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Antibody Drug Discovery and Development: Hit Generation, Engineering, Cell-line Development, IND enabling studies, and Biosimilars

Speakers: Donald McCarthy, Mohan Srinivasan, Guna Kannan, Erin Filbert, Deepali Sawant, Bo Yu, Nicola Stagg, Richard Boismenu
Organizers: Donald McCarthy, Mohan Srinivasan, Bo Yu, Wenfeng Xu
Date: 2019-11-12
Time: 8:45-17:00 Pacific Time
Registration fee (USD): Regular: $195; Academic: $125; For unemployed or students: $30; For vendor-show rep: $35; For major-sponsor rep (incl lunch): $0
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: (2)Abzena; Cytovance Biologics;(Major Sponsorship - lunch session still open)
Vendor show vendors registered to date: (9)BioIVT; ChemPartner; Emerson Collective; Eurofins Pharma Discovery Services; Intertek; JOINN Biologics; MabPlex USA, Inc.; MicroConstants; PHC former Panasonic Healthcare
Registration deadline:2019-11-12  (it will close sooner if the seating cap is reached)

About the Topic

Topics to be covered:

1. Overview of therapeutic mAbs (Donald McCarthy, Panorama Reserach Institue)
2. Antibody discovery (hit generation & characterization): antibody target category and selection, hybridomas/humanization, phage display, humanized mice or mice with humanized repertoire, single B cell screening technologies, analytical & biophysical methods for antibody characterization (Mohan Srinivasan, TRex Bio)
3. Antibody engineering (for activity & stability): unconventional formats (camelids, nanobodies, bispecifics), Fc/glycan engineering, stability assessment, optimization for development (Guna Kannan, Denali)
4. in vitro assays for antibody evaluation (‚ÄčErin Filbert, Apexigene)
5. in vivo animal models for antibody evaluation (Deepali Sawant, Amgen)

6. Cell line development/CMC: Clone selection/cell line development, characterization, purification, formulation, process development, large scale & GMP manufacturing (Bo Yu)
7. IND enabling studies: ADAs/immunogenecity, GLP tox, PD/PK, preparing for and engaging with the FDA (Nicola Stagg, Genentech)
8. Biosimilars: manufacturing, comparability, clinical trial and regulatory approval (Richard Boismenu, Coherus)


Organizing Committee: Donald McCarthy, Mohan Srinivasan, Wenfeng Xu


2019-12-10, In Vitro Diagnostics (IVD), Companion Diagnostics (CDx) and Precision Medicine
2020-01-10, All about half-life: which one should I use? (tentative title)
2020-01-21, Considerations for Successful Clinical Development: Fundamentals and Best Practices for Clinical Trial Design, Biostatistics, and Data Management
2020-02-11, Development of Drug/Device Combinations
2020-02-24, MS Courses by Dr. Jack Henion: Advanced LC-MS/MS (Day1) & Interpretation of MS/MS CID Spectra (Day2)
2020-03-16, Clinical Trials Essentials: An Intensive One-Week Course (register for the full week or half day sessions)
2020-04-10, Biopolymer-based conjugation of therapeutic proteins and antibodies for improving drug properties (tentative title)
2020-05-12, Regulated Large Molecule Bioanalysis: Fundamentals, the New FDA Guidance and Beyond
2020-05-22, No More Undruggables: Unconventional Approaches for Drug Discovery and Design - prodrugs, PROTACS, fragment-based design, directed evolution and beyond
2020-06-23, Advances in Immuno-Oncology (A Joint Symposium by PBSS and BioScience Forum)
©Pharmaceutical & BioScience Society, International; Last Modified: 10/20/2019; Admin Logon
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