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    Non-regulated and unproven stem cell therapies continue to pose risks to patients, and aggressive and deceptive marketing tactics often blur the line between hope and fraud. In this webinar, you will gain insights from a landmark class action lawsuit against a clinic that falsely claimed to regenerate lung tissue. Despite lacking scientific evidence, the clinic used deceptive marketing to mislead patients—until legal action shut it down and secured a multi-million-dollar verdict for those affected. This session will also explore the vital role of scientific and medical experts in litigation. Learn how researchers and clinicians can contribute to legal proceedings, provide expert opinions, and uphold ethical standards in the rapidly evolving field of cell and gene therapy. We will discuss the litigation process, protections for expert witnesses, and how expert testimony can safeguard patient trusts and drive regulatory improvements.

    Non-regulated and unproven stem cell therapies continue to pose risks to patients, and aggressive and deceptive marketing tactics often blur the line between hope and fraud. In this webinar, you will gain insights from a landmark class action lawsuit against a clinic that falsely claimed to regenerate lung tissue. Despite lacking scientific evidence, the clinic used deceptive marketing to mislead patients—until legal action shut it down and secured a multi-million-dollar verdict for those affected. This session will also explore the vital role of scientific and medical experts in litigation. Learn how researchers and clinicians can contribute to legal proceedings, provide expert opinions, and uphold ethical standards in the rapidly evolving field of cell and gene therapy. We will discuss the litigation process, protections for expert witnesses, and how expert testimony can safeguard patient trusts and drive regulatory improvements. 

    Daniel J. Weiss

    ISCT President-Elect 2024-2026 Professor of Medicine Affiliate Professor of Bioengineering

    University of Vermont

    Daniel Weiss began his education at Cornell University studying Anatomy and Physiology/ Biology where he graduated Cum Laude with his bachelor's degree in 1981. He then began pursuing his PhD and MD at the Mount Sinai School of Medicine of the City University of New York where he graduated in 1988 and received a doctoral dissertation award for “Thesis of Unusual Distinction”. His work brought him from New York to Seattle, Washington where he worked in pulmonary and critical care medicine at the University of Washington. He later moved to the University of Vermont to work as an assistant and associate professor in cell and molecular biology up until he became a professor in the department of medicine in 2011. Dr. Weiss currently works as a pulmonary and critical care specialist and splits his time between leading his research team in several projects in the Weiss Laboratory and working at the hospital doing clinical work. Through his time working in research and academia, he has been able to obtain many research grants to continue his work on improving the lung health of patients. One of his more notable grants was recently awarded to focus on lung damage caused by COVID-19 which is a vital area of study now and looking forward to the future. Many of his works have been published and most significantly, was his work on stem cells and cell therapies in lung biology and lung diseases. Weiss’s passion for improving the health of patients afflicted with lung diseases has pushed him to bring together the great minds of a team of engineers, scientists, and laboratory specialists to better understand the physiology of these diseases and to create advanced therapies to help treat and prevent them.

    Ben Vinson

    CEO and Attorney

    Vinson Law

    Ben A. Vinson, Jr. has over a decade of experience working in asbestos law, beginning his career at Fleming & Associates in Houston, TX. At Fleming & Associates, Ben began work as a law clerk in December 2009, eventually working as an investigator in May 2011. In April 2012, Ben was admitted to practice law in the state of Florida, and in July 2012, he left Fleming and Associates and formed his own practice, Vinson Law P.A., and continued working in asbestos-related law.

    Ben earned his J.D. from the South Texas College of Law in May 2011, notably finishing the program 6 months ahead of schedule. Ben also competed in Mock Trial Summer Academy at the United States District Court for the Southern District of Texas. He earned his B.A. in Economics from the University of Texas in May 2003. Ben is also a 2013 graduate of Gerry Spence’s Trial Lawyer’s College.

    In February 2014, Ben opened his practice further to begin working on auto collision and personal injury cases, and in April 2014 was admitted to practice in the United States District Court for the Southern District of Illinois. Ben is a member of the American Association for Justice (AAJ), as well as a member of the AAJ’s Asbestos Litigation Group, the Florida Justice Association, and the Tampa Bay Trial Lawyer’s Association.

    In October 2016, Ben obtained a 3.4 million dollar Hillsborough County, Florida jury verdict. His client had suffered a traumatic brain injury when rear-ended by a tractor-trailer. Also in 2016, Ben filed a class action suit on behalf of allegedly defrauded patients of the Lung Institute. On December 1, 2019, the Washington Post‘s lead story in its print edition was about the case. In 2020, Ben Vinson and co-counsel achieved class certification status on behalf of over 900 deceived former patients.

