Regenerative Medicine Essentials Course

Course Instructors

The 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

Lynn Allen-Hoffmann, PhD
Professor, Department of Pathology and Laboratory Medicine, University of Wisconsin

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

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

Karl-Erik Andersson, MD, PhD
Professor, Wake Forest Institute for Regenerative Medicine

Joseph Andrews, PhD
Director, Human Research Protection Program and Institutional Review Board, Wake Forest School of Medicine

Joydeep Basu, PhD
Director, Process Research and Translation, Tengion

Colin Bishop, PhD
Professor, Wake Forest Institute for Regenerative Medicine

Khalil Bitar, PhD
Professor, Wake Forest Institute for Regenerative Medicine

George Christ, PhD
Professor, Wake Forest Institute for Regenerative Medicine

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

John Fisher, PhD
Professor and Associate Chair, Fischell Department of Bioengineering, University of Maryland

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

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

Deepak Jain, PhD
Chief Technology Officer, Tengion

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

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

Kristina Lauritsen, PhD
Senior Scientific Reviewer, Office of Combination Products, Food and Drug Administration

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

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

Brian Moore, MS
Assistant Director, Human Research Protection Program and Institutional Review Board, Wake Forest School of Medicine

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

Emmanuel Opara, PhD
Professor, Wake Forest Institute for Regenerative Medicine

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

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

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

Jan Wagner, DVM, PhD
Professor of Pathology, Emeritus, Wake Forest School of Medicine

William Wagner, PhD
Director, McGowan 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

James Yoo, MD, PhD
Professor, Associate Director and Chief Scientific Officer, Wake Forest Institute for Regenerative Medicine

 

Course Instructors

 

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

Anthony Atala, M.D., 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, The Journal of Rejuvenation Research, and Gene Therapy and Regulation; as Executive Board Member or Section Editor of the journal Tissue Engineering, International Journal of Artificial Organs, and Current Urology Reports; and as Editorial Board member of Expert Opinion on Biological Therapy, Biomedical Materials, Journal of Tissue Science and Engineering, the Journal of Urology, Recent Patents on Regenerative Medicine, BioMed Central-Urology, and Urology.

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, 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,  and the Gold Cystoscope award from the American Urological Association for advances in the field. In 2011 he was elected to the Institute of Medicine of the National Academy of Sciences.  Dr. Atala 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.  A Time Magazine poll ranked Dr. Atala as the 56th most influential person of the year 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, and in Time Magazine as one of the top 5 medical breakthroughs of the year.

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 approximately 300 physicians and researchers.  Ten applications of technologies developed in Dr. Atala's laboratory have been used clinically. He is the editor of thirteen books, including Principles of Regenerative Medicine, Foundations of Regenerative Medicine, Methods of Tissue Engineering, and Minimally Invasive Urology. He has published more than 300 journal articles and has applied for or received over 200 national and international patents. Back to top.
   
AllenHoffman Lynn Allen-Hoffmann, PhD
Professor, Department of Pathology and Laboratory Medicine, University of Wisconsin

Lynn Allen-Hoffmann has been Professor of Pathology at the University of Wisconsin Medical School since 1988 and has received continuous funding from the National Institutes of Health for her research program. She has extensive leadership experience and previously directed a multi-college Center at the University of Wisconsin-Madison. Dr. Allen-Hoffmann is the Founder, CEO, Chief Science Officer and a Director of Stratatech Corporation. Stratatech is a regenerative medicine company focused on the commercialization of novel skin substitute products for therapeutic and research use. The company was founded in 2000 to commercialize an extraordinary discovery made at the University of Wisconsin-Madison. The discovery of NIKS® cells – a human keratinocyte cell line that produces living tissue nearly identical to native human skin – has the potential to revolutionize wound care. 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.
   
Karl Erik Andersson Karl-Erik Andersson, MD, PhD
Professor, Wake Forest Institute for Regenerative Medicine

Dr. Karl-Erik Andersson was born and raised in Sweden. He received his medical degree from the University of Lund in 1968, where he subsequently worked as a lecturer in Clinical Pharmacology. He completed his Ph.D. at the Department of Pharmacology, Lund University, in 1973. In 1975 he obtained a Swedish specialist degree in Internal Medicine and was appointed as Professor of Clinical Pharmacology at the University of Odense, Denmark. From 1976 to 1978 he had the same position at the University of Aarhus, Denmark. From 1978-2006 he was Professor and Chairman of the Department of Clinical Pharmacology, University of Lund, Lund, Sweden. He has been visiting professor at the Department of Obstetrics and Gynaecology, University of Toronto (1983-1985) and at the Department of Urology, University of Virginia, Charlottesville, USA (1997-1998). From 1993 to 2000 Dr. Andersson was elected Research Dean of the Medical Faculty at the University of Lund. He is a member of many international societies including the American Urological Association, the European Association of Urology, and the International Society for Sexual and Impotence Research. He also serves on the Editorial Boards of several journals including Urology, European Urology, Neurourology and Urodynamics, International Journal of Impotence Research, and British Journal of Pharmacology. During his career, Dr. Andersson has authored more than 700 articles in peer-reviewed international journals. Back to top.
   
