Planning for Successful Product Launches
Summary: There has been increased focus and efforts on developing treatments for diseases with smaller patient populations, diseases for which there are no currently approved treatments, and diseases that have historically not prioritized by the pharma industry. Accelerating the approval process offers significant benefits, both for patients and for the drug innovators, but the reduced timelines can create significant challenges for product development, cGMP manufacturing, and scale-up, and alignment with any outsourcing partners involved in the project.