Save the Date for Applied Pharmaceutical Analysis 2020!

October 12- 14, 2020 Main Conference

Short Courses - Sunday, October 11, 2020

Boston Park Plaza
50 Park Plaza at Arlington Street
Boston, MA 02116

Click to Download 2019 APA Program Guide


APA 2019 Plenary Speakers 

Paula Annunziato  

Paula Annunziato, MD, Vice President and Therapeutic Head, Vaccines Clinical Research, Merck

Vaccine Development - A Multi-Disciplinary Commitment to Protect Public Health

  Samir Hanash  

Samir M. Hanash, MD, PhD, Professor, Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center

Mining the Proteometabolome for Precision Medicine

Nina Isoherrenan  

Nina Isoherranen, PhD, Professor, Vice Chair, Pharmaceutics, Department of Pharmaceutics, University of Washington

Predicting in vivo Drug–Drug Interactions Involving Multiple Precipitants

  Irina Koroleva  

Irina Koroleva, PhD, Director, Translational Medicine, Rubius Therapeutics

Translational Medicine in the Era of Cellular Therapies: Challenges and Opportunities in Developing PK Bioanalytical Method(s)


APA 2019 Confirmed Speakers

AWS Patrick Combes  

Patrick Combes, Amazon Web Services Worldwide Technical Leader - Healthcare and Life Sciences

Biopharma-Industry Compliance in the Cloud



Phillip Sundman, Director PDM Bioinformatics and System Validation at Pfizer

Approaches and Considerations for Utilizing the Cloud for Cost Effective Instrument Data Storage

 04 zoom in Sanne Demandt  

Sanne Demandt, PhD, Group Leader, Charles River Laboratories, Leiden

Advances and Challenges for T Cell Therapies

  Prashant Desai  

Prashant Desai, PhD, Research Advisor and Group Leader, Computational ADME, Eli Lilly and Company

Realistic Application of Machine Learning ADME Models to Impact Drug Discovery

Foti Profile  

Rob Foti, PhD, Principal Scientist, Amgen

Navigating ADME Challenges with Non-Opioid Based Pain Therapeutics


Kaushik Mitra, Director, Molecular and Investigative Toxicology, Merck

An Integrated Strategy Utilizing Transcriptional Profiling to De-Risk Bioactivation-Mediated Drug-Induced Liver Injury

Jaya Goyal APA2019

Jaya Goyal, PhD, Vice President, Bioanalytical, Pharmacology and Biomarker Development, Wave Life Sciences, Ltd.

Combinatorial Approaches for Bioanalysis of Stereopure Oligonucleotides

   Klarissa Jackson APA2019    

Klarissa Jackson, PhD, Professor, University of North Carolina Chapel Hill Eshelman School of Pharmacy

Metabolic Activation of Tyrosine Kinase Inhibitors by Cytochromes P450: Impact of Interindividual Variation

Young Jeong  

Hyunyoung (Young) Jeong, PharmD, PhD, Professor, College of Pharmacy, University of Illinois at Chicago

Gut Microbiota Modulates Acetaminophen-Induced Hepatic Injury

  Liang Jin APA2019  

Liang Jin, PhD, Senior Scientist, DMPK, AbbVie Bioresearch Center

Improve Target Discovery from Label-Free Proteomic Data by Machine Learning Algorithms

Colleen Kelly  

Colleen Kelly, MD, FACG, Associate Professor of Medicine, Warren Alpert Medical School of Brown University

Update on Fecal Microbiota Transplantation: Indications, Methodologies, Mechanisms and Future Perspective

   Dan Kim    

Dan Kim, M.S., Senior Scientist, DMPK, AbbVie

Development and Application of LC/MS BA Platform for Biologics

Priyanka Kulkarni APA2019  

Priyanka Kulkarni, PhD, Scientist, Pharmacokinetics and Drug Metabolism, Amgen

Modeling and Simulation to Study the Impact of Transporter-Enzyme Interplay on Drug-Drug Interactions


Mike Lee, PhD, Founder and President, Milestone Development Services

Failure is an Option if You Keep Trying...

Mark Milton  

Mark Milton, PhD, Executive Director, PK Sciences - Global Head Opthamology TA, Novartis Institutes for Biomedical Research

The Development of Viral Vector-Based Gene Therapies: It's Not What You Do But the Way That You Do It.

  Russell Mortshire    

Russell Mortishire-Smith, PhD, Senior Consulting Scientist, Applied Informatics, Scientific Operations, Waters Corporation

Approaches to Real Time Prediction of Collision Cross Section Values

Heather Myler APA2019  

Heather Myler, PhD, Director, Bioanalytical Laboratories, PPD

ADA Validation Testing and Reporting Global Harmonization

   lisa ocallaghan    

Lisa O'Callaghan, PhD, Associate Principal Scientist, PPDM, Merck

Method Improvements for Discovery Monoclonal Antibody Pharmacokinetics

Mireia Fernandez Ocana  

Mireia Fernandez Ocana, PhD, Biomarker Discovery Lead, Pfizer

Immunoaffinity LC-MS/MS Technologies for Translational Safety Biomarker Development

   Leila Pirhaji APA2019  

Leila Pirhaji, PhD, Founder and CEO, ReviveMed

Translating Metabolomics into Therapeutics Insights using Artificial Intelligence

Terry Podoll head shot page 001  

Terry Podoll, PhD, Principal Consultant, IV/PO LLC

Acalabrutinib Bioavailability, Biotransformation, and Excretion using a Microtracer and Tang, the Human ADME Formulation Every Mother Trusts

