Plenary Speaker

Courtney Horvath, PhD, DABT

Global Head of Strategy, Planning & Operations, Translational Medicine @ Novartis Institutes for Biomedical Research

Perspectives from a Mom-cologist

Plenary Speaker

Justine Cunningham, PhD, DABT

VP Nonclinical Development @ RegenX Bio

Bench to Bedside: Nonclinical Considerations for First in Human Dosing for Novel Gene Therapies

Plenary Speaker

Menglun Wang, PhD

Machine Learning Reviewer @ US FDA

Application of AI on Drug Development and Regulatory Decisions

Plenary Speaker

Qi Liu, PhD

Associate Director for Innovation & Partnership at Office of Clinical Pharmacology @ US FDA

Application of AI on Drug Development and Regulatory Decisions

Laura Armstrong, PhD

Principal Scientist, Discovery Toxicology @ Bristol Myers Squibb

Molecular Mapping of Heterogeneous Organs with Spatial Transcriptomics

Samantha Atkins, PhD

Scientist @ Moderna

Using Human Liver-on-a-Chip to Predict and De-risk LNP and mRNA Toxicities

Michael Beshiri, PhD

Senior Scientist @ AstraZeneca

Intestinal Organoids As Models To Predict and Evaluate Toxicity

Roger Kamm, PhD

Cecil H. Green Distinguished Professor, Emeritus @ MIT
Biological Engineering

Title TBD

Tynisha Glover, PhD

Scientific Director, Nonclinical Safety Leader, NCS Cell Therapy modality and NCS Heme DAS lead @ The Janssen Pharmaceutical Companies of Johnson & Johnson

Unique Aspects for Building a Cell Therapy Nonclinical Safety Strategy

Bethany R. Hannas, PhD, DABT

Director, Toxicology @ Eli Lilly and Company

Key Considerations for DART Assessment of Oligonucleotides

Taylor Hickman

Principal Scientist, Investigative Toxicology at Takeda

New Approach Methodologies for In Vitro Safety Assessment of Cell Therapies and Engagers

Li-Chin Yao, PhD

Scientist @ The Jackson Laboratory

Evaluation of Safety and Efficacy of Antibody Therapies in PBMC Humanized Mice

Satoko Kakiuchi-Kiyota, PhD, DABT

Distinguished Scientist & Small Molecule Drug Discovery Portfolio Safety Leader @ Genentech

No Panic All Disco: De-risking Pre-clinical Toxicity with a Potential First-In-Class TRPA1 Antagonist GDC-6599 for Respiratory Disease.

Dinah Misner, PhD, DABT

Vice President @ Aligos Therapeutics

Development of Novel siRNAs: General Paradigm and Case Study of an siRNA for Treatment of Chronic Hepatitis B

Stephen Nowakowski, MS

Senior Industrial Hygiene and Safety Consultant @ SafeBridge Consultants

Evaluating and Controlling Biologically-Derived Materials

Claudia Sehner, PhD

Principal Scientist / Toxicology @ Boehringer Ingelheim

Health Based-Exposure Limits (OELs, PDEs) for New Modalities: How are they calculated, and for which type of modalities are they needed?

Tada Shinozawa, PhD

Director @ Takeda, Japan

Drug Safety Risk Mitigation With Organoid-based Approach 

Keith Tanis, PhD

Director of Systems Toxicology @ Merck & Co. Inc

Evaluation of Drug-Induced Toxicity of Specific Cell Lineages in Rodent Bone Marrow Via Transcriptional Biomarkers of Hematopoietic Cell Subpopulations

Michael V. Templin, PhD

Scientific Advisory Services @ Charles River Laboratories

Non-clinical Development of Oligonucleotides: Opportunities, Challenges, and the Balancing Act Between the Two

Oliver Thomas

Scientific Director @ Amgen Research (Munich) GmbH

Development of Novel Human-Specific Therapeutics with Only Partial or No Cross-Reactivity to Standard Toxicology Species: Case Examples

Liz Tonkin, PhD, DABT

Senior Principal Scientist @ Genentech

Know Your Target: Unexpected Safety Findings with a T-cell Dependent Bispecific Antibody for Solid Tumors

AJ Troiano, PhD RBP

Global Director, Biosafety & Toxicology @ FUJIFILM Diosynth Biotechnologies

Biologics and Advanced Therapies Manufacturing: Employing Biorisk Management and Occupational Toxicology in CDMO Operations

Elizabeth Vancza, PhD

Associate Director, Occupational & Environmental Toxicology @ Merck & Co.

Adapting Occupational Toxicology to Navigate a New Modality Landscape – How Hazard Assessment Considerations are Evolving Alongside our Pipelines

Krishna Yekkala, BVSc, PhD, DACVP, DABT

Scientific Director, Pathology @ The Janssen Pharmaceutical Companies of Johnson & Johnson

An Introduction to Ocular Oligonucleotide Therapies: In-Life Observations and Associated Pathology

Alison Crawford, PhD

Associate Director of Immuno-Oncology @ Regeneron Pharmaceuticals 

Title TBA

Maureen Bunger, PhD, MBA

Senior Director Marketing and Product Management @ Altis Biosystems

RepliGut® StemTox™ Assay: A human primary stem cell-based in vitro assay for predicting the gastrointestinal toxicity risk of therapeutic agents

Qingcong Lin, PhD

EVP of Medicilon; President of Medicilon USA Corp

Nonclinical Safety Evaluation of Nanolipid Particles

Albert Li, PhD

Chief Scientific Officer of Pharmacology and Toxicology @ Discovery Life Sciences

Metabolism Dependent Xenobiotic Toxicity Detected with Co-Cultured Hepatocytes and CD34+ Hematopoietic Stem Cells (HSC)