This podcast presents ten crucial questions for emerging biotech companies to consider when reviewing their Chemistry, Manufacturing, and Controls (CMC) strategies at year-end. The questions cover various aspects, including regulatory milestones, data analytics, risk management, quality assurance, and future goals. Each question includes examples illustrating its importance for successful drug development. The ultimate aim is to ensure a robust CMC strategy aligned with regulatory expectations and industry best practices, thereby minimizing delays and maximizing the chances of successful submissions. Failing to address these questions could result in significant setbacks.

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Cracking the Code

CMC Regulatory Compliance in Early Drug Development

Summary

This two-part blog post and podcast series provides a guide for small biotech companies on navigating Chemistry, Manufacturing, and Controls (CMC) regulatory compliance during drug development. It emphasizes the importance of strategic CMC planning, risk assessment, and early engagement with regulatory authorities from Phase 1 through Phase 3 clinical trials. The series stresses the critical role of CMC in ensuring product quality and safety, highlighting the benefits of prior initiatives such as the Quality by Design (QbD) approach. The first part focuses on early-stage development, while the second part (not included here) will cover the transition to market. Ultimately, the goal is to help biotech companies successfully bring new therapies to market. Stay tuned for Part two where we focus on Later Phase 2 and Phase 3 planning later this Winter.

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This Podcast offers a structured approach to setting drug specifications when data is limited. It emphasizes a risk-based strategy using industry standards and conservative initial ranges, iteratively tightened as more data becomes available. The process includes focused data collection, regulatory compliance, and Quality by Design principles. Cross-functional collaboration and thorough documentation are crucial for ensuring product quality, manufacturability, and regulatory success. Ultimately, the guide provides a roadmap for navigating the complexities of specification setting in data-scarce pharmaceutical development.

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