Applied Pharmaceutical Analysis 2021 

 October 12-14, 2021 - Virtual Event

Regulated Bioanalysis Workshop - Tuesday, October 12, 2021

Discovery Bioanalysis and New Technologies Workshop - Wednesday, October 13, 2021

Mechanistic ADME Workshop - Thursday, October 14, 2021



APA 2020 Plenary Speakers

Richard Yost APA2020   

Professor Richard A. Yost, PhD

Colonel Allen R. and Margaret G. Crow Professor, Department of Chemistry, University of Florida

The Triple Quadrupole: Innovation, Serendipity and Persistence

Mark Rose APA2020  

Mark Rose, PhD

Director of Drug Metabolism and Pharmacokinetics, CHDI Foundation

The Role of Non-Profits in Drug Discovery and Development

rigoberto hernandez  

Professor Rigoberto Hernandez, PhD

Gompf Family Professor of Chemistry, Department of Chemistry, Johns Hopkins University

Value of Diversity, Inclusion and Equity in the Sciences

Jack Uetrecht APA2020  

Professor Jack Uetrecht, MD, PhD

Professor of Pharmacy and Medicine, Canada Research Chair in Adverse Drug Reactions, University of Toronto

Predicting the Unpredictable: How the Innate Immune Response to Drugs Predicts Risk

APA 2020 Invited Speakers

Jim Gllick APA2020

Jim Glick, PhD, Section Head, Translational and Investigational Labs, PK Sciences, Novartis

Immunogenecity Data and the Regulatory Landscape: Bioanalytical Lessons Learned from a Recent Biological Licensing Application Approval


Susovan Mahopatra, PhD, Associated Director, Wave Life Sciences

Bioanalytical Strategies, Considerations, and Solutions for Development of Stereopure Oligonucleotide Therapeutics

Chongwoo Yu 

Chongwoo Yu, PhD, Master Clinical Pharmacology Reviewer, DCEP, Office of Clinical Pharmacology, OTS/CDER/OMPT/FDA

"Importance of Bioanalysis in Drug Development"

  Sean Kim APA2020

Sean Kim, PhD, Head, DMPK and Clinical Pharmacology, Blueprint Medicines

"ADME and Clinical Pharmacology of AYVAKIT™"

Timothy Mack APA2020

Timothy Mack, PhD, Senior Principal Scientist, Celgene

Title TBA

  Min Meng Denali 

Min Meng, Deputy CEO at Chongqing Denali Medpharma, Co. Ltd

Establishing a Western Styled Bioanalytical Lab in China: Lesson Learned and Future Perspective

 Barry Jones photo

Barry Jones, PhD, Director, Q2 Solutions

High Resolution Mass Spectrometry and Nano-Flow Liquid Chromatography for Critical Reagent-Free Quantitation of Intact Peptides


Pieter Dorrenstein 

Pieter Dorrenstein, PhD, Director, Collaborative Mass Spectrometry Innovation Center, Co-Director Institute for Metabolomics Medicine Skaggs School of Pharmacy & Pharmaceutical Sciences, Univ. of California

Metabolomics Repository Scale Analysis Tools to Learn Microbial Metabolite-Disease Associations


Bonnie Rup, PhD, Biopharmaceutical Development Expert; Bioanalysis, Immunogenicity, Regulatory, Bonnie Rup Consulting LLC

Immunogenicity Risk Assessment to Inform Early Project Decision Making

  Jim Shen APA 2020

Jim Shen, PhD, Director, Bioanalytical Science, Technical Outsourcing Management Lead, Bristol-Myers Squibb

How to Work with Chinese CRO's to Support NMPA Submission of BMS Assets

Sekhar Surapaneni 

Sekhar Surapaneni, PhD, Vice President, Nonclinical Disposition Assessment, Bristol-Myers Squibb

Challenges with Ozanimod Approval

   Xiaodong Fang

Xiaodong Fang, PhD, Associate Director, Takeda DMPK

"ddPCR and RT-ddPCR Method Validation for Cell and Gene Therapy Support"


 Kevin Johnson

Kevin Johnson, PhD, Scientist, Genentech

Distinct Species Differences for Aldehyde Oxidase Metabolism and Observed Kinetic Isotope Effects in In Vitro and In Vivo

  Tu Yian APA2020 

Yu Tian, PhD, Director, Drug Metabolism and Pharmacokinetics, AbbVie

Microbiome Mediated Pro-Drug Metabolism and Application in Gut- Restricted Drug Design

unadkat jashvanat APA

Jashvant (Jash) D. Unadkat, PhD, Milo Gibaldi Endowed Professor, Department of Pharmaceutics, School of Pharmacy, University of Washington

