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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 Bioanalytical & Biomarker Services; 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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