RME Course Instructors
Director, Wake Forest Institute for Regenerative Medicine
Anthony Atala, MD is a practicing surgeon and a researcher in the area of regenerative medicine. His work focuses on growing human cells, tissues and organs.
Dr. Atala works with several journals and serves in various roles, including Editor-in-Chief of: Stem Cells- Translational Medicine; Current Stem Cell Research and Therapy; Therapeutic Advances in Urology; and BioPrinting.
Dr. Atala is a recipient of awards, including the US Congress funded Christopher Columbus Foundation Award, bestowed on a living American who is currently working on a discovery that will significantly affect society, the World Technology Award in Health and Medicine, the Samuel D. Gross Prize in Surgical Research, the Innovation Award from the Society of Manufacturing Engineers, the Rocovich Gold Medal, and the Edison Science/Medical Award for work in 3D Bioprinting. In 2011 he was elected to the Institute of Medicine of the National Academy of Sciences, and in 2014 was inducted to the National Academy of Inventors as a Charter Fellow. Dr. Atala’s ongoing work has been described in the lay press. Dr. Atala’s work was listed in 2007 as Time Magazine’s top 10 medical breakthroughs of the year, by Discover Magazine in 2007 as the Number 1 Top Science Story of the Year in the field of medicine, by Smithsonian Magazine in 2010 as one of 40 things to know about the next 40 years, by Time Magazine in 2011 as one of the top 5 medical breakthroughs of the year, by the Huffington post in 2011 as one of 18 great ideas for the future, and by Time Magazine in 2013 as one of 5 discoveries that will change the future of organ transplants. Dr. Atala was named by Scientific American in 2010 as a Medical Treatments Leader of the Year for his contributions to the fields of cell, tissue and organ regeneration, by U.S. News & World Report in 2009 in as one of 14 Pioneers of Medical Progress in the 21st Century, by the American Association of Retired Persons in 2012 as one of the 50 influential people who will make life better, and by Scientific American in 2015 as one of the world’s most influential people in biotechnology.
Dr. Atala has led or served several national professional and government committees, including the National Institutes of Health working group on Cells and Developmental Biology, the Bioengineering Consortium, the National Cancer Institute’s National Cancer Advisory Board, and was the Founder of the Regenerative Medicine Foundation. Dr. Atala heads a team of over 450 physicians and researchers. Over twelve applications of technologies developed in Dr. Atala’s laboratory have been used clinically.
He is the editor of fourteen books, including Principles of Regenerative Medicine, 3D Biofabrication, Essentials of Stem Cell Biology, and Methods of Tissue Engineering. He has published more than 500 journal articles and has applied for or received over 250 national and international patents.
Dr. Ahmed is an Infodemic Manager for the WHO. Her specialties are Community Medicine, Public Health and International Health. She has an MsC in International Health from the Karolinska Institutet and Humbold University of Berlin. She received her MAS in Spatial Analysis in Public Health from the Johns Hopkins Bloomberg School of Public Health.
Dr. Allickson has a doctorate in health sciences along with a master’s in medical laboratory sciences. An experienced scientist with regulatory expertise, she has more than 25 years of experience in clinical translation of cellular therapies and regenerative medicine products including business management and board directorship experience.
At the Institute, Dr. Allickson heads the clinical translation team streamlining development to create a robust pipeline of products in early phase clinical trials and FDA registered products including cell therapy, tissue engineered organs and tissues, biomaterials and devices. She is one of the founding members of the International Society of Cellular Therapy and has been a member of the American Association of Blood Banks (AABB) for 29 years. Dr. Allickson is on the Board of Directors for AABB and IWEUS Capital along with Regenerative Medicine Outcomes Foundation as a scientific advisor, editorial board of CELLR4, vice chair for Cord Blood Association Quality Committee, Technical Advisory Board for Tissue Engineered Products under ICCBBA, grant reviewer for state funded initiatives such as CIRM and serves on the ISCT Commercialization Committee.
Dr Kersti Alm is the CSO at Phase Holographic Imaging (PHI), Lund, Sweden.
Digital holographic imaging has existed as a brainchild since the '70s. Now, it is a reality since computers became powerful enough to handle the algorithms required to reconstruct the hologram of an imaged object – or even living cell cultures. PHI has proudly been part of this development and today advances cutting-edge research by applying digital holography to cell-based science.
Dr. Alm has already cooperated with PHI since 2005 and is a vital part of the PHI team since 2009. All insights gained through her PhD studies at Lund University, Sweden, her postdoc time at Roswell Park, Buffalo, NY, and the years after that working as a researcher and lecturer at Lund University, have been applied in the development of a genuinely novel cell analysis system. Her focus has been to develop a method that will neither cause cell stress nor harm while also providing accurate kinetic data. This goal has been reached both through in-house studies and collaborations as well as joint publications with researchers around the world, e.g., at Malmö and Lund universities, North Eastern University in Boston, UCSF in California, and many more.
Professor, Wake Forest Institute for Regenerative Medicine
Graça Almeida-Porada, M.D., Ph.D. is a Professor of Regenerative Medicine and the Director of the Fetal Research and Therapy Program at Wake Forest Institute for Regenerative Medicine. Dr. Almeida-Porada’s research focuses on the development of cellular and gene delivery platforms to treat genetic and immune-mediated diseases. She is particularly interested in improving the outcome of stem cell transplantation and gene therapy in fetal and neonatal patients with genetic disorders, and in developing therapies for children with immune-mediated diseases.
She has been a member of several NIH study sections, she serves as an Editor, or on the Editorial Boards, of several scientific journals, she is the co-editor-in-chief of Current Stem Cell Reports. She was inducted into Phi Beta Delta in 2006. She is the co-founder of the International Fetal Transplantation and Immunology Society. Dr. Almeida-Porada holds several patents and has authored more than 200 scientific works including papers, abstracts, and book chapters.
Professor, Wake Forest Institute for Regenerative MedicineDepartment of Chemical Engineering, Institute for Medical Engineering and Science, Harvard-MIT Division of Health Sciences & Technology; David H. Koch Institute for Integrative Cancer Research
Professor Daniel G. Anderson is a leading researcher in the field of nanotherapeutics and biomaterials. He is appointed in the Department of Chemical Engineering, the Institute for Medical Engineering and Science, the Koch Institute for Integrative Cancer Research, and the Harvard-MIT Division of Health Science and Technology at MIT. The research done in Prof. Anderson’s laboratory is focused on developing new materials for medicine. He has pioneered the development of smart biomaterials, and his work has led to advances in a range of areas, including medical devices, cell therapy, drug delivery, gene therapy and material science.
Prof. Anderson received a B.A. in mathematics and biology from the University of California at Santa Cruz and a Ph.D. in molecular genetics from the University of California at Davis. His work has resulted in the publication of over 400 papers, patents and patent applications. These advances have led products that have been commercialized or are in clinical development, as well as to the foundation of companies in the pharmaceutical, biotechnology, and consumer products space including CRISPR Tx (Nasdaq:CRSP), Living Proof, Sigilon, Verseau Tx, and Olivo Labs.
Cellular and Tissue Therapy Branch, Center for Biologics Evaluation and Research, US FDA
Steven R. Bauer, Ph.D., is the Chief of the Cellular and Tissue Therapy Branch (CTTB), Division of Cellular and Gene Therapies (DCGT) in the Office of Tissues and Advanced Therapies (OTAT) at the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA). As the Chief of CTTB, Dr. Bauer supervises CBER scientific staff engaged in review of cell-based biological therapies, policy development in emerging areas of cellular therapies and regenerative medicine, and research relevant to their use in clinical trials. His current research focuses on multipotent stromal cell biology and stromal cell-hematopoietic cell interactions that influence development of lymphocytes.
Dr. Bauer received his Ph.D. in Biochemistry from the University of Maryland in 1986. From 1986 though 1991, Dr. Bauer was a scientific member of the Basel Institute for Immunology in Basel, Switzerland. In 1991, Dr. Bauer joined CBER’s Division of Cellular and Gene Therapies.
Karen Barnes is a mega-connector, visionary, ecosystem builder and Founding CEO of her sixth startup, Agile City Winston-Salem — a nonprofit innovation consultancy focused on designing and building entrepreneurial and innovation ecosystems through a suite of offerings. Prior to founding Agile City, Barnes served for three years as the Founding Executive Director of Venture Cafe Winston-Salem, where she and her team convened the ecosystem weekly, launched a Minority and Women's Business Center, and created a public-private partnership to launch a startup recruiting initiative. Previously, she was a founding partner for an applied artificial intelligence startup; Vice President of Insights for a research and advertising agency completely focused on sustainability; the founder of her own marketing and communications consulting firm; and strategic lead for several advertising agencies working with Fortune 100 clients, including Boeing, ConAgra Foods, MillerCoors, Johnson & Johnson, Steelcase, Georgia-Pacific, Toshiba, Hanes, General Mills and Lowe's Home Improvement. Barnes has a master's degree in journalism and public affairs from The American University, and a bachelor's degree in English Literature from Hollins University. She's a devoted partner to her artist wife, doting dog mom to a spoiled rotten Golden Retriever and a pretty decent golfer.
National Eye Institute
National Institutes of Health
Steven Becker, Ph.D., joined the National Eye Institute (NEI) in 2014. He currently leads the Office of Regenerative Medicine as its Associate Director. The office coordinates the regenerative medicine programs at NEI which include the Audacious Goals Initiative (AGI) for Regenerative Medicine, the 3-D Retina Organoid Challenge (3D ROC), and the AMD Integrative Biology Initiative. Dr. Becker serves on a number of committees including the NIH Regenerative Medicine Innovation Project (RMIP) and the National Academies of Sciences, Engineering, and Medicine Forum on Regenerative Medicine.
Dr. Becker has a B.A. in biology from the University of Virginia and a Ph.D. in cell biology from Yale University. He came to the NIH in 2008 as a member of the Biological Imaging Facility at the National Institute of Allergy and Infectious Disease. In 2012, Dr. Becker became a AAAS Science & Technology Policy Fellow and worked at the NIH Center for Regenerative Medicine, a NIH Common Fund initiative created to catalyze the induced pluripotent stem cell field.
Dr. Bertram brings over 35 years of medicine development leadership, funding and expertise with demonstrated innovations in small molecular and cellular therapeutics. Tim is an experienced Chief Executive Officer with a demonstrated history of working in the biotechnology industry. Currently, CEO of ProKidney, a multi-national privately owned clinical-stage cellular therapeutics company focusing on treatment of chronic renal disease. Serves as Director of NexImmune a cell-based immuno-oncology biotechnology company with committee leadership. Previously, Tim served as CEO of RegenMed Therapeutics, after serving as President of Research and Development to bring four cell-based therapeutic products from discovery through Phase II clinical development.
Dr. Bertram is highly skilled in Research and Development (R&D), Life Sciences, Regenerative Medicine, Clinical Development, and Molecular Biology. He possesses strong business development experience and expertise in raising private and public funds. Dr. Bertram was a senior executive at Pfizer, SmithKline Beecham Pharmaceuticals, and Procter & Gamble Corporate Research where his career focused on taking molecular entities from research through clinical development and registration. These development efforts lead to the commercialization of eight medical products that are changing and improving lives around
the world. Tim started his professional career on faculty at the University of Illinois and as a visiting scientist at the National Institutes of Health.
Tim and his wife Julie, a former nurse, have three children, four grandchildren and make their home in Statesville, North Carolina.
Mr. 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 Rick to transition into venture capital in the mid 1980's with American Healthcare Funds. 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.
In each of his five prior venture funds, he 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.
Additionally, he has served as Director and/or active investor in many companies including Saladax, Lantos Technologies, Cytyc (acquired by Hologic), AbT (now OSI), Somatogen (acquired by Baxter), EdenTec (acquired by Nellcor), Exact Sciences, IPC The Hospitalist Company, GeneOhm (acquired by Becton Dickinson), Zonare, TransMedics, US Servis (acquired by McKesson); and the former public health insurance company Washington National.
In addition to Excel, he 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 and the National Regenerative Medicine Foundation.
Bob is the President of Winston Starts. Winston Starts' mission is to help drive future economic health of Winston-Salem, the Triad, and North Carolina through entrepreneurship, by providing
intense, inspiring, and duration-appropriate support for startups with nationally scalable business models. Bob is also Chairman of the Board of Healthy Bytes, a start up nutritional counseling company that connects expert dietitians to providers, employers and patients. Bob is an accomplished operational executive, with solid track record of growing technology services and technology enabled businesses, with global management experience in Europe and Asia Pacific.
Bob was CEO of Hostway, a $70M Cloud and Data Center services company; Senior Vice President of $750M, IT Infrastructure Services division at Cognizant Technology Solutions;
Chief Operating Officer at Pegasus Solutions, a $200M global technology and business process services company for the Hospitality industry; President of AimNet Solutions a $30M Mid-
Market focused IT professional and managed services company; and started his career with 18 years at IBM in several leadership roles in Sales and Marketing. He has successfully raised
private equity capital funding and completed Merger and Acquisitions from both a buy and sell perspective. Bob graduated from the University of Scranton and currently lives in Winston
Jake earned his BA in Organismic and Evolutionary Biology at Harvard University. He has a professional background in research labs, genetics, and cell culturing. As an applications scientist at Scientific Bioprocessing, Jake supports new product development and testing, and problem solves for each customer's unique bio-application. Jake is dedicated to improving the science surrounding cell culture and helping customers attain their scientific goals.
Professor, Biology; Director of the Skeletal Research Center at Case Western Reserve University
Arnold I. Caplan, Professor of Biology and Director of the Skeletal Research Center at Case Western Reserve University. He received his Ph.D. from The Johns Hopkins University School of Medicine.
Dr. Caplan is a national and international scholar focusing on experimentation in the area of musculoskeletal and skin development. He has published over 465 papers and manuscripts and has long been supported by the NIH and other non-profit and for-profit agencies for his efforts in trying to understand the development, maturation and aging of cartilage, bone, skin and other mesenchymal
tissues and for his pioneering research on Mesenchymal Stem Cells.
