| ||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.
| || || |
| ||Rick Blume|
Managing Partner, Excel Medical Ventures, LLC
Rick Blume has been financing
companies in healthcare for over three decades. His early investment banking
career involved financing and banking relationships with hospitals, payers,
physicians, and new biotech companies. The excitement he saw at Genentech, in
its early years, led him to transition into venture capital in the mid 1980's. Rick
co-founded CB Health Ventures in 1998 where he assembled what is now the core
of Excel including Steve Gullans, PhD, and Tricia Moriarty. He is currently on
the board at Saladax Biomedical.
In each of his five prior venture funds Rick has followed the same successful
strategy: invest broadly in healthcare across various sectors and stages and
focus on businesses that lower costs and improve outcomes. By having savvy healthcare
providers as limited partners and advisers, Rick has built up an extraordinary
network to help with due diligence and market acceptance issues.
Rick has served as a director or active investor in many companies including
Lantos Technologies, Cytyc (acquired by Hologic - HOLX), AbT (now OSI - OSIP),
Somatogen (acquired by Baxter - BAX), EdenTec (acquired by Nellcor), Exact
Sciences (EXAS), IPC The Hospitalist Company (IPCM), GeneOhm (acquired by
Becton Dickinson - BDX), Zonare, US Servis (acquired by McKesson); and the
former public health insurance company Washington National. In addition to
Excel, Rick has been active in initiating and teaching courses in venture
capital and entrepreneurship at both Boston College Carroll School of
Management and Simmons College School of Management, and serving on the Boards
of the Chicago Biomedical Consortium, the National Regenerative Medicine
Foundation, and Stanford Associates Board of Governors. Rick did his
undergraduate studies at University of the Pacific and Stanford. His MBA is
from Stanford University. Back to top.
| || || |
| ||Craig L. Duvall, PhD|
Assistant Professor Biomedical Engineering
Advanced Therapeutics Laboratory, Vanderbilt School of Engineering
Dr. Craig Duvall completed his undergraduate studies at the University of Kentucky in 2001 and immediately started his doctoral studies in BME at Georgia Tech and Emory University. His Ph.D. work was jointly directed by Bob Guldberg, a mechanical/biomedical engineer from Georgia Tech, and Bob Taylor, a cardiologist from Emory. In 2007, Dr. Duvall joined the polymeric drug delivery technology labs of Patrick Stayton and Allan Hoffman in Bioengineering at the University of Washington for postdoctoral research. Based on the foundations built from these combined experiences, the Duvall Advanced Therapeutics Laboratory (ATL) was launched in the Vanderbilt Biomedical Engineering Department in 2010. The ATL is funded by grants from NIH, DOD, NSF, AHA, and ADA. Back to top.
| || || |
| || ||Ed Field, MBA|
President, Spine/Disc Division, BioRestorative Therapies
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.
| || || |
| ||Ian Harris, PhD|
Project Development Team Leader at Cell Therapy
Janssen Research & Development LLC
Dr. Ian Harris is currently a Senior Director in Cell Therapy at Janssen Research & Development where he is the Product development team leader for Palucorcel, which is being developed for the treatment of geographic atrophy and has responsibility for the cell platforms including manufacturing process development, mechanism of action and analytical development. Dr Harris has a Ph.D. in Biochemistry & Molecular biology from the University of Leeds in the UK, where his career started in regenerative medicine. Back to top.
| || || |
| ||Rosemarie Hunziker, PhD|
Director of Tissue Engineering and Regenerative Medicine
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
NIH / NIBIB
Rosemarie Hunziker, Ph.D. is the Director of Tissue Engineering and Regenerative Medicine at the National Institute of Biomedical Imaging and Bioengineering (NIBIB) within the National Institutes of Health (NIH) in the US Department of Health and Human Services (DHHS). In that capacity she has programmatic oversight of discovery and applied research grants.
