Professor of Pediatric Hematology-Oncology & Health Sciences. Areas of special interest include Immunotherapy and CAR-T cells, leading a major collaboration with Indian Institute of Technology at Powai (IIT-B) and National Cancer Institute, Bethesda that led to India’s first indigenously developed and approved CART-cell product. Principal Investigator at CAR T- & Cell Therapy Center (CTCTC) at TMC developing multiple cell & gene therapies for cancer and related indications. Leads multi-center randomized controlled trials of Indian Pediatric Hematology- Oncology Group (InPHOG) as core-member of ALL ICiCLe- Trial Group, and Study Chair of Multicentre RCT of Pediatric Hodgkin Lymphoma. Other areas of interest in research are Histiocytic Disorders, Cancer associated Thrombosis and Immunology in Malignancies. Senior member & past-Convener of Pediatric Hemato-lymphoid Group at Tata Memorial Center Mumbai that oversees a clinical program of 11-1200 new case of leukemia, lymphoma and histiocytic disorders in children annually and a DM Pediatric Oncology Training program that enrols 6 new students a year.

Dr (Lt Col) Pawan Kumar Gupta, is President – Medical & Regulatory Affairs, Stempeutics Research, Bangalore since October 2008, which is the first stem cell company in India focusing on clinical development of major unmet medical needs using allogeneic bone marrow derived Mesenchymal Stromal Cells.

Dr Pawan is a Hematologist & Medical Scientist and has worked in Armed Forces in India for 24 years. He has worked in Stem Cell Institute, University of Minnesota and trained in the field of stem cells. He was the former Dean of Manipal Institute of Regenerative Medicine, Bangalore. Under his leadership the product stempeucel® has progressed from pre-clinical to clinical trials and has been granted manufacturing and marketing approval for three indications in India.

  He has more than 100 publications and is the Asia Regional Vice President of International Society of Cell & Gene Therapy.  

Dr. Rahul Purwar is a professor at Department of Biosciences and Bioengineering at IIT Bombay. He

holds a Ph.D. in Molecular Medicine from Hannover Medical School, Germany. Dr. Rahul’s

professional journey spans various prestigious institutions and roles. He started his post-doctoral

fellowship at Harvard Medical School, Boston, USA. After his fellowship, he joined ImmunoGen,

Inc. (Boston, USA), as a scientist before returning to India as a faculty member at IIT Bombay.

His lab at IIT Bombay developed indigenous technology platform for CD19 CAR-T cell therapy, a

type of gene therapy. Based on his research at IIT Bombay, Dr Purwar founded ImmunoACT in 2018,

first cell & gene therapy company in India. Upon successful multiple clinical trials, ImmunoACT

received market authorization of the country’s first CAR-T cell therapy, and Honorable President of

India dedicated CAR-T cell therapy to the nation on April 4th, 2024. This is the first of many planned

milestones in democratizing access to advanced cell & gene therapies in India.

Dr. Purwar’s research work is well-recognized in the scientific community, with numerous

publications to his credit in esteemed journals. His contributions to the field of Biosciences & Bioengineering are commendable and his work continues to inspire many in the scientific community.

An esteemed leader in the biologics, cell and gene therapy industry with over two decades of expertise in developing molecules for the US and EU markets in the biologics space. In addition to a strong background in structural, biophysical, process development, analytical, and biological assays, Lakshmikanth has demonstrated expertise in cell and gene therapy programs using AAV and Lentiviral vector based therapies over last eight years. He has filed several patents in the field of product development in biologics and cell and gene therapies and been part of successful approvals of US IND’s, BLA’s and EU MAA’s for biosimilars. As the Chief Scientific Officer at Immuneel Therapeutics, Lakshmikanth oversees a team of professionals dedicated to the development of novel cell and gene therapy products and platforms. The key achievements of the same include technology transfer of antiCD19-CAR-T from HCB to Immuneel facility in India, resulting in a commercial approval of the first global CD19-CAR-T product (Qartemi®) in India, as well as successful development of a patented SIM-CAR-T platform resulting in both 3 and 7 day CAR-T product. Other notable achievements include development of an allogenic CAR-T platform and evaluation of novel humanized AntiCD19-gd CAR-T with established POC data for further studies. Prior to the current role, Lakshmikanth has served as Chief Scientific Officer of InnovaVector SRL a Gene therapy company based in Naples, Italy. He also served as Sr. Vice President, at Intas Pharmaceuticals handling R&D and Manufacturing Sciences for both Biologics and Cell and Gene therapy verticals, where he set up the R&D facility and programs for both Gene therapy and CAR-T cell therapies. Prior to that he has also served in various leadership roles in Biological Evans, Sanofi and Dr Reddy’s Laboratories.

