Workshop Summary

Oligonucleotides and peptides can be distinguished from small molecules in several ways. However, in other ways they are also unlike conventional well-characterized therapeutic protein drugs. Specific regulatory guidance is not available for these types of modalities, leading to inconsistent approaches to setting specifications and lack of standard methodology for related substances. 

This workshop is designed to provide a venue for informal discussions among the attendees from the industry, academicians and from regulatory agencies to identify common industry bench-marking practices as well as existing regulatory and scientific considerations that are applicable to the development of suitable control strategies for these moieties.

The two-day workshop will begin with an overview of commonly used control strategies for these modalities including process considerations, impurity thresholds, degradation and stability issues, approaches to developing appropriate specifications, formulation-specific aspects, analytical tools for characterization, new technologies, and acceptable paradigms for starting materials. We plan to have a couple of traditional talks about the available regulatory considerations from a US and EU perspective, and case studies to lay the groundwork for the discussions.  The second day will cover these topics in more detail.

Program–Coming Soon!

Who Should Attend?

This workshop will be of interest to any groups in the Pharmaceutical Industry involved in designing or implementing the control strategies for oligonucleotide and peptide drugs. These will include personnel in:

  • Product/Process Development,
  • Analytical Development,
  • QC,
  • Stability,
  • Regulatory Affairs,
  • Quality Assurance
  • Project Management

The topic will be of direct and immediate relevance for companies focusing on these emerging modalities which now encompass a diverse range of therapeutic approaches and chemical structures.

Registration Information

Registration Type Early Registration
(November 15-March 21, 2018)
On-Site Registration
(March 22-On-site)
Member $1,395 $1,570
NonMember $1,840 $1,950
Government  $560 $620
Student $200 $225

Registration Fee Includes:

    • Full participation in the workshop
    • Morning and afternoon beverage breaks
    • Lunch on Monday and Tuesday
    • Reception on Monday evening

Register Here


Sheraton Silver Spring Hotel
8777 Georgia Avenue 
Silver Spring, Maryland 20910

More information coming soon!

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