Dr. Hunziker brings a diverse background to this broad sphere of research. After receiving a Bachelor of Science in Microbiology from the Philadelphia College of Pharmacy and Science (now the University of the Sciences in Philadelphia), she set off to study the complex antigenic profile of bovine lymphocytes and earn a Master of Science in Immunogenetics from Ohio State University. Her Ph.D. work with Tom Wegmann at the University of Alberta involved analysis of the cell surface immunogens at the maternal-fetal interface. Post-doctoral training at the Laboratory of Immunology, National Institutes of Allergy and Infectious Diseases (NIAID/NIH) focused on the generation of transgenic mouse models of histocompatibility antigen variants to study mechanisms of immune recognition and tolerance. Rosemarie set up the NIAID's Transgenic Mouse Facility at the FCRDC in Fort Dietrick, MD to supply intramural scientists with mouse lines engineered to express their protein of choice. After organizing and running that effort for seven years, she left NIH to join the Advanced Technology Program (ATP) at the National Institute of Standards and Technology (NIST, Department of Commerce). ATP awarded grants to for-profit companies for high-risk R&D. There she was a Program Manager in the Chemistry and Life Science Office, with responsibilities to monitor and advance the life science portfolio, with particular emphasis on Tissue Engineering.
After a brief stint in private consulting advising biotechnology companies on strategic use of federal research grants to advance their business goals, Rosemarie returned to NIH in 2004 to help accelerate technology transfer at the National Institute of Dental and Craniofacial Research (NIDCR) and oversee the Dental Biomaterials portfolio. In January, 2007 she moved to her current position at the NIBIB. She is committed to nurturing discovery science and realizing the practical benefits of the exciting developments at the forefront of cell-based tools and therapies. 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.
| || || |
| ||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.
| || || |
| ||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.
| || || |
| ||Ki-Blum Lee, PhD|
Associate Professor, Chemistry and Chemical Biology
Ki-Bum Lee is an associate professor of Chemistry and Chemical Biology at Rutgers University, where he has been a faculty since 2008. He received his Ph.D. in Chemistry from Northwestern University (with Chad. A. Mirkin; 2004) and completed his postdoctoral training at The Scripps Research Institute (with Peter G. Schultz; 2007). The primary research interest of Dr. Lee’s group is to develop and integrate nanotechnologies and chemical functional genomics to modulate signaling pathways in stem cells towards specific cell lineages or behaviors. In particular, his group is exploring critical problems in cancer biology and stem cell biology pertaining to the cell-microenvironmental interactions, and how to control these interactions at the subcellular and single cell level using chemical biology and nanotechnology. From this research effort, he has developed technology platforms that may overcome one of the critical barriers to harnessing the full therapeutic potential of stem cells.
One of the critical barriers to harnessing the full therapeutic potential of stem cells is the development of an easy, effective, and non-toxic methodology to control differentiation into specific cell lineages. In this regard, Dr. Lee’s group has recently focused on developing a variety of technologies to selectively control the differentiation of stem cells [e.g. Human Pluripotent stem cells (PSCs; hESCs and hiPSCs), Neural stem Cells (NSCs), and Mesenchymal Stem Cells (MSCs)] towards specific cell lineages (e.g. neurons, oligodendrocytes, chondrocytes, muscles, osteocytes, and adipocytes). One approach involved the synthesis and application of a multifunctional vehicle comprised of cyclodextrin-modified dendritic polyamine construct (termed DexAM) to facilitate the simultaneous delivery of siRNA molecules and hydrophobic small molecules (J. Am. Chem. Soc., 2013). Multi-modal magnetic core-shell nanoparticles have also been used to effective deliver genetic material into NSCs using a magnetic-filed-facilitated delivery method and to monitor the delivery through dark-field imaging (Angewandte. Chem. Int. Ed., 2013). Substrates containing arrays of graphene-nanoparticle hybrids were also generated and seen to be a remarkable platform for NSC differentiation in neurons and the subsequent alignment of axons (Advanced Materials, 2013). With the goal of achieving an enhanced stem cell-based therapy for CNS-related injuries and diseases, his group is currently designing nanomaterial-based 3D scaffolds to enhance cellular viability and to spatiotemporally modulate NSC differentiation (Advanced Materials, 2014). Having the motivation to develop a highly robust, efficient nanoparticle-based platform to regulate gene expression and eventually stem cell reprogramming, his group has developed the NanoScript is the first nanomaterial TF protein that can interact with endogenous DNA as well as control stem cell differentiation to general useful cell linages such as cartilage, bone, muscle cells, and neuronal cells (ACS Nano, 2014; J. Am. Chem. Soc., 2015; ACS Nano, 2015; Angewandte Chemie, 2015).
