By Alexander Alex, C. John Harris, Dennis A. Smith
With a spotlight on case reviews of R&D courses in numerous affliction parts, the booklet highlights basic productiveness matters the pharmaceutical has been dealing with and explores power methods of enhancing learn effectiveness and efficiency.
• Takes a complete and holistic method of the issues and strength ideas to drug compound attrition
• Tackles an issue that provides billions of bucks to drug improvement courses and well-being care costs
• Guides discovery and improvement scientists via R&D levels, instructing requisites and the reason why medicinal drugs can fail
• Discusses strength methods ahead using new techniques and possibilities to lessen attrition
Read or Download Attrition in the pharmaceutical industry : reasons, implications, and pathways forward PDF
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Additional resources for Attrition in the pharmaceutical industry : reasons, implications, and pathways forward
Sample text
The consequence of this situation is that safety‐related attri tion in human trials will continue because the preclinical safety assessment of drugs is an oversimplification of the real human response to a drug and that some very useful ther apies will be abandoned because we cannot adequately risk‐assess their effects in humans due to an underdeveloped approach to research into human side effects. 2 Basic Mechanisms of an Adverse Event Sometimes Require not only Many Thousands of Patients to be Exposed, but also that more than One Drug in the Class be Developed such that a Specific Common Mechanism can be Identified or at least a ‘Class Effect’ can be Postulated With this statement, one must acknowledge the com plexity of biological systems in general and these same systems under the influence of a 16 ATTRITION IN DRUG DISCOVERY AND DEVELOPMENT pharmacological intervention in particular.
These are areas where both regula tors and payers would welcome new innovation. But the focus on new targets that failed to translate into clinical efficacy has been a major source of attrition in modern portfolios. Indeed, in a review of sources of attrition by the management consultancy firm McKinsey’s, novel mechanisms were twice as likely to suffer attrition in clinical development than known mechanisms [53]. Selecting which biological mechanisms we choose, in most disease areas, remains the primary challenge.
Although it feels like the major pharmaceutical company model of drug discovery is broken, and the pharmaceutical industry is in decline, global pharmaceutical companies 36 ATTRITION IN DRUG DISCOVERY AND DEVELOPMENT still spent an estimated $135B in 2011 of R&D. So it is probably fairer to say that it is chang ing. Large and significant grants are being made by the government and charity sectors, and they are liable to increase. New models of pharmaceutical R&D are being explored, such as open innovation.