    In 2017, Ben Vinson was named US Supreme Court Bar Member & “Officer of the Court”.

    In 2017, 2018, and 2019, Ben was awarded the distinction of being a Top 40 Under 40 Trial Lawyer for the State of Florida. Membership in the Top 40 Under 40 association is by invitation only and is extended exclusively to those individuals who exemplify superior qualifications, trial results, and leadership as a Civil Plaintiff trial lawyer. Selection is based on a thorough multi-phase objective process which includes peer nominations combined with third-party research.

    In 2018, Ben was awarded a lifetime achievement award for the Northern Florida region from America’s Top 100 Attorneys.

    In 2019, Attorneys Ben and co-counsel Mark Alonzo won a multimillion dollar mesothelioma verdict in downtown Philadelphia, Pennsylvania. With the help of the firm’s head Asbestos Paralegal, Lauren Zoons, they were able to receive a 2 million dollar verdict in favor of Mrs. Sylvia Holder, widow of deceased Navy Machinist Mate Mr. Ernest Holder.

    In 2019, Ben Vinson was selected to the 2019 Florida Super Lawyers Rising Stars list. No more than five percent of the lawyers in Florida are selected by Super Lawyers and no more than 2.5 percent are named to the Rising Stars list. Super Lawyers evaluates outstanding lawyers who have attained a high degree of peer recognition and professional achievement by using a patented multi-phase process that includes a statewide survey of lawyers, an independent research evaluation of candidates and peer reviews by practice area.

    Ben gained entry in to the Multi-Million Dollar Advocates Forum in 2017. Established in 2007, the Multi-Million Dollar Advocates Forum is one of the most prestigious groups of trial lawyers in the United States. Membership is limited to attorneys who have won verdicts of two million dollars or more. Ben was awarded entry in 2017, and qualified again in 2019.

    Ben has Avvo rating of 10. Over the course of 12 years Vinson Law has grown to fifty staff serving over two thousand injured clients. We are fulfilled by primarily helping the elderly, and over half our clients are Veterans or their families. Our mission is helping others then ourselves, and we strive relentlessly to deliver on that purpose.

    On June 14, 2024 the Vinson Law trial team including Mark Alonzo, Lauren Zoons, Melissa Inch, Steve Barnes, and Ben Vinson secured a nine million dollar verdict on behalf of 1052 class members against the Lung Institute: Class Action Against Lung Institute Ben competed in an IRONMAN triathlon, clocking in at a little less than fifteen hours. In 2023 Ben became a Certified Ultramarathoner. In his free time, he enjoys spending time with his sons Ben Andrew III, Smith, and Davis Vinson, and his wife Megan.

    Bambi Grilley

    ISCT Chief Regulatory Officer Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy Professor, Pediatrics

    Baylor College of Medicine

    For over 30 years, Bambi Grilley has worked primarily in the field of Clinical Research, focused predominately on oncology. She worked in and supervised the lnvestigational Drug Pharmacy at MD Anderson Cancer Center for 10 years and following that, she accepted a position as the Administrator of the IRB and IACUC at Baylor College of Medicine and served in that position for 2 years. For 25 years she served on the BCM IRB and for the majority of that time, as a vice-Chair. She is currently a Professor, Pediatrics at BCM and the Director of Clinical Research and Early Product Development for the Center for Cell and Gene Therapy where she is responsible for coordinating the development, implementation, and conduct of clinical research protocols for use in four affiliated hospitals and institutions. Her expertise has helped to establish the Protocol Review Committees, the Data Review Committees, the Clinical Research Quality Control Program and the Clinical Research Quality Assurance Program. In the 26 years she has been with CAGT, she has assisted investigators in conducting over 2000 clinical research studies and the submission of 113 Investigator Initiated, cell/gene therapy related INDs and currently, 29 of those clinical research treatment studies are active with CAGT. 

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    One of the biggest headlines for our field was the recent approval of Ryoncil - we're delighted to have Silviu Itescu, MBBA, FRACP, CEO of Mesoblast, as the featured presenter for this town hall meeting. This is your chance to not only get the inside details from the Mesoblast breakthrough, but to also connect with the ISCT Community and meet our North America leadership team in this virtual forum - if you're a cell and gene therapy therapy professional, there's a lot of value for you! Among key updates for the region, you'll hear of some exciting highlights from our team - selected sessions and programs that they (and you!) don’t want to miss at the ISCT 2025 Annual Meeting in New Orleans.