In recognition of his outstanding scientific achievement at Rutgers, Dr. Lee has received several awards including NIH Director’s New Innovator Awards (2009), American Chemical Society New Directions (ND) Award (2015), Science Center’s QED Award (2016), Board of Trustees Research Award for Scholarly Excellence (2013), Burroughs Wellcome Fund Collaborative Research Grant Award (2014), Busch Biomedical Grant Award (2013), New Jersey Spinal Cord Exploratory Research Award (2013), Johnson and Johnson Proof-of-Concept Award (2011), Faculty Research Grant Award (2012), New Jersey Spinal Cord Research Award (2009), and Grant Proposal Development Award (2008). He is the first author, co-author, and corresponding author of approximately 60 articles published in high-profile journals including Science, Cell Stem Cell, Nature Chemical Biology, J. Am. Chem. Soc., Angew. Chem, Int. Ed., Nano Letters, ACS Nano, Advanced Materials, Accounts of Chemical Research, Chemical Reviews, Biomaterials, Scientific Reports, Lab Chip, Small, Phys. Chem. Chem. Phys., Nanomedicne, and Cancer Research, which are highly cited (>5000). [Total 67 publications, >5000 citations, h-index: 27; 22 Patents/applications] 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.
| || || |
| ||Kacey Marra, PhD|
Associate Professor, Departments of Plastic Surgery and Bioengineering
Co-Director, Adipose Stem Cell Center
McGowan Institute for Regenerative Medicine, University of Pittsburgh
Kacey G. Marra, PhD, is an associate professor in the Departments of Plastic Surgery (primary) and Bioengineering (secondary) at the University of Pittsburgh. She is also a core faculty member in the McGowan Institute for Regenerative Medicine, where she has served as a member of the Executive Committee since 2004. After earning her PhD in organic chemistry in 1996 from the University of Pittsburgh, she was a postdoctoral fellow for Elliot Chaikof at Emory University. Following four years as a research scientist at Carnegie Mellon University conducting bone tissue engineering research, Kacey became the director of the Plastic Surgery Research Laboratory at the University of Pittsburgh in 2002. Dr. Marra has a publication record of over 130 peer-reviewed articles in the area of tissue engineering and regenerative medicine, including a landmark paper that was among the first to examine the effects of adipose stem cells in peripheral nerve gaps. Dr. Marra has presented or co-authored more than 420 abstracts. Dr. Marra has served as principal investigator on NIH, NSF, and DoD grants in the area of regenerative medicine, and she also has both industry and foundation support. Her laboratory consists of 25+ members, and she also co-directs the Adipose Stem Cell Center with Dr. J. Peter Rubin. Back to top.
| || || |
| ||Raul Mitrani, MD|
Director, Clinical Cardiac Electrophysiology
Director, Cardiac Electrophysiology Laboratory
University of Miami, Miller School of Medicine
Dr. Raul Mitrani is Director of Clinical Cardiac Electrophysiology, and Director of the Cardiac Electrophysiology Laboratory at University of Miami, Miller School of Medicine. As an Academic Cardiac Electrophysiologist, Dr Mitrani treats patients with simple and complex cardiac arrhythmias including atrial fibrillation, ventricular tachycardia, supraventricular tachycardia and syncope. He performs the full gamut of cardiac ablation procedures as well as cardiac electrical device implants.
In addition to his clinical responsibilities, Dr Mitrani is actively involved in research and teaching. He has authored or coauthored numerous papers on diverse topics including the role of cardiac stem cells in cardiac arrhythmias, optimal blood pressure control in patients with atrial fibrillation, and others. Recently, he has co-authored chapters and review articles on the topic of Sudden Cardiac Death. He is currently involved in preclinical studies on the effects of mesenchymal stem cells in a post –infarct swine model. He is involved in various NIH-sponsored trials including the CONCERT-HF Trial, a study of Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure (CONCERT-HF; NCT02501811). He also is involved in studies examining the effects of Mesenchymal Stem Cells in patients with nonischemic cardiomyopathy (POSEIDON-DCM -NCT01392625) and ischemic cardiomyopathy (TRIDENT -NCT02013674). He participates in NIH sponsored multicenter trials such as the CABANA Trial, a study to compare catheter ablation versus pharmacologic therapy in patients with atrial fibrillation. Back to top.
| || || |
| ||Keith Murphy|
Co-Founder, Chairman and Chief Executive Officer, Organovo, Inc.
