CONFIRMED SPEAKERS

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LIVE PLENARY AND KEYNOTE
Speakers and Chairs

Halvard Bönig attended Medical School in Dusseldorf, London and Memphis, Tennessee. He is board certified as a pediatrician and transfusionist. His chief scientific interests are translational cell and gene therapy and hematopoietic stem cells. He is currently a Professor for Translational Development of Cell and Gene Therapies at Goethe University, Frankfurt, Germany, as well as an Affiliate Professor of Hematology at the University of Washington in Seattle, Washington.

Halvard has published more than 160 peer-reviewed research papers and serves on several scientific journals’ editorial boards. He leads an academic GMP core unit which develops and manufactures cell and gene therapy medicines for clinical use, including the product he will be talking about in his 2020 ISCT plenary presentation.

Medical degree “maximum cum laude” in July 1987 (University of Milan).
Speciality in Pulmonary Diseases in November 1987 (University of Milan) and in Pharmacology in July 1992 (University of Milan).

  • Full Professor in Respiratory Medicine at the University of Modena Reggio Emilia and Director of the Respiratory Unit at the University Hospital of Modena.
  • Director of the Post-doctoral School in Respiratory Diseases at the University of Modena-Reggio Emilia
  • Director of School of Physiotherapy at the University of Modena-Reggio Emilia (2018-to date).
  • Member of the Board of Professors at the PhD Course on “Clinical and Experimental Medicine“ at the University of Modena and Reggio Emilia.

Dr. Clini has received the following awards and scientific fellowships:

  • National award “DOMPE’ in PNEUMOLOGIA” (1990), National award “Boheringer-Ingelheim” for the best research “ex-aequo” in the Speciality degree (1990)
  • National award “Giovani Ricercatori” of the SIMeR Scientific Society (1996),
  • International European Respiratory Society “COPD Research Local (Italy) Award” (2001)
  • International “Fellow of the ERS-European Respiratory Society” (2015).

Dr. Clini has published:

  • 345 articles (232 original articles on international peer-reviewed journals)
  • 66 articles on Italian non-indexed journals
  • 25 educational articles
  • 22 articles in meeting proceedings
  • 47 chapters of books/books
  • 318 abstracts/communications (171 on international indexed journals).
  • Bibliometry (updated April 2019) – ISI – Web of Knowledge H-index 36; SciVerse – Scopus H-index 40

Dr. Heidi Elmoazzen is currently the director of Canadian Blood Services’ Stem Cell Program and is responsible for overseeing the national public cord blood bank and stem cell registry and has been with CBS for 8 years.

Dr. Elmoazzen obtained her Ph.D. in Medical Sciences from the University of Alberta with a concentration in cryobiology. She then went on to do a post-doctoral fellowship at Harvard Medical School and Massachusetts General Hospital in Boston, USA. Following her fellowship, she became an instructor at Harvard Medical School and an Assistant in Bio-engineering in the Department of Surgery and Obstetrics and Gynaecology. Her area of research was focused on fertility preservation and developing novel biopreservation techniques for stem cells and reproductive cells. 

Her main areas of expertise and experience include bio-preservation, stem cell banking and translational medicine. She has published two book chapters on stem cell preservation as well as over 30 journal papers. She has hundreds of contributed and invited presentations at various national and international meetings.

Carlos Fonck is a principal scientist at BioMarin Pharmaceutical in San Rafael, CA. He is the non-clinical project lead for BMN 270, an AAV-based gene therapy for patients with severe hemophilia A, currently in phase III clinical trials. He previously worked at Bayer Healthcare, GSK, AstraZeneca Pharmaceuticals as a pharmacologist and toxicologist in support of indications in rare diseases, hematology, oncology, neurology and psychiatry, developing large and small molecules as well as cell-based and gene therapies. Carlos was a postdoc at the California Institute of Technology where he worked with transgenic mice to study receptor-channel pathophysiology, and received a Ph.D. from the University of Southern California working in the area of neurotoxicology. Carlos has 20 peer-reviewed publications.

Dr. Jacques Galipeau is the Don and Marilyn Anderson Professor of Oncology within the Department of Medicine and UW Carbone Comprehensive Cancer Center at the University of Wisconsin in Madison, and is Associate Dean for Therapeutics Development at the University of Wisconsin School of Medicine & Public Health.  Dr. Galipeau has an NIH-funded research program in the study and use of mesenchymal stromal cells as an immunotherapy of catastrophic illnesses including cancer and immune disease. He is an internationally recognized expert in translational development of cell therapies and the sponsor of a series of FDA-sanctioned clinical trials examining the use of autologous marrow-derived mesenchymal stromal cells for immune disorders, including Crohn’s disease and graft vs host disease.  He has also developed the field of fusion engineered cytokines known as fusokines, as a novel pharmaceutical means of treating immune disorders and cancer.  He is the director of the University of Wisconsin Advanced Cell Therapy Program whose mission is to develop personalized cell therapies for immune and malignant disorders and to promote and deploy first-in-human clinical trials of UW cell therapy innovations to improve outcomes for children and adults.

Dr. Bernd Giebel studied biology at the University zu Köln and received his PhD in 1996 at the Institute for Developmental Biology in Köln. 1999 he moved to the Heinrich-Heine-University of Düsseldorf, started to work with human hematopoietic stem and progenitor cells and set up his own group. In 2008 he moved to the Institute of Transfusion Medicine at the University Hospital Essen. Here, he continues his studies on human somatic stem cells. As a second topic, in 2009, his group started to work on purification and analysis methods for EVs, setting a focus on mesenchymal stem/stromal cell-derived EVs (MSC-EVs). Together with collaboration partners the group demonstrated the therapeutic potential of prepared MSC-EVs in a human GvHD-patient and in different animal models. It is the current goal to optimize the MSC-EV production and characterization process to efficiently translate MSC-EVs into the clinics.

B Giebel was a member of the ME-HAD COST Action and led the working group Diagnostic & Therapeutic Potential of Microvesicles and Exosomes (ME). Since 2012 he is an active member of the International Society of Extracellular Vesicles (ISEV) and coordinated an ISEV position paper regarding the therapeutic application of EVs. Furthermore, he is the president of the German Society of Extracellular Vesicles (GSEV), which he founded together with other German EV experts on March 2nd 2017. According to his expertise, he became part of the scientific advisory board of two SME companies, Innovex Therapeutics and EVOX. More recently B. Giebel got involved in the International Society of Gene and Cell Therapy (ISCT) now heading an exosome working group intending to promote translation of MSC-EVs into the clinics.

After completing his clinical training in Cardiology, Prof. Massimiliano Gnecchi moved to the USA to work as a postdoctoral research fellow and research associate at Harvard and Duke University. During that time, he was the first to demonstrate that MSCs repair cardiac damage through paracrine mechanisms rather than through myocardial regeneration. So far, his original works describing the “paracrine theory” published in Nature Medicine, FASEB Journal, PNAS, Molecular Therapy and Circulation Research have been cited more than 5,000.

Prof. Gnecchi is currently Associate Professor of Cardiology at the University of Pavia and Cardiologist at the Coronary Care Unit of the IRCCS San Matteo Hospital in Italy. He is the Director of the Research and Clinical Laboratories of the Department of Cardiology. His current translational research interests are stem cell paracrine mechanisms and use of iPSC for disease modelling and drug testing. Prof. Gnecchi is also involved with clinical research and clinical trials with a focus on acute cardiac care, sudden cardiac death and acute myocardial infarction. Prof. Gnecchi is Chair of the Cardiovascular Committee and Vice President elect Europe of the ISCT.

Dr. Michael Hudecek performed medical training at the University of Leipzig, Germany, where he also commenced his specialist training in hematology and oncology. In 2007, Michael joined the Fred Hutchinson Cancer Research Center in Seattle as a post-doctoral research fellow, where he trained in the laboratory of Prof. Stanley R. Riddell and worked on identifying and validating novel tumor antigens in hematologic malignancies, the design and functional optimization of chimeric antigen receptor (CAR) constructs, as well as defining optimal cellular compositions of CAR T-cell products. In 2012, Michael was recruited to the Universitätsklinikum Würzburg, Germany, where he established a translational research program on CAR T-cell immunotherapy. At present, this program comprises physicians, scientists, doctoral students, master students and technicians in a multidisciplinary, international team that performs cutting-edge research with focus on novel transformative CAR technologies, and first-in-man clinical application of novel CAR-T products. Michael is an extraordinary member of the Bavarian Academy of Sciences, and recipient of the 2017 Artur Pappenheim Award of the German Society for Hematology and Medical Oncology.

Donald B. Kohn, M.D. is a Professor in the Departments of Microbiology, Immunology & Molecular Genetics and Pediatric (Hematology/Oncology) at UCLA. He is a board-certified pediatrician with >30 years of experience in clinical bone marrow transplantation. His principle area of research is the development and application of methods for gene therapy of blood cell diseases, such as Severe Combined Immune Deficiency and Sickle Cell Disease using autologous hematopoietic stem cells. His lab has investigated methods for optimal lentiviral vector-mediated gene delivery and expression and gene editing with human HSC, performing clinical trials of gene therapy for genetic diseases and pediatric HIV/AIDS.

Dr. Kohn was the recipient of a Distinguished Clinical Scientist Award from the Doris Duke Charitable Foundation (2000-2007), is a past-President of the American Society of Gene and Cell Therapy (2004) and the Clinical Immunology Society (2014); and was a member (and Chair) of the NIH OBA RAC (2010-2015)

Dr. Angela Krackhardt is Professor of Translational Immunotherapy and senior physician at the department of Hematology and Oncology at the III. Medical Department, TU München, Germany. She studied Medicine in Berlin and accomplished her clinical training in Internal Medicine, Hematology and Oncology, in Berlin and Munich. She did a Postdoc at the Dana Farber Cancer Institute in Boston, USA, followed by an appointment as Instructor. In 2005, she started her own Research Group at the Institute of Molecular Immunology, Helmholtz Zentrum München. In 2010, she was appointed as Professor at the TU München and is additionally appointed as senior physician at the Klinikum rechts der Isar. Her scientific focus is the identification of target antigens, especially neoantigens most suitable for T-cell based immunotherapies, the genetic manipulation of T-effector cells by tumor-reactive T-cell receptors, the establishment of xenogenic mouse models and development of in vivo imaging of tumor-reactive T cells. Her clinical focus is the implementation and translation of novel immunotherapeutic approaches including cellular therapies. She is additionally Director of the apheresis unit and heads specialty clinics for patients with malignant melanoma and multiple myeloma.

Full Professor of Hematology
Head of the Section of Hematology and Bone Marrow Transplant Unit, Department of Medicine, University Hospital of Verona (Italy)

  • 1992: M.D. graduation at the University School of Medicine in Verona (Italy).
  • 1996: Specialization in Hematology at the University of Verona (Italy)
  • 2001: Ph.D. in Experimental Hematology at the University of Milan (Italy)
  • 2000-2001: Academic Visitor and Research Associate at the Departments of Hematology (Prof. J.M. Goldman) and Immunology (Prof. R. Lechler) Imperial College School of Medicine, Hammersmith Hospital, London, U.K. with a research project about the immune regulation by mesenchymal stromal cells in allogeneic bone marrow transplantation.
  • 2011-present: Member of the Mesenchymal Stromal Cell (MSC) Committee of ISCT

Author of 135 papers, with a global impact factor of 766.087, with 8.185 citations and h-index = 43 according to Scopus, 8.293 citations and h-index = 43 according to Web of Science. Author of more than 250 abstracts at national and international congresses and 8 scientific book chapters.

Dr. Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, is the Founding Director of the Clinical Cell and Vaccine Production Facility (CVPF) in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania. He received a B.A. (Biology) from Penn and a Ph.D. in Immunology and Infectious Diseases from Johns Hopkins. First-in-human adoptive immunotherapy trials include the first use of a lentiviral vector, the first infusions of gene edited cells, and the first use of lentivirally-modified cells to treat cancer. Dr. Levine has overseen the production, testing and release of 3,000 cellular products administered to >1,200 patients in clinical trials since 1996. He is co-inventor of the first FDA approved gene therapy (Kymriah), chimeric antigen receptor T cells for leukemia and lymphoma, licensed to Novartis. Dr. Levine is co-inventor on 24 issued US patents and co-author of >160 manuscripts and book chapters with a Google Scholar citation h-index of 75. He is a Co-Founder of Tmunity Therapeutics, a spinout of the University of Pennsylvania. Dr. Levine is President Elect of the International Society for Cell and Gene Therapy and serves on the Board of Directors of the Alliance for Regenerative Medicine. He has been interviewed by the NY Times, Wall Street Journal, Washington Post, NPR, Time Magazine, National Geographic, Forbes, BBC, and other international media outlets.

Associate Professor Rebecca Lim has been researching the potential and limitations of amniotic epithelial cells in regenerative medicine since 2008. Her research team has uncovered mechanisms through which the hAECs modulate inflammatory events and bolster endogenous repair processes. They have demonstrated that hAECs are able to directly influence the stem cell niche in order to bring about tissue regeneration. This work has now progressed to clinical trials across multiple clinical indications including premature babies with bronchopulmonary dysplasia and cerebral palsy, and adults with liver cirrhosis, Crohn’s related perianal fistulas and acute ischaemic stroke. Most recently her team has begun to develop an extracellular vesicle biology arm to their research, in an effort to develop a cost-effective approach to regenerative medicine for urgent unmet medical needs.

A/Prof Lim holds joint appointments with the Department of Obstetrics and Gynaecology, Monash University and The Ritchie Centre, Hudson Institute of Medical Research. A/Prof Lim is an NHMRC Career Development Fellow (Industry) where her work aims to bring novel automated solutions to cell manufacturing for the regenerative medicine sector. She was awarded an NHMRC Research Excellence Award in 2019. She is the Scientific Director of the Cell Therapy and Regenerative Medicine Platform at the Monash Health and Translation Precinct, which manufactures cell-based products for early phase clinical trials. She is passionate about clinical translation, patient advocacy and discovery research.

