Revised on June 28, 2021
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 management of trials in relation to dosing, formulation, delays, vendor selection, and perhaps most critically, milestones.
One main goal for the sponsor’s clinical supply group is First Patient In (FPI), that monumental first dosing of an investigational drug product to a patient enrolled in the drug’s clinical trial. FPI has become a key marker 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 meeting this target.
So why are FPIs sometimes disregarded by clinical supply groups? There may be an expectation that FPI won’t succeed in the planned timeline, given supply chain unpredictability and concerns of vendors not providing what they promise.
Anyone who has worked in small pharma can tell you: Many contract packaging organizations (CPOs) prioritize larger clients, keeping them happy at all costs — often at the expense of smaller clients’ timelines.
Every year, large CPOs with stockholders need to improve profitability over the previous year to meet corporate goals. This is a considerable factor in prioritizing how resources (such as open rooms or packaging technicians) are used. Prioritized work that was profitable “enough” a few years ago may now be 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 may 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 sales 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 work without consideration to available capacity. (When was the last time a large vendor turned down a Phase 3 study?)
Larger CPOs are also known to have some tolerance for delayed shipments, with roughly 10% of kits routinely delayed by a day or so. Yes, these are short delays experienced by a small number of clients, but those clients are likely operating within tight schedules already. One short delay can push their study past the FPI date.
Finally, larger companies don’t always take kindly to changes mid-process, and they won’t necessarily hustle as needed to accommodate changes inherent to clinical drug trials.
All of these realities put smaller clients’ trials at risk unnecessarily. This is why Xerimis developed our zero-miss guarantee: Assuming our clients deliver their materials on schedule, Xerimis will never be the reason an FPI is missed.
This promise stems from our thoughtful forecasting and refusal to overpromise. We assess timelines before accepting work, letting clients know if we think we cannot meet their intended FPI. With Xerimis, all jobs are based on FPI and patient-visit priority, not preferred-contract priority. No one gets deprioritized. We do what’s needed to help every client make FPI: All packaging runs are prioritized over profitability, which means we never bump shipments. If another client has an urgent need, there’s no impact on your timeline. We add resources and adjust as needed.
If our clients miss their own internal milestones during the packaging process, we do everything in our power to accommodate. We make up time for clients in a way that other companies don’t or can’t. In fact, we might be the reason they make their FPI when hiccups occur.
Xerimis’ agility is our key to meeting FPI, and this is driven by our understanding of the stakes at hand. In our industry, small studies may consist of a few hundred vials, containing a couple thousand dollars’ worth of material each. No detail can be taken for granted. So beyond hitting FPI dates, our agility means never having to sacrifice attention-to-detail or quality in completing a job.
Upchain delays and client preferences shouldn’t keep entire trials from succeeding. Xerimis refuses to let our clients 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.