Attrition in the pharmaceutical industry : reasons, - download pdf or read online

By Alexander Alex, C. John Harris, Dennis A. Smith

ISBN-10: 1118679679

ISBN-13: 9781118679678

ISBN-10: 1118819446

ISBN-13: 9781118819449

ISBN-10: 1118819586

ISBN-13: 9781118819586

ISBN-10: 1118914341

ISBN-13: 9781118914342

ISBN-10: 3820156151

ISBN-13: 9783820156157

With a spotlight on case reviews of R&D courses in various affliction parts, the ebook highlights primary productiveness matters the pharmaceutical has been dealing with and explores power methods of enhancing study effectiveness and efficiency.

• Takes a accomplished and holistic method of the issues and power ideas to drug compound attrition
• Tackles an issue that provides billions of bucks to drug improvement courses and healthiness care costs
• Guides discovery and improvement scientists via R&D phases, educating specifications and explanation why medicinal drugs can fail
• Discusses capability methods ahead using new ways and possibilities to lessen attrition

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Extra resources for Attrition in the pharmaceutical industry : reasons, implications, and pathways forward

Example text

3. An enormous amount of resource must be spent on characterizing a drug’s therapeutic and side effects before other possible uses can be identified. In the context of safety‐related drug attrition, let us look at these three aspects in a little more detail. 1 Safety Issues are Nearly Impossible to Predict with any Useful Accuracy With this statement, one’s mind automatically goes to the ability of preclinical species to reflect side effects in humans, which by some estimations is quite reasonable.

1 (Cont’d) United States Germany, United Kingdom, United States, others Germany Germany United Kingdom, others Japan France Spain United Kingdom, United States, others France, Germany, others France Argentina, Canada, Italy, others Worldwide European Union, United States, South Africa, Japan Country Antibiotic Anesthetic Peripheral venous disorders Antibiotic Anti‐inflammatory analgesic Benign prostatic hypertrophy Antipsychotic Antiviral Anti‐inflammatory Congestive heart failure Anxiolytic Antidepressant Diabetic complications Anxiolytic and muscle relaxant Indication Low blood sugar; hemolytic anemia; kidney, liver dysfunction; allergic reactions Allergic reactions and cases of hemolytic anemia, leading to three patient deaths Aplastic anemia Drug interaction and deaths.

A drug may be accepted under one or more of these programs. Fast‐track review is granted upon request to facilitate development and speed review of compounds for life‐threatening diseases. A fast‐track designation allows the drugs to receive some or all of the following: •• More frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval •• More frequent written correspondence from the FDA about such things as the design of the proposed clinical trials and use of biomarkers •• Eligibility for accelerated approval and priority review, if relevant criteria are met Attrition in Phase IV 19 •• Rolling review, which means that a drug company can submit completed sections of its biologics license application (BLA) or new drug application (NDA) for review by the FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed (BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA) Breakthrough status is granted upon request for drugs for life‐threatening diseases where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint and includes the benefits of fast‐track review and in addition intensive guidance on an efficient drug development program, beginning as early as phase I, as well as organizational commit­ ment involving senior managers.

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Attrition in the pharmaceutical industry : reasons, implications, and pathways forward by Alexander Alex, C. John Harris, Dennis A. Smith


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