiris launched the first commercial stem cell product, Osteocel®, and in 2012, received the world's first approval for a stem cell drug, Prochymal®, to treat children suffering from graft vs. host disease, an often fatal side effect of a bone marrow transplant. Under his leadership Osiris developed and commercialized five cell therapy products responsible for more than $1 billion in cumulative sales.
Prior to joining Osiris, Dr. Mills was a co-founder and Vice President of Regeneration Technologies. Dr. Mills invented the company’s core technology, BioCleanse®, the first system accepted by the FDA for the sterilization of human tissue for transplantation. BioCleanse products have been used in over three million surgical procedures without a single case of disease transmission.
Dr. Mills currently serves as the Chairman of Tissue Banks International (TBI), the largest provider of ocular tissue for vision restoration. He also serves on the Board of the Alliance for Regenerative Medicine and the Wake Forest Institute of Regenerative Medicine Advisory Board.
He holds a Ph.D. in drug development from the University of Florida, where he also earned his bachelor's degree in microbiology and cell science and completed an internship in clinical pathology. He is married with two children and is a certified pilot. Back to top.
| || || |
| ||Sean Murphy, PhD|
Fellow, Wake Forest Institute for Regenerative Medicine
Sean Murphy received his Ph.D. From Monash
University in Australia under the supervision of Profs. Alan Trounson, Euan
Wallace and Graham Jenkin. He developed methodologies to isolate and
characterize fetal stem cells for clinical applications and demonstrated their
potential for treating lung disease. He is currently a postdoctoral research
fellow at the Wake Forest Institute for Regenerative Medicine, North Carolina, mentored
by Prof. Anthony Atala. His research focuses on developing perinatal stem cell
therapies for lung diseases such as cystic fibrosis and is supported by an
American Lung Association Senior Research Training Fellowship and a Chapman
Foundation grant. Back to top.
| || || |
| ||Thinh Nguyen, PhD|
Director, Office of Combination Products, Food and Drug Administration
Mr. Nguyen is the Director of the Office of Combination Products (OCP) in the United States Food and Drug Administration since January 2008. OCP is primarily responsible for making jurisdictional determinations, coordinating premarket reviews, ennsuring consistent and appropriate postmarket regulations, and developing policy, guidance, and regulations. Prior to joining OCP, Mr. Nguyen spent 7 years as the Director for the Premarket Approval Section in the Center for Devices and Radiological Health where he played a key role in the passage of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and the Medical Device User Fee Amendment of 2007 (MDUFA) legislations. During this time, he had established significant policies and written numerous guidance documents relating to the PMA programs (e.g., expedited review, user fees, PMA actions). Prior to coming to the FDA, Mr. Nguyen worked as a senior electronics engineer for the Naval Electronics Systems Engineering Center, Portsmouth, VA, from 1986 to 1993 where he was responsible for developing hardware/software for testing aircrafts and radar systems. Mr. Nguyen received a bachelor degree with honor in Electrical Engineering degree from North Carolina State in 1986.
| || || |
| || ||Amit N. Patel, MD, MS|
Director, Clinical Regenerative Medicine and Tissue Engineering at the University of Utah
Amit Patel, MD, MS, is an associate professor in the Division of Cardiothoracic Surgery at the University of Utah School of Medicine and Director of Clinical Regenerative Medicine and Tissue Engineering at the University of Utah. His clinical interests include heart surgery for coronary disease, valve repair and replacement, heart failure, aortic surgery and stent grafts. Dr. Patel utilizes minimally invasive surgical approach when possible and this is determined on an individual patient basis. Thoracic interests include lung and esophageal surgery. His interests in thoracic oncology include minimally invasive (VATS) lung resections and hyperthermic chemotherapy for mesothelioma.
Dr. Patel’s research includes studies in autologous stem cell therapy- researching the effects of stem cell transplantation in treating cardiomyopathy, limb ischemia(inadequate blood flow to the leg), and skin graft regeneration following burn injuries. Currently he is participating in a number of trials using autologous adult stem cells to treat cardiomyopathy and limb ischemia. In addition to cardiac research his thoracic research includes cancer stem cell identification and destruction, as well as novel agents to selectively attack lung cancer, thoracic sarcoma, and metastatic diseases. Back to top.
| || || |
| ||Chris Porada, PhD|
Professor, Wake Forest Institute for Regenerative Medicine
Dr. Christopher Porada received his Bachelor’s in
Molecular Biology from Colgate University in 1991 and his PhD in Cellular and
Molecular Pharmacology and Physiology from the University of Nevada in 1998.
