Wednesday, October 3, 2018: 8:30 a.m. - 5:00 p.m.
Thursday, October 4, 2018: 8:30 a.m. - 5:00 p.m.
(Sign-in/registration begins at 7:30 a.m. both days)
Goals and Objectives:
- Communicate to stakeholders the “state of the science” regarding technological approaches for prediction of immunogenicity including non-clinical (in silico) studies for detection of neo-antigens, the use of novel animal models, and strategies to de-immunize protein molecules.
- Explore strategies for choosing appropriate tools and interpreting the results since the novel tools and information available in this field are complex and not amenable to simple prescriptive approaches during drug development.
- Advances in understanding the biology of T- & B-cell responses as it applies to the immunogenicity of therapeutic proteins
- New analytical techniques and improvements in existing technologies to predict immune response to therapeutic proteins
- Mathematical models that can integrate seemingly disparate measurements related to immunogenicity
- Big data and immunogenicity: How “omics” workflows can be used to generate and analyze large data sets as they relate to immunogenicity
- Identification and application of biomarkers for predicting immunogenicity
- The Holy Grail: Deimmunizing protein therapeutics
- The human cost and the economic burden: How immunogenicity affects patients and the economic burden on the healthcare system
Who Should Attend:
This workshop is open to the public. The intended audience includes those with an interest in immunogenicity of therapeutic proteins and related assessments including the biopharmaceutical industry and related companies, regulators, patient advocacy groups, academic researchers, clinicians involved in patient care and clinical research, government agencies, payors such as insurance companies, medical product policy makers, and the public.
Agenda, Accommodations, Directions, and Parking Information:
Information regarding FDA lodging, ground transportation, airport information, directions, security, parking, and FAQs is available online.
Registration for FDA and non-FDA Attendees:
Remote Access Information/Instructions/Webcast Registration (pre-registration is required):
This public workshop will be available to view via webcast but pre-registration is still required. After you register using the above links, you will receive links via email as Outlook calendar invitations with information on how to access the live webinars. You must log in with your username and password which you create when you register. You must pre-register at least one day before the event to ensure that the access link emails and outlook invitations are received for each day.
For questions and reasonable accommodations:
For questions, please contact FDA-CERSI-Collaborative-Workshop@fda.hhs.gov.
This event will be recorded and made available to the public after its conclusion. Any information shared publicly by participants in the audience during the event will become part of that recording. This includes the verbal question and answer sessions.
Americans with Disabilities Act
FDA-White Oak shall provide, to the extent required by the Act, such auxiliary aids and/or services as may be reasonably requested for use in public areas, provided that reasonable advance written notice is provided to FDA of such needs. If special accommodations are needed due to a disability, please contact Donna Blum-Kemelor, Project Manager, at least seven (7) days in advance of the workshop.