Ensuring the safety of patients in vaccine clinical trials requires close cooperation between sponsors and vaccine suppliers.
Jennifer Worsfold, Director of Customer Services and Deputy GM, Fisher Clinical Services (FCS), said that sponsors and supply chain managers must “ensure the safety of vaccine study subjects and ensure the safe passage of vaccine, which is typically valued at 100 times the cost of shipping, to global trial sites.”
During her presentation at the 2010 World Vaccine Congress in Lyon, France, Worsfold discussed the challenges involved in supplying and conducting vaccine clinical trials. She explained how FCS, an organization that provides clinical supply chain and project management solutions to the life science industry, is meeting the challenges of controlled temperature supply chain for global clinical studies.
The FCS strategy for establishing a robust supply chain for vaccine trials involves a rigorous process of proven durability. Worsfold said that planning for a vaccine clinical trial should begin “approximately four to six months in advance; although with its established processes and experiences, FCS can work with shorter timelines.” The FCS strategy is intended to allow designers and engineers to examine the entire supply chain process for a specific study, making recommendations about adjustments and improvements. Worsfold said that the FCS also incorporates “critical Interactive Response Technology (IRT) to integrate the drug supply chain management processes of packaging and distribution with the clinical processes of patient enrolment and treatment.” Additional components include identifying secondary packaging needs once decisions about packaging and shipping have been made and IRT has been incorporated, and determining the need for ancillary supplies, because “supplies taken for granted in Western countries may not be readily available in some emerging markets,” Worsfold said. FCS also ensures that storage and distribution are sufficient in sub-Good Manufacturing Practice (GMP) hubs and sites, evaluates the need for reverse logistics during or after the study, along with destruction of unused trial supplies, and confirms differing temperature and handling requirements for comparator/concomitant vaccines.
The recent surge in biologics testing has prompted a tightening of regulations around temperature control and monitoring, which includes analytical and stability testing, labeling, and bio-repository and bioservices. The high cost and limited supply of vaccines have led FCS to develop a detailed protocol for use in crafting a robust controlled temperature supply chain, enabling FCS to craft a custom distribution strategy that takes into account depot/sub-depots, vaccine supply, kit size, temperature requirements, customs/import requirements, and budgetary discipline.
Worsfold said that, “with respect to shipping vaccines, the selection of containers and temperature monitoring are the most critical elements.” There is a new generation of shipping containers that incorporate new technologies for reducing or preventing temperature fluctuations (for example, Phase Change Materials (PCM) and vacuum panels), albeit at higher cost. The latest advances in temperature monitoring involve the use of Universal Serial Bus (USB) port monitors.
It is critical to meet the strict standards of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Clinical Practice (GCP) as a means of ensuring overview and control. To prevent clinical trial delays, it is also important to meet regulatory standards in all regions where trials are planned or underway and in which licensure is sought. The requirements of the European Medicines Agency (EMA), the regulatory authority for the 27-member European Union (EU), often differ substantially from regulatory authorities in other key markets, such as the US Food and Drug Administration.
Worsfold recommended that biopharmaceutical companies preparing to scale up to global vaccine trials should develop good partnerships between suppliers and sponsors in order to facilitate a distribution strategy, ship within a region wherever possible using qualified couriers, define a range of shippers based on a review of stability data and destination, monitor and ensure safe passage from hour 1 to delivery, be flexible in processes and choices by relying on supply chain experts to make recommendations, communicate clearly with all parties. “Balancing risk, cost, compliance, and timelines is important while keeping in mind at all times that the safety of study subjects is the primary concern for all clinical studies,” she said.