Transcript
Page 1: Career Opportunities in the Life Sciences Industry

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“Career Opportunities in the Drug Development Process”

www.biocrowd.com

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Drug Development Process

Discovery

Development

Clinical Testing

Licensure

Marketing & Sales

Manufacturing

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Drug Discovery

• Target identification and validation

• Production and/or synthesis of “drugs”

• Interaction between drugs and targets characterized and validated: tested for efficacy in vitro and in animal models of disease

• Personnel involved: chemists, molecular biologists, animal handlers, bioinformatics, biochemists, protein chemists, etc.

• Degree requirements: bachelors through Ph.D.

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Drug Development

• Process of production/synthesis of drug is validated and “scaled up’ to produce large quantities of the “drug”

• Detection and analytical methods for the drug are created and validated

• Toxicology and ADME experiments performed in animals• Investigational New Drug Application (IND) is prepared

and submitted to the Food and Drug Administration (FDA)• Personnel required: process chemists, analytical chemists,

pharmacologists, toxicologists, regulatory affairs, drug safety, animal handlers, veterinarians, quality control, quality assurance, etc.

• Degree requirements: associate through Ph.D./M.D./DVM

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Clinical Testing

• IND is approved by FDA and drug is tested in human clinical trials

• Phase I trials are conducted to assess drug safety; typically tested in healthy human subjects

• Phase II trials are conducted to assess drug efficacy in patients suffering from the “target disease”; dosing is determined and numbers of patients in the trials are typically small

• Phase III trials are conducted to assess overall therapeutic effect of “drug” in large numbers of ill patients

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Clinical Testing (cont’d)

• Personnel required: clinical research associates (CRA), nurses, physicians, statisticians, clinical operations, data management, safety monitors, etc.

• Degree requirement: nursing/bachelors through M.D.

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Licensure

• Data from Phase I-III clinical trials tabulated and analyzed for overall safety and therapeutic efficacy

• A New Drug Application (NDA) is prepared and submitted to the FDA for review

• Personnel required: regulatory affairs specialists, drug safety personnel, pharmacologists, physicians, statisticians, marketing, etc.

• Degree requirements: bachelors through M.D./Ph.D.

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Manufacturing

• NDA is approved by the FDA; drug must be manufactured in large quantities to meet therapeutic demand

• Drug is manufactured in a pharmaceutical plant or protein production facility

• Personnel required: pharmaceutical operators, analytical chemists, quality control, quality assurance, regulatory affairs, sterile fill operators, formulations, drug safety, marketing, engineers, etc.

• Degree requirement: associate through bachelors

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Sales & Marketing

• Drug must be advertised, marketed, and sold by manufacturer to the public

• Distribution channels must be developed and a sales force must be trained to sell the drug

• Personnel required: advertising, marketing, accounting, administrative support, sales, etc.

• Degree requirements: associate through bachelors


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