In an industry as competitive as the pharmaceutical industry, innovation is the best strategy for success. Unfortunately, innovation in this industry is a challenging process. The drug development process is a long, taxing, and exhaustive process, regardless of the size of a company. Although the process becomes easier with more available resources, workforce, and a better understanding of the regulatory requirements, many major pharma companies may still struggle to complete the process without experts’ guidance.
The drug development process across the world is divided into various phases, starting from drug discovery to post-marketing safety surveillance. There are five phases of drug development in the United States, including discovery, research, and acquiring regulatory approval from the US Food and Drug Administration (FDA).
Many top pharmaceutical companies leverage market research services and product research solutions to ensure an effective drug development process. In this article, Infiniti’s experts discuss the five phases of the drug development process and the value of product research services during each phase.
The pharmaceutical industry is highly competitive, and companies must prepare for every aspect of competing in this market. Speak to our industry experts to learn how Infiniti’s solutions can help pharmaceutical companies stay ahead of the curve.
Five Phases of the Drug Development Process and How Infiniti’s Product Research Services Can Help
Infiniti’s experts analyzed the drug development process in the US pharmaceutical process and identified the following five phases of drug development:
Discovery and Development
The first phase of the drug development process is the discovery of a hit compound. Academic and industry scientists identify a potential target for any disease and aim to discover and develop a compound that can alter the druggable target activity. A target is considered druggable if it can be changed or treated by therapeutic agents. Various screening methods such as phenotypic screening or fragment-based screening are then used to identify a hit compound, and the effect of the said compound is analyzed. Multiple hit compounds may be used to address the same or various druggable targets for a disease. To determine the drug candidate that the scientists choose to take forward as a clinical candidate, they must ensure that it affects the selective target, generates the desired effect, and has adequate bioavailability. Additionally, it must have a toxicity profile, manufacturing suitability, and cost-effectiveness.
Product research solutions enable companies to evaluate and understand this phase of discovery and development. With advice from Infiniti’s product research experts, companies gain in-depth insights into the scalability of the clinical candidate and illustrative guidance regarding the cost-effectiveness of their drug. Additionally, with data-driven insights, scientists can identify unmet needs and target the ideal population, and companies can analyze competitors’ targets.
The second phase of drug development involves proving the efficacy and safety of the drug candidate. In vitro and in vivo testing methods are utilized to study the candidate’s biological effects. This includes testing animal models and evaluating the impact on a species with a similar genetic makeup. To acquire approval from regulatory bodies, such as the US FDA, it is crucial to conduct this research while considering species-specific physiology and sex-specific responses in the animals. The FDA provides a specific set of regulations for the second phase of the drug development process. These regulations include basic requirements for personnel, facilities, equipment, and more. While preclinical studies are short, they must provide information regarding toxicity and dosing levels. This helps the researchers determine if the drug candidate meets preclinical requirement levels and can be tested on human subjects.
With guidance from product research experts, researchers and companies can attain crucial information regarding regulatory requirements. They can also understand the strategies, technologies, and equipment leveraged by their competitors, and always remain a step ahead. Additionally, product research solutions can enable companies to identify gaps in their offerings or operations and address them by developing data-driven strategies.
Designing an effective clinical trial requires rigorous research, planning, and studying. Researchers must develop a specific protocol or plan, review preliminary information about the clinical candidate, and accordingly develop research questions and objectives. This information helps the researchers decide various important factors, such as selection criteria, number of participants, length of the study, administration and dosages, methods of collection, and data analysis. One of the crucial stages of the clinical research phase is submitting an Investigational New Drug (IND) Application. There are three kinds of IND applications, investigator, emergency use, and treatment. The FDA team has 30 days to review the IND application and respond in one of two ways, approval, or a clinical hold to delay or stop the investigation. The clinical research stage of the drug development process has between three to four phases within it, which depends on the protocol decided by the researcher. Obtaining guidance from the FDA at this stage of the process is possible, including extensive technical assistance, if a drug developer chooses to leverage the aid.
Infiniti’s product research experts can enable companies to design an effective clinical trial protocol, gain a comprehensive understanding of the FDA guidance and approval requirements. Further, researchers can analyze and evaluate the factors being taken into consideration regarding the clinical trial design with expert guidance. Additionally, the drug developers will receive recommendations and directions regarding the crucial IND application.
The drug development process is challenging and long drawn. To learn more about the process, and overcoming obstacles with product research solutions, request more information.
FDA Drug Review
Once a researcher or company has evidence regarding the drug’s safety and efficacy, they may file a New Drug Application (NDA) to market the drug with the FDA. This application includes all the relevant data from the preclinical and clinical research phases. The application should consist of details regarding the proposed labeling, safety updates, drug abuse information, patent information, directions for use, and more. The FDA then reviews all the details of the application. In the case that the application is incomplete, they will refuse to file the NDA. If it is complete, the FDA review team can take between 6 to 10 months to review the drug and the data and decide to approve it. This process includes a thorough review of each section by the relevant team member, routine inspections of clinical study sites across the country, and the compilation of all reviews and documents into an “action package.” Often, there is a set of issues that need to be resolved before the FDA approves the drug. In certain cases, resolution may include conducting more studies, at which point the drug developers can decide if they want to complete the drug development process. In particular situations, the FDA may approach their advisory committees for independent, expert inputs and advice, including a representative to provide the patient perspective.
Infiniti’s product research solutions can enable drug developers to ensure the NDA is complete and qualifies for all the regulatory requirements. Additionally, our experts can provide researchers with crucial information regarding other patents in the market and the patent process. Product research solutions also help developers understand the patient’s perspective, ensure that their drug fulfills unmet needs, and is positively received by patients and representatives.
Approval and Post-Marketing Safety Surveillance
Once a drug has been approved, and companies begin manufacturing and marketing, the FDA continues to survey the drug in the market. This includes the announced or unannounced inspection of manufacturing facilities and regulations regarding prescription drug advertisements and promotional labeling. The post-marketing safety surveillance aims to evaluate the long-term efficacy and safety of the drug, potential problems that could arise outside of a controlled environment, and possible use for unapproved conditions. The FDA also has various programs that allow professionals, consumers, and manufacturers to report any issues associated with a drug. Additionally, the introduction of the Sentinel Initiative enables the FDA to use major existing electronic health databases to spot safety issues easily.
Product research solutions enable drug developers to stay a step ahead of the FDA regulations and ensure their drug meets all the requirements. Infiniti’s experts can also guide companies regarding the compounds, packagers, and manufacturers to ensure post-marketing safety with well-researched insights. Manufacturers can also learn about the ideal equipment and technologies for manufacturing the drug and the FDA regulatory requirements.
Infiniti’s product research solutions can enable companies to overcome the difficult drug development process’s various challenges. Our experts provide insights regarding regulatory requirements, ideal technologies, competitors’ strategies and patents, and consumers’ unmet needs. This offers companies and researchers a substantial strategic advantage, a clear plan through the five phases, and the post-marketing and manufacturing stages. With expert insights, experienced advice, and crucial data, drug developers can prepare, implement, and complete an efficient and safe drug development process.
Infiniti’s product research solutions can enable companies to overcome the drug development challenges and establish themselves as industry leaders. Request a free proposal to leverage Infiniti’s data-driven insights, expert guidance, and unparalleled strategies.