Sunday
2:00 pm - 9:00 pm
Arrival and Check-in
6:00 pm - 7:00 pm
Dinner
7:30 pm - 7:40 pm
Introductory Comments by GRC Site Staff / Welcome from the GRC Chair
7:40 pm - 9:30 pm
Keynote Session: Modeling Complex Biological Systems
Discussion Leader: Helen Haggerty (Janssen, United States)
7:40 pm - 7:55 pm
Opening Remarks
7:55 pm - 8:10 pm
Introduction by Discussion Leader
8:10 pm - 9:10 pm
Dennis Discher (University of Pennsylvania, United States)
"Physics and Biology of Microenvironments and Their Impact on Cellular Function"
9:10 pm - 9:30 pm
Discussion
Monday
7:30 am - 8:30 am
Breakfast
8:30 am - 9:00 am
Group Photo
9:00 am - 12:30 pm
Emerging Applications of Big Data and Machine Learning in Safety Assessment
Discussion Leaders: James Stevens (Leiden University, United States)
9:00 am - 9:15 am
Introduction by Discussion Leader
9:15 am - 9:45 am
Jeffrey Sutherland (Novartis Institutes for BioMedical Research, United States)
"Quantitative Risk Assessment in Lead Optimization: Predicting Clinical Adverse Events From Secondary Pharmacology Profiling"
9:45 am - 10:00 am
Discussion
10:00 am - 10:25 am
Coffee Break
10:25 am - 10:55 am
Daniel Rudmann (Charles River Laboratories, United States)
"Driving Innovation, Quality, and Efficiency in Toxicologic Pathology Using Deep Learning Convolutional and Adversarial Neural Networks"
10:55 am - 11:05 am
Discussion
11:05 am - 11:25 am
Fauve Versaevel (Junior Pathologist at Janssen, Belgium)
"Quantification of Olney Lesions using Deep Learning"
11:25 am - 11:35 am
Discussion
11:35 am - 11:55 am
Tijo Thomas (AIRA Matrix Pvt Ltd, India)
"Deep Learning-based Approach for Assessment and Quantification of Testicular Toxicity in Rodents"
11:55 am - 12:10 pm
Discussion
12:10 pm - 12:30 pm
General Discussion
12:30 pm - 1:30 pm
Lunch
1:30 pm - 4:00 pm
Free Time
3:00 pm - 4:00 pm
The GRC Power Hourâ„¢
The GRC Power Hourâ„¢ is designed to address diversity and inclusion in the scientific workplace by providing a safe environment for informal and meaningful conversations amongst colleagues of all career stages. The program supports the professional growth of all members of our communities, including ethnicity, race and/or gender identity by providing an open forum for discussion and mentoring.
Organizer: Lauren Lewis (Bristol Myers Squibb, United States)
4:00 pm - 6:00 pm
Poster Session
6:00 pm - 7:00 pm
Dinner
7:30 pm - 9:30 pm
Leveraging Human Genetics and Big Data to Inform Drug Safety
Discussion Leader: Blanca Rodriguez (University of Oxford, United Kingdom)
7:30 pm - 8:00 pm
Danish Saleheen (University of Pennsylvania, United States)
"The Human Knockout Project"
8:00 pm - 8:10 pm
Discussion
8:10 pm - 8:40 pm
Lucas Ward (Alnylam Pharmaceuticals, United States)
"Genetic Variation in Drug Targets and Organ Systems Side Effects"
8:40 pm - 8:50 pm
Discussion
8:50 pm - 9:20 pm
Hao Zhu (Rutgers University, United States)
"Adverse Outcome Pathways (AOP) to Predict Toxicity of New Compounds, And Illustrate Relevant Toxicity Mechanisms"
9:20 pm - 9:30 pm
Discussion
Tuesday
7:30 am - 8:30 am
Breakfast
9:00 am - 12:30 pm
Biomarker Science in Drug Discovery and Development
Discussion Leaders: Vishal Vaidya (Pfizer, United States)
9:00 am - 9:10 am
Introduction by Discussion Leader
9:10 am - 9:40 am
Ravi Kodihalli (Pfizer, United States)
"Biomarkers for Drug Induced Liver Injury in Humans"
9:40 am - 9:55 am
Discussion
9:55 am - 10:05 am
Steven Johnson (Northwestern University, United States)
"Whole-body Imaging of Cell Death Provides A Systemic, Minimally Invasive, Dynamic, and Near-real Time Indicator For Chemotherapeutic-Induced Drug Toxicity"
10:05 am - 10:10 am
Discussion
10:10 am - 10:40 am
Coffee Break
10:40 am - 11:10 am
Vishal Vaidya (Pfizer, United States)
"Biomarker-Driven Precision Medicine in Early Clinical Development"
11:10 am - 11:20 am
Discussion
11:20 am - 12:00 pm
June-Wha Rhee (City of Hope, United States)
"Cardiovascular Safety using iPSC and Omics Applications in Oncology Patients"
12:00 pm - 12:10 pm
Discussion
12:10 pm - 12:20 pm
Laura Booth (Newcastle University, United Kingdom)
"Investigating GDF15, a Novel Senescence-Associated Secretory Factor, in Delayed Symptomatic Anthracycline-Induced Cardiotoxicity"
12:20 pm - 12:25 pm
Discussion
12:25 pm - 12:30 pm
General Discussion
12:30 pm - 1:30 pm