Andrews Joseph Andrews, PhD
Director, Human Research Protection Program and Institutional Review Board, Wake Forest School of Medicine

Joseph E. Andrews, Jr., PhD is the Director of the Human Research Protection Program (HRPP) and Institutional Review Board (IRB) at Wake Forest School of Medicine. Dr. Andrews coordinates the ethical and regulatory oversight of approximately 2400 active biomedical research projects. He also serves as a liaison between the research community and institutional leaders and works with these groups on matters policy development and implementation. Back to top.
   
Basu Joydeep Basu, PhD
Director, Process Research and Translation, Tengion

Joydeep Basu is Director of Process Research and Translation at Tengion, Inc. Current interests and responsibilities include potency assay, bio-distribution and mechanism of action for Tengion’s clinical product candidates Neo-Urinary Conduit (NUC) and Neo-Kidney Augment (NKA). Joydeep also led development of Tengion’s Neo-Esophagus and Neo-Intestine pre-clinical programs. Prior to joining Tengion in 2008, Joydeep spearheaded preclinical translation of Multistem and led development of the human artificial chromosome gene therapy platform at Athersys, Inc. Joydeep received his PhD from Cornell University in 1999 and his BA from the University of Cambridge in 1993. Back to top.
   
Colin Bishop Colin Bishop, PhD
Professor, Wake Forest Institute for Regenerative Medicine

Dr. Colin Bishop was born in Portsmouth, England. He received his Ph.D in Immunogenetics in 1979 from the Department of Immunology, London Hospital Medical College, University of London. After a postdoctoral fellowship at the Netherlands Cancer Institute, Amsterdam, he moved to the Institute Pasteur, Paris in 1981 where he worked on the genetics of sex-determination. In 1990 he moved to the University of Tennessee, Memphis where he was Professor in the Departments of Obstetrics & Gynecology and Microbiology & Immunology, and Director of basic research for the OB/GYN laboratories. In 1993 he returned to France to direct the INSERM (NIH equivalent) research unit 406 “Medical Genetics and Development” at the La Timone Hospital, Marseille. He was also a founding member of the “Developmental Biology Institute of Marseille-Luminy” (IBDM). After 3 years he returned to the USA to take up the position of Professor at Baylor College of Medicine, Houston in the Department of Obstetrics & Gynecology, with a joint appointment as Professor in the Department of Molecular & Human Genetics. He also directed the basic research program for OB/GYN Laboratories. He joined WFIRM in September 2006 and directs the genetics and developmental biology component of the Institute. Back to top.
   
Khalil Bitar Khalil Bitar, PhD
Professor, Wake Forest Institute for Regenerative Medicine

Dr. Khalil N. Bitar grew up in Beirut, Lebanon. After graduation from the American University of Beirut (AUB), he pursued a career in Neurogastroenterology. He obtained his Masters in Physiology with emphasis on neurophysiology from the Universite de Provence (Marseilles, France) under Professeur Claude Roman and trained with Professeur Noel Mei at the Centre National de la Recherche Scientifique (CNRS) at the Institut De Neurophysiologie Vegetative (INP1). After obtaining his PhD in 1976, Dr. Bitar immigrated to the USA, trained with Dr Gabriel Makhlouf at the Medical College of Virginia and became a faculty member there. Dr. Bitar then moved to the University of Michigan where he spent 22 years directing the GI molecular motors laboratory at the Medical School. He has received several awards, including the Research Scientist Achievement Award and the League of Research Excellence from the University of Michigan, and was inducted as a Fellow of the American Gastroenterological Association. Back to top.
   
George Christ George Christ, PhD
Professor, Wake Forest Institute for Regenerative Medicine

Dr. Christ received his Ph.D. in Pharmacology at Wake Forest University in 1987, and then did a postdoctoral fellowship in the Department of Pharmacology at Mount Sinai Medical Center in NYC. From 1989 until 2004 he was a faculty member at the Albert Einstein College of Medicine in the Bronx, NY, with appointments in the Departments of Urology, Physiology and Biophysics. 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.
   
