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12 November 2019 | Story Leonie Bolleurs | Photo Leonie Bolleurs
Farmovs
At a first for South Africa, the SACRA clinical trials capacity-building workshop with government, research institutions, and industry, were from the left: Dr Nathaniel Mofolo, Dr Rita Nathan, Dr Mojalefa Maseloa (Head: Clinical Services in the Clinical Unit at the Universitas Hospital) and Sue Baily (Site Management Head at IQVIA).
Whether it is to treat the flu or a more serious illness, all medicines go through a very costly and lengthy research process before being approved for prescription to patients. The cumulative time from the beginning of trials to marketing approval has increased over the past ten years. 

According to Dr Vathi Papu-Zamxaka from the South African Clinical Research Association (SACRA), South Africans would not have had access to safe and effective medicines, had it not been for the intensive research conducted on new medicines. 

On 7 November 2019, a group of 115 delegates representing the Free State Department of Health, the UFS, private research sites, and the pharmaceutical industry met at FARMOVS on the Bloemfontein Campus of the University of the Free State (UFS) for the SACRA clinical trials capacity-building workshop.

2,1 billion dollars to develop one successful drug

Dr Michelle Middle, Chief Medical Officer at FARMOVS, provided some interesting stats on the process for drugs to hit the shelves: “One out of 10 drugs entering human research will be approved. The cost of development of one successful drug is approximately 2,1 billion dollars. And the time to develop a drug, from submission of the Investigational New Drug Application (IND) to approval by the Food and Drug Administration (FDA), is between 12 and 15 years.”

Dr Middle stated that drug development is one of the most regulated processes, with ethics and patient safety governing the undertaking. “With SAHPRA (South African Health Products Regulatory Agency) having some of the strictest regulations in the world, South Africa has a good history of running trials.  In addition, fast growth is expected for the pharmaceutical market on the African continent, necessitating the need for increased clinical trials on this continent,” she said. 

Very few clinical trials hosted in South Africa 

Although Africa has the broadest genetic variability of all human populations and carries 17% of the global population, very few clinical trials are hosted on the continent. Globally, there are currently approximately 322 000 clinical trials being actively conducted, of which only 1 700 are conducted in Africa, i.e. less than 3%.  Even worse, only 304 of the 1 700 trials running in Africa are conducted in South Africa.  There is thus a critical need for South Africa as a country to market itself as a clinical trial destination and to attract more trials to the country.

South Africa’s competitive edge lies in being known for its ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)-compliant top-quality research, racial and genetic diverse trial participants, good medical infrastructure and expertise, and the good reputation of the regulator (SAHPRA). “There are, however, a need for transformation and capacity building in clinical research in the country,” said Dr Middle. 

Dr Rita Nathan, Head of Clinical Services in the Clinical Department at the Universitas Hospital, who was representing government at the workshop, is looking to strengthen clinical trials across government and industry by focusing on, among others, funding models, operations management, and service delivery. 

From the UFS Faculty of Health Sciences, Dr Nathaniel Mofolo, Head of the School of Clinical Medicine, said collaboration between stakeholders is important. “This initiative is giving direction to the UFS vision of being a research-led university.” 

Other topics discussed at the workshop include the clinical trials landscape, how clinical trials work, the patient factor, ethics in clinical trials, and the economic aspect of clinical trials. 

News Archive

Researchers international leaders in satellite tracking in the wildlife environment
2015-05-29

 

Ground-breaking research has attracted international media attention to Francois Deacon, lecturer and researcher in the Department Animal, Wildlife and Grassland Sciences at the UFS, and Prof Nico Smit, from the same department. They are the first researchers in the world to equip giraffes with GPS collars, and to conduct research on this initiative. Recently, they have been joined by Hennie Butler from the Department of Zoology as well as Free State Nature Conservation to further this research.

“Satellite tracking is proving to be extremely valuable in the wildlife environment. The unit is based on a mobile global two-way communication platform, utilising two-way data satellite communication, complete with GPS systems.

“It allows us to track animals day and night, while we monitor their movements remotely from the computer. These systems make possible the efficient control and monitoring of wildlife in all weather conditions and in near-to-real time. We can even communicate with the animals, calling up their positions or changing the tracking schedules.

“The satellite collar allows us to use the extremely accurate data to conduct research with the best technology available. The volume of data received allows us to publish the data in scientific journals and research-related articles.  

“Scientific institutions and the public sector have both shown great interest in satellite tracking, which opens up new ground for scientific research for this university. Data management can be done, using Africa Wildlife Tracking (AWT) equipment where we can access our data personally, store it, and make visual presentations. The AWT system and software architecture provide the researcher with asset tracking, GPS location reports, geo-fencing, highly-detailed custom mapping, history reports and playback, polling on demand, history plotting on maps, and a range of reporting types and functions,” Francois said.

Data can be analysed to determine home range, dispersal, or habitat preference for any specific species.

Francois has been involved in multiple research projects over the last 12 years on wildlife species and domesticated animals, including the collaring of species such as Black-backed Jackal, Caracal, African Wild Dog, Hyena, Lion, Cheetah, Cattle, Kudu, Giraffe, and Black Rhino: “Giraffe definitely being the most challenging of all,” he said.

In 2010, he started working on his PhD, entitled The spatial ecology, habitat preferences and diet selection of giraffe (Giraffa camelopardalis giraffa) in the Kalahari region of South Africa.

 

Since then, his work has resulted not only in more research work (supervising four Masters students) but also in a number of national and international projects. These include work in the:

  • Kalahari region (e.g. Khamab Nature Reserve and Kgalagadi Transfrontier Park)
  • Kuruman region (Collared 18 cattle to identify spatial patterns in relation to the qualities of vegetation and soil-types available. This project took place in collaboration with Born University in Germany)
  • Woodland Hills Wildlife Estate and Kolomella Iron Ore – ecological monitoring
  • A number of Free State nature reserves (e.g. Distribution of herbivores (kudu and giraffe) and predators (camera traps)

Francois is also involved with species breeding programmes and management (giraffe, buffalo, sable, roan, and rhino) in Korrannaberg, Rustenburg, Hertzogville, Douglas, and Bethlehem as well as animal and ecological monitoring in Kolomella and Beesthoek iron ore.

Besides the collaring of giraffes, Francois and his colleagues are involved in national projects, where they collect milk from lactating giraffes and DNA material, blood samples, and ecto/endo parasites from giraffes in Southern Africa.

With international projects, Francois is working to collect DNA material for the classification of the nine sub-species of giraffe in Africa. He is also involved in projects focusing on the spatial ecology and adaptation of giraffe in Uganda (Murchison Falls), and to save the last 30 giraffe in the DRC- Garamba National Park.

This project has attracted a good deal of international interest. In June 2014, a US film crew (freelancing for Discovery Channel) filmed a documentary on Francois’ research (trailer of documentary). Early in 2015, a second crew, filming for National Geographic, also visited Francois to document his work.

 

More information about Francois’ work is available at the GCF website. 

Read Francois Deacon's PhD abstract

Direct enquiries to news@ufs.ac.za.

 

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