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Workshop

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


Speakers: Henry Chan, BMS; Lawrence Dearth, BMS; Dan Zhu, BMS; Kaia Sartori, BioData Solutions; Mangala Hariharan, Mirati Therapeutics; Sharon Gao, Bright Peak Therapeutics; Sara Glickstein Bar-Zeev, Genentech; Michelle Mazzoni, Capstan Therapeutics; Arianne L. Motter, FDA
Organizers: Robyn Rourick (Genentech), Lilia Koriazova, PhD (Erasca), Mangala Hariharan, PhD (Mirati Therapeutics), Carolina Caffaro, PhD (Janux Therapeutics), Lina Ma, PhD (Janux Therapeutics)
Date: 2023-12-04
Time: 8:45-17:30 Pacific Time
Registration fee: Regular attendees: $295; Academic/Students/Postdocs: $125; Major Sponsorship: $3000; Vendor Show: $695; On-site Registration:$500. Lunch, and refreshments included.
Location: The Alexandria at Torrey Pines
Major Sponsor: (2)Mycenax; Veloxity Labs
Vendor show vendors registered to date: (21)Abzena; Agilent Technologies; Altasciences; Altruist Biologics (Innovent Biologics); Applied StemCell, Inc; Aroga Biosciences Inc.; Aton Biotech; Attentive Science; ChemPartner; Curia; Ellegaard BioResearch; GemPharmatech LLC; Inotiv; ITR Laboratories Canada Inc.; Meadowhawk Biolabs; Promega corporation; QPS, LLC; Revvity; Seer Bio; Shanghai Medicilon; SOLVO/CRL
Registration: http://www.PBSS.org
Registration deadline:2023-12-03  (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: the Do's and Don'ts in an IND
Time (PT) Topic
8:45-9:00 am PBSS Welcome and Introduction (Shichang Miao, PBSS; Lilia Koriazova, Erasca)
9:00-9:20 am Bench to Bedside: Biotherapeutics preclinical research to IND filing (Henry Chan, Exec. Director/Discovery Biotherapeutics, BMS)
9:20-9:50 am Biotherapeutic candidate discovery to lead optimization (Lawrence Dearth, PhD, Associate Director, Discovery Biotherapeutics, BMS)
9:50-10:25 am Non-clinical pharmacology for biotherapeutics (Dan Zhu, PhD, Senior Director, Discovery Biotherapeutics, BMS)
10:25-10:35 am Major Sponsor’s Presentation (Veloxity Labs) 
10:35-10:50 am Break Period & Vendor Show
10:50-11:45am Pharmacokinetic/Pharmacodynamic and bioanalytical considerations for successful IND filings (Kaia Sartori, Lead Consultant, BioData Solutions, LLC.)
11:45-12:35 pm Lunch (Sponsor, Wuxi AppTec)
12:35-1:45 pm Preclinical toxicology points to consider for biotherapeutic IND submissions (Mangala Hariharan, PhD, Associate Director, Toxicology, Mirati Therapeutics)
1:45 - 2:45 pm IND-enabling CMC activities for biotherapeutics (Sharon Gao, VP of CMC at Bright Peak Therapeutics)
2:45 - 2:55 pm Major Sponsor’s Presentation (Mycenax)
2:55 - 3:15 pm Break Period
3:15-3:50 pm Clinical Development Plan (Sara Glickstein Bar-Zeev, PhD, Principal Clinical Scientist, Genentech) 
3:50-4:20 pm Regulatory strategies and interactions with FDA: Industry perspective & how to prepare for FDA meetings (Michelle Mazzoni, Sr. VP, Regulatory and Quality, Capstan Therapeutics)
4:20-4:55 pm INDs for Biologics: The regulatory perspective (Arianne Motter, PhD, DABT, Senior Toxicologist/CDER/OND/DPT-ID, FDA)
4:55-5:25 pm Panel Discussion (All Speakers)
5:25 - 6:25 pm Happy Hour (Sponsored by Alturas Analytics, Inc.)


2024-07-23, Why All These New Modalities?
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2024-10-17, [Free Online] Patient Centric Blood Sampling for Facilitating De-centralized Clinical Trials: Implications for ClinOps, PK/ClinPharm, Bioanalytical and Biomarkers
2024-10-17, [Free Online by PBSS-San Diego] Patient Centric Blood Sampling for Facilitating De-centralized Clinical Trials: Implications for ClinOps, PK/ClinPharm, Bioanalytical and Biomarkers
┬ęPharmaceutical & BioScience Society, International; Last Modified: 6/13/2024; Admin Logon
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