Dr. Nathan Chomilo received a Zoology degree from Miami University (Oxford, OH) and graduated from the University of Minnesota Medical School. He completed his combined residency in Internal Medicine and Pediatrics at the University of Minnesota and was the Pediatric Chief Resident at the University of Minnesota Children's Hospital. He practices as a General Pediatrician at Brookdale Clinic and an Internal Medicine Hospitalist at Methodist Hospital with Park Nicollet Health Services/HealthPartners. His advocacy work includes the impact early childhood intervention and healthcare access have on the long-term prospects of our children and how physicians and health systems can address racial & health equity.
He is a member of the American Academy of Pediatrics Council on Early Childhood and Section on Minority Health, Equity & Inclusion, is one of the Early Childhood Champions for the MN chapter of the AAP, currently serves as the Medical Director of Reach Out and Read Minnesota, is an Adjunct Assistant Professor of Pediatrics at the University of Minnesota Medical School where he is a clinic preceptor and a member of the Medical School's Admissions Committee, has been appointed to the Governor's Early Learning Council and helped start the organization Minnesota Doctors for Health Equity (MDHEQ) where he serves as the Vice-President.
His advocacy work with Reach Out and Read MN & MDHEQ has been recognized by Minneapolis St Paul Magazine in their 2018 Top Doctors: Rising Stars edition, by Reach Out and Read National which awarded him the 2018 Medical Champion Achievement Award and the City of Minneapolis Department of Civil Rights which recognized him as a 2019 History Maker at Home recipient. In December, 2020, Dr. Chomilo was named Minnesota's new Medicaid medical director by the Minnesota Department of Human Services (DHS).
Marie Csete MD, PhD is the CEO of ConeSight Therapeutics, leading commercialization of the company's cell therapies for blinding diseases, discovered in the Harvard laboratory of Michael Young PhD. Dr. Csete received her undergraduate degree in music at Princeton University, MD from Columbia University's College of Physicians & Surgeons, and PhD in Biology at Caltech. She is a board certified anesthesiologist with sub-specialty certification in critical care, and specific expertise in solid organ transplantation. Dr. Csete is an active volunteer in the Medical Reserve Corps (HHS) of Los Angeles, (adjunct) Professor of Anesthesiology at USC, serves on the SAB of several biotech companies as well as non-profit Pasadena Bioscience Collaborative, CA Liver Research Institute, and the Phil Simon Clinic Tanzania Project. Previous leadership positions include (first) CSO of CIRM, and CEO of the Huntington Medical Research Institutes.
Dr. Tracy Criswell is currently an Associate Professor at the Wake Forest Institute for Regenerative Medicine. She received her Bachelor's of Science degree in Biology from the University of Cincinnati in 1998 (Magna Cum Laude) and her PhD in Cellular and Molecular Biology from Case Western Reserve University in 2004. Her thesis work focused on identifying the cellular effects of low dose ionizing radiation exposure on breast cancer. After the completion of her PhD, Dr. Criswell joined the laboratory of Dr. Carlos Arteaga at Vanderbilt University where her research focused on the role of TGFβ signaling in breast cancer metastases. In 2009, she joined the Wake Forest Institute for Regenerative Medicine as a senior research fellow and was subsequently promoted to a faculty position in 2012. In addition to WFIRM, Dr. Criswell has cross appointments in Integrative Physiology and Pharmacology, Molecular Medicine and Translational Science and the Virginia Tech-Wake Forest University School of Biomedical Engineering and Science. She currently serves as a liaison for Women in Medicine and Science (WIMS), serves on the Wake Forest Graduate School Council and is Co-Chair of the WFGS Committee on Race and Equity. She is actively involved in curriculum development at WFIRM, and is a mentor for high school, undergraduate and graduate student trainees.
Dr. Aubrey de Grey is a biomedical gerontologist based in Mountain View, California, USA, and is the Chief Science Officer of SENS Research Foundation, a California-based 501(c)(3) biomedical research charity that performs and funds laboratory research dedicated to combating aging. In addition, he is Editor-in-Chief of Rejuvenation Research, the world's highest-impact peer-reviewed journal focused on intervention in aging. He received his BA in computer science and Ph.D. in biology from the University of Cambridge. His research interests encompass the characterisation of all the types of self-inflicted cellular and molecular damage that constitute mammalian aging and the design of interventions to repair and/or obviate that damage. Dr. de Grey is a Fellow of both the Gerontological Society of America and the American Aging Association, and sits on the editorial and scientific advisory boards of numerous journals and organisations. He is a highly sought-after speaker who gives 40-50 invited talks per year at scientific conferences, universities, companies in areas ranging from pharma to life insurance, and to the public.
Mike Druckman leverages his prior experience at the FDA – and what he has learned since then while extricating companies from regulatory problems – to anticipate and prevent life science clients from getting into trouble in the first place.
Mike understands the business challenges that companies face in a highly regulated environment. He actively works with other Hogan Lovells lawyers experienced with government reimbursement, anti-kickback limits, product liability, and a full range of other regulatory areas to craft approaches that will maximize clients' opportunities and minimize their risks.
Mike chairs the firm's Cell, Tissue, and Gene Therapies Working Group, a cross-disciplinary team that advises companies in this emerging space on the evolving regulatory and business challenges they face. Mike and the team work closely with companies developing stem cells, cord blood, placental tissues, gene therapies, proteins, and other cellular products to help people with serious health problems.
Mike also advises companies with a full range of regulatory challenges involved in investigating new drugs, biologics, and combination products, obtaining FDA approval for those products, and in promoting, selling, and distributing them. His experience also includes the Drug Supply Chain Security Act, pharmacy compounding, expanded access/compassionate use clinical trials, orphan drug exclusivity, and precision medicine and companion diagnostics.
Ysabel Duron is a pioneering, award-winning Latina journalist, and a leading figure in cancer education in the Latino community in the US.
Ms. Duron was a journalist and TV news anchor for more than 43 years winning numerous awards, including two EMMYS. She has been inducted into the Hall of Fame of the National Association of Hispanic Journalists and given the Living Legacy Award by the Chicana/Latina Foundation. In 2019 she received a Lifetime Achievement Award from the International Women's Media Foundation, which she helped found 30 years earlier to help put women's voice front and center in covering the news.
As a journalist she covered her own battle against Hodgkin's Lymphoma, using her reporting to help raise awareness about the disease and the health disparities involved in treating it in communities of color.
In 2003, as a result of her own experience, she founded Latinas Contra Cancer, a non-profit organization that advocates for and serves the Latino community. She drove development of programs to address gaps across the cancer continuum from community education and navigation into screening to psychosocial support groups, treatment and survivorship.
Her early mantra when she launched Latinas Contra Cancer was talking about cancer won't kill us, the silence will.
She successfully piloted a lay community navigator program in the public health care system's Sobrato Cancer Center in San Jose, California, dedicated to providing support and guidance for low income, Spanish-speaking patients. In 2008, she launched the biennial National Latino Cancer Summit bringing community together with researchers to network, learn from each other and find ways to collaborate. In 2016 the Summit spotlighted Precision Medicine - concerned the cutting-edge science would exacerbate disparities if underserved communities could not access it.
In 2017 she was appointed, by NIH Director Francis Collins, to the Institutional Review Board (IRB) for the All of Us Research Program, formerly known as President Obama's Precision Medicine Initiative.The role of the IRB is to protect the rights, welfare and privacy of research participants. As a patient advocate, Ms. Duron also works to ensure that research is inclusive of racial/ethnic minorities, and is sensitive to historic, cultural and language barriers, and bias, that hinder their successful engagement.
She is now the President of The Latino Cancer Institute (TLCI), a national network of Latino cancer service agencies addressing the community's cancer disparities.
Shannon received his PhD from the University of Tennessee, Knoxville in Biochemistry, Cellular and Molecular Biology. His expertise is around T-cell, HSC, and ES/iPSC cell biology, and has been with Cytiva (formerly GE Healthcare) Cell and Gene Therapy for over 11 years. He is a member of the International Society for Cell Therapy (ISCT) Process and Product Development (PPD) committee, and has authored numerous papers within the field of cell biology and manufacturing. He is currently Cytiva's Cell and Gene Therapy Enterprise Solutions and FastTrak Leader. Shannon lives with his wife and 2 kids in Knoxville, TN.
Dr. Jennifer Elisseeff is the Morton F. Goldberg Endowed Professor of ophthalmology and a professor orthopaedic surgery at the Johns Hopkins School of Medicine. She also holds appointments in the Johns Hopkins Department of Chemical and Biological Engineering and Department of Materials Science and Engineering. Her research focuses on tissue regeneration. Dr. Elisseeff is the Jules Stein Professor of Ophthalmology and director of the Translational Tissue Engineering Center.
Her team is engaged in engineering technologies to repair lost tissues. Specifically, she is examining hydrogels as a scaffold for tissue engineering and is working to develop an artificial cornea.
Dr. Elisseeff received a bachelor's degree in chemistry from Carnegie Mellon University and a Ph.D. in medical engineering from the Harvard-MIT Division of Health Sciences and Technology. After doctoral studies, Dr. Elisseeff was a fellow at the National Institute of General Medical Sciences Pharmacology Research Associate Program. She joined the Johns Hopkins faculty in 2001.
Temitayo Famoroti is a Medical Doctor (MD) trained as a Pathologist in the field of Clinical Virology, a vaccinologist with strong interests in public health, epidemiology, viral respiratory infections, immunology and drug safety. He is Board certified by the College of Medicine South Africa (CMSA).
He was actively involved in the COVID-19 response team in South Africa as a front line clinical and laboratory health care worker in the laboratory diagnosis of COVID-19 and teaming up with hospital clinicians in addressing the COVID-19 pandemic.
He participates in public health programs such as the prevention of mother to child infection of HIV and Hepatitis B infections (PMTCT), vaccine advocacy, immunizations systems and viral vaccine preventable diseases surveillance as well as the expanded program on immunization (EPI).
Temitayo has a passion for laboratory diagnostics and the management of infectious diseases. He keeps up to date with the current changes in the world of immunology, viral associated oncology, molecular biology, emerging and re-emerging pathogens, drug and vaccine development.
Medical Officer, Emmes
Dr. El Fiky is a Harvard-trained and educated clinical research expert and is currently is a full-time Medical Officer at a global regulatory and clinical research consulting firm, EMMES, headquartered in the Washington DC metropolitan region. His duties include medical monitoring, phramacovigilance, drug risk assessment/mitigation and regulatory oversight of clinical trials assessing safety and efficacy of novel drugs, vaccines and stem cell therapies.
Dr. El Fiky received his medical degree from Egypt's University of Alexandria and Ph.D. in Experimental Pathology/Immunology from the University of California-Irvine. His clinical training specialized in infection control and laboratory medicine particularly molecular identification of virulence factors of endemic vector- and blood-borne pathogens. Dr. El Fiky’s PhD thesis and postdoctoral research revealed a novel signaling mechanism for type I interferon and investigated molecular signaling mechanism of cytokines in cancer, inflammation, and allergic pathogenesis. After completing his medical training and ABMM- approved fellowship, he continued postdoctoral training at the NIH’s National Cancer Institute, National Institute of Allergy and Infectious Diseases, and the FDA’s Office of Vaccine Research and Review. He completed his clinical trial training at Harvard Medical School.
Dr. El Fiky co-authored peer-reviewed novel research publications in addition to a book chapter on clinical and regulatory pathway of stem cell-based therapy in the United States.
Dr. El Fiky was awarded Harvard University’s clinical research scholarship, the FDA’s Commissioner Citation Award and the University of California’s William Holcomb Award for Excellence in Biomedical Research.
Dr. El Fiky gave a lecture at the 2017 and the 2019 TERMIS meetings in Charlotte, NC and Orlando, FL, respectively, on the regulatory pathway for mesenchymal stromal cell-based therapy in the United States focusing on the NIH’s Production Assistance for Cell Therapy (PACT) program.
Dr. John P. Fisher is the Fischell Family Distinguished Professor and Department Chair in the Fischell Department of Bioengineering at the University of Maryland. Dr. Fisher is also the Director of the NIBIB / NIH Center for Engineering Complex Tissue (CECT) that aims to create a broad community focusing on 3D printing and bioprinting for regenerative medicine applications. As the Director of the Tissue Engineering and Biomaterials Laboratory, Dr. Fisher's group investigates biomaterials, stem cells, bioprinting, and bioreactors for the regeneration of lost tissues, particularly bone, cartilage, and cardiovascular tissues. Dr. Fisher's laboratory has published over 200 articles, book chapters, and proceedings (9500+ citations / 53 h-index) as well as delivered over 350 invited and contributed presentations, while utilizing over $15M in financial support from NIH, NSF, FDA, NIST, DoD, and other institutions.
Dr. Fisher has been elected Fellow of the American Institute for Medical and Biological Engineering (2012), the Biomedical Engineering Society (2016), and the International Academy of Medical and Biological Engineering (2020).
Dr. Garza is currently Professor of Orthopedic Surgery, Professor of Otolaryngology, and Director of Human Regenerative Cell Trials at Tulane University School of Medicine; he is also Professor of Surgery and Professor of Otolaryngology at UT Health-SA. He was the Founder and Chairman of their Division of Plastic and Reconstructive Surgery. He served on the University's Executive Committee as Associate Vice President for the health science center.
Dr. Garza is President of the Texas Center for Cell Therapy and Research at the Texas Center for Athletes and is a past president of the Texas Society of Plastic Surgeons. He served on the Board of Regents for the Texas State University System, where he was a two-term Chairman of the Board, serving eight years as chair of the Academic and Health Affairs Committee and a member of the Governmental Relations Committee.
An accomplished clinical researcher, he is one of the first clinician/scientists in the nation to receive an Institutional Review Board approval for a research study involving the use of human regenerative cells for the treatment of osteoarthritis of the human knee joint. His work has been published in The Journal of Regenerative Medicine and the American Journal of Sports Medicine. He is currently the principal investigator for 2 FDA Phase III cell therapy trials, one for knee osteoarthritis and one for shoulder rotator cuff tears. He has been an invited keynote speaker and panelist at several international stem cell conferences. He is an internationally known expert in the treatment of sports-related facial injuries. From his work in the research laboratory, Dr. Garza holds a U.S. patent on a protective facemask used by NBA, Hockey, Baseball and collegiate players. He is a medical consultant to the NFL New Orleans Saints and NBA San Antonio Spurs; team physician for The University of Texas at San Antonio; and served as tournament physician for several NCAA Final Four basketball tournaments, USA Boxing and U.S.A. Olympic Trials.
