“ Career Opportunities in the Drug Development Process ” www.biocrowd.com
Bioscience Industry Statistics <ul><li>There are over 1,500 bioscience companies in the U.S. today </li></ul><ul><li>Biosc...
Drug Development Process Discovery Development Clinical Testing Licensure Marketing & Sales Manufacturing
Drug Discovery <ul><li>Target identification and validation </li></ul><ul><li>Production and/or synthesis of “drugs” </li>...
Drug Development <ul><li>Process of production/synthesis of  drug is validated and “scaled up’ to produce large quantities...
Clinical Testing  <ul><li>IND is approved by FDA  and  drug is tested in human clinical trials </li></ul><ul><li>Phase I  ...
Clinical Testing (cont’d) <ul><li>Personnel required:  clinical research associates (CRA), nurses, physicians, statisticia...
Licensure <ul><li>Data from Phase I-III clinical trials tabulated and analyzed for overall safety and therapeutic efficacy...
Manufacturing <ul><li>NDA is approved by the FDA; drug must be manufactured in large quantities to meet therapeutic demand...
Sales & Marketing <ul><li>Drug must be advertised,  marketed, and sold by manufacturer to the public </li></ul><ul><li>Dis...
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Career Opportunities in the Life Sciences Industry

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Career Opportunities in the Life Sciences Industry

  1. 1. “ Career Opportunities in the Drug Development Process ” www.biocrowd.com
  2. 2. Bioscience Industry Statistics <ul><li>There are over 1,500 bioscience companies in the U.S. today </li></ul><ul><li>Bioscience companies employ approximately 191,000 people </li></ul><ul><li>The market capitalization (total market value of publicly-traded U.S. bioscience companies) was $206 billion as of April 2003 </li></ul><ul><li>There are currently more than 370 bioscience drug products in various stages of clinical development in the U.S. </li></ul>
  3. 3. Drug Development Process Discovery Development Clinical Testing Licensure Marketing & Sales Manufacturing
  4. 4. Drug Discovery <ul><li>Target identification and validation </li></ul><ul><li>Production and/or synthesis of “drugs” </li></ul><ul><li>Interaction between drugs and targets characterized and validated: tested for efficacy in vitro and in animal models of disease </li></ul><ul><li>Personnel involved: chemists, molecular biologists, animal handlers, bioinformatics, biochemists, protein chemists, etc. </li></ul><ul><li>Degree requirements: bachelors through Ph.D. </li></ul>
  5. 5. Drug Development <ul><li>Process of production/synthesis of drug is validated and “scaled up’ to produce large quantities of the “drug” </li></ul><ul><li>Detection and analytical methods for the drug are created and validated </li></ul><ul><li>Toxicology and ADME experiments performed in animals </li></ul><ul><li>Investigational New Drug Application (IND) is prepared and submitted to the Food and Drug Administration (FDA) </li></ul><ul><li>Personnel required: process chemists, analytical chemists, pharmacologists, toxicologists, regulatory affairs, drug safety, animal handlers, veterinarians, quality control, quality assurance, etc. </li></ul><ul><li>Degree requirements: associate through Ph.D./M.D./DVM </li></ul>
  6. 6. Clinical Testing <ul><li>IND is approved by FDA and drug is tested in human clinical trials </li></ul><ul><li>Phase I trials are conducted to assess drug safety; typically tested in healthy human subjects </li></ul><ul><li>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 </li></ul><ul><li>Phase III trials are conducted to assess overall therapeutic effect of “drug” in large numbers of ill patients </li></ul>
  7. 7. Clinical Testing (cont’d) <ul><li>Personnel required: clinical research associates (CRA), nurses, physicians, statisticians, clinical operations, data management, safety monitors, etc. </li></ul><ul><li>Degree requirement: nursing/bachelors through M.D. </li></ul>
  8. 8. Licensure <ul><li>Data from Phase I-III clinical trials tabulated and analyzed for overall safety and therapeutic efficacy </li></ul><ul><li>A New Drug Application (NDA) is prepared and submitted to the FDA for review </li></ul><ul><li>Personnel required: regulatory affairs specialists, drug safety personnel, pharmacologists, physicians, statisticians, marketing, etc. </li></ul><ul><li>Degree requirements: bachelors through M.D./Ph.D. </li></ul>
  9. 9. Manufacturing <ul><li>NDA is approved by the FDA; drug must be manufactured in large quantities to meet therapeutic demand </li></ul><ul><li>Drug is manufactured in a pharmaceutical plant or protein production facility </li></ul><ul><li>Personnel required: pharmaceutical operators, analytical chemists, quality control, quality assurance, regulatory affairs, sterile fill operators, formulations, drug safety, marketing, engineers, etc. </li></ul><ul><li>Degree requirement: associate through bachelors </li></ul>
  10. 10. Sales & Marketing <ul><li>Drug must be advertised, marketed, and sold by manufacturer to the public </li></ul><ul><li>Distribution channels must be developed and a sales force must be trained to sell the drug </li></ul><ul><li>Personnel required: advertising, marketing, accounting, administrative support, sales, etc. </li></ul><ul><li>Degree requirements: associate through bachelors </li></ul>
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