Immunogenicity Training Course II  

Program

Preliminary Program

Saturday, May 18, 2013 

8:00 am–8:30 am
Opening Remarks
Course Moderator
Marie Rock, Ph.D.
WIL Laboratories

8:30 am–10:00 am
Immunogenicity of Therapeutic Proteins
Steve Swanson, Ph.D. Amgen Inc.

10:00 am–10:30 am
Beverage Break  

10:30 am–noon
Regulatory Perspective on Immunogenicity
Laura Salazar-Fontana, Ph.D. 
U.S. Food and Drug Administration

Noon–1:15 pm
Lunch
Lunch is complimentary to all attendees.

1:15 pm–2:30 pm
Humanized Mouse Models: Applicability and Potential Use inImmunogenicity Studies
Terry Goletz, Ph.D. 
U.S. Food and Drug Administration

2:30 pm–3:45 pm
Engineering Considerations for Therapeutic Monoclonal Antibodies andProteins
Wolfgang Glasener, Ph.D.
Eli Lilly and Company

3:45 pm–4:15 pm
Beverage Break 

4:15 pm–5:30 pm
Breakout Sessions 

Session 1: PEG Constructs Advantages and Bioanalytical Challenges Relatedto Immunogenicity
Jeff Salilstad, M.S.
Sailstad and Associates 
Andy Vick, Ph.D.
WIL Laboratories

Session 2: Immunogenicity Aspects of Non-protein Therapeutics andOligoneucleotides
Philip Oldfield, Ph.D.
Philip Oldfield Bioanalytical Consulting

Session 3: Round Table: Topics Relating to Immunogenicity Testing
Susan Kirshner, Ph.D. 
U.S. Food and Drug Administration

Sunday, May 19, 2013

Course Moderator
Marie Rock, Ph.D.
WIL Laboratories

8:00 am–9:30 am
Overview of New Draft Immunogenicity Guidance
Amy Rosenberg, M.D. 
U.S. Food and Drug Administration

9:30 am–10:00 am
Beverage Break  

10:00 am–11:15 am
Incorporation of Anti-therapeutic Antibody Assays into Clinical and Pre-clinical Study Design
Valerie Quarmby, Ph.D.
Genentech, Inc.

11:15 am–12:30 pm
Antibody Specificity: Characterization of IgG, IgM, and IgE Anti-therapueticAntibodies
Suzanna Tatarewicz, M.S.
Amgen Inc. 

12:30 pm–1:30 pm
Lunch
Lunch is complimentary to all attendees.

1:30 pm–2:45 pm
Hypersensitivity Reactions
Andrew Erdman, Ph.D.
Genentech, Inc.

2:45 pm–4:15 pm
Current Statistical Recommendations in ADA Testing
Viswanath Devanarayan, Ph.D.
AbbVie

4:15 pm–4:30 pm
Beverage Break  

4:30 pm–5:30 pm
Breakout Sessions
Session 1: Pre-Exsisting ADA
Steven Keller, Ph.D.
AbbVie

Session 2: Neutralizing Antibody Assays: Cell Based Assays, Non-cell BasedAssays and Confirmatory Methods
Valerie Leesch, Ph.D.
WIL Laboratories

Session 3: Reagent Preparation and Characterization to Support ADA Testing
Medha Kamat, Ph.D.
EMD Milipore

Session 4: Open Discussion on Statistical Aspects of Immunogenicity Assessment
Viswanath Devanarayan, Ph.D.
AbbVie 

Ronald Bowsher, Ph.D.
b2-stats Consulting

Session 5: Case Study: Immunogenicity Risk Assessment
Robin Marsden, M.S.
Ambrx, Inc. 

Heather Meyler, Ph.D.
Bristol-Myers Squibb Company

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