The Impact of Supply Chain Inefficiencies on Biotech Startups
- PRONAV
- Sep 12
- 5 min read
Biotech startups often operate in small teams with limited capital and stretched resources, meaning a single missed shipment or documentation error can cost months of progress and a substantial amount of money. The costs associated with planning and running a clinical trial are high, with the estimated average budget of a Phase 1 clinical trial ranging from $1.4 million to over $6 million1. Apart from monetary costs, delays resulting in missed milestones and reputational damage can severely impact investor confidence and patient recruitment. Biotech startups often only have one shot at getting it right in early-stage trials, and the effects of supply chain inefficiencies can be devastating for both Sponsors and the patients they serve.
Where Do Supply Chain Inefficiencies Typically Arise?
Poor Planning or Forecasting
Clinical trial supply chains are highly complex operations that require the coordinated movement of various components, drug products, and critical data across multiple sites and often across international borders or regulatory jurisdictions2. Maintaining visibility and control over this process demands meticulous planning and precise forecasting to ensure that every step along the supply chain proceeds without disruption.
Inadequate planning or failure to accurately forecast downstream timelines can lead to resource scarcity, vendor misalignment, and quality release delays. By contrast, robust planning allows each stakeholder to prepare resources, documentation, and quality processes in advance, ultimately safeguarding trial timelines and ensuring that investigational products reach patients without unnecessary interruptions.
Misalignment Between Supply Chain Vendors
The flow of products and documentation between the many vendors that make up the clinical trial supply chain must be carefully managed to ensure that the correct product and associated documentation are supplied to the correct vendor at the correct time. Vendors, CDMOs, qualified persons (QPs), testing labs, and couriers each require specific validated documentation in order to proceed with the next steps. If incorrect documentation is provided or if the documentation is delayed, then the following steps in the supply chain will also be delayed. Similarly, misalignment between vendors on the manner in which materials must be packed and shipped in order to meet transportation regulatory requirements, particularly for biologics shipped by air, can cause shipping delays, temperature excursions, and potentially loss of product.
Lack of Real-Time Visibility
A lack of visibility into clinical trial supply chain data can create misalignment between clinical operations and Chemistry, Manufacturing, and Controls (CMC) supply because neither side has a real-time, accurate view of inventory levels, manufacturing timelines, or shipment status. Without this transparency, clinical teams may schedule trial activities that the supply team cannot support, while CMC teams may produce or ship materials misaligned with actual trial needs, leading to delays, wasted resources, or missed study milestones.
The Consequences for Emerging Biotechs
Inefficiencies in the clinical trial supply chain can have serious consequences, especially for biotech startups that commonly have limited resources to fall back on.
Delays in patient recruitment
Delays in manufacturing timelines, batch release, and product delivery can have a detrimental effect on patient recruitment. Recruiting for clinical trials is challenging, especially for rare diseases where patient populations are small. Delays can cause missed opportunities to treat the available patients, thereby prolonging the recruitment process3. In addition, delays can have further consequences, such as missing funding deadlines, impacting follow-on research and/or the feasibility of the clinical trial itself.
Reputational Damage
Startups depend heavily on investors and grants to fund clinical development, with continued access to this funding hinging on the achievement of specific milestones and demonstration of a clear potential return on investment (ROI). Inefficiencies in the supply chain can harm a startup’s reputation, eroding trust and investor confidence, and in some cases, resulting in funding being reduced or withdrawn. These setbacks can also tarnish the company’s standing with regulators and clinical research organizations (CRO), as persistent supply chain issues signal an inability to reliably deliver on commitments.
Lost Startup Window
Operational efficiency in trial startup is not a checkbox; it’s the foundation for staying on schedule, preventing cost overruns, and having the capacity to deliver treatments to patients safely and on time. Inefficiencies within the supply chain can severely impact the launch of a new trial due to the loss of site availability, changes in patient populations in the interim, or even reallocation of funding due to missed milestones. This missed start-up window often means extending the overall study timelines, which can not only incur significant additional cost, but also threaten the feasibility of the trial4.
Loss of future revenue
Beyond these direct operational and reputational impacts, trial delays can have a profound impact on potential future revenue. According to updated empirical research by the Tufts Center for the Study of Drug Development, each day of a delay in drug development can translate to approximately $500,000 in lost approved drug sales in the future5 - a financial setback that underscores the importance of maintaining clinical trial supply chain efficiency and reliability.
What the Most Prepared Trial Sponsors Do Differently
Preparation is key to ensuring that your clinical trial supply chain runs as smoothly as possible. To achieve this, the most successful startups:
Create supply chain roadmaps from the outset, ensuring that there is full clarity with respect to product and quality information flows. Identification of bottlenecks or potential misalignments in both product flow and quality data across the complete supply chain is critically important right from the start.
Involve QPs and regulatory experts from an early stage to ensure compliance across all planned or potential trial geographies.
Use real-time tracking platforms, such as PROMAP that offer structured task management and control over document workflows, ensuring full visibility throughout the process. This helps identify and resolve issues immediately, minimizing the risk of delays or non-compliance.
Anticipate risk and incorporate buffers to allow for the inevitable plan changes.
Avoid Common Pitfalls with PROMAP.
Contact Us today to discuss how PROMAP, our proprietary cloud-based task management and data-sharing platform, can help you simplify the most complex supply chain challenges in order to avoid supply chain inefficiencies. PROMAP provides a centralized, real-time solution for storing, sharing, and reviewing critical regulatory and batch certification data and documents allowing you to streamline your supply chain task & document management.
References
1. Sertkaya A, Wong HH, Jessup A, Beleche T. Key cost drivers of pharmaceutical clinical trials in the United States. Clin Trials Lond Engl. 2016;13(2):117-126. doi:10.1177/1740774515625964
2. Lai J, Forney L, Brinton DL, Simpson KN. Drivers of Start-Up Delays in Global Randomized Clinical Trials. Ther Innov Regul Sci. 2021;55(1):212-227. doi:10.1007/s43441-020-00207-2
3. Videnovic A, Pfeiffer HCV, Tylki-Szymańska A, et al. Study design challenges and strategies in clinical trials for rare diseases: Lessons learned from pantothenate kinase-associated neurodegeneration. Front Neurol. 2023;14:1098454. doi:10.3389/fneur.2023.1098454
