Evaluation of Pharmaceutical Drug Development Lifecycle
摘要
Value in healthcare is the measured improvement in a patient’s health outcomes for the cost of achieving that improvement. The goal of value-based care transformation is to enable the healthcare system to create more value for patients. The pharmaceutical industry is very conscious of any development efforts that can help reduce costs and minimize the time it takes for the products to reach the commercial market. Similarly, numerous opportunities exist to help enhance the value proposition of pharmaceuticals. Among all the opportunities, product design, development, and manufacturing play a significant role. A shining example of the impact of pharmaceuticals on the society was witnessed recently. The year 2020 has been challenging in all socioeconomic aspects. Not only had the COVID-19 pandemic devastated the global economy, but it also bared the fault lines that continue to exist in society. Our combined fragility has never been as evident as these current times. On a positive note, though, this pandemic has also allowed us to reset our thinking about global health systems and sincerely evaluate their sustainability. The speed by which the mRNA vaccines were developed and introduced globally is something we in the pharmaceutical industry should be very proud of. The mRNA vaccines represent a promising alternative to conventional vaccine approaches because of their high potency, capacity for rapid development, and potential for low-cost manufacture and safe administration. Recent technological advances have largely overcome these issues, and multiple mRNA vaccine platforms against infectious diseases and several types of cancer have demonstrated encouraging results in both animal models and humans. However, other aspects of drug development, such as discovery, clinical trials, manufacturing, and regulation, have also seen significant positive changes in the last few years. For example, the philosophy of patient-focused drug development (PFDD) and modernization of pharmaceutical manufacturing provides a new template for product development that hopes to reduce drug development time and make it more cost-effective. Therefore, a review of the current state of the pharmaceutical industry is important as the battle against disease is far from being won.