Cambridge Healthtech Institute’s Ninth Annual

Immunogenicity Assessment & Clinical Relevance

Overcoming Challenges for Meaningful Evaluation

October 24-25, 2017 | The Westin Alexandria | Washington, DC

 

The generation of meaningful immunogenicity data with clinical relevance is beset with many challenges. Top of the list for 2017 is the challenge of cut point determination and assay validation. This conference addresses this with several case studies and a discussion with the FDA. A close second in the list of challenges is management of drug and target interference in the assay in both clinical and non-clinical studies. The third is Nab assays which continue to improve and evolve. There is uncertainty about when these should be implemented, their usefulness, how much time to devote to them and how to deal with all the variation. The fourth is the presence of pre-existing positive ADA activity in study patients as investigators have difficulty distinguishing between these and potential immune responses to the drug. The final is determining the relationship between assay data and the clinical outcome, particularly the impact on PK and efficacy.


This event will present industry case studies on how these challenges are addressed for a range of products, so that immunogenicity data can be assessed and presented to the regulatory authorities in a meaningful way.

 KEYNOTE

Immunogenicity and Gaining Regulatory Approval for a Biosimilar

Susan Kirshner, Ph.D., Associate Chief, Immunology Lab, Therapeutic Proteins, Biotechnology, FDA/CDER

 

CRITICAL ISSUES WITH CUTPOINTS AND ASSAY VALIDATION

Case Study on Dealing with the Critical Issues in Assay Validation: The Devil is in the Detail

Don Zhong, Ph.D., Senior Scientist, PKDM Bioanalytical Sciences, Amgen, Inc.

Is There a Minimum Cut Point Value for an Immunogenicity Assay?

Robert J. Kubiak, Ph.D., Senior Manager, R&D, Translational Science, MedImmune LLC

Generating Clinically Relevant Immunogenicity Data: Setting Appropriate Assay Cut Points and Categorizing ADA Positivity

Michael Partridge, Ph.D., Senior Staff Scientist, Bioanalytical Sciences, Regeneron Pharmaceuticals

Cutpoints and Clinical Interpretation of Immunogenicity

Viswanath Devanarayan, Ph.D., Director, Global Exploratory Sciences, Abbvie

Discussion with the FDA on Current Recommendations on the Setting of the Cutpoint

Susan Kirshner, Ph.D., Associate Chief, Immunology Lab, Therapeutic Proteins, Biotechnology, CDER/FDA

 

EXPERIENCES WITH NEUTRALIZING ANTIBODY ASSAYS

Development of an ADCC-Based Neutralizing Antibody Assay

Shan Chung, Ph.D., Senior Scientist and Group Leader, BioAnalytical Sciences, Genentech, Inc.


Case Study on Multiple NAb Assays for Enzyme Replacement Therapies

Lakshmi Amaravadi, Director, Bioanalytical Sciences and Biomarkers, Sanofi


To NAb Assay or not to NAb Assay

Lauren Stevenson, Ph.D., Director, Translational Sciences, Biogen Inc.

 

 

MANAGING DRUG TARGET INTERFERENCE

Case Studies on Managing Drug Target Interference

Mauricio Maia, Ph.D., Senior Scientist, Bioanalytical Sciences, Genentech, Inc.

DEALING WITH PRE-EXISTING POSITIVE ADA ACTIVITY IN STUDY PATIENTS

Experiences with Pre-Existing Antibodies with a Multi-Domain Protein

Jim McNally, Ph.D., Associate Director and Immunogenicity Expert, Global Early Development, Quantitative Pharmacology & Drug Disposition, EMD Serono

IMMUNOGENICITY ASSESSMENT FOR SPECIFIC PRODUCTS AND THERAPEUTIC AREAS

Challenges and Case Studies in Immunogenicity Assessment for Ultra-Rare Diseases

Tressa Allington, Ph.D., Development Scientist, Bioanalytical Development, Alexion

Development of Multiplex Sensitive ADA Assays for CRISPR/Cas9 Gene Therapies

Junxia Wang, Ph.D., Associate Director, Preclinical Sciences, Editas Medicine

INTERPRETATION OF ADA DATA AND ITS CLINICAL RELEVANCE.

Clinical Immunogenicity of a Checkpoint Inhibitor

Theresa Goletz, Ph.D., Director, Clinical Immunology, EMD Serono

 

 

Immunogenicity Challenges in Clinical Development of Biotherapeutics

Rong Zeng, Ph.D., Director, Bioanalytical Sciences, OncoMed Pharmaceuticals



For more details on the conference, please contact:
Nicole Lyscom Ph.D.
Senior Conference Director
Cambridge Healthtech Institute
Tel: +44 7791 866489 
Email: nlyscom@healthtech.com  
For exhibit & sponsorship opportunities, please contact:
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Tel: 781-972-5412
Email: cbenton@healthtech.com

OutlookYouTubeFacebookLinkedInTwitter
#IMN17

Japan-FlagKorea-FlagChina-Simplified-FlagChina-Traditional-Flag

Register Now

Download the Brochure

Sponsorship and Exhibit

Conference at a glance

Celebrating 25 years