Contributed Commentary by Alyssa Gilliam and Chad Crafford, ICON 

January 5, 2023 | Cell and gene therapies (CGT) have made substantial progress in recent years thanks to several breakthroughs and higher flow of funds into the space. Despite this progress, the challenges of working with living therapies remain highly complex, risk-laden, and time-consuming. The obstacles faced in managing the clinical supply for such trials must be considered carefully. More than in traditional clinical trials, the unique manufacturing process and logistical complexity require intense resource allocation and therefore meticulous planning and rigorous controls to enable responsive, agile strategies.  

Here we outline a few practical considerations for managing your CGT supply chain to minimize risk, mitigate cost, and complexity. 

Strategic Flexibility   

A well-thought-out strategy should encompass all aspects of CGT supply chain management. This planning should consider various scenarios so that you can flex and pivot to avoid disruptions and ensure these sensitive materials are appropriately managed.  

Detailed planning wedded to a willingness to adapt will expediate efficient decision-making. It is here that technology meets its limitations—as an industry, we still rely on human expertise and proverbial boots on the ground to observe and respond to novel real-world challenges.   

Avoid Ambiguity 

Clearly defining handoff points and protocols, developing responsibility matrixes and identifying potential drop-out points along the logistics journey will minimize risks and mitigate delays or potential confusion. These steps may seem simple, but they are foundational to a successful logistics strategy for CGT. In our experience, when the CRO holds the vendor contracts, we have more visibility in creating and tracking shipments and other critical milestones in the logistical process. Operating autonomously cuts decision-making time, increasing flexibility and agility, and allowing for more timely action. 

Know Your Limits, Plan for Them 

For CGT trials, contingency planning must be exhaustive because unpredictable behavior is a given. Sponsors are dependent on specialist manufacturers and distributors that own their respective scopes. A CRO’s deeper bank of experience in CGT, logistics and distribution can provide richer strategic value. For example, while we don’t typically control the manufacturing process, CROs’ experience can help you prepare for the “inevitable” by planning for the mishaps.   

Many CGTs in development are from emerging biotechs that stand to benefit most from an experienced CRO’s strategic insight. They can leverage the CRO’s networks, relationships and groomed expertise in specialty services to benefit their CGT trials. However, some sponsors initiating their first CGT trial may carry misconceptions about clinical research in this particularly challenging area.  

Clarity in Communication 

Structured communication can reduce confusion and improve timelines. Sites are bombarded with inquiries from CRAs, CTMs, clinical supply managers, and logistics coordinators. Identifying a single point of contact for sites cuts through the noise, protects site personnel’s time, and creates a clear channel for priority communication. Standardized email cadences alert appropriate parties to key milestones and study mailboxes help organize and prioritize digital communications. 

CGT is time-sensitive, from harvest to transport to treatment. Even minor lags in communication can snowball into treatment-threatening delays. We operate 24/7 support and triage services so we can carefully maintain relationships with clinical sites to foster improved communication and timeline management.  

Scalable Structures  

Splitting the daily responsibilities of a Logistics Coordinator from the higher-level duties of the Logistics Manager provides an operational expert on-the-ground to manage supply chain and logistical challenges that inevitably arise. It streamlines workflows, provides autonomy for faster decision-making, and mitigates cost due to a lower billing rate. As clinical trials grow in size and complexity, this allows for logistics coordinators to scale up under the manager.  

Similarly, strong relationships and networks are key to scalability and providing options for sponsors as CGT expands into the global arena, including recent growth in Australia and Asia-PAC.  

Cost Mitigation 

CGT is expensive. The intensive, custom and highly technical requirements drive costs. Efficient resourcing allocation and budget management are crucial to keep trials on track.   

CGT’s future is likely to be characterized by innovation in therapeutic approaches and manufacturing methods. As the field matures, CROs will expand our alternative vendor options which in turn leads to additional cost containment.   

A Human Future 

CGT has evolved rapidly, with several therapies progressing from experimental stages to approved treatments. This transition has the potential to revolutionize the treatment of previously intractable diseases, offering hope to a broader patient population.     

While there are challenges and uncertainties to address, the combination of scientific progress, responsive strategies and a dedicated human element positions CGT to have a profound impact on healthcare.   

Alyssa Gilliam is Vice President, CSM & IRT at ICON. She oversees the company’s strategy in clinical supplies management and interactive response technology. She brings 25 years of experience in clinical and project management experience, with ten years focused on IRT expertise and four years specifically on clinical supplies management, including CGT studies. She can be contacted at alyssa.gilliam@iconplc.com.  

Chad Crafford, Clinical Supplies Manager at ICON, has nearly 20 years of experience in the clinical research industry, with the last 8 years involved in project management for global clinical supplies. He can be contacted at charles.crafford@iconplc.com.