Mr. Murphy has more than 20 years of experience in biotechnology, including co-founding Organovo in 2007 and serving in Product Strategy and Director of Process Development roles at Amgen. His ten years at Amgen included four years as Global Operations Leader for the largest development program in Amgen’s history, Phase 3 osteoporosis/bone cancer drug denosumab. At Amgen, he also worked to develop several other novel formulation and device products. Prior to Amgen, he played a central role at Alkermes, Inc. on the development team for their first approved product, Nutropin (hGH) Depot. He holds a B.S. in chemical engineering from the Massachusetts Institute of Technology and is an alumnus of the UCLA Anderson School of Management. Back to top.
| || || |
| ||Sean Murphy, PhD|
Assistant Professor, 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.
| || || |
| || ||Gail K. Naughton, PhD|
Founder, Chairman and Chief Executive Officer, Histogen, Inc.
Gail K. Naughton, Ph.D., founded Histogen, Inc., a regenerative medicine company, in 2007, and currently serves as CEO and Chairman of the Board. In addition, Dr. Naughton served as Dean of the College of Business Administration at San Diego State University from 2002 through 2011. Prior to that, she spent more than 15 years at Advanced Tissue Sciences, where she was the company’s co-founder and co-inventor of its core technology. During her tenure there, Dr. Naughton held a variety of key management positions, including president, chief operating officer, chief scientific officer and principal scientist. While serving as an officer and director of the Company, Dr. Naughton oversaw the design and development of the world’s first up-scaled manufacturing facility for tissue engineered products, established corporate development and marketing partnerships with companies including Smith & Nephew, Ltd., Medtronic and Inamed Corporation, was pivotal in raising over $350M from the public market and corporate partnerships, and brought four human cell-based products from concept through FDA approval and market launch. Dr. Naughton holds over 100 U.S. and foreign patents and has been extensively published in the field of tissue engineering and regenerative medicine. In 2000, Dr. Naughton received the 27th Annual National Inventor of the Year award by the Intellectual Property Owners Association in honor of her pioneering work in the field of tissue engineering.
Dr. Naughton serves as a director for several not-for-profit foundations and also sits on the scientific and industry advisory boards of leading universities including the Georgia Institute of Technology, the SDSU College of Business Administration Board, the advisory board of the Lavin Entrepreneurial Management Center, and Perminova. She is also a member of the San Diego State University Corporate Governance Institute and sits on two public boards, C.R. Bard, Inc. and Cytori Therapeutics Inc.
She has received numerous awards for her leadership in both science and business including the 1998 ARCS Association, National Scientist of the Year, 2001 Women of the New Millenium Award, presented by Feminine Fortunes Magazine, Volume 2, 2001, Lindbergh-Carrel Prize for outstanding contributions to the development of perfusion and bioreactor technologies for organ preservation and growth presented by Charles and Anne Lindbergh Foundation and Alexis Carrel Foundation and the 2006 “Woman of the Year” award by San Diego Magazine.
Dr. Naughton earned her Ph.D. in Basic Medical Sciences and her M.S. in histology from the New York University Medical Center. She earned an executive MBA in 2001 from the Anderson School at the University of California, Los Angeles. Back to top.
| || || |
| ||Daniel K. Nelson, MS, CIP|
Professor and Director of U.S. Environmental Protection Agency and University of North Carolina - Chapel Hill
Dr. Daniel Nelson is Director of the Human Research Protocol Office for the National Health and Environmental Effects Research Lab (NHEERL), U.S. Environmental Protection Agency (EPA). He is also Adjunct Professor of Social Medicine and Pediatrics, and Faculty Associate in the Center for Bioethics at the University of North Carolina-Chapel Hill. Trained in medical physiology, Nelson previously held faculty appointments at the Mayo Clinic, the University of Rochester and UNC-Chapel Hill, where he directed the Institutional Review Boards for 16 years. A national leader in the field of human research protections, Nelson has served as past-president of the Applied Research Ethics National Association (ARENA); charter member of the Council for Accreditation and Site Visitor, Association for the Accreditation of Human Research Protection Programs (AAHRPP); charter member of the Council for Certification of IRB Professionals (CCIP); and consultant to the federal Office for Human Research Protections (OHRP). From 2004-2014, he chaired a subcommittee of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), which advises DHHS on the regulations that govern this area. In 2013 Nelson was honored by Public Responsibility in Medicine and Research (PRIMR) with the ARENA Legacy Award, for leadership and contributions to the field of research ethics. Back to top.
