Explore Indian strengths in process development, phase III & IV trials: Pfizer (India) MD
Indian pharma industry can attract global tie-ups in process development and Phase III and Phase IV clinical trials, said H Sidi Said, managing director, Pfizer (India) Limited. Speaking at the special plenary session on 'pharmaceutical industry: New Frontiers in pharmaceuticals R&D and India's strengths in new drug discovery', organized as part of India Chem 2002 here, Said opined that India's strengths lie in these three areas of new drug discovery. The presence of cost effective and excellent medical community, scientists and tremendous patient pool and diversity were identified as the reason why India has turned an attractive destination for clinical trials. However, guarantees for adequate protection for innovation and data exclusivity and confidentiality were prerequisites before the country can reap the benefits of its strengths, he added.
Talking about new frontiers in pharmaceutical R&D, Said pointed out to the entry of "drug designers" as the biggest development of the recent era. "While the random trial and error method used for new drug discovery used to take over 10 to 12 years for a potential outcome, today computer designed drug candidates can be identified in thousands within in a day. Syrrx and Celera have made it possible thereby bringing cutting down the time factor by years" he said. He also said that USA has in a given year atleast 22,000 organ transplants which includes 13,000 kidneys, 4500 livers, 2500 hearts, 1200 pancreas and 900 lungs thereby heralding a new approach to treatment and medicines. In USA, the number of persons diagnosed to have cancer has become 1.4 million at a given time and the country has reached a stage where 50% of these patients are cured. Commenting on the latest advances in drug research, he said that the first cancer vaccine is expected to be ready by 2005.
He also pointed out to the recent trends in the biotech industry of USA where 120 biotech products have already received FDA approvals. While 300 are in late stage phases, 50 products are undergoing clinical trials, he informed. Said informed that that the US biotech sector received $ 33 billion from the share market during the period for enabling such developments.
Dr Henk Pluim, Global Project Director, Solvay Pharmaceuticals B. V., Netherlands, also highlighted the chances of India in partnering with global pharma leaders in the areas of gene discovery, bioinformatics, gene cloning, function analysis and assay development. He felt that Indian companies and research institutions have the strengths to collaborate in these areas and global pharma majors are looking forward to outsource these services.
According to him, cost effectiveness and abilities in process chemistry are the definitive strengths of Indian drug industry. However, he doubted India's technical and infrastructure capabilities to go ahead with drug discovery research. Absence of a history in drug discovery, ambiguous approach on IPR issues and India's incapability to undertake global clinical research programmes (owing to the prohibitive cost factor) were highlighted as the weaknesses.
He felt that India's opportunities in the field of new drug research lies very much with its success in partnering with global players. He wanted Indian industry to realise its core competency and plans its future.
Dr Himadri Sen, president, Pharma Research and Regulatory Affairs Lupin Ltd., (Research Park) wanted Indian drug industry to take note of the booming market for drug delivery technology. He opined that sales of drug delivery products will expand faster and will fetch Indian companies risk free money as compared to the commonly talked about high risk, high value research model. Pointing out that $ 90 billion worth molecules are turning off patent by 2008, Dr Sen asked to work on improving these chemical entities and also extend its life cycle as a business model of the future.