Dr Sai-Kiang Lim graduated with a B.Sc (Hons) from NUS, a PhD from SUNY at Buffalo and did post-doctoral training at Columbia University. She led independent research groups at NUMI, NUS (1996-2001), Genome Institute of Singapore, A*STAR (2002-2007) and then Institute of Medical Biology, A*STAR (2007-present). Her current research interest is on the small 50-200 nm Mesenchymal Stem Cell (MSC) extracellular vesicles (EVs) with specific emphasis on their therapeutic applications in animal models of diseases, and characterizing the physical and biochemical properties of the different types of small MSC EVs and their biogenesis. Her lab recently identified 3 types of small MSC EVs; each has a unique permutation of lipids, proteins and RNA. The functions of these different EVs are currently under investigation.

Dr. Marcela Maus is the Director of Cellular Immunotherapy at the Massachusetts General Hospital Cancer Center and an Attending Physician in the Bone Marrow Transplant and Cell Therapy division of Oncology at the Massachusetts General Hospital. Dr. Maus is an Assistant Professor at Harvard Medical School, an Associate Member of the Broad Institute of Harvard and MIT, and an Associate Member of the Ragon Institute of MGH, MIT, and Harvard.

Dr. Maus is a translational physician-scientist in the field of immunology, particularly as it relates to cancer. Her lab focuses on the design, generation, and use of innovative forms of immune cell engineering, including chimeric antigen receptors. Her laboratory investigates basic mechanisms of human immunology to design and test novel immune-based therapeutic interventions in vitro, in mouse models, and in patients.

Dr. Maus received her S.B. from the Massachusetts Institute of Technology, and her M.D. and Ph.D. degrees from the University of Pennsylvania. Dr. Maus trained in internal medicine at University of Pennsylvania and in hematology and medical oncology at Memorial Sloan Kettering, and is board-certified in these three disciplines. Her laboratory research training was focused on gene and cell therapies, and occurred in the laboratories of Dr. Katherine High, Dr. Michel Sadelain, and Dr. Carl June.

Emanuele is Head of Europe for Cell and Gene Therapies at Novartis Oncology, where he oversees all commercialization aspects of this portfolio in Europe, including Kymriah.  With his team, he focuses on expanding access for this one-time therapy across Europe – they have innovated business and reimbursement models and executed them since September 2017.

Emanuele is with Novartis since 2012.  He joined the Sandoz Division with the Global Strategy Team, where he managed the collaborations with Novartis Pharmaceuticals and Alcon. He then became Head of Specialty and Hospital Franchises, Central/Eastern Europe, where he developed a specialty expansion strategy.  Emanuele later served as Business Unit Head, Rx in Romania. In this role he grew the team to drive the expansion into CNS, respiratory, and rheumatology franchises. 

Prior to joining Novartis in Europe he was based in the USA where he was Vice President of Business Development at Nano Terra, Engagement Manager at McKinsey & Co and a Senior Research Investigator at Surface Logix, where he helped to establish the company’s drug discovery platform. Emanuele was also the co-founder of Enumeral Biomedical and served on its BOD through its public listing in 2014.

Emanuele holds a PhD in Physical Chemistry from Harvard University and BS and MS degrees in chemistry from Georgetown University.

Dr. Marc Peschanski is MD (1978), PhD (1980) and DSc (1985), and currently Scientific Director of the I-STEM Institute (Institute for Stem cells Therapy and Exploration of Monogenic diseases), based at the Evry Genopole (France). I-Stem is entirely dedicated to the exploration of stem cell therapeutic potentials in rare diseases of genetic origin, including cell therapy and pharmacology derived from stem cell modeling.

His team performed the first transplants of fetal neurons in France in 1991 in patients with Parkinson’s disease, and the world’s first in patients with Huntington’s chorea in 1996, as well as a gene therapy trial in patients with Huntington’s disease in 1998, with intra-cerebral transplantation of CNTF-producing cells. More recently, he has developed treatments using repurposed drugs for Steinert myotonia and Phelan-McDermid autistic syndrome, identified via the exploration of patients-derived pluripotent stem cells. He has recently started a first cell therapy clinical trial using embryonic stem cell-derived retinal pigmented epithelial cells for patients with retinitis pigmentosa.

Co-founder and first chairman of the European Network of NeuroTransplantation (NECTAR) in 1991, he has since coordinated several European research networks in gene and cell therapies.

Professor Rasko is an Australian pioneer in the application of adult stem cells and genetic therapy. Since 1999 he has directed the Department of Cell and Molecular Therapies at Royal Prince Alfred Hospital and the Gene and Stem Cell Therapy Program at the Centenary Institute, University of Sydney.

John Rasko is a clinical haematologist, pathologist and scientist with an international reputation in gene and stem cell therapy, experimental haematology and molecular biology. In over 160 publications he has contributed to the understanding of stem cells and blood cell development, gene transfer technologies, cancer causation and treatment, human genetic diseases and non-coding RNAs.

He serves on Hospital, state and national bodies including Chair of GTTAC, Office of the Gene Technology Regulator – responsible for regulating all genetically-modified organisms in Australia – and immediate past Chair of the Advisory Committee on Biologicals, Therapeutic Goods Administration. Contributions to scientific organisations include co-founding (2000) and past-President (2003-5) of the Australasian Gene & Cell Therapy Society; Vice President (2008-12) and President (2018-20) International Society Cell & Gene Therapy; Scientific Advisory Committees and Board member for philanthropic foundations; and several Human Research Ethics Committees. He is a founding Fellow of the Australian Academy of Health and Medical Sciences. He is the recipient of national (RCPA, RACP, ASBMB) and international awards in recognition of his commitment to excellence in medical research, including appointment as an Officer of the Order of Australia.

Katy Rezvani, MD, PhD is Sally Cooper Murray Chair in Cancer Research, Professor of Medicine, Chief of the Section for Cellular Therapy, Director of Translational Research and Medical Director of the GMP Facility at MD Anderson Cancer Center. She has over 170 peer-reviewed publications related to immunotherapy, cellular therapy, and hematopoietic transplantation and is Specialty Chief Editor for cancer immunity and immunotherapy for Frontiers in Immunology.

She is on the Center for International Blood and Marrow Transplant (CIBMTR) clinical trials advisory committee, a member of the BMT CTN Cell and Gene Therapy, a member of the Hematologic and Immunologic Gene & Cell Therapy Committee and serves on the ASH Task Force on Immunotherapies. Dr. Rezvani has served on the organizing committees of the Society for Natural Immunity, International Society of Cell Therapy, and Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR.

Dr. Rezvani’s lab studies the role of natural killer (NK) cells in mediating immunity against hematologic malignancies as well as solid tumors, and seeks to understand the mechanisms of tumor-induced NK cell dysfunction. The goal of this research is to develop strategies to genetically engineer NK cells to enhance their in vivo anti-tumor activity and persistence. Findings from her lab have led to the approval and funding of Phase I/II studies of immunotherapy in patients with hematologic malignancies and solid tumors, as well as the first-in-human clinical trial of off-the-shelf CAR-transduced cord blood NK cells in patients with relapsed/refractory lymphoid malignancies.

Dr. Rezvani’s work is supported by grants from the National Cancer Institute, the Leukemia and Lymphoma Society, the American Cancer Society, and the Cancer Prevention & Research Institute of Texas (CPRIT). She serves as Co-Leader of the Stem Cell Transplantation and Cellular Therapy Program of the MD Anderson Cancer Center Support Grant.

Paula Río has been working in the field of Fanconi anemia (FA) gene therapy for 20 years, in the design of new vectors for the treatment of the disease (González-Murillo et al, 2010), in the characterization of different preclinical models of the disease (Rio et al., 2002; Rio et al., 2008) and in the translation of gene therapy to the clinic (Jacome et al. 2006; Jacome et al., 2009; Tolar et al., 2012). Her studies in the field of gene therapy in Fanconi anemia started with her Thesis entitled” Gene therapy for Fanconi anemia subtype A in a mouse model” directed by Prof.  J.A. Bueren and Dr. J.C. Segovia with a distinction “cum laude”. She attained a post-doctoral position in Prof. Hanenberg’ lab (Children’s Hospital, Düsseldorf), where she was involved in the characterization of a new FA gene (Levran et al., 2005).

In 2005 she moved to CIEMAT where she started working in the development of a new protocol to correct hematopoietic stem cells (HSCs) from FA patients by gene therapy (Jacome et al., 2006; Jacome et al.,2009) and the design of a new lentiviral vector that has received the orphan drug designation both by the EMA and FDA (Ref: EMA/COMP/662962/2010 and #DRU-2016-5193, respectively). In 2017 she participated in a study demonstrating for the first time that a short transduction protocol allows the engraftment of corrected cells from FA patients in immunodeficient mice (Rio*, Navarro* et al., 2017).

Now she is deeply involved as Associated investigator in two different clinical trials focused on the harvest and correction of HSCs from Fanconi anemia A patients (FANCOSTEM, Eudra CT: 2011-006197-88 and FANCOLEN, Eudra CT: 2011-006100-12) (Río et al. 2019). She is also in charge of Production department of the GMP facility Clinistem for the development of gene therapy trials for rare diseases.

Since 2010 she has been working in gene editing, first by targeting HSCs from FA patients by Homologous recombination (Rio*, Baños* et al., 2014; Diez et al., 2017) and nowadays by Non-homologous end joining using the CRISPR/Cas9 system (Román-Rodriguez et al., 2019).

She has published 42 articles (PubMed; H index: 18), received 6 International Awards including the Young investigation Award of the European Society of Cell and Gene Therapy .

Paula has been for four years a Board Member of the Spanish Society of Gene and Cell Therapy. She also evaluates papers from different specialized journals  and participates actively in the Fanconi anemia Gene Therapy working group.

Nowadays she is co-principal investigator in two different projects, one focused on Gene editing in FA, granted by Rocket Pharma and a project supported by the Ministry of Science, Innovation and Universities entitled: Gene therapy and other innovative therapies for the treatment of inherited bone marrow failure syndromes (GENECURE).

She participates as inventor in two recent patent application in USA:  

  • “Methods for enhancing lentiviral transduction using transduction enhancers”. Application number: 62/7712,146.
  • “Gene Therapy for Patients with Fanconi Anemia”. Application number: PCT/US2017/050837. 

Patricia Rocco, MD, PhD, is Vice-President of ISCT for the South and Central America regions and an elected Full Member of the National Academy of Medicine in Brazil and Brazilian Academy of Science. She is a Full Professor at the Federal University of Rio de Janeiro, where she heads the Laboratory of Pulmonary Investigation and leads a team of 50 people, including associate professors, postdoctoral fellows, and graduate and undergraduate students. Prof. Rocco has authored and co-authored more than 320 peer-reviewed publications (H index: 46) and 120 book chapters. Her research activities focus mainly on the pathophysiology of acute (ARDS) and chronic (asthma, COPD and silicosis) pulmonary diseases and the development of new approaches (cell and gene therapies) for their treatment. She is currently coordinating clinical trials of bronchoscopic administration of mesenchymal stromal cells for patients with severe COPD in Brazil. Prof. Rocco has more than 300 invited presentations.

Eva Rohde is Head of the Department of Transfusion Medicine at the University Hospital of the Paracelsus Medical University in Salzburg, Austria. She received her M.D. from the Karl-Franzens University of Graz, Austria in 1994, finished training in Transfusion Medicine in 2005 and spent several years in stem cell research as a postdoctoral fellow. Her research focuses on the application of stem cell-based therapies with special emphasis on their extracellular vesicles (MSC-EVs). Eva Rohde is Founding Member of the Spinal Cord Injury and Tissue Regeneration Center Salzburg (SCI-TRECS), Austria and Director and Qualified Person of the SCI-TReCS GMP Unit. The GMP Unit in Salzburg has achieved the pharmaceutical manufacturing authorization for MSC and MSC-EVs in 2015 and participated a clinical trial testing MSCs in multiple sclerosis. Recent effort is directed towards the preclinical characterization and the regulatory requirements for the clinical assessment and future application of stem-cell based products, including stromal cell-derived extracellular vesicles (EVs). In vitro and in vivo potency assays to define the immunomodulatory, neuroprotective, neuroregenerative and scarless healing support of MSC-EVs are currently developed. In a recent named patient use experiment, a single treatment of the inner ear with MSC-EVs was performed in cooperation with partners from the medical school Hanover and resulted in a very good safety outcome over a period of more than 12 months.

Alberto is Head of the Cell and Gene Technologies Business Unit at Lonza Pharma & Biotech, the leading global CDMO with a prominent presence in new modalities. Together with his team, Alberto’s objective is to serve customers by taking their products through the technical CMC journey to commercialization and industrial scale manufacturing.

Before joining Lonza Pharma & Biotech, Alberto was a Partner at McKinsey & Company, accruing 12 years of experience working closely with established industry leaders and emerging players. Alberto led the Biotechnology service line, as well as the Pharmaceutical and Medical Product practice, and has a deep knowledge of the manufacturing challenges faced by companies in the biopharma space.

Alberto is passionate about biotechnology – the science and the business.

Dr. Sandeep Soni is an Associate Professor of Pediatrics in the Division of Stem Cell Transplantation and Regenerative Medicine at Lucile Packard Children’s Hospital of Stanford University, Stanford, USA. His clinical research focuses on Stem Cell Transplant and Gene-Therapies for rare hematologic diseases like Fanconi Anemia, Sickle Cell Disease and Thalassemia. He is involved in multiple gene-therapy trials, both with gene-insertion and gene-editing strategies from academia and industry, and his translational research focus is on understanding the mechanisms related to the efficacy of gene-therapy for hemoglobinopathies.

Dr. Clotilde Théry is an INSERM director of research (DR1) working at Institut Curie, where she heads a team created in 2007 within the “Immunity and Cancer” INSERM Unit U932, entitled “Extracellular Vesicles, Immune responses and Cancer”. Since 1998, her scientific interests have focused on the study of exosomes (and more recently extracellular vesicles in general), secreted by immune and tumor cells, and their roles in communications between tumors and the immune system. Her goals are to understand the physiological functions of EV secretion during an in vivo immune response and during tumor growth, and her approach is to continuously go from basic cell biology questions on their modes of formation to application of this knowledge to in vivo situations, and eventually clinical applications.

