As pharma and biotech companies continue to try and streamline their clinical supply chains, particularly the costs associated with the manufacture and distribution of investigational medicinal products (IMP), waste management is becoming an area of increasing focus.
How, where and when the destruction of IMP material occurs depends on many factors. Perhaps the most obvious of these is cost. It should be calculated before study start-up whether it is more economical to destroy expired or unused IMP material at the site itself or for the material to be shipped back to the Sponsor for destruction. However, neither should Sponsors underestimate the time required to ensure proper disposal of IMP. Even if the Sponsor has delegated the destruction of IMP to the site, quantities of IMP material must be recorded and reconciled by the Sponsor before it is disposed of and any discrepancies need to be investigated. Dependant on whether or not there are any discrepancies in product quantity, this can add a significant amount of time onto the official closure of a study.
The second factor which comes into play when deciding how to achieve IMP destruction is international and regional regulations. While the EU regulations for the destruction of IMP are clearly laid out in Annex 13 and tend not to give rise to different interpretations, Sponsors have found themselves faced with greater difficulties when attempted to decipher the regulations in place in more remote regions such as Russia. Biopharma companies with enough resources can afford to hire in-house specialist teams to interpret the regulations of these countries but smaller companies usually must rely on local contracted partners to guide them through complex regional regulatory landscapes.
Serbia is a notoriously difficult area to work in at the moment due to changing regulations on the destruction of expired or unused IMP material. The changed clause will state that Sponsors are no longer allowed to remove IMP material from the site and ship it out of Serbia for destruction. Instead, all IMP must be destroyed at a government-designated location. Two problems have arisen due to this regulatory change. The first is that there is some disagreement on when the regulation is due to come into force. Some companies have already seen CROs refuse to transport material back to them for destruction as they believe that the regulation has already come into force. Of course, this problem is short-term and will likely disappear once the regulations are better communicated. The second problem, however, is set to be more long-term and costly for Sponsors. This concerns the increased cost and time which will be the consequence of these new regulations. Some biopharma companies feel that the most cost-effective method of dealing with the destruction of IMP under the Serbian government’s new conditions is to get their CROs to take responsibility for subcontracting out the removal of the material but some CROs do not want to take on this responsibility so negotiations could be lengthy and laborious.
A third factor in IMP destruction is the size and number of trials which are taking place. As the complexity of clinical supply increases with multiple trials so also does the amount of waste. In this case, waste does not just refer to expired or unused IMP material but also the boxes which sites may find themselves inundated with before long. Some larger biopharma companies have began recognising this as a problem and, keen to save resources and also shrink their carbon footprint, have started to look into reusable packaging and other sustainable options.
However, perhaps there are more obvious strategies for reducing waste which do not require companies to invest in expensive new technologies. For instance, any project manager or clinical operations professional will tell you that one of the biggest culprits for wasted product is slow patient recruitment. Some industry experts estimate that often the forecasting of IMP in relation to patient recruitment is so inaccurate that only 5-10 percent of IMP is actually used due to Sponsors having to resupply because of product expiration. Therefore, it can be argued that the solution to IMP waste is to invest in good old-fashioned patient feasibility questionnaires rather than the latest ‘green’ technology.