PLENARY LECTURE

William Hwang, MD, PhD

Assistant Professor @ Harvard Medical School

Single-Cell Spatial Dissection Of the Pancreatic Tumor Microenvironment

PLENARY LECTURE

Joe Rajarao, PhD, MBA

Senior Manager @ Accenture

Application of AI in Drug Development

PLENARY LECTURE

Terry Van Vleet, PhD, DABT, FATS, ERT

Head of Investigative Toxicology and Pathology @ AbbVie

Prospects for New Approach Methodologies and Complex In Vitro Models to Reduce, Refine and Replace Animals in Drug Safety Testing 

PLENARY LECTURE

Chongwoo Yu, PhD

Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration

Lessons Learned from Regulatory Submissions Involving Endogenous Therapeutic Analyte Bioanalysis: Do You See What I See?

Yi-Ying Chen, MSc & MSRA

Chemist, OSIS, CDER, US Food and Drug Administration

Recent Data Integrity Findings in Bioresearch Monitoring

Nazneen Bano, PhD

Regulated BA Immunogenicity & Molecular @ Merck

Navigating Challenges in the Development of Neutralizing Antibody Assays: Key Considerations and Strategies

Audrey Arjomandi, PhD

Principal Scientist @ Genentech

Development of Nonclinical Total Anti-drug Antibody (ADA) Assays to Support The Reproductive Toxicology Studies for Zinpentraxin Alfa 

Jason DelCarpini, PhD

Director, Bioanalytical and Molecular Assays @ Moderna

Bioanalytical Method Case Studies Across the mRNA-LNP Therapeutic Portfolio

Reilly Eason, PhD

Senior Scientist @ Merck

Basics of Machine Learning and its Applications in Drug Discovery

Youhei Kosugi, PhD

Associate Director @ Takeda

Bio-digital Transformation  of Proteomic Analysis

Jeff Lin, PhD

Senior Scientist/Large Molecule Bioanalytical Group @ Genentech

Characterizing In Vivo Stability of Large Molecule Conjugates Using Complementary Bioanalytical Tools

Lori Payne, PhD

Executive Director of Business Development @ Alturas Analytics

"Space - the final microsampling frontier/ Mitra Device /Part II"

Jasleen K. Sodhi, PhD

Associate Director of DMPK @ Septerna

Recent Advancements in Predicting CYP-Independent Metabolism

Sandhya Subash, PhD

Pharmaceutical Chemistry, Research Associate @ Washington State University

Uncertainties and Opportunities in Predicting Non-CYP Mediated Drug Metabolism

Xiaomin Wang, PhD

Scientific Director @ BMS

Accelerator Mass Spectrometry (AMS) Applications for Supporting Clinical Development

Kaushik Mitra, PhD

Distinguished Scientist, DMPK & Preclinical Safety Assessment, TAL Speciality Ophthalmology JnJ; Adjunct Professor, Med Chem, UMC

Mitigation Strategies for Drug-Induced Liver Injury (DILI) - Still an Aspiration?

Xiaoyun Yang, PhD

Principal Scientist @ Genentech

Implementation of Low Volume Sampling Technologies for PK and Biomarker Analysis: Technical and Logistical Challenges and Solutions

Long Yaun, PhD

Director/Head of Bioanalytical Group @ Biogen

A Novel Hybridization LC-MS/MS Methodology for Bioanalysis of siRNA

Elaine Tseng,

Principal Scientist @ Pfizer

Predicting Clinical Drug-Drug Interactions of Cytochrome P450 Time-Dependent Inhibitors - How Successful Are We?

Jayaprakasam (Prakash) Bolleddula, PhD

Senior Director, Clinical Pharmacology @ iTeos Therapeutics

Prediction of Aldehyde Oxidase Mediated Clearance: Recent Progress in Quantitative Translation

Sean Xiaochun Zhu, PhD

Scientific Director @ Takeda

A 'Missing' Trazpiroben Metabolite Observed As the Most Abundant Metabolite in Human Plasma and Urine

Milan Kothiya, MS

Principal Scientist @  Eli Lilly and Company

Measuring Endogenous and Trangene-expressed Protein Levels in Gene Therapy Bioanalytical and Biomarker Studies

Faye Vazvaei, PhD

Executive Director of the Regulated PK & ADA Bioanalysis Group @ Merck Research Laboratories; 

The Evolving Role of Bioanalytical Scientist in Drug Development Beyond ICH-M10

 Richard Hughes, PhD

Scientific Director, Resolian

"Domain Specificity In the Tabs and Nabs Assay: Never too late for the characterization of ADA for multi-domain therapeutics"

Qiushi Liu, PhD

Scientist Drug Metabolism & Pharmacokinetics @ Takeda

Evaluation of Brain Region- and Cell Type-Derived Spatial Knockdown Efficacy of Oligonucleotides Using A Spatial Transcriptomics Platform

 Aihua Liu, PhD

Executive Director, Bioanalysis @ Resolian

"The Challenges and Solutions in Developing Ultra-sensitive LC-MS Bioanalytical Assay for Oligonucleotides"

 Nagendra Chemuturi, PhD

Senior Director, ADME @ Eli Lilly

The Role of DMPK in non-viral Gene Therapies

 Minu Pilvankar, PhD

Principal Scientist @ Boehringer Ingelheim

Preclinical To Clinical Translation of ADCs Using PK/PD Modeling

 Adam Amaral, 

Associate Director @ Intellia Therapeutics, Inc.

Empirical PK/PD Modeling of Novel In Vivo CRISPR/Cas9 Genome Editiong Therapies

 Maciej Zamek-Gliszczynski, PhD

Senior Fellow & Director @ GSK

Human ADME Characterization of Linerixibat Reveals Unusual PK Properties: Implication for Clinical Development

 Julia Schulz Pauly, PhD

PBPK Modeling @ AbbVie

Hepatocyte Uptake & Loss Assay (HUpLA): Prof-of-concept Of An All-in-one System for Same Day Measuring Hepatoic Influx, Egress, and Metabolic Clearance Based On the Extended Clearance Concept

 Joyce Liu, PhD

Principal Scientist @ Genentech

Impact of Missing Metabolites During Lead Optimization in Drug Discovery

Carrie Vyhlidal, PhD

Associated Director, CGT @ KCAS Bio

PCR-Based Assays for Bioanalysis: Challenges and Latest Recommendations

Stefanus J. Steyn, PhD

Research Fellow, PK/PD & Metabolism, Inflammation & Immunology PDM Lead @ Pfizer

Addressing Protac^TM ADME Challenges

Amanda Leskovar, PhD

Director, Project Management @ ICON Laboratory Services

Regulatory Inspections From a CRO Perspective - Balancing Guidance, SOP's and Sponsor Direction

 Stephen English, PhD

Director, 14C-Bioanalysis @ Pharmaron

Qualification of Low Energy Accelerator Mass Spectrometer and Opportunities To Increase Industry Utilization

 Syed Ali, PhD

Senior Scientist @ Moderna

A Comparison of bDNA and RT-qPCR Methodologies for Quantitation of LNP Encapsulated mRNA

 Tom Zhang, PhD

Chief Scientific Officer, Large Molecule Bioanalysis @ Worldwide Clinical Trials

Unlocking Bioanalytical Automation: Bridging Development and Practical Application

 Robert Proos, PhD

Senior Manager, Metabolomics and Lipidomics Applications @ Sciex

Build Resilience and Maintain Unparalleled Sensitivity for Long-Term Bioanalysis