Title: “Stem cell therapy, opportunities, and challenges from a pharmaceutical perspective”
Allan E. Karlsen holds a position as Vice President and Head of Stem Cell Research at Novo Nordisk and Interim head of Novo Nordisk Research Center Oxford.
After graduating from the University of Copenhagen in 1988, Allan worked in the academic milieu at the Hagedorn Research Institute and Steno Diabetes Center (both supported by NN), at the University of Washington, Seattle, USA and at the University of Lund and Karolinska Institute, Sweden, before receiving his PhD in 1995, also from University of Copenhagen. Between the academic and corporate career at Novo Nordisk starting in 2004, Allan worked for 3 years in a biotech start-up company, Inoxell. He was appointed adjunct professor in the Department of Clinical Sciences at Lund University in 2005.
Allan has more than 15 years of teaching experience at both undergraduate and postgraduate levels and is the author/co-author of more than 100 scientific publications, reviews and patents with focus on diabetes pathogenesis.
Presently Allan is VP of Stem Cell Research at NN and has been involved in driving our stem cell program in T1D over the last 10 years and the recent expansion of our stem cell platform to other serious chronic diseases.
Title: “The role of the innate versus the adaptive immunity in cell transplantation”
Maria Koulmanda is the Director of Non-Human Primate Research at Beth Israel Deaconess Medical Center (BIDMC) and an Associate Professor of Medicine and Surgery at Harvard Medical School in Boston, MA. Her principle research interest is in the basis and treatment of diabetogenic autoimmunity and islet transplant tolerance in mice and non-human primates. She has led studies in which self-tolerance to islets was successfully restored in new onset frankly diabetic NOD mice treated with Power Mix (IL-2.Fc etc), alpha 1-antitrypsin or anti-TNF-a. In addition to her research, she is the Director of the Islet Isolation Core at BIDMC. She previously served as President of the Cell Transplant Society (CTS, now CTRMS) from 2013-2015 and is currently a member of the CTRMS Council. She is also a member of several national and international societies, including the American Society of Transplantation, the International Transplant Society, the Transplant Society of Australia and New Zealand, and the TTS.
Title: “Macroencapsulation as a safe means to deliver therapeutic cells and proteins to patients”
Dr. Robert Johnson is a pioneer in the development of immunoisolation cellular therapies and has been involved in diabetes research since his postdoctoral days in the Center for Endocrinology, Metabolism and Nutrition at Northwestern University Medical School. Dr. Johnson began his career at Baxter Healthcare Corporation where he emerged as a pioneer in managing the development of cellular and gene therapy products for the treatment of chronic diseases, including diabetes, hemophilia, liver failure and cancer. In 1998, Dr. Johnson was recruited by the CEO of VitaGen, Inc. and venture capitalists to lead a team of scientists and engineers developing a cellular therapy for individuals suffering from acute liver failure. Dr. Johnson took the company from R&D through a successful IND filing with FDA and into Phase I clinical trials. This was for a cellular therapy/device combination product. In 2003, Dr. Johnson was recruited as president of Spectral Genomics, Inc., a spinout from Baylor College of Medicine. The company’s focus was the development of microarrays for detection of chromosomal abnormalities. He was responsible for developing R&D, manufacturing, QA, regulatory, sales and marketing capabilities. After the successful sale of Spectral Genomics to PerkinElmer in 2007, Dr. Johnson joined Baylor College of Medicine as General Manager of its Clinical Genetics Laboratory. He went into semi-retirement in 2012 and joined the Institute for Cellular Transplantation at the University of Arizona as a part-time faculty member in January 2017.
Dr. Johnson holds a bachelor’s degree in chemistry from Temple University and a Ph.D. in biochemistry from Princeton University.
Title: “Non-Invasive Tracking of Naked, Scaffolded or Encapsulated Cells In Vivo”
Jeff W.M. Bulte, Ph.D., is a Professor of Radiology, Oncology, Biomedical Engineering, and Chemical & Biomolecular Engineering at the Johns Hopkins University School of Medicine. He serves as the Director of Cellular Imaging in the JHU Institute for Cell Engineering. He received his PhD degree summa cum laude From the University of Groningen, The Netherlands in 1991. Dr. Bulte spent 10 years at the National Institutes of Health in the Laboratory of Diagnostic Radiology Research, first as a postdoctoral fellow and then as a Staff Scientist. He was recruited to Johns Hopkins University as an Assistant Professor in 2001, became an Associate Professor in 2002, and a Full Professor in 2006. He is a Fellow and Gold Medal awardee of the ISMRM and a Distinguished Investigator of the Academy of Radiology Research. He has published over 250 peer-reviewed publications and 40 book chapters.
