Author: Jon Cofsky

Revised on June 8, 2021

As the clinical supply industry evolves, so does its vernacular. Small molecules are making way for large ones, resulting in “genetic therapies.” We no longer work in ambient conditions; today, “controlled room temperature” best describes the handling process. Even the term “sponsor company” evolved from the fact that companies other than R&D pharmaceuticals are running trials.

One drawback to this evolution is language’s habit of lingering beyond its logical lifespan. If you still “dial” someone’s number but haven’t touched a rotary phone in decades, or “roll up” the automatic windows in your car, you understand the habit of holding onto sayings even after they stop making literal sense. In the clinical packaging industry, a memorable example is IVRS, short for Interactive Voice Response Systems. When IVRS began giving way to voiceless Interactive Response Technology (IRT) in the late 1990s, “IVRS” hung on, serving as the default terminology for years after voice features had faded.

Today, the term “CMO” is the primary offender on the nomenclature front. If the exact definition of CMO leaves you scratching your head, it’s proof positive of the problem. Today, we still — astonishingly — use “contract manufacturing organization” to describe the drug substance manufacturer, the drug product manufacturer, the fill/finish vendor, and the clinical packaging group that does not technically “manufacture” a single thing.

The misnomer traces back a few decades to when pharmaceutical companies handled packaging, labeling, and distribution in-house. Executed in close proximity to manufacturing and production (by companies best known for manufacturing and production), packaging, labeling, and distribution were lumped under the “manufacturing” umbrella. In time, pharmaceutical companies restructured and began outsourcing manufacturing, packaging, labeling, and distribution to vendors designed specifically for those highly regulated services. Erroneously, the “CMO” categorization went along with all these activities.

This ambiguity strikes at the very heart of how different stages of drug development are managed when outsourced. CMC professionals — the acronym standing, of course, for Chemistry, Manufacturing, and Controls — select, qualify, and oversee vendors that manage the drug substance manufacturers, the drug product manufacturers, and the fill/finish stages of drug development. But it is the clinical supply managers who select and actually work with the clinical packaging vendors. For this reason, a new term has emerged for providers specializing in packaging, labeling, and distribution: contract packaging organizations (CPOs). This naming breakout is in step with the clinical supply industry’s commitment to advancing drug innovation within a field that can’t afford confusion.

Xerimis is a CPO with global experience. By identifying as a CPO rather than a CMO, we distinguish ourselves from companies that don’t offer our caliber of expertise and specialization in clinical trial packaging, labeling, distribution, and related services. Contact us to learn more.

These are unprecedented times in our industry. The immediate need for COVID-19 treatment and vaccine has created a clinical trials scenario that would’ve been unthinkable just six months ago. Vaccine development typically takes 10-15 years. Yet reports indicate that it took about eight weeks from first receiving the Coronavirus in labs to the first dosing of a test vaccine. Nearly every pharma company examined their commercial and clinical lines to find treatment potential that could help provide relief for the growing number of COVID patients. Now the world eagerly awaits news for effective treatments and ideally a vaccine.

Hundreds of pharma companies are racing to identify treatments and vaccine for COVID-19. As early as February, Xerimis saw requests for packaging as COVID-focused trials began in earnest. These COVID studies moved though our system—from formal quote to packaged supplies—at a rapid pace unlike any before.

Flexibility and speed have been core tenets of Xerimis since our beginnings in 2001. We’ve proven that agility in clinical packaging, along with a commitment to quality, make a successful combination for meeting timelines and FPI for all studies. Following this model positions us to deliver in a high-pressure scenario marked by both volume and urgency.

The COVID-19 pandemic has tested our abilities and shown that Xerimis was built for responsiveness and urgency. Thanks to our well-established systems and experienced team, we’ve been able to turn around quotes for COVID-related projects in under 24 hours. Standard Xerimis quote turnaround time is 5 business days, while the industry standard is 2 to 3 weeks. More importantly, Xerimis has been able to facilitate contracts, supplies, packaging, labeling, batch record review and approval, release, and shipment in record time without compromising quality.

Several sponsor companies of COVID-vaccine trials selected Xerimis as their partner based on our reputation and responsiveness. We were also able to support sponsor companies who required quicker turnaround of their supplies than they would receive from a large vendor. They transferred supplies to Xerimis and we provided faster, more flexible service.

