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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

UFS council elects Nwaila and Hancke
2005-03-15

Dr Charles Nwaila, Superintendent-General of Education in the Free State, was elected Vice-chairperson of the UFS Council and Judge Faan Hancke was re-elected as Chairperson today.

According to the Rector and Vice-Chancellor, Prof Frederick Fourie, the election of Dr Nwaila is an important achievement for the UFS as Dr Nwaila is a well known leader in education in the Free State.

Dr Nwaila pledged to work constructively with the UFS council and management to ensure that the UFS benefits all people of the province and the country.

The appointments are valid for a term of three years from 1 June 2005 to 31 May 2008.

The elections took place at the quarterly meeting of the UFS Council where a number of other key transformation steps were approved.

The Council approved a Strategic Plan for the UFS which reflects a renewed focus on transformation of the institution, calling it an important roadmap for the future of the UFS.

According to Prof Fourie, the Strategic Plan tried strike a balance between continuity and change, addressing the need to remain an excellent university in an ever-changing context and environment.

Prof Fourie said transformation had many aspects and dimensions and could not be reduced to an issue of numbers.

The Strategic Plan identifies five strategic priorities and corresponding challenges in the next phase of transformation.

The priorities are:

  • quality and excellence

  • equity, diversity and redress

  • financial sustainability

  • regional co-operation and engagement.

  • outward thrust

Prof Fourie said that besides the five strategic priorities the plan also reflected concrete actions and interventions to address them.

He said the renewed focus on transformation is embedded in the priorities and specific actions that are identified.

The Council congratulated the management for the roadmap and for the achievements that have already been achieved in terms of transformation.

In order to draft a comprehensive Transformation Plan that will give substance to certain aspects of the UFS Strategic plan – or roadmap – the Council approved the establishment of a Transformation Plan Team.

The team will consist of about 16 people, which includes the two coordinators, Prof Teuns Verschoor, Vice-Rector: Academic Operations, and Dr Ezekiel Moraka, Vice-Rector: Student Affairs.

According to Prof Verschoor, the team was chosen and approved by the Executive Management earlier for the individual contributions that they could make.

While the individuals do not represent particular constituencies on campus they are a very diverse group of persons in terms of race, gender and various sections of the campus and the satellite campuses.

Prof Fourie, said there was an urgency and importance attached to the work of the Transformation Plan Team.

He said that while the team must produce a plan within a tight deadline, the task must be carried out very well, which could mean different stages in the work of the team.

According to the Rector, the UFS must take the lead in best practice transformation, while not underestimating the complexity of the issues facing the UFS.

The full list of names will be finalized soon.

MEDIA RELEASE
Issued by: Mnr Anton Fisher
Director: Strategic Communication
Cel: 072 207 8334
Tel: (051) 401-2749
11 Maart 2005

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