On average, more than a billion dollars are spent on developing a pharmaceutical drug. However, out of thousands of potential drug compounds, only a handful reach the market shelf. Despite technological advances in methodology and execution, the drug development process is still an expensive and lengthy effort. Pharmaceutical drugs spend multiple years passing through different phases of drug development.
As the demand for newer therapeutic products increases, drug developers must continue producing drugs that increase the quality of life of several patients. This pressure has further increased the burden on different drug development phases. Newer tools such as advanced LC-MS and ELISA methods have helped drug developers increase the chances of drug development success. However, these technological advancements cannot influence the efficiency of drug approval.
Hence, the current article highlights five key factors that determine drug approval efficiency. Although companies cannot control each aspect at the individual phase of drug development, these five factors can help mitigate most issues related to drug approval.
Portfolio strategy
Sponsors must have a robust methodology that defines the probability of regulatory, technical, and market access for the pharmaceutical drug product. Special care must be taken to reconsider incentives that may reduce the friction between the functional and company goals. This strategy helps in publishing correct documentation for regulatory clearance.
Innovative approaches
ELISA services and ELISA labs must help sponsors employ innovative tools in the drug development process. Besides, innovative approaches for analyzing the size of market segments can help monitor potential competition. Drug approval chances can increase when sponsors consider different perspectives involving market players, benefits, and risk opportunities.
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Analyze prospective drug products
Before commencing a drug development initiative, sponsors must analyze the disease of interest. Based on the initial assessment, sponsors can study the potential benefits and risks of the pharmaceutical drug. For instance, a disease with no available treatment will outweigh the potential risks to the patients. On the other hand, if a drug has potential side effects and there are already drugs available for the disease of interest, regulatory bodies may not approve the drug product.
Investigate the benefit/risk profile
Understanding safety and efficacy data are crucial for regulatory approvals. Sponsors conduct several preclinical and clinical trials before applying for FDA approvals. Data from these studies show how safe and effective the drug is for the intended population. Besides, sponsors must also assess the toxicity data and compare the drug with current standards. The regulatory bodies consider all these factors and weigh the benefits against potential risks before approving a drug product.
Management strategies
Almost all drugs have toxicity to some extent. Hence, sponsors must have adequate systems to mitigate these risks. In some cases, simple management plans will suffice. For example, generate a drug label describing side effects. On the other hand, more complex strategies will be necessary, such as implementing a Risk Management and Mitigation Strategy. A robust management strategy ensures that the drug development program does not slow down due to regulatory inefficiencies.
Therefore, to accelerate drug approvals, sponsors must emphasize the above five points to manage or prevent a slowdown of regulatory approvals.