Regenerative Medicine Essentials Course

Course Instructors

The 2015 Regenerative Medicine Essentials course will feature prominent members of the Wake Forest Institute for Regenerative Medicine (WFIRM) faculty along with distinguished invited guests. See a complete list of course instructors below and click on their names to see detailed bios.

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

Julie Allickson, PhD
Director, Translational Research, Wake Forest Institute for Regenerative Medicine

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

Tim Bertram, DVM, PhD
President, Research and Development and Chief Scientific Officer, Tengion

Ed Field, MBA
Chief Operating Officer, Cytomedix, Inc.

Beth Fordham-Meier
Principal and Founder, NovoCreation Consulting, LLC

Xiaosong Gu, MD
Director, Jiangsu Key Laboratory of Neuroregeneration of Nantong University

Scott Guelcher, PhD
Associate Professor of Chemical and Biomolecular Engineering, Vanderbilt University

Ben Harrison, PhD
Associate Professor, Chief of Laboratory Operations, Wake Forest Institute for Regenerative Medicine

John Jackson, PhD
Associate Professor, Wake Forest Institute for Regenerative Medicine

Peter C. Johnson, MD
Vice President, Research and Development and Medical Affairs, Vancive Medical Technologies

Nancy King, JD
Co-Director, Center for Bioethics, Health and Society, Wake Forest University

Susan Kornetsky, MPH
Children's Hospital Boston

Joanne Kurtzberg, MD
Director, Pediatric Blood and Marrow Transplant Program, Duke University Medical Center

Jeanne F. Loring, PhD
Director, Center for Regenerative Medicine at The Scripps Research Institute

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

Todd McAllister, PhD
Co-Founder and CEO, Cytograft Tissue Engineering, Inc.

C. Randal Mills, PhD
President and Chief Executive Officer, California Institute for Regenerative Medicine

Sean Murphy, PhD
Post-Doctoral Fellow, Wake Forest Institute for Regenerative Medicine

Thinh Nguyen, PhD
Food and Drug Administration

Amit N. Patel, MD, MS
Director, Clinical Regenerative Medicine and Tissue Engineering at the University of Utah

Chris Porada, PhD
Associate Professor, Wake Forest Institute for Regenerative Medicine

Mahendra Rao, MD, PhD
Vice President, New York Stem Cell Foundation

Buddy Ratner, PhD
Director, University of Washington Engineered Biomaterials Engineering Research Center

Bernard Siegel, JD
Genetics Policy Institute

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

Julie Watson, JD
Special Counsel, Marshall, Gerstein & Borun, LLP

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

 

Course Instructors

 

Anthony Atala Thumbnail 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 Julie Allickson, PhD
Director, Translational Research, 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.
   
Almeida Porado 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.
   
 Bertram 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.
   
 Field Ed Field, MBA
Chief Operating Officer, Cytomedix, Inc.

Ed Field currently is the Chief Operating Officer of Cytomedix, Inc. (OTCBB:CMXI), a US-based company that is developing and commercializing autologous regenerative biotherapies that promote healing by harnessing the innate regenerative capacity of platelets and adult stem cells. Mr. Field had been the President and COO of Aldagen, Inc. prior to its acquisition by Cytomedix in February 2012. Mr. Field had been instrumental in the advancement of Aldagen's clinical-stage products, the establishment of internal manufacturing operations and the raising of venture capital to support its operations. 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 is the Treasurer of the Alliance for Regenerative Medicine and the Chair of its Capital Formation Committee. He also serves as the Chairman of the North Carolina Biotechnology Association. Back to top.
   
Fordham Meier Beth Fordham-Meier
Principal 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 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 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.
   
Harrison 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 John Jackson, PhD
Associate Professor, Wake Forest Institute for Regenerative Medicine

Dr. John D. Jackson is an Associate Professor in the Institute for Regenerative Medicine at Wake Forest School of Medicine. He received his Ph.D. degree in Medical Sciences (Experimental Hematology) from the University of Nebraska Medical Center. He served as Technical Director of the Cell Processing Laboratory at the University of Nebraska Medical Center which provided support for the bone marrow transplantation program.  His research interests are in the area of stem cell biology with particular emphasis on the use of stem cell populations in tissue and organ regeneration. He is a member of Tissue Engineering and Regenerative Medicine International Society (TERMIS). Back to top.
   