Lunch
1:30 pm - 4:00 pm
Free Time
4:00 pm - 6:00 pm
Poster Session
6:00 pm - 7:00 pm
Dinner
7:30 pm - 9:30 pm
Microphysiological Models: Advances in Modeling Complex In Vivo Functions and Organ Responses
Discussion Leader: Anthony Bahinski (Vivodyne, Inc)
7:30 pm - 7:45 pm
Introduction by Discussion Leader
7:45 pm - 8:10 pm
Mark Donowitz (Johns Hopkins University School of Medicine, United States)
"Use of Human Enteroids in Understanding Human Disease Pathophysiology and Therapy"
8:10 pm - 8:20 pm
Discussion
8:20 pm - 8:45 pm
Julie Kim (Northwestern University, United States)
"Microphysiological Models of Female Reproductive Biology"
8:45 pm - 8:55 pm
Discussion
8:55 pm - 9:20 pm
Girija Goyal (Wyss Institute, United States)
"Predicting Vaccine Efficacy and Immune Responses Using the Human Lymph Node Organ Chip"
9:20 pm - 9:30 pm
Discussion
Wednesday
7:30 am - 8:30 am
Breakfast
9:00 am - 12:30 pm
New Paradigms in Translational Safety Science
Discussion Leader: Jaqueline Kinyamu-Akunda (Janssen R&D, United States)
9:00 am - 9:35 am
Lyn Jones (Dana-Farber Cancer Institute, United States)
"Targeted Protein Degrader Safety and Emerging Applications of Functional Genomic and Proteomic Profiling"
9:35 am - 9:45 am
Discussion
9:45 am - 10:20 am
Patricia Ryan (AstraZeneca - Gaithersburg, MD, United States)
"Nonclinical Safety Assessment in the Absence of a Pharmacologically Relevant Species: What Makes Sense"
10:20 am - 10:30 am
Discussion
10:30 am - 11:00 am
Coffee Break
11:00 am - 11:35 am
Michael Morton (ApconiX Ltd, United Kingdom)
"Novel Electrophysiological Approaches to Understanding Drug-Induced Seizure"
11:35 am - 11:45 am
Discussion
11:45 am - 12:20 pm
Eric Sobie (Icahn School of Medicine at Mount Sinai, United States)
"Novel Computational Approaches to Understanding Drug-Induced Arrhythmia"
12:20 pm - 12:30 pm
Discussion
12:30 pm - 1:30 pm
Lunch
1:30 pm - 4:00 pm
Free Time
4:00 pm - 6:00 pm
Poster Session
6:00 pm - 7:00 pm
Dinner
7:00 pm - 7:30 pm
Business Meeting
Nominations for the Next Vice Chair; Fill in Conference Evaluation Forms; Discuss Future Site and Scheduling Preferences; Election of the Next Vice Chair
7:30 pm - 9:30 pm
Novel Therapeutic Modalities: Challenges and Opportunities in Nonclinical Safety Assessment Strategies
Discussion Leader: Jeff Willy (Vertex Pharmaceuticals , United States)
7:30 pm - 8:00 pm
Fiona Spence (Novartis Institutes for Biomedical Research, United States)
"Navigating Pre-Clinical Safety in Targeted Protein Degradation"
8:00 pm - 8:10 pm
Discussion
8:10 pm - 8:40 pm
Justine Cunningham (SANA Biotechnology, United States)
"Nonclinical Considerations for Developing an Intravenous Syste?mic CAR-T cell Therapy"
8:40 pm - 8:50 pm
Discussion
8:50 pm - 9:20 pm
Sarah Lamore (Wave Life Sciences, United States)
"RNA Therapeutics"
9:20 pm - 9:30 pm
Discussion
Thursday
7:30 am - 8:30 am
Breakfast
9:00 am - 12:30 pm
Full Utilization of the Clinical Experience in the Nonclinical Space
Discussion Leader: Myrtle Davis (Bristol-Myers Squibb, United States)
9:00 am - 9:15 am
Introduction by Discussion Leader
9:15 am - 9:55 am
Aarti Asnani (Beth Israel Deaconess Medical Center, United States)
"Cancer Therapy and Cardiotoxicity: Toward a Mechanistic Understanding"
9:55 am - 10:05 am
Discussion
10:05 am - 10:30 am
Coffee Break
10:30 am - 11:10 am
Michelle Janelsins (University of Rochester, United States)
"Pre-Clinical and Clinical Assessment of Cancer-Related Neurotoxicity"
11:10 am - 11:20 am
Discussion
11:20 am - 12:00 pm
Yinghong (Mimi) Wang (University of Texas MD Anderson Cancer Center, United States)
"Clinical Management of IO-therapy Mediated GI Toxicities"
12:00 pm - 12:10 pm
Discussion
12:10 pm - 12:30 pm
General Discussion
12:30 pm - 1:30 pm
Lunch
1:30 pm - 4:00 pm
Free Time
4:00 pm - 6:00 pm
Poster Session
6:00 pm - 7:00 pm
Dinner
7:30 pm - 9:30 pm
Keynote Session: Advancing Drug Safety Through Innovation
Discussion Leader: Ruth Roberts (ApconiX, United Kingdom)
7:30 pm - 7:40 pm
Introduction by Discussion Leader
7:40 pm - 8:40 pm
Manasi Nandi (King's College London, United Kingdom)
"Mathematical Modelling of Big Data: Application to Drug Safety"
8:40 pm - 9:05 pm
Discussion
9:05 pm - 9:25 pm
General Discussion
9:25 pm - 9:30 pm
Closing Remarks
Friday
7:30 am - 8:30 am
Breakfast
9:00 am
Departure