Karla Villa is a dedicated Market Access Specialist at Terumo Blood and Cell Technologies, where she has contributed to the team's success for over two years by leveraging her expertise in billing and reimbursement. With a background in healthcare administration, including her role as Senior Analyst and Transition Lead at DaVita Kidney Care, Karla has honed her attention to detail and deep understanding of operational excellence. She is passionate about improving patient access and streamlining healthcare delivery. At Terumo, Karla collaborates to innovate patient care pathways, ensuring the highest standards of service and outcomes.

Ms. Leppke is the senior director of public policy and strategic partnerships for the Association for the Advancement of Blood and Biotherapies (AABB) where she is responsible for advancing advocacy and driving public policy initiatives on improving access to transfusion medicine and biotherapies.  Ms. Leppke has over 15 years of experience in health care management, reimbursement, access-to-care policy and analysis, and stakeholder engagement. Prior to her role at AABB, Ms. Leppke served as the Director of Public and Payer Policy at the National Marrow Donor Program where she led multi-stakeholder teams to successfully pass federal and state policies to protect access to cellular therapies for patients with blood cancer and other blood diseases and disorders.  Prior to that, Ms. Leppke managed and led efforts in organ transplant policy where she provided strategic leadership and direction on organ allocation policy, transplant research, and payment analysis, strategically engaging with external stakeholders. Her experience includes leading government affairs and policy teams to drive change in the federal, state, and local legislative and regulatory settings. Ms. Leppke has her master’s degree in public health administration and policy from the University of Minnesota.

Dr Maziarz has been involved in clinical investigation and translational research, for over three decades, beginning with research and clinical training at the Dana-Farber Cancer Institute and the Brigham & Women’s Hospital and continuing in 1991 when he moved to OHSU to develop a transplantation immunology program and served as the medical director of the adult OHSU stem cell transplant program since 1994.His research involved the immunology of transplantation or its complications, particularly in studying the immunopathophysiology of GVHD. He has served as principal investigator or co-investigator on over 100 clinical trials including multiple initiatives sponsored by numerous national transplant organizations including SWOG, CIBMTR, ISCT, NMDP and BMT CTN. Within the BMT CTN, he serves on the Steering committee, chaired the Regimen Related Toxicity Committee, was a member of the GVHD Committee and served as the principal investigator for the BMT CTN on the first multicenter, stem cell transplant trial for patients with advanced chronic lymphocytic leukemia (BMT CTN 0804).He also served on the writing committee for the first national multicenter, randomized trial between conventional and reduced intensity transplantation (BMT CTN 0901) and for transplantation for HIV associated malignancies. He currently serves as Chair of the Regimen Related Toxicity Strategic Planning Committee of the BMT CTN for the planned State of the Science Symposium, to define cell therapy and transplant clinical trials over the next 5 years.A special interest has been the intersection of transplantation and health policy; he has served as consultant to the Oregon Health Resource Commission assessing indications for autologous transplantation and analyzing efficacy of reduced intensity allogeneic transplantation as a standard of care for adults with hematologic malignancies. He also has been an active member of the Health Policy working committee of the CIBMTR, served as a member of the ASBMT reimbursement committee and served as Chair of the NMDP financial working group for their system capacity initiative regarding transplantation expansion and most recently is Chair of the Health Economics SIG for ASTCT. At OHSU, he had maintained a laboratory focused on basic and preclinical models focused on how to reduce the risks for morbidity and mortality associated with graft versus host disease. Most recently, his focus has been on the toxicity and efficacy of immune effector cell therapy. He has opened IEC multiple trials, assisted in the generation/ writing of new emerging trials utilizing CART and NK cells for a variety of disease indications and was the Chair of the Scientific Steering Committee for the Juliet trial that led to the approval of tisagenlecleucel for advanced diffuse large B cell lymphoma.

