The role of clinical supply is a very crucial link in the supply chain, yet one that is often glossed over by other groups along that chain. Many decisions are made upstream that have direct impacts on what can be done once a project is handed off to you and your team, without much consideration to the impact it has on the management of trials as it relates to dosing, formulation, delays, vendor selection, and perhaps most critically… milestones.
One of the main goals for the Sponsors clinical supply group, and impactful to the entire company goal tracker, is First Patient In. FPI has become one of the key markers for venture capital directors and corporate heads looking to set milestones for goal achievement. Unlike many other milestones and achievements, FPI is an easy metric to track: “Did the patient receive drug on July 1st? Yes or no?” The answer has significant implications, not just on the company tracker, but all the way to Wall Street and beyond. The bonuses of the entire company often rest on your shoulders.
Tracking toward the FPI is therefore a critical part of supply chain management, as predictable and unpredictable factors can push back the supply chain. A vendor’s ability to provide what they promise, and overcome unforeseen challenges, can between the difference between making the FPI or not.
So why are FPIs sometimes disregarded by clinical supply groups?
Anyone who has worked at smaller Pharma can tell you: Many Clinical Packaging Organizations (CPO’s) prioritize larger clients, keeping them happy at all costs – often at the expense of smaller trials’ timelines.
Every year, large CPO’s – companies with stockholders – need to improve profitability over the previous year to meet corporate goals. This is a considerable factor in prioritizing where resources (such as open rooms or packaging technicians) are placed. Prioritized work that was profitable “enough” in, say, 2015 is now deprioritized and put into less desirable slots because the percentage of profitability no longer meets the new priority/profitability model. If a job or a shipment requires overtime, that work does not get done today. Maintaining HIGH profitability, not just profitability, is priority.
Growth rates set by corporate are prioritized, as well. Large vendors are under tremendous stress to grow at or beyond reasonable limits each year. Even when operations are at capacity and timelines are slipping, the sales team is pushed to close bigger and more elaborate new work without consideration to the actual capacity. (When was the last time a large vendor turned down a phase III?)
Larger CPO’s are also known to have some tolerance for delayed shipments; with ten percent or so of kits routinely delayed by a day or so. These are short delays experienced by a small number of clients, yes, but those clients are likely operating within tight schedules. One short delay can push their drugs past FPI dates.
Finally, larger companies don’t always take kindly to changes mid-process, and won’t necessarily hustle as needed to accommodate changes inherent to clinical drug trials. Flexibility is an asset for vendors of small and mid sized pharma.
All of these realities put smaller trials at risk – unnecessarily. This is why Xerimis’ developed our zero missguarantee: Assuming our customers deliver on their milestones, Xerimis will never be the reason an FPI is missed. In fact, we might be the reason you make it
This promise stems from our thoughtful forecasting and refusal to overpromise. We assess timelines beforeaccepting work, letting clients know before they commit to us if we think we cannot meet their intended FPI. With Xerimis, ALL jobs are based on FPI and patient visit priority, not a preferred priority contract. No one gets de-prioritized. We do what’s needed, often at the expense of profitability, to help every client make FPI: Allpackaging runs are prioritized over profitability, which means shipments are never delayed. If another client has an urgent need, there’s no impact on your timeline. We add resources and adjust as needed.
When our clients do miss their own internal milestones during the packaging process, we do everything in our power to accommodate. We make up time for you in a way that other companies don’t or can’t.
Xerimis’ agility is the key reasons we always meet FPI, and is driven by our understanding of the stakes at hand. In our current industry, small studies may consist of a few hundred vials containing two thousand dollarsworth of material each. In other words, no detail can be taken for granted. We understand this. And beyond hitting FPI dates, our agility has other benefits for clients.
Upchain delays and client preferences shouldn’t keep entire trials from succeeding. Xerimis refuses to let our customers feel the burden of the inevitable shifts and changes that occur during a clinical trial. Even more, we refuse to play favorites. Every Xerimis client is a client whose FPI we protect and prioritize, as reflected in our zero miss guarantee.