In 2018, there are numerous issues within the clinical supply chain that continue to make an already intricate process more complex. After speaking with over 40 clinical supply professionals across the industry, I got to grips with some of the key concerns facing the supply chain today.

Some of the topics discussed range from regulatory compliance to the temperature maintenance of clinical supplies in distribution.

Annex Changes and the Brexit Factor

One of the most pressing items voiced by almost all interviewees was annex changes that impact the distribution requirements of clinical supplies to Europe. Whether you’re a European or a U.S. company running a trial in the EU, the industry as a whole needs to familiarize itself with the regulations impacting the distribution of drugs.

Loi Luu from CytomX Therapeutics said understanding QP release regulation is at the top of her priorities. She took this a step further by pointing out the need to look at ‘manufacturers not based in the U.K. in order to plan for Brexit.’ Luu said the U.K.’s decision to leave the EU adds another layer of complexity to QP releases, as well as a barrier to partnering with European, and more specifically, U.K.-based CMOs.

Additionally, any annex changes have a tremendous impact on the entire supply chain and manufacturing in the EU. Robert Bronstein from Dynavax followed a similar logic by pointing out that many clinical packaging groups are based in the U.K. When Brexit comes into effect, people may start sourcing products from elsewhere. Ultimately, understanding what impact Brexit will have on regulations and how to prepare for it is a leading challenge faced by pharmaceutical leaders.

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Packaging Concerns – The Cold Chain Conundrum

But what of the impact on product distribution within the supply chain? Maintaining the integrity of clinical supplies while in distribution remains a persistent issue in the industry – be it clinical or commercial. Pitsata Malveda from Quark Pharmaceuticals said airlines are responsible for the overall integrity of the shipment while it’s in transit. This means they must have the right equipment in place, such as refrigerators to ensure temperature sensitive products remain stable. Therefore, it is crucial pharmaceutical companies are aware of and are prepared for unforeseen events in transit, such as products being bumped onto other flights, tarmac time, paperwork, and customs and border difficulties.

Another point highlighted is how the packaging used for clinical material is a central part in protecting the product’s integrity. Best practices in cold chain shipping needs to be established for the industry – is air freight more effective than sea shipments? Does the volume of the shipment impact the measures that should be taken in cold chain shipments? What devices should be used that best log the temperature of products in transit? What are the costs of shipping for different storage solutions? These are some of the questions that need to be answered in order to solve the cold chain conundrum.

Implementing a Robust IRT System

Moreover, understanding how data management systems can remedy concerns in clinical trials is proving to be a challenge. For instance, CRT/IRT systems which give alerts as to what is happening in depots, on inventory and in trials, are often difficult to understand. Some of these systems have limitations in terms of what they can program. Some organizations have better capabilities to support clinical trials in a more efficient manner. The ultimate goal with automated systems is to find out which is more effective in reconciling inventory, adding in comparators, and managing the expiration of products.

Senior employees from Gilead mentioned how IRT systems should be used as a tool to tie inventory levels to forecasting as an automatic process. This is because during the planning process, reconciling the numbers can be tricky due to the number of people managing complicated studies in various locations. Therefore, a robust IRT system can be influential as a forecasting tool.

What does the Future Hold?

As a whole, several issues persist in different areas of the clinical supply chain. On one hand, the solutions to many of these issues seem to favor technological innovation that can facilitate exiting processes. This can be in the form of cold chain packaging or real-time temperature loggers. On the other hand, solutions can also be found through simplifying guidelines so that the industry is aware of the barriers. Ultimately, preparation is key when planning for future trials.