Immunogenicity Determinants and Correlates

Registration is now open at: Immunogenicity Determinants and Correlates Regonline

Purpose of Meeting:

Immunogenicity Determinants and Correlates is a non-commercial meeting, sponsored by the Institute for Immunology and Informatics (University of Rhode Island)  and organized by individuals from a wide range of backgrounds including industry and academics as well as regulatory agencies such as the FDA, EMEA and NIHS (Japan).

Organizers for this meeting include: Michel Awwad, Pfizer; Chris Bailey-Kellogg, Dartmouth; Michael Brehm, UMass; Sara Brett, GSK, Leslie Cousens, EpiVax; Annie De Groot, EpiVax; Eric Furfine; Eleven; David Scott, USUHS; Terry Goletz, Amgen; Anish Suri, Bristol Myers Squibb; Nick Marsh, Adnexus; Dale Greiner, UMass; Bonita Rup, Pfizer; Daniela Verthelyi, FDA; Eric Wakshull, Genentech.

The goal of this meeting is to provide an opportunity to discuss the drivers of  immunogenicity and the application of scientific research to improving protein therapeutics and vaccines; to bring vaccine experts, immunologists, and protein therapeutics developers together for discussion of the latest determinants, correlates, and models for predicting immunogenicity. Interactive panels and poster sessions have been designed to encourage the exchange of information on the best methods for predicting and mitigating immunogenicity to cross-pollinate between vaccine and protein therapeutics fields.

Registration for the meeting includes registration for the Tregitope Update (click  for more information), Participation in the Tregitope Update is included in the IDC Registration fee. Alternatively registrants may wish to participate in the TRIAD iVAX Toolkit workshop, where immunogenicity screening and vaccine design tools supported by the TRIAD grant ( will be showcased.

DRAFT AGENDA (Current as of March 05 2011):

1st Immunogenicity – Determinates and Correlates Conference

DATE: May 9 -10 (Monday – Tuesday)




139 Mathewson Street
Providence, RI 02903 Registration:


Institute for Immunology and Informatics

THE UNIVERSITY OF RHODE ISLAND- Feinstein Providence Campus

80 Washington Street, 2nd Floor

Providence, RI  02903 ;

Campus Map, Directions, Parking:

Official visitor information about Providence:



Monday – May 9, 2011


Presenter(s) Subject(s)

Annie De Groot, M.D. / Denice Spero Ph.D. Institute of Immunology and Informatics– Welcome

Michel Awwad Ph.D. (Pfizer) – Introduction to the conference, Orientation.



9:30 AM-1:20 PM

Session I:   Determinants – Predicting Immunogenicity [Session Order NOT FINAL]
9:30 AM-9:45AM Session introduction- Session Chairs and Panel Leaders: Eric Furfine, Eleven Bio and Terry Goletz, Amgen—Brief mention of rationale for session and topics to be covered–
9:45 AM-10:10 AM Christopher Horvath, Alexion (Confirmed)  

The role of Complement in immunogenicity: Mechanism of Action, Toxicity and Hypersensitivity

10:10 AM-10:35 AM Daniela Verthelyi, FDA (Confirmed) Breaking tolerance: Innate Immunity and Danger
10:35 AM -11:05 AM BREAK – Coffee in Poster Session Area
11:05 AM-11:35 AM Michel Awwad, Ph.D, Pfizer Aggregates: Td or not Td?
11:35 AM -12:05 PM David Scott, Uniformed Services University of Health Sciences (Confirmed) Tolerance, Breach of Tolerance, Contribution of Tregs / Self vs Nonself, T-cell Epitopes
12:05 AM -12:30 AM Invited Speaker: 

Liisa Selin, M.D. UMass Medical School (Confirmed)



Role of Heterologous Immunity in Immune Response (Cross-reactive epitopes)







DAY 1: Monday – May 9, 2011

Presenter(s) Subject(s)


12:30– 1:30 PM LUNCH – On Site (included in registration) or local eateries…
1:30 PM- 1:55 TBN Glycosylation, Sialation, DC-Sign 


1:55 PM-2:15 PM Lenny Moise Ph.D., University of Rhode Island (Confirmed) De-immunization (for better protein therapeutics) and De-tolerization (for better vaccine design)
2:15 PM-2:45 PM Panel discussion- Question and Answers- Panel Leaders: 

Eric Furfine, Eleven Bio and Terry Goletz, Amgen and Speakers

Role of Complement, innate immunity, T cells and B cells in the immune response to infection, vaccination, and protein therapeutics