    One of the biggest headlines for our field was the recent approval of Ryoncil - we're delighted to have Silviu Itescu, MBBA, FRACP, CEO of Mesoblast, as the featured presenter for this town hall meeting.

    This is your chance to not only get the inside details from the Mesoblast breakthrough, but to also connect with the ISCT Community and meet our North America leadership team in this virtual forum - if you're a cell and gene therapy therapy professional, there's a lot of value for you!

    Among key updates for the region, you'll hear of some exciting highlights from our team - selected sessions and programs that they (and you!) don’t want to miss at the ISCT 2025 Annual Meeting in New Orleans.

    Candice Herd-Sagar

    Cellular Therapy Scientist

    Dr Alberts, Bouwer & Jordaan Inc. (ABJ)

    Candice Herd-Sagar (PhD Candidate Medical Immunology, Univ Pretoria) is a cellular therapy scientist involved in the first CAR T manufacturing set up in South Africa. She is uniquely placed to provide insight from a research, industry, and regulatory perspective on the development of CGT products in the African context as a result of her experience.

     

    Candice Herd - Cellular Therapy Scientist - ABJ Inc | LinkedIn

    Murray Logan

    Scientific Project Manager / Consultant

    Novita Biotechnology

    Murray Logan is a cellular biologist specializing in the intersection of genetics, immunology, and virology. He is a PhD Candidate in Medical Immunology at the University of Pretoria and is passionate about the growth of the biotechnology sector in South Africa. He is also committed to training and mentoring the next generation of cellular biologists.

     

    https://www.linkedin.com/in/murray-l-33b00617/

    Mirja Krause-Onwukwe

    Service Operations Manager, Senior Quality Manager

    Hudson Institute Cell Therapies, Melbourne, Australia

    Dr. Mirja Krause-Onwukwe is Service Operations Manager, Senior Quality Manager at the Hudson Institute Cell Therapies (HICT) in Melbourne Australia. Coming from a translational research background, she has extensive experience in Early Phase Cell Therapy Clinical Trials. At HICT she is leading the facility to enable and facilitate bone marrow transplants and CAR-T trials. Mirja is an Early Stage Professional (ESP) member of ISCT Australia and New Zealand Regulatory Affairs Committee (ISCT ANZ LRA).

     

    Hudson Cell Therapies - Hudson Institute of Medical Research

    Dr Theo Gerdener

    Haematologist and Medical Director

    Alberts Cellular Therapy (ACT) Pretoria and Medical Director at DKMS Africa

    Dr Theo Gerdener is a haematologist at Alberts Cellular Therapy (ACT) in the City of Johannesburg, Gauteng, South Africa. He is immersed in regulatory and clinical aspects in developing CAR T-cell protocols at Alberts Cellular Therapy (ACT) Pretoria. He is also an advocate for stem cell donation in South Africa through his work with as Medical Director at DKMS Africa (see Life on the waiting list: Black stem cell donors urgently needed to save lives, by Lilita Gcwabe / September 14, 2023 / Features, News https://health-e.org.za/2023/09/14/life-on-the-waiting-list-black-stem-cell-donors-urgently-needed-to-save-lives/ )  

     

    Dr Theo Gerdener Clinical Haematologist Midstream & Pretoria East | ABJ Inc

    Blood cancer patients need better support structures

    Theo Gerdener - Haematologist - ACT | LinkedIn

    Dr Candice L. Hendricks

    Paediatric Haematologist and Clinician scientist

    University of Pretoria

    Dr Candice Hendricks is a paediatric haematologist and clinician scientist at the University of Pretoria and is immersed in the clinical aspects of cell and gene therapy and has written about how to practically and ethically develop access to these therapies in South Africa, including through advocating for increased training, the formation of a South Africa cell and gene therapy society, identifying patients, and establishing registries.

     

    Equitable access to cell and gene therapies in South Africa: opportunities and hurdles

      Candice Laverne Hendricks - Pretoria, Gauteng, South Africa | Professional Profile | LinkedIn

    Prof Michael S Pepper

    Research Professor Dept. Medical Immunology, Director Institute for Cellular and Molecular Medicine, Director SAMRC Extramural Unit for Stem Cell Research and Therapy, Faculty of Health Sciences, University of Pretoria, South Africa

    University of Pretoria

    Prof Michael Pepper is the Director of the Institute for Cellular and Molecular Medicine (ICMM), Director of the South African Medical Research Council Extramural Unit for Stem Cell Research and Therapy, and Research Professor in the Department of Immunology in the Faculty of Health Sciences at the University of Pretoria (Professor Michael S Pepper | University of Pretoria). Many researchers and clinicians in South Africa involved in cell and gene therapy are associated with the ICMM. He is a highly regarded academic and clinician-scientist (no longer practicing) and has been involved in several facets of the ELSI of cell and gene therapy. He is also a bioentrepreneur having co-founded Antion Biosciences, Transcure Bioservices and Altera Biosciences.

