Once a drug receives regulatory approval, the clock starts ticking to get high-quality products packed, shipped, and available on the market. At this critical stage, the consequences of poor alignment with a CMO earlier in the development cycle come to light, while agency and compliance-related chokepoints have the potential to trigger unexpected delays. These challenges 鈥� and how to avoid or mitigate them 鈥� are explored in episode four of Sharp鈥檚 Our Experience is Your Strength podcast.
Episode 4 鈥� Managing your commercial drug launch 鈥� the good, the bad & the crazy!
In this episode, two of Sharp鈥檚 experts draw on decades of pharma packaging experience with Steve Jacobs to discuss effective handovers between clinical and commercial, the best time to start planning for a product鈥檚 launch, and key factors and considerations that can compress 鈥� or extend 鈥� timelines.
鈥淪uccessful launches demand both expertise and agility,鈥� says Sharp鈥檚 Chief Commercial Officer Jeff Benedict 鈥淚t鈥檚 not just about meeting the urgency of launch 鈥� it鈥檚 also about collaborating and planning for what comes next, ensuring long-term scalability and supply.鈥�
Above all else, Tonya Schmouder, Strategic Client Relationship Manager at Sharp advises to communicate a clear launch and post-launch plan with everyone involved and never underestimate the time needed for proper planning. 鈥淎lways start planning well earlier than you think you need to,鈥� she ultimately advises.
With real-world insights, behind-the-scenes stories, and practical advice, this podcast sheds light on the critical transition from development to launch 鈥� and how the right partnerships combined with proactive planning can mean the difference between costly delays and seamless market entry.
This is the fourth instalment in a series by Sharp, titled Our Experience is Your Strength. Across the episodes, host Steve Jacobs is joined by seasoned experts in formulation, sterile manufacturing, clinical supplies, commercial packaging, and sustainability to explore a range of challenges across drug development and commercialization, with a focus on getting the best results through contract services. Each episode draws upon key learnings gathered across Sharp鈥檚 70-plus years of experience as a CDMO, helping to set listeners up for success with their chosen vendor.
