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
![]() |
Professor Richard A. Yost, PhDColonel Allen R. and Margaret G. Crow Professor, Department of Chemistry, University of FloridaThe Triple Quadrupole: Innovation, Serendipity and Persistence |
|
![]() |
Mark Rose, PhDDirector of Drug Metabolism and Pharmacokinetics, CHDI FoundationThe Role of Non-Profits in Drug Discovery and Development |
|
![]() |
Professor Rigoberto Hernandez, PhDGompf Family Professor of Chemistry, Department of Chemistry, Johns Hopkins UniversityValue of Diversity, Inclusion and Equity in the Sciences |
|
![]() |
Professor Jack Uetrecht, MD, PhDProfessor of Pharmacy and Medicine, Canada Research Chair in Adverse Drug Reactions, University of TorontoPredicting the Unpredictable: How the Innate Immune Response to Drugs Predicts Risk |
APA 2020 Invited Speakers
![]() |
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, PhD, Master Clinical Pharmacology Reviewer, DCEP, Office of Clinical Pharmacology, OTS/CDER/OMPT/FDA "Importance of Bioanalysis in Drug Development" |
![]() |
Sean Kim, PhD, Head, DMPK and Clinical Pharmacology, Blueprint Medicines "ADME and Clinical Pharmacology of AYVAKIT™" |
|
![]() |
Timothy Mack, PhD, Senior Principal Scientist, Celgene Title TBA |
![]() |
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, PhD, Director, Q2 Solutions High Resolution Mass Spectrometry and Nano-Flow Liquid Chromatography for Critical Reagent-Free Quantitation of Intact Peptides |
|
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, 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, PhD, Vice President, Nonclinical Disposition Assessment, Bristol-Myers Squibb Challenges with Ozanimod Approval |
![]() |
Xiaodong Fang, PhD, Associate Director, Takeda DMPK "ddPCR and RT-ddPCR Method Validation for Cell and Gene Therapy Support"
|
|
![]() |
Kevin Johnson, PhD, Scientist, Genentech Distinct Species Differences for Aldehyde Oxidase Metabolism and Observed Kinetic Isotope Effects in In Vitro and In Vivo |
![]() |
Yu Tian, PhD, Director, Drug Metabolism and Pharmacokinetics, AbbVie Microbiome Mediated Pro-Drug Metabolism and Application in Gut- Restricted Drug Design |
|
![]() |
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 |
|
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 |
||
![]() |
Guodong Zhang, PhD, Group Head & Associate Director at Alnylam Pharmaceuticals Bioanalytical Strategies for RNAi Therapeutic Development |
![]() |
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, PhD Student @ School of Public Health, Yale University "Applications of NGS in Cancer Screening and Early Detection Using ctDNA" |
![]() |
Robert Strum, PhD, Principal Scientist PK, PD, Metabolism (PDM), Zoetis "The Utility of HRMS in Quantitative Bioanalysis Labs" |
|
![]() |
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, PhD, Scientist Global DMPK Group, AbbVie "Analysis of Cleaved Protein from Conditional Intact Molecule Using JESS Technology" |
|
|
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 |
|
![]() |
Joshua Elias, PhD, Mass Spectrometry Leader at the CHAN ZUCKERBERG BIOHUB Mapping Host-Microbe Interactions with Mass Spectrometry |
![]() |
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, Quality Assurance Director @Alturas Analytics Virtual Realities: Hosting Remote Audits (including the FDA) in a Post-COVID World |
![]() |
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
Microbiome/Microbiota
Gene and Cell Therapy
HRMS/HRMS Quan
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