Thank you for visiting Fisher Clinical Services, Allentown
Fisher Clinical Services Allentown provides world class clinical supply support and capacity to the full range of pharmaceutical and biotech companies. From virtual start-ups to the global top 10, clients with varying needs and goals benefit from our 25 years experience across all types of clinical trials.
Clients experience the focus and dedication of a workforce that consistently delivers innovative and high quality packaging, labeling, and distribution expertise, solutions, and services. This innovation drives new services like automated assembly and labeling for pre-filled syringes, and it guides us to better ways of managing supply chain challenges for large and small molecules in ambient, refrigerated, and frozen conditions and for scheduled drugs.
“We invite you to visit our facility and learn how these industry leading professionals can help you achieve your clinical trial supply goals and contribute to the success of your clinical trials.”
Largest ambient and cold packaging storage facility for clinical trials
Allentown Fast Facts:
Location: 92mi / 152km West of New York City
Nearest Airport: Lehigh Valley International (ABE)
Distance from Airport(s) to Facility:
– 15 miles from Lehigh Valley International (ABE)
– 69 miles from Philadelphia International (PHL)
– 88 miles from Newark Liberty International Airport (EWR)
Fun Fact: Allentown briefly hosted the Liberty Bell during the Revolutionary War.
Five Facts on the U.S. Healthcare Industry:
Key Benefits for Sponsors
Largest ambient and cold storage facility for clinical trials with:
A large pharmaceutical company was planning to conduct an infectious disease trial for the treatment of Hepatitis C. The global trial would cover over 40 countries and require the labeling and distribution of more than 250,000 pre-filled syringes over the course of the study. The investigational drug product had to be maintained at a temperature of 2 to 8° Celsius, with a maximum time out of environment (TOE) of 6.5 hours. Only one comparator drug was suitable for use in the study. The comparator product came in a single use prefilled syringe, with a one-half inch needle and a needle-stick protection device (NSD). The comparator syringe could accommodate 180-mcg, 135 mcg, 90 mcg and 45 mcg dosing regimes.
The sponsor faced 2 significant hurdles in executing its trial:
• The comparator had to be blinded using a label that met the exact dosage specifications of the branded product.
• The sponsor company had to match its own investigational product packaging and labeling to the comparator. This required not only same size syringes but also labels that contained similarly precise dosing regimens for patients.
The sponsor however, could find no supplier in the market that could meet the level of labeling precision required to blind the comparator or to similarly label its investigational product.
The sponsor had experience with Fisher Clinical Services in the past and approached Fisher Clinical Services’ project management team to discuss possible solutions to the hurdles it was facing. The Fisher Clinical Services team felt that they could develop an innovative approach that would meet the specified level of labeling precision the trial required. To do so, Fisher Clinical Services assembled a global team representing its engineering expertise from the United States, United Kingdom and Switzerland, to convene and develop a solution. This team was able to engineer high-precision labeling equipment and labels that could be used to meet the exacting dosage requirements of this, and future trials, where labels require precision dosing graduation.
The High-Precision labeling capability was designed to include vision system verification of label position. To ensure precision labeling, the equipment had to be programmed for the exact dimensions of the pre-filled syringe as well as the label. In coordination with the Fisher Clinical Service packaging engineers and the sponsor team, a label was designed that would achieve the best possible blinding against the comparator product and could be placed on the pre-filled syringe within a detectable tolerance level of +/-0.7mm.
Together with the sponsor, Fisher Clinical Services developed acceptable precision standards and conducted extensive testing where extractable volumes were compared to the measured distance on the label, to ensure the level of precision was met. The complete system was ultimately qualified according to the co-developed precision standards.
Since 2011, 19 production runs have been executed and more than 50,000 syringes have been successfully shipped to over 40 countries. Fisher Clinical Services global team of engineers was able to develop a first-in-industry capability that is now available to all sponsors requiring varying level of precision dosing graduation on labels.
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There are times when clinical trial supply management takes a back seat to the many other urgent priorities leading up to study start. In one case, a supply chain manager position went unfilled at a mid-sized pharmaceutical company for a period of four months. The other members of the supply chain team were expected to pick up the slack left by the departing manager. And there was plenty of work to go around because two trials were each expecting 900 volunteers in 28 North American, European and Asia Pacific countries.
A problem waiting to happen
Having run a number of successful trials in the past, the company had a liberal policy for producing clinical material. Its main goal was to ensure each site had enough to fulfill dosing requirements; a modest level of overage was tolerated. This gave some people on the team full confidence that there would be plenty of investigational medication on hand at the clinical sites to meet the needs of the protocol.
