Bringing a new drug to market can be a heavy financial burden on any pharmaceutical company. It has become even more burdensome over the last several years as the industry pushes the boundaries of innovation. This is because newer, often more-complex therapies not only increase risk in drug development but also drive costs even higher.
A recent analysis of the investment needed to develop a new prescription medicine shows the total cost can be as high as $2.6 billion.1 That number becomes even more staggering when you consider the fact that only about 12 percent of drug candidates that make it to Phase I testing are eventually approved by the FDA.2 The investment companies lose as a result may be too devastating to their bottom line to ever recover.
That is why it is important to have a clinical packaging strategy that can successfully manage the supply of your expensive drug product throughout the duration of clinical testing. To do this, sponsor companies must balance control of the drug supply with control of shipping costs. Achieving this requires maximizing the amount of drug available for distribution while minimizing overages across clinical trial sites.
The following six strategies can be used to find balance; nevertheless, they all require the support of a trusted clinical packager. Without this valuable insight, a company could experience a costly interruption or extended delay and, as a result, a devastating impact on its timeline to commercialization.
1) Employ a Drug-Sparing Strategy
If there is a limited drug supply that can be manufactured only in small amounts infrequently, the sponsor company’s clinical group must design the study to be as drug-sparing as possible. Plan your patient enrollment timeline so supplies can be distributed when patients are enrolled — not prior to — and build in lead time to get the clinical supplies to the appropriate site on time. It then becomes up to the clinical supply group and clinical packager to determine the optimal balance between maintaining control of the drug supply and maintaining control of shipping costs. Shipping supplies out per patient helps maintain control of the drug supply, but it must then be determined if the sponsor company can afford the shipping costs associated with this strategy. An experienced clinical packager can identify the optimal balance between these two extremes.
2) Ensure Rigorous Patient Screening and User- Friendly Packaging
Drug waste is never wanted in any clinical study, especially in one where the drug is in limited supply. If drugs are going to be sent to clinical sites, the sponsor company should do everything it can to make sure they will actually be used. This starts with a rigorous screening process of potential patient candidates to ensure they meet the study’s patient qualification standards. Some studies are already challenged by the inherent characteristics of the target patient pool, such as with Alzheimer’s or addiction patients. If a company does not carefully screen patients and, if necessary, evaluate compliance using a run-in study, drug is wasted when it is administered to patients who will ultimately not take it.
User-friendly packaging is another issue that needs to be addressed to minimize drug waste. An experienced clinical packager can identify packaging that will encourage compliance. For example, a blister pack is the preferred packaging over a bottle for complicated dosing schemes. This is because it can clearly indicate to the patient which pill should be taken when rather than relying on the patient to remember. While user compliance is not necessarily a clinical supply issue, it does create a risk of drug waste if a patient drops out of the study due to confusion. By putting thought into how the drugs should be packaged, drug waste can be minimized.