Complex DDI and Transporter/Metabolism Interplay: Insights from Extended CL Model


Dr. Tee Zhang cropped


Tianyi Zhang, PhD, Executive Vice President of Frontage Laboratories Inc., and General Manager of Frontage China

Bioanalytical Method Transfer to Support NMPA and Global Studies Fillings


Huiyu Zhou, PhD, Head of LC/MS Group, BioMarin Pharmaceuticals

Overcoming ADA Interference by Using a Hybrid LC/MS/MS Method to Qualify a Therapeutic Protein in Human Plasma


Joleen T. White, PhD, Bioassay Development Lead at Bill and Melinda Gates Medical Research Institute

Practicing Immunogenicity Risk Assessment on Published PEGylated and Multi-specific Biotherapeutics

Zhang Guodong

Guodong Zhang, PhD, Group Head & Associate Director at Alnylam Pharmaceuticals

Bioanalytical Strategies for RNAi Therapeutic Development

  Aaroin Teitelbaum 

Aaron M. Teitelbaum, PhD, Principal Scientist, Drug Metabolism and Pharmacokinetics Department, Boehringer Ingelheim Pharmaceuticals

Flipping the Metabolic Switch from CYP3A4 to CYP1A1 in Smokers: Correlation between In Vitro and Clinical Data

Ming Chen

Ming Chen, PhD Student @ School of Public Health, Yale University

"Applications of NGS in Cancer Screening and Early Detection Using ctDNA"

   Robert Strum APA2020

 Robert Strum, PhD, Principal Scientist PK, PD, Metabolism (PDM), Zoetis

"The Utility of HRMS in Quantitative Bioanalysis Labs"

Hiroshi Sugimoto APA 2020 

Hiroshi Sugimoto, PhD, Senior Scientist and Group Leader in Global DMPK, Takeda

"Insights on Digital Droplet PCR Based Cellular Kinetics and Biodistribution Assay Support for CAR-T Therapy"


  Carmin Szynal APA2020 

Carmin Szynal, PhD, Scientist Global DMPK Group, AbbVie 

"Analysis of Cleaved Protein from Conditional Intact Molecule Using JESS Technology"

Frank Scheffler

Frank Scheffler, PhD, Head of Business Development and Global Collaboration, Hypha Discovery Limited

How to Secure Access to Difficult-to-Synthesize Metabolites for MIST Compliance: A One-Step Multiple Tool Approach


 Yen Ho, PhD, Cell Therapy Safety Group at BMS

Use of Cell Based Off Target Screening in CART Programs

 Josh Elias

Joshua Elias, PhD, Mass Spectrometry Leader at the CHAN ZUCKERBERG BIOHUB

Mapping Host-Microbe Interactions with Mass Spectrometry

  ChadChristianson headshot 

Chad Christianson, PhD, Senior Principal Scientist, Alturas Analytics, Inc.

Ready, Willing and Stable? Advice from the LC/MS Experts on Analysis of Unstable Compounds and Drugs

David Schumacher 

 David Schumacher, Quality Assurance Director @Alturas Analytics

Virtual Realities: Hosting Remote Audits (including the FDA) in a Post-COVID World

  Ismael zamora 

 Vendor Presentation: Latest Advances in LCMS and Recommendations for 2021

Ismael Zamora, PhD, CEO @ Lead Molecular Design and Associate Professor @ Pompeu Fabra University, Barcelona


Sessions for APA 2020 Workshops 

Regulated Bioanalysis

Regulatory Bioanalysis

When Bioanalytical Data were Critical to a Drug Product Submission or Approval

Regulatory/Immunogenicity Risk Assessments and Integrated Summary of Immunogenicity

Cell and Gene Therapy Bioanalysis in Regulated Environment

Chinese Bioanalytical Space/Regulatory Environment

Discovery Bioanalysis and New Technologies

New Technology and Platforms for Discovery Bioanalysis


Gene and Cell Therapy


Mechanistic ADME

Current and Emerging Topics in Transporter and CYP Mediated Drug-Drug Interactions

Unusual Approaches to ADME Studies

Metabolism and Toxicology - Predictive Approaches

ADME Challenges in Drug Approval - Case Studies

Combined Workshop

New Analytical Techniques - Biomarkers, Liquid Biopsy, Imaging

Exosomes (EV) and Biomarkers



Click to Download 2019 APA Program Guide

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Regulated Bioanalysis


Mechanistic ADME


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APA 2020 will take place on-line, October 11-16th, 2020


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