How New Drugs or Devices are Made
Drugs and biologic products are usually created in three stages: Discovery, Development, and Marketing. Medical devices follow similar, but not identical, steps.
Many drugs and devices fail during Discovery or Development and never make it to market.
Drug Discovery involves screening, identification, and synthesis of chemicals to evaluate their use as new medications. It involves people from a wide range of scientific disciplines such as biology, chemistry, pharmacology, computational sciences as well as patent attorneys. During Discovery the drug is not given to humans and regulatory agencies like the FDA are not involved in overseeing the Discovery process.
Biomedical engineers play major roles in the discovery and creation of medical devices.
Because studies during the Discovery stage are not conducted in humans, there is no need for regulatory approval and the FDA does not get involved.
If a drug looks promising during Discovery, the company will move the drug into the Development process a program to conduct more tests in the laboratory, in animals and in humans to see if the drug will be safe enough and effective enough to be marketed as a drug product.
Since this will require studies in humans, the company must get FDA approval to do these studies. To get FDA approval, the company must file an IND (Investigational New Drug) application and submit the information that they have collected so far that suggests that the compound might be useful as a drug. (see the Regulatory Background tab for more information). During Development, teams of scientists and clinicians take a chemical or device that has been identified in Discovery and put it through a series of tests to see if it will be safe and effective enough to use as a medical treatment. These tests include "non-clinical" studies of safety and pharmacology in the laboratory and in animal models; and "clinical" trials, where the drug is tested in people. Clinical trials help the company learn if the drug is safe and effective enough to be submitted for FDA review. The testing usually takes several years. After all the studies are completed, detailed summaries of all the clinical trials are submitted to the FDA in a New Drug Application (NDA). After reviewing this information, if the FDA agrees that the product is safe and effective enough, it can be marketed as a new drug or device.
The clinical trials may be conducted in the United States or in other countries with similar health care practices. The US Food and Drug Administration is the organization that approves drugs for use in the United States.
Development requires input from pharmacologists, toxicologists, physicians, clinical monitors, drug manufacturing and packaging, regulatory affairs, project managers, and product development advisors.
Once a drug is approved by the FDA, it can be sold in the United States. Other counties have similar regulatory organizations and similar requirements for clinical trials and regulatory review before marketing.
The commercial stage of distributing and selling drugs requires support from sales and marketing staff, who usually have scientific training; medical writers; physicians and pharmacists who work as drug information specialists; post-marketing safety monitors; manufacturing; packaging; attorneys; and regulatory directors. This creates many job opportunities.