The website explains in detail how the drug development takes place and how investments made in pharmaceutical companies are affected by this process. The website begins by asserting that there is higher probability of getting 12 male children in a row than a drug seeing the shelf of a pharmacy (Williams par. 1). With that noted, it is therefore imperative for an investor in the health sector to understand the dynamic of drug-manufacturing.
The initial stage is the drug discovery which involves identify a molecule e.g. a protein or gene that participates in a disease (Williams par. 2). If the molecule is involved in the disease, the process moves to the next step i.e. preclinical testing. Preclinical testing is further divided into two stages; in vitro and in vivo testing (Williams par. 3). In vitro testing is conducted in test tubes while in vivo testing is done on animal model, after satisfactory results in in vitro testing (Williams par. 3). The preclinical stage is done to ensure that the drug is safe to be conducted on human subjects in the clinical trials (Williams par. 3). If the preclinical testing, which usually take up to four years, is not successful, the drug manufacturer will not advance the drug.
After successful preclinical trials, the manufacturer moves to file the investigational new drug application (IND) with the Food and Drug Administration (FDA) (Williams par. 4). The FDA will examine how the molecule works and how it is produced. Once approved, the drug moves to Phase 1 of clinical studies. This phase is conducted on a few healthy subjects. In spite of many investors increasing their stock on biotech companies after successful Phase1, the phase is not intended for efficacy but ascertaining the appropriate dosage (Williams par. 4). Phase 2 involves a larger number of people and actual patients of the disease are introduced as subjects. This stage examines the possible side-effects, safety and dosage of the drug. Satisfactory results of stage 2 encourage investors to increase their investments.
After this, the manufacturer meets with the FDA to lay down the efficacy and safety criteria of assessing the drug in Phase 3 (Williams par. 5). The failure rate at Phase 3 is substantially low. A successful Phase 3 will see the increase in stock value of the company. Failure at this point will be very disappointing as most drug usually take up to ten years to reach this point.
The final point will be to file for new drug application (NDA). The FDA will review the application within ten months. However, certain urgent applications are reviewed within six months (Williams par. 6). The FDA can either; approve, reject or reject and lay out some concerns that need to be addresses before the drug is approved.
Work Cited
Williams, Sean. "The Drug Development Process Explained In Detail And How It Impacts Your Investments -- The Motley Fool". The Motley Fool. N.p., 2016. Web. 10 Aug. 2016.