Peter C Johnson 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.
   
King Nancy King, JD
Co-Director, Center for Bioethics, Health and Society, Wake Forest University

Nancy M. P. King, JD, is Professor, Department of Social Sciences and Health Policy and Wake Forest Institute for Regenerative Medicine at Wake Forest School of Medicine, and Co-Director of the Center for Bioethics, Health, and Society and the Graduate Program in Bioethics at Wake Forest University.  Her scholarship addresses a range of bioethics issues, including: informed consent in health care and research; medical decisions at the beginning and end of life; the development and use of experimental technologies; preclinical and animal research; international and cross-cultural questions in human subjects research; benefit and uncertainty in human subjects research; ethical issues in large-scale genetic research and biobanking, gene transfer research, and regenerative medicine; and connections between science, ethics, design, and policy in biotechnology research.  She has published over 100 scholarly articles and book chapters, and is co-editor of The Social Medicine Reader (2nd ed., Duke University Press, 2005), Beyond Regulations: Ethics in Human Subjects Research (UNC Press 1999), and Bioethics, Public Moral Argument, and Social Responsibility (Routledge 2012).  She has served on hospital ethics committees, IRBs, DSMBs and the NIH Recombinant DNA Advisory Committee, and has taught research ethics in national and international settings. Back to top.
   
  Susan Kornetsky, MPH
Children's Hospital Boston
   
Kurtzberg Joanne Kurtzberg, MD
Director, Pediatric Blood and Marrow Transplant Program, Duke University Medical Center

Dr. Joanne Kurtzberg is an internationally renowned expert in pediatric hematology/oncology, pediatric blood and marrow transplantation, umbilical cord blood banking and transplantation, and novel applications of cord blood in the emerging fields of cellular therapies and regenerative medicine. Dr. Kurtzberg pioneered the use of umbilical cord blood as an alternative stem cell source for unrelated hematopoietic stem cell transplantation (HSCT). Over the last two decades Dr. Kurtzberg has established an internationally known pediatric transplant program at Duke which treats children with cancer, blood disorders, immune deficiencies, hemoglobinopathies and inherited metabolic diseases. In 2010, Kurtzberg established the Julian Robertson Cell and Translational Therapy Program (CT2) at Duke.  CT2 focuses on translational studies from bench to bedside with a focus on bringing cellular therapies in regenerative medicine to the clinic. Recent areas of investigation in CT2 include the use of autologous cord blood in children with neonatal brain injury and cerebral palsy, as well as preclinical studies manufacturing oligodendrocyte-like cells from cord blood to treat patients with acquired and genetic brain diseases. Studies of autologous bone marrow ALDHbright cells in adults with stroke and radiation induced brain injury are also underway.  Plans are ongoing to extend this work to the use of autologous cord blood in a study of young children with Autism Spectrum Disorder.

Dr. Kurtzberg established one of the largest unrelated donor cord blood bank, the Carolinas Cord Blood Bank, in the world at Duke in 1998.  The bank has a current inventory of >40,000 units and has provided cord blood units to over 2,200 patients undergoing unrelated donor HSCT over the past 10 years. Dr. Kurtzberg’s lab has developed novel assays to predict cord blood potency from segments attached to cryopreserved cord blood units, and is performing translational research testing cord blood expansion, cellular targeted therapies and tissue repair and regeneration. In 2012, under the direction of Dr. Kurtzberg, the Carolinas Cord Blood Bank received FDA approval for DuCord, a stem cell product derived from umbilical cord blood, for use in transplants between unrelated donors and recipients. Dr. Kurtzberg currently holds several INDs for investigational clinical trials.

Dr. Kurtzberg has published over 300 peer-reviewed papers, multiple chapters and scientific reviews.  She is a member of the American Society of Hematology, the American Association of Blood and Marrow Transplantation, the American Society of Pediatric Hematology/Oncology, the International Society of Cellular Therapies, the Pediatric Blood and Marrow Transplant Consortium (PBMTC), and other organizations.  She serves on the Board of the Foundation of Accreditation of Cellular Therapies, co-chairs the National Marrow Donor Program’s Cord Blood Advisory Group and is a member of the Advisory Council of Blood Stem Cell Transplantation to Health and Human Services.  Dr. Kurtzberg was awarded a Lifetime Achievement Award from the PBMTC in 2012. Back to top.
   
