Pharmaceutical & BioScience Society, PBSS

Workshop

[In-Person] Preclinical Development and IND Filing for Antibody-Based Therapeutics: Nuts, Bolts and Best Practices

Speakers: Laurence Fayadat-Dilman (Merck and Co), Keegan Cooke (Amgen), Jay Tibbitts (Surrozen), Robert Caldwell (AbbVie), Lilia Koriazova (Erasca), Sara Glickstein Bar-Zeev (Genentech); Key Kang (Genentech), Arianne L. Motter (FDA)
Organizers: Ayse Meric Ovacik (Genentech); Smita Salian-Mehta (Gilead); Isabel Figueroa Amenabar (Amgen); Laurence Fayadat-Dilman (Merck and Co); Minli Xie (Erasca); Snow Ge (Biobridge Pharma); Shichang Miao (Amgen)
Date: 2023-05-24
Time: 8:45-17:25 Pacific Time
Registration fee: Regular attendees: $295; Academic/Students/Postdocs: $125; Major Sponsorship: $3000; Vendor Show: $695; On-site Registration:$500
Location: Crowne Plaza, Foster City, CA (San Francisco Bay Area)
Major Sponsor: (2)Mycenax; Veloxity Labs
Vendor show vendors registered to date: (23)Abzena; Alturas Analytics; Biointron; BioTether Sciences; Charles River Labs; CHIRON Recombinant Proteins; Correlia Biosystems Inc; CP Lab Safety; Ellegaard BioResearch; Emery Pharma; Frontage Laboratories; Gator Bio; GBI Bio; Inotiv; IRBM; KCAS Bio; Meadowhawk Biolabs; Medicilon; MilliporeSigma; Novogene Corporation Inc.; Q2Lab Solutions; QPS, LLC; WuXi AppTec
Registration: http://www.PBSS.org
Registration deadline:2023-05-23 (it will close sooner if the seating cap is reached)

About the Topic

Commercial clinical pipeline of mAbs has vastly increased in recent years; the mAbs based therapeutics in development has been growing at an incredible pace. The investigational new drug application (IND) application is an important step to achieve in mAb based therapeutics, and understanding the requirements for a successful IND filing is utmost 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 mAb based therapeutics. In this workshop, we will cover the best practices for a successful IND package of mAbs. Our highly experienced speakers will discuss the preclinical studies for mAb based therapeutics IND packages. This workshop will be suitable for novice drug developers and small molecule drug development experts who are interested in mAb therapeutic development.

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
FDA’s perspective by an FDA reviewer

Time (PT)	Topic	Presenter
8:45-9:00 am	PBSS Welcome and Introduction	Snow Ge (BridgeBio Pharma)
9:00-9:20 am	1. Overview of preclinical development and IND filing requirements for antibody-based therapeutics	Ayse Meric Ovacik, PhD, Senior Principal Scientist, Genentech
9:20-9:50 am	2. Overview of antibody-based therapeutics: structure, generation, design, and optimization	Laurence Fayadat-Dilman, PhD, Executive Director, Discovery Biologics, Merck & Co, Inc.
9:50-10:25 am	3- Non-clinical pharmacology considerations for bi-specific antibodies	Keegan Cooke, BA, Principal Scientist Oncology Research, Amgen
10:25-10:35 am	Major Sponsor’s Presentation	Mycenax Biotech Inc.
10:35-10:50am	Break Period & Vendor Show	-
10:50-11:45am	4- Pharmacokinetic/Pharmacodynamic and bioanalytical considerations for successful IND filings	Jay Tibbitts, DVM, PhD, Vice President Non-Clinical Development, Surrozen
11:45-12:35pm	Lunch	Sponsor: Pharmaron
12:35-1:45pm	5- Preclinical toxicology points to consider for biotherapeutic IND submissions	Robert Caldwell, PhD, Senior Principal Research Scientist, Toxicology, AbbVie
1:45-2:45pm	6. IND-enabling CMC activities for therapeutic antibodies	Lilia Koriazova, PhD, Sr. Director, Biologics Pharmaceutical Sciences, R&D department, Erasca
2:45-2:55pm	Major Sponsor’s Presentation	Veloxity Labs
2:55-3:10pm	Break	-
3:10-3:45pm	7- Clinical Development Plan	Sara Glickstein Bar-Zeev, PhD, Senior Clinical Scientist, Genentech
3:45-4:15pm	8. Regulatory strategies and Interactions with FDA: Industry perspective & how to prepare for FDA meetings	Key Kang, MSc, Global Regulatory Leader and Group Director, Genentech Inc.
4:15-4:50pm	9- INDs for biologics: The regulatory perspective	Arianne Motter, PhD, DABT, Senior Toxicologist/CDER/OND/DPT-ID, U.S FDA
4:50-5:25pm	Panel Discussion	All Speakers
5:25-6:25pm	Happy Hour	Sponsor: Alturas Analytics

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