Drug Development Process

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Drug Development Process

  1. 1. “ The Biopharmaceutical Drug Development Process ” Clifford S. Mintz, Ph.D. www.bioinsights.com
  2. 2. Drug Development Process Discovery Development Clinical Testing Licensure Marketing & Sales Manufacturing
  3. 3. 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 in vitro </li></ul><ul><li>Tested for efficacy in animal models of disease </li></ul><ul><li>Technology transferred to development group </li></ul>
  4. 4. Drug Development <ul><li>Process of production/synthesis of drug is validated and “scaled up” to produce larger 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>
  5. 5. 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>
  6. 6. 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) or Biological License Application (BLA) is prepared and submitted to the FDA for review </li></ul><ul><li>The NDA must contain: </li></ul><ul><ul><li>All pre-clinical and clinical data </li></ul></ul><ul><ul><li>Documentation that describes the manufacture, formulation, validation and packaging/labeling of the drug </li></ul></ul><ul><ul><li>Production facility design and operation </li></ul></ul><ul><ul><li>Marketing Plan </li></ul></ul><ul><li>If the application is approved, the company is granted a license to manufacture the product </li></ul>
  7. 7. Manufacturing <ul><li>NDA or BLA is approved by the FDA; drug must be manufactured in commercial quantities to meet therapeutic demand </li></ul><ul><li>Drug is manufactured in protein production facility built and validated by the licensee or via a contract manufacturing organization (CMO) </li></ul><ul><li>This process is guided by cGMP regulations </li></ul><ul><li>Manufacturing facilities are initially inspected and then monitored from time to time by FDA </li></ul>
  8. 8. Scale Up and Production <ul><li>Commonly referred to as “upstream processing” </li></ul><ul><li>Expression of recombinant proteins in animal cells, bacteria, yeast and other systems </li></ul><ul><li>Process is carefully controlled and tightly regulated; must be highly reproducible with as little variation as possible </li></ul><ul><li>Quality systems management is critical </li></ul><ul><ul><li>Documentation, e.g. SOPs, validation, batch records, etc. </li></ul></ul><ul><ul><li>QC & QA </li></ul></ul><ul><ul><li>Facilities and environmental monitoring, equipment validation, cleaning control, etc. </li></ul></ul>
  9. 9. Protein Purification and Recovery <ul><li>Commonly referred to as “downstream processing” </li></ul><ul><li>Recombinant protein is isolated and purified via a variety of biochemical methods </li></ul><ul><li>Purified protein is analyzed and characterized by sophisticated analytical methods to insure identity </li></ul><ul><li>Like the upstream process, downstream processing is carefully controlled and tightly regulated; must be highly reproducible with as little variation as possible </li></ul><ul><li>Quality systems management is critical </li></ul><ul><ul><li>Documentation, e. g, batch records, analytical reports, lot numbers are assigned </li></ul></ul><ul><ul><li>QC & QA </li></ul></ul><ul><ul><li>Facilities and environmental monitoring, equipment validation, cleaning control, etc. </li></ul></ul>
  10. 10. Finished Product <ul><li>Purified recombinant protein is placed into final container via a “sterile fill” process </li></ul><ul><li>Vial or package are given lot numbers and labeled according to licensing requirements </li></ul><ul><li>Finished product is shipped from manufacturer to drug distributors and then sold to public </li></ul><ul><li>Microbiological testing, QC, stability testing and other QA functions are critically important and vital to insure product quality and safety </li></ul>
  11. 11. Conclusions <ul><li>The entire drug development process from discovery through licensing takes approximately 10-15 years </li></ul><ul><li>All aspects of development are very tightly controlled and highly regulated by cGMPs </li></ul><ul><li>cGMPs play a vital role in the production of safe and efficacious clinical materials and finished drug products </li></ul><ul><li>Mandatory adherence to cGMPs insures that product quality and safety is maintained through the lifecycle of an FDA-approved drug product </li></ul>

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