Biologics means big bucks and big rewards. The pharma industry is keen to capitalize on this success as revenues are tipped to reach over $407 billion by 2018. By this time, more than 50% of the top 100 selling drugs will be biologics. Sounds like an easy win—more effective treatments that are better tolerated by patients and a great return for development organizations. Think it’s an easy win? That depends. The development of new biologics is expensive and more unpredictable than traditional small-molecule research and development (R&D). The main challenge is defining a repeatable and consistent process, which all comes down to the data.
Researchers embarking on a new project are under pressure to meet ever-shorter deadlines and achieve certain milestones linked to funding. This means the data behind the science are often left to individuals inputting information into Excel. Once the research is complete, analyzing the information is like looking into a black hole, since it’s difficult to trace where the data came from.
Manufacturing, on the other hand, must ensure product consistency and quality to create a more repeatable process over time. Manufacturing is responsible for tight controls at the source to decipher variables and changes in conditions. Putting these controls in place becomes difficult when the starting point is already blurred.
If biopharma firms are looking to accelerate scientific innovation, they need to share and access information across the organization in a collaborative way. Automating these processes with the right technology, such as an effective data and work flow management platform, will speed up development through traceable and accurate information.
Discovering a new biological drug should lead to influential treatment. Individual ad hoc processes might work in the early stages, but they aren’t scaleable or cost effective. It’s about having consistency and data that are rich in context as well as quality because the end product can only be as good as the process it was based on.
Dr. Eliot Randle is Head of Global Solutions Consulting at IDBS; www.idbs.com.