Over the last 2-3 decades, the number of new drug products entering the market is slowly decreasing. Today t drug developers are increasingly pressured to introduce novel drug products for multiple diseases and medical conditions. However, drug developers must also focus on reducing costs and expenditures while ensuring new drugs are developed for specific medical conditions. Although rising costs are generally the primary trend, increasing regulations, reimbursement challenges, recruitment and retention, and generic competition are other factors affecting the entire process of drug development.
Earlier mergers between different companies gave rise to mega giants such as Pfizer. Such consolidation initially proved cost-efficient. However, they still needed to address the underlying challenges of the organic growth of drug products. This trend was then followed by the merger of pharmaceutical and biotech companies. This merger gave rise to the success of biologics and other promising therapeutics. However, these companies still face challenges while developing biotechnology and pharmaceutical products. Hence, the current article addresses key considerations and challenges in each phase of drug development.
Challenges and Considerations in Drug Development
Today drug developers employ multiple bioanalytical methods, including multiplex cytokine assays, multiplex ELISA assays, custom Luminex assays, and LC-MS systems. These methods require intense development and validation. For example, LC-MS validation will need technicians with expertise in LC-MS assays. Hence, drug developers should continually invest and focus on acquiring expert talent and expertise.
Over time, regulatory requirements have increased progressively. This growth has increased both the length and size of clinical trials, eventually increasing the overall costs of the drug development process. Besides, more study subjects are needed for clinical trials to achieve the statistical standards of FDA requirements for demonstrating drug efficacy and safety. These demands have led to conducting clinical trials in different countries to increase the sample sizes, which have their own regulations.
Notably, there has been an increase in safety recalls of approved drugs. Such interventions have further increased the regulations around the risk profiles of drug products and the burden on clinical trials and post-marketing commitments.
When a patent for a particular drug expires, its sales drop exponentially. Hence, companies must have a contingency plan before the patent expires. Sometimes, drug developers focus on systems for patent expiry even before the product is released in the market. There are multiple strategies to protect a drug product, and the choice will depend on the intended pharmaceutical product. Some potential approaches include new formulations, licensed generics, combination products, and over-the-counter switching.
In-house development is generally achievable for large and medium-sized companies. These companies have the resources to build and monitor large research teams. This model has several advantages. Companies don’t have to reinvent their approach, and such a consistent strategy proves to be cost-effective. However, small biotech and pharmaceutical companies do not have the luxury of having extensive in-house research teams. Hence, many focus on outsourcing bioanalytical studies to contract research organizations such as Northeast BioAnalytical Laboratories to expedite their drug development process. Although outsourcing has multiple benefits for a small-size company, they also have some disadvantages going forward.