Pharma and biopharmaceutical sponsors face numerous challenges along the drug development continuum—meeting First Patient In (FPI) timelines for clinical trials should not be one of them.
 
Avoiding potential delays is key to achieving development milestones. Maximizing flexibility is often a solution, particularly while awaiting Investigational New Drug (IND) approval. PCI Pharma Services leverages its experience, expertise, and innovative technologies to provide flexible primary and secondary packaging solutions for the most demanding Phase I – Phase IV clinical studies, along with a unique Pre-IND strategy.
 
In February 2020, PCI entered the Canadian market with the strategic acquisition of Bellwyck Pharma Services, located in Burlington and Mississauga, Ontario. PCI is the only full-service clinical trial services company located in Canada. The facilities custom solutions include packaging and labeling, kit design, label design and printing, storage, distribution, and regulatory support. These thorough capabilities allow a customized approach to clients unique trial requirements.
 
In addition to supporting the Canadian biopharma industry, PCI’s Canadian facilities benefit U.S. sponsor companies in the interim Pre-IND filing phase.
 
How it works
PCI’s Speed to Study™ offering is designed to expedite the initiation of clinical trials, providing the necessary flexibility to accelerate drug development timelines and allowing drug candidates to move forward faster. PCI’s Pre-INDservice offering, provided by its Canadian clinical site, can support U.S. based sponsors that manufacture drug product outside of the U.S. to progress clinical trial materials while awaiting IND approval from the FDA. This mitigates potential delays meeting FPI timelines.
 
Once filed, it takes a minimum of 30 days to gain IND approval from the FDA, during this time sponsors are unable to ship drug product to or within the U.S. Leveraging PCI’s Pre-IND services, sponsors can transfer drug product into PCI’s Canadian clinical facility for packaging, and as a result, clinical supplies are ready and waiting to ship once the IND is approved.
 
Tim Roberts, Vice President of Global Sales for Clinical Services at PCI, explains, “Under the Pre-IND structure, drug product can be imported to Canada to be packed and labelled during the IND review. By shipping a client’s material into our Canadian facility, we can perform GMP packaging, labeling and/or kitting processes, sign off on batch records, and hold finished goods until the client gets the go-ahead to ship into the U.S.” Roberts noted that this typically saves eight to twelve weeks in any U.S. based trial.
 
“The risks of labeling and packaging pre-IND are low, and the timeline benefits gained through a pre-IND strategy often outweigh the risks,” Roberts added. “This strategy is often used to support aggressive FPI timelines.”
 
Successful Pre-IND strategy
In one case, a client approached PCI with a packaging requirement that involved a complex blistering solution designed to meet compliance and patient dexterity issues. The client was awaiting IND approval for its drug and did not want to miss the FPI date. 
 
To meet the challenge, PCI and the client agreed to a new process to fulfill the packaging requirement in Canada. The client’s drug was sent to Burlington for primary and secondary packaging as an intermediate step while the IND was under review. Once the IND was approved, the packaged blisters would be sent to PCI’s Rockford, IL location for distribution.
 
“PCI Clinical Trial Services listened to the needs of the customer and was able to provide a flexible and simple solution to its challenge, which allowed the client to meet its packaging requirements and dose patients within its project deadlines,” Roberts said. “PCI is committed to supporting our clients with packaging solutions that truly differentiate by delivering a flexible approach and ensuring safe delivery of therapies with peace of mind.”

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