   Brooke Rock APA2019  


Brooke Rock, PhD, Principal Scientist, Pharmacokinetics and Drug Metabolism, Amgen

Transforming Traditional SM ADME Assays to Support the Translation of siRNA Pharmacology from the Benchtop to the Clinic


Magdalena Tary-Lehmann, MD, PhD, Co-Founding Scientist and CSO, Cellular Technology Limited

Immunogenicity Assessment in Support of Gene Therapy Program-Use of ELISPOT Technology

   Yu Tian  


Yu Tian, PhD, Director, Non-Regulated Bioanalysis Department, AbbVie Bioresearch Center

An Integrative Proteogenomics Pipeline Identifying Differentially Expressed Splicing Variants from IDB Patients

 Esther APA2019  

Esther van Duijn, PhD, Scientist, TNO (Netherlands Organisation for Applied Scientific Research)

Impact of AMS on Clinical Development: the Availability of Early Human ADME Data


Sheri Wilcox, PhD, Senior Director, Analytical and Discovery Sciences, SomaLogic Inc.

The SOMAscan® Assay and Pharmaceutical Development

Jingjing APA2019  

Jingjing Yu, MD, PhD, Associate Director, University of Washington Drug Interaction Database Program

Mechanistic Analysis of Pharmacokinetic-Based Drug-Drug Interactions with Recently Marketed Drugs: from in vitro to Clinical Relevance

   Li Yu APA2019    

Li Yu, PhD, Pharmaceutical Sciences Site Head NY and DMPK/PD Leader, Roche 

Identification and Characterization of Metabolites from the Human ADME Study on Alectinib - Overcoming the Low Sensitivity of the Conventional LC-LSC Method for Plasma

Sue Zhu  

Sue Zhu, PhD, Investigator II, PK Sciences, Novartis Institutes for Biomedical Research

Biopharmaceutics and Clinical Pharmacology Considerations for Tisagenlecleucel Development-The First FDA Approved CAR-T Cell Therapy


James Schiller, Dierector of GLP Reg. BA group at Merck

Strategy for Implementation of 2018 FDA Bioanalytical Method Validation Guidance and Proactively Addressing the ICH M10 BMV Draft Guidline Internally and/or with Outsourcing Partners - Pharma Perspective


Jennifer Zimmer,PhD, Laboratory Dierector at Alturas Analytics

Strategy for Implementation of 2018 FDA Bioanalytical Method Validation Guidance and Proactively Addressing the ICH M10 BMV Draft Guideline Internally and/or with Outsourcing Partners - CRP Perspective


Huidong (Ryan) Gu, PhD Senior Research Scientists, Bristol-Myers Squibb

In-Sample Calibration Curve Using Multiple Isotopologue Reaction Monitoring of a SIL-Analyte for LC-MS/MS Bioanalysis 


Ajit Suri,PhD, Senior Scientific Director, Takeda Pharmaceuticals

ADC Developement and Global Regulatory Approval(s) - Adcetris Experience

Derek Lowe, Director Chemical Biology Therapeutics at Novartis Institutes for BioMedical Research

Fortune Favors the Prepared Mind 


Arjun Arumugam, M.D., Executive Director, Azidus Laboratories Limited

Mark Dysinger, Development Scientist, Bioanalytical Development, Alexion Pharmaceuticals

Judith Greengard, PhD, RAC, Senior Director, Assay Development and Bioanalysis, Adverum Biotechnologies, Inc.

Huidong Gu, Senior Research Scientist II, Bristol-Myers Squibb

Sam Haidar, Ph.D., Senior Advisor, OSIS/OTS/CDER, U.S. Food and Drug Administration

Amit Kalgutkar, Ph.D., Research Fellow, Pfizer

Seema Kumar, Ph.D., Associate Director, EMD Serono

Luna Liu , M.S., Principle Scientific Researcher, Genentech

Derek Lowe, Director in Chemical Biology & Therapeutics, NIBR

Jean-Claude Marshall, Ph.D., Head of Clinical Biomarker Technologies, Pfizer

Katie Matys, M.S., Associate Director, PPD

Kaushik Mitra, Ph.D., Director, Molecular and Investigative Toxicology, Merck

James Schiller, Director, Merck

Michael Skelly, Ph.D., Lead Pharmacologist, CDER/OTS/OSIS, U.S. Food and Drug Administration

Fan Wu, Senior Principal Scientist, Celgene Corporation

Yuching Yang, Ph.D., Clinical Pharmacometrics Reviewer, U.S. Food and Drug Administration


Sessions for APA 2019 Workshops 

Regulated Bioanalysis

FDA/Regulatory Session

Digital State of Regulated Bioanalysis

Bioanalytical Support of Novel Therapies and New Modalities in Clinical Development

Implementation of 2018 FDA BMV Guidance/ICH M10

Frontiers of Biomarker Bioanalysis

Discovery Bioanalysis and New Technologies

Novel modalities, guidance for new modalities

Cellular and Gene Therapies


Advanced LC-MS and Applications of HRMS

AI Session - Predict the Structure

Mechanistic ADME

Not Your Average Human ADME Study

Toxicity and Drug Metabolism: Advances in the Mechanistic Understanding that Inform Risk Management

Improved Clinical Outcomes Through Modeling

Insights and Development Challenges of New Modalities

From Accidents to Innovation: Serendipity in Drug Discovery


Expanding Horizons - Beyond Mechanistic ADME and Bioanalysis Workshop (NASH/Fibrosis/Microbiome)


APA 2018 Conference Program


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Click here to register for the APA 2020 conference online.

APA 2020 will take place October 11-14th, 2020 at:

Boston Park Plaza Hotel

Boston, MA


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