Author: wpteam

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

Posted on by wpteam

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.  

Thank you to our team and our vendors

Posted on by wpteam

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

COVID-19 Update: Vital Operations Continue at Xerimis

Posted on by wpteam

On Saturday, March 21st, the Governor of New Jersey issued an Executive Order No. 107 requiring all Non-Essential Retail Businesses to close. Xerimis is not forced to close our business since Xerimis is part of the pharmaceutical supply chain responsible for providing medicines to patients, and as such is considered in the category defined as Healthcare/Life Sustaining businesses.

The ongoing efforts to contain the spread of the COVID-19 virus throughout the world make this a very dynamic time for individuals and businesses alike. Xerimis continues our commitment to the safety of our clients, patients, and team members. We have transitioned many Xerimis employees to remote working to the greatest extent possible. We continue with our on-site activities including receiving, packaging, distribution and returns accountability and have implemented aggressive cleaning procedures for all areas of the building.  Our staff is already cross trained which will allow us to perform the most critical activities at Xerimis.

We are working collaboratively with all clients to ensure supplies are packaged and dispatched as planned.  We recognize the impact of COVID-19 and the new challenges that are being presented to sponsors.  We are actively working with our partner couriers to set up direct to patient delivery when this option becomes necessary due to circumstances related to COVID-19. We will work with clients to ensure we prioritize the most critical needs for patients.

We have begun seeing countries impacted by the COVID-19 virus and shipping lanes being impacted. We continue to keep our clients updated regularly and look for alternatives as needed. The likelihood of disruption to other geographical areas cannot be ruled out with each passing day. We are committed to our partnership with you and to being here to support you and patients in this most serious time for our world.

Carol Sue Bernardo
CEO

Xerimis Coronavirus Planning Measures

Posted on by wpteam

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

Posted on by wpteam

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.