Immunogenicity

AAPS_Annual_Guidance_Forum_Agenda_v1.pdf


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Summary

Understand the immune response as a clinical development team is required to do in the development of biologics. This workshop covers key aspects of the assessment of immune response considerations in discovery and pre-clinical studies, from the clinical stages through approval. It is organized along the phases of drug development and uses case-study based presentations to demonstrate challenges and best practices. Discuss the current thinking on hot topics, including the appropriate approach for assessments in non-clinical trials; developing immunogenicity assays for novel constructs; developing immunogenicity risk assessments for clinical development; and current expectations for assay validations. 

Learning Objectives

  1. Develop a better understanding of key challenges and critical steps to understanding immunogenicity to maximize success in clinical development programs.
  2. Gain an understanding of the immunogenicity challenges across disciplines outside of your own expertise.
  3. See how the challenges of immunogenicity relate to each stage of the drug development process.
  4. Prepare to work with development teams to troubleshoot unexpected immunogenicity problems.
  5. Understand regulatory requirements and how to navigate regulatory submissions when immunogenicity challenges arise.

 

Committee

Chad Briscoe, Ph.D., BioAgilytix

Jim McNally, Ph.D., BioAgilytix

Johanna Mora, Ph.D., Bristol Myers-Squibb

Registration

Registration

 

Full Event

Single Session

Member

$295

$150

NonMember

$395

$200

Student Member

$95

$50

 

All registrants will have access to the session slides and recordings post-event.

Group Registration
Bring four or more paid full conference attendees from the same company and receive a 15% discount per full conference registration. This offer cannot be used with other discounted offers (e.g. speaker rate, complimentary sponsor passes, student rates, etc.). Please email [email protected] for your discount code. The deadline to redeem is May 20, 2021.  If your group does not meet the minimum requirement, AAPS reserves the right to alter your registration fee.

Cancellation & Refund Policy

Cancellations must be submitted to AAPS in writing to [email protected] and will be honored as follows:

AAPS will issue a refund to any attendee who cancels at least two (2) business days in advance of the event:

  • If you cancel your registration on/before May 19, 2022 you will be refunded your registration fees minus an administrative fee of $50 for members/non-members or $25 for students.
  • In the case of a multi-day event, cancellation must be received no later than 3 business days before the first scheduled webinar date/start time.
  • Cancellations received less than 2 business days before the scheduled event date/start time will not be refunded.
  • In the rare event that AAPS must cancel due to circumstances beyond our control, we will make every effort to notify attendees as quickly as possible. Attendees will be given the opportunity to either transfer to another virtual event or obtain a full refund.

No refunds will be given for “no shows” or for attendee technology problems. It is the responsibility of the attendee to test their computer setup before the start of the virtual event. If a technical failure at your home or workplace prevents access to the live event, you are not eligible for a refund. If the technical problem is due to our error, we will issue a refund.