Day Two: Immunogenicity Assessment and Clinical Relevance
Day 1 | Day 2 | Download Brochure
THURSDAY, NOVEMBER 17
7:30 – 8:15 am Breakfast Presentation
(Sponsorship opportunity available, please contact Katelin Fitzgerald, kfitzgerald@healthtech.com) or 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.
» KEYNOTE PRESENTATION
9:05 Clinical Immunogenicity Testing Road Map: What We’ve Learned from Clinical Studies
 Sue 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 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.
Sponsored by
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 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 Infection
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 Fitzgerald, kfitzgerald@healthtech.com) or Lunch on Your Own
12:30-5:30 Combined Plenary Session (Parts One and Two)
Day 1 | Day 2 | Download Brochure