After completing his PhD, he served as an Assistant and then Associate
Professor in the Department of Animal Biotechnology at the University of
Nevada, Reno. He has authored over 40 scientific publications and reviews, has
written chapters in several books, and served as an Associate Editor for
Experimental Hematology. He is a member of several international
societies including the American Society of Hematology, the International
Society of Experimental Hematology, and the American Society of Gene and Cell
Therapy, and regularly reviews for several international journals focused on
gene therapy, gene and drug delivery, stem cell biology, and stem cell
transplantation. Dr. Porada joined the faculty at WFIRM in 2011. Back to top.
| || || |
| ||Mahendra Rao, MD, PhD|
Vice President, New York Stem Cell Foundation
Dr. Rao is a renowned international expert in stem cell biology and the Vice President of the New York Stem Cell Foundation. He has served as Chief of the Neurosciences Section at the NIA, as the Vice President of Regenerative Medicine at Life Technologies, Co-Founder of Q Therapeutics, a neural stem cell company, and, most recently, the Director of the NIH Center for Regenerative Medicine, a trans-NIH initiative that focuses on the clinical translation of stem cell technology. Back to top.
| || || |
| ||Buddy Ratner, PhD|
Director, University of Washington Engineered Biomaterials Engineering Research Center
Dr. Buddy D. Ratner is the Director of University of Washington Engineered Biomaterials (UWEB21) Engineering Research Center and the Darland Endowed Chair in Technology Commercialization. He is Professor of Bioengineering and Chemical Engineering, University of Washington. Ratner received his Ph.D. (1972) in polymer chemistry from the Polytechnic Institute of Brooklyn. Ratner is a fellow of the American Institute of Medical and Biological Engineering (AIMBE), AVS, AAAS, ACS, POLY and the International College of Fellows Biomaterials Science and Engineering. In 2002 Ratner was elected a member of the National Academy of Engineering, USA. He has been involved in the launch of seven companies and won numerous awards including the AVS Welch Award (2002), Society for Biomaterials Founders Award (2004), the BMES Pritzker Distinguished Lecturer Award (2008), the Acta Biomaterialia Gold Medal (2009), the Galletti Award (2011) the George Winter Award of the European Society for Biomaterials (2012) and the University of Washington School of Medicine Lifetime Innovator and Inventor Award (2014). His research interests include biomaterials, tissue engineering, polymers, biocompatibility, surface analysis and plasma thin film deposition. Back to top.
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| ||Bernard Siegel, JD|
Founder and Executive Director, Genetics Policy Institute
Bernard Siegel is the founder and Executive Director of Genetics Policy Institute (GPI), a nonprofit organization with offices in Palm Beach, Florida and Palo Alto, California. He is the founder and co-chair of a series of global conferences, including the annual World Stem Cell Summit and founder and editor-in-chief of the peer-reviewed World Stem Cell Report.
Mr. Siegel first became involved with the scientific community when, in 2002, he filed a landmark case seeking a guardian for the alleged clone, "Baby Eve." The case was widely credited for exposing Clonaid, the so-called "human cloning company" as a sham. This case, and the media attention which ensued, allowed Mr. Siegel to meet with scientists and policy experts to discuss the need for legal and policy advocates for the scientific community. This led to Mr. Siegel's founding of the Genetics Policy Institute and his commitment to advocacy work on behalf of patients, doctors and researchers involved with the regenerative medicine community.
In 2003, he traded his 30-year courtroom career to found GPI and Stem Cell Action Coalition, which leads a global "Pro-Cures Movement." With the leadership of world-class advisory boards, GPI has filed briefs in federal litigation pertaining to stem cell funding and organized key meetings aimed at uniting the global stem cell community. In 2004, Mr. Siegel played a pivotal role in galvanizing a global movement that successfully lobbied the United Nations to reject a treaty that called for a prohibition of nuclear transfer, or therapeutic cloning.
