PLENARY LECTURE

Chandra Prakash, PhD

Senior Research Fellow @ Agios Pharmaceuticals

Human Mass Balance and Metabolite Profiling Studies: Regulatory Guidance, Technical Approaches and Clinical Implications

 Sean Kassim, PhD

Director, Office of Study Integrity and Surveillance, CDER, US Food and Drug Administration 

Oversight of Bioavailability and Bioequivalence Studies in Support of New and Generic Drugs and Therapeutic Biologics

PLENARY LECTURE

Gary Jenkins, PhD

Senior Director @ AbbVie

AI/ML in bioanalysis and drug discovery - talk title TBA

Lyn Jones, PhD

Principal Investigator @ Dana-Farber Cancer Institute

Analytical Strategies for Covalent Drug Discovery - Targeting Residues Beyond Cysteine

Kaushik Mitra, PhD

Distinguished Scientist, DMPK & Safety Assessment, Therapeutic Lead Ophtalmology, Cardiovascular & Metabolic Diseases @ Johnson & Johnson, Adjunct Professor, Med. Chem @ University of Missouri 

Talk title TBA

Matthew Wagoner, PhD

Global Head of Investigative Toxicology @ Takeda Pharmaceuticals

Mechanistic investigations of TAK-994 that lead to DILI - title TBA

Patrick Breslin

Principal Scientist @ Johnson & Johnson Innovative Medicine

Recommendations on cross-validation experiment design from bioanalytical and clinical pharmacology perspective - Title TBA

Wenkui Li, PhD

Director Bioanalytics @ Novartis Institutes for BioMedical Research (NIBR)

Metabolite bioanalysis on behalf of IQ consortium - Title TBA

Brad Roadcap, PhD

 Director @ Merck

Title TBA 

Lindsay King, PhD

Executive Director, Head Clinical and Translational Biomarkers, Translational Clinical Science @ Pfizer

Biomarker validation strategies in drug development - Title TBA

Krisna Duong-Ly, PhD

Associate Principal Scientist @ Merck

Identification of Critical Reagents for Novel Biotherapeutic Modalities: Considerations and Case Studies 

Rosemary Lawrence-Henderson

Principal Scientist @ Pfizer

Characterization of Critical Reagents with Different New Modalities

Amy Li, PhD

Principal Scientist @ Genentech

Signal-to-Noise Ratio: A Streamlined Alternative to Titer for Anti-Drug Antibody Assessment 

Kiyoto Aramis Tanemura, PhD

Research Investigator, Quantitative Systems Pharmacology @ BMS

ML Guided Selection of Chiral Supercritical Fluid Chromatography Conditions

Stephanie Pasas Farmer, PhD

President and Founder @ BioData Solutions Consulting and Software

Leveraging AI in Bioanalysis: Real-World Applications of Large Language Models

 Jan Elias, PhD

Principal Scientist @ Boehringer Ingelheim

Mathematical Modeling for Human Dose Prediction of Degraders

Diana Cha, PhD

Principal Scientist @ Alnylam Pharmaceuticals

LBA approaches and innovations - Title TBA

John Chen, PhD

Senior Vice President @ NovaBioAssays

LC-MS Bioanalytical Support for Oligonucleotide PK/PD Studies

Yunlin Fu, MS

Senior Principal Scientist @ Novartis

Bridging HELISA and LC-MS for Quantification of siRNA and Its Metabolite in Preclinical Studies

Emilee Knowlton, PhD

Immunology Sales Specialist @ ProImmune, Inc.

immunopeptidomics for immunogenicity - Title TBA

Xiaobin Zhang, PhD

Associate Director @ Takeda

Immunogenicity Risk Assessment at the pre-IND Stage: Integrated Immunogenicity Risk Assessment in Protein-based Biotherapeutic Drug Development

Mark Niosi

Principal Scientist @ Pfizer

Title TBA

Jesse Yu, PhD

DMPK Scientist @ Relay Therapeutics

ADME Profiling of Clinical Stage PROTAC's

Martin Dowty, PhD

Scientific Director, DMPK/Safety Development Biological Sciences @ AbbVie

DMPK Considerations for the Development of Targeted Covalent Inhibitor Drugs: An IQ Consortium Assessment

 Aimee Mattei, PhD

Director of Immunoinformatics @ EpiVax

In Silico Immunogenicity Risk Assessment: AI-Enhanced Prediction of Clinical Immunogenicity Outcomes with EpiVax's ISPRI Toolkit

Fabio Broccatelli, PhD

Head of DMPK and Computational Chemistry @ Altos Labs

 Early dose prediction and ADME properties - Title TBA

Yipei Zhang, PhD

Senior Scientist @ Takeda

A Two -cycle Immunoaffinity Enrichment Strategy with Acid Treatment to Enhance Biotherapeutics Assay Sensitivity in Tissues

 Maria Jadhav, PhD

Director, GCP Team Lead, Bioanalysis @ Novartis

Unraveling xRNA Immunogenicity: Insights and Future Horizons

 Brittany Youngs, 

Senior Scientist, Translational DMPK & Clinical Pharmacology @ Stoke Therapeutics

Overcomig Challenges Associated with ADA Assay Development for ASO's

 Jinsong Yang, PhD

Director, Bioanalytical Group Head @ Keros Pharmaceuticals

Clinical Immunogenicity Monitoring of an Fc Fusion Protein Drug with Two Endogenous Counterparts: From Screening to Domain Specificity and Cross-Reactivity

 Afsana Trini, PhD

Principal Scientist, Clinical Pharmacology, Pharmacometrics & Bioanalysis @ BMS

Immunogenicity AI/ML - talk title TBA

 Reilly Eason, PhD

Senior Scientist @ Merck

AI/ML applications in drug discovery - talk title TBA

 Wei Liang, PhD

Senior Scientist @ AbbVie

Leveraging AI in Computational Toxicology 

 Qinying Yu, PhD

Senior Scientist @ Genentech

New DILI mechanism - talk title TBA

Lionel Cheruzel, PhD

Senior Principal Scientist @ Genentech

AI-aided Drug Design From Drug Metabolism Perspectives

Paddy Eangoor, PhD

Senior Principal Scientist/Lab Head, TMU Lab Sci @ Sanofi

Strategic Bioanalytical Approaches for Complex Biologics: Tools and Case Studies

Douglas Donaldson, PhD

Senior Scientist @ Moderna

ADA's assay singlicate vs duplicate sample testing - talk title TBA