Cambridge Healthtech Institute’s 7th Annual

Oligonucleotide CMC & Regulatory Strategies

Enhancing Analytical Methods and Accelerating Time to Market

March 11-12, 2025

Cambridge Healthtech Institute's conference on Oligonucleotide CMC & Regulatory Strategies brings together top scientists and executives from leading biotech and pharma companies to share insights on new developments in analytical characterization, CMC, and regulatory strategies. The conference will provide an opportunity to discuss and collaborate on how to optimize product development processes and speed up time to market.

Coverage will include, but is not limited to:

Identifying the best analytical methods for characterizing impurities
Assay development, characterization, and validation
Comparability strategies
Adoption of innovative technologies in CMC
Implementation of AI and machine learning in CMC
Review of guidance from the FDA
How to prepare for a regulatory submission
Feedback on successful IND and NDA submissions
Overcoming common regulatory hurdles
Reducing costs and improving the efficiency of manufacturing processes
When to outsource manufacturing and what to assess when doing so
Examining the safety and toxicity of nucleic acids

The deadline for priority consideration is August 23^rd, 2024.

All proposals are subject to review by session chairpersons and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute’s policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

Opportunities for Participation: