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      US-India biopharma collaboration hailed at EPPIC annual symposium

      Posted AtIndiaPost.com

      The biopharm- aceutical industry will witness a tremendous growth in collaborative research and product development by Indian companies and US. That was the consensus opinion of leading industry experts from both the countries. The experts - all industry veterans with impressive resumes - had converged at the Clarion Hotel in Milbrae, California recently as part of a symposium highlighting US-India synergy in life sciences. The symposium was hosted by EPPIC, a San Francisco bay-area based organization for professionals from the life sciences industry. This event was well attended by professionals representing about 80 biotech, pharmaceutical and allied organizations from across the US and India.
      Among the speakers at the symposium was Mr. B.S. Prakash, Consul General of India who felt that the biopharmaceutical industry in the US and India were at the "cusp of a great opportunity" and that the "synergy between the world's largest democracy and the most powerful one was due in part to shared values and interests". The growth in US-India collaboration will be necessitated by emerging trends in the US life sciences industry including rapidly aging population, skyrocketing cost and slowing pace of new drug development, increasingly personalized medicine, political and social pressure to reduce excessive waste in the healthcare delivery, and stretched-thin industry R&D budgets, suggested Dr. Rashmi Bharbhaiya, CEO of Advinus Therapeutics, a leading Indian contract research organization (CRO) focusing on drug discovery and early-stage development.
      According to Dr. Bharbhaiya, India's highly educated, skilled, and relatively inexpensive workforce and sophisticated local biopharma companies attuned to global needs and requirements made that country a very attractive partner in drug development. "Cost of innovation in the developed world is too high," pointed Dr. Bala Manian, a successful serial entrepreneur and CEO of U.S.-based ReaMetrix, "and an out-of-box thinking is needed to overcome the current crisis in R&D productivity". Dr. Manian, who spends more than half his time in India where ReaMetrix has significant presence, proposed a new paradigm in biopharma R&D that exploits affordability and scientific skills of India to accelerate product development output of the US industry. "Where there is turbulence, there is opportunity" quipped Dr. Manian.
      The morning session of the symposium also featured a distinguished panel on "Affordable Innovation in Life Sciences" moderated by Dr. Dinesh Patel, CEO of Miikana Therapeutics. The panel represented experts from clinical development, vaccines, diagnostics, and drug discovery backgrounds. In response to a question from the audience, Dr. Anish Bhatnagar, Vice President of Clinical Development at Titan Pharmaceuticals estimated net costs savings afforded by going to India to be around 40-50% and found the data quality from India to be "good and acceptable by US FDA". One of the greatest advantages of doing clinical trials in India, felt Dr. Bhatnagar, was the English language and "the comfort from being able to read a patient chart". The morning session concluded with a comprehensive overview of opportunities for clinical research in India by Dr. Ferzaan Engineer, CEO of the Indian operations of Quintiles, one of the world's largest CRO companies. Dr. Engineer estimated that the CRO industry would grow to $25 billion worldwide by 2010. While Quintiles enrolled in India about 5% of 100,000 patients in the clinical trials it conducts, he felt there was potential for much more. Dr. Engineer cited "increasing acceptance for Indian data, the new regulations protecting patent rights in India, maturing regulatory environment for clinical trials, emergence of experienced talent pool, improving hospital and IT infrastructure, and rapidly growing domestic market" as the key factors that will transform CRO industry in India. The Indian CRO will soon be able to offer "a sort of dashboard to run clinical trials" offering not only clinical services but also technology services, he predicted.
      The second half of the symposium was focused on "follow on biologics", or generic biotech drugs. After an overview of the India-US pharmaceutical market by Ram Reddy, CEO of Global Industry Analysts, a regulatory perspective to the generic biotech drugs as provided by Dr. Duu-Gong Wu, Executive Director of PharmaNet. Dr. Wu, previously at the US FDA and part of FDA's follow on biologics working group, felt that FDA was in line with its European counterpart EMEA in terms of policy development. However, complexity of the biotech drugs and political and business lobby pressure was delaying issuance and implementation of any clear-cut policy. He also discussed current position of the FDA on follow on biologics. He felt that "some products may be approved without new legislations". Dr. Alan Liss, Senior Director of Biotechnology at Barr Pharmaceuticals, one of the largest generic drugs manufacturers in the US, proposed potential development strategies for introducing biogenerics. He felt that "India can offer significant biotechnology" towards biogeneric development. He also struck a note of caution by reminding the audience that complex biologics can not only differ "vendor-to-vendor" but also from "lot-to-lot" and that they are a "family of biological molecules". In a lighter vein, he wished that if there were "a vaccine against bureaucracy", biogenerics industry would move much faster.
      Dr Ram Mandalam, President, EPPIC opened the symposium by welcoming the attendees. He stated that the symposium is being organized at a time when pharmaceutical and biotechnological industries are undergoing a paradigm shift in ways to develop cost effective products while focusing on global markets for commercialization. In the end Dr Hersh Mehta acknowledged that it is the synergy between EPPIC volunteers, speakers and attendees made the event successful. EPPIC (Enterprising Pharmaceutical Professionals from Indian subcontinent) is a professional organization that provides a forum for promoting growth and development of individuals and corporations in pharmaceutical, biotechnological and related industries. EPPIC (www.eppicglobal.org) is managed and run by volunteers that include scientists, executives, entrepreneurs and attorneys.

      November 28, 2005


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