Fisher John Fisher, PhD
Professor and Associate Chair, Fischell Department of
Bioengineering, University of Maryland


Dr. John P. Fisher is Fischell Family Distinguished Professor and Associate Chair for Graduate Studies in the Fischell Department of Bioengineering at the University of Maryland.  Fisher completed a B.S. in 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).

Fisher, the Director of the Tissue Engineering and Biomaterials Laboratory, investigates biomaterials, stem cells, and bioreactors for the regeneration of lost tissues, particularly bone, cartilage, vasculature, and skeletal muscle.  Dr. Fisher’s research focuses on the development of biomaterials that can support the development of both progenitor and stem cells.  The lab examines questions related to how biomaterials affect endogenous signaling among embedded cells as well as the interactions between stem cells and host vascularization. The lab is supported by research grants from NIH, FDA, NSF, and other institutions, and has produced approximately 90 publications, 200 scientific presentations, and 8 patents.  Fisher has been the research advisor to 3 M.S. students and 11 Ph.D. students.  In addition, Fisher has mentored over 50 undergraduate researchers, including 2 who were named University of Maryland Outstanding Undergraduate Researchers, 4 who have received Howard Hughes Medical Institute Undergraduate Research Fellowships, and 18 supported by Maryland Technology Enterprise Institute ASPIRE Awards.

In 2012 Fisher was elected Fellow of the American Institute for Medical and Biological Engineering.  In addition, Fisher has received a NSF CAREER Award (2005), the Arthritis Foundation’s Investigator Award (2006), the University of Maryland Invention of the Year Award (2006), the Outstanding Graduate Alumnus Award from the Department of Bioengineering at Rice University (2007), the Engalitcheff Award from the Arthritis Foundation (2008), the University of Maryland Professor Venture Fair Competition (2009 & 2013 with A. Melchiorri), and the Teaching Excellence Award from the Fischell Department of Bioengineering at the University of Maryland (2011).

From 2007 to 2012 Fisher directed NSF supported Molecular and Cellular Bioengineering Research Experiences for Undergraduates Site.  Fisher has served as editor of several works, and is currently the Editor-in-Chief of the journal Tissue Engineering, Part B: Reviews.  Fisher has edited 2 books, and was the tissue engineering editor for the third edition of The Biomedical Engineering Handbook (2006).  In 2014, Fisher will co-chair the Tissue Engineering and Regenerative Medicine International Society – Americas Chapter Annual Meeting in Washington, DC. 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.
   
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.
   
Jain Deepak Jain, PhD
Chief Technology Officer, Tengion

Dr. Jain joined Tengion in 2004. and has over 28 years of experience in biotechnology, tissue engineering and regenerative medicine bioprocess research & development and GMP manufacturing. Before joining Tengion, Dr. Jain was Executive Director of Process Development and Manufacturing Technical Support at Advanced Tissue Sciences responsible for development of human-based tissue products for therapeutic applications in the skin, cartilage and cardiovascular areas. Dr. Jain has held several positions of increasing technical and management responsibility at Merck and Johnson & Johnson, leading the development of biotechnology products with a focus on recombinant proteins. Dr. Jain was instrumental in the development and manufacturing support of J&J’s multi-billion dollar product for the treatment of anemia. More recently, Dr. Jain was as a full-time consultant for Baxter Corporation responsible for establishing a commercial manufacturing facility overseas for a marketed recombinant protein. Dr. Jain is accomplished at directing product development from research to the clinic, process scale-up, technology transfers, GMP facility design, process validation and manufacturing of biotechnology-derived recombinant proteins and tissue engineered regenerative medicine products. He is highly experienced in regulatory CMC submissions for biologics, devices and combination products. Since joining Tengion in 2004, Dr. Jain has been responsible for bioprocess research & development and clinical manufacturing. Dr. Jain serves as the Chairman of Cell Therapy Ad hoc Advisory Panel for United States Pharmacopoeia and is a member of USP’s Biologics & Biotechnology Expert Committee. Dr. Jain has also served as Chairman of the American Society for Testing and Materials Task Group on Preservation of Cells and Tissue Engineered Medical Product’s with Cells. Dr. Jain has over 40 publications, presentations and abstracts, two book chapters and many patents in the field biologics, tissue engineering and regenerative medicine. Dr. Jain received a PhD from the Indian Institute of Technology, Delhi in Biochemical Engineering. 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.
   
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.
   