Since the company never replaced its clinical supply manager no one was making use of the company’s forecasting software that would have enabled demend planning. And the interactive response technology set up for the trial was configured in a way that made it ineffective. Compounding these issues was the fact that this trial involved seven different medications including a comparator and the test article, which in this case was an injectible drug that required refrigeration.
With no solid demand planning, the trial ran into serious trouble with stock outs at some clinical sites and incorrect drug shipments showing up at others. The company employees who were handling supplies on top of their other responsibilities took a lot of heat from those in clinical operations. Tensions rose between the sides and distrust grew as the trial began to track behind company goals. As the wave of anger grew inside the company, it was quickly followed by resentment coming from personnel at the clinical sites who had to reschedule patient visits due to supply shortages and mistaken shipments.
With their clinical trial program in serous trouble, the company turned to the Clinical Supply Optimization team at Fisher Clinical Services. After quickly assessing the level of damage and the current enrollment and site activation plan, a Fisher Clinical Services employee went to work reconfiguring the interactive response technology and programming the unused demand planning software so it would start producing accurate forecasting statistics. In short order the company had a demand forecast and supply plan for the first study – the one in trouble – and for the second study, which was soon due to begin enrollment. The value of these plans came clear when data rolled in from the sites showing patients were getting exactly what they signed up for and the company was saving money by avoiding supply wastage. The initial relief that came with the forecasting plan increased as supplies were rebuilt to three months of inventory.
“She gives it her 300%”
Commenting on this project, the company’s associate director of supply chain said the Fisher Clinical Services employee “rescued” the first trial and there have been no supply problems in the second study. The employee has a “very special approach to her job,” the associate director said. “She gives it her 300% and I do mean 300%.”
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A financially successful mid-sized pharmaceutical company determined that strategically supporting investigator initiated clinical research was a good opportunity to explore the safety and efficacy of one of its drug products in new indications.
The company assigned the growing clinical supply chain tasks to a recently hired consultant.. Just four months after he arrived on the scene the trials began to stock out. By this time the number of investigator initiated trials had grown to over 100 studies and several thousand patients.
Having utilized Fisher Clinical Services for supply chain oversight of their registration trials the company contacted Fisher Clinical Services for help. The Fisher Clinical Services Supply Chain Manager recognized that the consultant had not developed a demand plan nor had he been tracking important details such as packaging configurations, patient enrollment and drug expiry. Realizing that a clinical supply chain is dependent on a strong foundational base of data collection and forecasting, she utilized an industry leading forecasting simulation tool to develop a demand forecast across all 100 studies.
Building an Accurate Demand Plan
To develop a robust forecast, she needed to build assumptions around drug quantities, dosage and patient enrollment. Physicians and investigator site staff, inexperienced in setting up or managing clinical supply chains, often do not have the expertise to drive these projections.
Turning instead to the pharmaceutical company’s clinical teams for insight on drug utilization in these trials a series of assumptions were built in order to feed demand projections across the 100 trials. Upon completion of the initial demand plan, the Fisher Clinical Services Supply Chain Manager validated the results with the company’s operational teams. When the demand projection for investigational drug showed it would actually outpace commercial demand, the Supply Chain Manager recognized that the first pass assumptions needed greater scrutiny.
After additional data collection and further collaboration with the clinical team, clinical supplies and commercial manufacturing, the Supply Chain Manager determined the company’s initial assumptions were mistaken in projecting linear enrollment and patient dosing over 24 months. Digging into data used for marketing authorization of the commercial drug she determined that the average time on drug during a two year period was actually just 18 months. Knowing that the patient population for these trials was limited, she also revised the linear enrollment statistics to modify the clinical supply forecast. Careful analysis of the dosing schedule, particularly in regard to the utilization of titration vs. a standard dosing regimen, provided additional insight into how to optimize drug demand.
With a solid demand plan in hand, and agreement from the pharmaceutical company’s clinical and clinical supply teams as well as operational staff, the Fisher Clinical Service Supply Chain Manager began looking at creative ways to minimize drug wastage across the 100 studies while mitigating expiry issues.
Product Pooling is the Answer
Ultimately, she determined that product pooling was the ideal solution in this case. By packaging in bulk across several protocols at once and then applying variable text on custom labels just in time for shipment to the sites, the pharmaceutical company could leverage available supply while easily matching demand.
Savings Across the Study Lifetime
By utilizing the pooling strategy and more accurate demand plan the pharmaceutical company was able to utilize 30% fewer lots than would have been needed under it original supply strategy, ultimately saving the company a projected $10 million USD over two years.
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