Tim Wright, Editor06.02.15
PCI recently completed a North American storage and distribution facility for clinical trial materials on a 97,000 square foot site that was constructed to support growth in PCI’s clinical trial services business, which includes drug development and manufacturing, laboratory services, packaging and storage services, global logistics, as well as client supporting consultative services for executing global investigational studies. The new facility features storage for investigational supplies at controlled room temperature, as well as expansions of its cold chain storage capacity. A panel of PCI executives talked with Contract Pharma about the new facility as well as broader trends impacting the market.
Contract Pharma: How has business been with the new site up and running?
Bob Misher, senior vice president, PCI Clinical Trial Services: We have been very pleased by the response from our client base. Having the additional capacity as well as the dedicated returns management space and personnel has allowed us to keep pace with demand for supporting international studies, as well as strategy planning to support future needs for our clients and their evolving logistical supply strategy needs. We are working with clients to relook at how investigational study medicines are supplied to sites and patients. There are opportunities to make studies more effective, including optimizing timing, cost and certainly patient benefit. In addition, we have already been asked to expand our current capabilities into other cold chain areas such as -40°C and cryogenic storage at -196°C.
CP: What was the motivating factor(s) behind the expansion?
Misher: The expansion allowed PCI to have a dedicated logistical hub for North America. We had been operating a joint clinical packaging/labeling facility coupled with storage and distribution functions, but had reached a point where we needed dedicated space for the clinical logistics operations. Both the current growth of our business as well as the anticipated future growth warranted a strategy whereby we could devote a dedicated facility and dedicated personnel, with ample capacity to further grow and expand in a flexible workspace. Adding 93,000 square feet, complete with extensive yet expandable cold chain support and specialized DEA space, along with dedicated space for returns management, positions us to serve our clients both now and in the future. The site is extremely well thought out and provides a great foundation for meeting the ever-changing needs of clients.
CP: Talk about some of the broader trends impacting the direction of PCI’s business?
Brian Keesee, executive director, PCI North American Clinical Services: As growth in biotech medicines and other demanding products increases, so too does the demand for infrastructure to support the logistical requirements of these specialized and high value therapies around the world. Often these products warrant cold chain storage and handling, which require logistical support at 2-8° Celsius (35°F – 47°F), -20° Celsius (-4°F), or -80° Celsius (-112°F). Distribution of these medicines demand a host of specialized shipping containers and temperature monitoring devices as they are destined for investigational study sites around the globe.
The growth of specialized medicines and narrow therapeutic indications also dictates expensive active pharmaceutical ingredients and high value drug products. This trend, coupled with growth in pain management products often governed by the U.S. DEA or UK Home Office, has PCI significantly expanding its storage capabilities for products requiring highly securitized facilities. This includes on-site storage of DEA Schedule II and III-V drug products in vaults and specialized cages. PCI also operates dedicated stand-alone potent compound sites in the U.S. and UK for both packaging and distribution of SafeBridge rated compounds, often oncology therapies and treatments for autoimmune diseases.
I’ve spent over 15 years in the pharmaceutical industry supporting clinical services and pharmaceutical supply chain logistics. The scale of PCI’s new facility, particularly the cold chain and DEA storage, is impressive. It really enables a responsive approach to reducing lead times for investigational medicines, being able to package and expedite shipping clinical trial materials to investigational sites that are increasingly in very distant places. We are currently making hundreds of shipments per day. The site allows for very efficient logistics as we scale up with a focus on maintaining high service levels for our clients.
CP: What are PCI’s plans for future growth?
Dave Lecher, director, global logistics, PCI: As PCI analyzes industry trends and projects future growth requirements, the company had the foresight to plan for future expansions. The nature of the clinical trial services market requires us to provide an on-demand service. As clients come to us with special requirements, we have to be able to respond quickly to ensure the timeliness of their trial and ultimately increase their speed-to-market for commercialization. In some instances this may be a sizeable Phase III study with significant capacity needs. Our new site was built greenfield, with the anticipation that growth could begin to consume this new facility very quickly. With that in mind we planned for very rapid expansion of both our cold chain and controlled substances storage areas. For cold chain, that meant building specialized flooring for the temperature demands and utilities requirements to quickly turn on a request for additional capacity. We can then expand modularly and very quickly. Likewise, this consideration was given with our controlled substances storage areas. Construction of these types of facilities require strict interpretation of DEA standards. We have essentially pre-built our expansion into the facility, with floors and walls built at this time to adhere to DEA code ahead of the desired expansion. This will dramatically reduce the construction and approval lead time for expansion as compared to building from scratch. This allows us to support our client requirements rapidly, which is the name of the game.
