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Workshop
[In-Person] Antibody-Drug Conjugates from Discovery to Development: Chemistry, Engineering, Characterization, CMC, PK/Tox, Clinical Design and Intellectual Property
Speakers:
Tom Pillow, Genentech Bernhard Geierstanger, Firefly Biologics Ben Niu, Bristol Myers Squibb Dan Zhu, Bristol Myers Squibb Sharon Gao, Bright Peak Therapuetics Ayse Meric Ovacik, Genentech Sara Glickstein Bar-Zeev, Genentech Julia Minitti, Wilson Sonsini Goodrich & Rosati
Organizers:
Lilia Koriazova, PhD (Erasca, Inc.), Sara Glickstein Bar-Zeev, PhD (Genentech), Lawrence Dearth, PhD (BMS)
Date:
2024-12-10
Time:
8:45-17:00 Pacific Time
Registration fee:
Regular attendees: $295; Academic/Students/Postdocs/Out-of-pocket: $45; Major Sponsorship: $3000; Vendor Show: $695; Lunch Sponsorship: $1,250; Happy Hour Sponsorship: $975; On-site Registration:$500
Location:
Hyatt Regency La Jolla (3777 La Jolla Village Dr, San Diego)
Major Sponsor:
Vendor show vendors registered to date:
(8)Aliri Bioanalysis; Altasciences; KCAS Bio; Meadowhawk Biolabs; Promega corporation; Quantall LLC; Sai Life Sciences; Veranova
Registration: http://www.PBSS.org
Registration deadline:2024-12-09
(it will close sooner if the seating cap is reached)
About the Topic
Thirteen Antibody Drug Conjugates [ADC] have been currently approved for human therapeutic use by regulatory agencies worldwide, and the M&A transactions of ADC companies in 2023 alone has exceeded $50B. The remarkable clinical success is achieved with breakthrough innovations in payload and linker chemistries, amongst many other aspects, by concurrently improving safety and efficacy of ADCs, resulting in a more favorable therapeutic index for treating a given indication. ADCs, which are a combination of both small and large molecules, require carefully chosen tumor associated antigens for selective delivery of cytotoxic payload to minimize on-target off-tissue toxicity. They are also challenging molecules to develop from the CMC perspective. The ADC platforms are rapidly evolving to conjugate a variety of payloads that represent potent chemotherapy, immunotherapy, radiotherapy, and oligonucleotide agents. The huge therapeutic potential of these drugs has also created a highly competitive intellectual property space surrounding the ADC platform. The workshop will cover different topics ranging from design, synthesis, in-vitro & in-vivo evaluation, CMC to considerations for securing intellectual property rights of ADCs.
Time (PST) |
Topic |
Speaker(s) |
8:45 - 9:00 am |
PBSS Welcome |
Lilia Koriazova, PhD, Erasca, Inc. |
9:00 - 9:15 am |
Workshop Overview and ADC Overview |
Tom Pillow, PhD,Distinguished Scientist (Chemistry), Discovery Chemistry, Drug Discovery, Genentech |
9:15-10:00 am |
Chemistry of Linker Payload & Conjugation Techniques |
Tom Pillow, PhD,Distinguished Scientist (Chemistry), Discovery Chemistry, Drug Discovery, Genentech |
10:00-10:45 am |
Antibody Engineering for ADCs |
Bernhard Geierstanger, PhD, Co-founder and Chief Technology Officer, Firefly Biologics |
10:45 - 10:55 am |
Major Sponsor Presentation |
TBD |
10:55 - 11:15 am |
Break and Vendor Show |
- |
11:15am-12:00 pm |
Analytical and Biochemical Characterization of ADCs |
Ben Niu, PhD, Principal Scientist, Bristol Myers Squibb |
12:00 - 12:55 pm |
Lunch |
Sponsor TBD
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12:55-1:25 pm |
In-vitro and In-vivo Pharmacology for ADCs |
Dan Zhu, PhD, Senior Director, Bristol Myers Squibb |
1:25-2:10 pm |
CMC Challenges and Opportunities for ADCs |
Sharon Gao, PhD, VP, Chemistry, Manufacturing and Controls, Bright Peak Therapeutics |
2:10-2:55 pm |
PK and Toxicology Study Designs |
Ayse Meric Ovacik, PhD, Director and Distiguished Scienties, Genentech |
2:55-3:05 pm |
Major Sponsor Presentation |
TBD |
3:05-3:30 pm |
Break and Vendor Show and Raffle |
- |
3:30-4:15 pm |
Clinical Trial Design for ADCs |
Sara Glickstein Bar-Zeev, PhD, Senior Clinical Scientist, Genentech |
4:15-5:00 pm |
Intellectual Property of ADCs |
Julia Minitti, Partner at Wilson Sonsini Goodrich & Rosati |
5:00-5:30pm |
Panel Discussion and Closing Remarks |
All speakers |
5:30-6:30 pm |
Happy Hour |
Sponsor TBD |
About the SpeakersTom Pillow, Genentech
