May 14, 2019 Discovery Toxicology
May 15, 2019 Discovery and Development Toxicology
May 16, 2019 Development Toxicology
Session Topic Speaker Company Time
Registration    12:00-1:00
Conference Opening and Plenary Lecture Introduction  Christine Karbowski Amgen 1:00-1:10

Plenary Speaker 

"Big Data Meets Drug Discovery"

Astrid Ruefli-Brasse 23andMe 1:10-1:55

Session I:  Machine Learning/AI/Computational Approaches in Toxicology

Yoav Timsit, Blueprint Medicines and Christine Karbowski, Amgen

Session Topic Speaker Company Time
 Session Introduction     1:55-2:00
"Modeling of Big and Complex Data in Pharmaceutical Target and Chemical Safety Assessment” Matt Martin Pfizer 2:00-2:30
"Practical use of Computational Approaches to Impact Pipeline Programs with Potential Toxicology Concerns" Falgun Shah Merck 2:30-3:00
“So You Think You’ve Got Hematotoxicity...” Mary Huber STEMCELL Technologies 3:00-3:30
Break     3:30-3:55
"Using Data Science and AI to Improve the Safety of New Drug Candidates" Nigel Greene AstraZeneca 3:55-4:25
"Utility of Digital Pathology, Image Analysis, and Machine Learning in Toxicologic Pathology" Famke Aeffner Amgen 4:25-4:55
Poster Session and Reception     4:55-6:25
Session Topic Speaker Company Time
Registration and Breakfast 7:00-8:00

Session II: Non-Clinical to Clinical Translation

Padma Narayanan, Ionis Pharmaceuticals and Jon Maher, Genentech

Session Topic Speaker Company Time
 Session Introduction     8:00-8:05
“Non-clinical to Clinical Translation of Toxicity Associated with an Antibody-Drug Conjugate” Lise Loberg AbbVie 8:05-8:35
"Investigation of the Mechanism of a Small Molecule-Associated Coagulopathy" Satoko Kakiuchi-Kiyota Genentech 8:35-9:05
"Clinical Translation of Non-clinical Target Organ Toxicity:  The When and Why Nots" Ken Frazier GSK 9:05-9:35
Break     9:35-9:55

Session III: Organ on a Chip/3D Cultures

Michael Santostefano, Merck and Zoe Zhong, Genentech

Session Introduction     9:55-10:00
“Application of iPS-Derived Neural Spheroids In Drug Discovery” Matthew Wagoner Takeda 10:00-10:30
"Utility of Complex in vitro Liver Systems in Assessing the Safety of Drugs" Jose Lebron Merck 10:30-11:00
"An Industry Perspective on use of MPS in Drug Safety Assessment" Terry Van Vleet AbbVie 11:00-11:30
Panel Discussion     11:30-11:50
Lunch     11:50-12:50
DEVELOPMENT WORKSHOP (Wednesday May 15th, 2019)
Intro to Development Workshop and Plenary Lecture Florence Lorget Sangamo Therapeutics 12:50-1:00

Plenary Speaker 

"Preclinical Development of Gene Therapy Products: CBER Considerations"

Mercedes Serabian FDA 1:00-1:40

Session IV: Cell and Gene Therapy/New Modalities/Regulatory Interactions

Vito Sasseville, Novartis and Eunice Musvasva, Boehringer Ingelheim

Session Topic Speaker Company Time
 Session Introduction     1:40-1:45
"Use of Animal Models of Disease to Optimize Translation of Cell and Gene-Based Therapies" Joy Cavagnaro AccessBio 1:45-2:15
"Biodistribution and Immunogenicity Assessments to Support Gene Therapies: Challenges and Opportunities" Mark Milton Novartis 2:15-2:45
"Cell and Gene Therapy Product Development: A Funder’s Perspective" Abla Creasey CIRM 2:45-3:15
Break     3:15-3:35
"Nonclinical Studies Supporting Development of ZFN-Based Genomic Medicines for MPS II" Kathy Meyer Sangamo Therapeutics 3:35-4:05
“Regulatory Considerations for Nonclinical Safety Assessment of GalNAc-conjugated siRNAs” Joe Cichocki Alnylam 4:05-4:35
Panel Discussion     4:35-5:05
Poster Session and Reception     5:05-6:25
Session Topic Speaker Company Time
Registration and Breakfast 7:00-8:00

Session V: Predictive Toxicology

Paul Cornwell, Eli Lilly and Nardos Tassew, Genentech

Session Topic Speaker Company Time
Session Introduction     8:00-8:05
"Immunogenicity Prediction - Strategies and Challenges" Valerie Quarmby  Genentech 8:05-8:35
"Predictive Value of Nonclinical Studies To Support FIH" Tom Monticello Amgen 8:35-9:05
"Privacy-preserving Knowledge Transfer from Corporate Data to Federative Models” Thierry Hanser Lhasa Limited 9:05-9:35
Break     9:35-9:55

Session VI: Big Data and New Technologies

Rebecca Erickson, Denali Therapeutics and Lauren Mihalcik, Amgen

Introduction      9:55-10:00
"Toxicological Transfer Learning in AI: Combining Classification Datasets to Make Better Predictions" Thomas Hartung Johns Hopkins Bloomberg School of Public Health 10:00-10:30
"Accurate Prediction of Animal Toxicity Endpoints: All Things Considered in the Age of Big Data" Ivan Rusyn Texas A&M 10:30-11:00
"Using Population-Scale Genetic Databases to Inform Target and Drug Safety" Luke Ward Alnylam 11:00-11:30
“3D Printing of Pharmaceuticals and Accelerating Drug Development” Jae Yoo and Don Wetherhold Aprecia Pharmaceuticals 11:30-12:00
 Panel Discussion      12:00-12:20
Closing Remarks        12:20- 12:25 





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