Tuberculosis kills 1,000 people a day in India. The Open Source Drug Discovery (OSDD) programme, launched four years ago, could change that - not just because it's working to develop a new low-cost drug to treat cases in which current medicines are not effective, but also because of the unique way in which it is bringing thousands of researchers together.
Unlike conventional drug development by a group of scientists in a lab, the OSDD initiative has 6,500 registered participants from 130 countries. A virtual collaboration platform called Sysborg 2.0, developed with the help of Infosys, is uniting scientists, doctors, technocrats, students and software experts in this effort. Scientists can upload and discuss data, research findings and exchange ideas.
The goal of the collaboration is to develop a drug and that will then be manufactured and marketed by generic drug makers. The other big difference between the OSDD collaboration and traditional drug discovery could be a billion-dollar difference in the cost of research. The OSDD's cost will be zero: no royalty to the innovator and no intellectual property cost. This would mean that drugs will be cheaper for patients.
90% possible fall in the cost of creating a new drug - currently $1 bn - due to virtual collaboration.
"By using computational modelling and methods, we want to reduce the risk of failure - that is, of not finding a new drug - from one in 100 to one in 10 or five," says Samir K. Brahmachari, Director General of the Council of Scientific & Industrial Research (CSIR), the Indian government organisation which is leading the OSDD initiative.
The initiative's focus is currently on TB. Clinical trials are expected to begin by mid-2013 and, if all goes well, a new drug could hit the market by 2019. This venture is important because developing a drug for TB is not a commercially attractive proposition. The global market is worth $300 million to $400 million, and the cost of developing a new drug is twice as much.
The OSDD is also starting to work on malaria. Brahmachari says an open source model could have a far-reaching impact in treating diseases such as kala-azar, filariasis, dengue, chikungunya and diarrhoea, which especially affect poor communities in India and elsewhere.
"Open source holds a great deal of promise for development of new ideas and new ways of innovating," says Harish Iyer, CEO of Shantha Biotechnics, a Hyderabad company that belongs to French pharmaceutical giant Sanofi. "The approach uses greater participation and less hierarchy than traditional methods of innovation, and hence has the potential to create breakthroughs.''
He underscores, however, that such an approach can work only if the government is prepared to fund the product and its clinical development, which typically takes several years. Comparing OSDD with the drug research programmes of global companies is like comparing chalk and cheese. However, it is worth noting that so far all, the total expenditure on the programme has been only around Rs 25 crore. Brahmachari says: "We are seeking Rs 600 crore under the 12th Plan for this." He says the open source route could reduce the cost of developing a new drug from $1 billion to less than $100 million.
Open innovation is catching on among companies worldwide. GlaxoSmithKline
(GSK), for instance, is leading a global initiative to develop a malaria
vaccine. A couple of years ago, GSK opened up its data on chemical compounds or structures of possible drugs against malaria to the public. If other companies also share their data to encourage open innovation platforms, it could eventually improve the lives and health of millions. The possibilities are so enormous that Brahmachari sounds modest when he says: "Our goal is to bring down deaths due to TB from 1,000 a day to 100 by 2022."
E. Kumar Sharma