Progress in Advanced Cellular and Gene Therapies in South Africa

Candice Herd-Sagar, MSc
Cellular Therapy Scientist
Drs Alberts, Bouwer & Jordaan (ABJ)
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, BSc (Hons), MS
Scientific Project Manager / Consultant
Novita Biotechnology
South Africa

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, BSc, MSc, PhD
Service Operations and Quality Manager 
Hudson Institute of Medical Research 
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).

Dr. Theo Gerdener
Haematologist and Medical Director
Alberts Cellular Therapy (ACT) and DKMS Africa 
South 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.

Dr. Candice L. Hendricks, MBChB, FC(Paed)SA, MMed, Cert Clin Haem (SA) Paed, PhD
Paediatric Haematologist and Clinician Scientist 
University of Pretoria 
South Africa

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.

Prof. Michael S. Pepper, MBChB, PhD, MD, PD
Professor and Director of Institute for Cellular and Molecular Medicine
Faculty of Health Sciences, University of Pretoria
South Africa

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. 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.

Ignatius Viljoen, BPharm, MM(Hons) 
Business Development and GxP Consultant 
ArexCell
South Africa & Malawi

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.