Dr. Garza is widely recognized for his work in the health care field, garnering high honors with AMA's "Emerging Leaders" award; San Antonio Business Journal's "Outstanding Physician" award; elected by his peers as President of the Texas Society of Plastic of Plastic Surgeons and the Futrell Society at the University of Pittsburgh. He was invited by the Forbes group to participate in the invitation-only Forbes Healthcare Summit in 2012. In 2011, he was recognized for his business acumen by being honored as "Businessman of the Year" by the Hispanic Chamber of Commerce.
He is a member of the NFL Alumni Association and serves as one of their Senior Medical Advisors. Dr. Garza was inducted into the Tulane Athletic Hall of Fame and the National Hispanic Sports Hall of Fame.
He earned his M.D. (with honors) and D.D.S. degrees from Louisiana State University; Plastic and Reconstructive Surgery at the University of Pittsburgh; he is board-certified in two surgical specialties and has authored book chapters and dozens of medical journal articles and abstracts.
Dr. Riccardo Gottardi is an Assistant Professor of Pediatrics and of Bioengineering at University of Pennsylvania. Dr. Gottardi leads the Bioengineering and Biomaterials Laboratory at the Children's Hospital of Philadelphia, working closely with clinicians to develop engineering solutions for pediatric airway disorders focusing on translational tissue engineering and on novel preventative drug delivery approaches with accelerated pathway to the clinic. His lab investigates the basic cellular, molecular, and microbiological mechanisms as well as the genetic aspects of ear, nose, and throat damage and healing, and combines the development of organ-on-chip and animal models of cartilage, vocal folds, and craniofacial tissues to study growth, disease, and repair.
Dr. Gottardi received a BSc in General Physics and a MSc in Applied Physics (Medical Physics) from University of Pisa, Italy, and a PhD in Biomedical Engineering from the University of Genova, Genoa, Italy. During his PhD, he was also a visiting student at the University of Basel, M.E. Müller Institute for Structural Biology, Biozentrum, Basel, Switzerland.
While at the University of Pittsburgh, Dr. Gottardi worked with Rocky Tuan, PhD, and Steven Little, PhD, as a Postdoctoral Fellow and Research Assistant Professor.
Dr. Gottardi's research interests include: Modelling osteoarthritis and osteochondral crosstalk via organ-on-chip culture for the development of new drugs; tissue engineering repair of the musculoskeletal system; regenerative rehabilitation for cartilage regeneration; decellularized matrix approaches to tissue repair; airway engineering; and, studying the effects of the microbiome on airway disorders and repair.
AO Research Institute Davos, Switzerland
Sibylle Grad is a Principal Scientist at the AO Research Institute Davos (ARI), Switzerland. She is the deputy Program Leader of the Regenerative Orthopaedics Program and the focus area leader for intervertebral disc and cartilage research. Sibylle Grad obtained her PhD in Natural Sciences from the Department of Cell Biology of the Federal Institute of Technology in Zürich (ETHZ), Switzerland. After completing her first post-doctoral training, she joined the AO Research Institute Davos to set up a cartilage bioreactor system. She has since then acquired extensive research expertise in tissue engineering and regenerative medicine with focus on cartilage and intervertebral disc repair and regeneration. Her projects include whole organ culture models and bioreactors for intervertebral disc disorders, cell therapy, molecular therapy, annulus fibrosus repair, circulating and tissue biomarkers; bioreactor loaded explant models for cartilage and osteochondral defects. Her expertise in advanced ex-vivo organ culture systems for studying both disease/ degeneration and repair/ regeneration in orthopedic research is widely acknowledged. Sibylle Grad is also a private docent with habilitation at the ETHZ and course leader in the graduate program of the ETH Department of Health Science and Technology. She has obtained funding from many national, European and international agencies, and has been section leader and partner of several collaborative projects. She is a co-organiser of the eCM Annual Conference and has served as Topic Chair, Spine section research chair, and program committee member of the Orthopaedic Research Society. Her publication list includes more than 115 peer-reviewed articles and 10 book chapters.
Dr. Gary Green is assistant professor and chief workforce development officer for the Wake Forest Institute for Regenerative Medicine and chief workforce development officer for the RegenMed Development Organization. His academic interests include education and workforce development for regenerative medicine and related convergent technologies. Prior to joining WFIRM, Green was president of Forsyth Technical Community College in Winston-Salem, NC, a regional and national leader in biotechnology education. The National Center for the Biotechnology Workforce was established there under his leadership and he hosted visits to the College's biotechnology program by Presidents George W. Bush and Barack Obama. He has presented on bioscience workforce development regionally, nationally, and internationally, including White House, Department of Labor, US-EU, APEC, and US-Canada workforce conferences. Green has appeared on CNN, C-SPAN, and NPR addressing education and workforce development issues. He is an affiliate graduate faculty member at the Belk Center for Community College Leadership and Research at North Carolina State University and is co-chair of the National Industry Advisory and Leadership Council of InnovATEBio: The National Biotechnology Education Center. He also serves on the advisory board of the National Center for the Biotechnology Workforce and the board of directors of Higher Ed Works, a North Carolina educational advocacy organization. Green received his BA, MA and EdD degrees from the University of Kentucky.
Robert Guldberg is the DeArmond executive director of the Phil and Penny Knight Campus for Accelerating Scientific Impact and Vice President of the University of Oregon. A serial entrepreneur and internationally renowned bioengineer, Guldberg's research is focused on musculoskeletal mechanobiology, regenerative medicine, and orthopaedic medical devices. Over his 25+ year academic career, Dr. Guldberg has produced over 270 peer-reviewed publications, served as an advisor and board member for numerous biotechnology companies, and co-founded six start-ups. He was previously executive director of the Parker H. Petit Institute for Bioengineering and Bioscience at Georgia Tech from 2009-2018. In 2018, he was selected to lead the Knight Campus as its inaugural Executive Director, where he has led the creation of its strategic plan, hired faculty into the campus' first building opened in 2020, and launched the University of Oregon's first ever engineering degree program. At the national level, Dr. Guldberg is past Chair of the Americas Chapter of the Tissue Engineering and Regenerative Medicine International Society (TERMIS-AM). Dr. Guldberg is an elected fellow of TERMIS, the American Society of Mechanical Engineers (ASME), the American Institute for Medical and Biological Engineering (AIMBE), and the National Academy of Inventors (NAI).
Natalia Gulyaeva is managing partner and heads the firm's Global Regulatory & IP, Media and Technology (IPMT) Practice Group and Life Sciences & Healthcare Industry Group for Russia/Commonwealth of Independent States (CIS). Her diverse practice encompasses IP portfolio management, IP dispute resolution (arbitration and litigation) and IP transactional work.
Natalia is praised by peers and clients for "her business sense and clear management style," is defined as "creative, flexible, and able to guide clients through the specifics of the Russian market," and a "tough and focused attorney".
Clients compliment Natalia for her ability to see legal matters from an in-house counsel perspective. She is well-known for a chain of victories in complex IP disputes before the Russian courts. She is equally creative and successful in handling disputes between international and domestic corporations in Russia and other CIS countries, and for coordinating multi-jurisdictional dispute resolution (including both litigation and arbitration). Natalia is admitted to represent clients before the Russian PTO, and enjoys rights of audience in the Chamber for Patent and Trademark Disputes and Russian courts. Natalia is admitted for practice in Russia and England & Wales.
Natalia is widely published and is a regular speaker at high profile conferences, including Saint-Petersburg International Legal Forum (SPILF), INTA, ICC, IAPP, MIP, ABA, IBA, WIPO, CIArb and many other events.
Natalia is included in the lists of arbitrators of many domestic and international institutions and has experience acting as both counsel and arbitrator.
Professor of Medicine, Molecular and Cellular Pharmacology, University of Miami; Director, Interdisciplinary Stem Cell Institute
Dr. Hare graduated from the University of Pennsylvania and has a medical degree from Johns Hopkins University. He did his residency at Hopkins and fellowships at Hopkins, Harvard University and The Brigham and Women's Hospital in Boston. Dr. Hare was Professor of Medicine and Biomedical Engineering and director of cardiac transplantation at Johns Hopkins, leading their heart failure program, before he joined the faculty at University of Miami.
Dr. Hare is one of the world's leading pioneers in the use of stem cell therapy to repair damaged hearts. He recently released findings on the first human clinical trial testing a stem-cell based treatment for heart attack patients, which showed the stem cell treated patients had lower rates of cardiac arrhythmias, and had significant improvements in heart, lung and symptom status. His work is widely published and has included recent articles in The New England Journal of Medicine, Nature, Proceedings of the National Academy of Sciences, Circulation, and Circulation Research"
Dr. Hare is the principal investigator on a National Institutes of Health Specialized Center for Cell-Therapy (SCCT) funded stem cell study for patients with congestive heart failure.
Alicia D. Henn PhD MBA is Chief Scientific Officer for BioSpherix, Ltd. Previously, Dr. Henn was a researcher in the Center for Biodefense Immune Modeling at the University of Rochester and at Vaccinex, LLC. At BioSpherix, Dr. Henn has crafted the company's first scientific program, collaborating with scientists world-wide to advance cell-based therapies and research. Dr. Henn also established a comprehensive training program for customers using cytocentric cell processing systems. Dr. Henn owns the In Vitro Reproducibility and Physiologic Cell Manufacturing groups on LinkedIn. She also writes the cytocentric blog, promoting clonable, aseptic and physiologically relevant cell environments for better scientific reproducibility and translatability.
Chief Technology Officer, RegenMed Development Organization (ReMDO); Executive Director, Regenerative Medicine Manufacturing Society (RMMS)
Dr. Hunsberger obtained his B.A. in neuroscience from Wesleyan University and his Ph.D. in neuroscience from Yale University where his work focused on the beneficial effects of exercise in treating depression. He then did his postdoctoral work at the National Institutes of Health where he was the Julius Axelrod Post Doctoral Fellow and worked in areas of mood disorders and stroke. He then was a research fellow at the National Institutes of Health Center for Regenerative Medicine where he coordinated efforts for advancing clinical translation of stem-cell technologies. He then came to Wake Forest Institute for Regenerative Medicine where he worked on various director initiatives seeking to translate regenerative medicine technologies into the clinic to treat patients.
Dr. Hunsberger is currently chief technology officer of a non-profit organization, RegenMed Development Organization (ReMDO) that is advancing regenerative medicine manufacturing platform technologies in pre-competitive space. One of the programs focuses on development of a universal media to support clinical cell manufacturing. The other program focuses on development of a tunable bioink system for 3D bioprinting. He is also executive director of the Regenerative Medicine Manufacturing Society (RMMS) which is a professional society that has a vision of enabling the adoption of manufacturing platform technologies into standards, regulatory pathways, and commercial products by assembling a diverse network of stakeholders.
Associate Professor, Wake Forest Institute for Regenerative Medicine
Dr. John D. Jackson is an Associate Professor in the Institute for Regenerative Medicine at Wake Forest School of Medicine, Winston Salem, NC. He received his Ph.D. degree in Medical Sciences (Experimental Hematology) from the University of Nebraska Medical Center, Omaha, NE. He received post-doctoral training at DNAX Research Institute, Palo Alto, CA. At DNAX Research Institute, Dr. Jackson was involved in research directed to the study of the role of cytokines in the regulation of hematopoietic and immune systems.
In 1990, Dr. Jackson joined the Department of Pathology and Microbiology at the University of Nebraska Medical Center, Omaha, NE as an Assistant Professor. He was also appointed Technical Director of the Cell Processing Laboratory at the University of Nebraska Medical Center which provided support for the bone marrow transplantation program. His research focus during this time was directed toward the effects of cytokines and other agents on hematopoietic mobilization for transplantation as well as hematopoietic and immunological recovery following transplantation. In 2010, Dr. Jackson moved to Wake Forest School of Medicine and serves as an Associate Professor in the Institute for Regenerative Medicine. His research interests have broadened to include engineering of tissues and organs including skin, inner ear, muscle, bone, cartilage, kidney, ovary and corporal tissue.
Mandi Jacobson's practice includes both advisory and contentious matters across a variety of sectors, including the life sciences (pharmaceuticals and medical devices), food and beverage, cosmetics, industrial chemicals, and automotive sectors.
Her practice focuses primarily on product liability (advice and litigation) and the regulation of a broad range of products in Australia. Mandi acts for clients in relation to regulatory compliance, consumer law, therapeutic goods (medical devices including PPE and medicines) registrations and listings, product recalls, compliance with voluntary and mandatory standards and orders, product liability, privacy issues, and advertising/labelling.
Deepak. Jain, PhD has over 40 years of experience in the development of tissue engineered and cell therapy products. Dr. Jain is currently the Chief Operating Officer at ProKidney. Previously, Dr. Jain was the COO at Twin City Bio before co-founding and running RegenMed Therapeutics as COO. Earlier, Dr. Jain was Senior Vice President of Bioprocess R&D and Technical Operations at Tengion responsible for bioprocess research, process development and clinical manufacturing of advanced regenerative medicine and cell therapy products including urinary bladder replacement and kidney regeneration. Prior to Tengion, Dr. Jain was the Executive Director of Process Development and Manufacturing Technical Support at Advanced Tissue Sciences responsible for development of two tissue engineered marketed products for therapeutic applications in the skin, cartilage and cardiovascular areas. Dr. Jain has held several positions 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 served as the Chairman of Cell Therapy Ad hoc Advisory Panel for United States Pharmacopoeia and served as a member of USP's Biologics & Biotechnology Expert Committee and 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. Amritha Jaishankar serves as the Executive Director, Maryland Stem Cell Research Fund [mscrf.org] (MSCRF). In this role, Amritha is responsible for oversight of all MSCRF activities, programs, scientific management and oversight of the portfolio, as well as MSCRF business development. She works with stem cell scientists and a variety of key stakeholders to develop a collaborative research program and promote commercialization of stem cell technologies. MSCRF has invested over $170 million in identifying, supporting, and accelerating cutting-edge research, innovation, clinical trials and commercialization of human stem cell-based technologies in Maryland. Amritha brings over a decade of experience in stem cell research in federal, university, and industry settings. She is passionate about using stem cell technologies to accelerate cures for patients in need. Her experience in and outside of the laboratory has made her a proven leader and champion for stem cell research and commercialization. She was recently recognized for her leadership in life sciences and contributions to the community by Women in Bio Capital Region and as a 2020 Leading Women honoree by The Daily Record.
