Career Opportunities in the Life Sciences Industry
Post on 17-May-2015
- 1. Career Opportunities in the Drug Development Process www.biocrowd.com
2. Bioscience Industry Statistics
- There are over 1,500 bioscience companies in the U.S. today
- Bioscience companies employ approximately 191,000 people
- The market capitalization (total market value of publicly-traded U.S. bioscience companies) was $206 billion as of April 2003
- There are currently more than 370 bioscience drug products in various stages of clinical development in the U.S.
3. Drug Development Process Discovery Development Clinical Testing Licensure Marketing & Sales Manufacturing 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.
5. Drug Development
- Process of production/synthesis ofdrug 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
6. Clinical Testing
- IND is approved by FDAanddrug is tested in human clinical trials
- Phase I trialsare conducted to assess drug safety; typically tested in healthy human subjects
- Phase II trialsare 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 trialsare conducted to assess overall therapeutic effect of drug in large numbers of ill patients
7. Clinical Testing (contd)
- Personnel required:clinical research associates (CRA), nurses, physicians, statisticians, clinical operations, data management, safety monitors, etc.
- Degree requirement:nursing/bachelors through M.D.
- 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.
- 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
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