Career Opportunities in the Life Sciences Industry

“ Career Opportunities in the Drug Development Process ” www.biocrowd.com

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.

Drug Development Process Discovery Development Clinical Testing Licensure Marketing & Sales Manufacturing

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.

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

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

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.

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.

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

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

Career Opportunities in the Life Sciences Industry

by Clifford Mintz on Feb 26, 2009

Accessibility

Categories

Upload Details

Usage Rights

1 Embed 4

Statistics

Career Opportunities in the Life Sciences Industry — Presentation Transcript