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MAIN CONFERENCE
WEDNESDAY, APRIL 8
7:30am Registration and Morning Coffee
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Screening
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Confirmatory Assays
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Strategies to Address Drug Interference
8:30
Chairperson’s Opening Remarks
Lawrence
N. Callahan, Ph.D., Chemist, Office of the Commissioner, FDA
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KEYNOTE PRESENTATION
8:40 Immunogenicity Assessment: Things to Consider When Developing the Strategic Plan
Steven J. Swanson, Ph.D., Executive Director, Clinical Immunology, Amgen Inc.
The field of immunogenicity assessment continues to evolve as new methods are developed and new expectations from regulatory agencies are developed. When deciding on the strategy to assess the immunogenicity of new protein therapeutics there are several important factors that should be considered. This presentation will highlight some of those important factors.
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9:10 Next Generation Biologics: Deimmunization and Tolerance Induction
Anne S. De Groot, M.D., CEO/CSO EpiVax, Inc.; Professor and Director, Institute for Immunology and Informatics, University of Rhode Island; Pediatric Infectious Disease, Brown University Medical School
We have developed and validated a set of tools with three
primary applications to drug development: 1) ranking of the overall
immunogenicity of proteins according to their putative T-cell epitope content,
2) analysis of the protein for clusters of T-cell epitopes (the underlying cause
of immunogenicity), and 3) pinpointing of key residues that can be strategically
altered to disrupt those epitope clusters. In addition, we have identified a set
of putative natural T regulatory epitopes (Tregitopes) which, when
co-administered with an antigen, cause the expansion of antigen-specific
adaptive. We have now confirmed that co-administration of Tregitopes with a
range of proteins (such as Ovalbumin, Botulinum toxin peptides, Dust mite
antigen, flu epitopes) in vitro and in vivo leads to
suppression of T cell and antibody responses to the test antigens. The mechanism
of suppression appears to be due to the induction of antigen-specific adaptive
tolerance induction (De Groot AS et al. Activation of natural regulatory T cells
by IgG Fc-derived Peptide “Tregitopes” Blood (2008) 112: 3303).
9:40 Immunogenicity Assay Cut-point(s)
Eric Wakshull, Ph.D., Senior Scientist & Group Leader, Bioanalytical R&D, Genentech, Inc.
Recent guidance white papers have recommended a risk-based approach to developing immunogenicity strategies and assays in support of protein therapeutic pre-clinical and clinical development. The current recommended approach for establishing a cut-point for screening assays based upon population variability and a target 5% untreated positive rate for drug-naïve samples has been extended to include methods for determining cut-points for confirmatory and titration assays. The basis for unified approach will be described for all three cut-points, and examples provided. We feel this consistent approach provides an unbiased cut-point at each step of sample analysis and in particular helps solve the common observation of titer samples not crossing their cutpoint.
10:10 Coffee Break in the Exhibit Hall
11:10 Immunogenicity and T cell responses: What Can We Learn from Monitoring T-Cell Responses to Autoantigens?
Vicki Seyfert Margolis, Ph.D., Chief Scientific Officer, Immune Tolerance Network
Due to very low frequencies of autoantigen-specific T cells, their detection may be problematic and requires very sensitive methods for monitoring various cell functions. We developed and optimized conditions for an Elispot assay that enables us to monitor responses to autoantigens in Type 1 Diabetes and Multiple Sclerosis. This assay will be introduced for monitoring T-cell immunogenicity responses.

11:40 Adverse Reactions to Biologics: Accurate and Quantitative Measurement of Specific Antibodies
Jörgen Dahlström, Ph.D., Phadia AB
Phadia has 40 years of experience in quantitative measurement of specific antibodies. With a yearly production of 70 million tests Phadias
ImmunoCAPTM technology has a proven track-record with high sensitivity, user independent results, regulatory approval and long term stability making it well suited for measuring specific antibodies to biologics in clinical development.
Sponsored by

12:10 Immunogenicity and Cell Based Assays on the Meso Scale Discovery (MSD) Platform
Neeta Shenoy, Ph.D., Scientist, Meso Scale Discovery
Meso Scale Discovery offers significant advantages for the rapid development and robust implementation of immunogenicity assays in preclinical and clinical settings to detect and characterize antibodies produced in response to biological therapeutics. High sensitivity, broad dynamic range and tolerance to free drug, along with reduced matrix effects and a simplified workflow renders the platform ideally suited to address the challenges of immunogenicity assays.
MSD also provides solutions for cell based assays including NAb (neutralizing antibody) assays. Cell based assays on the MSD platform can range from quantitation of secreted proteins such as cytokines, monitoring changes in receptor phosphorylation status or modulation of one or more intracellular markers, to characterizing interactions between proteins and cell surface receptors.
12:40
Luncheon Presentation II (Opportunity Available)
1:10 Break
1:30 Risk Assessment of Immunogenicity and Clinical
Expectations
Deborah Finco-Kent, Ph.D.,
Immunogenicity Lead, Drug Safety Research & Development,
Pfizer Inc.
This talk will provide some
representative nonclinical and clinical case studies with
several types of biological therapeutics. Each case study will
include a discussion regarding risk assessment as it relates
to immunogenicity, Immunogenicity assessment plans for the
particular program and regulatory feedback with respect to
immunogenicity assessment.
2:00 Problem Solving
Break-out Session: Drafting a Risk-based Immunogenicity Plan
for a New Biologic Candidate
Facilitators:
Table 5
Darshana Jani, Senior Associate Scientist, Biogen Idec Inc and Jaya Goyal, Associate Director, Clinical Science & Technology, Biogen Idec Inc.
Table 6
Eric Wakshull, Ph.D., Senior Scientist & Group Leader, Bioanalytical R&D, Genentech, Inc.
Table 7
Bonita Rup, Assistant Vice President, Protein Bioanalysis, Bioanalytical R&D, Drug Safety and Metabolism, Wyeth Research
Table 8
Deborah Finco-Kent, Ph.D., Immunogenicity Lead, Drug Safety Research & Development, Pfizer Inc.
3:05 Refreshment Break in the Exhibit Hall
3:45 Chairperson’s Remarks
Joy Cavagnaro, Ph.D., DABT, RAC, President, Access BIO LC
3:50 The Value of Immunogenicity Assessment in Preclinical Development
Joy Cavagnaro, Ph.D., DABT, RAC, President, Access BIO LC
Since administration of human proteins to animals is expected to eliciting an immunological response the primary objective of assessing preclinical immunogenicity is to better define the PK/PD profile, exposure margins and estimates of toxicity which may be impacted by antidrug antibodies. Animal models can also be useful in assessing relative immunogenicity and in validating de-immunization strategies.
4:20 A Regulatory Perspective
Lawrence N. Callahan, Ph.D., Chemist, Office of the Commissioner, FDA
4:50 Networking Cocktail Reception in the Exhibit Hall
6:00 Close of Day
For more information, please contact:
Leslie C. Lilly, BSN, RN
Conference Director
Cambridge Healthtech Institute
250 First Avenue, Suite #300
Needham, MA 02494
Phone: 978 371 5942
Fax: 781-972-5425
email: llilly@healthtech.com
For exhibit and sponsorship information, please contact:
Carol Dinerstein
Senior Manager-Business Development
Cambridge Healthtech Institute
250 First Avenue, Suite #300
Needham, MA 02494
Phone: 781-972-5471
E-mail: dinerstein@healthtech.com
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