     

    Professor Michael S Pepper | University of Pretoria

     

    Michael Pepper - Director, Institute for Cellular and Molecular Medicine, Faculty of Health Sciences - University of Pretoria | LinkedIn

    Ignatius Viljoen

    Ignatius Viljoen is a seasoned professional with over 30 years of experience in product and business development, supply chain and logistics, and general management. He has extensive experience in leading multicultural teams and working in multinational biopharmaceutical companies. He is also a pharmacist and CQI-certified pharmaceutical quality system (PQS) auditor. In 2016, Ignatius transitioned from molecule-based pharmaceuticals to cell-based products. He founded ArexCell, which assists pre-clinical cell-based product (CBP) developers with developing target product profiles (TPP) and de-risking critical quality and process decisions (CQAs and CPPs) that may have long-term safety and efficacy impacts. His skills and professional experience, combined with a deep understanding of the regulatory requirements for cell-based products, make him a valuable asset to any company developing cell-based products.

    Ignatius is passionate about improving patient access to CBPs and gene therapies in low-and-middle-income countries (LMIC). He is working towards a PhD at the Institute of Cellular and Molecular Medicine (ICMM) at the University of Pretoria, where he addresses safety and efficacy questions related to non-commercial CBPs. He is an active contributor to the field and has published several papers in peer-reviewed journals on this topic.

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    Organized by the ISCT ESP Committee: Mentoring & Career Development Working Group. Are you seeking to unlock funding opportunities for your projects but unsure of where to start? Register for the ISCT Early-Stage Professionals’ informative webinar designed to equip you with essential skills in grant writing. Whether you’re new to grant writing or looking to refine your skills, in this interactive session, we will cover the essentials of navigating the world of grants and funding opportunities from USA and EU perspectives. You will learn the ins and outs of the grant application process, from understanding different funding sources to crafting compelling proposals that resonate with funders. In addition, you will receive guidance on developing a funding plan, along with career strategies that can significantly improve your chances of securing competitive research funding. Our expert speakers will share their knowledge and experiences, helping you navigate common challenges and pitfalls in grant writing. Take charge of your career development and don't miss an opportunity to gain valuable insights and practical tips that can help you navigate the grant writing process with confidence.

    Organized by the ISCT ESP Committee: Mentoring & Career Development Working Group.

    Are you seeking to unlock funding opportunities for your projects but unsure of where to start? Register for the ISCT Early-Stage Professionals’ informative webinar designed to equip you with essential skills in grant writing. Whether you’re new to grant writing or looking to refine your skills, in this interactive session, we will cover the essentials of navigating the world of grants and funding opportunities from USA and EU perspectives. You will learn the ins and outs of the grant application process, from understanding different funding sources to crafting compelling proposals that resonate with funders. In addition, you will receive guidance on developing a funding plan, along with career strategies that can significantly improve your chances of securing competitive research funding. Our expert speakers will share their knowledge and experiences, helping you navigate common challenges and pitfalls in grant writing. Take charge of your career development and don't miss an opportunity to gain valuable insights and practical tips that can help you navigate the grant writing process with confidence.

    Monica Klein

    Senior Associate Consultant

    Mayo Clinic

    Dr. Monica Klein currently serves as the Medical Director of the Components Laboratory and Associate Medical Director of the Human Cellular Therapy Laboratory within the Division of Transfusion Medicine at Mayo Clinic in Rochester, Minnesota. Dr. Klein completed fellowships in Cellular Therapy and Transfusion Medicine at Mayo Clinic and medical school and residency training in Anatomic and Clinical Pathology at the University of South Alabama.  Dr. Klein is a diplomate of the American Board of Pathology, certified in Anatomic and Clinical Pathology and Blood Banking/Transfusion Medicine.  Dr. Klein is passionate about advancing the fields of Cellular Therapy and Transfusion Medicine through clinical practice, research, and mentorship.  