Dr. Gabrielle O’Sullivan is the Executive Officer of Royal Prince Alfred Hospital Institutional Biosafety Committee and has extensive experience in the regulation and risk assessment of gene technology, particularly in the contexts of biosafety, biomedical research, clinical trials, and cell and gene therapies. She is a member of the Australian Government Department of Health Gene Technology Technical Advisory Committee (GTTAC) and Gene Technology Ethics and Community Consultative Committee (GTECCC), co-chair of the ANZ Legal and Regulatory Affairs Committee of the International Society Cell & Gene Therapy (ISCT), and a member of the Ausbiotech & Medicines Australia Cell & Gene Therapy Catalyst Expert Working Group on policy and advocacy. 

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.

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.

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 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 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 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 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. 

AssociateProfessor Blyth is a haematologist, bone marrow transplant physician and theclinical lead for the Immune Effector Cell Service at Westmead Hospital inSydney, Australia. She is a Principal Research Fellow at the Westmead Institutefor Medical Research, University of Sydney. She is the ANZ Regional VicePresident-elect for ISCT. As a member ofthe Westmead Cell Therapies Group she has 18 years’ experience in bringing celland gene therapy technologies to patients in clinical trials. This encompassesthe development of novel cellular therapies that are manufactured at theWestmead Human Applications Laboratory, designing trial protocols, treatingpatients on trials and assessing the biological effect of cellular therapiesusing multiparameter analysis tools.

Dr Siok Tey is a Group Leader at QIMR Berghofer Medical Research Institute and a Senior Staff Specialist in Haematology and Bone Marrow Transplantation at the Royal Brisbane and Women’s Hospital. She also serves as Medical Director for the Good Manufacturing Practice Facility at QIMR Berghofer and Clinical Director for Genetically Modified Cell Therapies at RBWH. Siok received her medical training at the University of Queensland and her research training at the Center for Cell and Gene Therapy, Baylor College of Medicine (USA), followed by a PhD in immunology at QIMR Berghofer.  Her research interests are the immunobiology of bone marrow transplantation and the development of novel immunotherapeutics using cell and gene technology. She currently leads a phase I clinical trial using place-of-care generated Chimeric Antigen Receptor (CAR) T cells.

A/Prof Jane Oliaro is the Chief Scientist for the Centre of Excellence in Cellular Immunotherapy and a Group Leader in the Cancer Immunology Program at the Peter MacCallum Cancer Centre. Jane’s research program uses immunological assays, genetic screening and preclinical models to understand tumour immune evasion and resistance to immunotherapies such as checkpoint blockade and CAR-T cell therapy. She has a particular interest in novel immunotherapeutic approaches for the treatment of lymphoma and multiple myeloma and is a Theme Leader for the Barrie Dalgleish Centre for Myeloma Research and Related Blood Disorders. Jane also leads a translational program focused on the development of novel cell-based immunotherapies through the Centre of Excellence in Cellular Immunotherapy Development Program. In this role, Jane works closely with Peter Mac clinicians and onsite manufacturing company, Cell Therapies Pty Ltd, to translate novel cellular immunotherapies into proof-of-concept clinical trials in partnership with Australian researchers and biotech. 

A/Prof Micklethwaite is a physician scientist working in the fields of bone marrow transplant and cell and gene therapy. He is the Medical Director of the Blood Transplant and Cell Therapies Laboratory, NSW Health Pathology ICPMR Westmead and a chimeric antigen receptor (CAR) T-cell clinician at Westmead Hospital. His research interests are in developing new cell and gene therapies, he has been an investigator on multiple cell therapy trials for treatment of infection and haematological malignancies including first in-man CAR T-cell trials treating leukaemia and lymphoma. He is the recipient of multiple competitive grants from the Australian National Health and Medical Research Council and other funding bodies. He has been a member and chair of the Australian Therapeutic Goods Administration Advisory Committee on Biologicals for the last 10 years and has served as co-chair of the International Society for Cell and Gene Therapy Immuno-Gene Therapy Committee. He is a clinical associate professor at the University of Sydney.

Mat received his PhD in Virology from the Australian National University in 2004 on myxoma virus vaccine development. He then did a postdoctoral fellowship at the University of Florida in poxvirus research
(basic virology, animal models of smallpox, vaccine and antiviral development). A brief stop in the private research sector for two years (Johnson and Johnson Research in Sydney in novel nucleic acid technologies) was followed by four years at CSIRO Animal Health Labs in Geelong, working on emerging arbovirus infections. Mat joined the Therapeutic Goods Administration in 2013 as the Biologicals framework (covering human cell and tissue products) was implemented. He has worked on quality (CMC) evaluations for biological medicines, human tissue products, cell and gene therapies, both in the commercial registration and clinical trials pathways, as well as providing advice to Sponsors and other stakeholders in the cell therapy space, and contributed to projects to update and modify the biologicals framework.

Thane completed a Master's of Science at the Rockefeller University in New York City while on a Fulbright Fellowship. He completed medical school at the University of British Columbia and then AP/CP residency at the University of Calgary. He completed his transfusion medicine fellowship at Mayo Clinic and is currently a cellular therapy and regenerative medicine fellow at the University of Minnesota. He will be joining Alberta Precision Labs as transfusion and cell therapy physician in July and will oversee standard-of-care and investigational products.

Teddy obtained his MD/PhD degree from the Mayo Clinic and is currently wrapping up a combined training in Clinical Pathology and Transfusion Medicine with a focus on Cell and Gene Therapies. Prior to this, he completed a Pediatric internship and a Post-doctoral fellowship in Cellular Therapy. For the last five years, he has trained under the mentorship of Dr. David McKenna, the Medical Director of the GMP facility at the University of Minnesota that supports a range of Cell and Gene therapy INDs. He has experience working with approved products and clinical trials, including gene-edited hematopoietic stem cells (HSCs), CAR-T cells and NK cells as well as various levels of expertise in developing tumor-infiltrating lymphocytes (TILs), Tregs and MSCs. 

Prof. Müller obtained his MD in Freiburg, Germany and started his clinical education in Hamburg. With a focus on targeting malignant B cells from his early research career he did a postdoctoral fellowship with Dr. Ira Pastan, at the NCI on resistance to CD22-targeted therapy in ALL and aggressive lymphoma. After his post-doc he continued the work on B cell targeting in Erlangen, Germany using first antibody directed therapies and then CAR T cells with a focus on immunologic questions. As head of the CAR T cell unit he pioneers CAR T cell therapies in novel indications including solid tumors but also rheumatologic diseases.

Simona Stankeviciute, MD, MSc, has a background in clinical and regulatory research and development. Dr. Stankeviciute's professional experience includes working as a clinician at the Hospital of Lithuanian University of Health Sciences Kauno klinikos, Clinical Expert for the European Medicines Agency (EMA) and served as an alternate member of the Committee for Medicinal Products for Human Use (CHMP). Currently she works at Parexel where she provides regulatory and clinical expertise, optimizing product development programs and serving as a trusted advisor to clients. During both her time at the agency and Parexel, she is working on a number of Cell and Gene projects.

"At 18, I started my working life as a Biomedical Scientist in Haematology. I was diagnosed with Systemic Lupus Erythematosus at 27 and had an anti-dsDNA at >300 in 2018. In 2019, at 57, I was diagnosed with Diffuse Large B Cell Lymphoma and received 4 lots of chemotherapy and radiotherapy treatments, meaning that I had 2 relapses. After the 2nd relapse, I was privileged to be selected to have CAR-T cell therapy. My T cells were trained to kill the cancerous B cells, and I was given them back on 16/2/22 (an exciting day as a former Biomedical Scientist!). My cells did their big job in 28 days! My clinician told me I was in the Goldilocks zone (not too hot, not too cold) after 2 weeks and I am still in the Goldilocks zone now over 3 years later. In addition, my dsDNA is now at 20 so no Lupus treatment needed. I do lots of voluntary work as a CAR-T advocate with Blood Cancer UK, and I was the Patient Case Study in their Action Plan presented at Westminster in September 2024."

