Oligopep

Workshop Summary

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

This workshop provides a forum for informal discussions from the industry, academic, and government attendees to identify common industry benchmarking 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 event begins with an overview of commonly used control strategies for oligonucleotides and peptides, 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 will facilitate several discussions surrounding the available regulatory considerations from an EMA and FDA perspective, and provide case studies to lay the groundwork.  The second day will cover these topics in more detail.

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.

Who Should Attend?

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

  • Product/Process Development
  • Analytical Development
  • Quality Control (QC)
  • Stability
  • Regulatory Affairs
  • Quality Assurance (QA)
  • 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 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.


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)