    Mikey Creane

    Translational Research Manager

    HAON Lifescience

    Dr. Mikey Creane obtained his BSc in Physiology, MSc in Regenerative Medicine, and PhD in Translational Cell Therapy in University of Galway between years of 2005-2016. After his Postdoctoral research training Dr. Creane worked for many years as a Research Fellow and Programme Manager in the Regenerative Medicine Institute in University of Galway where he worked on translating stromal cell therapies from laboratory studies to first in human testing. Dr. Creane has also worked as Strategic Lead for the Centre of Cell Manufacturing Ireland which is an academic Good Manufacturing Practices facility located in University of Galway. Dr. Creane recently joined HAON Lifesciences as Translational Research Manager where he is leading the preclinical development of novel cell therapies for rare diseases.  

    Suzanne Glass

    Grants Manager

    Center for Regenerative Biotherapeutics, Mayo Clinic

    Suzanne currently serves as the Grants Manager in the Center for Regenerative Biotherapeutics at Mayo Clinic. She has worked for Mayo Clinic for the past 26 years in various leadership capacities, including operations coordinator for a Regenerative Medicine and Histology Core Laboratory, and as a member of the Executive Committee (non-voting) for the Armed Forces Institute for Regenerative Medicine (AFIRM). In addition, she was a senior program coordinator with responsibility for grant writing, budget development and maintenance of internal/external funding sources (e.g., National Institutes of Health and Department of Defense, Advanced Research Project Agency for Health), strategic initiatives, human resources, intellectual property and clinical trial management within research and the clinical practice.

    John Zurn

    Program Manager – Research Operations

    Mayo Clinic

    Jon Zurn is the director of the Strategic Funding Office for Research at Mayo Clinic. The office works to advance the priorities of Research, working to bring funders and research collaborators together. Jon focuses on program development, extramural fund planning, and expanding the scope of Mayo Clinic’s $700 million annual federal, state, and international portfolio. Jon Zurn holds an MBA with a focus on business development. He has been involved in research development and business planning for nearly twenty years and has been with Mayo Clinic since 2007.

    John Pius Dalton

    Science Foundation Ireland Professor in Molecular Parasitology

    University of Galway

    Prof. John Pius Dalton carried out his BSc and PhD in Zoology/Parasitology at University College Dublin, Ireland. Over the last 35 years he has researched in the USA (Johns Hopkins School of Medicine, Baltimore, MD, and National Institutes for Allergies and Infectious Diseases, Bethesda, MD), Australia (Queensland Institute for Medical Research, Brisbane, and University of Technology, Sydney, Sydney), Canada (McGill University, Montreal) and Ireland (Dubin City University and Queen’s University Belfast).  He has published >245 manuscripts, edited Fasciolosis 1st/2nd Edition and has been involved in two start-ups (Ildan Biotech, Ireland, and Helmedix, Australia). Over the last 20 years he has drawn funding from industry, Europe (FP3, FP4, FP7 and Horizon 2020) and was part of several major vaccine collaborations including  PARAGONE and PARAVAC Vaccines Consortium. He was recipient of a Canadian Institute for Health Research (CIHR) Chair Tier 1 (2009-2014) and a European Research Council (ERC) Advanced Grant (2013-2018). He won the NSW Government award in Biotechnology in 2009, Queensland Institute for Medical Research Bancroft Medal in 2012 and the UK Royal Society Wolfson Research Merit Award in 2013 for his work in parasite immunology and vaccine development. He is currently a Science Foundation Ireland Professor in Molecular Parasitology (2019-2024), and an established Professor in the School of Natural Science at the University of Galway. His goal is to understand the fundamental biology of parasites and their complex relationship with their hosts, both animal and human. With this knowledge he is designing new strategies to diagnose zoonotic parasitic infections and developing new protein and nucleic acid vaccines.

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    WEBINAR DESCRIPTION: Join the International Society for Cell & Gene Therapy (ISCT) for an in-depth webinar on the evolving reimbursement landscape for CAR-T therapy. This session is essential for professionals navigating the complexities of cost, coverage, and regulatory considerations associated with CAR-T treatments. The webinar will be led by industry experts discussing recent developments in CAR-T reimbursement. Participants will explore case studies showing how policies impact patient access to CAR-T therapy, highlighting challenges and opportunities. Additionally, participants will gain knowledge and evidence to engage with policymakers and stakeholders for equitable reimbursement policies, ensuring timely and affordable access for patients.

