By Jeffrey M Gimble
The ebook offers with either the summary and sensible elements of relocating from a univerisity laboratory to a place within the biotech undefined. every one bankruptcy lists universal and special good points to judge breaking down complicated judgements into viable components. numerous sections supply "how to" publications for the instruction of manuscripts, patents, delivers, and inner corporation records. *Written by way of an skilled academician and profitable biotechnology entrepreneur*Reviews the fundamental instruments taught in a conventional college *Identifies new methods those those instruments may be utilized in the company world*Details the 'nuts and bolts' essential to negotiate a winning place within the biotech
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Additional resources for Academia to Biotechnology: Career Changes at any Stage
Chapters 8–12 will expand on specific features of this process. In the best of all possible worlds, your scientific research will lead to a product with clinical utility. This product may take the form of a therapeutic (drug, protein, nucleic acid, or cell-based biologic), a diagnostic, or a device. S. Food and Drug Administration (FDA) or its equivalent agency in other countries will regulate the final product, regardless of its form. Without the FDA’s approval, you will not be able to license, market, or sell your product for use in the United States.
4. Clinical trials (Phase I–III): This stage is the initial testing of the potential product in human subjects. The clinical trials will require coordination with physicians, patients, and hospitals as well as monitoring and oversight by both an Institutional Review Board (IRB) and in-house medical/clinical experts. It may be necessary to involve a “for-hire” Contract Research Organization (CRO) to provide some of these functions. Phase I studies focus almost exclusively on safety issues and involve only a small number of patients.
You should take the path of least resistance to reach this point. mil/baa/ Grants page for the Defense Advanced Research Projects Administration (DARPA). gov/grants/ Grants page for the Department of Energy. cfm Grants page for the National Institutes of Health (NIH). htm Grants page for the National Science Foundation (NSF). htm Home page for the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). mil/ Home page for DARPA. org/ Home page for the Institutional Animal Care and Use Committee (IACUC).