Manufacturing Revolution In Life Sciences: Safeguarding Your Data As You Try To Get Ahead

By Petter Moree, Industry Principal, OSIsoft

Long timelines and high costs have always been challenges pharmaceutical companies had to face while navigating the path of bringing a new drug to market, which is estimated to take an average of at least 10 years and $2.5 billion.¹ Now, as the industry transitions from blockbuster drugs to niche drugs for smaller patient populations, competition is fiercer than ever. Manufacturers are in a high-stakes race to market with every step – and any delay – impacting their place at the finish line. This is compounded by the fact that only 1 in 5,000 molecules created actually get commercialized.²

To stack the odds in their favor, manufacturers are investing heavily in R&D to identify and pursue any drug candidates that show promise during the early stages of development. Moving to the next phase with those that do requires enough material for the clinical trial phases, which is often limited. For any company without the internal resources or capacity to produce these materials, working with a contract manufacturer (CDMO or CMO) may be the fastest and most economical option to get ahead. One may even decide to continue this relationship into commercial manufacturing. But what risks do manufacturers face when they put the future of their company in the hands of the partner, specifically when it comes to maintaining the data integrity required for quality and regulatory compliance? And more importantly, how do they safeguard it?