Kenny Hodge currently serves as the Vice President of Government Affairs for Kimbell & Associates. In this role he works with the government affairs team to develop client-specific strategies and then executes them on Capitol Hill.  Coming from a long line of healthcare professionals in his family, Kenny has spent his entire professional career at the intersection of healthcare and politics. Since first joining the firm in 2010, Kenny has taken a lead role translating coding, coverage, and payment issues in the Medicare payment rules into Capitol Hill advocacy efforts supporting access for innovative technologies; and he is proud to serve as the Director of Government Affairs for the Institute for Gene Therapies (IGT), an advocacy organization launched in 2020 specifically to help address access challenges surrounding the development and adoption of gene therapy products.   Kenny has volunteered time working for over a half-dozen Republican Senate and Congressional campaigns during his time in Washington; assisting in data collection, data analysis, policy research, and other field activities. Kenny has also been utilized as a public speaker for various events, including courses at Columbia University’s School of Public Health.   Kenny was raised in Louisville, Kentucky and graduated from the University of Kentucky with a BS in Biology, where he was a member of the varsity men’s tennis team. In his spare time, Kenny can be seen in the surrounding states with his dog, a fly fishing rod, or a set of downhill skis. On occasion, he'll still pick up a racket and hit the courts.

J. Wade Atkins is an MT ASCP with a Specialty in Blood Banking, is credential as a Certified Advanced Biotherapies Professional, a certified Quality Auditor through the American Society for Quality and has a Master of Science in Health Care Administration.

 For 22 years he has been associated with quality assurance and regulatory affairs for the Department of Transfusion Medicine (DTM) in the Clinical Center for the National Institutes of Health in Bethesda Maryland and is currently supervising a staff of 9 quality associates. He has responsibilities for ensuring compliance with standards and regulations for manufacturing high quality products.

 The DTM is a full-service blood bank with a licensed collection facility and a full transfusion service and maintains an active HCTP manufacturing facility that supports roughly 80 protocols and 35 or more of those are regulated by IND at the FDA. The Blood establishment and Center for Cellular Engineering employee about 200 staff.

In her role with SCB, Katie brings a combination of leadership and technical skills gained from her prior experience as a researcher, a postdoctoral community advocate, and a scientific policy advisor in Congress.

 Prior to joining SCB, Katie worked in U.S. House of Representatives for the Committee on Energy and Commerce as the American Society of Hematology’s inaugural American Association for the Advancement of Science (AAAS) Science & Technology Policy Fellow. Before the fellowship, she conducted research on rare blood clotting diseases at the University of Alabama at Birmingham, where she also founded a patient education program. She holds a PhD in Chemistry from Binghamton University, where she studied neurotransmitter kinetics.

Christine joined the Parenteral Drug Association (PDA) as their Senior Standards Manager in 2017. Prior to this, she was affiliated with the American Type Culture Collection where over 16 years, she served in numerous capacities, to include technical services, a cell biology lab, and as a standards and certification specialist. She served for 13 years in clinical transplant in the histocompatibility lab at the Medical College at Virginia in Richmond, Virginia, Sentara Norfolk General Hospital in Norfolk, Virginia. She also worked as a Senior Donor Services Coordinator for the “Be The Match” program operated by the National Marrow Donor Program/ CW Bill Young Marrow Program in the Washington DC area. She earned her degree from Virginia Tech.   

Dr. Viswanathan is a Scientist at the Osteoarthritis Program, Division of Orthopedic Surgery, Schroeder Arthritis Institute and the Krembil Research Institute (University Health Network) and an Associate Professor at the Institute of Biomedical Engineering and at the Division of Hematology, Department of Medicine (University of Toronto).

 Dr. Viswanathan is leading international efforts to standardize MSC nomenclature and create reference materials for MSC research. Dr. Viswanathan sits on the Standard Council of Canada’s Mirror Committee for International Organization for Standardization (ISO TC276) on Analytical Methods and Bioprocessing, and is on the steering and working committee of an international Standards Coordinating Body (SCB). Dr. Viswanathan is a formal liaison between ISO TC276 and the International Society of Cell and Gene Therapy (ISCT). Dr. Viswanathan is Associate Editor of Cytotherapy, the official journal for ISCT and N. American VIP Elect (2024-2026) for ISCT.

Samuel C. F. Couto, PhD, is a researcher at the Blood Center of São Paulo (Fundação Pró-Sangue) and also serves as an associate researcher at the University of São Paulo in Brazil. After earning his degree in Biological Sciences from PUC-Campinas University, Dr. Couto pursued a PhD in Biotechnology at the University of São Paulo, followed by postdoctoral fellowships at both the University of São Paulo's Medical School and Children’s National Hospital in Washington, D.C. He is particularly interested in increasing access to cellular and gene therapies in lower-middle-income countries. He also leads the Laboratory of Stem Cell Processing at the University of São Paulo’s Clinics Hospital (HC/FMUSP).