Lauritsen Kristina Lauritsen, PhD
Senior Scientific Reviewer, Office of Combination Products, Food and Drug Administration


Kristina Lauritsen, PhD is a regulatory health scientist in the FDA’s Office of Combination Products (OCP), which resides in FDA’s Office of Medical Products and Tobacco. Dr. Lauritsen’s primary focus is in providing scientific input on matters of product classification (drug, device, biologic, or combination product), product assignment, and associated regulatory policy. She received her Ph.D. from Georgetown University (tumor biology) and her B.S. from Shippensburg University (biology). Dr. Lauritsen has over 10 years of experience in regulatory science, having originally joined the FDA in 2003 as a premarket reviewer in the Center for Devices and Radiological Health, Office of Device Evaluation. She has been with OCP for the past seven years. 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.
   
Mills C. Randal Mills, PhD
President and Chief Executive Officer, California Institute for Regenerative Medicine

C. Randal Mills, PhD, is President and Chief Executive Officer of the California Institute for Regenerative Medicine (CIRM). Prior to joining CIRM in May 2014, Mills was the former President and CEO of Osiris Therapeutics. Under Mills’ leadership Osiris developed the world’s first approved stem cell drug, remestemcel-L for graft versus host disease in children, a devastating complication of bone marrow transplantation that can be fatal. Mills, a member of the stem cell agency’s Grant Review Board for the past five years, was at Osiris for almost ten years before stepping down last December. Prior to that he served in several executive leadership roles with RTI Biologics Inc., and was a founding member of that company’s predecessor, the University of Florida Tissue Bank. He also served, at the appointment of the U.S. Secretary of Health and Human Services, as a voting member of the National Institutes of Health and AIDS Research Advisory Council and was vice chairman of the American Association of Tissue Bank’s Standards Committee. Mills has a bachelor’s degree in microbiology and cell science and a Ph.D. in drug development from the University of Florida. Back to top.
   
Moore Brian Moore, MS
Assistant Director, Human Research Protection Program and Institutional Review Board, Wake Forest School of Medicine

Brian Moore currently serves as the Assistant Director of the Human Research Protection Program and Institutional Review Board at the Wake Forest School of Medicine. Mr. Moore has over 12 years of experience in the design, conduct, and review of clinical research, and has co-authored over 20 scientific abstracts and/or manuscripts. He completed his graduate studies at Wake Forest University. 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.
   
Opara Emmanuel Opara, PhD
Professor, Wake Forest Institute for Regenerative Medicine

Dr. Emmanuel C. Opara was originally trained as a clinical biochemist at the University of Surrey, Guildford Surrey, England, where he received his M.Sc degree. He obtained his Ph.D from the University of London, England in 1984 when he came to the U.S as a W.H.O Fellow in Endocrinology/Metabolism at the Mayo Clinic in Rochester, MN. From there, he proceeded to the NIDDK of the National Institutes of Health in Bethesda, MD where he served as a Visiting Fellow from 1986 to 1988 when he was recruited to the faculty of the Department of Surgery at Duke University Medical Center, Durham, NC. In 2003 he joined the faculty of the Pritzker Institute of Biomedical Science and Engineering at the Illinois Institute of Technology, Chicago while serving as Senior Investigator in the Human Islet Transplant Program at the University of Chicago.

Dr. Opara serves as Associate Editor for Pancreas and as a reviewer for more than thirty peer-reviewed scientific and medical journals. Dr. Opara has led or served on numerous professional and government committees, including National Institutes of Health, the US Food & Drugs Administration, and Centers for Disease Control Study Sections. He is a member of many Professional associations and has organized and chaired several symposia for the American Federation of Medical Research. He has several patents dealing with cell microencapsulation procedures and devices. He has received many honors and awards, including the Distinguished Service Award of the Society of Black Academic Surgeons in 2007. 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.
   
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.
   
Jan Wagner Jan Wagner, DVM, PhD
Professor of Pathology, Emeritus, Wake Forest School of Medicine

Dr. Wagner is currently a Professor Emeritus in the Dr. Wagner is currently a Professor Emeritus in the Department of Pathology at Wake Forest School of Medicine. She joined the Wake Forest University Medical Center in 1985. She obtained her Ph.D. from the WFU Bowman Gray School of Medicine and joined the faculty in Comparative Medicine in 1989. Dr. Wagner is board-certified by the American College of Laboratory Animal Medicine (ACLAM).  She is currently the Chair of the Board for the North Carolina Association for Biomedical Research, and a member of the Board of Trustees for the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC).

