Erik Lemay is the Global Head of External Manufacturing for Servier and is responsible for the end-to-end delivery of Servier’s global portfolio of products that are manufactured at CMO partners.
The pharmaceutical manufacturing process is extremely complex, comprising numerous steps from raw material acquisition, active pharmaceutical ingredient (API) synthesis, formulation, packaging, and distribution. At each stage, rigorous quality control measures are employed to ensure the product’s integrity and even more critically, patient safety.
At Servier, we are committed to ensuring all our products meet the highest standards of quality, safety, and efficacy for the patients we serve. We offer a full range of drug substance and drug product manufacturing, development, and packaging services for distribution in the U.S. and worldwide.
We recently enhanced our supply chain organization to meet the increasing complexity driven by the development of our product portfolio, with many new fixed dose combinations and new flows and supplies. Our research and development in oncology, one of our core therapeutic areas, is concentrated on hard-to-treat cancers, including glioma, or brain tumors, as well as hematologic and pediatric cancers.
In the case of glioma, manufacturing brain-penetrant oncology treatments presents unique challenges due to the complex nature of both cancer therapeutics and the biological barriers that protect the brain. One example is vorasidenib, Servier’s investigational oral, selective, and brain-penetrant dual inhibitor of mutant IDH1 and IDH2 enzymes for the potential treatment of low-grade glioma, where therapeutic progress has been stagnant for decades.
Due to accelerated clinical trial enrollment and proof of efficacy, Servier is working fast to determine filing timelines and availability of clinical supply. The formulation of vorasidenib is complex, and in order to ensure that the product meets the highest quality, safety, and efficacy standards, it is critical we have a series of safety and performance tests in place throughout the supply chain process.
Due to accelerated clinical trial enrollment and proof of efficacy, Servier is working fast to determine filing timelines and availability of clinical supply
Our supply chain organization is fully integrated into Servier, with multiple partners across business development, manufacturing, distribution, clinical and commercial partners, and global operations. This ensures a high level of regulatory and safety compliance across the global Servier network, as well as efficiencies that provide reductions in cost and time to market.
Flexible manufacturing systems and robust supply chain management (SCM) are also needed to ensure that therapies reach patients in a timely way. In the context of pharmaceutical manufacturing, the coordination and management of all activities involved in the flow of products from the raw material stage to the final customer, is especially critical due to the complexity of the processes, quality control requirements, and potential impact on patient health and safety.
In my role in manufacturing and supply chain, which includes managing over 20 contract manufacturing organizations (CMOs) for the end-toend delivery of Servier’s products; my priority is maintaining an agile strong supply chain, built to deliver the right product with the right quality at the right place and at the best cost.
To that end, my team is responsible for the day-to-day management and oversight of all production activities, such as forecasting, batch production, release of the product and shipment. By managing this complex interplay of materials, processes, regulations, and logistics, SCM helps ensure that safe and effective treatments reach the patients who need them in a timely and cost-effective manner.
Effective SCM ensures:
• Steady supply of high-quality materials
• Quality checks at every stage, from raw materials to the finished product, to ensure safety and efficacy
• Inventory management to balance overstocking, which can result in the waste of products with limited shelf life, and understocking, which can result in drug shortages
• Coordinated logistics so that medicines reach their destination on time and in good condition
• Risk management to account for supply disruptions, regulatory changes, or product recalls
The Impact of Outside Factors
The recent COVID-19 pandemic highlighted the vulnerabilities in many global supply chains and underscored the importance of building more resilient systems. With raw materials and manufacturing facilities scattered across the globe, managing the supply chain’s complexity has become a pressing concern to ensure the timely delivery of treatments.
Despite these complexities, the industry is adaptable and innovative, and we are committed to finding ways to incorporate new technologies, streamline processes, and ensure the highest quality standards.
By embracing technological advances, prioritizing quality control, and constantly striving for efficiency, we can ensure that safe and effective treatments reach the patients who need them, in a timely manner – ultimately driven by a common goal of improving patient outcomes and saving lives.
