Drug Development is a long process. It usually takes about ten years or more for drug discovery & development. Plus, a tremendous amount of investment is required to complete all the phases of drug development. Biotech and pharma drug development process succeed by shrinking the drug development timeline and redistributing their needs to a drug discovery CRO like northeast bioanalytical laboratories and various other services.
An Overview of phases of the drug development process
• Drug development costs range from $2 to $3 billion and may span from 7 to 12 years.
• Beginning with the drug discovery phase, critical steps include preclinical testing, Phase 1–3 clinical trials, FDA New Drug Application (NDA) approval, and subsequent Phase 4 clinical research.
• Academic entrepreneurs should understand each phase’s unique needs, their potential role in the process, and the services their academic medical center can provide.
Phases And Stages
- Step 1: Discovery and Development
- Step 2: Preclinical Research
- Step 3: Clinical Research
- Step 4: FDA Drug Review
- Step 5: FDA Post-Market Drug Safety Monitoring
Discovery and Development
Drug discovery can occur through different pathways. These include
1) repurposing an existing molecule;
2) creating variants of an existing molecule (such as through cis/trans isomers);
3) identifying a molecule that acts on a specific biochemical pathway (perhaps one that the academic entrepreneur has been researching),
4) finding a new compound in nature that humans or animals can use
Once they identify a promising compound for development, experiments are conducted to gather information.
Preclinical studies are in vivo studies. Initially, they are conducted on animals to test toxicology. Later, animal models of the disease allow for assessing disease-modifying effects. The purpose of this research is to obtain approval from FDA for an IND that will, in turn, allow for the study of human subjects.
They conduct experiments to gather information on:
- How it is absorbed, distributed, metabolized, and excreted.
- Its potential benefits and mechanisms of action.
- The best dosage.
- The best way to give the drug (such as by mouth or injection).
- Side effects or adverse events can often be referred to as toxicity.
Invivo testing is the testing done on animals. In vitro is research conducted in a laboratory.
Researchers design clinical trials to answer specific research questions about a medical product. These trials follow a particular study plan, called a protocol, which the researcher or manufacturer develops.
Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large-scale, Phase 3 studies. The above process is conducted in the bioanalytical laboratory; Northeast bioanalytical laboratories provide the best bioanalytical lab services.
FDA Drug Review
The FDA is a federal agency of the United States Department of Health and Human Services. It is responsible for protecting and promoting public health. To achieve this, the FDA controls the safety and effectiveness of all drugs.
After the FDA approves, the compound can be sold by the pharmaceutical company for the FDA-approved indications.