“Dear Sponsor, we regret to inform you…”—not the message any drug developer wants to receive. Cell-based assays have repeatedly appeared in FDA Complete Response Letters (CRLs). So, what is going wrong, and how can development teams better prepare? In this webinar, we’ll examine recent FDA CRLs to identify the most common deficiencies related to cell-based assays in regulatory submissions. Drawing directly from FDA observations and current guidance documents, we’ll translate these findings into practical recommendations that can help developers build more robust assays, strengthen validation strategies, and reduce regulatory risk. Whether you’re developing biologics, cell therapies, or gene therapies, this session will provide insight into what the FDA expects and how to avoid the pitfalls that continue to delay regulatory approvals. 

What You’ll Learn

• The most common cell-based assay deficiencies identified in recent FDA CRLs. 
• The regulatory expectations behind these FDA observations. 
• Practical strategies to strengthen cell-based assay development, validation, and regulatory readiness. 

Integrated CRO-CDMO partnerships promise to streamline drug development by bringing development, manufacturing, and clinical execution together under one strategic framework. But integration isn’t achieved simply by combining services. It depends on connecting decisions, processes, and teams across the development lifecycle.

Clinical supply chain is the function that makes this possible.

Serving as the bridge between drug development and clinical operations, clinical supply chain connects manufacturing, quality, regulatory, packaging, labeling, distribution, and clinical execution into a coordinated strategy. It helps ensure information, materials, and decisions move efficiently across functions, reducing operational risk and supporting more predictable study execution.

In this webinar, we’ll examine how clinical supply chain connects development and clinical operations to enable coordinated execution across integrated CRO-CDMO programs. Using the framework of people, processes, and systems, we’ll explore the operational capabilities that help sponsors strengthen collaboration, reduce risk, and realize the full value of an integrated partnership. 

Attendees will learn:

• The role clinical supply chain plays in connecting development, manufacturing, and clinical operations.
• How embedding clinical supply chain strategy early improves alignment, reduces operational risk, and increases agility throughout study execution.
• Why people, processes, and systems are essential to transforming integrated services into integrated execution. 

Plasmid DNA is a critical starting material for cell and gene therapies, viral vectors, mRNA therapeutics, and DNA vaccines, but manufacturing it consistently at the required quality and scale can present significant technical and operational challenges.

This webinar will examine key considerations for optimizing plasmid design, process development, production, and analytical control across development stages. Attendees will learn how advanced plasmid engineering, high-performance production strains, scalable purification technologies, and phase-appropriate quality strategies can help improve yield, supercoiling, ITR integrity, and manufacturing timelines.

The session will also explore how an integrated approach spanning plasmid design, CMC development, analytics, and GMP manufacturing can reduce risk and support programs from preclinical development through commercialization.