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THE PHARMA REVIEW (NOVEMBER 2009)

Drug Discovery Modalities – Need For A Paradigm Shift

Dr. M.D. Nair

Introduction: In recent times the issue of Drugs R&D which is the lifeline of modern pharmaceutical companies has been discussed with a high degree of concern in view of the enormous escalation in costs and the consequent unaffordable (by the majority of World’s population) prices of drugs . The industry has so far been unable to find appropriate solutions to this menacing problem. To afford the high costs of R&D and improve performance, R&D-based Pharmaceutical Companies have been pursuing the strategic route of Mergers and Acquisitions during the last few decades. The alliances thus forged were in many cases among near equal partners such as Glaxo-Wellcome and Smith Kline, Pfizer and Warner Lambert, Pfizer and Pharmacia-Upjohn, Hoechst and Roussel, CIBA and GEIGY, CIBA-GEIGY and Sandoz, Bristol Myers and Squibb, Aventis and Sanofi, Pfizer and Wyeth etc. There are also several instances of large Pharmaceutical Companies acquiring stakes in smaller Companies to strengthen their research pipelines such as Roche and Genentech, J&J and Centocor, J&J and Alza Corporation etc. These alliances not only improved the finances of the new entity, but also complemented their therapeutic ranges, R&D pipelines and marketing strengths. However, the size of the new Companies compel them to deploy their R&D efforts and investments only in areas aimed at discovery and development of Blockbusters for lucrative markets. In the process the priorities of these Companies are increasingly shifting to markets rather than meeting medical needs. In the wake of decreasing chances for the discovery of potential blockbusters , that avenue is also shut in most cases. The new alternative, largely triggered by the success of a few biotech products is to go for speciality care products catering to treatment of limited number of patients (personalised medicines) rather than for primary care for large populations.

History of Drug Discovery
Even though there were no organized research efforts in the early days of usage of drugs, Botanicals were the main stay during the 1800’s . Some of the drugs ‘discovered’ during those days such as quinine, morphine, codeine, digitalis, aspirin etc are relevant even today. An insight into microbial theory of infections followed by the discovery of Penicillin during the Second World War opened an era of Antibiotics in the 40’s. The structure of the DNA elucidated by Watson & Crick was to play a major role during the decade of the 50’s and 60’s so much so that these decades represented the golden era of drug discovery. New fundamental ideas on a variety of disease areas such as Cardiovascular and Central System disorders, Immune disorders and Metabolic Diseases were mooted during these years and based on experimental models developed for them and random screening of synthetic molecules a large number of drugs were discovered during this decade. Late 70’s and early 80’s saw the advent of modern biotechnology. The setting up of the first Biotech company, Genentech in 1976 and the launch of the first recombinant protein, Human Insulin, heralded a new era with major implications for the future of drug discovery and development. Emphasis since the second half of nineties shifted to major efforts to reduce the costs of drug research, development of more specific , effective and safe drugs using approaches different from those hitherto followed by the R&D based Pharmaceutical companies. 

 

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