CMOs and CPOs: the Critical Difference

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 itself 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 systems began giving way to voiceless interactive response technology in the late nineties, “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 clinical packaging groups that do not often “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 these highly regulated services. Strangely and erroneously, the “CMO” categorization went along with them.

This ambiguity strikes at the very heart of how different stages of drug development are managed. CMC monitoring – the acronym standing, of course, for Chemistry, Manufacturing and Controls – selects, qualifies, and oversees vendors that manage the drug substance manufacturers, the drug product manufacturers, and the fill/finish stages of drug development. These are the CMC vendors and their areas of concern. But it is the clinical supply managers that select, and actually work with and manage, the clinical packaging vendors. 

For these reasons and more, Xerimis and others in the industry are describing packaging specialists with a name that describes us accurately: Contract packaging organizations (CPOs). By identifying as a CPO rather than a CMO, we distinguish ourselves from companies that don’t always offer our caliber of experience, expertise, and specialization.

This naming breakout is in step with the clinical supply industry’s commitment to identifying people and services by the service they truly provide. CRO, CMO, and IRT are other relatable examples of clear-cut nomenclature within a field that can’t afford confusion.

Put to the Test: Flexibility in the Pandemic Age

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.

Focused on Your FPI

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. 

Why Small and Medium-Sized Pharmaceutical Companies Must Rethink Their CPO Strategy

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 Clinical 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.  

Thank you to our team and our vendors

As we continue to monitor the Covid-19 virus and its impacts, I wanted to take a moment to extend a thank you to our team and our vendors. The past weeks have been challenging for everyone around the world, but amidst those challenges, we’ve truly seen the best in all of us and what we’re all capable of together.

To our team, your commitment to our work has been an inspiration. You’ve modified processes and taken time away from family to ensure that critical trials continue to happen. You know the importance of the work we’re doing, and you know the impact it can have on the entire world.

To our vendors, none of this would be possible without the critical role you play in the supply chain. Cartons and bottles are being produced, temperature controlled-shipments maintained, and courier services are delivering. You each play an essential role in the clinical trial process, and we thank you.

We know that the future will bring its own challenges, but I feel optimistic having seen what we’ve been able to achieve over these past weeks. Thank you for dedication and hard work, and commitment to making a difference.

Carol Sue Bernardo
Chief Executive Officer and Managing Director

Xerimis Coronavirus Planning Measures

Xerimis is committed to the safety of our clients, patients, and own team members while we continue to ensure that your clinical supplies are packaged, dispatched and delivered with minimal disruption.

Xerimis operates under GMPs and as such we have existing policies and procedures in place for ensuring clean environments, proper hygiene by all employees and have a written plan in place should a pandemic crisis occur. In addition, we are also following recommendations provided to the public by the Centers for Disease Control (CDC) regarding the Coronavirus.

Xerimis will continue to monitor communications and statements from our approved couriers that may impact their services in specific geographic locations. In turn, we will directly notify our clients of any potential impact to their shipping lanes or if any shipment request is unable to be completed due to government-imposed travel restrictions. Currently there are no restrictions on shipments within the United States and Canada. Globally, there are restrictions to specific geographical areas within countries such as China, Italy, Iran and South Korea; however, there has been no impact to ongoing shipments from Xerimis locations to date. The likelihood of disruption to other geographical areas cannot be ruled out only passenger travel is more likely to be impacted than the approved couriers we use. This is a dynamic situation and as such the information or restriction may be subject to change without notice. Xerimis will endeavor to ensure clients that may be impacted by such restrictions are notified as early as possible.

How auditors benefit from our cloud-based quality system

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, and that’s critical to successful outcomes: our clients’ auditors.

Auditors have grown accustomed to electronic computerized setups that require them onsite, at a company’s computers, 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 cloud-based 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.