Alan L. Jakimo is a member of the Board of Directors of Regenerative Medicine Foundation, which he joined in 2019. He also serves RMF as a Senior Policy Research Fellow, a position that he also held at Genetics Policy Institute, a predecessor of RMF. Mr. Jakimo began working with GPI in the fields of policy research and patient advocacy in 2007. His involvement in the field of developmental biology began during his tenure as a securities and technology transactions lawyer in the New York office of Brown & Wood LLP, which merged in 2001 with Sidley & Austin LLP (ultimately becoming Sidley Austin LLP). He joined a predecessor of Brown & Wood as an associate in 1980 and, after taking retired partner status from Sidley Austin in 2017, he joined the investment banking group at T.R. Winton & Company, LLC. Mr. Jakimo is an Adjunct Professor of Law at Hofstra University where he teaches courses on health law and how the law influences the discovery-to-development-to-commercialization pathway followed by regulated medical products and therapies. He also serves on the Board of Directors of The Cancer Trust, a not-for-profit organization focused on the formation of collaborative research consortia comprised of comprehensive cancer centers, as well as on the Advisory Council of the Center for Radiological Research at Columbia University and the Corporate Advisory Board at the Cold Spring Harbor Laboratory. Mr. Jakimo holds a B.A. in Mathematics from Colgate University and an M.B.A. and J.D. from Harvard University.
Tom Kalil is Chief Innovation Officer at Schmidt Futures. In this role, Tom leads initiatives to harness technology for societal challenges, improve science policy, and identify and pursue 21st century moonshots.
Prior to Schmidt Futures, Tom served in the White House for two Presidents (Obama and Clinton), helping to design and launch national science and technology initiatives in areas such as nanotechnology, the BRAIN initiative, data science, materials by design, robotics, commercial space, high-speed networks, access to capital for startups, high-skill immigration, STEM education, learning technology, startup ecosystems, and the federal use of incentive prizes.
Babak Kateb, MD is a neuroscientist with more than 20 years of research experience. His research has been focused on introduction of advance diagnostics and therapeutics into clinical neuroscience in order to rapidly identify and introduce game changing technologies to treat neurological disorders such as brain cancer, Alzheimer's disease, Parkinson's disease, and other brain and spinal disorders. He did his educational training at TUSOM, USC, did his research fellowship at USC-keck School of Medicine, Department of Neurosurgery and also studied VLSI system design at USC Department of Electrical Engineering at the Ming Hsieh Institute.
Babak established the Society for Brain Mapping and Therapeutics (SBMT) while doing his research fellowship 15 years ago at USC. Currently, he is the founding chairman of the board of directors & CEO Society for Brain Mapping and Therapeutics (SBMT), President and Scientific Director of the Brain Mapping Foundation and Director of National Center for Nano-Bio-Electronics; the center is focused on integration of nanotechnology, cellular therapeutics/stem cell, medical device and imaging; he is also a director of Brain Technology and Innovation Park and CEO of Smart Microscopy Inc.
Babak was Director of Research and Development in the Department of Neurosurgery at City of Hope Comprehensive Cancer Center where he established collaboration with NASA and published and pioneered the technique for using NASA multiwall carbon nanotubes to activate macrophages for brain cancer immunotherapy. While at City of Hope, he received NASA Tech Brief Award for his pioneering work on sniffing cancer cells using NASA's electronic nose.
In 2010, he joined Department of Neurosurgery at Cedars Sinai Medical Center as a research scientist where he developed partnership between Cedars-Sinai and NASA and established a clinical trial using NASA UV imaging for intraoperative brain mapping. He also patented a technology to microwave brain cancer, which was approval by the FDA for soft tissue; the technology also could be used for brain, liver, head and neck, prostate and breast cancer. He was also Scientific a Director and a Chief Strategy Officer (CSO) at California Neurosurgical Institute from 2015-2017 where he co-authored a nanoneurosurgery paper in Nature-Scientific Reports.
In 2015, Society for Brain Mapping and Therapeutics and Brain Mapping Foundation Board of Directors presented him with Pioneer in Medicine award. He has been recognized by Vice President Biden, Mayor of Los Angeles, and Governor of California for his dedication in science. He is currently collaborating with Los Alamos National Lab (LANL) and had duel appointment with NASA/JPL as a visiting scientist. His research at NASA and LANL involves the use of Artificial Intelligence(AI), Augmented Reality (AR), Virtual Reality (VR) and supercomputing for brain mapping and therapeutics, use of LANL advance ultrasonic technology for brain stimulation; Babak has many patents in these areas.
He has established a new publication with PLoSOne, which is called PLoSOne_ NeuroMapping & Therapeutics, which he serves as editor-in-chief and was the force behind 3 successful NeuroImage-Brain Mapping and Therapeutics special issues. He is the editor of the inaugural Textbook of Nanoneuroscience and Nanoneurosurgery, published by, Taylor & Francis (2013) and the editor of the inaugural Neurophotonic and Brain Mapping (2017).
Babak has been deeply involved in global neuroscience legislation through his close collaboration with the US Congressional Neuroscience Caucus as well as members of Canadian Parliaments. He has chaired 6 Congressional briefings: Brain Mapping Days (2012-2017) at the United States Congress on Brain Mapping; one Brain Research Day at the Canadian Parliament in 2013 and one Brain Mapping Day at the joint sessions of Australian Senate and Parliament in 2015. His initiatives have impacted the health care delivery to the wounded soldiers in the US. He has been one of the key players in President Obama's BRAIN initiative and co-author of the G20 World Brain Mapping and Therapeutics Initiative and African Brain Mapping Initiative. He has chaired G20 Brain Initiative Summits since 2014 inaugural meeting in Australia.
He is an artist who has had galleries for his paintings and currently does medical illustration for medical textbooks; He is also a 15 time marathon runner.
Melissa King is a passionate advocate for patients of chronic illness and disease as well as the medical research that can help reduce their suffering. An expert at engaging multiple stakeholders and communicating effectively with varied audiences, she has been a champion for the California stem cell research program since before it formally existed.
Ms. King served as a senior member of the successful 2004 campaign for California's Proposition 71, the California Stem Cells for Research And Cures Act. During the final weeks of the Prop 71 campaign, at the request of campaign Chair Robert Klein, Ms. King worked with legal counsel to form the non-profit Americans for Cures so that support during the organizational period of the new stem cell funding agency could be funded with tax-exempt donations to a 501(c) 3 organization. She hired initial staff for the non-profit and then transitioned several to be the first employees of the new state funding agency.
Ms. King played a central role in the founding, building and first seven years of operations of the unique $3 billion State research funding agency created by Prop 71, the California Institute for Regenerative Medicine (CIRM). During this time, she worked hand-in-hand with CIRM's Chair and its founding 29-member governing Board on setting the strategic vision for the agency as well as developing the processes and policies by which CIRM operates. Ms. King guided the Board through 1500+ hours of public meetings, during the sale of the first bonds to fund the agency as well as the development and awarding of the first billion dollars in grants, including the Facilities Grant Program leveraging $271 million of CIRM's funds to attract $880 million in other support for $1 billion in scientific research facilities in California.
In addition to her work at CIRM, Ms. King has helped drive and manage successful launches of numerous companies, programs and products in the healthcare, technology and consumer products industries.
She has a B.A. from Wellesley College and an MBA from the Stanford Graduate School of Business.
Professor, Department of Social Sciences and Health Policy, Wake Forest School of Medicine; Professor, Wake Forest Institute for Regenerative Medicine; Co-Director, Center for Bioethics, Health and Society and Graduate Program in Bioethics, Wake Forest University
Nancy M. P. King, JD, is Professor in the Department of Social Sciences and Health Policy and Wake Forest Institute for Regenerative Medicine at Wake Forest School of Medicine, and Co-Director of the Center for Bioethics, Health, and Society and the Graduate Program in Bioethics at Wake Forest University. Her scholarship addresses a range of bioethics issues, including: informed consent, benefit, and uncertainty in health care and research; the development and use of experimental technologies; international and cross-cultural questions in human subjects research; and ethical issues in “big data” research and biobanking, gene transfer research, regenerative medicine, and other novel biotechnologies.
Professor King has published over 100 scholarly articles and book chapters, and is co-editor of The Social Medicine Reader (2nd ed., Duke University Press, 2005; 3rd ed. forthcoming), Beyond Regulations: Ethics in Human Subjects Research (UNC Press 1999), and Bioethics, Public Moral Argument, and Social Responsibility (Routledge 2012). She teaches a variety of courses in bioethics, medical humanities, and research ethics to medical students and faculty and to graduate students in bioethics and the health sciences.
Professor King has served on hospital ethics committees, IRBs, DSMBs and the NIH Recombinant DNA Advisory Committee, and has taught bioethics in national and international settings. She is a Fellow of the Hastings Center and a member of the DHHS Secretary’s Advisory Committee for Human Research Protections.
James Kovach MD, JD serves as Director, Entrepreneurship and Innovation at the University of California Davis Health System, where he supports UC Davis faculty, staff and student training in entrepreneurship and engages in industry outreach.
Dr. Kovach is also Chief Innovation Officer of Aggie Square. Aggie Square is an innovation center launched by UC Davis to spur economic growth in Sacramento through partnerships with the City of Sacramento and other entities, while encouraging collaborations across UC Davis disciplines—in life sciences, food systems, mobility, government, civic technology, arts and communications.
Dr. Kovach received his medical degree with distinction from the University of Kentucky while simultaneously playing in the National Football League. Following his NFL career, he attended law school at Stanford University and practiced corporate law in Palo Alto California.
Dr. Kovach established the Technology Transfer Program at the Case Western Reserve University School of Medicine. He also helped launched and has served as Chief Operating Officer of Athersys, Inc. (NASDAQ: ATHX), a leading public biotechnology company developing stem cell therapeutics.
Dr. Kovach has also served as President of the Buck Institute for Age Research. Named by NIH as a national center of excellence, the Buck Institute is an independent research institute dedicated exclusively to research on aging and age-associated disease.
Dr. Kovach played 7 years in the National Football League (NFL) as a middle linebacker for the New Orleans Saints and San Francisco 49ers. He has served previously as a member of the NFL Head, Neck and Spine Committee. He is a member of the College Football Academic Hall of Fame. He is the leading tackler in the history of the University of Kentucky and 4th leading tackler in Southeastern Conference history
Dr. Kovach is a Board member of the California Institute of Regenerative Medicine.
Dan Kracov is co-chair of Arnold & Porter's global Life Sciences and Healthcare Regulatory practice. For decades, he has been one of the foremost Food and Drug Administration lawyers in the country, and his expertise in critical regulatory matters has been widely recognized by Chambers, the Legal Times, Best Lawyers in America, and other publications. LMG Life Sciences recently named him the 2020 Pharmaceutical Regulatory Attorney of the Year. A particular focus of his practice is assisting pharmaceutical, biotechnology, and medical device companies in negotiating challenges relating to the development, approval and marketing of FDA-regulated products. In addition to day-to-day counseling on regulatory strategies and concerns, Mr. Kracov regularly handles product and compliance-related government and internal investigations and enforcement, the development of global corporate compliance programs, and due diligence in financings, mergers and acquisitions. He has a widely recognized experience in biomedical public policy matters, including Congressional investigations and advising on FDA-related legislation.
Dr. 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 serves as the Director of the Marcus Center for Cellular Cures (MC3), Director of the Pediatric Blood and Marrow Transplant Program, Director of the Carolinas Cord Blood Bank, and Co-Director of the Stem Cell Transplant Laboratory at Duke University.
Dr. Kurtzberg's research in MC3 focuses on translational studies from bench to bedside, seeking to develop transformative clinical therapies using cells, tissues, molecules, genes, and biomaterials to treat diseases and injuries that currently lack effective treatments. Recent areas of investigation in MC3, which are funded by the Marcus Foundation, include the use of autologous cord blood in children with neonatal brain injury, cerebral palsy, and autism, as well as preclinical studies manufacturing microglial oligodendrocyte-like cells from cord blood to treat patients with acquired and genetic brain diseases. Studies of donor cord blood cells in adults with stroke and children with cerebral palsy and autism are also underway.
Dr. Kurtzberg's lab has developed novel chemotherapeutic drugs for T-cell Leukemias, assays enumerating ALDH bright cells 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. Dr. Kurtzberg currently holds several INDs for investigational clinical trials.
Laura joined Greater Winston-Salem Inc as Senior Vice President of Economic Development in July of 2020, where she leads business recruitment, retention/expansion and entrepreneurial support efforts for Forsyth County. Prior to this role, she served as Business Recruitment Manager for the Economic Development Partnership of North Carolina. She was responsible for attracting new business across North Carolina markets, including the Triad. As EDPNC's only industry-specific recruiter, Laura's projects focused on food and beverage processing and value-added agriculture, supporting the state's top industry, agriculture. At EDPNC, Laura was successful in attracting over 2,400 jobs and $365M in capital investment.
Laura has also held economic development positions in Asheville and Savannah, GA. A native North Carolinian, Laura grew up in Wilson and attended Wake Forest University, where she earned an undergraduate degree in Communications and Entrepreneurship and a Masters of Science in Management.
Associate Professor (Tenured), Wake Forest Institute for Regenerative Medicine
Deputy Director, Tissue Engineering Program; Director, Biofabrication Core
Wake Forest School of Medicine
Sang Jin Lee, Ph.D. is currently a tenured Associate Professor at Wake Forest Institute for Regenerative Medicine (WFIRM), Wake Forest School of Medicine. Dr. Lee received his Ph.D. in Chemical Engineering at Hanyang University, Seoul, Korea in 2003 and took a postdoctoral fellowship in the Laboratories for Tissue Engineering and Cellular Therapeutics at Harvard Medical School and Children’s Hospital Boston and the WFIRM where he is currently a faculty member. He is also cross-appointed to the Virginia Tech-WFU Biomedical Engineering and Science. Dr. Lee has authored more than 140 scientific publications and reviews, has edited 2 textbooks, and has written 34 chapters in several books.
