Guidance

AAPS_Annual_Guidance_Forum_Agenda_v1.pdf


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Workshop Summary

The goal of this workshop is to discuss challenges, issues, and concerns for two FDA guidance documents that are important to AAPS members.

Day 1: Drug Products, including Biological Products, that Contain Nanomaterials.                                       
Draft guidance for industry, December 2017

Day 2: Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products
Draft guidance for industry, April 2016

Both days will feature plenary speakers and have breakout-style sessions on several topics. This format will provide ample opportunity for participants to engage in open dialogue with regulators, academia and industry scientists, with the goal of providing insight into the guidance for submission of regulatory applications.

Participants of this event will:

Day 1: Drug Products, including Biological Products, that Contain Nanomaterials

  • Understand the critical quality attributes (CQA) and regulatory pathway for drug products with nanomaterials.
  • Discuss CQA and different aspects of regulatory pathways.
  • Gain insight into problems and issues encountered during the drug discovery process and the interface between drug discovery and development.
  • Gain insight into the guidance for submission of regulatory applications.
Day 2: Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products
  • Understand assay development and validation for immunogenicity testing of therapeutic protein products.
  • Discuss issues related to Assay Cut Point and ways of monitoring the performance of the assay. 
  • Learn how to bridge the data from pre-clinical to clinical and understand the relevance given that most preclinical data does not correlate directly to the human experience.
  • Gain insight into the guidance for submission of regulatory applications.


 

Registration Information

Registration Closed

Registration Fee Includes:

    • Access to the Slides post event
    • Continental Breakfast daily
    • Buffet lunch daily
    • Evening reception (Tuesday Only)

Cancellations

Cancellations must be submitted to AAPS in writing by August 27, 2018 sent via email to registration@aaps.org.

Cancellation requests received by this date will be refunded less a $100 administrative fee for members and non-members, and $50 for student registrants. Refunds will not be issued for requests received August 28, 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.

Housing

Sheraton Silver Spring

8777 Georgia Avenue

Silver Spring, Maryland, 20910

Special rate of $169/night is available until August 25, 2018.


Book Now!

You may also reserve your room by phoning the hotel directly at +1.301.589.0800 (group reservation code, A109AA)

Driving & Parking Information

Featured hotel amenities

  • Self-parking at $14 per day
  • Complimentary wifi
  • 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 Airport)
    • 28 miles - IAD (Washington Dulles International Airport)




Program Committee


Scott McNeil, Ph.D.,
Frederick National Lab 

Sesha Neervannan, Ph.D.,
Allergan

Susan Kirshner, Ph.D.,
  U.S. Food & Drug Administration  

Binodh DeSilva, Ph.D.,
Bristol-Myers Squibb

Vinod P. Shah, Ph.D., 
VPS Consulting, LLC

Rachael Crist, Ph.D.,
NIH/NCL