A Biotech Manager's Handbook

A Biotech Manager's Handbook

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A biotech manager's handbook lays out - in a simple, straightforward manner - for the manager or would-be entrepreneur the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to terms with. Small companies do not have big budgets to hire people or time to become an expert in so many areas. The book starts by outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). Succeeding chapters deal with the basics of intellectual property, perspectives from a university technology transfer office and how to raise some initial funding from an investor and entrepreneur. No other 'how to' manual exists for this sector Written by a range of expert professionals in each area, all in one book Is the only 'bench to bedside' book covering the whole spectrum of development10.3 Regulation in the USA: the FDA 256 10.3.1 Investigational new drug (IND) 256 10.3.2 New Drug Application ... Efficacy 262 10.5 How regulatory requirements guide drug discovery and development 263 10.5.1 Regulatory affairs andanbsp;...


Title:A Biotech Manager's Handbook
Author: M O'Neill, M M Hopkins
Publisher:Elsevier - 2012-05-02
ISBN-13:

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