Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
CASE STUDY TOTAL SUPPLY CHAIN ASSURANCE PROGRAM TURNS AROUND GLOBAL TRIAL INTEGRATED TECHNOLOGY AND SERVICES HALTS STOCKOUTS AND STEMS PATIENT LOSS End-to-end supply chain solutions that encompass technology and management services are not mere matters of convenience; they actually improve study efficiencies that translate into savings. When the same partner provides the trial forecast, drug supply strategy, and the interactive response technology, the study benefits from a virtuous cycle of information. Processes are coordinated to ensure that the right drug is on hand at sites at the right time. One sponsor came to appreciate these benefits after the company’s Clinical Supply team first attempted to perform the forecast and devise the supply strategy themselves. IT BECAME CLEAR THAT SOMETHING WAS AMISS IN ONE YEAR, 838 PATIENTS WERE BEING TURNED AWAY AT THE SITES BECAUSE THERE WASN’T ENOUGH OF THE RIGHT DOSE STRENGTH IN THE RIGHT COUNTRY AT THE RIGHT TIME TO MEET THE PATIENT DEMAND THE SITUATION: SUPPLY AND DEMAND NOT SYNCHED The sponsor of a Phase III trial spanning more than 700 sites in 49 countries turned to Almac for its interactive response technology, IXRS®, and for kit production and distribution. The sponsor’s own Clinical Supply team furnished the drug forecast and the resupply strategy. After the first year of the trial, which was to run for nine years, it became clear that something was amiss. The rate of insufficient product alerts generated by IXRS rose sharply, reaching a high of 4.7 percent in the second year of the trial. This meant that in one year, 838 patients—between two and three a day—were being turned away at sites because there wasn’t enough of the right dose strength in the right country at the right time to meet patient demand. The randomised, double-blind trial was challenging for the sponsor to supply because: • The sheer number of countries involved created great complexity • There were extreme peaks and troughs in product demand due to the recruitment pattern • The dosing was titrated, and different kits were required at different visits • The patient visits were many months apart, while the product’s shelf life was 18 months As a result, the resupply strategy was not synched with actual patient demand, and frustration was mounting at clinical sites as well as within the sponsor’s Operations team. An inordinate number of patients were leaving the study and enrolling in competing trials, of which there were many. ALMAC MANAGERS WERE ABLE TO IDENTIFY THE TWO ROOT CAUSES OF THE PROBLEM THE SOLUTION: A CLOSED LOOP SYSTEM OF FORECASTING, TRACKING, AND RESUPPLY ALMAC EXPERTS DEDICATED THEMSELVES TO PREPARING A NEW RESUPPLY STRATEGY AND THEN RECONFIGURING IXRS TO EXECUTE THE STRATEGY Immediately, two Almac experts—one with a specialty in supply chain management technology and the other with a deep background in supply chain planning—dedicated themselves to preparing a new resupply strategy and then reconfiguring IXRS to execute the strategy. Because all of the necessary expertise resided within Almac, we were able to recommend a solution to the sponsor in just a week. In consultation with the sponsor, Almac managers were able to identify the two root causes of the problem: 1. The sponsor’s initial forecast was not being updated to reflect actual product demand based on recruitment trends and study progress 2. Production was not being implemented in time to replace used / expired product in the supply chain. Understandably, the sponsor’s Clinical Supply team needed expert help from specialists in order to manage a study of this size and complexity. Almac presented the sponsor with a new forecast produced by our Supply Wise™ forecasting tool. The obvious differences between Almac’s forecast and the one the sponsor had been using convinced the sponsor that Almac should assume responsibility for regularly forecasting product demand, revising the supply strategy, and harmonising production campaigns with the forecast. THE RESULTS: OPTIMISED PRODUCTION AND DISTRIBUTION 20+8+6+4+4+2 Throughout the life of the trial, Almac continued to update the supply forecast, an exercise made both efficient and accurate by the fact that Almac’s IXRS system provides real-time updates on patient enrolment, product usage, and expiry dates directly into Supply Wise™. Over time, as the sponsor’s product production “caught up” with Almac’s forecast, the rate of insufficient product alerts dropped sharply from its high of 4.7 percent to a reasonable 0.2 percent, patient discontinuations decreased dramatically, and complaint calls from sites dropped in equal measure. (See Figure 1.). Figure 1: Insufficient Product Alerts Total IXRS Drug Assignments 17,907 29,332 16,981 15,369 14,232 1,173 Year 2011 2012 2013 2014 2015 2016 Failure Rate (Alert %) 4.7% 0.9% 0.6% 0.3% 0.3% 0.2% 7.97% 4.52% 2.73% 2.73% 0.22% Patient Discontinuation Rate (%) 3.48% www.almacgroup.com WITH THE TOTAL SUPPLY CHAIN ASSURANCE PROGRAM, THE SPONSOR WAS ABLE TO BUDGET MORE REALISTICALLY, PREVENT WASTAGE IN THE SUPPLY CHAIN, AVOID STOCKOUTS, AND RETAIN PATIENTS IN THE STUDY The rate of patient discontinuation was at its height in 2012 when nearly eight percent of enrolled patients exited the study. While certainly not all of the discontinuations were attributable to drug stockouts, let’s assume that a modest 10 percent were. Based on that assumption—and knowing that the average cost of recruiting and retaining each patient in a study is $25,000—we can calculate the sponsor’s Return on Investment (ROI) by using the Almac Clinical Forecasting Services. Between 2012 and 2013, a total of 202 fewer patients dropped out of the study, 20 of which we assume to be related to the improved drug supply. Thus, between 2012 and 2013 alone, every dollar spent on Almac’s intervention saved the sponsor an estimated $14, for a remarkable ROI of 1:14. Overall, based on very conservative estimates, the sponsor saved the staggering costs (easily amounting to more than $1 million) of replacing scores of patients over the long course of this very large trial. In addition, the sponsor was able to keep the trial on track in meeting its deadlines. Coordinated oversight of the entire supply chain was key to optimising both production and distribution. With the Total Supply Chain Assurance Program, the sponsor was able to budget more realistically, prevent wastage in the supply chain, avoid stockouts, and retain patients in the study. Learn more about ALMAC ONE click here or email us at [email protected] All our clients have unique needs. That’s why we develop unique solutions. This is the GET IN TOUCH UK Almac Group (Global Headquarters) Seagoe Industrial Estate Craigavon BT63 5UA United Kingdom US Almac Group (US Headquarters) 25 Fretz Road Souderton, PA 18964 United States of America ASIA PACIFIC Almac Pharmaceutical Services Pte. Ltd. (Asia Pacific Headquarters) 9 Changi South Street 3 #01-01 Singapore 486361 [email protected] +44 28 3835 2121 [email protected] +1 215 660 8500 [email protected] +65 6309 0720 AM8379