Webinar on October 19 @ 11a-12p Eastern Supply Chain Planning for Today's Uncertain World Read the Event Recap Supply chain leaders in life sciences companies operate in a highly uncertain environment. Commercial and regulatory uncertainty is now compounded by the risk of supply disruptions and geopolitical barriers. For companies [...]
Event Recap: Building High-Touch Patient Supply Chains Patient Outcomes: A Shift in Industry Focus The healthcare industry is increasing use of patient outcomes as a measure of quality and value. This drives biopharmaceutical companies to focus on patients in their commercial operations, technical operations, and supply chain. It was first prioritized [...]
Benefits of Using Foreign Trade Zones for Emerging Biotech Companies We often see clients incurring high duties on importing key starting materials into the US. For emerging companies conducting R&D, paying duty on each import can significantly impact cashflow, sometimes measuring in the hundreds of thousands of dollars. This impact is amplified [...]
PDF Available > Planning for, establishing, and managing the Clinical Supply Chain has its own set of challenges – regulatory requirements, clinical uncertainties, nuances of sourcing drug substance and API material, and logistical constraints including access to new points of patient care. Clinical supply leaders need to manage all of these while ensuring quality [...]
Today’s biopharmaceutical supply chains often stretch around the world. Key starting materials (KSM) and API originate more frequently from Asia. Manufacturing is commonly conducted in Europe and North America. And commercial distribution is spread across the globe. This globalization has resulted in increased logistics and global trade compliance (GTC) complexity along with ever-changing import/export [...]
Emerging pharmaceutical companies frequently place responsibility for clinical supply chain management on their clinical operations team and CROs. This approach can work initially for small, resource-constrained organizations. However, it does not help companies build the internal capabilities, knowledge, and resources to successfully run their clinical supply chain over time as they grow. One [...]
A cancer treatment company with a strong development pipeline had more than a dozen clinical studies in process and that number was growing. A lean team was managing everything and, like many emerging biotech companies, relied on CROs for many clinical operations activities. As those programs progressed through development, our client was dealing [...]
Introducing Demand & Operations Planning Assumptions and decisions built into clinical trial design have a major impact on emerging companies’ capacity planning and supply strategy. Protocol changes affect enrollment rates, production volumes, regulatory activities, logistics and managing data. It makes planning particularly challenging for both clinical and commercial production. Our client was [...]