CP: What about unmet needs in the market?
Misher: Consideration was also given to unmet needs in the industry, particularly for returned investigational drugs. At the completion of investigational studies partially used and unused medication needs to be returned and reconciled. Often this is an overlooked aspect of trial management and can create regulatory headaches for sponsor companies. PCI has built a dedicated facility along with a dedicated staff for processing and storage of returned drug product. This includes providing accountability down to the individual unit dose level. Returned investigational medicines can be kept in storage until the completion of the investigational study, or may be designated for destruction upon reconciliation. PCI’s new site accommodates both options.
With an increasing regulatory focus, ensuring IMP is returned, reconciled, destroyed and properly documented can present significant challenges. Sponsor companies are under tremendous pressure to initiate trials as quickly as possible once approved. Once the trials are under way the focus is on assuring a continuous supply, but often fail to give adequate planning to the management of the return IMP throughout the duration of the study. We can be their central return drug center for all clinical studies to help them work through the logistics of getting the product back to the designated return drug site, performing the appropriate level of reconciliation, identifying discrepancies, and ultimately how to disposition the study medicine. This assures that the return drug process is performed consistently across all studies with no issues when regulators review this data during their NDA product approval process.
CP: How is PCI leveraging its current technology?
Greig Ross, manager, clinical technology, PCI: The processes involved in moving clinical materials to and from investigational sites within the global clinical supply chain create opportunities to improve both efficiency and precision. PCI has analyzed industry trends and then evaluated technologies and best practices for the online consumer retail market to evaluate where there may be overlap with the potential of addressing unmet needs. Increasingly we are embracing technology to provide a more efficient way of working for us and our customers.
Order fulfilment is a core service in which performance is measured in speed and accuracy. Using technology to integrate with our upstream partners allows direct order entry into both our PCI systems as well as our couriers, resulting in a quick turnaround and assurance that the supplies will be delivered to the exact destination. After order entry, the use of 2D data matrix barcode scanning during the pick, pack and ship steps eliminates human error and ensures order accuracy is preserved throughout the order processing.
When the sponsor has finished recruitment and the patients have progressed through the treatment period, attention shifts to the close out activities including returns and reconciliation. Again this is an area where we have looked beyond our immediate market to embrace technologies that offer new solutions for our study administrators. Consumer retail readily allows a customer to quickly and conveniently process a product return and we wanted to provide that same experience. We have recently launched an online service to allow sites to log a return and print the courier box label in a simple one step process. This new service has enhanced the customer experience in two aspects. The user processing the return, typically a site monitor with a CRO, can now quickly and conveniently complete the steps involved to initiate a return. Secondly the sponsor organization benefits from the visibility of knowing when each return has been initiated, giving them increased awareness of the study close out steps.
CP: What are some other recent PCI investments?
Ravi Nalliah, director, global strategy development, PCI: In fall of 2014 PCI made two large strategic acquisitions to expand its current service offerings. In August PCI acquired Penn Pharma, a leading provider of manufacturing services for both clinical studies as well as commercial medicines. This move significantly expanded PCI’s ability to support formulation development, early stage analytical activities, clinical scale manufacturing, as well as supporting the transition to successful commercialization of pipeline drugs. Penn Pharma also offers specialized services in development, manufacture and packaging of potent compounds by virtue of its expert staff and award winning specialized contained manufacturing facilities in the UK.
Subsequent to the Penn Pharma acquisition in 2014, PCI acquired UK-based Biotec Services International. With the addition of Biotec, PCI greatly expanded its ability to support international studies requiring cold chain packaging, labeling and logistics. Biotec’s expertise includes support for cold chain materials with controlled temperature requirements down to -196°C, and complemented PCI’s established cold chain services in North America and Europe.
The clinical trial manufacturing sector incorporating finished dosage manufacturing, primary and secondary packaging and labeling, along with comparator sourcing is the greatest cost in clinical trial supply and logistics, accounting for more than two thirds of outsourcing revenue in this sector.
