Contributed Commentary by Stefan Dürr

October 26, 2018 | Our industry has a 200% drug supply overage problem in clinical trials. Study organizers often supply individually per study, some of which are complex or multi-phase studies. Many study sponsors tend to package “too much” or “too early,” to be on the safe side. Overwhelmingly, these studies often are delayed and have wasted a large quantity of the drugs they’ve already prepared.

Drug pooling can help. In pooling drug supplies across different studies, you are much more able to minimize risk and keep your overage lower, because the forecasted need across multiple studies can be more accurately calculated and stocks at depots can be used more flexibly. In fact, I would expect the overage need on pooled studies to be reduced by 20-50%.

Drug pooling is the common practice of strategically using drugs across different clinical studies to significantly reduce drug overages and maintain drug supplies for study patients. This strategy, used in conjunction with an IRT system, is one Cenduit’s Drug Supply Center of Excellence recommends. Many of our clients are exploring drug pooling in response to the continued modernization and complexity of clinical trials in which a one-size-fits-all approach simply does not work.

When to Use Drug Pooling as a Part of Drug Supply Chain Management

Pooling can be appropriate when the study drug lends itself to being used in the same kind of design across different protocols. Often these protocols are running concurrently, and the drug is packaged in the same way. The more studies you run together, the bigger the benefit of pooling. (However, if the design of the drug is specific to a study, there is typically no point with pooling it with another study.)

Drug pooling has been discussed for over 10 years. This type of modeling is not technically challenging, it has tremendous benefits, and is one of the most under-utilized drug supply management strategies with an IRT system. The main benefit is cost savings. Across numerous industry biopharma conferences, attendees may observe presentations of the great financial savings that pooling can provide across a clinical program. Why does this matter? If you can pool a drug across studies you need less stock, because you can be more flexible with your drug.

Consider this hypothetical scenario: Suppose you have 6 studies in the U.S. with the same drug. Perhaps one study is running slower than expected, and another is running faster than expected. With pooling, a sponsor can elect to send more drug to the study that is running faster. This action will not affect your stock because there is already another study that is running a bit delayed.

Regulatory challenges are a potential issue with drug pooling. Different local regulations, especially across European countries, make sponsors initially reluctant to pool despite the planning benefits. However, there are numerous cases of sponsors who pool that are living with the regulatory pushback, and have become good enough in practice to defend potential hurdles.

Where is Drug Pooling Headed? Cost Savings and Eliminating Drug Overage Challenges

The next natural evolution of drug pooling needs to be a global consensus building of best practices across countries and regions, to reap the benefits and potential efficiency savings. The need for multi-geographical regulatory buy-in will ultimately help sponsors with potential savings as a part of their drug supply chain strategy. On the other hand, if one or more countries won’t accept pooling, the practice would need to be adjusted in certain countries and not in others, and you would lose part of the savings.

It is clear drug pooling offers an important benefit from a logistical and supply chain perspective, and makes it easier to have the drug available for patients. Clinical studies are large and costly. If we can adopt new methods to bring down costs, in the end we can help to bring down the cost of drugs throughout the program and when they’re on the market, as well.

Stefan Dürr is Senior Director of Project Management, and Head of the Cenduit Drug Supply Center of Excellence. He can be reached at stefan.duerr@cenduit.com.