Title: “Optical measurements of oxygen in vivo at transplant sites”
Dr. Botvinick is a Professor of Biomedical Engineering and Surgery, and is Associate Director of the Edwards Lifesciences Center for Advanced Cardiovascular Technology (ELCACT) at the University of California Irvine. His research program has two areas of focus, one in mechanobiology and the other in medical device development. These two efforts occur in his laboratories located within the ELCACT and the Beckman Laser Institute and Medical Clinic. In general, both the mechanobiology and medical device efforts utilize photonic tools such as nonlinear microscopy, optical tweezers, luminescent reporters, and laser induced cavitation.
The Botvinick laboratory is currently funded by the US Air Force Office of Scientific Research, Juvenile Diabetes Research Foundation, and the Helmsley Charitable Trust to:
Title: “Oxygenation of free and encapsulated transplanted islets”
Per-Ola Carlsson is a professor in Medical Cell Biology at Uppsala University, Sweden. He also serves as a senior consultant in endocrinology and diabetology at Uppsala University Hospital.
His research focus has during the years been on islet vascular biology and engraftment of transplanted pancreatic islets. The work includes basic science work on the microcirculation and oxygenation of pancreatic islets in correlation to islet function and metabolism, as well as the paracrine role of islet endothelial cells for beta-cell function. Other studies have dealt with obstacles in engraftment of transplanted pancreatic islets and strategies to overcome these hurdles in order to improve results of pancreatic islet transplantation. He has also focused on cell therapy studies to prevent development of overt type 1 diabetes in newly diagnosed patients with type 1 diabetes, as well as on the use of macroencapsulation in clinical islet transplantation. He has authored more than 170 peer-reviewed publications.
Title: “Imaging β-cell mass in the human pancreas (Clinical)”
Gary W. Cline received Bachelor of Science degree in Biochemistry and a PhD in Physical Organic Chemistry from the University of Missouri. During a Post-Doctoral term in the laboratory of Dr. Martin Saunders at the Yale Chemistry Department, his research focused on the deuterium and 13C equilibrium isotope effects. Upon recruitment to the Yale University School of Medicine in 1989, where he currently holds appointment at Professor, his research transitioned to the development of stable-isotope tracers techniques for evaluating whole-body and tissue-specific metabolic fluxes in relation to diabetes and obesity. A complimentary area of research is in the development of non-invasive in vivo MR spectroscopy to assess diabetes-related changes in metabolite concentrations and fluxes in brain, muscle, and liver, and PET imaging to measure changes in pancreatic beta-cell mass and signaling in the context of impaired insulin secretion with T2DM and regeneration or transplantation as a viable option for treating insulin-dependent diabetes (T1DM and T2DM).
Title: “Towards An Optimized Bioartificial Pancreas: Adaptive Oxygen Supply With Changing Oxygen Consumption Requirements”
Prof. Colton received the BChE at Cornell University and PhD at MIT, both in Chemical Engineering. At MIT, he was the first Bayer Professor of Bioengineering and served as Deputy Head of his department. He has more than 240 publications from his research, which has ranged over broad areas of bioengineering encompassing applications to kidney disease, cardiovascular disease, cancer, and diabetes. His contributions to diabetes therapy include work on glucose sensors, physiological pharmacokinetics of glucose homeostasis, islet microencapsulation, development of assays for islet quality characterization, and the role of oxygen in islet viability and function. He pioneered hybrid bioartificial pancreas devices and developed methods for improving oxygen supply to microencapsulated insulin secreting tissue.
