Past Workshop:

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.

View Detailed Agenda (PDF)

Co-Sponsored by:


Program Committee

Nanda Subbarao, Ph.D.,
Biologics Consulting Group, Inc

Kavita Vyas, Ph.D.,
Food & Drug Administration 

Nina Cauchon, Ph.D.,
Amgen Inc.

Elena Gubina, Ph.D.,
Food & Drug Administration 

Fouad Atouf, Ph.D.,
U.S.  Pharmacopeia (USP)

James S. Bernstein, Ph.D.,
Live Oak Pharmaceutical Consulting