    Presented by: ISCT Industry Committee

    January 14, 2025

    Webinar Description:

    Join the International Society for Cell & Gene Therapy (ISCT) for an in-depth webinar on the evolving reimbursement landscape for CAR-T therapy. This session is essential for professionals navigating the complexities of cost, coverage, and regulatory considerations associated with CAR-T treatments.

    The webinar will be led by industry experts discussing recent developments in CAR-T reimbursement. Participants will explore case studies showing how policies impact patient access to CAR-T therapy, highlighting challenges and opportunities. Additionally, participants will gain knowledge and evidence to engage with policymakers and stakeholders for equitable reimbursement policies, ensuring timely and affordable access for patients.

    Karla Villa

    Market Access Specialist

    Terumo Blood and Cell Technologies

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

    Susan Leppke

    Sr, Director, Public Policy & Strategic Partnerships

    AABB

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

    Richard Maziarz

    Medical Director, Blood & Marrow Transplant & Cellular Therapy Program

    OHSU

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

    Kenny Hodge

    Vice President, Government Affairs

    Jeffrey J. Kimbell & Associates, Inc.

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

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    Hosted by the ISCT Asia Regional Leadership, this Town Hall offers the opportunity to learn about key priorities in the region, how to get the most out of your membership with ISCT, and ways you can actively participate and contribute. Gain insights directly from our current leaders into resources and initiatives aimed at supporting our members in the region. This recording also features presentations from our guest speakers: Shin Kawamata, MD, PhD, CEO of Cyto-Facto Inc. and Huji Xu, PhD, Professor of Medicine at Tsinghua University.

    Hosted by the ISCT Asia Regional Leadership, this Town Hall offers the opportunity to learn about key priorities in the region, how to get the most out of your membership with ISCT, and ways you can actively participate and contribute. Gain insights directly from our current leaders into resources and initiatives aimed at supporting our members in the region.

    This recording also features presentations from our guest speakers: Shin Kawamata, MD, PhD, CEO of Cyto-Facto Inc. and Huji Xu, PhD, Professor of Medicine at Tsinghua University.     

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    WEBINAR DESCRIPTION: In October 2023, the FDA issued a guidance document on Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies. This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation and Research (CBER) designed to identify and recognize Voluntary Consensus Standards (VCS) to facilitate the development and assessment of regenerative medicine therapy (RMT) products regulated by CBER when such standards are appropriate. Standardization bodies such as Standards Coordinating Body (SCB) and the American National Standards Institute (ANSI) have helped to introduce and facilitate the VCS process, however, many stakeholders are unclear about the process. This webinar will discuss the VCS process, what the stakeholders need to know, and how to develop one. A case study of an actual international consensus standard development of tissue-specific MSC biobanking, characterization, terminology with extensive and iterative input from ISCT will also be presented.

    Presented by: ISCT South and Central America Regional Executive Committee

    November 20, 2024

    Webinar Description:

    Join us for an insightful journey into the evolving field of mitochondrial transfer and transplant with our webinar titled "Mitochondria Transfer and Transplant: Powering the Cell Therapy Field. Co-organized by the ISCT South & Central America (SCA) Regional Executive Committee and Associação Brasileira de Terapia Celular e Gênica (ABTCel-Gen), the event will be co-chaired by Virginia Picanço-Castro, PhD and Andrés Caicedo, PhD.

    The webinar will open with Andrés Caicedo providing an introduction to the field and key insights from his laboratory team's pioneering research on mitochondrial transfer in skin cells and its application in wound healing and tissue regeneration. He will emphasize how mitochondria have evolved from being seen as mere powerhouses of the cell to “Living Drugs” with immense therapeutic potential.

    Our featured speaker, Jonathan Brestoff, MD, PhD, will present his groundbreaking research on mitochondria transfer between adipocytes and macrophages, showcasing the intersection of immunometabolism and mitochondrial biology. Maroun Khoury, PhD, will delve into the revolutionary use of mitochondria transfer in CAR T cell therapies, highlighting its potential to transform cancer treatment.

    This exclusive event offers members of the International Society for Cell & Gene Therapy (ISCT) an opportunity to explore how mitochondria are driving advances in cell therapy, addressing key challenges in immune dysfunction, and tissue repair. Engage with leading experts and discover how mitochondrial research is reshaping the future of regenerative medicine.


