The Value of An Executive Sponsor with Tech Transfers
The relationship you build with your executive sponsor (ES) is the most critical relationship you will build with your CDMO partner and will serve as the foundation for long-term commercial success. At the core of vendor selection activities, it is vital to understand the CDMO’s flexibility and culture, models and scale of equipment, technical and analytical capabilities, regulatory support, quality system, and audit inspection history – and it is equally as vital to understand its executive sponsorship model. Learn more about why this is a vital component of your process.
The Role of On-Demand Manufacturing and Derisking in Accelerating Early Clinical Trial Success
June 4th 2025Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.
Fast and Efficient Sialic Acid Clone Selection Using Lectin-Based High-Throughput Screening
June 2nd 2025Glycosylation is a common and critical post-translational modification that affects protein function and therapeutic efficacy, making its monitoring and accurate quantification essential for drug development.