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| ||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.
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| ||Jan Nolta, PhD|
Director, Stem Cell Program and Institute for Regenerative Cures
Scientific Director, UC Davis GMP Facility
Editor, Stem Cells
University of California, Davis
Jan A. Nolta, Ph.D., is the Director of the Stem Cell Program at UC Davis School of Medicine, and directs the Institute for Regenerative Cures. She also serves as the Scientific Director of the large UC Davis Good Manufacturing Practice Facility, and as Scientific Director of the Statewide California Umbilical Cord Blood Collection Program. In 2013 she was ranked as one of the “Global Top 50 Most Influential People in the Field of Stem Cells.”
The UC Davis stem cell program has over 150 faculty members collaborating to work toward regenerative medicine-related cures for a spectrum of diseases and injuries. The current research in Dr. Nolta’s laboratory is focused on developing therapies that will use gene-modified bone marrow - derived mesenchymal stem/ stromal cells to deliver factors for treating Huntington’s disease and vascular disorders. The group that she oversees in the UC Davis Shared Translational Laboratory is helping UC Davis teams develop numerous clinical trials of gene and cell therapy, with ten adult stem cell therapies already in the clinic, and another twenty in the pipeline.
A scientist with more than 25 years’ experience with human stem cells and clinical trial development, Dr. Nolta has published over 150 peer-reviewed manuscripts in the stem cell field and has authored 30 book chapters. She has served on over 200 review panels for the National Institutes of Health and other grant-funding agencies, is Editor for the Journal “Stem Cells” and was editor of the Book "Genetic Engineering of Mesenchymal Stem Cells". Dr. Nolta received a prestigious five –year Transformative Grant Award from the NIH office of the Director to study exosome- and nanotubule-mediated transfer of microRNA from cell to cell, an area important in both stem cell and cancer research. She has also been funded as Co-PI on three large disease team grants that have the goal of developing and delivering novel Phase 1 clinical trials. In these teams she works with physician/scientists who will deliver the treatments to patients who have few other options. Her passion is team training and working with large groups of scientists, patient advocates and MDs to develop novel therapies. Back to top.
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| ||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.
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| ||Mahendra Rao, MD, PhD|
Vice President, New York Stem Cell Foundation
Dr. Rao is a renowned international expert in stem cell biology, is Professor at WFIRM and Vice President of the New York Stem Cell Foundation. He has served as Chief of the Neurosciences Section at the NIA, as Vice President of Regenerative Medicine at Life Technologies, Co-Founder of Q Therapeutics, a neural stem cell company, Director of the NIH Center for Regenerative Medicine, a trans-NIH initiative that focused on the clinical translation of stem cell technology, Chair of the CBER (FDA) advisory committee (CTGTAC) and has served on advisory panels for the governments of the U.S., Singapore and India on hESC policy. Dr. Rao serves on several editorial boards, review panels scientific advisory boards and company boards. Dr. Rao currently serves on the Board of CESCA, Stempeutics, Megakaryon and Q therapeutics all companies involved in stem cell processing and therapy. He also serves on the SAB’s of several other companies and maintains an active research program in neural development. Back to top.
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| ||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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| ||Jon A. Rowley, PhD|
Chief Executive & Technology Officer, RoosterBio, Inc.
Jon A. Rowley, PhD, is the Chief Executive and Technical Officer of RoosterBio Inc. Jon started RoosterBio in 2013 as part of his personal quest of having the biggest impact possible on the commercial translation of technologies that incorporate living cells, including cellular therapies, engineered tissues, and tomorrow’s medical devices. Jon holds a PhD from the University of Michigan in Biomedical Engineering and has authored over 30 peer reviewed manuscripts and 20 issued or pending patents related to biomaterials development, tissue engineering, and cellular therapy. Jon started his industry career at BD as a scientist and R&D manager in a Cell & Tissue Technologies group focused on applying high throughput screening technologies to cell therapy media development and tissue engineering. Jon then contributed to the clinical development of Aastrom Biosciences’ Tissue Repair Cell product, where he was Sr Manager of Process Development responsible for manufacturing process improvements and cell delivery to the patient. Jon most recently spent five years as Director of Innovation and Process Development in Lonza’s Cell Therapy CMO business, and currently resides in Walkersville, MD with his wonderful wife and their three young children. Back to top.
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Founder and Executive Director, Regenerative
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.
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. 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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