He is the recipient of many prestigious research awards including the Food, Pharmaceutical, and Bioengineering Division Award, American Institute of Chemical Engineering (1999), the Lifetime Contribution Award in Bioartificial Organs from the Engineering Foundation (1998). Gambro AB Award, International Society of Blood Purification (1986), the Curtis W. McGraw Research Award, American Society for Engineering Education (1980), the Allan P. Colburn Award, American Institute of Chemical Engineers (1977) and the Camille and Henry Dreyfus Foundation Teacher-Scholar Award (1972).
Title: “Using bile acid metabolism to assess functions of isolated hepatocytes”
Ewa Ellis has a PhD in Experimental Medicine from the Karolinska Institute where she works as the Director for the Liver Cell Laboratory at Division of Transplantation Surgery, Department of Clinical Science, Intervention and Technology. Dr. Ellis is specialized in human hepatocyte isolation, hepatocyte cultures and hepatocyte transplantation. Dr. Ellis is 45 years old and she is active in the Cell Transplant and Regenerative Medicine Society as the chair for the web and social media committee and she has been a CTRMS council member for 6 years. Dr. Ellis is also on the advisory board for the Liver Academy at Karolinska. Ongoing research projects includes: Hepatocyte transplantation for A1AT deficiency in lung transplanted patients. Isolation of human hepatocytes from disease and neonatal livers. Large scale production of human liver spheroids. Large scale bioreactor cultures and proliferation of primary human hepatocytes. Cold storage of cells and tissue. Tracking transplanted hepatocytes using biomarkers, identifying diseases with high liver cell turnover. Hepatocyte transplantation in Apo E-/- mice. Protein augmentation by transfection of modified RNA. Rare metabolic liver diseases. Role of FGF19 in human liver and bile acid metabolism. Studies on bile acid and lipoprotein metabolism in humanized FRGN mice. Human chimerism. Liver regeneration in ALPPS.
Title: Multimodal Imaging of Vascularization and Oxygenation of Cells and Tissues
Dr. Arthur F. Gmitro is a Professor of Medical Imaging and Optical Sciences at The University of Arizona. He is also a member of the Graduate Interdisciplinary Program in Biomedical Engineering. Dr. Gmitro received his PhD in Optical Sciences from the University of Arizona in 1982. Before returning to the UA as a faculty member in 1987, he was an Assistant Professor of Diagnostic Radiology at Yale University.
Dr. Gmitro has been involved in medical imaging research for over 30 years, has done work in technology development in CT, MRI, and optical imaging, and has published more than 60 papers on a variety of topics in medical imaging. He has applied these technologies in clinical and research applications including neurological imaging, cancer, and cardiovascular imaging. The focus of his research is on the development of new imaging technologies and their application in basic and applied clinical science. A major area of research in his laboratory is development of optical biopsy systems for cancer detection. They have pioneered the development of the confocal microendoscope and are actively involved in developing and testing this technology in the area of cancer diagnosis. His laboratory has also developed a multi-modality imaging platform utilizing window chambers in animal models to enable better preclinical testing of novel diagnostic and therapeutic approaches.
Dr. Gmitro is the recipient of the Rudolph Kingslake award from SPIE (Society of Photooptical Instrumentation Engineers) and the Francois Erbsmann prize from IPMI (Information Processing in Medical Imaging). Dr. Gmitro’s major areas of research are in Magnetic Resonance Imaging and Biomedical Optical Imaging. He has done fundamental work in the development of these technologies and directs an active research program in both areas. Dr. Gmitro is the Director of the NIH supported Training Program in Biomedical Imaging and Spectroscopy and Leader of the Cancer Imaging Program.
