Providing a Pathway for Patients: CalCog’s Experience with Expanded Access Programs

More than 2 billion people—the vast majority of whom live in low- and middle-income countries—lack access to essential medications [source]. From pain medication to antibiotics to insulin, patients simply can’t wait for life-saving therapeutics. Cue: Expanded Access (Compassionate Use) Programs.??

The U.S. Food and Drug Administration (FDA) describes compassionate use as “a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases or conditions. Such investigational drugs/devices have not yet been approved by the FDA and they have not been proven to be safe and effective.” [source]?

Unfortunately, delivering investigational drug product outside the constructs of a clinical trial presents unique challenges.??

The Challenges of Expanded Access Programs?

Clinical trials are complex, but expanded access programs take these challenges to a new level. CalCog uses our experience to streamline a pathway through the often challenging expanded access landscape.?

Some of the challenges of Expanded Access Programs include:?

• Prescribing activity from physicians is sporadic and difficult to forecast?
• Patient populations can be very small?
• Drug supply requests are often time-sensitive?
• Extensive coordination is required for distribution and logistics to reach patients globally?
• Relabeling and/or repackaging are often required?
• Regulatory requirements are demanding and regularly evolving?

Global Expanded Access Program Management Capabilities?

Whether you call it expanded access program (EAP), early access, compassionate use, managed access program—different names for the same need—CalCog has over twenty years of experience managing expanded access programs serving patients worldwide.?

CalCog leverages its nearly three decades of managing investigational drug supply, including packaging, labeling, storage, and distribution for global clinical trials, to provide best-in-class expanded access program drug supply management services. If you have the regulatory resources to support your Expanded Access Program but need drug supply management expertise, CalCog is your perfect partner.?

• Global network of GMP facilities for packaging, labeling, and storage.?
• Same-day shipping options to help medication get to patients quicker.?
• Robust inventory management to ensure accuracy and prevent delays.
• Import/export experts to manage the details of moving medications worldwide, including transportation charges, documentation, importer of record services, customs clearance, duties, and taxes.

“CalCog fully understands the importance of Expanded Access Programs and the benefit to patients. We pride ourselves in our ability to treat all our clients on an individual level, offering a dedicated team carefully curated and positioned to ensure seamless communication and results to our clients and their patients.?Our clients appreciate our commitment to offering a quality service that adapts quickly to changes that arise throughout the program.”?- Tess Saltmarsh, PhD, Global Director of Client Services

ABOUT CALCOG??

?CalCog has been dedicated to supporting the clinical trial supply chain since 1996. With the infrastructure, expertise, and quality management systems of a large company and the speed and responsiveness of a small company, CalCog is a valuable clinical supply resource for small and medium-sized pharmaceutical and biotech organizations.?

We strive to find the best ways to support the clinical supply needs for every clinical trial, overcoming physical and regulatory barriers while maintaining the flexibility needed to meet client timelines.?

Click here to learn more about CalCog's expanded access services.?

www.calcog.com | [email protected]?

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