Despite breaking global sales records in 2015, biopharmaceutical companies are witnessing a slowing in growth and are under increasing pressure from payers and competitors to reduce costs. Compounding this, a recent study has found that the average cost of new drug and biologics development is now in excess of $2.5 billion, and growing at a rate of more than 8% per year.
Cost reduction initiatives in R&D organizations frequently focus on the potential benefits of process improvements such as enhanced monitoring and improved QC of raw materials but often overlook the impact of better data management. Those that do typically focus on achieving efficiency gains by transitioning from paper to electronic systems but while such a transition has been demonstrated to save time3, efficiency gains are only beneficial if any time saved is used productively.
This whitepaper introduces the concept of the electronic Development Record (eDR) and how a holistic, platform approach to the capture, management and re-use of product and process data can propel the development process forwards, reduce costs, improve quality and enhance corporate image.