Drug developers are finding it difficult to navigate obstacles during the Covid-19 outbreak. The pandemic has forced the pharmaceutical industry to come up with innovative solutions for the discovery and development of drug products while simultaneously coming up with alternative ways to carry out existing trials to suit the current environment. As the demand for sophisticated and custom-made solutions increases, the development of biological molecules and vaccines will need appropriate immunology, analytical and bioavailability of drugs.
The role of bioanalytical assay validation services
The pandemic has forced several biotechs and pharma companies to reduce their operations. However, many of their research and development projects are still in progress. Such uncertain times mean companies have started outsourcing more drug-related work, typically bioanalytical assays that they used to keep in-house. Particularly bioanalysis method validation services have been a boon in such challenging times, as they provide bioanalytical method validation and accelerate project timelines. Additionally, during the Covid-19 pandemic, assay validation services are helping companies develop assays for the rapid development of vaccines and therapies.
Today whatever is remotely possible is done remotely. Even in drug development, the pandemic has instantaneously changed the whole drug development process. Bioanalytical assay validation providers have enabled remote monitoring of bioanalytical assays. Such remote monitoring has facilitated quick and efficient assay transfer among laboratories. For smooth and reliable remote monitoring, internal study monitors with remote review and site auditing have established confidence among sponsors. Besides, sponsors are kept updated with the release of several virtual content such as articles, podcasts, white papers, webinars, and videos.
Enabling real-world evidence
With the necessity of time, both the companies and regulatory bodies are increasingly showing pragmatism in real-world evidence and post-marketing surveillance. A mixture of a global pandemic and lack of robust real-world data has further strengthened the need for urgent and actionable information. Bioanalytical validation services have helped fill this void of assay development by providing robust and reliable bioanalytical method validation. They have made full use of this pandemic, further boosting its reliability to deliver what policymakers and regulators need.
Currently, several pharmaceuticals and biotech companies are using real-world data for identifying drug and treatment options in the Covid-19 space. Regulatory bodies have now recognized that data collected from traditional randomized trials on drug products and therapeutics need additional support from real-world data. If drug companies can make use of this moment and come up with innovative solutions, the entire healthcare system will experience an accelerated drug development process without the need of sacrificing key aspects of efficacy, safety, and affordability.
The solution
Bioanalytical assay validation services and bioavailability testing have helped build transparency in regulatory-industry communications, making the bioanalytical method validation process more open and less formal. The Covid-19 pandemic has shown us the actual picture of our healthcare system, and the sooner drug developers and pharmaceuticals adapt and speed up, the more robust and reliable drug products will come to the market. If all participants can efficiently collaborate to bring drug products in such uncertain times, we would be better equipped to face any such obstacles in the imminent future.
