- October 02-03, 2018
08:00 PM - 08:00 PM EDT
Collaborative Workshop hosted by: Centers of Excellence in Regulatory Science and Innovation (CERSIs) and FDA*
October 3-4, 2018
Wednesday, October 3 (Day 1):
8:30 a.m. – 5:00 p.m. (Registration begins at 7:30 am)
Thursday, October 4 (Day 2):
8:30 a.m. – 5:00 p.m. (Registration begins at 7:30 am)
About the Workshop
Goals and Objectives:
Protein therapeutics have continued to gain an increasing share of the pharmaceutical market and now provide medical interventions for some of the most complex and intractable diseases. Immunogenicity, the propensity of a therapeutic protein to induce immune responses, principally by development of antibodies, may affect safety and/or efficacy, and is thus an important concern in the development and regulation of protein therapeutics. Patients, regulators and the biopharmaceutical industry are all affected by immunogenicity. Recently, both the US Food and Drug Administration and the European Medicines Agency have released Guidance Documents for industry focusing on immunogenicity.
This timely public 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 specific objectives of this 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.
- 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.
Location and Logistics:
The Food and Drug Administration
10903 New Hampshire Avenue
The Great Room
Silver Spring, MD 20993
Details on FDA lodging, ground transportation, airport information, directions, security, parking, and FAQs are available at : http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm
Note: This workshop will be recorded for later viewing.
Registration for In-Person or Remote/Virtual Attendance for FDA and non-FDA Attendees:
There will be no registration fee to attend in-person or access the workshop via the webcast, but registration is required for each of the two days of the workshop.
To register to attend in person or by webinar, go to the below links for each day of the two-day workshop (to attend the full workshop, you must register for Day 1 and Day 2 separately).
Registration Instructions (pre-registration is required):
- To register for in-person attendance, please click the link below on the days you want to attend, and then follow the instructions on the registration pages.
- If registering for the webcast, after you register, 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.
LINKS TO REGISTER for In-PERSON or WEBCAST (public attendees and FDA staff):
Registration Link – Wednesday, October 3, 2018 (Day 1):
Registration Link – Thursday, October 4, 2017 (Day 2):
Please provide the information requested for each attendee. Note: for those with Adobe Connect accounts, you will be asked for your password, or to create a new password.
For technical assistance please contact Jeffery Rexrode.
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, or email: firstname.lastname@example.org at least 7 days in advance of the workshop.
Requests for sign language interpretation or Computer Aided Realtime Translation (CART)/captioning should be made 2 weeks in advance of the workshop, no later than September 19, 2018. A request for either interpreting or captioning is to be sent directly to the FDA Interpreting Services Staff email account: email@example.com.
* Collaborative Workshop hosted by:
Centers of Excellence in Regulatory Science and Innovation (CERSIs):
- Johns Hopkins University
- University of Maryland
The Food and Drug Administration:
- Center for Drug Evaluation and Research (CDER)
- Center for Biologics Evaluation and Research (CBER)
- Office of Chief Scientist, Office of Regulatory Science and Innovation (OCS/ORSI)