C. Théry is regularly invited to write reviews on the subject of exosomes, EVs, their immune functions and their biogenesis. She has organized several symposia and sessions dedicated to exosomes in international meetings, and in particular a first “International Workshop on Exosomes” in Institut Curie, in Paris, in 2011, which led to the creation of the International Society for Extracellular Vesicles (ISEV), for which she served as Secretary General from 2012 to 2016. She has been Editor in Chief of the journal of the Society, J Extracell Vesicles, from its creation in 2012 until 2019.

Dr. Ting joined Athersys in 2001 as a Senior Scientist and has been promoted over this fifteen-year tenure at the Company, where he currently serves as Vice President of Regenerative Medicine and Head of Cardiopulmonary Programs. With more than thirty years of experience in cell and stem cell biology, Dr. Ting has developed expertise in translational clinical studies with adult stem cell therapies and has been responsible for all stages of the development of MultiStem® from the bench to the bedside. Dr. Ting manages all programs in the cardiovascular and pulmonary areas at the Company, as well as the evaluation of potential new uses for the cell therapy product. Dr. Ting serves on several regenerative medicine society committees including the International Society for Cell Therapy and the Alliance for Regenerative Medicine. From 1995 to 2001, Dr. Ting was a Principal Investigator and Head of the Screening for Novel Inhibitors group at the Institute of Molecular and Cell Biology (IMCB) at the National University of Singapore, where he established a multi-disciplinary group that focused on the identification of therapeutic targets and the development and implementation of high-throughput screens. Prior to joining IMCB, he was a post-doctoral fellow with Richard Scheller in the department of Molecular and Cellular Physiology at Stanford University. Dr. Ting received his Ph.D. in Cell Biology from Johns Hopkins University and his B.A. in Biology from Amherst College.

Dr. Viswanathan is an Affiliate Scientist at the University Health Network, and an Assistant Professor at the University of Toronto. Her research is focused on anti-inflammatory approaches to treat inflammatory diseases including using enhanced mesenchymal stromal cells (MScs) and ex-vivo polarized macrophages. As a translational scientist, she has overseen clinical translation of 13 cell-based therapies, including as co-PI on a pioneering MSC trial to treat OA patients. Dr. Viswanathan co-chairs a Cell Therapy Stakeholder’s Group (CTSG) that has bilateral interactions with Health Canada. Dr. Viswanathan is an expert member of ISO TC 276 focused on standards in cell-and gene therapies, and is an elected formal liaison between ISCT and ISO TC276. She also sits on ISCT’s MSC and NA LRA committees, and is an associate editor of Cytotherapy.

CONCURRENT SESSION
Speakers and Chairs
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Mehrshid Alai is VP of Global Regulatory CMC for Kite, a Gilead Company, where she is responsible for all aspects of Regulatory CMC, including development and life cycle management. Mehrshid has her Ph.D. in Biochemistry, Cell, and Molecular Biology from The Johns Hopkins University School of Medicine. Prior to Kite, Mehrshid was Interim Head of Global Regulatory CMC for Baxalta/Shire. She has over 28 years of industry experience and in her last position had the responsibility to oversee regulatory CMC aspects of all products including small molecules, biologics, complex biologics and devices. Previous to that she held various roles in R&D, Quality and Regulatory in Baxter.  She is a member of Gene Therapy Working Party and USP Complex Biologics Expert Committee.

Dr. Allickson has 30 years of experience in clinical translation of cellular therapies and regenerative medicine products including regulatory, business management and board directorship experience. She has 8 years’ experience as an executive officer with a publicly traded company building services for cellular banking including licensure of technology. Dr. Allickson is Director of the Regenerative Medicine Clinical Center at Wake Forest Institute for Regenerative Medicine. She heads the clinical translation team streamlining development to create a robust pipeline of products in development and early phase clinical trials including cell therapy, gene therapy, tissue engineered organs and tissues, biomaterials and devices. Prior to the Institute she was the Vice President of Research and Development and Laboratory Operations for Cryo-Cell International Inc. and held leadership roles at the University of Miami Diabetes Research Institute and the American Red Cross.  Dr. Allickson is on the Board of Directors for AABB and an Advisory/Science Board Member for Alliance for Cell Therapy Now and Regenerative Medicine Outcomes Foundation. She is on the Editorial board of CELLR4, Vice Chair for Cord Blood Association Quality Committee, Technical Advisory Board for Tissue Engineered Products under ICCBBA, Standards Coordinating Body- Tissue Engineering, grant reviewer for state funded initiatives such as CIRM and serves on the ISCT Commercialization Committee.  

Chris has over 20 years’ experience working on cell and gene therapies. He currently serves as SVP of Manufacturing at ICT and was previously VP of Manufacturing for Rocket Pharma, Sr. Director of Process Development and Commercialization for WuXi Apptec after having had responsibility there for Manufacturing Operations and Program Management for gene therapy clients. Chris was responsible for key programs including CAR-T, TIL, and classic CD34+ stem cell gene therapy. Prior to that Chris was responsible for running autologous cell therapy clinical trials for Cook Medical which included several different indications and studies from feasibility through Phase III/pivotal. Before Cook, Chris was at the Indiana University School of Medicine in several roles, including management of process development and clinical production capabilities at the IU Vector Production Facility. He also served as faculty with his own research programs on targeting of stem cells for gene therapy which resulted in issued (US9885059) and applied patents and spinout of Basilard BioTech from the University of California Riverside. Chris has served as an expert consultant to numerous companies on gene therapy and the production and use of viral vectors for gene therapies.

Chris has a Ph.D. in Cellular and Molecular Pathology from Vanderbilt University School of Medicine and was a Children’s Brittle Bone Foundation Fellow during his post-doctoral fellowship at Case Western Reserve University School of Medicine. He has a passion for driving gene therapy forward by solving the practical challenges associated with producing and using viral vectors to treat genetic diseases.

Prof. Pedro Baptista is originally from Portugal, where he graduated from the School of Pharmacy of the University of Lisbon. After that, he worked on clinical research at Eli Lilly & Co before engaging in his doctoral dissertation work, after being selected to the prestigious Gulbenkian Ph.D. Program in Biomedicine. From his Ph.D. thesis project, resulted the generation of the first human liver ever made in a laboratory, impacting the scientific community at large and widely broadcasted in the media all around the world.

He is currently a Group Leader at the Health Research Institute of Aragon (IIS Aragon) in Zaragoza, Spain and the founder of the Organ Bioengineering and Regenerative Medicine Laboratory at this institution. He is also an Assistant Professor at the Department of Biomedical and Aerospace Engineering at University Carlos III of Madrid, Spain. He is one of the founders and the Deputy Chairman of the European Association for the Study of the Liver (EASL) Consortium for Regenerative Hepatology and currently the Deputy Secretary General and an elected Board Governor of the European Society for Artificial Organs (ESAO). He is also a member of the Internal Scientific Advisory Board of IIS Aragon and iLITE French Consortium.

His current research focuses on creating bioengineered livers that can finally make the long-term transplantation of these lab-grown organs a reality. He is also working on liver stem cell biology and the development of novel methods to expand fetal and adult human stem/progenitor cells to the required large numbers necessary for organ bioengineering. Prof. Pedro Baptista is also interested in applying bioengineered hepatic tissues and organs to study developmental biology, physiology and drug discovery. He has authored two books, more than a dozen book chapters and multiple papers and reviews published in prestigious scientific journals. He is also the recipient of numerous national and international awards.

Jacqueline is the Chief Clinical Officer and a board Director of the Cell and Gene Therapy Catapult, the UK’s centre for the acceleration of the translation of cell therapies towards commercialisation.  Her groups include experts in Regulatory Affairs, Nonclinical testing, Clinical Operations and Development, including the roll out of Cell and Gene Therapies in a healthcare setting. Prior to this Jacqueline worked at the Scottish National Blood Transfusion Service where amongst other activities she designed the regulatory strategy for the Cellular Therapies for the Blood Transfusion Service and acted as Qualified Person for their release. Before that she held a number of post-Doctoral academic posts at the University of Edinburgh studying neuromuscular regeneration. She has considerable experience in the development, translation, clinical trial and approval of cell based medicinal products and therapies.

About the Cell and Gene Therapy Catapult

The Cell and Gene Therapy Catapult was established in 2012 as an independent centre of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialisation. With more than 180 employees focusing on cell and gene therapy technologies, we aim to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies.

Dr. Shirley Bartido joined Cellectis as Director of Regulatory Affairs in 2016. Dr. Bartido holds a PhD in Immunology and a MBA in Pharmaceutical Management from Rutgers University. She completed her doctoral studies at New York University elucidating an alternative Class II processing and presentation pathway utilizing a viral antigen. Her postdoctoral work at Memorial Sloan Kettering Cancer Center involved the development of DNA vaccines for the treatment of melanoma using the melanosomal antigen tyrosinase.

Following her postdoctoral work, she joined the Carl Icahn Institute of Gene Therapy and Molecular Medicine as an Assistant Professor to serve as the Assistant Director of the Gene Therapy Immunology Core Laboratory. In this role, she developed several immunomonitoring tools for assaying efficacy of adenoviral directed immunotherapies using AdV-IL-12 vectors targeting metastatic liver cancer. This was followed by an 11-year role as the Senior Quality Manager of the Cell Therapy and Cell Engineering Facility at Memorial Sloan Kettering Cancer Center. In this role, she developed the QA program for the development and GMP manufacturing of autologous CD19 Chimeric Antigen Receptor T-cell therapies for several clinical trials which targeted several indications in leukemia and prostate cancer as well as gene therapy for the treatment of B-Thalassemia using lentiviral transduced CD34+ HPSCs. She was an integral member in the design and construction of a state of the art GMP facility at MSKCC.

Presently, she is the Director of Regulatory Affairs at Cellectis Inc. The company’s platform is gene editing using TALEN based technology in the development of allogeneic CAR T-cells targeting hematological malignancies. She has authored several peer-reviewed publications in several well cited scientific journals and has been invited as speaker in many well attended conferences.

Martin Birchall is an internationally known ENT Surgeon with a special interest in throat disorders. He has introduced several World–firsts in transplantation and regenerative medicine, and improved the quality of care in the UK for patients with throat problems, both cancerous and benign. He is an accomplished lecturer and his various media appearances demonstrate his love for the public communication of medical science.

Founder and CEO Cellf Bio LLC. Recently retired Professor and Director of GI Programs Wake Forest Institute for Regenerative Medicine. Professor of Internal Medicine (Gastroenterology) and Professor of Physiology, Wake Forest School of Medicine, and Professor of Biomedical Engineering and Sciences, Wake Forest /VT School of Biomedical Engineering and Sciences.

Dr. Bitar has a broad background in neuro-gastroenterology and motility, with 40 years’ experience in NIH- funded research in the field. His laboratory has developed the technology to bioengineer internal anal sphincter (IAS) constructs from isolated internal anal sphincter (IAS) smooth muscle cells from the rabbit, mouse, pig and human. Dr Bitar’s lab, has a unique expertise in studying the functional physiological parameters necessary for a functional motility testing of different gut segments. They were the first to have developed the technology to co-culture smooth muscle cells with enteric progenitor neural cells. Their multiple collaborations have allowed them to be the first to successfully implant without rejection the intrinsically innervated IAS constructs.

Dr Bitar’s lab has been successful in developing an implanted human tissue engineered bowel, and develop technologies to successfully inject neuroprogenitor cells in an ex-vivo pylorus model to treat dysfunctional gastric emptying. This represents a great progression in autologous replacement therapies for incontinence, Hirschsprung’s and regenerative diseases affecting motility of the gut.

Dr. Björquist has a PhD in Biology/Biochemistry from Gothenburg University, and 50 + publications in peer reviewed journals, in addition to several book chapters and patents. His experience spans ten years within AstraZeneca R&D in Cardiovascular Diseases, twelve years at Cellartis/Cellectis as VP Regenerative Medicine, His responsibilities include a major collaboration with Novo Nordisk on development of a human embryonic stem cell derived beta cell treatment for diabetes and the development of human pluripotent stem cell derived cardiomyocytes and hepatocytes.

As of February 2014, he is CEO of VERIGRAFT AB, a pioneering company within tissue engineering and advanced regenerative medicine for use in treatment of cardiovascular, neuronal and other diseases.

Anne Black is a Regional Quality Assurance Specialist Pharmacist and a Qualified Person (IMP) working  within  the Specialist Pharmacy Service NHS Team in the UK.

Anne has spent most of her career in NHS Quality Assurance at Newcastle upon Tyne Hospitals NHS Trust where she has worked in QA until July 2017 when she became RQA for the North East and North Cumbria. She developed her interest and expertise in advanced therapy medicinal products as she became involved with the quality management of the Newcastle Cellular Therapies Facility and has since used this expertise to emphasise the important role of Pharmacy to optimise patient safety in the delivery of these medicines. Anne is Chair of the Pan-UK  Pharmacy Working  Group for ATMPs, and a steering group member of the Northern Alliance Advanced Therapy Treatment Centre.

Catherine Bollard received her medical degree at the University of Otago in Dunedin, New Zealand. She is Board certified both in Pediatrics and Hematology.  She worked in New Zealand and London, England before moving to Houston in 2000 where she was Professor of Pediatrics, Medicine and Immunology at Baylor College of Medicine (BCM) and Director of the Texas Children’s Cancer and Hematology Center Pediatric Lymphoma Program.

In August 2013, she moved to Washington DC to join Children’s National Health System and The George Washington University School of Medicine and Health Sciences. She is currently the Bosworth Chair for Cancer Biology, Director of the Center for Cancer and Immunology Research, and Director of the Program for Cell Enhancement and Technologies for Immunotherapy (CETI) at Children’s National Health System. She is a Professor of Pediatrics and of Microbiology, Immunology and Tropical Medicine at The George Washington University and Associate Center Director for Translational Research and Innovation at the GW Cancer Center. She is a member of the American Society for Clinical Investigation (ASCI) and is the immediate Past President of the International Society for Cellular Therapy (ISCT) and has chaired the Non Hodgkin Lymphoma (NHL) Committee of the Children’s Oncology Group since 2012. She was on the Board of Directors of the Foundation in for the Accreditation of Cellular Therapy (FACT) from 2010-2018 and in 2020 became the President Elect of FACT. Additionally, Dr Bollard was a member of the Cellular, Tissues and Gene Therapies Advisory Committee of the Food and Drug Administration (FDA) from 2015-2019.