Jeanne Loring 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.
   
Marini Frank Marini, PhD
Professor, Wake Forest Institute for Regenerative Medicine

Dr. Frank Marini, is a stem cell biologist who focuses on identifying stem cells in the development of cancer. His work involves novel non-invasive and invasive imaging techniques to track and identify cells while they participate in wound healing and tumor development. He currently heads the Center for Regenerative Imaging, and is a Professor of Regenerative Medicine and Cancer Biology at Wake Forest Institute for Regenerative Medicine. Back to top.
   
Todd McAllister 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.
   
Randal Mills 2015 C. Randal Mills, PhD
President 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.
   
Murphy Sean Murphy, PhD
Post-Doctoral 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
Food and Drug Administration
   
 Amit Patel 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.
   
Porada Chris Porada, PhD
Associate Professor, Wake Forest Institute for Regenerative Medicine

Dr. Christopher Porada received his Bachelor’s in Molecular Biology from Colgate University in 1991 and his PhD in Cellular and Molecular Pharmacology and Physiology from the University of Nevada in 1998. After completing his PhD, he served as an Assistant and then Associate Professor in the Department of Animal Biotechnology at the University of Nevada, Reno. He has authored over 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.
   
Rao 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 Picture 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.
   
  Bernard Siegel, JD
Genetics Policy Institute
   
Skardal Aleksander Skardal, PhD
Assistant Professor, Wake Forest Institute for Regenerative Medicine

Aleksander Skardal received his B.Sc. from Johns Hopkins University in 2005 and his Ph.D. from the University of Utah in 2010.  He joined the Wake Forest Institute for Regenerative Medicine in 2010 initially focusing on the application of hydrogel biomaterials for wound healing cell therapies and fabrication of environments for modulating stem cell behaviors and primary cell viability and function in vitro.  His current research continues to apply hydrogel biomaterials within the framework of several areas including: biofabrication of microtissue "organoids" for diagnostics (aka "Body-on-a-Chip"), host tissue organoids for in vitro modeling of metastasis phenomena and mechanisms, integration with microfluidic systems, and naturally-derived hydrogels for cell-free wound healing therapies. Back to top.
   
Julie Watson Revised Julie Watson, JD
Special Counsel, 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.
   
Williams David Williams, DSc
Professor and Director of International Affairs, Wake Forest Institute for Regenerative Medicine

Professor Williams has had 45 years experience in biomaterials, medical device and tissue engineering. During his career he has published over 30 books and 400 papers: his latest book, Essential Biomaterials Science will be published by Cambridge University Press in June 2014. He has been Editor-in-Chief of Biomaterials, the world’s leading journal in this field since 2000. He has received the major awards from the US, European and Indian societies of biomaterials including the Founders Award of the US Society for Biomaterials in 2007, and received the prestigious Acta Biomaterialia Gold Medal in 2012. In 1999 he was elected as a Fellow of the Royal Academy of Engineering and is a Foreign Fellow of the Indian National Academy of Engineering and a Fellow of the American Institute of Medical and Biological Engineering, all in recognition of his contributions to engineering in medicine. He is currently global President of the Tissue Engineering & Regenerative Medicine International Society.

Professor Williams left the University of Liverpool, UK, in 2007, where he had been Head of Clinical Engineering, Director of the UK Centre for Tissue Engineering and Pro Vice Chancellor of the University. While retaining the title of Emeritus Professor at Liverpool, he is currently Professor and Director of International Affairs, Wake Forest Institute of Regenerative Medicine, North Carolina, USA. In addition, he is a Visiting Professor in the Christiaan Barnard Department of Cardiothoracic Surgery, Cape Town, South Africa, a Visiting Professorial Fellow at the Graduate School of Biomedical Engineering, University of New South Wales, Australia, and a Guest Professor, at Tsinghua Universities, Beijing, and Advisory Professor at Shanghai Jiao Tong University, China. He is Visiting Chair Professor of Biomedical Materials, Taipei Medical University, Taiwan. In Cape Town, along with Professor Peter Zilla, the current Chris Barnard Professor of Surgery, he has formed a company that will produce low cost but high technology medical devices that can be used with minimally invasive procedures to treat young adults in sub-Sarah Africa, who currently have no therapies available to them. Back to top.
   

 

 

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