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[In-Person] Non-clinical safety assessments of biologics and novel modalities for IND/NDA Filing: Nuts, Bolts and Best Practices

Speakers: Christina de Zafra, Seagen; Kaushik Datta, BMS; Xiaoting Wang, Amgen; Haley Neff-LaFord, Seagen; Mayur Mitra, Genentech; Jessica Sims, Genentech; Brian Carr, Gilead; Carolyne Dumont, CRL
Organizers: Smita Salian-Mehta (Gilead), Doris Zane (Gilead)
Date: 2024-09-20
Time: 8:45-17:00 Pacific Time
Registration fee: Regular attendees: $295; Academic/Students/Postdocs: $45; Out-of-Pocket: $45; Major Sponsorship: $3000; Vendor Show: $695, Happy Hour Sponsorship: $975; Lunch Sponsorship: $1250; On-site Registration: $500
Location: Crowne Plaza, Foster City, CA (San Francisco Bay Area)
Major Sponsor:
Vendor show vendors registered to date: (3)Abzena; Emery Pharma; Meadowhawk Biolabs
Registration deadline:2024-09-19  (it will close sooner if the seating cap is reached)

About the Topic

With the advent of complex biologics and the increasing use of novel modalities over traditional antibodies during drug development, it has become critical to develop our understanding on their unique safety assessments and challenges. Pharmaceutical companies are challenging the dogma of traditional safety packages and providing evidence with more robust in-vitro packages demonstrating specificity and challenging use of in-vivo studies where pharmacologically relevant nonclinical species are not available. This workshop will focus on fostering deeper understanding of the participant on the inclusion of in-vitro and in-vivo safety packages and various unique first in human dose determination strategies for biologics and their unique modalities. Workshop will be initiated with an overview of biologics followed by presentations that will cover non-clinical safety assessment strategies with case study examples of a wide range of biologics including CD3 bispecific, peptide MHC, Antibody-drug conjugates and novel modalities like peptides and protein degraders. Common risk assessment like immunogenicity assays and cytokine assays will also be provided in shorter talks. The intent of this workshop is to enlighten the develop an understanding of toxicity risk assessments and share latest progress in the field of biologics to activate discussions that will lead to more successful IND/BLA submissions.

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