A black-empowered clinical research organisation with a commitment to building up local research capacity has been launched in South Africa.

The African Clinical Research Organisation (ACRO) is a joint venture between the black-empowered biotechnology company Batswadi Pharmaceuticals and LIFElab, one of three Biotechnology Regional Innovation Centres set up by the South African Department of Science and Technology (DST).

The initiative is spearheaded by chief executive officer Mary-Ann Richardson, former director, global clinical development – Africa at US-based contract research organisation (CRO) Kendle.

ACRO is “a turning point in South Africa’s research and development”, said Dr Blessed Okole, chief executive officer of LIFElab, the trade name for the East Coast Biotechnology Regional Innovation Centre. For the first time, he added, “research findings need not sit on the shelf, gathering dust, because of a lack of resources to commercialise them”.

The new CRO will manage Phase I-IV clinical trials for biotechnology, pharmaceutical and medical device companies, donor-funded and non-governmental organisations, research institutions and the government. Locally-owned biotech players will be guaranteed “competitive costing,” it promised.

The initial focus will be on studies for infectious diseases such as HIV/AIDS, tuberculosis and malaria, all of which benefit from “excellent” clinical research facilities in South Africa and the wider African continent, ACRO noted. Other disease areas will be added to the portfolio in due course.

Moreover, the long-term plan is to expand from ACRO’s South African base into a pan-African CRO. “Clinical research is being encouraged and promoted in African institutions as local scientists work to find solutions to local health issues,” Richardson stated. “It is ACRO’s mission to promote access to innovative medical products services and technologies throughout Africa.”

BEE status

The venture is expected to contribute significantly to job creation and capacity-building in a fast-growing South African clinical research sector, valued at more than R1 billion in 2000 and over R2 billion (€0.20 billion) last year. ACCRO was set up in line with the government’s National Empowerment and Healthcare Charter strategies, which look to boost interactions between healthcare multinationals and local black-owned businesses.

The joint venture arrangements for ACRO are a way of overcoming the difficulties multinationals can have in meeting ownership and control targets for black economic empowerment (BEE) status. As Richardson explained, the government takes BEE status into account when awarding tenders for activities such as supplying the essential drugs list. The South African authorities have helped to jump-start ACRO by providing investment of R12 million over three years through LIFElab.

In the past there has been criticism that CROs were “a very white industry,” Richardson told PharmaTimes Clinical News. Consequently, ACRO will build capacity predominantly from the black population while avoiding “tokenism,” she said.

There are also many doctors who want to get involved in clinical trials but need bringing up to speed, Richardson noted. One of ACRO’s functions will be to address the skills shortage in South Africa by providing training for clinical research associates and related professionals, as well as in academic institutions.

Ease the transition

At the same time, ACRO wants to ease the transition from the laboratory to the marketplace for local researchers who may find multinational CROs prohibitively expensive. It is also offering a broader palette than its competitors: local CROs “generally don’t do full service,” Richardson commented, adding that ACRO has a core staff capable of handling all aspects of clinical trials.

While ACRO will initially concentrate on the South African market, and on donor-funded trials in particular, in the longer term it hopes to have a network of CROs across Africa. At the moment, clinical trials in African countries tend to “go where the capacity is,” Richardson pointed out.

Having left Kendle at the beginning of June, Richardson has been spending the last couple of months getting the ACRO team in place. South Africa’s first locally owned, black-empowered, full-service CRO now has its “doors open for business”, she said, adding that ACRO is already attracting a lot of interest from local biotechnology companies.

Prior to joining Kendle, Richardson worked for US-based CRO PPD in South Africa and in 2004 she chaired the South African Clinical Research Association (SACRA). ACRO will be a member both of SACRA and of the UK-based Institute of Clinical Research.

The new CRO's offices are in Bryanston, Johannesburg.