     


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    WEBINAR DESCRIPTION: In October 2023, the FDA issued a guidance document on Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies. This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation and Research (CBER) designed to identify and recognize Voluntary Consensus Standards (VCS) to facilitate the development and assessment of regenerative medicine therapy (RMT) products regulated by CBER when such standards are appropriate. Standardization bodies such as Standards Coordinating Body (SCB) and the American National Standards Institute (ANSI) have helped to introduce and facilitate the VCS process, however, many stakeholders are unclear about the process. This webinar will discuss the VCS process, what the stakeholders need to know, and how to develop one. A case study of an actual international consensus standard development of tissue-specific MSC biobanking, characterization, terminology with extensive and iterative input from ISCT will also be presented.

    Presented by: ISCT North America LRA Committee

    November 19, 2024

    Webinar Description:

    In October 2023, the FDA issued a guidance document on Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies. This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation and Research (CBER) designed to identify and recognize Voluntary Consensus Standards (VCS) to facilitate the development and assessment of regenerative medicine therapy (RMT) products regulated by CBER when such standards are appropriate. 

     Standardization bodies such as Standards Coordinating Body (SCB) and the American National Standards Institute (ANSI) have helped to introduce and facilitate the VCS process, however, many stakeholders are unclear about the process.

    This webinar will discuss the VCS process, what the stakeholders need to know, and how to develop one. A case study of an actual international consensus standard development of tissue-specific MSC biobanking, characterization, terminology with extensive and iterative input from ISCT will also be presented.


     


    J. Wade Atkins, MS, MLS,SBB (ASCP), CQA , CABP(H)

    Supervisor, QA and Regulatory Affairs; Member of ISCT North America Legal & Regulatory Affairs Committee

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

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

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

    Catherine (Katie) Zander, PhD

    Director of Standards Education & Outreach

    Standards Coordinating Body

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

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

    Christine Aston-Roberts

    Standards Manager, Senior

    Parenteral Drug Association (PDA)

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

    Sowmya Viswanathan, PhD

    Scientist, Osteoarthritis Program, Division of Orthopedic Surgery, Schroeder Arthritis Institute and the Krembil Research Institute; ISCT North America Regional Vice-President Elect

    University Health Network

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

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

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    WEBINAR DESCRIPTION: Join us for a deep dive into the world of CAR-T cell therapy development with our webinar titled "Navigating CAR-T Cell Therapy Development: Insights from Leading SCA Academic Centers." Organized by the ISCT South & Central America (SCA) Regional Executive Committee and the South and Central America (SCA) Regional ESP Subcommittee. The event will be co-chaired by Samuel Couto and Lilia León Moreno. The webinar will open with Virginia Picanço-Castro sharing her experience from one of Brazil's leading institutes on the complete developmental journey of a CAR-T cell product, from bench to bedside. She will provide a detailed overview of the unique manufacturing challenges faced and the innovative strategies implemented to bring CAR-T cell therapies to clinical practice in Brazil. Andres Gomez will offer valuable insights from Mexico, discussing the development and implementation of CAR-T cell therapies within the local academic and clinical landscape. He will highlight the regulatory environment and the steps required to advance this novel treatment in Mexico. Chase Mccann will conclude the session by discussing the role of clinical trials in the development of CAR-T cell therapies, drawing from his experience at Children's National Hospital. He will focus on the latest advancements in pediatric applications and share real-world insights from ongoing clinical trials. This exclusive event offers members of the International Society for Cell & Gene Therapy (ISCT) an opportunity to explore the diverse paths of CAR-T therapy development across the South & Central America region. Engage with leading experts and discover the future of CAR-T therapy, from clinical trials to regulatory challenges and beyond.

    Presented by: ISCT South and Central America Regional Executive Committee & South & Central America Regional ESP Subcommittee

    November 5, 2024

    Webinar Description:

    Join us for a deep dive into the world of CAR-T cell therapy development with our webinar titled "Navigating CAR-T Cell Therapy Development: Insights from Leading SCA Academic Centers." Organized by the ISCT South & Central America (SCA) Regional Executive Committee and the South and Central America (SCA) Regional ESP Subcommittee. The event will be co-chaired by Samuel Couto and Lilia León Moreno.

     The webinar will open with Virginia Picanço-Castro sharing her experience from one of Brazil's leading institutes on the complete developmental journey of a CAR-T cell product, from bench to bedside. She will provide a detailed overview of the unique manufacturing challenges faced and the innovative strategies implemented to bring CAR-T cell therapies to clinical practice in Brazil.

     Andres Gomez will offer valuable insights from Mexico, discussing the development and implementation of CAR-T cell therapies within the local academic and clinical landscape. He will highlight the regulatory environment and the steps required to advance this novel treatment in Mexico.

