Emerging Markets: Setting a New Agenda - Pharmaceutical Executive


Emerging Markets: Setting a New Agenda

Pharmaceutical Executive

PE: What about a low cost 'value for many' approach to drug development?

We need to remember what Sir Francis Bacon once said: "When you want to achieve results that have not been achieved before, it is unwise to think that they can be achieved by using methods that have been used before." 'Value for many' implies creating therapeutics at not a few dollars a tablet, but a few cents a tablet. Improvements to current methods of drug development will produce only a modest return in lowering costs. Realizing significant drops in cost requires a radically different approach. Just as an illustration, let me cite two examples here.

First, traditional or alternative medicine can offer accessible and affordable healthcare, especially for preventive medicine and chronic pathophysiological states. It can also serve as a rich knowledge resource for new drugs. One promising approach is traditional knowledge-inspired reverse pharmacology, which comprises a rigorous scientific approach to use documented clinical experiences as well as qualitative patient experiences and observations for developing target candidates or formulations, through robust pre clinical and clinical research. In this process, safety remains the most important starting point and efficacy becomes a matter of validation.

Second is Open Source Drug Discovery (OSDD), which has the potential of providing a new, inexpensive way of discovering drugs by creative collaboration of scientists from around the world. The OSDD initiative launched by the Council of Scientific & Industrial Research of India has leveraged the distributive power of the Internet to tap hitherto-untapped human potential towards drug discovery. In less than three years, the OSDD community now comprises more than 4,500 scientists from over 130 countries. OSDD has integrated the in silico, or computer-based, approaches with actual laboratory experiments, with researchers sharing data in the open portal and receiving feedback from an open, collaborative community.

PE: What is your view on the potential for "frugal science" in biopharmaceuticals?

Recently, in a submission to The Economist magazine, George Whitesides of Harvard University discussed the promise of cost-conscious science. He said, "Western medicine does many things well, but it is not affordable in, or very useful to, most poor populations. What then should be the technology base for affordable health care? Answering that question requires the development of science that is conscious of cost from the beginning—a frugal healthcare that might, perhaps, be more related to public health than to end-of-life, high-tech medicine." I fully agree.

PE: Much of your career has been spent leading groups with a policy mandate to connect the regulatory responsibilities of government with the entrepreneurial instincts of private enterprise. What lessons can you provide in overcoming the historical divide between the public and private sectors? Is it possible for a country to prosper and innovate absent the firm hand of government? Are there good examples of productive partnerships between business and government to promote an innovation agenda?

I have had the privilege of chairing several high-powered national committees in India, which have dealt with complex policy issues. The assignments included the overhaul of the Indian drug regulatory system; finding solutions to the problem of spurious drugs; developing strategies on fast-tracking the recombinant pharma sector; promoting R&D and innovation in the Indian pharmaceutical industry; and examining the compatibility of excluding certain categories of innovative medical technologies from patentability under the WTO Agreement on Trade Related Intellectual Property Rights (TRIPS), where India is a signatory.

What are the lessons that I have learned from all this? First, drawing a distinction between the public good and private enterprise remains a contentious issue, especially in leading emerging markets like India, where 800 million people still earn less than $2 per day. One has to find innovative and creative solutions to create a balance between the aspirations of the private sector to make profits and the aspirations of all people to have access to health care at an affordable cost. The debate often gets politicized into a perceived conflict between "intellectual property rights" versus the "rights of the poor." I have always sought to find ways by which both sets of rights are protected. It is not an easy role to play; many times, emotions run high, and the "evidence-based analysis" that is sought does not take center stage. My task has always been to ensure that evidence—the facts—is not lost sight of in working toward a resolution.

There are a number of good examples of productive partnerships between business and government in promoting a broad innovation agenda. One of the programs I was personally responsible for was the New Millennium India Technological Leadership Initiative, launched in 2000. In this program, we established government-funded partnerships between the public and private sector to tackle some of the "grand challenges" that India would confront in the new century. When I left as Director-General of the Council on Scientific and Industrial Research (CSIR), there were more than 100 private-sector companies and 200-plus public institutions working together. Our list of achievements was long, and included the sponsorship of a new drug for treating psoriasis, developed at a fraction of the cost in the western world; it is now at the pivotal Phase III trial phase, and was done by using the reverse-pharmacology approach. Likewise, we produced an entirely new drug for treating tuberculosis—the first since commercialization of rifamypicin in 1963—as well as a world-class Bioinformatics software called Biosuite. Both are at the same high standard as Western science but much less costly to develop and sell.


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