Early Development Decisions That Support Clinical Readiness

Getting CMC Right Early: Foundations for IND Success Early-stage biotech companies face increasing pressure to accelerate timelines from discovery to IND. While scientific innovation remains the foundation of success, many programs experience delays due to gaps in Chemistry, Manufacturing, and Controls (CMC)—particularly across process development, analytical development, regulatory strategy, and manufacturing planning. In practice, most IND delays linked to CMC are not caused by late-stage issues, but by early development decisions that fail to account for manufacturability, process scalability, analytical readiness, and evolving regulatory expectations. For small and mid-sized biotech companies, limited in-house expertise in CMC and regulatory strategy—combined with unclear manufacturing approaches (in-house vs outsourcing vs hybrid CDMO models)—can further increase risk. This webinar will provide a practical overview of building an IND-ready CMC strategy, focusing on how to align process development, analytical development, regulatory requirements, and manufacturing strategy from the earliest stages. Key topics include bioprocess and analytical development, scale-up strategy, process understanding (CQAs and CPPs), regulatory alignment, manufacturing model selection, and risk mitigation in IND-enabling studies. Key topics: • Designing scalable, robust bioprocesses for biologics development • Building strong CMC data package for IND submission • Aligning early with GMP manufacturing and tech transfer requirements Early-stage biotech companies often face chemistry, manufacturing, and controls (CMC) challenges that can delay investigational new drug (IND) submissions and slow development timelines. This webinar explores how early decisions in process development, analytical strategy, manufacturing planning, and regulatory alignment can reduce risk and support smoother progression toward clinical milestones. Attendees will gain practical insights into building scalable biologics processes, improving manufacturing readiness, and strengthening cross-functional development strategies to support faster, more confident IND preparation and execution.