Sunday, 18 September 2016

CSIR Paves the Way for Equity in Healthcare Open Source Drug Discovery (OSDD)


Countless diseases afflict humankind all over the globe. What differentiates one individual from another with respect to tackling the menace of myriad illnesses is the sheer access to healthcare.

Social injustice in health arises primarily due to lack of information and financial barriers that invariably deprive the poor, in any community, from a fair opportunity to attain good health. Needless to say, for enhancing equity in healthcare, it is crucial to have effective health policies that timely bring the fruits of modern technologies to improve the health of the financially weaker individuals of society.
            
The high cost of a drug is mainly due to the huge monetary investment that has gone into developing that formulation. It is a hard fact that pharmaceutical companies go through a long, tough struggle to bring a brand new drug in the market, which may or may not become the standard treatment for a major disease. The journey of a new drug formulation from the laboratory to the market takes normally more than a decade of research involving both arduous bench work and millions of dollars, with no guarantee of success, as many a times even after years of investment of time and money, the new drug is unable to hit the market.

New drug research involves the Phase I, II and III trials followed by Clinical Trials. Only on successful completion of all these studies, which evaluate the efficacy and safety of the new drug, that the latter gets the final stamp of approval from the drug regulatory authorities of the country. It is all for this jubilant moment – akin to winning a jackpot – that pharmaceutical companies heavily invest and patiently wait for years, as the market returns from the sale of a new drug would be stupendous. However, only a few contenders in this race of new drug development succeed to reach the endpoint. No doubt then why most pharmaceutical companies prefer to just license the marketing rights of a drug from the original discoverer or they create and market generic versions of drugs developed by others.

In this light, just imagine a scenario where scientists from various research institutions worldwide, both public and private, join hands to collaboratively work to discover new drugs for a target disease. This is open source model of drug discovery that is poised to give even brilliant young researchers in colleges and universities an opportunity to contribute to the design and development of new drugs. Undoubtedly, the free flow of information amongst different sources on diverse aspects of drug discovery research would speed up the unraveling of new molecules that could become components of novel drug formulations to fight a particular disease. Sure, this model involves the coordinated activities of scientists from different areas like molecular biology, biophysics, biochemistry, chemistry and genetics to name a few.

Thanks to the Open Source Drug Discovery (OSDD) initiative of CSIR, today it is possible to establish a novel open source platform for both computational and experimental technologies to discover new drugs for infectious/neglected diseases that are affordable to the poor populations of the developing world. According to Dr Samir. K Brahmachari, former Director General CSIR and Chief Coordinator and Mentor, OSDD, not even a single new drug molecule against tuberculosis could come up despite over a decade of effort by Industry and R&D Laboratories, after the complete genome sequencing of Mycobacterium tuberculosis. This was because of lack of knowledge sharing among researchers as they worked as isolated groups.

IPR protection does not allow free knowledge sharing for drug discovery and also increases the cost of the drug. This patent-protected route of discovering new drugs, in the long run, suits only the rich who can afford those high-priced drugs. “I believe that affordable healthcare is a right for all. But, pragmatically speaking, when it comes to health, we need to have a balanced view between health as a right and health as a business,” says Dr Brahmachari. “With respect to diseases of the poor, like tuberculosis, where the market incentive is very small, it is not possible to convince the pharmaceutical companies to work on these drugs. Therefore, it is the responsibility of public-funded institutions to participate in this area in an open collaborative mode”, Dr Brahmachari further adds. In other words, for drugs that are primarily meant to be consumed by the poor, open source drug discovery is the right route.

OSDD is a CSIR-led Team India consortium with a global partnership. For popularizing the concept of OSDD, Dr Brahmachari explains through a simple analogy: “The strategy used to protect a factory is different from the strategy used to protect a paddy field. It might be worth building a wall around a factory and restricting access, but one does not build walls around paddy fields. If you do, then the cost of building and maintaining the wall will add to the price of rice, and the poor will no longer be able to buy it. Open source is for the 'paddy fields' that everyone needs, not for the luxury goods factory.”

OSDD aims to provide a global platform where the best minds can collaborate to solve the complex problems associated with discovering novel therapies for neglected tropical diseases like malaria, tuberculosis, leishmaniasis, etc. This joint endeavor promises to provide a unique opportunity for scientists, doctors, technocrats among other experts to work for a common cause.  The first phase of OSDD focused on developing drugs against M. tuberculosis including drug resistant and latent tuberculosis. The objective was to develop a web-based portal for data deposition, exchange, evaluation and tabulation for analysis. This would encourage collaborative sharing of know-how for the entire spectrum of processes in discovering new drugs for this age-old scourge that has one-third of the entire human population on Earth under its grip, particularly in the developing countries.

OSDD functions by breaking a large complex problem into simpler, smaller set of activities that have a clearer scope. Called ‘work packages’, the smaller sets of activities clearly specify the task to be carried out during the implementation of the Project. The timelines for the execution of such tasks is also well defined. Affordable drug development would thus be possible by concerted efforts on various work packages by all the contributing partners. For contributing to OSDD one simply needs a login followed by acceptance of ‘terms and conditions’, and depending upon one’s expertise, he/she could contribute to any of the work packages.

In this endeavor, an idea, a software, an article or molecule(s), etc., that help in expediting the process of drug discovery are treated as a contribution. The various challenges in drug discovery research are posted on the website, for anyone to take up and find relevant solutions, which are peer-reviewed. Appropriate rewards are given to select contributors in the form of credit points, for solving a defined problem. Based on the points accrued by the contributors they are awarded four levels of Membership cards (Blue, Silver, Gold and Platinum), providing the contributors of each card certain rights, privileges and responsibilities.


Explaining the essence of OSDD, Dr Samir K Brahmachari says that, "Most of the drug discoveries are made in a closed door environment, where highest degree of secrecy is maintained resulting in the lack of open participation of the entire academic world. The Open Source Drug Discovery Program aims to establish a novel web-enabled open source platform ― both computational and experimental ― to make drug discovery cost-effective and affordable by utilizing the creative potential of college and university students along with senior scientists, a collective approach to drug development.” As the mastermind behind the OSDD Project, Dr Brahmachari has also contributed to establishing an International Collaborative Center for Affordable Health (ICCAH), which operates with Government, International and Philanthropic funding.

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