This course will provide a detailed overview of the quickly growing and diversifying class of oligonucleotide drugs and their conjugates. While RNA-based therapeutics development has been around for more than 20 years, the product class did not see the kind of growth reflective of its therapeutic potential until recent years when key stability and delivery challenges were addressed by new scientific and technology approaches. This course will cover a broad range of topics related to chemistry, manufacturing, and controls (CMC) aspects of oligonucleotide drugs and their conjugates.
Course objectives:
- Provide an overview of the product class and the different types of RNA-based therapeutics that have been developed
- Review the overall manufacturing process approaches and associated control strategies
- Discuss key raw material considerations and challenges
- Review conjugation options and strategies
- Consider regulatory approaches, both in terms of licensure pathways and product quality/manufacturing considerations
- Discuss challenges associated with product complexity and gaps in existing regulatory guidance
- Discuss phase-appropriate analytical and product-characterization approaches
- Review approaches to specification-setting for key product quality attributes
Stats Snax discusses basic statistical concepts that apply to the pharmaceutical industry using examples from CMC development areas. Designed for non-statisticians, you will learn foundational concepts that CMC statisticians encounter in their daily interactions with clients.
If you have ever wondered, “What is a p-value?” or “How is expiry determined?” – This series is for you!
Learning Objectives:
- Foundational statistical concepts
- How the topic can be used in daily pharmaceutical operations
- Proper application of statistical concepts, and common misapplication (as appropriate)
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