In 2019 she became a member of the Frederick National Laboratory Advisory Committee (FNLAC) for the NIH and an ad hoc member of the Pediatric Oncologic Drugs Advisory Committee (ODAC) for the FDA. She has been an Associate Editor for the journal Blood since 2014 and recently completed her six year term on NCI’s Clinical Oncology (CONC) Study Section. Her bench and translational research focuses on improving outcomes for patients after hematopoietic stem cell and cord blood transplantation and on the development of novel cell therapies for viral diseases and hematologic malignancies including using cord blood as a novel donor source for virus-specific T cell therapies.

Gunther is, since January 2019, the EU Supply Chain Lead for CAR-T at Global Cell Therapy Development & Operations (CTDO) for Celgene’s growing Cell Therapy Manufacturing Network in preparation for commercial launches. He also serves as Apheresis Operations Head for EU.

Gunther comes from Novartis where he was Head Procurement of Cell & Gene therapies and Biologics Development. He supported work from April 2014 on the build of the Cell & Gene therapy Manufacturing and Supply Network from development throughout commercialization of the first approved CAR-T and of other Biologics and Cell & Gene therapy development projects.

Beforehand, Gunther worked in Technical Development for small molecules, devices, biologics, drug delivery, new technologies in clinical supplies manufacturing, supply chain management and CDMO management. 

Gunther is a licensed pharmacist and has a PhD in Biology from the University of Freiburg in Germany and is a Chartered Member of Purchasing and Supply (MCIPS).

Prof. Vincenzo Cardinale MD, PhD, is a clinician and scientist who has been performing translational research in gastroenterology and hepatology for over 10 years. He is an Associate Professor in Gastroenterology, Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome. He is dedicated to mentoring MD and PhD students, postdocs, and GI residents.

In 2010 he discovered stem/progenitor cell niches in the biliary tree and began studying their role in tissue regeneration, liver disease, diabetes, and malignancies. His pioneering studies have been recognized and confirmed in multidisciplinary settings and have contributed to advancements in primary sclerosing cholangitis, cholangiocarcinoma, non-anastomotic biliary strictures, and biliary diseases with pancreatic counterparts. His investigations on niches of stem/progenitor cells in the biliary tree, pancreas, and duodenum have opened new perspectives in regenerative medicine.

Jean-François has been working in the Biotech industry for the past 25 years with experiences in various big companies (GSK Vaccines, Sanofi) and CMOs (CMC biologics, Yposkesi).

Over this period, he was involved in the development and scale-up of different industrial processes based on mammalian cell lines to produce recombinant protein, vaccines, viral vectors with a strong focus on implementing new technologies while keeping an end-to-end vision on all aspect of manufacturability.

Dr. Clarke has over 15 years of experience developing enabling solutions to support cell and gene therapies. He is the Global Head of Cell Therapy at HemaCare, a leading provider of source material for clinical development and commercial manufacturing of cell-based therapies where he is actively engaged with industry experts to ensure the highest quality materials are delivered.

Previous roles include, Global Product Manager for Charter Medical’s cell therapy and bioprocessing single-use systems portfolio and Director of Research and Development for BioLife Solutions.

Dominic currently serves as the co-chair for the International Society for Cell and Gene Therapies Process and Product Development Committee with efforts directed towards translating research and process development from bench to clinic. 

Stuart was awarded his PhD by the University of Birmingham in 2005 after which his group developed a programme of immune based therapies for liver disease and liver cancer.  Backed by a successful National Institute for Health Research (NIHR) Biomedical Research Unit (BRU), he has undertaken a variety of first-in-man early phase clinical trials.  As the senior scientist within the BRU, Stuart led the development of cell therapy based around dendritic cell vaccination for primary liver cancer.  

Following this success, the University invested in the building and licencing of an ATMP manufacturing facility which Stuart now directs. The Advanced Therapies Facility manages the development of new ATMPs, both within the University of Birmingham and with UK and international partner organisations and is part of the UK government funded Advanced Therapies Treatment Centre programme. This initiative is tasked with developing streamlined manufacturing, logistics, and clinical pathways to improve access to ATMPs for patients within the National Health Service.  Birmingham, in partnership with other Midlands institutions and NHS Wales is one of three specialist centres in the UK.

Christoph is a Global Logistics Manager for Cell & Gene CAR-T Therapy at Novartis, where he oversees worldwide transportation and storage for Kymriah.

His role is to establish, transform and improve global logistics strategy and setups within both the clinical and commercial Cell & Gene CAR-T Therapy space, from patient starting material and critical raw materials all the way to finished product and delivery to patient.

Prior to joining Novartis, Christoph held various logistics management and supply chain roles in pharma, biotech and chemicals industry within Europe and in the United States.

MD degree at the University of Pavia in 1996. Post-graduate internship at the Vienna University (Austria). Residency in Hematology at the University of Ferrara. Post-Doctoral Associate at St. Jude Children’s Hospital in Memphis (USA, 2000-2003).

Currently, associate professor, director of the Residency School of Medical Oncology, of the Division of Medical Oncology and of the Program of Cellular Therapy and Immuno-oncology at the University Hospital of Modena and Reggio Emilia (Italy).

Since 2005 he is heading the Laboratory of Cellular Therapies. More than 140 papers with more than 21000 citations, 12 patents, five book chapters published, three books published. 22 grants as principal investigator with 11 on competitive calls, 10 grants as co-investigator all on competitive calls, 11 grants from biotech industries for sub-contracting investigations with a total of 14,6 Mio € since 2004.

Scientific founder of the university start-up Rigenerand raising 12,5 Mio € since 2009. Co-founder and coordinator of the Mirandola Science & Technology Park. 170 invited lectures as plenary speaker between national, international meetings and for University lectures, 14 peer reviewed oral communication and 31 posters presented in international meetings. Berlucchi Award for Research in Oncology (2012); “Fanfullino della Riconoscenza Premio Città Di Lodi” (2017); International Award Pico della Mirandola (2017). Referee and advisor for 16 research founding Bodies.

He has been co-founder of the Forum of Italian Researcher on MSC (FIRST), board member of JACIE, WBMT and scientific advisor for the Italian Minister of Health. He has been member of ISCT, ASH, ESCGT, IFATS, IPLASS. He has been President of ISCT 2014-2016, now member Emeritus, Member of the Strategic Advisory Council and Chair of the ISCT Presidential task-force on unproven cell and gene therapies.

I am a physician, hematologist and a Professor Emeritus for the University Paris Diderot.
From 1976 until 2005 I was the Medical Director of the Bone Marrow Transplant Service and Head of the Department of Hematology at Hôpital Saint Louis. I am a member of several Scientific Societies, including: The European Marrow Transplant Society (EBMT), World Marrow Donor Association (WMDA), Netcord, American Society of Hematology, American Society of Blood and Marrow Transplantation, European Hematology Association.

I am a fellow of the Royal College of Physicians (London) and an honorary professor at the universities of Bale, Liège and Budapest.
I have received numerous awards and distinctions in France and abroad, including the ranks of Commander of The Legion of Honor and Commander of the Order of Merit. More recently, I have been nominated for the distinction of Grand Officer of the Order of Merit. Finally, I received the Grand Prix INSERM, from the Academy of Medicine, ASH’s Pionner in Hematology Award, and the Prizes Ham Wasserman and Don Thomas and Carreras during international congresses.

Currently, I am the President and Chairperson of Eurocord/ Monacord and the leader of the “International Observatory of Sickle-cell Anemia.”
During several years, I was also the president of the European School of Hematology.

My research interests includes haematopoietic transplantation for malignant and non-malignant diseases, umbilical cord blood, selection of hematopoietic stem cell donors, cord blood banks and, in particular particularly, hereditary hematological diseases such as Fanconi and Sickle Cell Disease.
I performed the first successful human umbilical cord blood transplant, with the contribution of my colleague Hal Broxmeyer. And I successfully demonstrated that unrelated cord blood could be used as a source of hematopoietic stem cells.

I have published more than 800 articles in international peer-reviewed journals.

Dr. Hexner has two major research interests in malignant hematology: cellular therapies/ hematopoietic stem cell transplantation, and experimental therapeutics in myeloproliferative neoplasms (MPN). Both have a translational focus and align with her clinical roles as Medical Director of the Center for Cellular Immunotherapies and as Director of the MPN program at the University of Pennsylvania. She also serves as the Associate Director of the NIH CTSA-funded Masters in Translational Research program, where she co-directs a graduate level course in cell and gene therapy.

 

Chris Herbert is Director of Operations for Research and Innovation at Leeds Teaching Hospitals NHS Trust, one of the largest healthcare providers in the UK. In this role, Chris is responsible for the strategic development and management of the Trust’s Research and Innovation function which at any one time is supporting >900 live clinical research projects as well as a growing portfolio of “innovation” projects and strategic initiatives which include the collaborative development of medical devices, diagnostics and digital/AI tools. Reflecting the diversity of his role, he is a member of the management teams for the Northern Alliance Advanced Therapies Treatment Centre (NA-ATTC) which is supporting the clinical use of Advanced Therapies in the NHS and Northern Pathology Imaging Co-operative (NPIC) for the use of AI tools in digital pathology, both of which he helped to create.

Chris is passionate about bringing improvements to patient care through collaborative research and innovation and his career includes roles in technology transfer, medical device consultancy and business development, including a period of time working at the Cell and Gene Therapy Catapult. Prior to his move to more commercial and management roles, Chris’s research career focused on the use of viral vectors as cancer therapeutics. In his ‘spare’ time, Chris is an active musician and family man.

Emily Hopewell is the Director of Cell and Gene Therapy Manufacturing and an Assistant Professor in Clinical Medical and Molecular Genetics at Indiana University. She has over a decade of cellular therapy and laboratory experience. She received her PhD in Cancer Biology from the University of South Florida in 2012. She started her career as a Cell Therapy Technologist at the Moffitt Cancer in 2003. After completing her PhD in Cancer Biology at the University of South Florida in 2012, she returned to the Cell Therapy Facility as a Development Specialist and then Assistant Technical Director.

She joined Indiana University in 2018 and is charged with building and implementing manufacturing for Cell, Gene and Immune Therapy at IU. She has extensive experience with both standard stem cell therapy, as well as the next generation of cell and gene therapy, including contract manufacturing and FDA and FACT regulatory compliance.

She is active in the cellular therapy field, with a focus on educating professionals and providing career development opportunities. She is a member of the Early Stage Professionals committee at ISCT and has been instrumental in developing the ESP Mentoring Program. She was appointed as Interim Global Treasurer for ISCT in June 2019, and as such, sits on the Board of Directors, the Executive Management Committee, and is chair of the ISCT Finance and Audit Committee. She is also active in AABB as a member of the Cell Therapy Education Committee and was recently named as a Society for Immunotherapy in Cancer (SITC) representative for the annual Cell Therapy Liaison Meeting with the FDA and Co-Chair of the SITC Regulatory Subcommittee.

After spending 8 years in Contract Toxicology and 11 years as a Toxicologist in the Pharmaceutical Industry, I currently work as an Expert Pharmaco-Toxicologist within the Licensing Division of the Medicines and Healthcare products Regulatory Agency (MHRA) in London, whom I joined in 1996.  I am a European Registered Toxicologist and a Fellow of the British Toxicology Society.  I am also a Chartered Biologist and a Fellow of the Royal Society of Biology.

My current role principally involves assessing nonclinical data for Clinical Trial Authorisation (CTA) Applications and Marketing Authorisation Applications (MAA), both for non-biological and biological products, including advanced therapy medicinal products (ATMPs).  A further aspect of my job is to offer scientific advice to companies on behalf of  the MHRA.  I represented the EU in the ICH revision of the M3 Guideline, on the ICH S10 Guideline, on the Q&A document for ICH S3 (Toxicokinetics) guideline and on the ICH S11 (Nonclinical Studies to Support Paediatric Medicine) guideline.

I work closely with the UK’s National Centre for 3Rs (NC3Rs) and represent the MHRA on a Governmental body dealing with animal welfare.

I am also a guest lecturer at the University of Surrey, the University of Hertford and the University of Leicester and a frequent presenter at conferences around the world.

Prof. Christian Jorgensen is specialized in translational research for a better application of stem cells in immunology and rheumatology. C Jorgensen clinical interest are in stem cell , immunology and rheumatology. He is head of the clinical unit, “clinical immunology & Immuno-therapy in Rheumatology”, at University Hospital “Lapeyronie” (Montpellier). He leads Institute for Regenerative Medicine and Biotherapy IRMB dedicated to regenerative medicine. IRMB gathers scientist and clinicians on regenerative medicine and innovative immunotherapies.

The objectives of IRMB are to increase the knowledge of stem cell biology, interactions between stem cells and immune cells, stem cell niches and homing, as well as the role of epigenetics mechanisms in chronic and age related diseases. These researches include both basic biological aspects and innovative applications of regenerative therapy.

C Jorgensen has published extensively (over 200 publications in the field of Immunology and stem cell therapy applied for rheumatic diseases, h-index 45), and has a strong track record for competitive research grant from EU and ANR. Finally, today it coordinates the H2020 RESPINE project and a large scale project focusing on adipose-derived mesenchymal stem cells in osteoarthritis therapy (ADIPOA) and bone marrow stem cells for intervertebral disc. This translational activity leads to the launch of the biotech Medxcell.

C Jorgensen is a professor in the Faculty of Medicine Montpellier-Nimes (teacher in rheumatology, therapeutics and in charge of Master program “Evaluation & methodology of therapeutic trials”. He is expert for Biologics at French National Authority or Health (HAS), where he was former member of Transparency Comity at HAS, and former member of national scientific board of Inserm.