Bernhard Geierstanger, Firefly Biologics Bernhard Geierstanger is CTO and co-founder of FireflyBio, a bay area ADC startup. He is an expert in protein engineering, ADCs and biotherapeutics. Before FireflyBio, he worked at Merck (MRL) and the Genomics Institute of the Novartis Research Foundation (GNF) leading teams that develop innovative biotherapeutics. Several of these have advanced to clinical trials. He has also pioneered novel methods for protein modification, site-specific conjugation, and the use of immune stimulating ADC payloads. Bernhard holds a Ph.D. in Biophysics from UC Berkeley and was a postdoctoral fellow at Stanford University. He has authored more than 60 publications and is an inventor on more than 30 patents and patent applications.
Ben Niu is Principal Scientist at BMS, leading a pioneering team with focus on quality attributes of biotherapeutics using various characterization and separation techniques. Ben specializes in analytical characterization in both R&D and CMC environments, driving critical insights for drug discovery and development. He champions the integration of lab automation and data automation to bring new insights to analytical workflows.
Dan Zhu, PhD is a Senior Scientific Director- Discovery Biotherapeutics at Bristol Myers Squibb. She leads a skilled team to support biologic discovery, from target validation, biologic screening with bioassays, to drug candidate delivery. Prior to join Biotherapeutics group, Dan was part of Discovery Oncology at Celgene where she played a critical role in driving phenotypic-based drug discovery strategy and led several discovery projects of small molecule kinase inhibitors for anti-cancer therapy. Earlier in her career at Celgene, Dan investigated the potential application of IMiDs (CELMoDs) in solid tumor by tapping their immunomodulatory activities. Dan holds a Ph.D. in Molecular Cell and Developmental Biology from University of Miami and completed Post-Doctoral training at The Scripps Research Institute on tumor angiogenesis and metastasis. Outside the lab, Dan enjoys gardening and hiking with her friends and family.
Sharon Gao, Bright Peak Therapuetics
Meric Ovacik, PhD is a Distinguished Scientist and Director at Genentech in Preclinical-Translational PK/PD and has over 10 years in large molecule drug development. Her expertise include early lead identification and optimization for large molecules, designing preclinical PK/PD and safety studies to inform First-in-Human (FiH) dose and Phase I studies. Her current research interests are exploring novel therapeutic targets PK/PD properties across different therapeutic areas. She holds a PhD in Chemical and Biochemical Engineering from Rutgers University, and was postdoctoral fellow in Pharmaceutical Science at SUNY-Buffalo
Sara Glickstein Bar-Zeev, Ph.D., is a Principal Clinical Scientist in gRED OMNI Early ClinicalDevelopment, Genentech, Inc in South San Francisco. Her area of focus includes first-in-human and proof-of-concept clinical trials in non-oncology indications. She received her PhD at Cornell University in Neurobiology. Before joining Genentech in 2017, she spent a decade in Medical Communications, focusing on publication strategy and medical writing, and previously held research faculty positions at Cornell and Columbia Universities. She has completed fellowships in ophthalmology and psychiatry and has published more than 30 research papers during her time as an academic scientist.
Julia Minitti is a partner in the Palo Alto office of Wilson Sonsini Goodrich & Rosati, where she is a member of the patent and innovation strategies practice. Julia counsels clients in the biotechnology, chemical, and pharmaceutical industries on a wide range of intellectual property issues, including patent portfolio development and management, Orange Book listing, patentability, non-infringement, and freedom to operate. She also advises clients in connection with various transactions, such as mergers and acquisitions, licenses, and venture financings.Julia obtained her Ph.D. in organic chemistry from Brown University, where she worked on synthetic methodology for creating heterocycles and catalyzing conjugate additions. Prior to graduate school, she worked as a medicinal chemist at Albany Molecular Research.
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