Pharmaceutical Business Case Solution
Drug development plays a vital role in delivering effective and safe drugs to the world. The drug development cycle helps the whole world in introducing new drugs, which could save the patients and increase their life expectancy rates. Drug life cycles enables the world’s economies to maintain well-defined health standards in order to improve the living standards.
The economies are facing a strong need for the development of new drugs, just like the the Corona-virus Vaccine.Although there are different favorable treatments and therapies available, but still the shifting health trends and virus’ outbreaks requires the implementation of new and effective drugs.
However, developing new drugs is a very complicated and a very lengthy process. It is because of the reason that the development and application of drugs is difficult, as it takes a period of 10- 15 years to develop a new product.(McGrail, 2020) In addition, the drug development cycle is very uncertain as it comprises of different challenges, for instance: the downward market trends for a drug, identification of targets, increased cost and pricing pressures. In order to accelerate such a long and challenging drug development process; the pharmaceutical companies and the biotechnological firms must join hands by breaking the drug life components.
The Drug Life Cycle Process
The drug life cycle comprises of a lengthy period of 12-15 years, in order to introduce a drug into the market. Different pathways can speed up the drug development process for different diseases, such as: Cancer and AIDS. The complication level is very high to a extent that among thousand components of drug; only one is used for human testing and among five drugs, there are chances for one drug to get approved. In the United States, the drug development process is evaluated by the FDA (Food and Drug Administration).
From the above information, it can inferred that the control over the Research & development in the development of a new drug is very crucial for the pharmaceutical and biotechnological firms(Motley Fool Staff, 2016). Apart from the fast tracked drugs; it takes almost 12 years for a developed compound to return a percent of investment made into developing the drug, and sometimes the majority of these efforts go in vain as the investment does not produce any revenue at all.
The regulatory affairs are implemented in different parts of the world, in order to develop new drugs while maintaining the quality and safety standards. The Drug and the Cosmetics Act 1940 is practiced in India, the Food and Administration Act in United Sates and the Drugs Act of European Union and Australia, are followed to deliver the safe and effective drugs to the market(Manavalan, 2018). These all acts ensure the implementation of GMPs i.e. “Good Manufacturing Practices” in producing quality drugs.
The main concern of these acts is to ensure the quality production by looking at location and manufacturing facility’s surroundings, hygienic condition, water supply for manufacturing, waste disposal, clothing and sanitary requirements, equipment and facilities requirements for different dosage of forms,, medical services, packing, storage and labeling requirements etc. The countries follow the ICH (International Council for Harmonization) guidelines for maintaining the quality, safety and efficacy standards, in order to have an easy trading of goods between different countries.
The drug manufacturing organization must follow the ISO 9001; 2018’s standards, in understanding the organization, establishing Quality Management Systems, competency levels, quality policies, operational management and controls, product development and design, internal audit, performance evaluation, non-conformity and correction standards and in maintaining the continual improvement process. The pharmaceutical companies get the IS) 9001; 2015 certificate in order to ease the trade of their quality products. Similarly, the drug manufacturers must follow the ISO 14001; 2004 standards, which reveal that the drug manufacturing involves lesser pollutants.
Drug Life Cycle Components
The Drug life cycles involves six main components, which are defined as below:
Discovery refers to the process of discovering a new medicine. Drugs are discovered by the researcher through different sources. The outbreak of any disease allows the researchers to design a product, which could help in curing the disease and its potential harm to the community. For instance: the Covid 19 outbreak represented an urgent need for the whole world’s researchers to develop the Corona-virus vaccine, which could stop the several death rates caused by the pandemic.
In addition to this, the different tests of molecular compounds also enable the researchers to find out the potential benefits of the molecular compounds in dealing with a wide variety of diseases(US Food & Drug Administration, 2018). Discovery of new drugs is also done by the researcher through existing treatments, effects of which are unanticipated. The development of new technology also plays a crucial role is discovering new drugs. For instance, there are different modern technologies, which target the medical products towards specific body sites.
During the discovery phase, researchers have thousands of compounds as their candidates, which could be used as a medical treatment in future,but only a few compounds look attractive to researchers after an initial testing.
After the discovery phase and after finding the potential compounds for further development; the researchers start conducting experiments on gathering different information in order to find out the key benefits and implication of the discovered compound. The experimentation includes the identification of the compound’s characteristics, i.e. how the compound is absorbed, metabolized and excreted.
Secondly, the experimentation needs to find out the compound’s benefits and its mechanism related actions and quantity of dosage required to curb any disease. Moreover, the researchers need to find out the best ways for providing the drug’s dosage, i.e. whether the drug should be taken through mouth or nose or any other body part.
Moreover, the development phase involves finding out the adverse side effects of the discovered drug, which is also known as the compound’s toxicity. The compound is tested to know its effects over different groups of people.The groups include race, genders or ethnicity. Lastly the drug development phase finds the interaction of drugs with other drugs and the effects of the discovered components as compared to the similar drugs available.
- Preclinical Research
The researchers need to find out the toxicity and ability of drug to create serious harms if any, before testing the drug on a human. The preliminary research is comprised of two types, i.e. Vitro and Vivo testing. The Food and Drug administration has made a requirement over the testing laboratories to use GLP (Good Laboratory Procedures).
The GLPs are defined in the regulations of medical product development for the preclinical research. The basic requirements by the regulations include: conduction to be followed in the study, the usage of an appropriate personnel, equipment and facilities, operating procedures, quality assurance systems and generating the study reports. Although the preclinical research phase is not much lengthy, but it must provide details related to the toxicity and dosing information. The researchers decide whether to test the drug on people or not, after conducting their preclinical research and reviewing their findings.
- Clinical Trials
The preclinical research refers to determination of the drug’s safety, however it does not determine the interaction of a particular drug with the human body. The clinical research simply refers to the trials or studies made on the human body. Before designing a clinical study, the researchers must consider their objectives, such as: what they want to achieve at different phases of Clinical Research and consider the IND process (Investigational New Drug Process), before initiating the process on the people. The phases of the IND are described as below:
Firstly, the first phase involves designing of the clinical trials. These trials are used by the researcher to answers specific questions related to a product. A specific study plan, also known as protocol, is followed during the clinical trials. The prior information about the drug is reviewed by the researcher and the researcher further develops the criteria for conducting the clinical research, which includes:
- Selection Criteria about who will participate in the clinical research.
- What will be the number of participants for the study?
- The time period for conducting the study.
- Ways to limiting the research bias and using the control group.
- Identifying the ways for application and dosage of drugs to the patients.
- Determining what sort of assessments will be conducted and when and in what ways the data will be recorded, reviewed and analyzed.
The next phase follows the determination of the phase for the drug testing on the humans. The objective of this step is to determine the phase level for human testing. Generally, the clinical research is carried out through different phases, i.e. Phase 1 to phase 4, depending on the phase’s nature and the number of the participants.
Afterwards, the drug developers are advised to take advice of Food and Drug Administration over drug development, during any stage. The advice could be taken about the following the IND process guidelines and advise about the documents issued by the FDA over the drug development process……………………..
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