Member Wendy Upchurch introduced our speaker, her husband David Upchurch.  David is currently with Jaguar Health but has been in the pharmaceutical industry for over 25 years.  He spent 15 years with Gilead Sciences. His topic, “Putting the Pill in the Bottle”, took us through the lengthy and complicated development of a drug from discovery and concept to the shelf of your local pharmacy.  David explained the stages beginning with basic drug discovery into pre-clinical development and toxicology testing.  At this point it can be presented to the FDA for an initial drug approval.  Once accepted the process then moves to vigorous phases of testing.  Phase I testing is done in healthy human volunteers to insure the drug “does no harm”.   Phase II tests its efficacy with a larger sample of volunteers.  In Phase III the new drug goes up against a placebo to demonstrate its superiority.  The process to this point can take anywhere from 2 to 5 years.  If these are all successful the developer goes back to the FDA with their NDA (New Drug Application) which can take from 3 to 24 months for approval.  Then comes the final launch.  But this is no picnic.  In this highly regulated industry there is a specific process, much of it outlined both in the NDA and regulations, related to packaging, shelf life, distribution, traceability, temperature and anti-counterfeit protocols.  David showed us some of the sophisticated equipment necessary for creating the tablets.  If all goes well your local CVS will finally have this new drug on its shelves.  Thank you David for giving us a new appreciation of what goes into creating the next “miracle” drug.