Dr. Lee has extensive knowledge and experience in biomaterials science, especially, biodegradable polymers and tunable hydrogels, with specific training and expertise in key research areas for tissue engineering and regenerative medicine. His research team has developed various biomaterial systems that improve cellular interactions by providing appropriate environmental cues. These biomaterial systems consist of drug/protein delivery systems, nano/micro-scaled topographical features, and hybrid materials that can actively participate in functional tissue regeneration. Recently, his team is utilizing automated 3D bioprinting technology to manufacture complex, multi-cellular living tissue constructs that mimic the structure of native tissues. This can be accomplished by optimizing the formulation of biomaterials to serve as bioinks for 3D bioprinting, and by providing the biological microenvironment needed for the successful delivery of cells and biomaterials to discrete locations within the 3D structure.
Scripps Research Institute
Jeanne F. Loring is Professor emeritus at the Scripps Research Institute where she was founding Director of the Center for Regenerative Medicine. Dr. Loring has diverse experience: 15 years in biotechnology and 15 years of academic research, combining stem cells, genomics, epigenetics, bioinformatics, embryology and neurobiology. She has founded two stem cell-based biotechnology companies, Arcos Bioscience (now part of Viacyte) and Aspen Neuroscience, a biotechnology company founded in 2018 to continue development of an autologous neuron replacement therapy for Parkinson disease. She holds five patents on stem cells and genomics, and has published three books and more than 120 research articles.
In addition to her work on Parkinson disease, Dr. Loring investigates stem cell-based therapies for multiple sclerosis, studies the cellular basis for autism, and works with the San Diego Zoo Institute for Conservation Research in an effort to rescue the Northern white rhinoceros from extinction using stem cell technology. She is also involved in a project on the International Space Station to study neurogenerative disease in microgravity.
Dr. Loring is recipient of many awards for her accomplishments both as a scientist and an advocate for evidence-based therapies for patients and education. Through her NIH- and CIRM-sponsored laboratory courses, she has trained more than 400 scientists in stem cell technology. She serves on bioethics and scientific advisory boards, is on the editorial boards of several scientific journals, and advises governmental and private granting agencies in several countries. She is frequently interviewed for news reports about topics including cell and gene therapies, patient rights, the ethics of stem cell tourism, experiments in space, rescue of endangered species, and challenges for women in science and as entrepreneurs in biotechnology. She gives talks about her work at international conferences, is the featured speaker on numerous podcasts and webinars, is interviewed often by television networks, and has appeared in several documentaries.
Working as a catalyst in the field to create new global business opportunities for PHC business units and PHCHD subsidiary companies. Working directly with pharmaceutical companies, government agencies, academic institutions, and the investment community; providing them with Medical Device, Lifescience, and Healthcare IT solutions. Furthermore working intimately with Regenerative Medicine KOL's, and other leading academic institutions and entities that will help grow PHC Group businesses faster organically and inorganically while achieving the corporate mission of creating healthcare solutions that have a positive impact and improve the lives of people. Immediate past president of PHC Corporation of North America.
Janet Marchibroda serves as the President of Alliance for Cell Therapy Now, an independent, non-profit organization devoted to advancing the development and delivery of safe and effective cell-based therapies to patients in need. In addition to her role with the Alliance, she serves as a Fellow for the Bipartisan Policy Center, Executive Director for NFL Alumni Health, Board Member for HL7, and Co-Chair of Friends of HL7.
Marchibroda's other roles have included serving as Director of the Health Innovation Initiative and Director of the CEO Council on Health and Innovation at the Bipartisan Policy Center, Chief Health Care Officer for IBM, Senior Vice President for Health Policy and Technology at CNI, and Chief Operating Officer for the National Committee for Quality Assurance, an organization devoted to improving the quality of health care for Americans. She also served as founder and CEO of the eHealth Initiative, a non-profit, multi-stakeholder member organization that was instrumental in advancing legislation that provided nearly $40 billion in investments in health IT. She also served as Executive Director of Connecting for Health—an initiative supported by the Markle Foundation and Robert Wood Johnson Foundation and Chief Operating Officer for the National Coalition for Cancer Survivorship. Marchibroda also co-founded and served as Chief Operating Officer of a healthcare-related electronic publishing, data, and consulting services company which was later acquired by Bertelsmann AG.
Marchibroda efforts to support the federal government have included running a large-scale project at the Centers for Disease Control and Prevention (CDC) that rapidly deployed epidemiological, clinical, and data analytics support to more than 30 local health departments across the U.S. and territories to support mothers and babies impacted by the Zika crisis; running a CDC-led public-private sector partnership devoted to improving electronic information sharing between health care providers, their electronic health records, and more than 60 immunization registries across the country; and leading stakeholder engagement activities for the National Coordinator for Health Information Technology within the Department of Health and Human Services, following passage of the HITECH Act.
Marchibroda has been recognized as one of the Top 25 Women in Healthcare by Modern Healthcare, one of the Most Powerful Women in Healthcare IT by Health Data Management, and a recipient of the Federal Computer Week Top 100 Award.
Professor, Wake Forest Institute for Regenerative Medicine
Frank Marini is a professor at the Wake Forest Institute for Regenerative Medicine, with affiliation in the Department of Cancer Biology and the Center on Diabetes, Obesity and Metabolism at the Wake Forest School of Medicine. Marini earned his PhD at the University of Texas MD Anderson Hospital in 1998. His expertise includes molecular biology and microscopic imaging.
Michael May is President and CEO of the Centre for Commercialization of Regenerative Medicine (CCRM), a Canadian, not-for-profit that develops technologies, launches new companies and catalyzes investment in the field of regenerative medicine, including cell and gene therapy. CCRM is now seeking partners and financing for a commercial scale cell and gene therapy facility. Prior to CCRM, Michael was the President, and co-founder, of Rimon Therapeutics Ltd., a Toronto-based tissue engineering company developing novel medical polymers that possess drug-like activity.
Michael sits on a number of boards and advisory committees including: the ARM Foundation for Cell & Gene Medicine; AgeX Corporation; panCELLa Inc.; CCRM Enterprises; the International Advisory Board of the Swedish Centre for Advanced Medical Products (CAMP); the Poietis SAB; the Entrepreneurship Leadership Council at the University of Toronto; the Cell and Gene Therapy Insights, Editorial Advisory Board; the Commercialization Committee of the International Society for Cell and Gene Therapy; He is the Chairman of ExCellThera Ltd.
Dr. May completed his PhD in Chemical Engineering at the University of Toronto in 1998 as an NSERC Scholar and was awarded the Martin Walmsley Fellowship for Technological Entrepreneurship.
Dr. Andrea Mazzocchi is co-founder and CEO of Known Medicine, an oncology diagnostics company. She completed her PhD at Wake Forest School of Medicine in Biomedical Engineering working in the lab of Dr. Shay Soker and received her BS in Biomedical Engineering from Rochester Institute of Technology. She has spent the past several years focused on cancer precision medicine, tissue engineering, and biomaterials and holds an adjunct professorship at Wake Forest University teaching Tissue Engineering. Dr. Mazzocchi was a National Institute of Biomedical Imaging and Bioengineering T32 Predoctoral Training Grant Fellow and awarded the Mike & Lucy Robbins Fellow from Wake Forest Comprehensive Cancer Center. She has also received numerous awards from the Biomedical Engineering Society and the Tissue Engineering and Regenerative Medicine International Society for her work as both an undergraduate and graduate student.
Antonios G. Mikos is the Louis Calder Professor of Bioengineering and Chemical and Biomolecular Engineering at Rice University. He is the Director of the National Institutes of Health Center for Engineering Complex Tissues, the Director of the Center for Excellence in Tissue Engineering, and the Director of the J.W. Cox Laboratory for Biomedical Engineering at Rice University. He received his Dipl.Eng. (1983) from the Aristotle University of Thessaloniki, Greece, and his Ph.D. (1988) in chemical engineering from Purdue University. He was a postdoctoral researcher at the Massachusetts Institute of Technology and the Harvard Medical School before joining the Rice Faculty in 1992 as an assistant professor.
Mikos' research focuses on the synthesis, processing, and evaluation of new biomaterials for use as scaffolds for tissue engineering, as carriers for controlled drug delivery, as non-viral vectors for gene therapy, and as platforms for disease modeling. His work has led to the development of novel orthopaedic, dental, cardiovascular, neurologic, and ophthalmologic biomaterials. He is the author of over 640 publications and 32 patents. He is the editor of 15 books and the author of one textbook (Biomaterials: The Intersection of Biology and Materials Science, Pearson Prentice Hall, 2008). Mikos is among the top 1 percent most cited researchers in his field. He has been cited over 83,000 times and has an h-index of 150.
Dr. Maria Millan is a physician-scientist who has devoted her career to treating and developing innovative solutions for children and adults with debilitating and life-threatening conditions. After receiving her undergraduate degree from Duke University where she first entered the arena of immunology research, she returned to her home in New Jersey where she obtained her M.D. and then went on to complete her surgical training and post-doctoral research in Boston at Harvard Medical School – Beth Israel Deaconess Medical Center. After a transplant surgery fellowship at Stanford University School of Medicine, she began her academic career with a busy pediatric and adult transplant surgery practice focused on technical advancements and optimization of patient outcomes, including the treatment of rare fatal diseases. In parallel, she continued her bench research at Stanford and was promoted within 5 years to Associate Professor and the Director of the Pediatric Organ Transplant Program. She served on multiple leadership teams including the Faculty Senate and the Dean's faculty committee at Stanford University School of Medicine and served on the Children's Hospital operations committee and currently serves on the editorial board for Stem Cell Translational Medicine and multiple non-profit boards advancing initiatives in health and in growing the healthcare industry ecosystem in California and beyond. She has published in the areas of cell biology, immunology, and clinical organ transplantation.
With early signals from the science that stem cell and regenerative medicine therapy was the new frontier for medicine, she ventured into the private sector in 2006 to join StemCells, Inc., one of the earliest stem cell organizations and the first to enter into an FDA regulated clinical trial with a stem cell treatment for children with a fatal neurodegenerative disease. Dr. Millan then joined the California Institute for Regenerative Medicine in December 2012 where she led the formation of the Alpha Stem Cell Clinics Network, a network of California medical centers that specialize in rigorous and high quality clinical trials and top tier medical care for patients participating in these trials. This clinical network is now composed of seven medical centers and their affiliated hospitals across California and has supported over 130 clinical trials to date. As a key component of CIRM's bold 5-year strategic plan launched in 2016, which was designed to accelerate stem cell treatments to patients with unmet medical needs, Dr. Millan led the development of critical infrastructure, including specialized regulatory, preclinical research, manufacturing and clinical operations support for stem cell and regenerative medicine trials. In July 2017, Dr. Millan took on the role as President and CEO of CIRM and she was formally appointed by CIRM's Board in September 2017. Under her leadership, CIRM continues to drive the mission of accelerating stem cell treatments to patients with unmet medical needs, is on track to achieve its 5-year strategic plan, has now funded a 64 clinical trials and is continuing to grow this robust portfolio of high quality programs by the month. In addition, she led the initiative to partner with the NHLBI to drive the "Cure Sickle Cell" Initiative and this is yielding a robust pipeline of cell and gene therapy projects that are on the way to clinical testing.
President, Atrium Health Musculoskeletal Institute
Claude T. Moorman, III, MD is Professor and Edward N. Hanley, Jr. Endowed Chair of the Department of Orthopaedic Surgery and President of the Atrium Health Musculoskeletal Institute.
After graduating from Duke University and the University of Cincinnati College of Medicine, he did his residency at Duke University and a year-long Sports Medicine fellowship at the Hospital for Special Surgery in New York, NY. His initial academic appointment was at the University of Maryland where he started the Sports Medicine Program, and served as Head Team Physician for the Baltimore Ravens through their first Super Bowl. He was subsequently recruited back to Duke University where he served as the Vice Chairman, Chief of Sports Medicine, and Head Team Physician at Duke University through eight National Championships and five Bowl games! He ultimately formed the Urbaniak Sports Sciences Institute and served as the Executive Director for the remainder of his 20-year term in Durham. He was recruited to Atrium Health where he took up his current duties on January 1, 2018.
Dr. Moorman is board certified in orthopaedic surgery and has also been separately board certified in orthopaedic sports medicine. His orthopaedic clinical practice has an emphasis on complex shoulder instability and multiple ligament knee injuries. As President of the Musculoskeletal Institute, Dr. Moorman manages over 100 clinical faculty, 12 PhD faculty, 31 residents and fellows, and the ancillary services supporting the musculoskeletal service line. Dr. Moorman has devoted a significant portion of his career to education of undergraduates, graduate students, medical students, residents, and fellows. Dr. Moorman was a Professor in the Department of Evolutionary Anthropology where he taught an undergraduate course Anatomy 151, which was a cadaveric study of the lower extremities for 20 years. He has served as Residency Program Director, Fellowship Program Director and on the Education Committee at three different institutions and has been responsible for the education of 168 residents and 75 fellows. He has received the Resident Teaching Award on two separate occasions.
Dr. Moorman's productivity includes 201 publications--168 peer-reviewed manuscripts, 27 book chapters, and 6 textbooks. He has done over 1000 international, national, regional, and local scientific presentations. His awards include the Charles S. Neer Award for the outstanding basic science contribution in shoulder research, the AOSSM Aircast Award for basic science for work on the posterolateral corner of the knee, the Philip D. Wilson Award for outstanding research at the Hospital for Special Surgery, the AAOSM Aircast Award for clinical science for shoulder research, the North Carolina Orthopaedic Association Research Award, the Southern Orthopaedic Association Research Award, and a number of institutional awards for research and education. Dr. Moorman has been recognized in Castle and Connolly and Best Doctors for national recognition, NC Business Journal Best Doctors for regional recognition and Triangle Business Journal Best Doctors for local recognition for over 20 years. He has also received a number of community service awards including state honors as "Tarheel of the Week" by the Raleigh News and Observer in 2001 and the George F. Whitfield Eastern NC Sports Hall of Fame in 2020. Recently, Dr. Moorman was selected by the Southern Orthopaedic Association (SOA) as the "Distinguished Southern Orthopaedist" to be awarded at the annual meeting of the SOA in July 2021.
Dr. Moorman's current research focus is on multiple ligament knee (MLKI) injury and repair, complex shoulder instability, and regenerative medicine indications and techniques. This work has received funding from over 30 separate grants for funding and has been presented internationally.
