Fundisa African Academy of Medicines Development

Fundisa African Academy of Medicines Development is a non-profit organisation providing and promoting teaching and training in medicines development and regulation in South Africa and other African countries. The aim is to bring together relevant stakeholders from academia, industry, regulatory authorities and other institutions.

The offices of Fundisa African Academy of Medicines Development are located at Tiervlei Trial Centre, Tygervalley Health Centre, The View, 7th Floor, Old Oak Road, Cape Town, 7530, South Africa.

Prof Bernd Rosenkranz

President

Bernd Rosenkranz has a medical degree and is board certified Pharmacologist and Clinical Pharmacologist in Germany and South Africa and Fellow of the Faculty of Pharmaceutical Medicine (FFPM).

He has spent 23 years in the pharmaceutical industry, as Director of Clinical Pharmacology at Hoechst/Hoechst Marion Roussel in Germany, France and USA, Chief Medical Officer at 3ClinicalResearch in Berlin, Germany, and Vice President Clinical Development at Jerini, Berlin, Germany. From 2008 until 2016, he was head of the Division of Clinical Pharmacology, Stellenbosch University (South Africa) where he established the postgraduate programme in Pharmaceutical Medicine / Medicines Development (PharmaTrain Centre of Excellence).

Bernd Rosenkranz is guest scientist at the Institute for Clinical Pharmacology and Toxicology of the Charité University Medicine Berlin. He is member of the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP), the European PharmaTrain Federation, and Honorary Member of the South African Society for Basic and Clinical Pharmacology (SASBCP). He was Chair of the South African Congress of Pharmacology and Toxicology (SACPT 2010), and treasurer of the 17th World Conference of Basic and Clinical Pharmacology (WCP2014) and the 3rd World Conference on Pharmacometrics (WCoP2022). He is convener of a sub-team involved in preparing the COVID-19 Country Report commissioned by the South African government and member of the Scientific Core Team of an initiative on Talent Building within African Regulatory Agencies.

His work has been presented in more than 120 original publications, 18 book chapters, and more than 170 oral or poster presentations. He is Associate Editor of Frontiers in Pharmaceutical Medicine and Outcomes Research. Bernd Rosenkranz is vice treasurer of the Manenberg Aftercare Centre, Cape Town and airport chaplain in Berlin, Germany.

Dr Haylene Nell

Vice President

Haylene Nell is a Medical Doctor with post graduate qualifications in Pharmacology and Epidemiology. She is the Managing Member and Head of Tiervlei Trial Centre CC (TTC) which was founded in 2000, by Dr Frans Maritz and herself.

Since 1988, she has acted as Principal Investigator in > 100 clinical trials and participated in >400 trials in various therapeutic areas, with a special focus on Asthma and COPD. Haylene has developed several protocols for single centre studies, and was involved the the data management, statisitical analysis and clinical study reports for these "full services" studies.

Haylene Nell is co-presenter of the Post Graduate Diploma in Pharmaceutical Medicine, Division of Clinical Pharmacology, University of Stellenbosch, and has an appointment as Extra-ordinary Senior Lecturer, Faculty of Health Sciences, University of Stellenbosch.

Haylene Nell was appointed Extra-Ordinary Associate Professor for the South African Faculty of Natural Sciences, SA Herbal Science and Medicines Institute, University of Western Cape. She was Member Health Research Ethics Committee, Department Bioethics, Tygerberg Campus, University of Stellenbosch and served as executive member of South African Clinical Research Association (SACRA).

Prof Patrick Bouic

Secretary

Professor Patrick Bouic trained as an Immunopathologist in France and graduated with his PhD from the University of Claude Bernard, Lyon in 1984. He is a board certified Immunologist with the Health Professions Council of South Africa (HPCSA) since 1994 and has been with the University of Stellenbosch Medical faculty since 1984 in the Division of Pathology (Medical Microbiology). As an academic he lectures to undergraduate students and oversees many post-graduate candidates registered with the university.

He was the head of the diagnostic immunology laboratory for 20 years before forming the private company Synexa Life Sciences in Cape Town in 2002 where he is one of the founding Directors and serves as Chief Scientific Officer. Currently the company has its headquarters in Cape Town but also has a laboratory in London and is currently opening a new facility in Berlin. These laboratories provide biomarker support services in Europe for large pharma companies as well as the smaller biotechnology groups.

Patrick has a passion for knowledge sharing and to date has done over 150 conference presentations both locally as well as internationally. He is widely published (over 150 peer reviewed publications and several chapters in books) and has numerous patents covering new formulations derived from natural sources. He serves on the SAB of Becton Dickinson, an international company which develops reagents and technologies for diagnostics as well as research purposes.

Prof Colin Pillai

Colin Pillai runs two social ventures that develop scientific capability in drug discovery, clinical development and regulatory sciences in low- and middle-income countries. Previously, he worked as a pharmacometrician and a senior leader at Roche and Novartis in Switzerland.

He acquired his clinical and research experience in hospital and community pharmacy, academia and at the South African Medical Research Council's Tuberculosis Research programme running Phase 1 clinical trials.

Colin Pillai is an Honorary Professor at the University of Cape Town, a Honorary Fellow of the Royal College of Physicians and a Senior Advisor on capacity development for global health to the Bill and Melinda Gates Foundation.

Prof Helmuth Reuter

Helmuth Reuter is a registered rheumatologist and professor of internal medicine. He is the Executive Head of the Department of Medicine at Stellenbosch University and Tygerberg Hospital and Director of Winelands Rheumatology Centre. He studied medicine at Stellenbosch University and specialised thereafter in internal medicine, rheumatology and infectious diseases spending time in London, Cambridge, Norwich, Paris and at the National Institutes of Health (NIH) in Bethesda, Maryland (USA).

He is a member of the American Academy of Science, a member of the American College of Physicians, an associate of the South African College of Clinical Pharmacology, a fellow the Royal Society of Tropical Medicine and Hygiene, a fellow of the College of Physicians of South Africa, and a fellow of the Royal College of Physicians of Edinburgh.

His research interests include the therapeutic management of immune mediated inflammatory diseases specifically rheumatoid arthritis, spondyloarthritis, and systemic lupus erythematosus. He has been the principal investigator of many clinical trials and has co-authored more than 100 publications. He has contributed as an invited speaker at many national and international conferences.

Tirhani Maluleke

Tirhani Maluleke has a PhD in Pharmacology and a Postgraduate Diploma in Pharmaceutical Medicine from the University of Stellenbosch, South Africa. She has more than 17 years of experience in the pharmaceutical industry in various fields including market access, regulatory, and Clinical Trials; with special interest and expertise in regulatory/start-up, compliance and pharmacovigilance. With 7+ years’ senior / management role, her duties include training, mentoring and coaching junior colleagues.

She has worked across different pharma companies, CROs and the South African Health Products Regulatory Authority (formerly, Medicines Control Council).

Outside her professional role, she has been involved in various community building projects which mainly focused on mentoring, training and upskilling young people in townships and rural areas.