Aisha has twenty years of professional experience in medical, manufacturing, quality assurance, regulatory, and service related environments. While working at the University of Miami’s GMP facility, she has setup and managed many national and international state of the art research facilities. She routinely provides guidance to GMP facilities that are at various levels of maturity in their lifecycle to become FDA compliant. She has several years of experience and knowledge of FDA regulations, and practices regarding GMP in research facilities. She has served as the manufacturing and regulatory representative in Global Islet manufacturing team and provided US/EU regulatory input to various international organizations.

Aisha’s research interests include stem cell therapy, islet cell transplantation, spinal cord injury and regulatory issues and quality assurance. She is specialized in cell biology, microbiology, immunology, neuroscience and biochemistry. Her main focus is on optimization of stem cell culture techniques, specifically in these areas: 1) perfecting the culture methods and technique 2) in vitro assessment of stem cell potency and characterization 3) factors involved in stem cell growth and differentiation 4) also, optimizing islet isolation and transplantation techniques 5) developing cell characterization for Schwann cells and extensive experience in development of c-kit+ Cardiac Progenitor Stem Cells.

Proven leader to successfully analyze an organization’s critical business requirements, identify deficiencies and potential opportunities, and develop innovative and cost-effective solutions for enhancing competitiveness, increasing revenues, and improving quality of service.

She is an active member of American Association of Blood Bank (AABB), International Society of Cellular Therapy (ISCT), Regulatory Affairs Professional Society (RAPS), American Heart Association and Cells Transplant Society. She has the unique honor of performing the first successful Asian Pancreatic Islet Cell Transplant at Shanghai First People’s Hospital in China on January 26, 2003.

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 assays enumerating ALDH bright cells to predict cord blood potency from segments attached to cryopreserved cord

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.

John Laffey is Professor of Anaesthesia Intensive Care Medicine at the School of Medicine of the National University of Ireland, Galway and a Consultant in Anaesthesia and Intensive Care Medicine at Galway University Hospitals. He is vice-dean for Research at the College of Medicine, Nursing and Health Sciences at NUI Galway, and professor of Anesthesia, Critical Care Medicine and Physiology at the University of Toronto. Previously, he was founding co-director of the Critical Illness and Injury Research Centre at the Keenan Centre for Biomedical Research of St Michael’s hospital. His basic and translational research is focused on acute respiratory distress syndrome and sepsis. A current focus is on therapeutic potential of cell therapies for the critically ill. He also has a longstanding interest in the effects and mechanisms of action of carbon dioxide in the critically ill.

Aaron D. Levine is an Associate Professor in the School of Public Policy at Georgia Tech. He is also Co-Director for Engineering Workforce Development for the NSF Engineering Research Center for Cell Manufacturing Technologies (CMaT). His research focuses on the intersection between public policy and bioethics. Much of his work has examined the development of stem cell science, particularly research using human embryonic stem cells, and the translation of novel cell therapies. He also writes extensively on the oversight of contentious areas of medicine, such as assisted reproductive technology.

In 2012, he received a NSF CAREER award to examine the impact of ethical controversy on graduate science education and the development of scientific careers. He is an elected member of the Board of Directors of the American Society for Bioethics and Humanities and the Vice-Chair for Bioethics on the International Society for Cell Therapy’s Presidential Task Force on Unproven Cell Therapies. He is also a long-time member of the International Society for Stem Cell Research, the Association for Public Policy Analysis and Management and the American Association for the Advancement of Science. He is serving as an AAAS Leshner Leadership Institute Public Engagement Fellow for 2019-2020.

I was graduated in 1983 as a dentist and got in 1987 my postgraduate in Periodontics. I worked for 13 years in a private practice in Periodontics as one of the co-founders. Always interested and inspired by research, I went back to my Alma Mater, KU Leuven, Belgium, to obtain a PhD in biomedical sciences and started as head of Preclinical Envelopment in a biotech company, Tigenix, where I worked until 2011. At that time point I went back to KU Leuven, Belgium, as a Senior Preclinical/Clinical Translational Project Manager within Prometheus, KU Leuven, Belgium. In 2017 I got the opportunity, as a TERMIS representative, to become a member of the Regenerative Medicine Technical Advisory Group (RMTAG) of the ICCBBA.

 

 

Bill Milligan has over 25 years of executive leadership experience in business and corporate development, product development, marketing, pricing, reimbursement, and financing in the biopharmaceutical industry across a range of companies, therapeutic technologies, indications and regions.

Prior to his Cell & Gene Therapy experience as SVP Corporate & Business Development, Steminent, Biotherapeutics Inc.(Taiwan / USA) and VP Business Development, AventaCell Biomedical Co. (Taiwan / USA), Milligan served as Chief Business Officer for Migenix Inc.(TSE:MGI (Canada)), CEO / Director for Cytran Inc.(USA), and CEO / Director for Intellivax Inc.(USA) in the biotech sector. In Pharma, his roles included VP Sales Division, VP Biomedical Division and VP BD, Pricing, New Product Planning (Roche Canada), and Product Manager (Lilly Canada).

Milligan has served as Chair; ISCT Strategies for Commercialization (SFC) Organizing Committee (2018, 2019), and is currently Co-Chair, ISCT Business Models and Investment Sub-committee.

Detailed Bio: https://ca.linkedin.com/in/bill-milligan-051200b

Dr. Julie Murrell is the global head of Innovation Strategy for Gene Editing and Novel Modalities at MilliporeSigma. She is responsible for developing the roadmap for new products and services for the organization. She formerly led the Cell Therapy Bioprocessing R&D group at the company and was responsible for product development and providing external contract research services. Through that time, she led the efforts to establish robust assays, identify new targets as key quality attributes and develop scalable systems for cell therapy manufacturing, with a special focus on hMSCs, iPSCs and T cells. Previous roles include technology development of analytics for monoclonal antibody production and release, the use of bioinformatics for novel pathway identification, and time developing small molecule drug candidates. She earned a PhD in Cell and Developmental Biology in the Neuroscience department at Tufts University, completed a post-doctoral fellowship in translational medicine at Harvard Medical School and completed a Stem Cell fellowship at the University of Massachusetts. Her multi-disciplinary background has led to innovative team-driven approaches to identifying innovation areas.

Vivek Narayan, MD MSCE is an Assistant Professor of Medicine in the genitourinary medical oncology division at the University of Pennsylvania’s Abramson Cancer Center. He is a medical oncologist and clinical investigator specializing in the treatment of advanced prostate cancer and renal cell cancer. His research focuses on novel therapies for advanced urologic cancers, with a particular interest in novel cellular therapies. He is a co-investigator on a first-in-human, investigator-initiated clinical trial of a novel PSMA-redirected CAR-T therapy for men with castration-resistant prostate cancer. His early career achievements have been recognized by the Prostate Cancer Foundation and the AUA/Urology Care Foundation.

Rahul Palchaudhuri (Senior Scientist at Magenta Therapeutics, Cambridge MA) is the program lead for MGTA-117, Magenta’s most advanced ADC program for conditioning prior to hematopoietic stem cell transplantation (HSCT). Prior to joining Magenta Therapeutics, Dr. Palchaudhuri conducted his postdoctoral studies at Harvard University where he conceived and demonstrated the feasibility of ADC-based approaches to enable HSCT in mice. Rahul holds a doctorate in chemistry from the University of Illinois at Urbana-Champaign, and an undergraduate degree in chemistry from Grinnell College.

Biography Forthcoming

Dr. Suma Rao is senior director, Process Development at Allogene Therapeutics. She is responsible for process development, technology transfer and manufacturing support of all products from Phase 2 and beyond. Prior to this role, Suma severed as director of Global Operations at Amgen, where she was responsible for the commercialization of operational aspects of an asset through from Phase 3 studies through multi-country approvals and global launch. Before taking on this position she held various roles in Operations Strategy, Corporate Strategy and Process Development. Suma holds a Ph.D. In Chemical Engineering from Pennsylvania State University and a bachelors in Chemical Engineering from Bangalore University.

Stephan Reynier, MSc, joined Cellectis in April 2011. He serves as Chief Regulatory and Compliance Officer after holding the position of Head of Programs at Ectycell, a former subsidiary of Cellectis, from April 2011 to 2014 with the mission of managing and coordinating internal and external collaborative programs. As Chief Regulatory and Compliance Officer, Mr. Reynier is in charge of ensuring a speedy and successful development of the UCART product family by establishing close interactions with regulatory agencies such as EMA and FDA, while securing compliance to applicable regulations, regulatory guidelines and quality assurance standards. Mr Reynier has extensive experience, from his previous positions as Senior Director at Voisin Consulting Life Sciences and European Associate Director Medical Affairs at Gilead Sciences, in the design and implementation of regulatory strategies for the development of drugs and biologics, with a strong focus on cell and gene therapy.

Mr Reynier graduated as Agro-Engineer in France and received a Master of Science in Chemical Engineering from the University of Toronto, Canada.

Dr. Scott Rodeo is Professor of Orthopaedic Surgery at Weill Medical College of Cornell University and is an Attending Surgeon at the New York-Presbyterian Hospital and the Hospital for Special Surgery, where he is Co-Chief Emeritus of the Sports Medicine and Shoulder Service, Vice Chair of Orthopaedic Research, and Co-Director of the Orthopaedic Soft Tissue Research Program. He also serves as Director of the Center for Regenerative Medicine at Hospital for Special Surgery.  Rodeo is Head Team Physician for the New York Giants Football Team, and he served as a Team Physician for the United States Olympic Team in 2004, 2008, and 2012.  

His clinical practice involves orthopaedic sports medicine, with specialty interest in complex knee reconstruction (ligament, meniscus and cartilage surgery), tendon repair in the shoulder and other joints, and shoulder instability. He runs a translational research laboratory program investigating the cellular and molecular mechanisms of soft tissue repair. Rodeo graduated cum laude from Stanford University, where he completed his undergraduate work while competing on the Stanford Swimming Team. He completed medical school graduating with honors from Cornell University Medical College.

Dr. Krishnendu (Krish) Roy received his undergraduate degree from the Indian Institute of Technology (India) followed by his MS from Boston University and his PhD in Biomedical Engineering from Johns Hopkins University. After working for 2 years at Zycos Inc., a start-up biotechnology company, Dr. Roy left his industrial position to join the Biomedical Engineering Faculty at The University of Texas at Austin in 2002, where he was most recently Professor and Fellow of the Cockrell Chair in Engineering Excellence.

He left UT-Austin in July of 2013 to move to Georgia Tech. where he is the Robert A. Milton Chaired Professor in Biomedical Engineering. At Georgia Tech, he also serves as the Director of the newly established NSF Engineering Research Center (ERC) for Cell Manufacturing Technologies (CMaT) and The Marcus Center for Cell-Therapy Characterization and Manufacturing (MC3M) – as well as the Director of the Center for ImmunoEngineering. He is also the Technical Lead of the NIST/AMTech National Cell Manufacturing Consortium (NCMC), a national public-private partnership, focused on addressing the challenges and solutions for large scale manufacturing of therapeutic cells. Dr. Roy’s research interests are in the areas of scalable cell manufacturing, Immuno-engineering, stem-cell engineering and controlled drug and vaccine delivery technologies, with particular focus in biomedical materials.

In recognition of his seminal contributions to these fields, Dr. Roy has been elected Fellow of the American Institute for Medical and Biological Engineering (AIMBE) and Fellow of the Biomedical Engineering Society (BMES). In addition, Dr. Roy has received numerous awards and honors including Young Investigator Awards from both the Controlled Release Society (CRS) and The Society for Biomaterials (SFB), NSF CAREER award, Global Indus Technovator Award from MIT, the CRS Cygnus Award etc. He is also the recipient of Best Teacher Award given by the Biomedical Engineering Students at UT-Austin and the best advisor award given by bioengineering students at Georgia Tech.

He serves as a member of the Editorial Boards of the Journal of Controlled Release, the European Journal of Pharmaceutics and Biopharmaceutics, the Journal of Immunology and Regenerative Medicine, all from Elsevier, as well as the AiChE Journal of Advanced Biomanufacturing and Bioprocessing. He is a member of the Forum on Regenerative Medicine of the National Academies of Science, Engineering and Medicine (NASEM), and a Board Member of the Standards Coordinating Body (SCB) for Cell and Regenerative Therapies.

Antonio Ruiz-García is the Qualified Person and Quality Head of the Cell Production and Tissue Engineering Unit (UPCIT) of Virgen de las Nieves University Hospital in Granada, Spain.

A pharmacist from the University of Seville, Spain, he completed postgraduate studies specializing in pharmaceutical industry, beginning his professional career at the company Schering-Plough, currently Merck and Co. At the University of Granada, he completed a Master’s degree in Production of advanced therapies medicinal products and a Master’s degree in Tissue Engineering.

He began working at the UPCIT of Granada in 2008, being responsible for adapting three advanced therapeutic products to GMP production: allogeneic mesenchymal stromal cells, artificial cornea and skin obtained by tissue engineering.

Antonio is very involved in training of new professionals, collaborating across several master’s degree programs from the University of Granada, such as Biomedicine, Innovation in Medicines, and Translational Medicine.

Fermin Sanchez-Guijo, MD, PhD, is the Director of the Cell Therapy Area and Staff Member of the Hematopoietic Stem Cell Transplantation Unit at the IBSAL-Hospital Universitario de Salamanca, as well as Professor of Hematology & Cell Therapy at the University of Salamanca, Spain. He is a member of the JACIE Board and the Executive Committee of the Spanish Cell Therapy Research Network (TerCel). One of his main focus of interest is biology and role of MSC in normal and malignant hematopoiesis as well as their therapeutic role of these cells.

 

Dr. Shah is the Vice Chair of Research at BWH and an Associate Professor at Harvard Medical School. He is also the Director of the Center for Stem Cell Therapeutics and Imaging at BWH and the joint Center of Excellence in Biomedicine with KACST and BWH. He is a Principal Faculty Member at Harvard Stem Cell Institute in Boston.

