The formidable challenge of the biopharma industry to optimize its clinical supply chain was addressed by Dr. Mary Jo Lamberti, Senior Research Fellow at the Tufts Center for the Study of Drug Development, in her recent keynote address at the 9th Annual Conference of Bio Supply Management Alliance (BSMA), “Preparing the Biotech Supply Chain for 2025, The Onward March!”
At the event, Lamberti made the following points:
• Clinical trials are becoming increasingly global, time consuming and more complex
• Clinical supply chain models will need to adapt to meet the changing environment
• Changing supply model transforming from a centralized approach to a decentralized approach may be one strategy to service more local and regional clinical trial needs
The summary of her research yielded the following key findings:
• Logistical error rates on studies are low, but can have a major impact on studies when errors do occur
• Significant waste of clinical supplies is occurring, adding cost and inefficiencies in the clinical supply chain
• Companies are looking to utilize new technologies to improve management of clinical supply inventory
• New processes and new approaches to clinical supply models may be warranted
Lamberti’s analysis concluded, “45% of all amendments are deemed avoidable and the top reason for amending is changes in eligibility criteria and 40% of all amendments occur before FPF dose where implementation typically results in two months of unplanned delays and $535,000 in unplanned direct costs for a phase III protocol.”
She disclosed that the next steps of research were to, “Follow up study on how patient-centric approaches impact the clinical supply arena including any new strategies to improve study volunteer convenience in and access to clinical trials, and incorporate patient feedback into clinical trial medicine kit design, and the design and format of labeling and instructions, social media and wearables.”
Devendra Mishra, Executive Director of BSMA, observed, “We were reminded today that drug development in the overall supply chain of biopharma continues to be a huge investment where success rates are dismal. Collaboration for optimization at the head end of the supply chain is an imperative. We urge the technology enablers and service providers to facilitate the adoption of disruptive technologies of digital, data analytics, artificial intelligence, mobility, social media and the Internet to reduce cost of medicine and time to market. Identification and promotion of relevant technologies is a primary mission of BSMA.”
Subject-matter experts in the biopharma industry confronted the challenges of "Reducing Waste, Maximizing Efficiency and Streamlining Your Global Clinical Supply Chain" at the conference. The panel consisted of Malou Berdan, Senior Manager, Clinical Supply Chain, BioMarin; Irene Xie, Clinical Supply Chain Manager, Gilead Sciences; Renae Bentley-Gay, Team Leader, Clinical Supply Chain Optimization, Fisher Clinical Services; Ryan Mills, Associate Director, Enterey Life Sciences; and. Ravi Kiron, Managing Partner, BIOPHARMA Strategy.
