Oligopep

Co-Sponsored by: 
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Workshop Summary

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.

Workshop Details

Detailed agendaNow 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.

Registration Information

Registration Type Early Registration
(November 15-March 21, 2018)
On-Site Registration
(March 22-On-site)
Member $1,195 $1,335
NonMember $1,565 $1,660
Academic/Government  $560 $620
Student $200 $225

Registration Fee Includes:

    • Full participation in the workshop
    • Morning and afternoon beverage breaks
    • Lunch on Wednesday and Thursday
    • Reception on Wednesday evening

Register Here

Cancellations

Cancellations must be submitted to AAPS in writing by March 28, 2018 and faxed to +1.703. 243.5582 or sent via email to .

 

Cancellation requests received by this date will be refunded less a $250 administrative fee for members and non-members, and $30 for student registrants. Refunds will not be issued for requests received after March 28, 2018. All approved refunds will be issued after April 26, 2018.

Substitutions

Registrant substitutions from the same company may be submitted in writing at any time without penalty. If the membership status of the substitute differs from that of the original registrant, a refund or additional charge may apply. Send substitution requests to registration@aaps.org or fax to +1.703.243.5582.

Last updated: February 16, 2018

Housing

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

A special rate of $169/night is available for a limited number of rooms until March 13, 2018.


Book Now!

You may also reserve your room by phoning the hotel directly at 1.301.589.0800 (group reservation code: AD08AA).


Driving & Metro Information


Featured hotel amenities

  • Self- parking at $14 per day
  • Complimentary wifi for SPG (Starwood Preferred Guest) members. Sign up free here!
  • Complimentary shuttle to/from Silver Spring Metro Station

Location

Approximate distances:

  • 4 blocks - Silver Spring Metro Station (Red line)
  • 6 miles - Washington, DC               
  • 11 miles - DCA (Ronald Reagan Washington National Airport)
  • 22 miles - BWI (Baltimore/Washington International Thurgood Marshall Airport)
  • 29 miles - IAD  (Washington Dulles International Airport) 



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