Prof. Dr. Lorenzo Moroni studied Biomedical Engineering at Polytechnic University of Milan, Italy, and Nanoscale Sciences at Chalmers Technical University, Sweden. He received his Ph.D. cum laude in 2006 at University of Twente on 3D scaffolds for osteochondral regeneration, for which he was awarded the European doctorate award in Biomaterials and Tissue Engineering from the European Society of Biomaterials (ESB). In 2007, he worked at Johns Hopkins University as a post-doctoral fellow in the Elisseeff lab, focusing on hydrogels and stem cells. In 2008, he was appointed the R&D director of the Musculoskeletal Tissue Bank of Rizzoli Orthopedic Institute, where he investigated the use of stem cells from alternative sources for cell banking, and the development of novel bioactive scaffolds for skeletal regeneration. From 2009 till 2014, he joined again University of Twente, where he got tenured in the Tissue Regeneration department.
Since 2014 he works at Maastricht University, where he is a founding member of the MERLN Institute for Technology-Inspired Regenerative Medicine. In 2016, he became full professor in biofabrication for regenerative medicine.
His research group interests aim at developing biofabrication technologies to generate libraries of 3D scaffolds able to control cell fate, with applications spanning from skeletal to vascular, neural, and organ regeneration.
In 2014, he received the prestigious Jean Leray award for outstanding young principal investigators from the ESB and the ERC starting grant. In 2016, he also received the prestigious Young Scientist Award for outstanding principal investigators from TERMIS. In 2017, he was elected as faculty of the Young Academy of Europe and in the top 100 Italian scientists within 40 worldwide by the European Institute of Italian Culture. Since 2019, he is chair of the Complex Tissue Regeneration department and vice-director of MERLN. From his research efforts, 3 products have already reached the market.
Assistant Professor, Wake Forest Institute for Regenerative Medicine
Dr. Sean Murphy received his Bachelors degree in Molecular Biology (Honors) from the University of Western Australia in 2006 and his Ph.D. in Stem Cell Therapy in 2012. His thesis work focused on developing perinatal stem cells as a therapy for lung disease and contributed to an ongoing Phase I clinical trial for the treatment of bronchopulmonary dysplasia (BPD) in preterm infants. Dr. Murphy joined Wake Forest Institute for Regenerative Medicine in 2012 as a Postdoctoral Fellow and became an Assistant Professor in 2015.
Ann Murphy, PhD, is publisher and founding editor of three international, peer-reviewed journals: STEM CELLS, The Oncologist, and STEM CELLS Translational Medicine. Ann is also the founding Director General for the Society for Translational Oncology (STO).
Ann earned a Doctorate of Philosophy with distinction in Literature from New York University. She serves on the Regenerative Medicine Foundation Board and the Board of Visitors for the UNC Lineberger Comprehensive Cancer Center.
An actively practicing cardiologist and committed teacher, Kiran Musunuru, MD, PhD, MPH, ML, is Professor of Cardiovascular Medicine and Genetics in the Perelman School of Medicine at the University of Pennsylvania. His research focuses on the genetics of heart disease and seeks to identify genetic factors that protect against disease and use them to develop new therapies. He is a recipient of the Presidential Early Career Award for Scientists and Engineers from the White House, the American Heart Association's Award of Meritorious Achievement, the American Philosophical Society's Judson Daland Prize for Outstanding Achievement in Clinical Investigation, the American Federation for Medical Research's Outstanding Investigator Award, and Harvard University's Fannie Cox Prize for Excellence in Science Teaching. He recently served as Editor-in-Chief of the scientific journal Circulation: Genomic and Precision Medicine. He is author of The CRISPR Generation: The Story of the World's First Gene-Edited Babies and Genome Editing: A Practical Guide to Research and Clinical Applications. He is co-founder and Senior Scientific Advisor of Verve Therapeutics.
Chairman and CEO, 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.
The Nakayama Laboratory works on developing engineered and regenerative therapies to treat cardiovascular and musculoskeletal injuries and disease. Dr. Nakayama received her Ph.D. from the Department of Biomedical Engineering at the University of California, Davis. During her doctoral training, she worked towards developing regenerative therapies for congenital kidney diseases using decellularized extracellular matrices and stem cell-derived renal precursors.
Dr. Nakayama completed her postdoctoral training at the Stanford University School of Medicine in the Department of Cardiothoracic Surgery. During her time at Stanford, her research focused on building iPSC-derived small diameter vascular grafts and myocardial tissues and enhancing angiogenesis in ischemic and severely damaged limbs through the manipulation of the spatial and mechanical properties of biomaterials.
Dr. Nakayama joined the faculty at Oregon Health & Science University (OHSU) in the Department of Biomedical Engineering in January of 2020. The current research focus of the Nakayama Lab is the development of regenerative therapies for cardiovascular and musculoskeletal disease and injury using spatially patterned biomaterials and rehabilitation exercise.
Jan A. Nolta, Ph.D., is the Director of the Stem Cell Program at University of California Davis School of Medicine and directs the Institute for Regenerative Cures and the new UC Davis Gene Therapy Center. She also serves as the Scientific Director of the large UC Davis Good Manufacturing Practice Facility, and as PI of the California State Umbilical Cord Blood Collection Program. The UC Davis stem cell program has a large number of basic, translational, and clinical scientists collaborating to work toward regenerative medicine-related cures for a spectrum of diseases and injuries. Dr. Nolta is helping UC Davis teams develop numerous clinical trials of gene and cell therapy, with 40+ stem cell/regenerative medicine therapies already in the clinic, and over twenty in the pipeline. A California Institute for Regenerative Medicine "Alpha Clinic" Award was recently granted to UC Davis to administer FDA-approved stem cell and regenerative medicine therapies.
A scientist with 30 years' experience with human Hematopoietic and Mesenchymal stem cells, gene therapy, and clinical trial development, Dr. Nolta developed her passion for cellular therapy in the early 90's by helping to develop and administer the first umbilical cord blood hematopoietic stem cell gene therapy trials for newborns with "bubble baby disease" with her mentor Donald Kohn at the University of Southern California.
Dr. Nolta has published over 200 peer-reviewed manuscripts in the stem cell field, with over 13,000 citations, and has authored 30+ book chapters. She has served on over 250 review panels for the National Institutes of Health and other grant-funding agencies, was editor of the Book "Genetic Engineering of Mesenchymal Stem Cells", and has been Editor-in-Chief for the Journal "Stem Cells" for the past seven years.
Dr. Nolta is a native of Northern California, trained in Los Angeles and Washington University, and has been back at UC Davis in Sacramento now for over a decade. A major driving force throughout her career has been to provide service to teams working toward novel cures, and to foster a strong sense of community and teamwork. Team training is her passion and she leads several training initiatives at UC Davis and beyond. The fields of stem cells, immunotherapy, gene therapy and regenerative medicine are poised to change the face of healthcare. The new "living medicine" preparation and delivery will be performed by large teams of experts with different expertise and backgrounds. The UC Davis Stem Cell Program is committed to fostering teamwork, training the diverse science and healthcare work force of the future, and to continuing to improve and deliver these novel cutting edge therapies for patients who currently have few other options.
Gordana Vunjak-Novakovic is University Professor, the highest academic rank at Columbia University and the first engineer at Columbia to receive this distinction. The focus of her lab is on engineering functional human tissues for use in regenerative medicine and in patient-specific "organs-on-a-chip" for studies of human pathophysiology. She is well published and highly cited (h=128), mentored over 150 trainees, and launched four start-up companies with her students. She is a member of Academia Europaea, Serbian Academy of Arts and Sciences, National Academy of Engineering, National Academy of Medicine, National Academy of Inventors, and the American Academy of Arts and Sciences.
Graham is in the Children's Research Center of Michigan of the Carman and Ann Adams Department of Pediatrics, Wayne State University School of Medicine located at Children's Hospital of Michigan. Graham is the co-leader of the Integrative Health Sciences Facility Core of the NIH NIEHS funded program grant, Center for Urban Responses to Environmental Stressors (CURES), housed at the new integrative bioscience center at Wayne State University. Graham's research interests include the therapeutic potential and vulnerability of human stem cells with a particular focus on developmental models of the #1 inherited killer of infants, Spinal Muscular Atrophy. Graham is also the Editor-in-Chief of Stem Cells and Development, Executive Editor of Nucleic Acid Therapeutics, former Co-Editor-in-Chief of the World Stem Cell Report, a Section Editor for BioResearch Open Access, and Ethical Advisor for Mary Ann Liebert, Inc. publishers.
Gary Pigeau received his Ph.D. in Biotechnology from Brock University in St. Catharines, Ontario. He completed a postdoctoral fellowship at the University of Alberta with a visiting scientist appointment at the University of Oxford. Gary moved to private industry in 2008, where his research group focused on process development and scale-up of a proprietary bioprocess technology. He then moved to commercial, large-scale biomanufacturing in 2013. Gary joined Cytiva, formerly part of GE Healthcare's Life Sciences business, and the Centre for Advanced Therapeutic Cell Technologies (CATCT) at CCRM in 2016. He serves as Director of the collaborative facility in Toronto, Ontario with focus on biology support for New Product Introductions, internal technology development projects and contract process development services in cell and gene therapy.
Professor, Wake Forest Institute for Regenerative Medicine
Dr. Christopher Porada received his Bachelor’s degree in Molecular Biology from Colgate University in 1991 (magna cum laude, Phi Beta Kappa) and his PhD in Cellular and Molecular Pharmacology and Physiology from the University of Nevada in 1998 (summa cum laude), focusing on fetal gene therapy for the treatment of hematologic diseases. After completing his PhD, he conducted a post-doctoral fellowship in the Department of Medicine at the VA Medical Center in Reno, focusing on stem cell biology and the immune aspects of gene delivery. In 2001, he joined the Department of Animal Biotechnology at the University of Nevada, Reno as an Assistant Professor, and was subsequently promoted to an Associate Professor at the same Institution. He has authored over 125 scientific abstracts, over 60 full-length manuscripts, and has written chapters in nearly a dozen books. He serves on the Editorial Board for several international journals, and is a member of several international societies. Dr. Porada regularly serves as a reviewer for NIH, NYSTEM, several other international grant agencies, and over 40 international journals focused on gene therapy, gene and drug delivery, stem cell biology, cancer, and stem cell transplantation. Dr. Porada joined the faculty at WFIRM in 2011.
Tina Purnat is Principal Expert in eHealth and Digital Innovations for Public Health at ECDC.
Tina has worked at the intersection of health research, analysis and policy-making with an emphasis on digital health and health information systems. Most recently, she worked at WHO on frameworks for assessment and evaluation of AI and other digital health technologies in health, health information exchange and interoperability, and related aspects of health data governance for sharing, research and use in policy-making. As part of the WHO COVID-19 response, she worked in developing and formulating WHO infodemic response and evidence-based approaches to infodemic management interventions, for which she received the WHO Pathfinder and Innovation Award 2021.
She left basic science research in 2007 to join the European Centre for Disease Prevention and Control for the first time, to lead data collection, capacity building, and reporting of notifiable infectious diseases. She later worked at WHO and University of Munich as an analyst in clinical trials and implementation research studies in LMICs.
Between 2015-19, she was Unit Leader for Health Informatics and Information Systems, and 2016-2018 acting Unit Leader and Programme Manager for Health Information, Monitoring and Analysis at WHO Regional Office for Europe. There, she led the development of the European Health Information Gateway; capacity building courses in health information and evidence-informed policy-making; and assessment, integration and strengthening of health information systems in countries. She was managing editor of the European Health Report 2018, which outlined the vision for improved use of evidence, research and health information to inform policy-making in the WHO European Region.
Wenchun Qu, MD, MS, PhD is board certified in PM&R and Pain Medicine, and serves as the vice-Chair of Research and Innovation at the Department of Pain Medicine, the Director of Regenerative Pain Medicine at Mayo Clinic Florida, and Chair of Enterprise Spine Research Committee of Mayo Clinic. He holds the academic rank of Associate Professor of PM&R and Anesthesiology at Mayo Clinic Alix School of Medicine. Dr. Qu has special clinical and research interest in cell and gene therapy for treatment of spinal cord injury, degenerative disc disease, and osteoarthritis. Dr. Qu has published more than 60 peer reviewed manuscripts, 9 book chapters, and 3 books. He has been a prolific speaker and has received multiple national awards.
Mahendra Rao received his MD (MBBS) from Bombay University in India and his PhD in Developmental Neurobiology from the California Institute of Technology. Mahendra Rao is internationally known for his research involving human embryonic stem cells (hESCs) and other somatic stem cells and has worked in the stem cell field for more than twenty years with stints in academia, government and regulatory affairs and industry. Dr. Rao has an extensive background teaching medical and graduate students, as well as postdoctoral fellows at institutions including The Johns Hopkins University School of Medicine, The National Centre for Biological Sciences in Bangalore, India, and the University of Utah School of Medicine. Dr. Rao has published more than 350 papers on stem cell research and is the co-founder of a neural stem cell company Q therapeutics based in Salt lake City (Utah) and more recently NxCell based in California.
Until 2010 Dr. Rao led the Stem Cell and Regenerative Medicine division at LiFE Technologies and also served as the Chair of the CBER (FDA) advisory committee (CTGTAC). Dr. Rao serves on several scientific advisory boards to Pharma, journal editorial boards and oversight committees and advisory panels on large scale projects related to stem cell biology. Dr. Rao has served and continues on the Boards of several stem cell and regenerative medicine companies such Stempeutics, CESCA, CBR and Megakaryon. Dr Rao has also served on advisory panels to the governments of the U.S., Singapore and India on hESC and iPSC policy. He continues to work with the FDA and other regulatory authorities on PSC related issues most recently as the CIRM and ISSCR liaison to the ISCT.
Dr. Rao was the founding Director of the NIH Center of Regenerative Medicine and also the Chief of the Laboratory of Stem cell Biology at the NIH. Dr. Rao ongoing efforts are focused on translational work related to Parkinsons disease and glial cell pathology. Dr. Rao is an adjunct faculty member at Wake Forest Center For Regenerative Medicine and the VP of Strategic Affairs at Q therapeutics. He also serves as a consultant on Regenerative Medicine for the New York Stem Cell Foundation and continues to provide consultant and advisory services to biotechnology companies in the regenerative medicine field. Dr. Rao was recently named
one of the top ten influential people in the stem cell field and was honored recently by the Federation of Biologists (FABA) India for his achievements in the stem cell field and awarded the NBRI medal (India) for his contributions to neuroscience research.
