Updated: May 11
As we watch researchers work on developing a COVID-19 vaccine, have you wondered what steps there are prior to hearing "APPROVED"?
The drug development process relies heavily on 5 keys steps whose adherence dictates the chances of acquiring the regulator’s approval. While this article uses the FDA as its example, there are many nuances to the pathway depending on the type of product you are bringing to market and what part of the world you are registering the product in.
In the quest for serving humanity, doctors strive for an opportunity to make a greater impact on the lives of the generations of today & tomorrow & developing newer drugs & treating untreatable ailments is the righteous approach.
1. Discovery & Development
The drug discovery depends entirely on identifying the need for drug development & should be backed up by an in-depth study of the disease progression. The need for discovering a new drug is contingent on the intensity, severity, and present-day applicable treatments of the disease. The drug discovery deals with evaluating the potential impact of the drug on stopping or reversing the adverse effects of the disease. A new discovery becomes a mere necessity in an event where existing treatments appear to have unanticipated effects. The final research deduces a confined list of promising compounds having the potential of providing acceptable treatment of ailments without having severe adverse effects.
The next phase of the first step is the development of such a drug whose compound aces through the initial testing of the discovery phase. The chemical properties of the drugs are studied in order to acquire a better understanding of its absorption, distribution, & excretion pattern. The dosage, application, & evaluation of adverse effects are all studied in this phase.
2. Preclinical Research
Prior to the clinical research, the researchers are obligated to conduct preclinical research in order to evaluate its harm-causing potentials & toxicity levels. The two types of preclinical research include in vitro & in vivo. The former deals with laboratory testing while the latter comprises experimental investigation on living organisms. The FDA requires the researches to adhere to the guidelines provided by Good Laboratory Practices (GLP) which are defined in medical product development regulations for preclinical laboratory studies.
The preclinical study is an important phase of the drug development process whose implementation is needed for moving onto the next phase of clinical studies. The preclinical studies are not extensively large and are primarily conducted with an aim to provide precise & accurate information about drug dosage & toxicity levels. The results & findings of preclinical testing determine the need for further testing & clinical research.
3. Clinical Research
The preclinical success leads to in-depth clinical research conducted to study the behavioral response of the drug on the human body. The clinical research is sub-divided into phases each having a predefined set of aims & objectives. The clinical researches comprise 4 developmental phases whose aim is to study the safety & dosage, efficacy & side effects, efficacy & adverse reaction monitoring, and safety & efficacy.
The researchers are also responsible for designing clinical trials based on the industry’s standards established for the evaluation of a drug’s response on the human body. The clinical research follows up the inaugural Investigational New Drug Process (IND) which serves as a mandatory part of the drug development process.
The researchers require to submit the IND application to the FDA prior to embarking on the clinical research. This IND application includes animal study data & toxicity, manufacturing information, clinical protocols, previously conducted human research data, and the information about the investigator. The FDA is keen to assist the investigators & developers every step of the drug development process. In terms of inspection, the FDA IND Review Team comprising Project Manager, Medical Officer, Pharmacologist, Statistician, Pharmakineticist, Chemist, and Microbiologist takes up around 30 days to review the initial IND submission.
4. FDA Drug Review
Following the successful preclinical & clinical researches, the drug development files the New Drug Application (NDA) demonstrating the safety & efficacy of the drug. The NDA comprises experimental study reports, analytical data, and clinical results. From the date of the submission of New Drug Application, the FDA review team takes up a period of 6 – 10 months to grant approval based on the success of the inspection. The “Labelling Phase” follows the successful review and the drug is said to be approved for marketing.
The unapproved FDA reviews usually require additional experimental studies & claim resolutions and serve as the basis for further development. In the case of disagreement between the developer & FDA review team, the developer can file a formal appeal for the drug approval.
5. FDA Post-Market Drug Safety Monitoring
FDA continually inspect & reviews the efficacy & safety of the drug in order to acquire a better understanding of its effectiveness. Any further changes in the originally submitted NDA requires the approval of the FDA. The drug manufacturing factories are also continually inspected by the FDA in order to ensure the developers are abiding by good manufacturing practices.
The FDA does also hold the right to shut down the facility if it fails to meet the minimum standard criteria. Furthermore, every new drug is patent protected and only the sponsor holds marketing & distribution rights. The drug manufacturers work on wide-scale development of drug after the expiration of the patent.
There are many different groups that are working to create a vaccine for the coronovirus. Here is a site that tracks them.
Want to learn more about what it takes to commercialize your biotechnology idea? Click here.
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