By Chris Greco, manager of comparator and ancillary supplies, Catalent Pharma Solutions
Ensuring an adequate, timely, and quality supply of comparator product for clinical trials is critical, but clinical trial sponsors face several challenges in this endeavor. Delivery delays or under-projection of needed quantities could have a negative impact on timelines, budgets, and patients relying on new treatment options for unmet needs. However, there are ways in which sponsors can work effectively with clinical suppliers for accurate forecasting and comparator sourcing.
Here are some planning considerations to help you avoid clinical supply delays.
Gain an understanding of your wholesalers distribution model and business relationships with other supplier partners.
In some cases, a wholesaler may have in-depth processes for adding a new delivery location, but the study sponsor may not have the necessary licensing to make such a purchase directly. A sponsor could encounter some resistance when trying to place orders directly from a wholesaler.
There is also the cost to consider. Compared with a big company that buys supplies for many studies, a study sponsor may not be able to leverage its much-smaller annual spend with the wholesaler. For a one-time purchase, a wholesaler has much less incentive to spend time setting up its system to conduct the financial transaction with the sponsor. The wholesaler might even ask the sponsor to work with one of its suppliers instead of buying directly from them.
Discuss expiry requirements with your supplier early.
Manufacturers don’t typically provide older product for comparator studies. In some cases, if study planning begins early enough, a sponsor may receive a custom-manufactured batch of product with maximum expiry. If there are expiry requirements, the sponsor and manufacturer should discuss them early on and establish an expected minimum expiry timeframe.
For example, if at least 18 months are needed, manufacturers may try to fulfill that order as opposed to just taking the next shipment off the commercial distribution line.
During pre-planning, gain an understanding of typical available supply quantities from your suppliers.
Some assumptions can be made during preplanning on the basis of current conditions, for example, expiry. Suppose a study sponsor is not planning to make its first purchase for another 10 months. On the basis of the expiration date and the remaining shelf life of product being shipped, one can assume that the timeframe will be equivalent to product purchased later. The same is true for quantities and availabilities. There can be temporary ebb and flow of supply, but it is useful to know what quantities of a product are currently available. If study planning is done early enough (e.g., six to 12 months in advance), an assumption can be made that this quantity of product will still be available at the time of purchase.
If relevant, plan for international distribution considerations early.
If buying directly from local wholesalers, each transaction must be handled as a distinct purchase. Three separate purchase orders would be needed to buy from a wholesaler in Russia, the European Union, and the United States. In terms of transactions, they are considered separate purchases. However, they could be pooled as a single purchase if the different countries can use the same booklet label or product. It should certainly be left as a whole project at the clinical supply management and planning level; all of the information about the various lead times and expiries for each country from which product is sourced can be pooled and managed as part of one study.
Explore the benefits of a collaborative relationship with suppliers.
It is common these days to find manufacturers willing to collaborate. It is really about making it easy for both the manufacturer and sponsor. For example, by approaching the manufacturer with a clear supply plan and providing details about the specific product, quantities needed, delivery dates, and minimum expiry requirements allows a manufacturer to provide support and foster a collaborative relationship with two-way feedback. Armed with the information, the manufacturer can give feedback in terms of what is realistic, based on the existing supply chain. The parties can then work together to form a plan. In cases in which a manufacturer will not provide support or product for the study, it becomes necessary for a sponsor to work more closely with its supplier base. They may be buying the product from wholesalers or specialty pharmacies, typically in smaller quantities with shorter expiry and perhaps a bit more expensive. The same types of information must be provided—time lines, expectations, and targets to shoot for to meet the needs of the clinical trial.
Use demand forecasting to optimize supplies.
Scenario planning helps to determine ideal quantities for the study, but you may discover thru simulations that you have under or over-projected. If you don’t conduct the simulation test earlier enough and you find you have under-projected, you may not have time to purchase more clinical supplies. I think that under-forecasting is worse than over-forecasting. Although buying too much product results in excess or waste, buying too little could have a direct negative impact on the study and the patient, which is a much bigger problem.
Consider using suppliers with their own forecasting group.
If the knowledge and expertise for scenario planning are available internally, a study sponsor can work closely with its own comparative specialists to clearly understand inputs into the simulation, such as quantity restrictions, expiry limitations, and any other factors that will affect the sourcing strategy. It is still important to stay in constant contact with comparator resources to maintain a clear picture of the supply and any challenges. Although it is feasible to work with an internal group, many companies find that it is a bit easier to outsource forecasting and to have an external resource help manage it.