Current statistics illustrate around 80% of clinical trials enroll patients behind schedule and as many as 30% of patients in phase III drop out. As a result, timing and accuracy of the supply chain is therefore absolutely critical.
—TW
Contract Pharma: How has business been with the new site up and running?
Bob Misher, senior vice president, PCI Clinical Trial Services: We have been very pleased by the response from our client base. Having the additional capacity as well as the dedicated returns management space and personnel has allowed us to keep pace with demand for supporting international studies, as well as strategy planning to support future needs for our clients and their evolving logistical supply strategy needs. We are working with clients to relook at how investigational study medicines are supplied to sites and patients. There are opportunities to make studies more effective, including optimizing timing, cost and certainly patient benefit. In addition, we have already been asked to expand our current capabilities into other cold chain areas such as -40°C and cryogenic storage at -196°C.
CP: What was the motivating factor(s) behind the expansion?
Misher: The expansion allowed PCI to have a dedicated logistical hub for North America. We had been operating a joint clinical packaging/labeling facility coupled with storage and distribution functions, but had reached a point where we needed dedicated space for the clinical logistics operations. Both the current growth of our business as well as the anticipated future growth warranted a strategy whereby we could devote a dedicated facility and dedicated personnel, with ample capacity to further grow and expand in a flexible workspace. Adding 93,000 square feet, complete with extensive yet expandable cold chain support and specialized DEA space, along with dedicated space for returns management, positions us to serve our clients both now and in the future. The site is extremely well thought out and provides a great foundation for meeting the ever-changing needs of clients.
CP: Talk about some of the broader trends impacting the direction of PCI’s business?
Brian Keesee, executive director, PCI North American Clinical Services: As growth in biotech medicines and other demanding products increases, so too does the demand for infrastructure to support the logistical requirements of these specialized and high value therapies around the world. Often these products warrant cold chain storage and handling, which require logistical support at 2-8° Celsius (35°F – 47°F), -20° Celsius (-4°F), or -80° Celsius (-112°F). Distribution of these medicines demand a host of specialized shipping containers and temperature monitoring devices as they are destined for investigational study sites around the globe.
The growth of specialized medicines and narrow therapeutic indications also dictates expensive active pharmaceutical ingredients and high value drug products. This trend, coupled with growth in pain management products often governed by the U.S. DEA or UK Home Office, has PCI significantly expanding its storage capabilities for products requiring highly securitized facilities. This includes on-site storage of DEA Schedule II and III-V drug products in vaults and specialized cages. PCI also operates dedicated stand-alone potent compound sites in the U.S. and UK for both packaging and distribution of SafeBridge rated compounds, often oncology therapies and treatments for autoimmune diseases.
I’ve spent over 15 years in the pharmaceutical industry supporting clinical services and pharmaceutical supply chain logistics. The scale of PCI’s new facility, particularly the cold chain and DEA storage, is impressive. It really enables a responsive approach to reducing lead times for investigational medicines, being able to package and expedite shipping clinical trial materials to investigational sites that are increasingly in very distant places. We are currently making hundreds of shipments per day. The site allows for very efficient logistics as we scale up with a focus on maintaining high service levels for our clients.
CP: What are PCI’s plans for future growth?
Dave Lecher, director, global logistics, PCI: As PCI analyzes industry trends and projects future growth requirements, the company had the foresight to plan for future expansions. The nature of the clinical trial services market requires us to provide an on-demand service. As clients come to us with special requirements, we have to be able to respond quickly to ensure the timeliness of their trial and ultimately increase their speed-to-market for commercialization. In some instances this may be a sizeable Phase III study with significant capacity needs. Our new site was built greenfield, with the anticipation that growth could begin to consume this new facility very quickly. With that in mind we planned for very rapid expansion of both our cold chain and controlled substances storage areas. For cold chain, that meant building specialized flooring for the temperature demands and utilities requirements to quickly turn on a request for additional capacity. We can then expand modularly and very quickly. Likewise, this consideration was given with our controlled substances storage areas. Construction of these types of facilities require strict interpretation of DEA standards. We have essentially pre-built our expansion into the facility, with floors and walls built at this time to adhere to DEA code ahead of the desired expansion. This will dramatically reduce the construction and approval lead time for expansion as compared to building from scratch. This allows us to support our client requirements rapidly, which is the name of the game.
