Digital Transformation of Drug Development and Market Access
Utilizing people, process and technology to deliver more effective treatments to patients faster
The biopharmaceutical industry is challenged by time. It takes 7 to 12 years to bring a new product to market, but once a patent for a new treatment is filed, there is 20 years of patent protection before the drug becomes classified as a generic and is open to replacement by biosimilars.
Due to increases in protocol and medication complexity, together with changing regulatory requirements, the time taken to develop an approved drug has extended by 25% in recent years, coupled with an increase in costs. So, we have more expensive development programs but less time to recoup costs before patent expiration. We cannot continue to develop new treatments using the same processes and expect to see time and cost reductions.
What is Digital Transformation?
Digital technologies, coupled with the appropriately skilled workforce and innovative processes, can transform clinical development, regulatory affairs and market access activities. Digital Transformation is defined as the application of digital capabilities to processes, products, and assets to improve efficiency, enhance customer value, manage risk, and uncover new monetization opportunities, where digital capabilities are electronic, scientific, data-driven, quantified, instrumented, measured, mathematic, calculated and/or automated (1).
By applying technologies such as wearables, artificial intelligence, cloud platforms, and advanced analytics, together with use of innovative processes (e.g. in-silico trials, adaptive trials and virtual trials) digital transformation in the biopharmaceutical industry can enable accelerated clinical trial outcomes and commercialize treatments with a higher likelihood of market success. Clinical development can be evolved from a sequential, phased approach into a parallel approach, with the potential to significantly reduce timelines and costs.
Where is PAREXEL applying Digital Transformation to its processes and helping sponsors to transform their business?
PAREXEL connects a broad range of technology solutions with our clinical, patient, logistical and regulatory expertise, helping you realize more business value at every step in your life sciences journey. Through our partnership with Microsoft, other leading technology providers and pharma companies, we are developing innovative capabilities using the latest technologies including cloud, artificial intelligence, machine learning, RPA (robotic process automation – software robots), wearables and mobile apps, coupled with our scientific, regulatory, clinical and logistics expertise to deliver pragmatic solutions to enable biopharmaceutical companies to develop and gain market approval for increasingly complex therapies while reducing development timelines and costs.