Title: “Long Term Banking of Stem Cells and Tissues for Clinical Use”
Dr. Harris is a graduate of Wake Forest University in Winston-Salem, North Carolina where he obtained Bachelor of Science degrees (cum laude) in Biology, Mathematics and Psychology in 1978. He earned a Masters of Medical Sciences (summa cum laude) from Bowman Gray Medical School in 1980 and his Doctorate in Microbiology and Immunology (magna cum laude) from Bowman Gray Medical School in 1982. From 1982-1985 Dr. Harris was a Post-doctoral Fellow at the Ludwig Institute for Cancer Research in Lausanne, Switzerland. In 1985 he joined the faculty at the University of North Carolina-Chapel Hill as a Research Assistant Professor in the Department of Medicine. In 1989 Dr. Harris joined the faculty at the University of Arizona in Tucson as an Associate Professor in the Department of Microbiology & Immunology. In 1996 Dr. Harris was promoted to Professor of Immunology. Dr. Harris is also a Professor in the BIO5 research institute as well as a Professor of Medicine. Dr. Harris established the first cord blood bank in the USA in 1992. He currently serves as the Executive Director of the University of Arizona Biorepository, as well as Director of Quality at the university GMP Laboratory, and helps lead the Cellular Therapy & Regenerative Medicine Initiative. He is a member of the Arizona Cancer Center, a member of the Children’s Research Center, and a member of the Arizona Arthritis Center. Dr. Harris’s research interests include stem cells and regenerative medicine, cancer research/stem cell transplantation and gene therapy. He has published more than 300 articles (papers, book chapters and abstracts), given more than 100 talks on stem cells over the past 10 years, and has served as a consultant to the governments of China, Hong Kong, Singapore and South Korea. Dr. Harris has also founded 5 companies while at the University of Arizona; including Cord Blood Registry, Inc.; ImmuneRegen BioSciences, Inc.; QuReGen, Inc., AdiCyte and Family Cryo Bank.
Title: “Cell Targeting and Imaging of β-cells”
Dr. Hart received his B.S. in physiology from the University of Arizona in 2005 and subsequently taught high school biology in Mozambique, Africa, as a U.S. Peace Corps Volunteer. After completing his service, he returned to the University of Arizona, where he earned his PhD in physiological sciences, investigating novel approaches to pancreatic cell targeting using multivalent ligands. After earning his PhD, Dr. Hart joined the Division of Diabetes, Endocrinology, and Metabolism at Vanderbilt University Medical Center as a post-doctoral fellow in the laboratory of Alvin Powers. In this position, Dr. Hart specialized in several unique areas of diabetes research, including: cystic fibrosis-related diabetes, development of the human pancreas, and assessment of human islet function. During this time, he was responsible for overseeing highly complex and collaborative research projects, analyzing data, writing manuscripts, and managing several students and research technicians. Dr. Hart is skilled in several lab techniques, including: cell culture, calcium imaging, tissue imaging, transcriptomics, functional assessment of islet endocrine cells, immunochemistry, animal husbandry, small animal surgery, and islet isolation.
Title: “Oxygen Delivery to Islets in vitro and in vivo”
Dr. Hirotake Komatsu is a Staff Scientist at the Beckman Research Institute of City of Hope in the Department of Translational Research and Cellular Therapeutics.
Dr. Komatsu received his M.D. from Juntendo University in Tokyo, Japan in 2002 and his Ph.D. in Molecular Biology from Tohoku University in Sendai, Japan in 2013. As a gastroenterology surgeon in Japan, he saw first-hand how advances in the medical sciences contributed to cures for diseases, as well as encountered large numbers of patients suffering from diseases for which effective and accessible treatments have not been fully established. These experiences led to his current career as a scientist at City of Hope in the laboratory of Dr. Yoko Mullen, where his research is dedicated to establishing islet transplantation at the subcutaneous site. Based on his experience as a surgeon his research interests are primarily clinically oriented, which includes oxygen-related therapies and the effect of oxygen on cell survival, regenerative medicine of the pancreatic islets, bioengineering in cell transplantation, carcinogenesis of the pancreas and signal transduction, and cell and molecular biology of pancreatic cancer.
Title: “Novel technologies for oxygen measurements in encapsulated cells - Electron Paramagnetic Resonance Oxygen Mapping (EPROI)”
Dr. Mrignayani Kotecha, PhD, is a founding member and the CEO of O2M Technologies, LLC since its inception in Feb 2017. The company was formed with the purpose of bringing pulse electron paramagnetic resonance oxygen imaging (EPROI) to the market. Our commitment is to use oxygen imaging to build better cancer and regenerative medicine therapies. Prior to starting O2M, Dr. Kotecha was a research faculty in bioengineering department at University of Illinois at Chicago, a staff scientist at the University of Duisburg-Essen (Germany) and the Weizmann Institute of Science (Israel), and an assistant professor of Physics at the Government Model Science College, Jabalpur, India. Dr. Kotecha is the author of six book chapters, author or co-author of more than 30 peer-reviewed publications and an ASTM standard. Dr. Kotecha is the lead editor of 2017 Wiley book “Magnetic Resonance Imaging in Tissue Engineering” and the task group chair for 2017 ASTM standard F3224-17 “Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging”.
