AGENDA:

1st Immunogenicity – Determinants and Correlates Conference

DATES: May 9 -10 (Monday – Tuesday) and May 11 (Wednesday) (TREGITOPE)

LOCATION: THE HOTEL PROVIDENCE

www.hotelprovidence.com

Registration: http://www.regonline.com/Immunogenicity-Determ-Corr

 

DAY 1: VENUE: HOTEL PROVIDENCE

Monday – May 9, 2011

Times
Presenter(s) Subject(s)
9:00 AM INTRODUCTIONS
 

Annie De Groot, M.D., Director, Institute for Immunology and Informatics, The University of Rhode Island, CEO, EpiVax Inc.

Denice Spero Ph.D., Co-Director, Institute for Immunology and Informatics – Welcome

Michel Awwad Ph.D., Senior Director, Pfizer – Introduction to the conference, Orientation.

 

 

9:30 AM-1:20 PM

Session I:   Determinants – Predicting Immunogenicity
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, DVM, MS, DACVP, Senior Director of Translational Medicine, Alexion Pharmaceuticals  

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

10:10 AM-10:35 AM Daniela Verthelyi, M.D., Ph.D., Chief of Laboratory of Immunology of Division of Therapeutic Proteins, Food and Drug Administration 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., Senior Director, Pfizer Aggregates: Td or not Td?
11:35 AM-12:05 PM David Scott, Ph.D., Professor and Vice Chair for Research, Department of Medicine, Uniformed Services University of Health Sciences Tolerance, Breach of Tolerance, Contribution of Tregs / Self vs Nonself, T-cell Epitopes
12:05 PM-12:30 PM Liisa Selin, M.D., Ph.D., Professor, University of Massachusetts Medical School  

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

 

 

 

 

 

AGENDA: 

DAY 1: Monday – May 9, 2011

Times
Presenter(s) Subject(s)

 

12:30–1:30 PM LUNCH – On Site (included in registration) or local eateries…www.goprovidence.com
1:30 PM-1:55 PM Thomas Kieber-Emmons, Ph.D., Professor of Pathology, University of Arkansas Glycosylation, Sialation, DC-Sign, Lectins 

 

1:55 PM-2:15 PM Lenny Moise Ph.D., Principal Investigator, Institute for Immunology and Informatics, University of Rhode Island 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 Leslie Cousens, EpiVax

 

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, Ph.D., Research Assistant Professor of Medicine, University of Massachusetts Medical School  

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

 

3:45 PM-4:10 PM  

Matt Baker, Ph.D., Chief Scientific Officer, Antitope (England)

 

Utility of in vitro T cell Assays for assessing

immunogenicity of protein therapeutics

 

4:10 PM-4:40 PM Don Drake, Ph.D., Director of Immunological Research, Sanofi Pasteur, VaxDesign  

Employing the MIMIC® system to assess cross-reactive CD4+ T cells against the swine-origin H1N1 influenza virus

 

4:40 PM-5:00 PM Annie De Groot, M.D., Director, Institute for Immunology and Informatics, The University of Rhode Island, CEO, EpiVax Inc. 

Leslie Cousens, Ph.D., Director of Protein Therapeutics, EpiVax Inc.

 

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
6:15 PM Advisory Board Dinner (R.S.V.P)

 


 

AGENDA: VENUE: HOTEL PROVIDENCE

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, CEO, EpiVax Inc.

9:00 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, Ph.D., Executive Director, Amgen  

Characterization of anti-drug antibody responses is necessary to discern impact on pharmacokinetics, efficacy and safety of therapeutic proteins

 

9:40 AM-10:10 AM Chris Bailey-Kellogg, Ph.D., Associate Professor, Dartmouth College Deimmunization in Context
10:10 AM-10:40 AM Susan Richards, Ph.D., Group Vice President of Clinical Laboratory Sciences, Genzyme Immunosuppression /  Role in Biotherapeutics 

(e.g. Rituximab/Genzyme)

10:40 AM–11:10 AM  

BREAK- POSTER SESSION

 

11:10 AM-11:30 AM Shingo Niimi, Ph.D., Section Director, National Institute of Health Science (Japan) Japanese Regulatory Agency Perspective on Immunogenicity
11:30 AM-12:00 PM Jack Ragreb, M.D., Ph.D., Senior Regulatory Research Officer, Principal Investigator, National Institutes of Health  

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 Yvonne J. Rosenberg, Ph.D., CEO, PlantVax Inc. Lesson from Plants: N-linked Glycosylation and Immunogenicity
2:00 PM-2:30 PM Vibha Jawa, Ph.D., Principal Scientist, Amgen FPX Case Study
2:30 PM-3:00 PM Ciara Magee, M.D., Research Fellow, Brigham and Women’s Hospital Open – Selected from Abstract submissions:
3:00 PM-3:30 PM  

BREAK- POSTER SESSION

3:30 PM-4:00 PM Nader Najafian, M.D., Assistant Professor, Harvard Medical School, Brigham and Women’s Hospital  

Role of T cells and Tregs in Transplantation Transplant and Tolerance

 

4:00 PM-4:30 PM Federico Mingozzi, Ph.D., Director of Translational Research, Center for Cellular and Molecular Therapeutics, Children’s Hospital of Philadelphia Immunogenicity in Gene Therapy Vectors
4:30 PM–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.

