Oligonucleotides and peptides resemble biologics in some ways because of their molecular complexity but are much smaller in size. Therefore, there are unique concerns in the design of control strategies for these types of molecules. Specific regulatory guidance is not available, sometimes leading to inclusion of inappropriate strategies and methods.
This workshop provides a unique forum for direct discussions between speakers and attendees about the challenges faced by companies and regulatory agencies in designing and evaluating the control strategies for oligonucleotides and peptides during drug development and throughout the product lifecycle. The existing regulatory and scientific considerations that are applicable to these moieties will be discussed during the talks, and gaps in the guidance and technology will be explored during the panels and break-out sessions.
The two-day event begins with an overview of current regulatory and scientific considerations for oligonucleotide and peptide drug control strategies, including:
- Approaches to developing appropriate specifications
- Impurity thresholds
- Degradation and stability issues
- Analytical tools for characterization
The speakers include well-known experts from industry, FDA (CDER and CBER), EMA, and USP. In addition to in-depth presentations, they will facilitate several discussions surrounding current scientific, practical, and regulatory considerations, and provide case studies to lay the groundwork. Overall, this workshop promises to provide a comprehensive view of the existing practices, with an opportunity for attendees to influence the future paradigms.
Detailed agenda–Now Available!
Presentation files/handouts will be available only in electronic format and available for download from our website (passcode protected). All attendees will be responsible for bringing their own laptops or other electronic devices to the workshop to access speakers’ materials.