Ingrid is a Healthcare Analyst at Redwheel Life Changing Treatments Fund. The fund invests in publicly listed healthcare companies seeking to provide life changing solutions to patients, believing that what truly matters to patients has greater potential for long-term commercial success. Before joining Redwheel, Ingrid was a Biotech Equity Research Analyst at Bryan Garnier and Kempen, where she focused on the European biotech sector and its leading innovators in therapeutic development. Ingrid holds a Master’s degree in Science-Based Business from Leiden University and a Bachelor’s degree in Biology from Universidade Estadual de Campinas.

Mr. Poltilove serves as an advisor, consultant, and independent Board Director, helping companies with fund-raising, commercialization, and inorganic growth strategies. Previously, as Operating Partner with BroadOak Capital Partners, Mr. Poltilove led the firm’s investment strategy in Cell and Gene Therapy, Bioproduction, and Cell Biology. Mr. Poltilove joined BroadOak after 12 years with Thermo Fisher Scientific where he served as Vice President and General Manager. Mr. Poltilove started up and led long-range strategy and day-to-day operations for the company’s cell and gene therapy business. He built a team that delivered 50%+ annual growth and championed the acquisition of Brammer Bio. Prior to Thermo Fisher, Mr. Poltilove served as Director of Revenue Strategy & Operations at the Corporate Executive Board and also held several commercial strategy roles with Johnson & Johnson. He holds Bachelor’s degrees in Chemical Engineering and Economics from the Massachusetts Institute of Technology as well as an MBA from the J.L. Kellogg School of Management at Northwestern University.

Stefanos, PhD, is CEO of OneChain Immunotherapeutics, based in Barcelona, Spain, developing autologous and allogeneic a CAR-T products for haematological malignancies and solid tumours. With more than 20 years of broad experience in the cell and gene therapy space, BD, program management, manufacturing and basic research, brings a deep knowledge CGT sector. Former CBO of Bone Therapeutics, Belgium-based company, developing specialized cell therapies for orthopaedic disorders, Senior Vice-President at Cell Medica, and CBO at apceth GmbH. He also held the position of Director Business Development at Roche, focused on partnering activities in emerging science and technologies. Stefanos also worked at Lazard, the global investment bank, advising to a variety of life sciences firms on M&As and financing transactions.

Jonathan is a co-founder and general partner of Saisei Ventures, a leading healthcare focused venture capital firm with operations in the United States and Japan. Jonathan is an early-stage investor focusing on biotechnology and advanced therapies, with particular expertise in the development of cell-based therapies and gene-modified cells. Jonathan’s diverse background spans early-stage venture company creation and investment, strategic business partnering, and fund management. He has co-founded several biotechnology companies and served in various board roles. Previously, Jonathan was a CIHR Post-doctoral Fellow at the IRIC and received his PhD from the Department of Medicine at McGill University in Montreal, Canada.

Vered Gigi is a Principal with aMoon Velocity, where she drives due diligence on early-stage companies, with a focus on pharmaceutical and medical device companies. Prior to joining aMoon, Vered served as Chief Scientific Officer at Cure Pharmaceutical, a drug delivery company in the pharmaceutical & wellness space, and before that as a project leader at BCG Management Consulting in their healthcare practice. Her experience spans strategy, business development, R&D, and operations in both corporate and startup settings. Vered’s passion is in translating exciting science into therapies in a practical and sustainable fashion. Her experience taught her that not all discoveries are made equal and there is a time and a place for each. Vered completed her PhD in Immunology at the University of Pennsylvania, where she investigated nucleases and DNA repair mechanisms in the immune system and their contribution to cancer. She holds a BSc and MSc in Biomedical Sciences from Tel Aviv University.

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.

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.