Integrating The Digital And Physical Supply Chain In Clinical Trials

By Jim Murphy, President, Almac’s Clinical Technologies

For decades, the pharmaceutical industry was characterized as risk averse, conservative, and slow to change. In such an environment, being a change agent was not often a job requirement. That’s no longer the case, as innovation outside the laboratory is valued as never before. One change ready to be explored is improving the efficiency and effectiveness of the clinical supply chain by adopting a holistic model that will minimize costs, increase agility and control, and provide greater traceability.

THE BENEFITS OF A SEAMLESS DELIVERY MODEL
A holistic clinical drug supply solution combines an advanced technology platform for managing patients and supplies with the domain expertise and resources to perform end-to-end supply chain manufacturing and logistics. It enables seamless coordination of key steps — from supply planning and interactive response technology (IRT) implementation through to packaging, labeling, distribution, returns, and product destruction. It leverages realtime enrollment information and tight process integration to enable an iterative delivery model.

Adopting a holistic solution can be transformational. Although the benefits will vary from one study to the next, most companies should generally realize:

• Shorter start-up time lines, made possible by simplification of packaging design and IRT requirement definition.
• Reduced product wastage, through batch packaging and labelling operations.
• Greater adaptability to unpredictable enrollment patterns through realtime patient and drug information.
• Reduced logistics costs as a result of actively managed drug resupply strategies.
• Simplified management of mid study changes, whether the result of protocol amendments or Adaptive Designs.

Plus, the sponsor team’s experience during study start-up is improved when a partner takes responsibility for setting up the digital and physical elements of the supply system. Ideally, the relationship will transcend tactical execution and deliver on strategic goals that lead to continuous improvement and value creation.

IMPEDIMENTS TO PROGRESS
Although the advantages of a holistic solution are compelling, there are several reasons why many sponsors haven’t adopted a comprehensive approach:

1. Sweeping transformation of this nature often threatens the status quo for the sponsor team responsible for making outsourcing decisions. Additionally, entrusting a service provider with such significant responsibility can be unnerving for some companies.
2. Digital and physical supply chain services are typically outsourced at different times by different functions in the sponsor company, making broad scale decisions difficult.
3. Strategic outsourcing of this scope lends itself to risk-sharing arrangements, although the fact that protocols are prone to change makes it difficult to monitor and manage performance.

While these challenges may seem daunting, none are insurmountable.

A ROADMAP FOR CHANGE LEADERS
Companies interested in a holistic supply chain model can realize many benefits, but scaling up to the point where a large portion of a sponsor’s clinical programs are handled in this manner may be a lengthy process. Many companies begin with a pilot and wait for data demonstrating measurable value before institutionalizing the approach.

Change leaders who want to drive adoption of a new supply chain model will want to:

• explain the overall vision and desired benefits to the domain experts in the company’s IRT and drug supply teams
• use real-life case studies to provide proof points demonstrating the validity of the approach
• work with internal teams to identify potential pilot opportunities, which could include Phase 2 studies, investigator-initiated trials, or small trials involving biologics
• ensure executive-level sponsorship exists on both sides of the relationship in order to support alignment and aid in facilitation of change
• define key metrics for success
• collaborate with the vendor to produce a strategic plan to reduce the total number of study drug units produced and shipped
• conduct a pilot, monitor progress, and expect the vendor to provide meaningful and measurable benefits
• where appropriate, embed service provider resources into the organization to ensure smooth knowledge transfer and support effective expansion of the model.

Affecting operational change of this magnitude is never easy. Yet, with the right assistance and overall plan, it is quite achievable. In adopting a seamless delivery model across the digital and physical supply chain, change agents have a rare opportunity to transform a large and growing cost driver in drug development.

Jim Murphy is President of Almac’s Clinical Technologies Business Unit, a role he has held since 2006. He also leads Asia Pacific operations for the Almac Group, overseeing the company’s strategic expansion in the region.