Innovations to Meet Regulatory Requirements, Reduce Costs, and Improve Efficiency
Calabasas, November 12, 2015. The 2015 Bio Supply Management Alliance (BSMA) Conference met in Foster City, CA at the Crowne Plaza Hotel. Executives from over 40 biopharma companies addressed challenges and exchanged solutions for Clinical Supply Chain Management which poses one of the biggest challenges for supply chain managers in the biopharma industry. The fundamental takeaway for the clinical supply professionals was that growth in the number of trials, increased compliance and the global scope of trials, are spurring companies to automate outdated paper-based or spreadsheet based clinical supply chain processes. Based on detailed global surveys of clinical sites, vendors and sponsors have a great deal of improvement to help their sites be more successful. Presenters cited compliance issues – frequent production, protocol, formulation or labeling changes; multiple clinical sites; and, end-to-end clinical supply chain issues stretching all the way to the patient; as the biggest challenges
Making the Clinical Supply Chain Better Holistically
Bill Coakley, Director of Supply Chain Planning at BioMarin, moderated a panel titled, “Reducing Waste, Maximizing Efficiency and Streamlining Your Global Clinical Supply Chain.” He remarked that “The most important Key Performance Indicator (KPI) is that there are NO DRUG HOLIDAYS. In short, never run out of the drug. The clinical supply chain is not as evolved as some mature manufacturing industries. The amount of data and information that clinical supply chains need to capture is gigantic. Best practices are up to each individual company. There are no current industry standards about capturing and using data.”
Executives from Almac Services, BioMarin, Genentech, Merck, Global BioPharm Solutions and Shire discussed how many in the industry still rely on paper-based compliance systems or manual data entry into Excel spreadsheets. Automation solutions are gradually beginning to come. While only a few solutions are being used for forecasting, mainly Excel, SAP, and CLINapps, utilization of Monte Carlo simulations was noted. Simulation tool lets you know, for example, if the packaging configuration is appropriate. Monte Carlo simulation helps to identify blind spots, those circumstances with a high probability of failure. The panel consensus was that tracking orders and managing inventory required integrating data with vendors, distributors, IRTs and with the clinical sites.
Reaching the Patient — The Impact of Supply Chain on Investigator Sites
Amy Musolino, Program Director of New Service Development at Fisher Clinical Services, introduced attendees to the Investigator Site Panel (ISP). He stated, “Its mission is to identify, raise awareness and drive actionable change in the industry regarding the impact of clinical supplies on clinical sites’ ability to conduct research, retain patients, and the overall impact on the patient in clinical research. ISP recently conducted peer-to-peer surveys across a wide variety of sites on the impact of clinical supplies at investigator sites and received over 350 responses.” The ISP Survey highlighted that one single recommendation to a sponsor, vendor or CRO would be to provide pre-shipment notifications
Cold Chain and Clinical Supplies
Addressing the “Trends and Technology Innovations for Efficient Cold Chain Management and Distribution of Clinical Supplies” were executives from Fisher Clinical Services (Alex Guillen), Insyc Tom Robinson), Sensitech (Marsha Davis), Priority Solutions (Bill Rambo) and OncoMed (Julie Trulson). The executives noted that one of the biggest challenges has to do with shipping by air. Although real-time solutions are currently available for every mode of transportation, most clinical supplies are shipped by air which is highly regulated by the FAA (or similar agencies around the world). The FAA requires that all real-time electronic tracking and transmission sensors must auto-shut off during flight, then auto-turn on when the flight lands. Complicating matters, each sensor solution must be approved by each individual airline.
Then there’s the issue of knowing versus not knowing. Those who don’t want to know say that they trust their partners but what about those global destinations where the product may be held in customs until the product is no longer usable? Real-time reporting is imperative for quality assurance.
The panel also noted that in cold chain, the ultimate challenge is providing context. One vendor noted that the company has over 500,000 trailers monitored by either satellite or cellular. If a driver turns off the refrigeration unit containing a clinical trial shipment, the real-time system receives the input and recognizes the change of temperature. The critical piece is to filter that data to make it useful and actionable.
The Clinical Studies Management Systems
Bill Coakley, Director, Global Supply Chain Planning at BioMarin reported on “The Journey to Build a System for Managing Clinical Studies,” Two years ago, an FDA audit powered BioMarin’s journey to automate their clinical supply chain. Meeting the audit proved challenging because much of the information required was from paper-based and Excel spreadsheets from several sources going back several years. Since BioMarin was growing rapidly, and projecting several additional products moving into commercialization, it became clear a more automated process for capturing and maintaining this data would be necessary.
At the time of the FDA audit, BioMarin’s clinical supply chain needed to perform and maintain 27,000 manual transactions per year to remain compliant. Since the company was projecting within two years a growth to 50 studies per year, manual transactions would double to 54,000. Automation was the only solution. The company launched a four-part automation project to
- Install a Forecasting Tool that enables Clinical Supply Chain to calculate drug requirements and perform scenario planning, taking into account all key aspects defined in the protocol, including number of arms, enrollment projections, dose, countries, sites, etc.;
- Automate tracking of shipments and receipts which eliminated almost all manual transactions. This step also involved integrating inventory from distributors and multiple IVR systems into one system;
- Establish capabilities with the patient sites enabling them to perform Return, Accountability, and Reconciliation, and to allow the sites to electronically order only the drug and supplies specific to that study and that site; and
- Integrate the demand and supply into an ERP system allowing for full-scale MRP.
Automation and Streamlining of Clinical Supply Chain
Scott Hebner, Sr. Manager at Gilead (FPD Pilot Plant) and Arun Cavale, Supply Chain Process Designer at NexInfo presented a case study, “Automated Inventory Control and Visibility: Streamlining the Clinical Supply Chain.” The automation, developed with partner NexInfo, replaced the paper-based inventory and supply chain management system for their global operations… Gilead took the step because the multi-site facility with Foster City was projected to grow rapidly in coming years due to the growth of the company’s product pipeline. The company re-configured their facilities arrangement into a hub-and-spoke model with the warehouse as the central repository for all inbound and outbound materials.
Michelle Niles, Director of Business Development at CLINapps focused on the need to integrate data between all clinical supply chain partners in her presentation, “An information System to Manage Clinical Operations – Achieving Cost Reduction, Speed to Market and Compliance.” The two critical elements were seamlessly integration of data from multiple systems and readily configurable software for automated clinical operations.
Report from the EU: What’s up with IDMP?
In his presentation titled, “Getting Ready for the EU’s Identification for Medicinal Products (IDMP): Meeting the European Deadline”, Franck Toussaint, Managing Director of Biolog Europe (Belgium), noted that Industry members of Biolog Europe recently requested that we follow IDMP, the EMA’s proposed regulation on IDentification of Medical Products. The goal of IDMP is to identify all biopharma products with a single set of standards, establishing harmonization across all segments and products. IDMP provides for five certifications: Medicinal products, pharmaceuticals, substances contained (APIs), units of measurements, and forms, respectively. The target date for compliance is July 1, 2016, though there may be delays to 2017. IDMP was formulated as a counter-measure to drug counterfeiting. A secondary purpose is to more closely monitor the occurrence of side effects from medicines by improving communications across all segments of the supply chain. This effort must be an IT-driven process.