2:45 PM-3:15 PM BREAK – Coffee / Tea in Poster Session Area




3:15 PM-5:30 PM


Session II: Correlates – Biomarkers and Model Systems



3:15 PM-3:20 PM Session Introductions- Session Chair and Panel Leaders: Michael Brehm, UMass, David Scott, USUHS 

—Brief mention of rationale for session and topics to be covered–

3:20 PM-3:45 PM Mike Brehm, UMass Medical School (Confirmed)  

Animal Models that Correlate with Human Immune Response: HuSCID vs HLA Tg


3:45 PM-4:10 PM Matt Baker, Ph.D. Antitope (Confirmed) 

T effector Subsets, Tregs and T cell Assays: ELISpot, T cell Proliferation, FACS, T cell Subsets, Tregs 


4:10 PM-4:40 PM Don Drake, Ph.D. VaxDesign (a Sanofi Aventis Co.) (Confirmed  


Artificial in vitro Immune Systems: InVitro ALN (artificial lymph node models, Matrix-based method)



4:40 PM-5:00 PM Annie De Groot, M.D. URI/EpiVax and Leslie Cousens, Ph.D. EpiVax (Confirmed) 


iTEM: HLA as a biomarker – Predicting immunogenicity and the “personal” in vaccine and protein therapeutics


5:00 PM- 5:30 PM Panel Discussion- Moderators Michel Brehm, UMass and David Scott, USUHS and Speakers
5:30 PM Networking Reception – in Poster Session Area
Dinner on Your Own – See Patrick Lowney/ Karen Sorrento for Suggestions
6:00 PM–  

9:00 PM

Speaker Dinner (R.S.V.P)




DAY 2: Tuesday – May 10, 2011

Times Presenter(s) Subject(s)
8:30 AM-8:55 AM Annie De Groot, M.D. 

Director Institute for Immunology and Informatics

The University of Rhode Island

9:00 AM-AM  

Session III: Risk Mitigation – Preclinical Studies and Clinical Studies


9:00 AM-9:10 AM Session Introduction: Session Chair and Panel Leaders: Michel Awwad, Pfizer and Naren Chirmule, Amgen
9:10 AM-9:40 AM Naren Chirmule, Amgen (confirmed) Preclinical Approaches, Clinical Proof or Principle
9:40 AM-10:10 AM Chris Bailey-Kellogg (confirmed) Deimmunization in Context
10:10 AM-10:40 AM TBN Immunosuppression /  Role in Biotherapeutics 

(e.g. Rituximab/Genzyme)

10:40 AM – 11:10 AM  



11:10 AM-11:30 AM Shingo Niimi (NHS, Japan) (Tentative) Japanese Regulatory Agency Perspective on Immunogenicity
11:30 AM-12:00 PM Jack Ragreb (FDA/NIH) (Confirmed)  

FDA Perspective + New in vivo models


12:00 PM-12:30 PM Panel Discussion: Lead by Panel Leaders: Michel Awwad, Pfizer and Naren Chirmule, Amgen; Shingo Niimi NHS (Japan)
12:30 PM-1:30 PM Lunch
1:30 PM-4:30 PM Session IV: Case Studies
1:30 PM Opening Remarks – Moderators: Michel Awwad, Ph.D. Annie De Groot M.D.
1:30 PM-2:00 PM TBN Open – Selected from Abstract submissions:
2:00 PM-2:30 PM TBN Open – Selected from Abstract submissions:
2:30 PM-3:00 PM Nick Marsh, Adnexus Adnectins (Invited)
3:00 PM- 3:30 PM  


3:30 PM-4:00 PM Nader Najafian, Harvard /Brigham and Womens’  

Transplant and Tolerance (Confirmed)


4:00 PM-4:30 PM Federico Mingozzi, Children’s Hospital of Philadelphia, Gene Therapy (Confirmed) Immunogenicity in Gene Therapy Vectors
4:30 – 5:00 PM Panel Discussion –  Andy Glasebrook, Michel Awwad, Ph.D and Speakers 

Close of DAY 2- Closing Remarks Michele Awwad, Ph.D. Annie De Groot M.D.

This meeting is followed by a FREE TRIAD Toolkit (iVAX) training session; in addition, a Tregitope update is offered (see here for more information on the Tregitope Update). Register online here to reserve your seat at iVAX or Tregitope.