AGENDA:
1st Immunogenicity – Determinants and Correlates Conference
DATES: May 9 -10 (Monday – Tuesday) and May 11 (Wednesday) (TREGITOPE)
LOCATION: THE HOTEL PROVIDENCE
Registration: https://www.regonline.com/Immunogenicity-Determ-Corr
DAY 1: VENUE: HOTEL PROVIDENCE
Monday – May 9, 2011
Times |
Presenter(s) | Subject(s) |
| 9:00 AM | INTRODUCTIONS | |
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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.
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9:30 AM-1:20 PM
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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
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| 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)
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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
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| 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 |
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| 2:45 PM-3:15 PM | BREAK – Coffee / Tea in Poster Session Area | |
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3:15 PM-5:30 PM |
Session II: Correlates – Biomarkers and Model Systems
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| 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– |
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| 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
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| 3:45 PM-4:10 PM |
Matt Baker, Ph.D., Chief Scientific Officer, Antitope (England)
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Utility of in vitro T cell Assays for assessing immunogenicity of protein therapeutics
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| 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
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| 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.
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iTEM: HLA as a biomarker – Predicting immunogenicity and the “personal” in vaccine and protein therapeutics
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| 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. |
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| 9:00 AM |
Session III: Risk Mitigation – Preclinical Studies and Clinical Studies
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| 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
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| 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
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| 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
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| 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
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| 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
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| 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. |
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| 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
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| 12:30 PM-1:30 PM | LUNCH BREAK- LUNCH POSTER SESSION- WITH TRIAD
Joint Lunch with TRIAD Toolkit Trainees |
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| 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 ——————– |
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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 | ||
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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 |
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| 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 |
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| @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
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Hands-On Lab Training: HLA binding assays, ELISpot, FACS
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