Preclinical Development and IND Filing for Antibody Therapeutics: the Nuts, Bolts and Best Practices
Speakers:
Che-Leung Law, PhD (Abacus Bioscience); Paramita Mookherjee, PhD (Regeneron); Kelly Byrnes-Blake, PhD (Cascadia Drug Development Group); Aaron Pilling, PhD (Pharmefex Consulting); Jan L Hillson, MD (Cascadia Drug Development Group); Madeline Fort, PhD (Amgen); Jill Herendeen, PharmD (Rubicon Consulting Group); Declan Richards, MSc (Spannerwerks)
Organizers:
Peter Korytko, PhD, and Seattle PBSS Team
Registration Closes On:
October 13, 2025 - 12:00 AM PT
Registration Fee:
Regular attendees: $295
Academic or Self Paying: $45 (registration closes on 10/7/2025 for this category)
Major Sponsorship: $3,000
Vendor Show: $750
Happy Hour Sponsorship: $1,250
Lunch Sponsorship: $1,500
On-site Registration: $500
Location:
Seattle Asian Art Museum (1400 E Prospect St, Seattle, WA 98112)
Webcast for non-local attendees
Exhibitors (Vendors):
Labcorp, Ellegaard Bioresearch, ModernVivo, Coriolis Pharma, Inotiv, Altasciences, Aliri Bioanalysis, Biocytogen, WuXi Biologics, BioAgilytix - Durham, NC, Metabolon, Quantall LLC
The Investigational New Drug (IND) application is a critical milestone in developing antibody-based therapeutics. A clear understanding of IND filing requirements is important to ensure fast and efficient development. While the principles and basics are similar across different modalities for an IND filing such as safety studies, there are important aspects that need to be considered for antibody-based therapeutics. In this workshop, we will cover the best practices for a successful IND package of an antibody candidate. Our highly experienced speakers will discuss the preclinical studies for antibody-based therapeutics IND packages.
Topics to be covered:
- Overview of preclinical development and IND filing requirements for antibody-based therapeutics
- Required preclinical studies for
- Safety assessment
- Pharmacology
- Pharmacokinetics
- CMC (Chemistry, Manufacturing, Control)
- Clinical development plans
- Regulatory strategies and agency interactions
- FDA’s perspective
This is an in-person event at Seattle Asian Art Museum, Seattle, WA; In-person attendance for those in Seattle Area; Webcast available to other locations.
This is a non-ORCA sponsored event, but we will be in attendance.
What is Seattle PBSS? As the newest chapter to PBSS International, Seattle PBSS is a non-profit that promotes exchange of scientific ideas and provides growth opportunities in pharmaceutical / life science disciplines. They foster interactions and disseminate information through seminar luncheons, focused workshops (short courses), symposia, and webinars, as well as career development programs.
Future PBSS Events in 2026:
- Technical Workshop on CMC Formulations for Large Molecules
- Nuts and Bolts of INDs for Peptides – all day workshop
To learn more, see Seattle PBSS and PBSS International.
If you have questions about the October event, contact Seattle PBSS chair Peter Korytko, korytko@preclinicalgps.com