Lilia C. León-Moreno, PhD, is a posdoctoral researcher focused on the study of exosomes and mesenchymal stromal cells as a potential therapy for neurodegenerative diseases. She is interested in increasing the knowledge of the medical and scientific communities, and general public about advanced therapies and establishing a regulatory framework that enables the development of these therapies in Latin America. She is currently involved in the planning of a CDMO for cell therapy in Jalisco.

Virginia Picanço e Castro, PhD, is a prominent researcher at the Regional Blood Center of Ribeirão Preto in Brazil, where she focuses on pluripotent stem cells and cell reprogramming. After earning her degree in Biological Sciences from the University of São Paulo, Dr. Picanço e Castro pursued a Ph.D. in Genetics at the Medical School of Ribeirão Preto, followed by postdoctoral fellowships at both the Regional Blood Center and Indiana University. Her research explores the complex pathways involved in cell reprogramming, specifically aiming to generate pluripotent stem cells from human somatic cells. She also investigates the molecular mechanisms that regulate the differentiation of hematopoietic and pluripotent stem cells, with the ultimate goal of developing effective in vitro differentiation protocols.

Dr. Picanço e Castro’s work aims to create a comprehensive database of genomic proto-proteins involved in hematopoietic differentiation, which could lead to new gene overexpression techniques that enhance cell differentiation and reprogram fibroblasts into adult blood cells. Her research is highly relevant to Brazil's burgeoning biotechnology sector, with the potential to offer safer and more efficient stem cell-based therapies. She collaborates with leading national and international researchers and guides a team of students at the Biotechnology Laboratory Group, contributing to significant advancements in regenerative medicine and therapeutic innovation.

Andrés Gomez-De Léon, MD, is based in a University Hospital in Mexico and focuses on acute leukemia and hematopoietic stem cell transplantation. He is committed to enhancing healthcare access in low-resource settings, aiming to provide high-quality, cost-effective care. His institution is Mexico's largest transplant center, known for its pioneering work in outpatient allogeneic transplants. A graduate and faculty member of the American Society of Hematology Clinical Research Training Institute, he collaborates globally, drives clinical trials in leukemia, and builds a diverse research team. He also creates educational content in Spanish to promote hematology research and training across borders.

Chase D. McCann, PhD, MSPH, is an Assistant Research Professor of Pediatrics at The George Washington University School of Medicine and Health Sciences and the Assistant Director of Manufacturing at Children's National Hospital Cell Therapy Laboratory. He completed his Ph.D. in Immunology and Microbial Pathogenesis at Weill Cornell in 2020, following an M.S. in Public Health Microbiology from The George Washington University and a BSc in Biology and Neuroscience Psychology from UMass Amherst. His professional journey includes leadership roles in cell therapy and research positions at top institutions such as the University of North Carolina and Weill Cornell Medicine. Dr. McCann's research focuses on immune system mechanisms and cell therapy advancements, contributing to significant developments in pediatric and public health immunology.

Beth E. Roxland, J.D., M.Bioethics is a seasoned Attorney & Bioethicist with multifaceted experience across Industry, Law, Government & Academia. She serves as the Senior Advisor on Law, Policy and Ethics for Roxland Consultants Ltd., an independent consultancy where she leverages her unique expertise to provide comprehensive yet practical strategic advice and support to life-science, biotechnology & research entities, law firms, hospitals & healthcare practitioners, venture capital & financial institutions, and professional & patient associations confronting complex legal, ethical, operational & communications challenges in the scientific and medical arenas. Roxland is also a practicing attorney, specializing in litigation, regulation, torts, health law, public health & pandemics, and risk & crisis management. Roxland is a frequent public speaker & author, serves on several academic, medical and research oversight boards, and occupies leadership roles in professional societies.

Roxland’s executive experience includes her prior roles as:

• Johnson & Johnson's Bioethics and Strategy Leader, in the Global Chief Medical Officer's Office;
• Executive Director of The New York State Task Force on Life & the Law;
• Special Advisor to the Commissioner of Health on Stem Cell Research Ethics;
• Senior Litigation Associate at Simpson Thacher & Bartlett LLP;
• Federal Judicial Law Clerk in the Southern District of New York (S.D.N.Y.); and
• Adjunct Professor of Law at NYU School of Law. 

