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04/12/23 1
“Career Opportunities in the Drug Development Process”
www.biocrowd.com
04/12/23 3
Drug Development Process
Discovery
Development
Clinical Testing
Licensure
Marketing & Sales
Manufacturing
04/12/23 4
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.
04/12/23 5
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
04/12/23 6
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
04/12/23 7
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.
04/12/23 8
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.
04/12/23 9
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
04/12/23 10
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