Clinical Supply Distribution Strategy: Planning & Adapting

Interview with Dana Shull, PCI’s Senior Clinical Supply Manager, focusing on effective strategies for planning clinical distribution.

Dana highlights the importance of early preparation and shares valuable insights on creating a robust distribution plan. She discusses the critical information required to develop your strategy, how to assess and determine depot requirements, and practical approaches to efficiently adapt to changes during a study.

What is the goal of a good distribution strategy?

The goal of a good clinical distribution strategy is to ensure the seamless, timely, and cost-effective delivery of investigational products and related materials to clinical trial sites while maintaining product integrity, compliance with regulatory requirements, and alignment with study timelines.

Essentially, Correct Kit, Correct Location, Correct Condition, Correct Time – all to ensure drug product is at the clinical site, ready to be dispensed when a patient is ready to dose. From an overall study objective, a key goal is to avoid enrollment constraints due to limited supply availability. In order to achieve this, you need to establish compliance with GMP, GDP and GCP requirements in the early planning stages. Only then, can you manage and control risks to supply. 

What is the most important aspect in ensuring a robust distribution plan?

Alignment and understanding between your clinical operations and clinical supply chain teams is pivotal. Each team should understand and agree to the limitations of your available supply; country, site and subject lead times. The absence of a realistic overall supply strategy can make or break even the best planned studies.

While you can expect under recruitment in one country and over enrollment in others, it is critical for you to consider how the timing of such changes affects your overall supply so you can ensure continuity of all countries enrolling. In order to support a multi-faceted and changing enrollment environment, it is imperative to know your full supply chain capabilities and be willing to pivot when necessary.

TIP: Understanding drug sourcing and labeling, regulatory requirements as well as study requirements early will help you to quickly understand which options are feasible when determining depot needs and deciding on appropriate depot locations.

What are the main drivers when considering distribution strategy at a high level?

While international harmonization and improving processes continue to simplify planning to a degree (labeling and import requirements consistent across Europe for example), clinical supply chains still face many country specific regulatory and customs challenges. One key aspect of high-level distribution planning is the establishment of functional depot locations. 

Three key areas need to be understood prior to choosing depots that are both feasible and appropriate for your study. These include: drug sourcing and labeling, regulatory constraints, and import requirements. Keep in mind, some countries for example Japan and Brazil, do not offer choices due to regulatory, cultural or business expectations.

At what point should you be gathering information to help define your distribution plan?

If you have a draft protocol, you should start asking questions!  The earlier you begin drafting a plan, the better chance you have to drive changes that may positively affect your downstream activities. Key areas that can be shaped to drive efficiency include kit design, visit windows and dispensing quantities.

What information, in addition to the protocol, would you require to generate a distribution budget or spend forecast? 

For a basic budget, enrollment projections, site feasibility info/start up timelines and quantity of available drug should allow you to generate a high-level budget forecast and plan. To dial in on specific costs, you need to understand the courier routes, transit times and agreed depot locations.

What aspects do you think are most often overlooked when planning distribution strategy?

Typically the interconnectedness of all key functional planning areas in clinical trials is overlooked. Making decisions in a silo leads to supply chain inefficiency and wasted costs. A key remedy is to hold cross-functional meetings to avoid linear decisions.

Almost all planning tasks are inherently interdependent and touch on many functional areas. You should begin with the end in mind. Key tasks include: IRT vendor selection, kit design build and functionality, depot proficiency, country selection and enrollment capability. All are crucial factors in trial feasibility assessments at both the country and site level.

What factors are good to consider as a starting point when determining depot requirements?

Direct to Site (Central 
Depot)
Local or Regional Depot
No of subjects per countryHighX
Available DrugLowX
Shipping Timelines LongX
Regulatory & Customs High Costs, Long lead 
time, Import License 
Restrictions
X

When assessing your depot requirements, several key factors should be considered: Number of subjects per country, available drug, shipping timelines, regulatory and custom regulations are just a few and outlined above.  The best approach is to gather as much information as possible and assess the benefits from both a flexibility and budgetary perspective. One size does not fill all when it comes to depot establishment—your study design will dictate what is most efficient.

What is the key to adapting quickly to a change in your study?

Become a Subject Matter Expert (SEM) on your supply chain. This requires you to understand how your projected patient activity, shipping frequency and depot lead times affect your supply availability. Ask the questions; how long can I continue to supply my sites? What is the projected stock out date at the depot? What is the lead time to resupply the depot? Then consider protocol specifics; screening windows, visit windows and dispensing quantity. This will allow you adjust your IRT settings to centralize supply. In parallel, work with your CDMO and depots to expedite timelines for drug resupply.  

Are there still lingering effects from supply chain disruptions during the Covid-19 epidemic?

The challenges seen pre-Covid in maintaining standard shipping lead times were extensively exacerbated by the impact COVID-19 had on global travel and logistics. Most couriers operate using hybrid models using their own aircraft and routes alongside both commercial and passenger airlines. Post COVID, the number of commercial and passenger flights has reduced, and routes have changed limiting the options couriers have. The capacity within the network to meet clinical shipping requests remains diminished. Now more than ever, assessing your outgoing supply chain is critical to ensure that your shipment size, temperature condition and need by date can be accommodated, given the new logistics reality. This may mean increasing depot resupply frequency or adjusting IRT parameters to ship earlier to meet expected patient need.

When planning your distribution strategy, it is important to start early and in conjunction with cross-functional teams to ensure both harmonization and efficiency. In addition, it is imperative to know the key aspects of your supply chain so you can pivot when inevitable changes occur. With diligence and proper foresight, a robust supply chain is within reach.


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Our dedicated team of specialists will be happy to discuss any of your Clinical Distribution needs. Contact us on +1 215-613-3600 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com

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