     Chase Mccann will conclude the session by discussing the role of clinical trials in the development of CAR-T cell therapies, drawing from his experience at Children's National Hospital. He will focus on the latest advancements in pediatric applications and share real-world insights from ongoing clinical trials.

     This exclusive event offers members of the International Society for Cell & Gene Therapy (ISCT) an opportunity to explore the diverse paths of CAR-T therapy development across the South & Central America region. Engage with leading experts and discover the future of CAR-T therapy, from clinical trials to regulatory challenges and beyond.

     


    Samuel Campanelli Freitas Couto, PhD

    Coordinator of the Cell Therapy Laboratory at the Blood Center of São Paulo and researcher at University of São Paulo.

    São Paulo Blood Center (Fundação Pró-Sangue)

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

    Lilia Carolina León-Moreno, PhD

    Posdoctoral Researcher

    Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco

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

    Virginia Picanço e Castro, PhD

    Coordinator of the Biotechnology Laboratory at the Ribeirão Preto Blood Center and researcher at the CTC-USP

    Ribeirão Preto Blood Center

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

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

    Andrés Gómez-De León, MD

    Associate Professor of Hematology

    Universidad Autónoma de Nuevo León

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

    Chase D. McCann, PhD, MSPH

    Assistant Director of Manufacturing

    Children’s National Hospital

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

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    WEBINAR DESCRIPTION: While an increasing number of regulatory approvals in the Cell and Gene Therapy (CGT) field has fueled optimism for potential treatments and cures for debilitating and fatal conditions, constant challenges to US FDA oversight – by courts, federal and state legislatures, and rogue “stem cell clinics” - pose serious risks for individual patients and for the entire industry. This webinar begins with an overview of the U.S. legal landscape governing development and therapeutic usage of stem cell and gene therapies, including several recent, highly-consequential court rulings impacting the FDA and other federal agencies. The webinar then addresses recent state developments that have attracted little public attention, including new iterations of “Right-To-Try” and “Medical Freedom” laws, and their legal and practical impact on experimental stem cell and gene therapies. After exploring the wide-spread availability of unproven stem cell and regenerative interventions currently being offered by stem cell clinics and in other unregulated settings, the webinar will highlight existing risks for individual patients and the entire CGT sector, and ways these may be further exacerbated in the near future. The area of unproven stem cell and regenerative medicine clinics will be discussed in more depth as an exemplar of complex legal, policy and ethical challenges to federal and state regulators. The webinar will conclude with an interactive panel discussion and an open Q&A for attendees to raise issues and contribute to the discussion.

    Presented by: ISCT Committee on the Ethics of Cell and Gene Therapy (ECGT)

    October 29, 2024

    Webinar Description:

    While an increasing number of regulatory approvals in the Cell and Gene Therapy (CGT) field has fueled optimism for potential treatments and cures for debilitating and fatal conditions, constant challenges to US FDA oversight – by courts, federal and state legislatures, and rogue “stem cell clinics” - pose serious risks for individual patients and for the entire industry. This webinar begins with an overview of the U.S. legal landscape governing development and therapeutic usage of stem cell and gene therapies, including several recent, highly-consequential court rulings impacting the FDA and other federal agencies. The webinar then addresses recent state developments that have attracted little public attention, including new iterations of “Right-To-Try” and “Medical Freedom” laws, and their legal and practical impact on experimental stem cell and gene therapies. After exploring the wide-spread availability of unproven stem cell and regenerative interventions currently being offered by stem cell clinics and in other unregulated settings, the webinar will highlight existing risks for individual patients and the entire CGT sector, and ways these may be further exacerbated in the near future. The area of unproven stem cell and regenerative medicine clinics will be discussed in more depth as an exemplar of complex legal, policy and ethical challenges to federal and state regulators. The webinar will conclude with an interactive panel discussion and an open Q&A for attendees to raise issues and contribute to the discussion. 


     


    Beth Roxland, JD, M. Bioethics

    Senior Advisor on Law, Policy and Bioethics

    Roxland Consultants Ltd., The Roxland Law Firm

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

    Roxland’s executive experience includes her prior roles as:

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

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

    Kirstin Matthews, PhD

    Fellows in Science and Technology Policy

    Rice University's Baker Institute for Public Policy

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

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

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

    Paul Knoepfler, PhD

    Professor, Department of Cell Biology and Human Anatomy

    UC Davis Health, School of Medicine

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

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

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

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

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    In Conversation with Asia CGT Startups

    In Conversation with Asia CGT Startups
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