Russ Read has worked in the bioscience industry for over thirty - five years. He was formerly an executive with the Burroughs Wellcome and Glaxo Wellcome companies, heavily involved with the commercial development of antivirals for HIV illness like AZT and 3TC and was CEO of the Kucera Pharmaceutical Company- a bio-pharmaceutical company. He has led a national biotechnology workforce effort for sixteen years called the National Center for the Biotechnology Workforce (NCBW), based in Winston-Salem is a part of North Carolina's Community College System and Forsyth Technical Community College which focuses on achieving best practices for bioscience workforce training. Forsyth Tech, won a $15 million US DOL Trade Adjustment Assistance grant looking at building biosciences workforce skill standards and credentials. Russ was the consortium's Project Director from start to finish in October 2016. He was the Principal Investigator for the NSF ATE Project grant named the Biosciences Industry Fellowship Program and is the Principal Investigator for another NSF ATE Project grant called Biomedical Emerging Technology Applications or BETA Skills, at the interface between biomedical devices and tissue engineering, and most recently became a CO-PI of InnovATEBIO, an NSF ATE Biotech Education Center based out of Austin. He currently serves as a Past-Chair of the Advisory Committee for the NC Biotech Center's Piedmont Triad regional office and is a Director of NCBIO. He also served on the National Visitor's Committee of Bio-Link and AC2 Bio-Link Regional Center, Austin TX, an advisor to the NSF ATE NBC2 Bio-manufacturing program and a member of the workforce committee for the National Institute for Innovation in Manufacturing Biopharmaceuticals or NIIMBL. Russ has been twice recognized for his work by the North Carolina Biotechnology Center's TRIAD BIONIGHT for community support and service and for academic excellence.
Brock Reeve is Executive Director of the Harvard Stem Cell Institute. In partnership with the Faculty Directors, he has overall responsibility for the operations and strategy of the Institute which is comprised of the schools of Harvard University and its affiliated hospitals and research institutions. Under the leadership of its Executive Committee, HSCI invests in scientific research and its faculty has grown to include over 350 Principal and Affiliated members. The Institute is engaged with several leading pharmaceutical companies and foundations in joint research projects and its faculty have founded over 40 stem cell-related startup companies and serve on leading Scientific Advisory Boards.
Brock came to HSCI from the commercial sector with extensive experience in both management consulting and operations for technology-based companies, with a focus on life sciences. Brock received a BA and MPhil from Yale University and an MBA from Harvard Business School.
William (Bill) Martin Remak, Founded the Global Immunization Action Network Team (GIANT) and now serves as its senior advisor. He is a Medical Technologist and former faculty member of the University of California, San Francisco. Armed with a Bachelor of Science in Public Health Administration from San Francisco State University and a Master of Science in Clinical Science, Remak became a volunteer for the American Liver Foundation (ALF) and after a year joined the Board of Directors at the Northern California Chapter from 1994 through 2002. In close collaboration with the ALF Board and the Medical Advisory Board on advocacy, Remak worked on educational outreach campaigns and facilitated support groups for liver disease for many years. Remak is the founder and CEO of the California Hepatitis C Task Force, current Chairman of the International Association of Hepatitis Task Forces, Emeritus founding board member of the California Chronic Care Coalition (CCCC) in Sacramento. He is Executive Director of the National Working Group on Evidence Based Healthcare in Alexandria, Virginia and serves on the community advisory board to the VA National Hepatitis C Program. Remak sits on the Board of Directors and the community advisory committee of Partnership Health Plan of California, a managed care plan for Medicaid subscribers serving 14 Northern California Counties. He is also a founding senior executive board member and advocacy director of the FAIR Foundation, a national research advocacy and educational organization seeking reforms in our nation's organ transplant policies. Remak is a core advocate for the political action (American For Cures Foundation) that led to the creation of the California Institute of Regenerative Medicine (CIRM) and sat on the task force that developed its operational strategy. Remak has been an active driver of this research with the Americans for Cures Foundation and is one of its outspoken designated ambassadors. For several years Bill has been a preceptor for Master of Public Health and PhD students doing their internships at the University of San Francisco, School of Nursing and Health Professions.
Remak is a cancer survivor, twice received a liver transplant and a diabetic. He is an active member of the United States Coast Guard Auxiliary, now in his 37th year. He is the recipient of the American Liver Foundation- Excellence in Community Outreach and Education Award 2001 and the 2013 and 2016 National Health Pioneer Award for Hepatitis Advocacy from the Georgia Doty HIV and Hepatitis Outreach Foundation, Chicago, IL. As a respected author of articles on patient advocacy issues and healthcare innovation, Remak is also sought-after international speaker. He has served on review panels for the Institute for Clinical and Economic Review, Guidelines Working Groups for the American Society of Clinical Oncology and is a member of the Society for Gastroenterology Nurses and Associates, and Association of Health Care Journalists. Remak is a native of San Anselmo, Marin County, California, father of four, a grandparent, currently resides in Petaluma, minutes away from the beautiful wine district in Sonoma County, California.
Camillo Ricordi, M.D. is Professor and Director of the Diabetes Research Institute and the Cell Transplant Center at the University of Miami, Florida. He is the inventor of the method to isolate insulin-producing cells from the pancreas, which led to successful transplantation to reverse diabetes. The procedure is now used worldwide. Ricordi's research interests include reversal of autoimmunity, transplant tolerance, modulation of inflammation and regenerative medicine to prevent disease, and to prolong healthy lifespan (Healthspan). In 2020 he led the international team that successfully completed the first FDA approved controlled trial to treat the most severe cases of COVID-19 with stem cell infusions. The unprecedented results allowed for 100% patient survival at one month in subjects treated who were less than 85 year old, compared to 42% survival in the control group. Ricordi and his collaborators have recently launched the program www.fit4pandemic.com [fit4pandemic.com] to help the general population to prevent disease progression of the most severe forms of viral, autoimmune and age-related conditions, to prolong healthy lifespan (Healthspan). He received the Outstanding Scientific Achievement Award by the American Diabetes Association and was Knighted by the President of the Republic. In 2018 Ricordi was inducted into the National Academy of Inventors, and was appointed to the Italian Supreme Council of Health (Consiglio Superiore di Sanita'). Ricordi is the author of over 1,150 scientific publications that have been cited over 45,700 times. His H-index is 100 and as an inventor, he has been awarded 27 patents.
Beth E. Roxland is a seasoned Attorney & Bioethicist with multifaceted experience across industry, law, government & academia. Beth is a Strategic Advisor on Law, Policy & Bioethics at Roxland Consultants, Ltd., where she counsels life-science, health care & biomedical entities, clinical researchers, advocacy groups and professional associations on legal, ethical, operational & PR issues. Ms. Roxland serves in a range of capacities tailored to clients' needs, formulating practical approaches to complex issues, delivering solutions that bridge multiple areas of expertise.
Ms. Roxland is also the Principal of a law firm specializing in litigation, public policy, crafting legislation and governmental oversight frameworks, compliance & regulatory matters.
She is also a frequent public speaker & author, and serves on several academic & research oversight boards.
Ms. Roxland graduated from Columbia University with a degree in Biology, and from the University of Pennsylvania with joint degrees in Law and Bioethics (J.D. – M.Bioethics) magna cum laude.
Dr. Yoji Sato is the Head of Division of Cell-Based Therapeutic Products, Japan National Institute of Health Sciences. As a graduate student at the University of Tokyo and as a postdoc at the University of Cincinnati, he conducted researches on cardiovascular pharmacology, and succeeded in establishing a variety of transgenic mouse models to elucidate mechanisms of cardiac excitation-contraction coupling and heart failure. Dr. Sato's current research area is in the field of regulatory science for the quality and safety of cell therapy products (CTPs). He is currently leading a public-private partnership initiative (MEASURE Project) in Japan for validation of test methods for tumorigenicity assessment of CTPs, in collaboration with the Committee for Non-Clinical Safety Evaluation of Pluripotent Stem Cell-Derived Therapeutic Products, Forum for Innovative Regenerative Medicine (FIRM-CoNCEPT) and the Cell Therapy-TRAcking, Circulation and Safety Committee, the Health and Environmental Sciences Institute (HESI CT-TRACS). He is also serving as the Vice Chair of the Database Committee, the Japanese Society for Regenerative Medicine, which provides the National Regenerative Medicine Database (NRMD), a nation-wide patient registry system for clinical researches and post-marketing studies on CTPs, and as a topic leader of ICH-Q5A(R2) as well as a member of Technical Committees, Panel on Science and Technology, Health Science Council, the Japan Ministry of Health Labour and Welfare.
Joan’s work is focused on providing high quality educational programming within the field of tissue engineering and regenerative medicine. In her role, she also works to increase awareness of the Institute’s leadership role within the field of biomedicine. Joan's professional background includes more than 20 years of specialized experience in administration, education, research, fund raising, collaborative team building, program development and direct care/services delivery within the university, community and non-profit, public health, and education setting. Throughout her career, she has recognized the importance of education and the need to develop collaborative, multidisciplinary education and research training across formal and informal educational environments.
Adrienne is a fourth generation of mothers in her family to have a child born with Sickle Cell Disease.
She was one of the first supporters of the work done by Dr. Kohn in bone marrow and later stem cell transplants. As a true believer that science would cure Sickle Cell Disease, she has dedicated a large portion of her life to improving the lives and overall healthcare of those living with the disease. In the past three years she has found her voice as a Stem Cell Activist. Speaking in support of the funding for medical trails thru CIRM, her experience includes attending educational conferences and seminars, as well as meeting with Southern California Congress members to lobby for the support and passage of the Sickle Cell Education Act.
This has helped shape our mission: "Education and Advocacy with urgency"
Institute for Synthetic Bioarchitectures
BOKU - University of Natural Resources and Life Sciences
Executive Director, Regenerative Medicine Foundation
Bernard Siegel is the executive director of the nonprofit Regenerative Medicine Foundation (RMF), with a mission of accelerating regenerative medicine to improve health and deliver cures.
Bernie founded and co-chairs the annual World Stem Cell Summit and RegMed Capital Conference, founded and serves editor–in–chief of the peer-reviewed “World Stem Cell Report” (AlphaMed Press).
In 2002, he filed the first court case relating to reproductive cloning and is widely credited for debunking the claim of the group claiming that they cloned the first baby. As a recognized advocacy and policy expert in the fields of stem cell research, regenerative medicine and related subjects, Bernie works with the leading scientists and patient advocates, raising public awareness and educating lawmakers, the media and public. He is a frequent conference panelist and keynote speaker.
Professor, Sanford Burnham Prebys Institute & Department of Pediatrics, University of California-San Diego
Dr. Snyder earned his M.D. and his Ph.D. in neuroscience from the University of Pennsylvania in 1980. He completed residencies in pediatrics and neurology at Children's Hospital-Boston, Harvard Medical School and postdoctoral research at Harvard Medical School. In 1992, Dr. Snyder was appointed an instructor in neurology at Harvard Medical School and was promoted to assistant professor in 1996.
Dr. Snyder is regarded as one of the fathers of the stem cell field, having identified over 2 decades ago that cells that came to be called stem cells were a source of neural plasticity. He was the first to demonstrate that non-hematopoietic stem cells could mediate cell and gene replacement, home to injury, and perform protective, trophic, pro-regenerative, and anti-inflammatory actions. He was the first to isolate human neural stem cells. In 2003, after 23 years at Harvard, Dr. Snyder was recruited to Sanford Burnham Prebys Medical Discovery Institute as professor and director of the Stem Cells and Regeneration program.
Dr. Corné Swart is the Executive Director of Business Development & Global Sales at Cellbox Solutions GmbH. He has a background in Biotechnology with a focus on cell & tissue culture procedures, which he obtained from his studies at Stellenbosch University (South Africa) and Lund University (Sweden). After receiving his master's degree from Stellenbosch University, he went on to receive a doctorate from the University of Potsdam (Germany) for his work in the field of proteomics, that investigated the complex interplay between post-translational modifications and metabolism. At Cellbox Solutions, Dr. Swart has been collaborating with Key Opinion Leaders and other established customers in Academia, Pharma, Biotech on innovative projects that require the shipment of live cells and tissues under physiological conditions. These collaborations have generated valuable data on the benefits of using portable CO2 incubators and breathable packaging to ship biological material without any loss in quality and viability. In line with Cellbox Solutions' vision to heal patients through Regenerative Medicine technologies, Dr. Swart is working with logistics partners, healthcare experts and regulatory advisors to define the supply chain procedures that are required for the therapies of tomorrow.
National and international companies in the pharma, biotech and medical devices sector entrust Arne Thiermann with commercial contracts of strategic relevance as well as regulatory and compliance issues. Arne can assist you with his extensive experience in the drafting and negotiation of complex contracts in the life sciences sector. With a background in intellectual property law, Arne regularly handles licensing and development transactions in all stages of drug or device development. He further provides advice on strategic supply and manufacturing arrangements and helps you setting up R&D, marketing and distribution collaborations. You may also seek Arne's advice on regulatory issues in the context of researching, developing, marketing and distributing pharmaceutical products and medical devices.
Jonathan Thomas ("JT") has been Chair of the governing Board since June 2011. Prior to that he was a Co-Founding Partner at Saybrook Capital ("Saybrook"), an investment banking and private equity firm based in Santa Monica, California.
Long interested in the biological sciences, JT majored in Biology and History at Yale, where he graduated summa cum laude. As a George C. Marshall Scholar at Oxford, he then earned a PhD with a medical focus in Commonwealth History. He subsequently returned to Yale for a JD at the Yale Law School. While there, he retained an involvement with biology by teaching courses on the legal implications of genetic engineering and the impact of disease on history.
He went on to be an investment banker for Ehrlich Bober & Co. (a top-10 Wall Street public finance firm) where, among other things, he led a team that underwrote over $1 billion in various kinds of bonds for the Los Angeles Community College District. He left Ehrlich Bober in 1990 to co-found Saybrook. While with Saybrook, he led an early round of financing for Advanced Cell Technology (now Ocata Therapeutics), which now has two embryonic stem cell-based clinical trials in progress.