During this global crisis, we’ve been able to maintain our existing client studies to ensure no patient goes without supplies, while also meeting the demand for new and urgent COVID studies. We’ve kept true to our core values of flexibility, quality, and responsiveness. Xerimis is proud to be part of this race, providing critically needed clinical trial materials to patients for COVID-treatments and vaccine.

Revised on October 5, 2022

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.

Xerimis refuses to let our clients feel the burden of the inevitable shifts and changes that impact clinical trial timelines. 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.

The clinical trial landscape is changing.

Historically, smaller pharmaceutical companies focused on preliminary research, which they sold to larger pharmaceutical companies that sponsored Phase 2 and Phase 3 trials. 

That model has shifted as large pharma has become more focused on securing venture capital. In efforts to alleviate risk, today’s big pharmaceutical companies are less likely to sponsor trials themselves, and more intent on buying smaller pharma companies with existing data derived from successful clinical studies. 

The burden of clinical trials, then, has shifted from large pharmaceutical companies to these smaller pharmaceutical companies, many of whom are sponsoring multi-continent trials for the first time. Larger trials are more complex than domestic trials in a number of ways. 

• More regulation and moving parts
• QPs – Qualified Persons – are needed for EU releases
• In global trials, audits are required for facilities where drugs are manufactured and packaged
• QP releases are needed once a drug is ready and all certifications are complete

In light of these specifics, global trials require a contract packaging organization (CPO) with extensive experience in large, multi-continent studies. Small and medium-sized pharmaceutical companies sponsoring today’s large trials turn to experienced Phase 2 and 3 CPO vendors but are learning the hard way that they’re not a priority to these businesses.    

Large CPO vendors have a tendency to prioritize big pharma over smaller pharma, regardless of the size or scope of the trial. And it makes sense – the majority of their revenue comes from big pharma. But it makes for slower and more challenging trials for smaller pharma companies.

Big pharma ex-pats now working for small and medium-sized pharmaceutical companies need to realize they’re not going to have the same relationship with larger packaging companies now that they’re with a smaller pharmaceutical company. If a large pharma trial needs extra rooms at the last minute, for example, small and medium-sized clients’ trial needs get bumped.  All in all, medium-sized pharma tends to get lost in the matrix of customer service, which can have critical consequences for trials.  

Changes in the pharma industry have created a new reality: If you’re not large pharma, you don’t want to use a large CPO vendor.

At Xerimis, we’re dedicated to small and medium-sized pharmaceutical companies. 

• We’ll never bump your trial in favor of a larger client. That’s not how we do business.
• We’ll help you navigate large, multi-continent studies even if you’ve never done a Phase 2 or 3 trial before. 
• We’ll handle the complexities of global clinical supply so you can focus on the trial. You have enough on your plate as it is. 

Xerimis is the only CPO in the industry who prioritizes smaller pharma AND has the experience to navigate large, multi-continent studies. This is our niche. We welcome smaller pharmaceutical companies because it’s the small and medium-sized companies that are doing trials rather than doing venture-backed acquisitions. You can rely on our experience and our guarantee that your trial will be treated as a top priority – no matter the size of the company behind it.  

Last year, Xerimis upgraded to ZenQMS, a cloud-based quality management system. For all of its benefits, cloud-based technology is still surprisingly rare among quality systems in clinical trial packaging. As such, next-generation ZenQMS has been well received by a population we work with all the time: our clients’ auditors.

Auditors have grown accustomed to electronic setups that require them onsite, at a company’s computer, to access the documents necessary to perform a Good Manufacturing Practices (GMP) audit. Sometimes a company representative is appointed to supervise this process, standing in the room, or even helming the computer, ensuring the auditor accesses only the information needed. With Xerimis and ZenQMS, auditors are given much more autonomy via a secure, customizable portal. They can access their password-protected account from any browser, anywhere in the world. This translates to less time onsite at our facilities, system access free of a company liaison, and freedom from the hassle of downloading software or procuring a software-enabled device.

To further improve the user experience, Xerimis offers auditors a customized navigation guide, letting them easily locate the documents they’re looking for once they’re logged in.

Auditors’ goals are clear and critical: To perform a mandated Good Manufacturing Practices audit of Xerimis before a client or prospective client can entrust us with new or reoccurring work.

When an audit is free of logistical challenges, all parties win. With ZenQMS, Xerimis audits are uniquely efficient, offering an easier process for everyone involved.