| Monday, March 18th: Immunogenicity University |
| 7:45 |
Registration and Continental Breakfast
|
| 8:45 |
Welcome from "Dean"
Thomas Lee, Scientific Investigator, Clinical Immunology, GLAXOSMITHKLINE
|
| 9:00 |
Fundamentals of Immunogenicity Assessment
Holly Smith, Principal Research Scientist, Investigative Toxicology, ELI LILLY
|
| 11:00 |
Networking Break
|
| 11:15 |
Ongoing Assay Design and Modification Choices
Throughout the Drug Development Life Cycle
Joseph Bower, Executive Director – Immunochemistry, COVANCE
|
| 1:15 |
Luncheon
|
| 2:15 |
Optimal Formats for Identifying and Quantifying NAb
Response
Thomas Lee, Scientific Investigator, Clinical Immunology,
GLAXOSMITHKLINE
|
| 3:15 |
Close of Immunogenicity University
Distribution of Diplomas
|
| Tuesday, March 19th: Main Conference Day One |
| 7:45 |
Registration and Continental Breakfast
|
| 8:45 |
Chairperson's Opening Remarks
Holly Smith, Principal Research Scientist, Investigative Toxicology, ELI LILLY
|
| 9:00 |
FDA KEYNOTE Immune Tolerance Induction for Protein Therapeutics
Amy Rosenberg, Director, Division of Therapeutic Proteins, FDA
|
| 9:45 |
CASE
STUDY A Non-Leaching, Blocking Protein-Free Immunoassay – A New Way to Develop Immunoassays
Yanhe Tong, Large Molecule Bioassays, TEVA PHARMACEUTICALS
|
| 10:30 |
CASE
STUDY The Evolving Approach to Immunogenicity Assay
Development and Validation
Don Zhong, Senior Scientist, Clinical Immunology, AMGEN
|
| 11:00 |
Networking Break
|
| 11:30 |
CASE STUDY Using the Aushon BioSystems Technology to Develop
a Sensitive, Drug Tolerant Screening Assay
Jo Goodman, Senior R&D Manager, Bioanalytical Sciences,
MEDIMMUNE
|
| 12:15 |
Gauging the Utility of Reporting Low-Titer Antibodies
Swati Gupta, Principal Scientist, Bioanalytical Sciences, ALLERGAN
|
| 1:00 |
Luncheon
|
| 2:00 |
CASE STUDY
Highly Sensitive Non-Wash Immunoassays for
Immunogenicity and PD/PK Studies
Roger Bosse, Global Product Leader, Alpha Technology, PERKIN ELMER
|
| 2:30 |
CASE STUDY
Advances in Detection of Drug-specific IgE Antibodies to Biologics
Sue Richards, Group Vice President, Clinical Laboratory Sciences, GENZYME
|
| 3:15 |
Networking Break
|
| 3:45 |
CASE STUDY
Improvement of Drug Tolerance of an ADA Assay
Transitioning During the Phases of Drug Development
Sally Saeger, Principal Investigator, Bioanalytical Sciences, BRISTOL-MYERS SQUIBB
|
| 4:15 |
Worldwide Experience in Immunogenicity Assessment in Biosimilars
Carlos Sattler, VP, U.S. Clinical Development and Medical Affairs, SANDOZ
|
| 5:00 |
The Immune Response to Blood Coagulation Factor VIII
Pete Lollar, Professor of Pediatrics, Blood Disorder Center, EMORY UNIVERSITY
|
| 5:45 |
CASE STUDY
EBI-005: A Novel Protein Therapeutic Interleukin-1
Receptor Inhibitor for the Topical Ocular Treatment of
Dry Eye Syndrome – Has Low Immunogenicity Risk
Joseph Kovalchin, Associate Director, Pharmacology, ELEVEN BIOTHERAPEUTICS
|
| 6:15 |
Wine & Cheese Networking Reception
|
| 7:15 |
Close of Day One
|
| Wednesday, March 20th:Main Conference Day Two |
| 8:15 |
Morning Coffee
|
| 8:45 |
Chairperson's Opening Remarks
Holly Smith, Principal Research Scientist, Investigative Toxicology, ELI LILLY
|
| 9:00 |
FDA KEYNOTE Employing the Latest Advances in Preclinical Animal
Modeling of Immunogenicity
Jack Ragheb, Senior Regulatory Research Officer, CDER, FDA
|
| 9:45 |
Broadening the Types and Useful Applications
of Humanized Mouse Models
Bruce Torbett, Co-Director, CFAR and Proteomics Expression
Core, SCRIPPS RESEARCH INSTITUTE
|
| 10:30 |
Networking Break
|
| 11:00 |
FDA KEYNOTE From Science to Regulations: Immunogenicity Considerations in the Approval of Generic Enoxaparins in the U.S.
Daniela Verthelyi, Chief, Laboratory of Immunology, FDA
|
| 11:45 |
A Novel Approach for Multiplexed Detection, Isotyping, and Quantitation of IgG, IgA, and IgM PF4/Heparin Antibodies using SQI Diagnostics' Ig_PlexTM Technology
Jaymie Sawyer, VP of R&D, SQI DIAGNOSTICS
Robert Massé, VP of Large Molecule Bioanalysis, ALGORITHME PHARMA
|
| 12:30 |
Luncheon
|
| 1:30 |
Immunogenicity and Analytical Testing of Biosimilars:
Some Surprising and Not So Surprising Findings
David Peritt, Scientific Director, Immunology
HOSPIRA
|
| 2:00 |
CASE STUDY
Approaches to Increase Drug Tolerance of Assays
for the Detection of Anti-Drug Antibodies Against
Complex Proteins
Maria Barbosa, Senior Principal Scientist, Bioanalytical Sciences,
BRISTOL-MYERS SQUIBB
|
| 2:30 |
Networking Break
|
| 3:00 |
CASE STUDY
Nanoparticles and Immunogenicity
Marina Dobrovolskaia, Senior Scientist, Nanotechnology
Characterization Laboratory, NIH
|
| 3:30 |
CASE STUDY
Clinical Use of Nanoparticles to Avoid Immunogenicity
Lawrence Tamarkin, CEO,
CYTIMMUNE
|
| 4:00 |
Close of Conference
|