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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, FDA
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.
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?
Kasia Bourcier, Ph.D., Associate Director, Assays and R&D Immune Tolerance Network/UCSF
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 Problem Solving Break-out Session: Drafting a Risk-based Immunogenicity Plan for a New Biologic Candidate
12:10 Luncheon Presentation I (Opportunity Available)
12:40 Luncheon Presentation II (Opportunity Available)
1:10 Break
1:30 Chairperson’s Remarks
Joy Cavagnaro, Ph.D., DABT, RAC, President, Access BIO LC
1:35 Regulatory Guidance and Challenges
Daniela Verthelyi, Acting Chief, Laboratory of Immunology DTP/FDA (tentative)
2:05
Management of Immunogenicity
Jack A. Ragheb, M.D., Ph.D., Senior Regulatory Research
Officer, Laboratory of Immunology, DTP. CDER, FDA, Attending Physician, Allergy
Immunology Service, NIAID, NIH (tentative)
2:35 Sponsored Presentation I (Opportunity Available)
2:50 Sponsored Presentation II (Opportunity Available)
3:05 Refreshment Break in the Exhibit Hall
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 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.
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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