Predictive Immunogenicity for Better Clinical Outcomes Workshop
Hosted by CERSIs and the FDA
Wednesday, October 3rd and Thursday, October 4th, 2018
8:30AM-5:00PM (Registration begins at 7:30AM)
Food and Drug Administration (FDA) – White Oak campus – Building 31 Conference Center
The Great Room
10903 New Hampshire Avenue, Silver Spring, MD 20993
Join EpiVax in the upcoming days as we travel to Silver Spring, Maryland and attend the “Predictive Immunogenicity for Better Clinical Outcomes” Collaborative Workshop, hosted by the Centers of Excellence in Regulatory Science and Innovation (CERSIs) and the Food and Drug Administration (FDA). This workshop will present advances in the development of technological tools for predictions of immunogenicity and discussions on how to engage relevant stakeholders in application of these tools during drug development.
The objectives of the workshop are to:
- 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.
There will be several session themes including:
- 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
*Dr. Annie De Groot (EpiVax) will be a guest speaker at this session, presenting our current work in protein therapeutics, and the role of T cell epitopes in relation to immunogenicity.
This workshop is open to the public, and will be beneficial to individuals who have an interest in the immunogenicity of therapeutic proteins and related assessments,such as 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, and medical product policy makers.
For more information and/or to register, please visit the FDA’s main event page.