Dr. Shah and his team have pioneered major developments in translational cell therapy field, successfully developing experimental models to understand basic cancer biology and therapeutic cells for cancer. These studies have been published in a number of very high impact journals. Previously, Dr. Shah’s translational stem cell work has caught the attention in the public domain and as such it has been highlighted in the media world-wide including features on BBC and CNN. Recently, Dr. Shah’s laboratory has reverse engineered cancer cells using CRISPR/Cas9 technology and utilized them as therapeutics to treat cancer. This work was published in journal Science Translation Medicine and highlighted world-wide including features on Scientific American, New York Times and Scientific American. Dr. Shah holds current positions on numerous councils, advisory and editorial boards in the fields of stem cell therapy and oncology. In an effort to translate the exciting therapies develped in his laboratory into clinics, he has founded two biotech companies whose main objective is the clinical translation of therapeutic stem cells in cancer patients.

Dr Smith completed his PhD in the Microbiology and Immunology Department at the University of Melbourne, Australia. He then joined Rajiv Khanna at the QIMR Berghofer Medical Research Institute, Brisbane, Australia, to develop adoptive cell therapy approaches for viral associated diseases. His work has focused heavily upon process development of autologous therapies for immunocompromised patients and cancer patients and in defining correlates of potency following treatment. This work has been translated into multiple clinical trials in head and neck cancer, brain cancer, organ transplant recipients and multiple sclerosis patients. This work has now been licenced for commercial development by Atara Biotherapeutics, where Dr Smith works as a consultant.

Dr Karin Tarte has a background in Immunology and Hemato-oncology with a continuous focus on B-cell malignancies and Biotherapy. She heads a research unit of about 30 people, gathering clinicians and biologists, dedicated to basic and translational research. Her research is in particular dedicated to the understanding of normal and malignant tumor niches, with a specific interest for the mechanisms of the co-evolution of tumor clones and their supportive microenvironment. In agreement, she is involved in several research and clinical programs dealing with the understanding of the role of tumor microenvironment and how it could be a target for new therapeutic strategies and/or provide predictive and prognostic biomarkers. In addition, her interest for stromal cell function and heterogeneity has led her to the development of preclinical and clinical programs based on the use of mesenchymal stromal cells (MSC). As a PI and co-investigator of several programs from the French NCI (INCa) and French National Research Agency (ANR) she had the opportunity to develop fruitful collaborations with national and international academic and industrial partners leading to publications of highly cited papers and contributing to the design of new clinical trials.

Dr Dominic Wall serves as the Chief Scientific Officer for Cell Therapies and as the Executive Director of Business Ventures for the Peter MacCallum Cancer Centre. He has over 30 years’ experience in CAR-T manufacturing and development, along with his extensive background in Haematology and Pathology.

Dr. Wen Bo Wang is Senior Vice President, Technical Operations at Fate Therapeutics, overseeing the company’s manufacturing strategies for its pipeline of off-the-shelf cell-based cancer immunotherapy candidates and scaling the Company’s induced pluripotent stem cell (iPSC) product platform to support late-stage clinical and commercial operations. She was formerly Senior Vice President Cell Therapy R&D at Fujifilm Cellular Dynamics Inc (FCDI), where she was responsible for developing the cell therapy R&D strategy and the iPSC based pipeline products, and led the next generation production technology development efforts. Previously, she was VP Process Sciences, and directed scale up and scale out platform process development for iPSC based iCell products and MyCell products including automation and bioreactor work. Prior to joining FCDI in 2008, Dr. Wang was Group Leader, Process Sciences, at Geron Corporation, Menlo Park, CA working with embryonic stem cell derived cell therapies and dendritic cell cancer vaccine. From 2001 to 2005, Dr Wang held a number of positions at ViaCell, Boston, MA including Associate Scientific Director, ViaCord Human Umbilical Cord Blood Bank (a subdivision of ViaCell). Dr. Wang serves on the board of directors for Standards Coordinating Body and on ARM Cell Therapy Advisory Committee. Dr. Wang earned a B.S. in Biology from Ocean University of Qingdao, P.R. China and received her Ph.D. in Biology from Newcastle University, United Kingdom. She conducted post-doctoral training in Cryobiology at Biosciences Research Laboratory, USDA/Agricultural Research Service, Fargo, N.D.

Bettina Weigelin is a Group Leader at the Werner Siemens Imaging Center, Department for Preclinical Imaging and Radiopharmacy at the University of Tübingen, Germany. She obtained her PhD in Medical Sciences from the Radboud University of Nijmegen, The Netherlands, where she applied intravital multiphoton imaging to study cancer invasion and immune function in solid tumors. In 2016 she received a Rubicon Young Investigator Award (NWO) to support her stay at MD Anderson Cancer Center, Houston, USA, where she used intravital microscopy to understand immunosuppression mediated by the bone microenvironment to develop novel strategies for immunotargeting of bone metastasis. Her group, Multiscale Immunoimaging at the University of Tübingen, combines advanced microscopic techniques with state-of-the art macroscopic imaging to gain mechanistic insight in adoptive T cell therapies at the cellular and whole-body scale, to identify strategies for improved cancer immunotherapies.

 

Adrian Woolfson, BM, BCh, PhD, has over a decade of biopharmaceutical industry experience in drug discovery, medical affairs and early and late stage clinical development. Most recently, he served as Chief Medical Officer at Nouscom AG, a genetic cancer vaccine biotechnology company based in Basel, Switzerland, where he led the development of the company’s off-the-shelf and personalized neoantigen vaccine and oncolytic virus strategy. Dr. Woolfson previously worked at Pfizer Inc. and Bristol-Myers Squibb.

Dr. Woolfson completed post-graduate training in internal medicine at Addenbrooke’s Hospital Cambridge. He holds a BM BCh degree in Clinical Medicine from Oxford University and a PhD in molecular immunology from Cambridge University.

Patricia J. Zettler, JD is an assistant professor at The Ohio State University Moritz College of Law and a member of Ohio State’s Drug Enforcement and Policy Center and its Comprehensive Cancer Center. She teaches and writes about the U.S. Food & Drug Administration (FDA) and health law, including about pre-approval access to experimental interventions. Her scholarship has appeared in leading legal and health sciences journals including JAMA, Science, and EMBO Molecular Medicine. She also advises various groups and organizations on FDA law and policy, such as serving as a consultant to the National Academies of Sciences, Engineering, and Medicine’s Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse from 2016 to 2017. Before joining the faculty of The Ohio State University, she was on the faculty at Georgia State University College of Law and a Fellow at the Stanford Center for Law and the Biosciences. Before entering academics, she was an Associate Chief Counsel in the Office of the Chief Counsel at US FDA. She received her undergraduate and law degrees from Stanford University, both with distinction.

 

Academic Abstract Presenters
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Dr. Bao is currently the Global BD manager of Shenzhen Pregene Biopharma Co., Ltd. He is in charge of the cell therapy products licensing-in and licensing-out activities in the company, and has established the cell production center in Bangkok and organized the first CAR-T clinical trial in Thailand. He obtained his PhD in National University of Singapore and worked on cell therapy research and development for over 8 years.

Mason A. Chilmonczyk is a recent Mechanical Engineering PhD graduate (May, 2020 defense) from Andrei G. Fedorov’s lab at Georgia Tech. During the course of his PhD, Chilmonczyk developed the “Dynamic Sampling Platform (DSP)” for real-time, label-free, CQA identification and monitoring in bioreactors. Mr. Chilmonczyk aims to bring this advanced sensing technique to the cell and gene therapy industry to enable new forms of bioprocess quality monitoring, especially by providing feedback control to ad hoc processes for the scale up and scale out of advanced therapies.

Loïc M.A. Fiévet is an assistant pharmacist in Occitania French Blood Establishment (EFS), a unit that produces Advanced Therapy Medicinal Product for clinical trials. Loïc is pursuing a PhD at the French INSERM unit STROMALab (Heads: Prof. Dr. Louis Casteilla & Dr. Luc Sensebé, MD) on the generation of bone marrow organoids from adult stem cells.

Previously, he has worked as a Pharmacist resident in Toulouse University Hospital Centre to improve the accessibility of the newest cell and gene therapies in the clinic. He graduated two years ago with honors from Paul Sabatier Toulouse University with a doctorate in pharmacy (Pharm.D.) and two others degrees in Pharmacokinetics and Advanced Therapy Medicinal Product (ATMP) from Paris V Descartes.

Loïc has developed his translational vision by studying the plasticity of human mesenchymal stromal cells in 3D culture systems to generate vascularized organoids (Co-Directors: Dr. Frederic Deschaseaux & Dr. Pierre Layrolle).

On one hand, he tries to understand how to guide stem cells’ self-organization to improve in vitro models. On the other hand, his goal is to create graftable tissues and find predictive markers of efficiency for bone and hematopoietic regenerative therapies.

Winner of several oral presentation awards in National Congresses (SFTS; SFGM-TC), Loïc is also enthusiastic about teaching in medical school.

As the son of a physical education teacher, he is also a former tennis coach and a passionate NBA fan.

He is looking for a post-doctoral position (End of 2020) in Stem cell biology – 3D Tissue Engineering – Single-cell – Regenerative medicine – Organoids – Bone/Hematopoiesis.

Twitter: @LMA_FIEVET

Dr Gabor Foldes is an Associate Professor at the Heart and Vascular Centre, Semmelweis University Budapest and a research fellow at the National Heart and Lung Institute, Imperial College London. He has considerable experience in balancing clinical work with academia throughout his career. He has been working as a clinician (Internal Medicine and Cardiology) in Budapest and London since 2002. His clinical expertise are in the fields of heart failure and cardiovascular cell therapy. On the academic side, he received his PhD in cardiovascular biology in 2002. He completed a fellowship on cardiac progenitor cells at Harvard University in 2006 as well as the ISCT-ASBMT Cell Therapy Training Course in Philadelphia in 2019. Dr Foldes has extensive, translatable experience of stem cell biology, cardiovascular biology and pathology. Current research interests of his stem cell group are in new cellular and therapeutic mechanisms in vascular disease and developing novel therapeutic and diagnostic strategies for patients with peripheral artery disease. Their major research contributions to date have been to develop new vascular cell types from stem cells and to perform successful experiments with human pluripotent stem cell-derived vascular grafts. Dr Foldes is regular invited speaker at cardiovascular and stem cell meetings, and author, reviewer and editor for internationally recognised journals and books.

I hold a Master’s degree on Biological Engineering from Instituto Superior Técnico (IST), Universidade de Lisboa, Portugal. During my Master thesis I studied the interactions established between cancer cell populations in vivo, using a zebrafish model, at Champalimaud Center for the Unknown, Lisbon, Portugal. Currently, I am pursuing a PhD degree on Bioengineering Systems from the MIT Portugal Program. I have been developing my PhD thesis at iBB-Institute for Bioengineering and Biosciences, IST and at iMM Lisboa. The goal of my PhD thesis is to use extracellular vesicles (EVs) derived from human mesenchymal stromal cells (MSC) for the delivery of anticancer agents to treat cancer. In order to obtain a therapeutic product more readily translatable to the clinical setting, I have been developing bioreactor culture systems for the scalable and robust manufacturing of MSC-derived EVs.

 

Jae Young Lee is a director of R&D Therapeutics and Business development of ToolGen Inc., a gene editing based company.

Jae’s role in ToolGen Inc., as a business developer is to build external partnership and to establish strategic decision/plan. His role as a R&D director is to develop CRISPR/Cas9-based therapy. Jae received his BEng (First Class Honours) from the University of Melbourne and his PhD in Medicine (graduated with Dean’s Award for doctoral thesis excellence) from Monash University.

Dr. Lee is an entrepreneur and technology platform builder specializing in cellular systems. He has over 15 years of life science leadership experience spanning product development, technical operations, marketing management, and innovation. He is the Chief Operating Officer and co-Founder of Senti Biosciences, where he is leading technical operations for innovative cell and gene therapies. Previously, he was the co-founder and CEO of CellASIC, which was acquired by Merck KGaA, and served as the former Head of Cell Culture Systems at MilliporeSigma (part of Merck KGaA). He received his PhD in Bioengineering from UC Berkeley/UCSF and B.S. degrees in Chemical Engineering and Biology from the Massachusetts Institute of Technology. 

I am Hyun Jung Park from Cha university.
I conduct research on neuroscience and stem cells to contribute to better healthcare outcomes for all.

Education

2007-2010 Ph.D. in Biomedical
Ajou University, Suwon, Korea

2005-2007 M.S. in Biomedical
Ajou University, Suwon, Korea

Professional Experiences

2016-present Research Professor
Department of Biomedical, CHA University, Gyeonggi, Korea

2010-2016 Post-Doc
Department of Biomedical, Yonsei University, Seoul, Korea

2005-2006 Research assistant
Department of Neuroscience, Ajou University, Suwon, Korea

2004-2005 Research assistant
Department of Virus, National veterinary research, Anyang, Korea

Publications (First author)

Park HJ, Oh SH, Kim HN, Jung YJ, Lee PH. Mesenchymal stem cells enhance α-synuclein clearance via M2 microglia polarization in experimental and human parkinsonian disorder. Acta Neuropathol. 2016 Aug 6.

Park HJ, Shin JY, Kim HN, Oh SH, Song SK, Lee PH. Mesenchymal stem cells stabilize the blood-brain barrier through regulation of astrocytes. Stem Cell Res Ther. 2015 Sep
29;6:18

Park HJ, Shin JY, Kim HN, Oh SH, Lee PH. Neuroprotective effects of mesenchymal stem cells
through autophagy modulation in a parkinsonian model. Neurobiol. Aging. 2014
Aug;35(8):1920-8.

Park HJ, Shin JY, Lee BR, Kim HO, Lee PH. Mesenchymal stem cells augment neurogenesis in the subventricular zone and enhance differentiation of neural precursor cells into dopaminergic neurons in the substantia nigra of a Parkinsonian model. Cell Transplant. 2012 Apr 24.

Park HJ, Bang GY, Lee BR, Kim HO, Lee PH. Neuroprotective effect of human mesenchymal stem cells in an animal model of double toxin-induced multiple system atrophy-parkinsonism. Cell Transplant. 2011; 20:827-835.

Park HJ, Lee PH, Bang OY, Lee G, Ahn YH. Mesenchymal stem cells therapy exerts neuroprotection in a progressive animal model of Parkinson’s disease. J Neurochem. 2008 Oct;107(1):141-51.