 

5:30 PM Speaker Dinner (R.S.V.P)

 

 

 

 

 

AGENDA:  TREGITOPE MEETING

TO BE HELD AT HOTEL PROVIDENCE (See next page for TRIAD )

DAY 3: Wednesday – May 11, 2011

Times Presenter(s) Subject(s)

9:30 AM REGISTRATION and BREAKFAST
10:00 AM-10:20 AM  

Annie De Groot, M.D., Director, Institute for Immunology and Informatics, The University of Rhode Island, CEO, EpiVax Inc.

Tregitope Overview /History/ Status
10:30 AM-11:00 AM Leslie Cousens, Ph.D., Director of Protein Therapeutics, EpiVax Inc. Tregitopes: Mechanisms and Delivery
11:10 AM-11:40 AM Nader Najafian, M.D., Assistant Professor, Harvard Medical School, Brigham and Women’s Hospital Alloimmunity and Transplant Tolerance
11:50 PM-12:30 PM Federico Mingozzi, Ph.D., Director of Translational Research, Center for Cellular and Molecular Therapeutics, Children’s Hospital of Philadelphia Immune responses in AAV-mediated gene transfer 

 

12:30 PM-1:30 PM LUNCH BREAK- LUNCH POSTER SESSION- WITH TRIAD 

Joint Lunch with TRIAD Toolkit Trainees

1:30 PM-1:50 PM Wassim Elyaman, Ph.D., Instructor in Neurology, Brigham and Women’s Hospital  

Samia Khoury, M.D., Associate Professor, Harvard Medical School, Brigham and Women’s Hospital

Tregitopes, T helper cells and EAE (Confirmed)
2:00 PM-2:20 PM Bruce Mazer, M.D., Associate Professor, Department of Pediatrics, McGill University IVIG, Tregitopes and Allergy
2:30 PM-3:00 PM GROUP DISCUSSIONS – D. SCOTT/ A. De GROOT Moderating
3:00 PM CLOSING REMARKS (END OF PUBLIC MEETING)
3:30-5:00 PM

——————Closed meeting of Tregitope Collaborators – FUTURE DIRECTIONS ——————–

 

 

 

 

 

 

 

AGENDA:  TRIAD TOOLKIT TRAINING to be held at URI PROVIDENCE CAMPUS

DAY 3: Wednesday – May 11, 2011

Times
Presenter(s) Subject(s)

 

TRIAD TOOLKIT TRAINING : IVAX (Vaccines) and ISPRI (Protein Therapeutics) HANDS ON TRAINING
 

9:00–9:30 AM

Annie De Groot, M.D., Director, Institute for Immunology and Informatics, CEO, EpiVax, Inc. TRIAD TOOLKIT TRAINING
Epitope Driven Vaccines – Recent History
9:30–10:00 AM Denice Spero, Ph.D., Co-Director, Institute for Immunology and Informatics Overview of iCubed and Pilot Project Program
10-10:30 AM

WELCOME TEA & COFFEE @ iCubed

 

10:30–11:00 AM Bill Martin, Chief Information Officer, EpiVax, Inc. 

Matt Ardito, Chief Immunoinformatician, EpiVax, Inc.

TRIAD TOOLKIT TRAINING 

Introduction to ‘IVAX’

TRIAD Vaccine Design Toolkit

 

@iCubed IMMUNOINFORMATICS TRIAD TOOLKIT TRAINING AT iCubed
11:00-3:30 PM Eric Gustafson, Ph.D., Assistant Research Professor, Institute for Immunology and Informatics 

Matt Ardito, Bioinformatics Programmer, EpiVax, Inc.

Frances Terry, Bioinformatics Program Manager, EpiVax, Inc.

Hands-On Computer Training: T cell epitope prediction 

Conservation analysis & alignment, Vaccine Construction

12:30-1:30 PM

JOINT LUNCH with TREGITOPE MEETING will be served at 12:30 PM at Hotel Providence

 

 

@iCubed ALTERNATIVE – TRIAD CMI CORE LAB TRAINING AT iCubed
11:00-3:30 PM Loren Fast, Ph.D., CMI Core Director, Institute for Immunology and Informatics 

Joe Desrosiers, M.S., CMI Core Lab Manager, Institute for Immunology and Informatics

 

Hands-On Lab Training: HLA binding assays, ELISpot, FACS