Roxland graduated from Columbia University with a Bachelors degree in Biology, and from the University of Pennsylvania Magna Cum Laude with joint degrees in Law and Bioethics (Juris Doctorate – Masters in Bioethics). 

Kirstin R.W. Matthews, Ph.D., is a fellow in science and technology policy at Rice University’s Baker Institute for Public Policy and a lecturer in the Department of BioSciences at Rice University. She is also a track advisor for the Wiess School of Natural Sciences’ Professional Science Master in Biosciences and Health Policy, a core member of the Rice Synthetic Biology Institute, and a steering committee member for Rice’s Medical Humanities Research Institute.

Matthews is the director of the Baker Institute Science and Technology Policy Program and the Center for Health and Biosciences’ Biomedical Research Program. Her research focuses on ethical and policy issues at the intersection between traditional biomedical research and public policy. Specifically, she focuses on regulation and ethical issues associated with emerging biotechnology, including vaccines, stem cells, synthetic biology, and genomic medicine. Matthews also collaborates with Kenneth Evans and Neal Lane to understand how scientific advice is used in and provided for the federal government, including the White House Office of Science and Technology Policy (OSTP) and the President’s Council of Advisors on Science and Technology (PCAST).

Matthews has a B.A. in biochemistry from The University of Texas at Austin and a Ph.D. in molecular biology from The University of Texas Health Science Center at Houston.

Paul Knoepfler is an award-winning scientist who is particularly interested in what controls stem and cancer cell biological behavior.

Known also for his popular blog – ipscell.com – and passionate stem cell advocacy, Knoepfler and his laboratory team focus on how a cell’s pluripotency control machinery goes awry during cancer.

Knoepfler is using cutting-edge genomics technology to better understand why stem cells behave the way they do, and working to determine how cell behavior can be directed toward safe and effective clinical use as well as to develop new cancer therapies for kids.

He is the author of three books including Stem Cells: An Insider’s Guide and has a popular TED talk on CRISPR and designer babies.

Dr. Adriana Migliorini is a senior postdoctoral research fellow in Dr. Maria Cristina Nostro’s laboratory, at the McEwen Stem Cell Institute, University Health Network, Toronto, Canada. She studied medical biotechnology at the University of Florence (Italy) and completed her Ph.D. in human biology, at the Ludwig Maximilian University in Munich, Germany. Her research primarily revolves around the field of human pluripotent stem cells (hPSCs) and developmental biology, with a specific focus on the pancreas. Her current work involves investigating the composition and phenotype of the fetal pancreatic immune niche to gain a deeper understanding of its role during endocrine development and to explore novel applications for the treatment of Type 1 Diabetes (T1D).

Mustapha Najimi is director of research at the institute of Experimental and Clinical Research (IREC) of the Faculty of Medicine and Pharmacy-UCLouvain in Brussels. He holds a PhD in cell and molecular biology from the Pierre & Marie Curie University, Paris in 1999. He joined the team of Pr Etienne Sokal in 2003 to set up a platform of liver cells’ culture dedicated to the development of a clinical cell therapy program. Since then, he led the stem cell group and coordinated the cell culture technology platform of the laboratory of pediatric hepatology and cell therapy. Thanks to an accumulated know-how and significant knowledge of human liver cells’ biology as well as the strategies to isolate them, his research activity led to the discovery of a population of liver mesenchymal progenitor cells. Those cells were the subject of more than 40 international publications, more than 200 citations and the attribution of 7 related patents. Mustapha NAJIMI has actively been/is involved in i) the design and supervision of the large-scale production of the first batches of these progenitor cells, that have been infused to patients with liver diseases at Saint-Luc hospital- Brussels, ii) the technology transfer of this cell therapy product to a spinoff company, iii) the supervision of R&D activities related to those cells with an industrial vision. Thanks to an active network of international collaborations, he continues conducting his research investigations with the major objectives of better understanding the mechanisms governing liver regeneration and improving the use of cell therapy for liver defects.

hPSC-derived Liver Endothelium: A potential Cell Therapy for Hemophilia A

Gene therapy for haemophilia B widely adopted but problems remain for haemophilia A