As a recognized policy expert on stem cell research, regenerative medicine and cloning, Mr. Siegel works with the world's leading stem cell researchers and advocates. He works with grassroots activists throughout the United States, raising public awareness and educating lawmakers, the media and public on stem cells and regenerative medicine. Back to top.
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| ||Aleksander Skardal, PhD|
Assistant Professor, Wake Forest Institute for Regenerative Medicine
Skardal received his B.Sc. from Johns Hopkins University in 2005 and his Ph.D.
from the University of Utah in 2010. He joined the Wake Forest Institute
for Regenerative Medicine in 2010 initially focusing on the application of
hydrogel biomaterials for wound healing cell therapies and fabrication of
environments for modulating stem cell behaviors and primary cell viability and
function in vitro. His current research continues to apply
hydrogel biomaterials within the framework of several areas including:
biofabrication of microtissue "organoids" for diagnostics (aka
"Body-on-a-Chip"), host tissue organoids for in vitro modeling
of metastasis phenomena and mechanisms, integration with microfluidic systems,
and naturally-derived hydrogels for cell-free wound healing therapies. Back to top.
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| ||Julie Watson, JD|
Marshall, Gerstein & Borun, LLP
Julie M. Watson, special counsel at Marshall Gerstein & Borun LLP, concentrates on counseling related to intellectual property transactions with a particular emphasis in technology startups and university technology transfer. A licensing professional with over 25 years experience structuring complex intellectual property transactions in-house, Ms. Watson has a deep appreciation of clients’ needs and knows how to deliver strategic solutions. Ms. Watson manages the intellectual property program for the Wake Forest Institute for Regenerative Medicine, where she served as director of intellectual property and legal counsel prior to joining Marshall Gerstein & Borun. Ms. Watson holds a J.D., cum laude, from Wake Forest University Law School and is admitted to practice law in Illinois, North Carolina and before the USPTO. She holds an MA from Johns Hopkins University and is a Certified Licensing Professional™ (CLP), a credential issued by the Licensing Executives Society (LES) (USA and Canada), Inc. Ms. Watson is a frequent speaker and active participant in professional licensing organizations and has authored more than 50 national presentations and publications including peer-reviewed articles. Back to top.
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| ||David Williams, DSc|
and Director of International Affairs, Wake Forest Institute for Regenerative
Professor Williams has had 45 years experience
in biomaterials, medical device and tissue engineering. During his career he
has published over 30 books and 400 papers: his latest book, Essential
Biomaterials Science will be published by Cambridge University Press in June
2014. He has been Editor-in-Chief of Biomaterials,
the world’s leading journal in this field since 2000. He has received the major
awards from the US, European and Indian societies of biomaterials including the
Founders Award of the US Society for Biomaterials in 2007, and received the
prestigious Acta Biomaterialia Gold Medal in 2012. In 1999 he was elected as a Fellow of the Royal Academy of Engineering and is a Foreign Fellow of the Indian National Academy of Engineering and a Fellow of the American Institute of Medical and Biological Engineering, all in recognition of his contributions to engineering in medicine. He is currently global President of the Tissue Engineering & Regenerative Medicine International Society.
Professor Williams left the University of
Liverpool, UK, in 2007, where he had been Head of Clinical Engineering,
Director of the UK Centre for Tissue Engineering and Pro Vice Chancellor of the
University. While retaining the title of Emeritus Professor at Liverpool, he is
currently Professor and Director of International Affairs, Wake Forest
Institute of Regenerative Medicine, North Carolina, USA. In addition, he is a Visiting Professor in the Christiaan Barnard Department of Cardiothoracic Surgery, Cape Town, South Africa, a Visiting Professorial Fellow at the Graduate School of Biomedical Engineering, University of New South Wales, Australia, and a Guest Professor, at Tsinghua Universities, Beijing, and Advisory Professor at Shanghai Jiao Tong University, China. He is Visiting Chair Professor of Biomedical Materials, Taipei Medical University, Taiwan. In Cape Town, along with Professor Peter Zilla, the current Chris Barnard Professor of Surgery, he has formed a company that will produce low cost but high technology medical devices that can be used with minimally invasive procedures to treat young adults in sub-Sarah Africa, who currently have no therapies available to them. Back to top.
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