Roundtable Breakout Discussions

These interactive discussion groups are open to all attendees, speakers, sponsors, & exhibitors. Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.

TUESDAY, OCTOBER 23 4:40 PM

Immunogenicity Assessment & Clinical Relevance

Table 1: Cutpoints for Screening and Confirmatory Assays: Managing Change

Moderator: Mauricio Maia, PhD, Senior Scientist, BioAnalytical Sciences, Genentech, Inc.

Table 2: Dealing with Pre-Existing Positive ADA Activity in Study Patients

Moderator: Theresa J. Goletz, PhD, Global Head, New Biological Entities and Drug Disposition, EMD

Serono Research & Development Institute, Inc.

Table 3: Challenges in Developing Neutralizing Antibody Assays

Moderator to be Announced

Table 4: The Challenge of Drug- and Matrix-Interference in Immunogenicity Testing

Moderator: Weifeng Xu, PhD, Senior Research Investigator, Bioanalytical Science, Bristol-Myers Squibb

Table 5: Late Stage Clinical and Post-Marketing Strategies: Evolving ADA Assays Over Time

Moderator: Mitra Azadeh, PhD, Principal Scientist, Bioanalytical & Biomarker Development, Shire

Table 6: Meeting Regulatory Expectations Regarding Immunogenicity Assessment

Moderator to be Announced

Table 7: Immunogenicity Testing for Biosimilars

Moderator to be Announced

THURSDAY, OCTOBER 25 9:30 AM

Immunogenicity Prediction & Control

Table 1: Practical Application of Immunogenicity Preclinical Risk Assessment

Moderator: Steve Bowen, PhD, Team Leader, Chemist, Office of Biotechnology Products, CDER/FDA

Table 2: Current and Emerging Predictive Tools: Selecting Candidates and Predicting Clinical Outcome

Moderator: Jad Maamary, PhD, Senior Scientist, Merck and Co., Inc.

Table 3: Application of Mechanistic Modelling to Prediction of Immunogenicity

Moderator to be Announced

 

Table 4: Risk of Immunogenicity of Product and Process-Related Impurities, and Leachables/Extractables

Moderators: Daniela Verthelyi, PhD, Chief, Immunology Lab, Therapeutic Proteins, FDA/CDER Mohanraj Manangeeswaran, PhD, Therapeutic Proteins, FDA/CDER

Table 5: Progress towards Inducing Immunological Tolerance to Biotherapeutics

Moderator: Ronit Mazor, PhD, Scientist, Antibody Discovery & Protein Engineering (ADPE), MedImmune, Inc.

Optimizing Bioassays for Biologics

Table 6: Use of New Technologies in Bioassay Development

Moderator: Robyn Beckwith, PhD, Technical Development Scientist, Analytical Development and Quality Control, Genentech

Table 7: Benefits of Optimizing Bioassays with Design of Experiments (DoE)

Moderator: Martin Kane, MS, CRE, Managing Data Scientist, Statistical and Data Sciences Practice, Exponent

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