In addition to his financing expertise, JT brings legal expertise to help CIRM navigate clinical trials, bilateral collaborative agreements, intellectual property, loan agreements and other legal challenges that confront CIRM on an ongoing basis. His legal experience includes clerking for White House Counsel Lloyd Cutler in the last year of the Carter Administration and also for the Honorable George Mackinnon of the United States Circuit Court of Appeals for the District of Columbia Circuit. He later practiced at Munger, Tolles & Olson in Los Angeles.
JT also has a broad knowledge of governmental agencies, having served for seven years each as either member or vice president of the City of Los Angeles Board of Harbor Commissioners and as a member of the Governing Board for the Alameda Corridor Transportation Authority. In that latter role, he developed a plan to finance the $2.4 billion expansion of the Corridor rail lines from the Ports of Los Angeles and Long Beach to downtown Los Angeles. Through this government work and his many years in public finance, he has served at various times as underwriter, financial advisor and issuer of a wide range of tax-exempt and taxable bonds.
JT has worked closely with political officials at the federal, state and local level on a variety of projects for over 30 years. He was the chief government liaison to the Governor and State legislature for the Official Committee of Unsecured Creditors in the PG&E bankruptcy, for whom Saybrook acted as financial advisor in their Chapter 11 proceedings. He has structured a number of public/private partnerships, including the financing for the Dolby (formerly Kodak) Theatre in Hollywood, home to the Academy Awards.
JT has a long-standing commitment to patient advocacy. He spent more than 15 years on the Board of the Crippled Children's Society of Southern California and served as Chair for four years. The organization, now called AbilityFirst, assists children with spinal cord injuries and mental disabilities that could be targets of stem cell therapies. He is an Honorary member of the AbilityFirst Board.
Thomas Tubon is currently in transition to serve as the Chief Workforce Development Officer for the recently-funded BioIndustrial Manufacturing and Design Ecosystem (BioMADE) Manufacturing Innovation Institute, headquartered at the University of Minnesota, Saint Paul Campus. BioMADE joins eight DoD-sponsored institutes as part of the Manufacturing USA network and is the16th institute invested in creating an end-to-end ecosystems for domestic manufacturing to secure America's future through manufacturing innovation, education, and collaboration. Dr. Tubon will lead the Education and Workforce Development initiatives of the BioMADE Institute, with a focus on bioindustrial manufacturing and synthetic biology.
Prior to his appointment with the BioMADE NNMI, Dr. Tubon served as a Professor in the Biotechnology Program at Madison Area Technical College for 13 years. During this time, he led several National Science Foundation Advanced Technological Education grant projects to establish and scale an emerging technology program in Stem Cells and Cell Manufacturing and oversee a Coordination Network project for Advanced Manufacturing of Cell and Tissue Products. While at Madison College, Dr. Tubon was responsible for the development of bioscience workforce and strategic implementation of programs for local, regional, and national-level adoption and scale-up. In this role, he has facilitated the creation of a broad network of industry, community, and academic stakeholders, that promote career pathways in Science, Technology, Engineering, and Mathematics (STEM). Dr. Tubon also serves as a mentor with the NSF ATE Mentor Connect and Project Vision Programs.
Since 2019, Dr. Tubon has served as a CoPI on the NSF ATE InnovATEBIO Center for Biotechnology Education, and the NSF Advancing Research Impact in Society (ARIS) Center leadership team for workforce development and strategic partnerships.
Dr. Tubon holds a Ph.D. in Molecular Genetics from Stony Brook University and Cold Spring Harbor Laboratory and a BS in Molecular Biology from San Diego State University.
John Homans Professor of Surgery, Harvard Medical School; Chief, Department of Pediatric Surgery, Massachusetts General Hospital (MGH), Emeritus; Surgeon-in-Chief, MassGeneral Hospital for Children, Emeritus
Dr. Joseph Vacanti received his Bachelor of Science, summa cum laude, from Creighton University in 1970 and graduated first in his class. He received his MD, with high distinction, from University of Nebraska College of Medicine, and an MS from Harvard Medical School. He trained in General Surgery at the Massachusetts General Hospital, in Pediatric Surgery at Children's Hospital, Boston, and Transplantation at the University of Pittsburgh.
As an academic surgeon, Dr. Vacanti has been active in clinical innovation as well as basic research. He instituted New England's first successful pediatric ECMO program in 1984 while at Children's Hospital Boston. As well, he began the nation's first liver transplantation program specifically for the pediatric population. Dr. Vacanti has been working in the field of regenerative medicine and tissue engineering since the mid-1980s. Over the last 20 years, Dr. Vacanti has studied creating complete vascular networks as part of implantable tissue engineered devices which then allows the fabrication of large, complex living structures such as vital organs, extremities or craniofacial reconstruction. To further the field of tissue engineering and regenerative medicine, Dr. Vacanti was a founding co-president of the Tissue Engineering Society, now named the Tissue Engineering Regenerative Medicine International Society (TERMIS). It currently has 4100 active members from 80 countries worldwide. He also was founding senior editor of the journal "Tissue Engineering." It currently serves all of the members of TERMIS, 1700 libraries in 20 countries, and is provided free online to 106 developing nations. It has over 250,000 full text downloads and 500,000 abstract downloads per year with an impact factor of approximately 4.5. Dr. Vacanti has held academic appointments at Harvard Medical School since 1974. He has authored over 332 original reports, 70 book chapters, 57 reviews, and over 475 abstracts. He has 83 patents or patents pending in the United States, Canada, Europe, and Japan. Awards include the Thomas G. Sheen Award presented by New Jersey Chapter of the American College of Surgeons, recognition from the American Academy of Anti-Aging Medicine for contributions in the area of tissue replacement, the James Bartlett Brown Award from the Society of Plastic and Reconstructive Surgery, and the Clemson Award from the Society for Biomaterials. In addition, he was elected in 2001 to the Institute of Medicine of the National Academy of Sciences. In 2007, the Board of Directors of City Trusts acting for the City of Philadelphia awarded Dr. Vacanti the John Scott Medal. The John Scott Award is given to "the most deserving" men and women whose inventions have contributed in some outstanding way to the "comfort, welfare and happiness" of mankind and has been awarded in memory of Benjamin Franklin since 1822. Previous recipients include Marie Curie, the Wright Brothers, Thomas Edison and Jonas Salk. In 2009, Dr. Vacanti's innovation was included in the book, "1001 Inventions That Changed The World", by Jack Challoner. Dr. Vacanti is 2009 recipient of the American Surgical Association's prestigious Flance-Karl Award. Each year since 1996, the association has presented the prize to a surgeon who has made a seminal contribution in basic laboratory research that has application to clinical surgery. Dr. Vacanti became a 2011 Thomson Reuters Citation Laureate in the field of physiology or medicine. Thomson Reuters Citation Laureates are an elite group of highly citied, high impact researchers, who are likely contenders for other awards in the future including The Nobel Prize. In 2013, the American Academy of Pediatrics Section on Surgery named Dr. Vacanti the recipient of the William E. Ladd Medal. The Ladd Medal is the highest honor awarded by the Surgical Section of the American Academy of Pediatrics and is considered by many to be the most prestigious award in the field of pediatric surgery. In June of 2015, Dr. Vacanti received The Jacobson Innovation Award from the American College of Surgeons, their most prestigious recognition for surgical innovation. In 2017, Dr. Vacanti received the Lifetime Achievement Award from TERMIS – Americas Chapter. In 2018, he was elected to become President of the American Pediatric Surgical Association.
Director, McGowan Institute for Regenerative Medicines
Dr. Wagner is Director of the McGowan Institute for Regenerative Medicine as well as Distinguished Professor of Surgery, Chemical Engineering, and Bioengineering at the University of Pittsburgh. He serves as Scientific Director of the NSF Engineering Research Center on “Revolutionizing Metallic Biomaterials” and Chief Science Officer for the Armed Forces Institute of Regenerative Medicine. He holds a B.S. (Johns Hopkins Univ.) and Ph.D. (Univ. of Texas) in Chemical Engineering.
Professor Wagner is the Founding Editor and Editor-in-Chief of one of the leading biomaterials journals, Acta Biomaterialia. He is past-president of the American Society for Artificial Internal Organs (ASAIO) and past chairman of the Tissue Engineering and Regenerative Medicine International Society (TERMIS) Americas region. He is a fellow and former vice president of the American Institute for Medical and Biological Engineering (AIMBE) and has also been elected a fellow of the Biomedical Engineering Society, the International Union of Societies for Biomaterials Science and Engineering, TERMIS, and the American Heart Association. In 2006, he was selected to the “Scientific American 50”, the magazine’s annual list recognizing leaders in science and technology from the research, business and policy fields. His research has generated numerous patents (35 issued to date) and patent filings that have resulted in licensing activity, the formation of two companies, one of which initiated two clinical trials. Transfer of his group’s intellectual property has been recognized with University of Pittsburgh Innovator Awards in 2007, 2008, 2009, 2010, 2014, 2017 and 2018. Some of his awards include the Society for Biomaterials Clemson Award for Applied Research, the Chancellor’s Distinguished Research Award from the University of Pittsburgh, and the Senior Investigator Award from TERMIS-Americas. In 2017, he was inducted as a fellow of the National Academy of Inventors and in 2018 he was named Inventor of the Year by the Pittsburgh Intellectual Property Law Association.
In 2019, Dr. Wagner was promoted to the rank of Distinguished Professor, the highest recognition available to University of Pittsburgh faculty. In 2020, the 4th edition of the best-selling biomaterials textbook, “Biomaterials Science” was published with Dr. Wagner taking over the lead editor role and in partnership with a new generation editorial team. Dr. Wagner's research interests are in cardiovascular engineering with projects that address medical device biocompatibility and design, biomaterial development, and tissue engineering.
Professor and Director of International Affairs, Wake Forest Institute for Regenerative Medicine
Professor Williams has had 50 years experience in biomaterials, medical device and tissue engineering. During his career he has published over 35 books and 430 papers: his latest book, Essential Biomaterials Science was published by Cambridge University Press in 2014. He was Editor-in-Chief of Biomaterials, the world’s leading journal in this field for 15 years. He has received the major awards from the US, European and Indian societies of biomaterials including the Founders Award of the US Society for Biomaterials in 2007, and received the prestigious Acta Biomaterialia Gold Medal in 2012. In 1999 he was elected as a Fellow of the Royal Academy of Engineering, UK, and is a Foreign Fellow of the Indian National Academy of Engineering and a Fellow of the American Institute of Medical and Biological Engineering, all in recognition of his contributions to engineering in medicine. He was global President of the Tissue Engineering & Regenerative Medicine International Society between 2012 and 2015.
Professor Williams left the University of Liverpool, UK, in 2007, where he had been Head of Clinical Engineering, Director of the UK Centre for Tissue Engineering and Pro Vice Chancellor of the University. While retaining the title of Emeritus Professor at Liverpool, he is currently Professor and Director of International Affairs, Wake Forest Institute of Regenerative Medicine, North Carolina, USA. In addition, he is a Visiting Professor in the Christiaan Barnard Department of Cardiothoracic Surgery, Cape Town, South Africa, a Visiting Professorial Fellow at the Graduate School of Biomedical Engineering, University of New South Wales, Australia, and a Guest Professor, at Tsinghua Universities, Beijing, and Advisory Professor at Shanghai Jiao Tong University, China. . In Cape Town, along with Professor Peter Zilla, the current Chris Barnard Professor of Surgery, he formed a company that will produce low cost but high technology medical devices that can be used with minimally invasive procedures to treat young adults in sub-Sarah Africa, who currently have no therapies available to them. After 8 years work, and raising the equivalent of $30 million within Africa, his team successfully used their non-occlusive delivery system in a First-in-Man experience in January 2019, the first in the world.
Dr. Michael J. Yaszemski is the Krehbiel Family Endowed Professor of Orthopedic Surgery and Biomedical Engineering at the Mayo Clinic and director of its Biomaterials and Tissue Engineering Laboratory. He is a retired U.S. Air Force Brigadier General and served in the office of the Air Force Surgeon General and the office of the President of the Uniformed Services University of the Health Sciences prior to retiring in 2013. He previously served as president of the Mayo Clinic medical staff, and had served for 10 years as the Chair of the Spine Surgery Division of the Department of Orthopedic Surgery at Mayo Clinic Rochester prior to entering the presidential line. He received both Bachelor's and Master's degrees in Chemical Engineering from Lehigh University in 1977 and 1978, an M.D. from Georgetown University in 1983 and a Ph.D. in Chemical Engineering from the Massachusetts Institute of Technology in 1995. He organized and then served as the first Chair of the Musculoskeletal Tissue Engineering study section at NIH, and served as a member of the Advisory Council of the NIH National Institute of Biomedical Imaging and Bioengineering. He is currently a member of the NIH Advisory Council of the National Institute of Arthritis, Musculoskeletal, and Skin Diseases. He served as Chair of the FDA Center for Devices and Radiologic Health Advisory Committee, and is currently a member of the FDA Science Board. He is a member of the National Academy of Medicine and the National Academy of Inventors. He has 84 issued patents and 24 additional patents pending. He is an emeritus member of the Lehigh University Board of Trustees. His clinical practice encompasses spine surgery and musculoskeletal oncology. His research interests are in the synthesis and characterization of novel degradable polymers for use in bone regeneration, cartilage regeneration, nervous tissue regeneration, and controlled delivery of chemotherapeutic agents to musculoskeletal tumors.
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.
Current efforts focus on the creation of a National Science Foundation ATE Coordination Network (CN) to formalize a consortium focused on bio-economic growth through workforce development in the area of Advanced Manufacturing of Cell and Tissue-based Products (AMCTP). By AMCTP we refer to the use of cells (particularly but not exclusively stem cells) in applications that can involve complex tissues and organs and genome engineering. AMCTP requires a new kind of manufacturing that constructs biological systems in combination with natural or synthetic materials using robotics, microfluidics, 3-D printing, computational modeling, and novel types of engineering that we are only beginning to imagine. The products of AMCTP promise to deepen our understanding of the root causes of disorders and may provide effective methods for treating conditions such as Parkinson's disease, spinal cord injury, macular degeneration, and heart disease. There are ever-expanding career opportunities in this important field and there is an unmet need to develop a workforce with appropriate skills. Finding strategies to develop a skilled workforce in this complex domain is a task best addressed by a network of stakeholders from education, government, and industry. It is also important to include community representatives to help build a diverse workforce and inform the public about AMCTP.