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Issue dated - 12th September 2002

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‘‘All chains of drug development exist in India’’

Dr Bernard Fourie is the executive director of the Tuberculosis R&D Coalition of Stakeholders in High-Burden Countries - an initiative directed towards identifying existing R&D capability in high-burden countries. The Coalition aims to build research and technology partnerships between the coalition members and developed countries and facilitate the establishment of active collaborations in tuberculosis research. The coalition also aims to provide an operational base for and engage in projects in need of a multi-centre approach and encourage capacity building efforts as part of the R&D process. Dr Fourie was in India last week to promote the Coalition’s objectives and goals to various Indian stakeholders in TB research. Excerpts from the interview with Ananth Iyer:

The Tuberculosis R&D Coalition has identified India as a separate focal point. What role could India play in helping the Coalition’s objectives?

The Tuberculosis R&D Coalition was formed to support the objectives of the Global Alliance for Anti-TB Drug Development, and that is to find a new therapy for tuberculosis treatment by 2010. Amongst other things, this therapy must be affordable and accessible to high-burden countries. In response to that, the Coalition felt that there must be an opportunity for scientists from the high burden countries to participate in this process. Instead of waiting for the process of drug development to take place and playing a role of an evaluator, the high-burden countries can offer their scientific capabilities to fasten the process of drug development to meet the target of 2010.

And it is against this background that a number of colleagues from a variety of countries, including India, agreed to form a steering group and drive towards establishing a coalition of scientists from high-burden countries. We have kept India as a separate region simply because of the magnitude of the disease and the capability it offers. India is unique when compared to other developing countries. There is a great industry involvement here. There is also a lot of government control in research, which is not the case in other developing nations. Both of these unique scenarios must be turned into potential opportunities. We must recognise the role of government research institutions and the industry in TB R&D and organise their capabilities through the formation of a virtual organisation.

It is already clear that there are a number of institutions and individuals in India who are active in TB drug research. However, these activities need to be structured under a common umbrella. Also, we need to define what and where in the process of TB drug development lies India’s expertise and contribution. And by doing so we then create a capacity

for India to become exchange partner to other regions of the coalition whereby some of the developmental work could be shared.

Streamlining research capabilities will also ensure equity in research funding distributions. To give you an example, the meeting organised by AstraZeneca early this year in Bangalore was fantastic and I congratulate them. All the big funders were present in that meeting. However, if you ask the funding agencies now where will you put the money, they say either in individual researchers or in AstraZeneca. This dilemma can be avoided if India forms a coalition of various stakeholders.

Q It has been two years since the coalition model was first adopted in Brazil. What has been the progress there?

The scientists in Brazil organised a meeting two years back to expose themselves to the Coalition and also to the big funding agencies such as the Global Alliance. It was an impressive meeting, but, at the end of the day, what they presented was a number of loose strands. Each one of them was doing their own things. he funding agencies were not impressed. Brazilians became extremely frustrated, as the Global Alliance was not putting money into their ventures. They were also frustrated because their own government was not ready to invest in science.

Interestingly, in May 2001, the scientists wrote a document to form a Brazilian network. They chose a leader and developed a study proposal containing variety of aspect such as drugs, vaccines, and diagnostics, among other things. At the same time, they also proposed to offer the Brazil government a commitment for doing research on nationally important issues. They then approached the government and got substantial funding. In September this year, they will hold their first annual meet. This annual meet is attracting funders from all over the world. I am sure that the CEO of Global Alliance is the first one to confirm the participation. You see how the wheel has turned because now there is a definition to the Brazilian effort. They are quite clear on what they want to do and where they can contribute. A similar model could be followed in India to ensure that the capability is organised and showcased to attract investors.

Q Do you think the Brazilian model will work in India?

It is very much possible. All chains of drug development exist in India. All you need to do is to fit the jigsaw puzzle by forming a virtual organisation. We are planning to organise a meeting of very high profile technical personnels in India in November. This meeting will not be restricted to only drug development, but also for diagnostics and vaccines. We expect to create all possible awareness on the need to form a coalition in India through this meeting.

Q Since TB research is predominant in government-controlled institutions, there could be chances of duplicity. How do you tackle that?

One thing we want to avoid is people feeling threatened by such a coalition. If there is duplicity, it is possible that people may feel threatened. The objective of the coalition is to identify individuals or institutions who have workable ideas and, if they are interested, the Coalition can link their information or capabilities directly to the Global Alliance or other potential funders and really promote that development. The Coalition can also facilitate that idea to the local industry. But, nothing will be done to threaten people or force them to a compromise. People should be encouraged to join the coalition only if they see an opportunity for themselves. And our belief is that opportunity will only come if there is sufficient funding.

The way you do that is to become a part of the umbrella. India has collective expertise in drug development. It is important to exploit this expertise and move some logical projects through the pipeline and demonstrate that we can handle an agent. Maybe, Global Alliance is sitting on a compound they want to move through the pipeline, but are not able to do so due to lack of collective systems. India can attract this molecule.

Q Will the Coalition also embark upon common research programmes among the various regions?

Definitely. The Coalition is planning to start with medicinal plant screening project at high capacity to identify leads for developing TB drugs. I am not saying that this programme will happen for sure, but a proposal is being put forward to member researchers. The coalition will also try to facilitate the process of attracting funds. And it will not be a single funding body. We already have the interest of WHO Tropical Disease Research wing. The WHO has approached the Coalition to apply the available funds. This is recognition of the fact that Coalition might have a capability that can be exploited. This is a very recent development.

Q Do you think the target of 2010 set by Global Alliance for a new TB drug is realistic?

TB unfortunately is a slow disease. Therefore, any investigation by nature is longer compared to any other organism you study. So this long drawn up time frame for the development of the drug is just beyond reality, and therefore, you need to have partnerships to shorten the period as much as you can. It is an ambitious target. It can be made realistic provided: - We have compounds that have undergone a little bit of work. So, Global Alliance is particularly looking for compounds that are in late stage discovery.

- Or, it must be a existing drug that could be optimised or its combination with other medications are being investigated. That is another possibility of reaching a new treatment with existing compounds. This is the main target at the moment since we can minimise risks. We should see 2010 as some sort of a target to get started, but even if it is delayed by a couple of years it is okay. But what is not okay is the target stretching to 2020. We have to put all our eggs into our basket by taking up five or six compounds and develop simultaneously. It is also possible that some companies are developing a drug and we do not know of it at this stage. It is possible that a new drug might hit the market before the target date.

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