Save the Date for Applied Pharmaceutical Analysis 2019!

September 9-11, 2019

Revere Hotel Boston Common 
200 Stuart Street 
Boston, MA 02116

APA 2019 Plenary Speakers 

		Paula Annunziato, MD, Vice President and Therapeutic Head, Vaccines Clinical Research, Merck Vaccine Development - A Multi-Disciplinary Commitment to Protect Public Health				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 Isoherranen, PhD, Professor, Vice Chair, Pharmaceutics, Department of Pharmaceutics, University of Washington Predicting in vivo Drug–Drug Interactions Involving Multiple Precipitants				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

		Patrick Combes, Amazon Web Services Worldwide Technical Leader - Healthcare and Life Sciences Biopharma-Industry Compliance in the Cloud				Scott Davis, Associate Director, Information Technology, PPD Bioanalytical and Vaccine Laboratory Data Storage in the Cloud
		Sanne Demandt, PhD, Group Leader, Charles River Laboratories, Leiden Advances and Challenges for T Cell Therapies				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
		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, PhD, Vice President, Bioanalytical, Pharmacology and Biomarker Development, Wave Life Sciences, Ltd. Combinatorial Approaches for Bioanalysis of Stereopure Oligonucleotides				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
		Hyunyoung (Young) Jeong, PharmD, PhD, Professor, College of Pharmacy, University of Illinois at Chicago Gut Microbiota Modulates Acetaminophen-Induced Hepatic Injury				Liang Jin, PhD, Senior Scientist, DMPK, AbbVie Bioresearch Center Improve Target Discovery from Label-Free Proteomic Data by Machine Learning Algorithms
		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, M.S., Senior Scientist, DMPK, AbbVie Development and Application of LC/MS BA Platform for Biologics
		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 Title TBA
		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 Mortishire-Smith, PhD, Senior Consulting Scientist, Applied Informatics, Scientific Operations, Waters Corporation Approaches to Real Time Prediction of Collision Cross Section Values
		Heather Myler, PhD, Director, Bioanalytical Laboratories, PPD ADA Validation Testing and Reporting Global Harmonization				Lisa O'Callaghan, PhD, Associate Principal Scientist, PPDM, Merck Method Improvements for Discovery Monoclonal Antibody Pharmacokinetics
		Mireia Fernandez Ocana, PhD, Biomarker Discovery Lead, Pfizer Immunoaffinity LC-MS/MS Technologies for Translational Safety Biomarker Development				Leila Pirhaji, PhD, Founder and CEO, ReviveMed Translating Metabolomics into Therapeutics Insights using Artificial Intelligence
		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, 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, PhD, Director, Non-Regulated Bioanalysis Department, AbbVie Bioresearch Center An Integrative Proteogenomics Pipeline Identifying Differentially Expressed Splicing Variants from IDB Patients
		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 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, 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

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

Ajit Suri, Ph.D., Senior Scientific Director, Quantitative Clinical Pharmacology, Takeda Pharmaceuticals

Fan Wu, Senior Principal Scientist, Celgene Corporation

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

Xu (Sue) Zhu, Ph.D., Senior Scientist, Novartis Institutes for Biomedical Research

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

Omics

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