Kim YJ, Park HJ, Lee G, Bang OY, Ahn YH, Joe E, Kim HO, Lee PH. Neuroprotective effects of human mesenchymal stem cells on dopaminergic neurons through anti-inflammatory action. Glia. 2009 Jan 1;57(1):13-23. The first two authors contributed equally to this work.

Park HJ, Lee PH, Ahn YW, Choi YJ, Lee G, Lee DY, Chung ES, Jin BK. Neuroprotective effect of nicotine on dopaminergic neurons by anti-inflammatory action. Eur J Neurosci. 2007;26:79-89.

I am a French pharmacist and currently a PhD student at the immunology and biotherapy lab of Rouen (Inserm U1234, Normandy University).

I work on stromal vascular fraction and adipose-derived stem cells for myositis treatment, but my pharmacist thesis focused on the impact of regulations on the development and marketing of advanced therapy medicinal products.

Khaled Sanber is a PGY-5 resident in the Medical Resident Investigator Track (MeRIT) at Baylor College of Medicine (BCM). Dr. Sanber is currently doing his post-doctoral research training at The Center for Cell and Gene Therapy (CAGT) under the supervision of Drs. Meenakshi Hegde and Nabil Ahmed. He earned his M.D. from the University of Jordan and then Ph.D. in Gene Therapy from University College London (UCL) Cancer Institute. His research project is focused on engineering chimeric antigen receptor (CAR) T cells using CRISPR/Cas9 gene-editing to improve activity against solid malignancies, specifically using a glioblastoma model. Dr. Sanber will be starting his fellowship training in Hematology/Oncology at Johns Hopkins University in June 2020, where he plans to continue working on developing novel cancer immunotherapies.

Postdoctoral Research Fellow at Queen’s University Belfast. Striving to contribute to a MSC based therapy for Acute Respiratory Distress Syndrome (ARDS). Acts on projects related to 1) development of new therapies for ARDS; 2) cell-based therapy in ARDS; 2) mitochondrial dysfunction; 3) mechanisms of potentiation and activation of mesenchymal stromal cells, 4) extraction and evaluation of the therapeutic potential of extracellular vesicles and 5) development of new therapies for the treatment of neglected diseases.
Johnatas has completed Master’s and Ph.D. in Biological Sciences (Physiology) from Carlos Chagas Filho Institute of Biophysics (IBCCF) at Federal University of Rio de Janeiro (UFRJ) with collaboration abroad as visiting PhD student at Semmelweis University School of Medicine – Budapest-Hungary (2012-2013). He has experience in the field of Physiology, with emphasis on cardiorespiratory physiology and pathophysiology, acting mainly on the following topics: respiratory mechanics, experimental models, acute respiratory distress syndrome, mitochondria dysfunction, cell-based therapy, regenerative medicine and pharmacological therapy.

Gaurav Sutrave is a clinician scientist currently undertaking a PhD in the field of cellular therapy through the University of Sydney. His work focuses on assessing alternative methods of gene modification and novel manufacturing protocols for the generation of chimeric antigen receptor T cells. He holds a dual fellowship with the Royal Australasian College of Physicians and the Royal College of Pathologists of Australasia, and as the current Bone Marrow Transplant and Cell Therapies Fellow at Westmead Hospital in Sydney, assists in several cell therapies clinical trials.

Rui has 13 years’ experience in early stage device and process development for cell therapy manufacturing. During his training, Rui has cultured human primary and stem cells in bioreactors for his PhD in the MIT-Portugal program and developed a new filtration device for cell washing in at the Biochemical Engineering Department of UCL, London, UK.

Currently, Rui is the Head of Acoustic Cell Processing at FloDesign Sonics, a MilliporeSigma company, where he leads the life sciences group in the development of the Acoustic Affinity Cell Selection system for Cell and Gene Therapy manufacturing.

Dr. Xu earned her B.S. in Applied Bioscience from Zhejiang University, China and later M.S. in Microbiology from New York University. She completed her Ph.D. study at Lewis Katz School of medicine, Temple University in 2014, where she investigated the regulation of type I interferons in dendritic cells in viral infection, systemic lupus erythematosus and melanoma. In November 2014, she joined Product Development Laboratory as a Research Specialist at Center for Cellular Immunotherapies, University of Pennsylvania. In 2017, she was promoted as Project Manager, and investigated the novel manufacturing platforms and evaluated predictive and prognostic biomarkers for immune-gene therapies. Since August 2018, she serves as Associate Director focusing on developing the new manufacturing platforms to improve the quality of cellular products.

Xiaoran Zhang completed her work under the supervision of Prof. Andy Peng Xiang, the Director of Center for Stem Cell Biology and Tissue Engineering at Sun Yat-Sen University. This study showed in a mouse model of LPS-induce lung injury that the inflammatory cell infiltrations were reduced and lung injury was improved within 6 hours after MSCs infusion. ChAT, VAChT of lung tissues were significantly increased after MSCs treatment. This work identify a previously unrecognized mechanism of mesenchymal stem cells (MSCs)-mediated activation of the cholinergic anti-inflammatory pathway in alleviating ARDS-like syndrome, which provide evidences for clinical translation of MSCs in patients with ARDS.

Xiaoran Zhang completed her PhD in June 2017 from Sun Yat-Sen University and is now in her first post-doctoral position in the same group. One of her previous study reported that MSCs were modified by chemokine receptors to target the damaged tissues and highly intensified their immunomodulatory effects in vivo. In the future she will continue her work on immunomodulation of MSCs in inflammation-related diseases or conditions, and she will focus on their cellular and molecular mechanisms.

Dr Dandan Zhu is a clinician-scientist passionate about regenerative medicine. Her research in bronchopulmonary dysplasia (BPD) is crucial to the design of the now-completed Phase 1b, first-in-human trial. This trial assessed the safety of intravenously delivered allogeneic amnion epithelial cells (hAECs) for premature babies with established BPD. With her translation mindset and clinical training, Dr Zhu has been working on developing clinical scale production for cell and exosome based therapies.

Corporate Session Speakers and Chairs
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Symposium Presenters

Dr. Marcela Maus is the Director of Cellular Immunotherapy at the Massachusetts General Hospital Cancer Center and an Attending Physician in the Bone Marrow Transplant and Cell Therapy division of Oncology at the Massachusetts General Hospital. Dr. Maus is an Assistant Professor at Harvard Medical School, an Associate Member of the Broad Institute of Harvard and MIT, and an Associate Member of the Ragon Institute of MGH, MIT, and Harvard.

Dr. Maus is a translational physician-scientist in the field of immunology, particularly as it relates to cancer. Her lab focuses on the design, generation, and use of innovative forms of immune cell engineering, including chimeric antigen receptors. Her laboratory investigates basic mechanisms of human immunology to design and test novel immune-based therapeutic interventions in vitro, in mouse models, and in patients.

Dr. Maus received her S.B. from the Massachusetts Institute of Technology, and her M.D. and Ph.D. degrees from the University of Pennsylvania. Dr. Maus trained in internal medicine at University of Pennsylvania and in hematology and medical oncology at Memorial Sloan Kettering, and is board-certified in these three disciplines. Her laboratory research training was focused on gene and cell therapies, and occurred in the laboratories of Dr. Katherine High, Dr. Michel Sadelain, and Dr. Carl June.

Tutorial Speakers and Chairs

Alex is Vice President, Services and Alliances at WorldCourier, part of AmerisourceBergen’s global specialty logistics business. As strategy and services lead, Alex is responsible for developing and executing key strategic initiatives. He also oversees delivery of key World Courier services, including Clinical Supply Solutions and personalised supply chain logistics (direct-to-patient and cell and gene therapy). Alex is based in World Courier’s global headquarters in London. Before joining World Courier in 2013 as Head of Pricing, Alex spent nearly 3 years with Oliver Wyman as a consultant in the Health and Life Sciences practice. Alex holds a PhD in Experimental Solid State Physics from Imperial College, London

Katrin Mestermann, PhD, performed scientifical training at the University Hospital of Würzburg, Germany. In her doctoral thesis, Katrin analyzed the use of tyrosine kinase inhibitors to modulate CAR T cell activity and function. In 2015, she received additional training at The SCRIPPS research Institute, FL, in the laboratory of Christoph Rader. In Florida, she focused on the development of antibody libraries that can be used to generate chimeric antigen receptors. Since 2019, Katrin is a Postdoc in the Max-Eder Research Group of Michael Hudecek. Here, she holds responsibility for the development of safety switches in CAR T cell therapy, and the preclinical validation and clinical translation of a variety of CAR products.

Ali Mohamed, PhD, VP of Chemistry Manufacturing and Control, Immatics US Inc. in Houston TX is leading the development and manufacturing of Adoptive Cell Therapies for various solid cancers in collaborations with University of Texas MD Anderson Cancer Center. Dr. Mohamed has nearly 20 years of experience in process development and GMP manufacturing of regenerative medicine, cell and gene therapy products at various CMOs and clinical stage companies. Before joining Immatics, Dr. Mohamed was the senior director of manufacturing operations/ manufacturing development at PCT (now HCATS) helping their clients manufacture cell & gene therapy products. Before joining PCT, Dr. Mohamed led the development of AlloCure’s MSCs for acute kidney injury and previous to that he helped Lonza clients develop various cell therapy products. Dr. Mohamed holds a PhD in Molecular Pharmacology from Medical College of Ohio and postdoctoral fellowship in neuroscience and neurobiology from the Georgetown University Institute of Cognitive and Computational Sciences (GICCS).

Dr Montero Julian was previously the R&D Director for 3 years of Chemunex R&D developing microbiological detection solutions for the healthcare industries. With over 25 years of biotechnology, clinical diagnostics, life sciences and pharmaceutical microbiology experience, he has an extensive knowledge of all the quality control of Biotechnology drugs and Cell & Gene Therapies (ATMPs). Félix is an expert in the field of rapid and alternative microbiological methods.
Active member of the PDA, USP, ISAC, A3P and the BioPhorum group.
Félix holds a PhD in Immunology from the University of Aix-Marseille in France.

Alex is the Chief Business Officer for Asymptote, a specialist in cryopreservation technology now part of Cytiva. Alex has been part of the VIA Capsule development since its inception over five years ago.

Cathy is Senior Product Manager of Cytiva’s (formerly GE Healthcare) portfolio to address the unique challenges of cryopreservation and distribution in cell and gene therapies.

Sarah has over 10 years of experience in cell therapy, biomedical research and development.
She is a pharmacist from education and has a PhD in pharmaceutical and biomedical sciences, specialised in stem cell biology. In 2010, she joined Promethera BioSciences, a biopharmaceutical company dedicated to the development of cell therapy products based on allogeneic adult stem cell technology to treat liver diseases. She headed the R&D, QC and Preclinical Departments.

In 2015, she joined Celyad, a biopharmaceutical company, specialised in autologous and allogeneic cell therapy. Celyad’s core business lies in the field of immune-oncology, and more specifically the development of NK-receptor based CAR T therapies. Sarah initially led the immune-oncology program at R&D level, focused on technology transfer, product characterization and optimization. Since 2016, she heads the QC Department, covering release of clinical products and raw material, analytical method development and translational research activities.

Dr. Viswanathan is an Affiliate Scientist at the University Health Network, and an Assistant Professor at the University of Toronto. Her research is focused on anti-inflammatory approaches to treat inflammatory diseases including using enhanced mesenchymal stromal cells (MScs) and ex-vivo polarized macrophages. As a translational scientist, she has overseen clinical translation of 13 cell-based therapies, including as co-PI on a pioneering MSC trial to treat OA patients. Dr. Viswanathan co-chairs a Cell Therapy Stakeholder’s Group (CTSG) that has bilateral interactions with Health Canada.

Dr. Viswanathan is an expert member of ISO TC 276 focused on standards in cell-and gene therapies, and is an elected formal liaison between ISCT and ISO TC276. She also sits on ISCT’s MSC and NA LRA committees, and is an associate editor of Cytotherapy.

Associate Professor Dominic Wall is Peter Mac’s Executive Director of Business Ventures. This role provides leadership and management for programs and departments relating to both existing and emerging business ventures, as well the new Centre of Excellence in Cellular Immunotherapy which was established in 2019 with an $80 million contribution from the Commonwealth Government.

This program intends to provide new means for Australian patients to access innovative cell based immunotherapy products such as CAR‐T cells.

He is also the Chief Scientific Officer of Peter Mac’s majority owned and controlled independent and commercial business Cell Therapies Pty Ltd which provides specialized contract manufacturing and testing of cells for human therapy, predominantly in the field of cellular immunotherapy and gene therapy.

Dominic is responsible to provide the executive support for all of these businesses to flourish in a public hospital setting. Dominic has been directly involved in cell therapy manufacturing since the 1990s and was responsible for manufacturing Australia’s first CAR‐T products in 2008. Cell Therapies has Australia’s only TGA licence for manufacturing of both commercial and clinical trial CAR‐T products, and Dominic carries final accountability for quality and manufacturing of those products.

He has also been involved in pathology service delivery since his training in London at the University of London School of Pathology at Middlesex & UCH, followed by a PhD at the University of Melbourne and a Founding Fellowship in the Faculty of Science in the Royal College of Pathologists of Australasia.”

Shigeki Yagyu is a Pediatric Oncologist and Assistant Professor at Kyoto Prefectural University of Medicine (KPUM) in Japan. In addition to leading teams of physicians for high quality patient care, Shigeki also heads a basic and translational research laboratory focused on the development of novel cell and gene therapy approaches for hematologic and solid malignancies. In particular, he is interested in the clinical application of non-viral cancer immunotherapy, including CAR-T cells and NK cells. Shigeki previously performed his postdoctoral training in Malcolm Brenner’s laboratory at Baylor College of Medicine where he investigated mesenchymal stromal cells and induced pluripotent stem cells for cell therapy. He also holds multiple patents related to diagnostic tools for neuroblastoma, the development of novel CAR-T cells, and manufacturing of CAR expressing immune cells.”

Global Showcase Speakers and Chairs

Biography Forthcoming

Breanna Borys graduated with a BSc in Chemical Engineering in 2016 and is a senior PhD candidate in Biomedical Engineering at the University of Calgary. Her publications have focused on using computation fluid dynamic modeling to evaluate and predict ideal hydrodynamic environments in stirred suspension bioreactors for large-scale expansion of pluripotent stem cells.