Title: “In vitro and In vivo enhanced oxygen and nutrient delivery to encapsulated cells”
Thomas Loudovaris is the Islet Transplant Program Manager in the Tom Mandel Islet Transplant Program at St. Vincent’s Institute in Melbourne, Australia. Dr Loudovaris’ involvement in encapsulation research began over 30 years ago with his post-doctoral studies under the supervision of Professor Tom Mandel at the Walter and Eliza Hall Institute on a Baxter Healthcare funded project. There he was studying the immunological protection of allografts and xenografts by encapsulation. He then continued his interest in cell therapies through encapsulation as a scientist and then senior manager in the Cell and Gene Therapy Unit at Baxter Healthcare, USA. In 1999, Dr. Loudovaris co-founded the cell encapsulation company, TheraCyte Inc., in California. The technology was based on work developed at Baxter with the expectation of delivering encapsulated cell therapies. Through Baxter and TheraCyte, Dr. Loudovaris has been involved in human clinical studies and a couple of FDA Investigational New Drug (IND) Applications. He returned to Australia in 2005 to become Islet Program Manager where has taken the human isolation process from a laboratory research procedure to a process producing islets for human transplantation. This lead to first successful islet transplants in the States of Victoria and South Australia. In addition to his role in the human islet program, he has a continued interest and research involvement in cell transplantation and encapsulation and has collaborated with Professor Klearchos Papas at the University of Arizona on oxygenated device projects over the past seven years.
Title: “Cryopreservation of Amniotic Stem cells for donor matched clinical application”
Dr. McAllister is the Executive Director at the Amnion Foundation, a public stem cell bank that is developing technology pioneered by Dr. Anthony Atala at Mass General Hospital in Boston (www.amnionfoundation.org). Amnion’s mission is to extend the successful model of public marrow and cord blood banking to provide immunologically matched stem cells with therapeutic capabilities beyond diseases of the blood. Prior to Amnion, Dr. McAllister was co-founder and CEO of Cytograft, a cardiovascular regenerative medicine company that developed cell-based therapies to repair and rebuild diseased tissues without using synthetic biomaterials. Dr. McAllister was also the co-Director of the Center for Regenerative Medicine at the St. Joseph’s Translational Research Institute in Atlanta, Georgia, where he oversaw a broader range of cell-based cardiovascular repair technologies. He has a B.S degree in Mechanical Engineering from the University of Washington, and a Ph.D. in Biomedical Engineering from the University of California, San Diego. With more than two decades of experience, Dr. McAllister is a well-known thought leader in the field of Regenerative Medicine. He has published his work in high impact journals including the New England Journal of Medicine, Lancet, and Nature Medicine. He is on the editorial board of the Journal of Biofabrication and on the Industry Committee for the Journal of Tissue Engineering. He is on the Executive Board for the International Cell Medicine Society, and has sat as a reviewer or external advisory board member for AFIRM, NIH, and NSF EPSCOR grants. He is well known for pioneering a business model that prioritizes capital efficiency and research focus, and has shared this knowledge on the advisory boards of several companies, including BioCardia, Lumen Therapeutics, Vault Stem Cells and others.
Raphael P. H. Meier, MD, PhD is a surgeon and researcher working in the field of transplantation. He completed his surgical training and thesis in Geneva, Switzerland. He is now working as a visiting assistant professor at the University of California San Francisco, division of Transplant Surgery. He divides his time between clinical work and research with a focus on islet and pancreas transplantation. His current research interests are clinical islet/pancreas, kidney and liver transplantation, stem cell-based immunomodulation, new immunosuppressive agent development, alternative sites for islet transplantation, islet microencapsulation, islet xenotransplantation, and age, genetic and proteomic aspects in organ transplantation. He is the treasurer of the Swiss association for research in surgery and a committee member of the Swiss society for visceral surgery. Since 2015, he is a committee member of the Young Investigator Committee of the International Pancreas and Islet Transplant Association.
