A Translational Medicine Model in Drug Discovery and Development- Its Time for Radical Solutions for the Pharmaceutical Industry Perils
Giora Feuerstein, Assistance Vice President Head Discovery Translational Medicine Pfizer Inc,
The Pharmaceutical Industry Contemporary Perils
The productivity of the pharmaceutical industry in delivering new medical entities (NMEs) has been stagnating over the past decade in spite of exponential increase in R&D investment [1,2]. This situation is having significant impact on the Pharma business at large, which has exhibited significant market capitalization losses likely to exacerbate in the next 5 years as patent protection (estimated at $50-60 billions) due to expire. Moreover, loss of revenues due to removal from the market of 'block buster' drugs due to safety concerns (e.g., vioxx) and restrictive labeling and warning (e.g., PPAR gamma modulators for diabetes) confounded by heightened restrictive regulatory labeling for new drugs (e.g., cardiovascular safety requirements for diabetes drugs) are adding significant challenges. Overall, the new financial and regulatory environments over the unacceptable attrition rate in realizing NMEs, likely contributed to the recent bouts of mergers and acquisitions within leading Pharmaceutical industries (e.g., Merck-Schering Plough, Pfizer-Wyeth, Roche-Genentech). Consequent to such events, Pharma R&D continues to shrink along with loss of tenth of thousands of highly educated, trained, skilled and experienced professionals, many to leave the industry altogether. This spiral of detrimental events could further lead to stagnation and failures in realizing NMEs.
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