Dr. Bronshtein earned his Ph.D. from the Faculty of Biotechnology at the Technion—Israel Institute of Technology, under the supervision of Prof. Marcelle Machluf, where his dissertation focused on the development of a cell-derived therapy for HIV/AIDS. During his studies, Dr. Bronshtein co-invented the Nano-Ghosts, a novel naturally-targeted drug-delivery system derived from the cytoplasmic membranes of mesenchymal stromal cells (MSCs). Dr. Bronshtein pursued a three-years postdoctoral fellowship at the Nanyang Technological University (Singapore) under the supervision of leading material scientists Professors Subbu Venkatraman and Freddy Boey, where he led a group of researchers studying MSCs in cardiac restoration therapies. Before joining Bonus Therapeutics, Dr. Bronshtein served as the Research Manager at the Technion Laboratory for Cancer Drug Delivery & Cell Based Technologies, developing multiple applications of MSCs in tissue engineering, cell therapy, and drug delivery.

With a strong scientific background in research (PhD at Paris VII University; post-doctoral experience at Rockefeller University), Sylvanie joined industry 20 years ago, first as a technical leader in a service laboratory, and then as a R&D manager in bioMerieux, accumulating experiences in developing and using molecular methods for industry quality controls. In 2012, after a Master of Business at Audencia business school, she joined the global marketing department of bioMérieux, where she is defining and guiding the development of new solutions for pharmaceutical microbiological controls.

Shae Disney manages the logistics and quality aspects of clinical and commercial CAR-T cell products for Cell Therapies and the Peter MacCallum Cancer Centre. She is a trained nurse in the fields of transplant haematology, transfusion and apheresis, which contributes to her dedication to patient treatment delivery.

Dr. Epstein graduated from Harvard College in 1983, Harvard Medical School in 1988 and completed his Residency and Fellowship in Medicine and Cardiology at the Brigham and Women’s Hospital, where he also completed an HHMI Postdoctoral Fellowship in Genetics. In 1996 he accepted a position as Assistant Professor of Medicine in the Division of Cardiology at the University of Pennsylvania. From 2006-2015, he served as Chairman of the Department of Cell and Developmental Biology and Scientific Director of the Penn Cardiovascular Institute. He is currently the William Wikoff Smith Professor, Executive Vice Dean and Chief Scientific Officer at the Perelman School of Medicine at the University of Pennsylvania.
Dr. Epstein has been the recipient of numerous awards, including the Sir William Osler Young Investigator Award from the Interurban Clinical Club (2001), the Outstanding Investigator Award from the American Federation for Medical Research (2006) and the Harriet P. Dustan Award for Science as Related to Medicine from the American College of Physicians (2020). He is a member of the Philadelphia College of Physicians, American Academy of Arts and Sciences, American Association of Physicians, Past President of the Interurban Clinical Club, Past President of the American Society for Clinical Investigation and a member of the National Academy of Medicine (previously the Institute of Medicine). He serves on several editorial boards, and is a past Deputy Editor of the Journal of Clinical Investigation. Dr. Epstein was a founding co-director of the Penn Institute for Regenerative Medicine in 2007.
Dr. Epstein’s research has focused on the molecular mechanisms of cardiovascular development and implications for understanding and treating human disease. His group has been at the forefront of utilizing animal models of congenital heart disease to determine genetic and molecular pathways required for cardiac morphogenesis, with implications for pediatric and adult cardiovascular disease. Stem cell, angiogenesis and epigenetic studies have had direct implications for the development of new therapeutic agents for heart failure and myocardial infarction.”

Dr. Genser-Nir is responsible for the development of a SF, XF and ACF culture platforms for the isolation, expansion and differentiation of hMSC from various sources. Among the different developed products is the flagship product, MSC NutriStem® XF, a SF XF culture medium for the isolation and expansion of hMSC from various sources. Dr. Genser-Nir earned her Ph.D. from the Faculty of Medicine at the Technion—Israel Institute of Technology.

Dr. Hartounian leads the Biopharma Division at NJII, helping biopharmaceutical companies transform discovery into commercial production. He has nearly 30 years’ experience in the biotechnology industry working for companies such as DuPont, Monsanto, SkyePharma and Vyteris. He contributed to two FDA-approved product launches ⁠— DepoCyt and DepoMorphine ⁠⁠— and has served as the CEO of public and private biopharma companies. He also founded the companies MicroIslet, Protagenic Therapeutics, and DiaVacs and has worked in a variety of product lines ⁠— including cell therapy, oncology, women’s health, pain management and drug delivery. In addition, Dr. Hartounian is an adjunct associate professor of Chemical Engineering at Columbia University, and in 2020 was appointed to the Affiliated Faculty in NJIT’s Department of Chemistry and Environmental Science. He earned his Ph.D. in Chemical Engineering from the University of Delaware.

Ian’s scientific background is in molecular and cellular biology, with particular experience of pharma and biopharma drug discovery (cancer & inflammatory disease) – from leading Target ID & Validation groups in big pharma and start-up biotech, more recently through commercial, business development and operations roles, including supporting the progress of a mAb drug through Phase I and II clinical trials. A personal highlight was the experience gained from running a small biotech company as CEO between 2002 and 2006, to a UK public stock listing in 2004. Ian’s current role in Agilent, is to build awareness and growth of Cell Analysis into the pharma and biopharma segment, with particular emphasis on early translational drug discovery and immunotherapy.

Michael Kapinsky has a strategic marketing role at Beckman Coulter’s Flow Cytometry division (Beckman Coulter is a Danaher company), being responsible for clinical research flow cytometry reagents including DURAClone.

Michael is a chemist by training. In 2002 he received his PhD at the Institute of Laboratory Medicine of the University of Regensburg/Germany. He transitioned back-to-back into Beckman Coulter’s flow cytometry division in Germany as field application specialist, still spending most of his time in the lab. In this function, Michael developed a novel antibody panel design method patented in US and EU.

Beside a handful of peer-reviewed publications in international life science journals he contribution by his technical support to the success of The ONE Study (www.onestudy.org), considered today as the gold reference in flow cytometry standardization. He was granted the Danaher “Excellence in Innovation” award for his contributions to the development of a novel diagnostic method for infectious diseases.

Rachel is partnering with sales, marketing and Pall’s technology teams to build company prominence as a preferred partner for the development and manufacturing of virus based therapeutics with a focus on Gene Therapy. In addition to supporting global customers and building high level networks, Rachel is supporting various internal cross-functional activities including due diligence and new product development.

Rachel has more than 20 years of experience in the field of scalable biologics and gene therapy manufacturing of therapeutic products, viral vector and proteins for gene therapy and biologics. She completed her Ph.D. in Food Engineering and Biotechnology at the Technion-Israel Institute of Technology, Israel. Rachel joined Pall in 2014 and currently serves as a process development services senior lab manager in charge of upstream and downstream process development, scale-up, and manufacturing support activities for the gene therapy and biologics markets. Prior to joining Pall, Rachel held several scientific and leadership roles at Microbiology & Molecular Genetics department at Harvard Medical School, SBH Sciences, Seahorse Biosciences, and Goodwin Biotechnology.

Cláudia Lobato da Silva received a Diploma in Chemical Engineering (Biotechnology), Instituto Superior Técnico (IST), Technical University of Lisboa (Universidade Técnica de Lisboa, UTL), Portugal, in 2001, and got a Ph.D. in Biotechnology in 2006 at IST-UTL in collaboration with the University of Nevada, Reno, USA. She is Assistant Professor (with Tenure) at the Department of Bioengineering, IST, Universidade de Lisboa, Lisboa.
Cláudia Lobato da Silva’s research interests at the Stem Cell Engineering Research Group (SCERG) of iBB – Institute for Bioengineering and Biosciences, IST, include expansion of human stem cells, cellular therapies with human adult stem cells, production of extracellular vesicles, and bioreactors. She is co-author of more than 80 scientific articles published in international peer-reviewed journals and 14 book chapters. Presently, She is Member of the Pedagogical Council at IST and serves in the Editorial Board of BMC Biotechnology as Associate Editor. From 2015-2019, She was the Vice-President of the Portuguese Society of Stem Cells and Cellular Therapies (Sociedade Portuguesa de Células Estaminais e Terapias Celulares (SPCE-TC)).

Gerry McKiernan brings over 15 years of quality experience in R&D and GMP manufacturing in Europe and Australia to his role as the Director of Quality for Cell Therapies. He was the driving force behind Cell Therapies obtaining GMP manufacturing licenses for clinical and commercial T-cell products from Australia’s TGA.

Bill Milligan has over 25 years of executive leadership experience in business and corporate development, product development, marketing, pricing, reimbursement, and financing in the biopharmaceutical industry across a range of companies, therapeutic technologies, indications and regions.

Prior to his Cell & Gene Therapy experience as SVP Corporate & Business Development, Steminent, Biotherapeutics Inc. (Taiwan / USA) and VP Business Development, AventaCell Biomedical Co. (Taiwan / USA), Milligan served as Chief Business Officer for Migenix Inc.(TSE:MGI (Canada)), CEO / Director for Cytran Inc.(USA), and CEO / Director for Intellivax Inc.(USA) in the biotech sector. In Pharma, his roles included VP Sales Division, VP Biomedical Division and VP BD, Pricing, New Product Planning (Roche Canada), and Product Manager (Lilly Canada).

Milligan has served as Chair; ISCT Strategies for Commercialization (SFC) Organizing Committee (2018, 2019), and is currently Co-Chair, ISCT Business Models and Investment Sub-committee.

Detailed Bio: https://ca.linkedin.com/in/bill-milligan-051200b

After obtaining his diploma in Biology from the Karlsruher Institute of Technology (KIT), Dr. Philipp Nold successfully performed his PhD studies at the renowned University Hospital of Giessen and Marburg in Germany where he graduated in 2017. In his PhD studies he conducted research on the GMP-conform production of human mesenchymal stem-cells in bioreactors. Based on this work, utilization of these cells as a therapeutic agent was applied successfully. With this knowledge, he became an infield application and stem cell specialist for Eppendorf.
In his lecture he will talk about the different parameters which you have to consider to successfully design and optimize your stem-cell production in stirred-tank bioreactors.

Mathieu Porte is Bioproduction R&D Manager at
Polyplus-transfection®. After obtaining his  Biotechnology Engineering Degree
from the renowned European School ESBS (Strasbourg, France), he worked as
Research Assistant at New England Biolabs and UCSF. He joined Polyplus-transfection® in 2009. During 10 years in the Bioproduction R&D group, he carried out the development of several innovative transfection solutions dedicated to biomanufacturing.

 

Todd has been with Pall since 2006. He has over 20 years of research experience with expertise in mammalian cell culture, process development and analytical method development. He currently leads the Gene Therapy Upstream Cell Culture and Analytics Team in the Biotech Process R&D group. He holds a B.S. in Biochemistry and B.S. in Psychology from Michigan State University. When not at work, Todd enjoys gardening and spending time with his young children.

Julie Smolich is the senior vice president of provider services at NMDP/Be The Match. She provides leadership and strategic direction to the teams focused on product and service delivery to transplant center customers and partners, as well as commercial entities leveraging NMDP/Be The Match’s vast capabilities. 

Julie is responsible for identifying and understanding market and customer needs and translating that into the development and implementation of new and/or improved services and solutions that will ultimately help more patients who may benefit from transplantation or other emerging cell and gene therapies.

She has extensive and varied experience in leadership roles, product/portfolio management, new product development, strategic planning, and process development and improvement.

Prior to joining Be The Match in 2017, Julie spent 16 years at Capella Education Company where she held several leadership positions. Most recently, she was the vice president and general manager of a multi-million dollar business unit where she led the innovation of a ground-breaking academic delivery model called FlexPath. Earlier in her career, she worked in the financial services industry at Piper Jaffray and Ernst & Young.

Smolich earned her Master of Business Administration from Capella University and holds a Bachelor of Science in Accounting from St. Cloud State University.

Dr Dominic Wall serves as the Chief Scientific Officer for Cell Therapies and as the Executive Director of Business Ventures for the Peter MacCallum Cancer Centre. He has over 30 years’ experience in CAR-T manufacturing and development, along with his extensive background in Haematology and Pathology.

Sebastian Warth joined CellGenix in 2017. As a senior scientist he took over development of the CellGenix T Cell Medium and oversaw the generation of application data.

Sebastian holds a diploma degree in Molecular Medicine from the University of Freiburg, Germany. He received his doctoral degree in Molecular Immunology from the Ludwig-Maximilians-University of Munich, Germany. He has authored several research publications in high-impact journals.

Before joining CellGenix in Freiburg in 2017 he worked as medical and pharmacovigilance consultant for the pharma industry in the E.U. and in the U.S. “

Dr. Xuan Xu is a Field Application Scientist (FAS) at RoosterBio Inc. Her role as a FAS is mainly to provide technical support to the commercial team, as well as manage customer product/technical inquires, including performing laboratory demonstrations at customer sites. Besides this, she also travels actively to conferences or customer centers to give talks or training sessions. Her educational background includes a Ph.D. in Molecular Medicine from the University of Texas Health Science Center at San Antonio (UTHSCSA), and a B.A. in Life Sciences from Fudan University in Shanghai, China. Dr. Xu conducted postdoctoral research at NCI/NIH prior to joining RoosterBio with a research focus on the studies of the mechanisms of signaling crosstalk in early embryonic development and tumorigenesis using both stem cell and cancer cell systems. Her research work has been published in top journals including Mol. Cell, PNAS, EMBO Rep, PLoS Biol, etc.

John Zhao is currently part of the Process Technologies group within the Cell Process Development and Gene Editing department at bluebird bio. His research focuses on exploring new technologies and methods to implement into a cell therapy product. Prior to bluebird, John worked in a variety of cell therapy labs including research in cardiac cell therapy and manufacturing a HSC product for clinical trials. John received his MS in 2017 in Biochemistry at the University of Louisville and his BS in 2012 in Bioengineering from Cornell University.