Title: “Results of clinical application of fetal liver cell transplantation and new horizons”
Dr Giada Pietrosi graduated in Medicine and Surgery, and performed her residency in Gastroenterology, in Italy. From 2001 to 2003 she served as a Specialist Registrar at Liver Transplant and Hepatobiliary Unit, Addenbrooke’s NHS Hospital of Cambridge, and Research Fellow at Hutchison-MRC Medical Research Cancer Centre at University of Cambridge (England). Then she completed a three year Fellowship in Transplant Hepatology at IRCCS-ISMETT, a multiorgan Transplant Center (University of Pittsburgh Medical Center) in Italy (Palermo). In 2006 she was appointed as Consultant Hepatologist at IRCCS-ISMETT and started to be involved in the field of Regenerative Medicine by collaborating to the development of the clinical program of fetal liver progenitor cell transplantation in patients with end-stage liver disease. Since 2013, she is Clinical Assistant Professor of Medicine in the School of Medicine, Department of Medicine, University of Pittsburgh. She is currently involved in the treatment of a rodent model with liver cirrhosis with amnion-derived stem cells demonstrating a significant improvement in reducing portal hypertension and liver fibrosis. Dr. Pietrosi has published more than 30 papers in peer reviewed journals (H-index 12), and her clinical activity has always been coupled with highly focused research aimed at developing alternative therapeutic strategies for treating patients with chronic liver disease or acute liver decompensation.
Title: Noninvasive monitoring of hepatocyte transplantation by MRI: Lessons learned from studies in large animals
Nathanael Raschzok is a board-certified surgeon employed at the Department of Surgery of the Charité − Universitätsmedizin Berlin, Germany. Morover, he is fellow of the Clinican Scientist Program of the Berlin Institute for Health and Principal Investigator of the Organ Recovery Group of Experimental Surgery. He is strongly interested in the development of new strategies in liver transplantation and support. Dr. Raschzok has broad experience in isolation of primary hepatocytes, in tracking of transplanted hepatocytes by MRI - especially in large animal models - and in hepatocyte and liver transplantation. The results of his work, which led to several peer-reviewed journals and presentations in scientific congresses, was the basis for his habilitation thesis, which he defended in 2017.
Title: “Cell Product quality assessment based on measurements of oxygen consumption”
Dr. Suszynski is a chief resident in the Department of Plastic Surgery at the University of Texas Southwestern Medical Center. He completed both his MD and PhD (bioengineering) at the University of Minnesota in the Twin Cities. His academic interests have been in tissue engineering and cell transplantation with an emphasis on developing strategies for adequate oxygen delivery. His has also done work in the area of cell product quality assessment, including in the use of oxygen consumption rate measurements to assess the quality of pancreatic islets as well as fat grafts prior to transplant. His clinical interests reside in hand and reconstructive microsurgery.
Title: “19F Nuclear Magnetic Resonance (NMR) Measurements Of Oxygen Within Macroencapsulation Devices In Vivo”
Paul Wang is an MD/PhD candidate in the University of Minnesota Medical Scientist Training Program. Prior to entering the program, he earned a B.S. in Chemistry from the University of California, Berkeley. Currently, he is being advised by Professor Michael Garwood at the Center for Magnetic Resonance Research (CMRR) where he is working towards a PhD in Biomedical Engineering. His research focuses on the construction and development of a compact, desktop MRI pO2 scanner for making non-invasive, in-vivo oxygen measurements within islet macro-encapsulation devices. This work is a collaborative effort between multiple investigators whose combined expertise spans Halbach magnet construction, FPGA spectrometer fabrication, novel accelerated MRI methods development, and islet macroencapsulation technology.
Title: “Cryopreservation of stem-cell derived β-cells for clinical transplantation”
Louise Winkel, PhD, received her education from University of Copenhagen within Biology with focus on stem cell- and islet biology and did her PhD and subsequent PostDoc within beta cell development and regeneration. She then took up a position at Thermo Scientific, establishing a novel stem cell lab in order to support global product development and moved on to Novo Nordisk a year later, where she has been employed since 2013 within the Stem Cell to Beta Cell project, contributing to protocol development, testing of devices and heading the Encapsulation Track, including external collaborations.