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Part One: Immunogenicity Assessment and Clinical Relevance - Day 2

Conference Proceeding CD Now Available
  • Speaker Presentations
  • Poster Abstracts
  • and More!

Day Two: Immunogenicity Assessment and Clinical Relevance

Day 1 | Day 2 | Download Brochure 


7:30 – 8:15 am Breakfast Presentation
(Sponsorship opportunity available, please contact Katelin Fitzgerald, kfitzgerald@healthtech.comor Morning Coffee


8:30 Chairperson’s Remarks

Meena Subramanyam, Ph.D., Vice President, Translational Sciences & Technology, Biogen Idec, Inc.

8:35 Case Study on Immunogenicity Testing from Non-Clinical to Clinical

Deborah Finco, Ph.D., Senior Principal Scientist, Drug Safety R&D, Pfizer, Inc. - Biography

Xiaflex is a drug product comprised of two collagenase enzymes intended for the treatment of Dupuytren. Due to the localized administration of the drug, there is little/no systemic drug exposure. This presents some unique aspects to the program. This talk will concentrate on immunogenicity results and assays as well as some other endpoints used in the non-clinical and clinical studies. Post marketing commitments will also be presented.


9:05 Clinical Immunogenicity Testing Road Map: What We’ve Learned from Clinical Studies

Sue RichardsSue Richards, Ph.D., Group Vice President, Clinical Laboratory Sciences, Genzyme Corp.Biography

The ability of a drug to elicit an immune response is routinely evaluated as a component of clinical development for biotherapeutics. However, immunogenicity assessment often does not end with just testing drug-specific antibodies and neutralizing antibodies. Additional characterization is often necessary in the context of safety or efficacy evaluations. A number of factors can be considered when implementing further in-depth analyses. Case examples will be presented to demonstrate approaches taken to support clinical programs and lessons learned.

9:35 Interference Observed During Immunogenicity Assessment of an Fc-Engineered Therapeutic Antibody

Sally FischerSally Fischer, Ph.D., Senior Scientist & Group Leader, Bioanalytical Research and Development (BARD), Genentech, Inc. - Biography

An anti-therapeutic antibody response in patients depends on a number of factors including patient population, disease state, route of delivery or characteristics specific to the product. This presentation will discuss a case study where the challenges encountered during development of a clinical ATA assay were due to the specific patient population as well as the engineered therapeutic antibody.

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10:05 A Streptavidin Coated Plate for Long-Term Clinical Studies

Pankaj Oberoi, Ph.D., Director, Scientific Services and Research & Development, Meso Scale Discovery

There is increasing demand for a streptavidin coated plate that satisfies the demands of long-term clinical trials, especially for immunogenicity studies. MSD® has made substantial investments in optimizing the production and characterization of reagents and manufacturing processes associated with the production of Streptavidin coated plates. The plates are subject to seven independent measurements of plate uniformity in a well-defined QC process. Furthermore, the plates maintain performance through a shelf life of 30 months, reducing the frequency of new lot validations. Data supporting the performance of the plates has been collected from over 4000 plates comprising 200 production lots over a two year period.

10:35 Networking Coffee Break in the Exhibit Hall with Poster Viewing

11:10 Detecting, Characterizing, and Dealing with Pre-Existing ADA in Clinical Studies

Stephen KellerStephen Keller, Ph.D., Associate Director, Pre-Clinical and Clinical Development Sciences, Abbott Biotherapeutics Corp. - Biography

ADA methods are becoming increasingly effective at identifying subjects that develop post-treatment antibody responses to biotherapeutics. Occasionally, however, very high assay signals are seen in samples from drug-naïve populations, raising the questions of what’s being detected and what to do about it? This presentation will use case studies to illustrate this phenomenon and offer some perspective on what should be done to follow up such observations.

11:40 Cut Point Rules for Development of an ELISA to Detect Antibodies to a Clinically Asymptomatic Virus InfectionBrian Schlain

Brian Schlain, Lead, Non-Clinical Statistician, Biostatistics, Biogen Idec, Inc. - Biography

PML is a rare brain disease caused by the JC virus (JCV). A 2-step assay (ELISA screening + supplemental confirmation) was developed to detect anti-JCV antibodies in serum or plasma. While the false negative rate in the assay was determined using sera samples from urinary JCV DNA shedders who were assumed sero-positive for JCV antibodies, false positive rates could not be directly controlled, as JCV infection is asymptomatic.

12:10 pm Luncheon Presentation
(Sponsorship opportunity available, please contact Katelin or Lunch on Your Own

12:30-5:30 Combined Plenary Session (Parts One and Two) 

Day 1 | Day 2 | Download Brochure 

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