Dr. Wagner was the Vice President and Senior Associate Dean for Research at Wake Forest Baptist Health with responsibilities to improve operational excellence and to expand opportunities for WFU faculty to excel in grant acquisition, research, and scholarship. In this position, she was charged with fostering and facilitating research funding opportunities, creating linkages between and among faculty to generate new partnerships, and executing the research strategic plan. Her role was to partner with the school of medicine’s dean in broadening and executing the vision of science and research at both the school and the medical center overall and assuring research compliance throughout the medical center.

Previously, Dr. Wagner was the Associate Dean for Research and Director of the Animal Resources Program (ARP) and led a team through numerous successful visits for the Association for the Assessment and Accreditation of Laboratory Animal Care, International (AAALAC). In 2011, the Office of Research team also received their first time accreditation for the Association for the Accreditation of Human Research Protection Program (AAHRPP). Dr. Wagner was the Institutional Official for both human and animal subject research and these accreditations assure the highest standards in biomedical research.

Dr. Wagner was professor with tenure in the Department of Pathology/Comparative Medicine, an associate in the Institute for Regenerative Medicine, and member of the Diabetes Research Center. She was also the Training Director for veterinarians in Comparative Medicine and worked to expanded training programs for veterinarians interested in translational and biomedical research.

Dr. Wagner’s research interests are in diabetes, lipids and cardiovascular disease, nutrition, and women's health. She has developed a research portfolio involving translational diabetes research using primate models of obesity and diabetes and has been continually funded through NIH and industry partners since 1991.  Dr. Wagner has published over 120 manuscripts and book chapters and has given over 100 talks around the world. She has also established funding opportunities with industry partners for preclinical studies assessing more than 60 drug candidates. Back to top. 
   
WWagner William Wagner, PhD
Director, McGowan Institute for Regenerative Medicine

Dr. William R. Wagner is a Professor of Surgery, Bioengineering and Chemical Engineering and serves as the Director of the McGowan Institute for Regenerative Medicine at the University of Pittsburgh.  He also serves as Deputy Director of the NSF Engineering Research Center on “Revolutionizing Metallic Biomaterials”.  He holds a B.S. (Johns Hopkins, 1986) and Ph.D. (University of Texas, 1991) in chemical engineering and has been on the faculty at the University of Pittsburgh since 1991.  Dr. Wagner's research interests are generally in the area of cardiovascular engineering with projects that address medical device biocompatibility and design, tissue engineering, and targeted imaging.

Professor Wagner is the Founding Editor and Editor-in-Chief of one of the leading biomaterials and biomedical engineering journals, Acta Biomaterialia, and currently serves on the editorial boards of the Journal of Biomedical Materials Research part A, Biotechnology and Bioengineering, the Journal of Tissue Engineering and Regenerative Medicine, Experimental Biology and Medicine and the executive advisory editorial board for Organogenesis.  Dr. Wagner is a past president of the American Society for Artificial Internal Organs (ASAIO; 2010) and serves on the Executive Board of the International Federation of Artificial Organs (IFAO; 2009). He is a fellow and former vice president of the American Institute for Medical and Biological Engineering (AIMBE; 2000) and has also been elected a fellow of the Biomedical Engineering Society (BMES; 2007), American Heart Association (2001), and the International Union of Societies for Biomaterials Science and Engineering (IUSBSE; 2008).  In 2009 he was selected as the Society for Biomaterials representative to the IUSBSE.  He has served as Chairman for the Gordon Research Conference on Biomaterials: Biocompatibility & Tissue Engineering, the First World Congress of the Tissue Engineering and Regenerative Medicine International Society (TERMIS) as well as the 2013 BMES Annual Meeting.  Dr. Wagner currently serves as the TERMIS Chair-Elect of the Americas Region.  His recent recognitions have included the 2011 Society for Biomaterials Clemson Award for Applied Research, the 2012 Chancellor’s Distinguished Research Award from the University of Pittsburgh and the Senior Scientist Award from TERMIS Americas.  Dr. Wagner’s research has generated numerous patents and patent filings that have resulted in licensing activity, the formation of a company, and University of Pittsburgh Innovator Awards in 2007, 2008, 2009, and 2010. Back to top.
   
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. He received the prestigious. In 1999 he was elected as a Fellow of the Royal Academy of Engineering 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 and the National University of Singapore.  He Visiting Chair Professor of Biomedical Materials, Taipei Medical University, Taiwan, and a Visiting Professor, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, India. 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.
   
Yoo James Yoo, MD, PhD
Professor, Associate Director and Chief Scientific Officer, 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. Back to top.

 

 

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