CP: What about unmet needs in the market?
Misher: Consideration was also given to unmet needs in the industry, particularly for returned investigational drugs. At the completion of investigational studies partially used and unused medication needs to be returned and reconciled. Often this is an overlooked aspect of trial management and can create regulatory headaches for sponsor companies. PCI has built a dedicated facility along with a dedicated staff for processing and storage of returned drug product. This includes providing accountability down to the individual unit dose level. Returned investigational medicines can be kept in storage until the completion of the investigational study, or may be designated for destruction upon reconciliation. PCI’s new site accommodates both options.
With an increasing regulatory focus, ensuring IMP is returned, reconciled, destroyed and properly documented can present significant challenges. Sponsor companies are under tremendous pressure to initiate trials as quickly as possible once approved. Once the trials are under way the focus is on assuring a continuous supply, but often fail to give adequate planning to the management of the return IMP throughout the duration of the study. We can be their central return drug center for all clinical studies to help them work through the logistics of getting the product back to the designated return drug site, performing the appropriate level of reconciliation, identifying discrepancies, and ultimately how to disposition the study medicine. This assures that the return drug process is performed consistently across all studies with no issues when regulators review this data during their NDA product approval process.
CP: How is PCI leveraging its current technology?
Greig Ross, manager, clinical technology, PCI: The processes involved in moving clinical materials to and from investigational sites within the global clinical supply chain create opportunities to improve both efficiency and precision. PCI has analyzed industry trends and then evaluated technologies and best practices for the online consumer retail market to evaluate where there may be overlap with the potential of addressing unmet needs. Increasingly we are embracing technology to provide a more efficient way of working for us and our customers.
Order fulfilment is a core service in which performance is measured in speed and accuracy. Using technology to integrate with our upstream partners allows direct order entry into both our PCI systems as well as our couriers, resulting in a quick turnaround and assurance that the supplies will be delivered to the exact destination. After order entry, the use of 2D data matrix barcode scanning during the pick, pack and ship steps eliminates human error and ensures order accuracy is preserved throughout the order processing.
When the sponsor has finished recruitment and the patients have progressed through the treatment period, attention shifts to the close out activities including returns and reconciliation. Again this is an area where we have looked beyond our immediate market to embrace technologies that offer new solutions for our study administrators. Consumer retail readily allows a customer to quickly and conveniently process a product return and we wanted to provide that same experience. We have recently launched an online service to allow sites to log a return and print the courier box label in a simple one step process. This new service has enhanced the customer experience in two aspects. The user processing the return, typically a site monitor with a CRO, can now quickly and conveniently complete the steps involved to initiate a return. Secondly the sponsor organization benefits from the visibility of knowing when each return has been initiated, giving them increased awareness of the study close out steps.
CP: What are some other recent PCI investments?
Ravi Nalliah, director, global strategy development, PCI: In fall of 2014 PCI made two large strategic acquisitions to expand its current service offerings. In August PCI acquired Penn Pharma, a leading provider of manufacturing services for both clinical studies as well as commercial medicines. This move significantly expanded PCI’s ability to support formulation development, early stage analytical activities, clinical scale manufacturing, as well as supporting the transition to successful commercialization of pipeline drugs. Penn Pharma also offers specialized services in development, manufacture and packaging of potent compounds by virtue of its expert staff and award winning specialized contained manufacturing facilities in the UK.
Subsequent to the Penn Pharma acquisition in 2014, PCI acquired UK-based Biotec Services International. With the addition of Biotec, PCI greatly expanded its ability to support international studies requiring cold chain packaging, labeling and logistics. Biotec’s expertise includes support for cold chain materials with controlled temperature requirements down to -196°C, and complemented PCI’s established cold chain services in North America and Europe.
The clinical trial manufacturing sector incorporating finished dosage manufacturing, primary and secondary packaging and labeling, along with comparator sourcing is the greatest cost in clinical trial supply and logistics, accounting for more than two thirds of outsourcing revenue in this sector.
Current statistics illustrate around 80% of clinical trials enroll patients behind schedule and as many as 30% of patients in phase III drop out. As a result, timing and accuracy of the supply chain is therefore absolutely critical.