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Minisymposium

Immunogenicity of Biologic Therapeutics


Speakers: Soumi Gupta, Anu Cherukuri, Lynne Jesaitis, Andrew Melton, Kevin Larimore, Brian Long (Biomarin); Shan Chung, Valerie Quamby, Montserrat Carrasco-Triguero, Eric Wakshull (Genentech)
Organizers:
Date: 10/11/2017
Time: 8:45-17:00
Registration fee (USD): Regular: $195; Academic: $125; Students & Unemployed: $35;
Location: Crowne Plaza, Foster City, CA
Major Sponsor: (1)Medpace
Vendor show vendors registered to date: (14)AIT Bioscience; Aragen Bioscience, Inc.; CMIC, Inc.; Eurofins; Immudex; Intertek; inVentiv Health Clinical; JOINN Labs; MicroConstants; Pacific BioLabs; PPD; Precision for Medicine; Science Exchange; WuXi AppTec
Registration: http://www.PBSS.org
Registration deadline:10/10/2017  (it will close sooner if the seating cap is reached)

About the Topic

Biotechnology-derived (biologics) therapeutics including  monoclonal antibodies, proteins, peptides, and enzymes have provided patients with targeted and effective medicines for numerous diseases. All therapeutic proteins have the potential to generate immune responses or immunogenicity through the anti-drug antibody (ADA) formation or cell based immune responses.  The challenge for industry is to understand the factors contributing to and predicting immunogenicity, to design assays to measure and monitor the immune response, and find improved methods of administering the biologic therapeutics to minimize any negative impact. 

This symposium will discuss challenges imposed by new FDA guidances and bioanalytical strategies for measuring clinical immunogenicity, tools for immunogenicity prediction, strategies for minimizing immunogenicity in the clinic and integrated data analysis plans.


Agenda:

8:45 – 10:15 am: Overview of immunogenicity of Biologic Therapeutics (Soumi Gupta, Anu Cherukuri)

10:20 – 10:50 am: Strategies for Bioanalytical Analysis to Enable Clinical Immunogenicity Assessment and Addressing new FDA Immunogenicity Assay Guidance – Challenges and Approaches (Andrew Melton)
10:55 – 11:10 am: Break
11:10 – 11:20 am: Major Sponsor's presentation (Medpace)
11:30 am – 12: 00 pm: Tools for immunogenicity prediction (Shan Chung)
12:00 – 1:00 pm: Lunch
1:05 – 1:35 pm: Risk-Based Approach for Assessment of Impurities (Valerie Quamby)
1:40 – 2:10 pm: Fit for Purpose NAb Assay Development (Kevin Larimore)
2:10 – 2:40 pm: Immune Tolerance (Brian Long)
2:40 - 2:55 pm: Break
3:00 – 3:30 pm: Immunogenicity of ADC and multi-domain characterization (Montserrat Carrasco-Triguero)
3:40 – 4:10 pm: Integrated Clinical Data Analysis (Eric Wakshull)
4:10 – 4:30 pm: Panel Discussion


2018-01-22, Preclinical development & IND/CTA Filing
2018-02-22, Metabolite Detection and Identification: Strategies, Techniques, and Case Studies
2018-03-12, Clinical Trials Essentials: An Intensive One-Week Course (register for the full week or half day sessions)
2018-04-24, Regulatory Authority Inspection Preparation and Outcomes
2018-05-22, Understanding and Overcoming High Clearance and Poor Bioavailability: Fundamentals, Investigations and Strategies for Drug Discovery
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