
Open Access 2025 Webinar: Progress in Advanced Cellular and Gene Therapies in South Africa
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South Africa is at the forefront of advancing cellular and gene therapies, driving research, innovation, and equitable access. This webinar will explore the country’s significant contributions to the field, highlighting key developments, regulatory frameworks, and the path toward safe and accessible treatments.
KEY LEARNING OBJECTIVES
• Identify key issues and requirements for advanced cellular and gene therapy in South Africa
• Analyse the progress, research, and implementation of these therapies in South Africa
• Evaluate challenges, including regulatory barriers and equitable access

Gabrielle O'Sullivan, PhD, MPH(Hons)
Executive Officer
Royal Prince Alfred Hospital Institutional Biosafety Committee (RPAH IBC)
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
Cellular Therapy Scientist
Alberts Cellular Therapy (ACT) South Africa
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
Scientific Project Manager / Consultant
University of Pretoria / Altera BioSciences
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.

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
Oncolab / 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

Dr Candice L. Hendricks
Paediatric Haematologist and Clinician Scientist
University of Pretoria / Alberts Cellular Therapy (ACT)
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
Professor and Director of Institute for Cellular and Molecular Medicine, Faculty of Health Sciences
SAMRC Extramural Unit for Stem Cell Research and Therapy / 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

Ignatius Viljoen
Business Development and GxP Consultant
ArexCell International
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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