May 16, 2023 Discovery Toxicology
May 17, 2023 morning Discovery Toxicology
May 17, 2023 afternoon Development Toxicology
May 18, 2023 Development Toxicology
 
DISCOVERY TOXICOLOGY WORKSHOP - TUESDAY MAY 16, 2023
Session Topic Speaker Company Time
Registration     12:00 - 1:00
Conference Opening and Plenary Speaker Introduction

Rama Pai, Merck & Connie Wu, Genentech

  1:00 - 1:10
Plenary Lecture: Safety Considerations for Selection and Development of Combination Therapies for Tuberculosis Monicah Otieno Bill and Melinda Gates Medical Research Institute 1:10 - 1:55

Session I:  Alternative Models

Chairs:  Jodi Goodwin, Takeda & Jon Heyen, Pfizer

Session Topic Speaker Company Time
Session Introduction     1:55-2:00
Utility of Zebrafish for Detecting Mitochondrial and Biliary Toxicities in Preclinical Safety Steven Cassar AbbVie 2:00-2:30
ID.Flow: A Physiologically Relevant Test System for Nonclinical Safety Assessment of Different Drug Modalities Erika Fletcher Immuneed  2:30-3:00
Vendor Talk - Human Intestinal Organoid Culture System for Drug-Induced Gastrointestinal Toxicity Screening Martin Stahl & Danny Leung   3:00-3:25
Break       3:25-3:50
Leveraging Organoids and Organs-on-Chip in Drug Development Kim Homan Genentech 3:50-4:20
Vendor Talk- ReachBio Acquired by Discovery Life Sciences, Expanding Toxicology Solutions

 Marcela Alomia & Emer Clarke

4:20-4:30
Preclinical Safety Evaluation of mRNA Cancer Therapeutics: A Platform Approach Anuhar Chaturvedi BioNTech SE 4:30-5:00
Poster Session and Reception     5:00-6:30
DISCOVERY TOXICOLOGY WORKSHOP- WEDNESDAY MAY 17, 2023

Session II: Understanding Unwanted Pharmacology

Chairs:  Jon Maher, Pliant Therapeutics & Yoav Timsit, Blueprint Medicines

Registration and Breakfast      7:00 - 8:00
Session Introduction      8:00 - 8:05
Elucidating On and Off-target Effects of Protein Degraders Through Quantitative Proteomics Joel Federspiel Pfizer 8:05 - 8:35
Current Strategies in Secondary Pharmacology and its Impact on the Safety of New Medicines Yoav Timsit Blueprint Medicines 8:35 - 9:05
Screening of Antibody, Protein, and Cell Therapeutics for Potential Off-targets Using Human Cell Microarray Technology  Diogo Rodrigues Ferreirinha Charles River Laboratories 9:05 - 9:35
Break     9:35 - 9:55

Session III: In Vitro and In Silico Predictive Immunogenicity

Chair: Prathap Mahalingaiah, AbbVie & Darcey Clark, Merck

Session Topic Speaker Company Time
 Session Introduction     9:55-10:00
Systems Biology Approaches to Understand Immunologic Response/Precision Medicine to Improve Vaccines in Young and Elderly Ofer Levy Boston Children's Hospital 10:00 - 10:30
Preclinical Immunogenicity Risk Assessment Approaches for Traditional Biologics and Next Generation Novel Modalities Vibha Jawa BMS 10:30-11:00
Advancement in Translational In Vitro Models for Preclinical Immunogenicity and Immunosafety Risk Assessment Ruchi Srivastava  AbbVie 11:00-11:30
Vendor Talk - Liver Spheroid Models for Predictive and Investigative Toxicology Bruno Filippi   11:30-11:55
Lunch     11:55 - 1:15
DEVELOPMENT TOXICOLOGY WORKSHOP- WEDNESDAY MAY 17, 2023
Workshop Introduction and Speaker Introduction Edward Dere Genentech 1:15- 1:25
Plenary Lecture: A Stem Cell-Derived Implant for Dry Age-related Macular Degeneration Dennis Clegg UCSB 1:25 - 2:05

Session IV: An Eye on the Eye!

Chairs: Edward Dere, Genentech & Christine Mollica, Amgen

Session Introduction      2:05 - 2:10
Ocular Inflammation in Non-clinical Ocular Toxicity Studies - An Evolution Understanding, Approaches, and Impact Helen Booler Novartis, Basel 2:10 - 2:40
The Bigger Picture of Inflammation Nora Denk Roche, Basel 2:40 - 3:10
Break     3:10 - 3:30
Vendor Talk: Nonclinical Safety Evaluation of Nanolipid Particles Renzong Xie   3:30 - 3:40
Looking to the Future: Evolving Considerations for Intravitreal (Ocular) Biologics Combination Toxicity Studies Rachel Andrews Genentech 3:40 - 4:10
Poster Session and Reception     4:10 - 5:25
DEVELOPMENT TOXICOLOGY WORKSHOP-THURSDAY MAY 18, 2023
Breakfast   7:00 - 8:00
Workshop Opening and Plenary Speaker Introduction     8:00 - 8:05
Plenary Lecture: BARDA, Medical Countermeasure Development, and the Animal Rule Paul Roney BARDA 8:05 - 8:45

Session V: ABC's of ADC's

Chairs: Michael Santostefano, Merck & Jairo Nunes, Novartis

Session Topic Speaker Company Time
 Session Introduction     8:45 - 8:50
Current Strategies of Lead Op for Existing and Novel Conjugates Melissa Schutten

Seagen

8:50 - 9:20
The Ultra-fast Journey of First Merck ADC Cuixian (Trisha) Yang Merck 9:20 - 9:50
Engineering Antibody-Drug Conjugates for Solid Tumors Ian Nessler  AbbVie 9:50 - 10:20
Break     10:20-10:40
Vendor Talk: In vivo Neuropathology: Detecting the Neurotoxicity of Candidate Drugs during Early Drug Discovery Craig Ferris  10:40-11:05

Session VI: Nitrosamine Impurities

Chairs: Betty Pettersen, Pfizer, Paul Cornwell, Eli Lilly, and Joe Cichocki, Vertex

Session Topic Speaker Company Time
 Session Introduction      11:05-11:10
Nitrosamine SAR: I'll Show You a Read-across Kevin Cross Instem 11:10-11:40
I've Got a Nitrosamine Impurity: What Now? Joel Bercu  Gilead Sciences 11:40-12:10
Schrödinger's Cat is Dead, but Not from Nitrosamine Exposure...Probably Robert Jolly Eli Lilly 12:10-12:40
Conference Closing     12:40-12:45

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May 16-17, 2023 Discovery Toxicology

May 17-18, 2023 Development Toxicology

Genentech, South San Francisco, CA

 

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The Boston Society (R) is an internationally-recognized NON-PROFIT organization dedicated to bringing the best scientific ideas to industrial practice through focused, timely workshops and conferences. 501(c)3

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