By Barry Rosenblatt, Ph.D., President, SME Biotech Consulting and Dave Kenyon, Ph.D., VP, Process Sciences Pharma Services Patheon
The biologics market is quickly evolving from a focus on developing blockbuster drugs to exploring niche markets with unmet needs. While the changes are exciting, they pose several risks to a molecule’s success as competition intensifies, timelines shorten and capacity challenges emerge. Yesterday’s solutions may not be a perfect fit for today’s molecules.
Given this backdrop, biopharmaceutical companies are increasingly looking for new strategies to bring biologics to market quickly and cost effectively. Companies must carefully assess whether their in-house teams can truly deliver everything a project needs to be successful-from accurate supply forecasting to successful IND submission to meeting aggressive timelines. In doing so, biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business.