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Bioanalytics
Bioanalytics
Bioanalytics
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Sunday, Nov 3
9:00 am
Welcome and Overview
Location: 214 CD
Virginia Litwin, PhD – Caprion Biosciences Inc.
Sunday, Nov 3
9:00 am
Workshop: Best Practices for the Development and Fit-for-Purpose Validation of Biomarker Methods (ticketed event)
Location: 214 CD
Virginia Litwin, PhD – Caprion Biosciences Inc.; Joel Mathews, Ph.D. – Ionis Pharmaceuticals
Sunday, Nov 3
9:10 am
Biomarker Assays (Immunoassay) in Drug Development - Impact and Challenges
Location: 214 CD
Lakshmi Amaravadi, PhD – Shire
Sunday, Nov 3
9:35 am
Biomarker Method (Immunoassay) Optimization, Quality Control
Location: 214 CD
john allinson, FIBMS – Immunologix Laboratories
Sunday, Nov 3
10:00 am
Biomarker Method (Flow Cytometry) Development/Optimization
Location: 214 CD
Kelly Lundsten – Biolegend
Sunday, Nov 3
10:25 am
Fit-for-purpose validity of biomarker methods based on analytical and physiological variability
Location: 214 CD
Viswanath Devanarayan, PhD, FAAPS – GlaxoSmithKline
Sunday, Nov 3
11:00 am
Tiered Validation Approach as Described in CLSI H62 Guideline for the Validation of Assays Performed by Flow Cytometry
Location: 214 CD
Steven Eck, Ph.D. – AstraZeneca
Sunday, Nov 3
11:30 am
Validation Strategies for Protein Biomarker Assays
Location: 214 CD
Yow Ming C. Wang, Ph.D. – U.S. Food and Drug Administration
Sunday, Nov 3
1:15 pm
A Regulator’s Perspective on Validation Strategies in Flow Cytometry
Location: 214 CD
Heba Degheidy, MD, Ph.D – U.S. Food and Drug Administration
Sunday, Nov 3
2:30 pm
Breakout Sessions
Location: 214 CD
Sunday, Nov 3
3:30 pm
Open Discussion & Closing Remarks
Location: 214 CD
Joel Mathews, Ph.D. – Ionis Pharmaceuticals
Sunday, Nov 3
9:00 am
Overview of the Cell and Gene Therapy Landscape and Bioanalytical Strategies
Location: 217 CD
Heather A. Myler, PhD – PPD
Sunday, Nov 3
9:00 am
Workshop: Best Practices and Bioanalytical Strategies for Cell and Gene Therapies (ticketed event)
Location: 217 CD
Heather A. Myler, PhD – PPD; Adrienne Clements-Egan, PhD – Janssen Biotherapeutics, Janssen R&D, LLC; Boris Gorovits, Ph.D. – Pfizer Inc.
Sunday, Nov 3
9:15 am
Orally Delivered ASO PK and Metabolite Profiling using both Hybridization ELISA and MS
Location: 217 CD
Anthony Kihm, Ph.D. – Janssen Research & Development LLC
Sunday, Nov 3
9:45 am
Strategy in Developing Quantitative Transgene and Expressed Enzyme Activity in the Absence of Reference Standards
Location: 217 CD
Mark H. Ma, Ph.D. – Alexion Pharma; Liching Cao – Sangamo Therapeutics
Sunday, Nov 3
11:00 am
qPCR Validation Criteria for the Assessment of Vector Copy Numbers and Viral Biodistribution and a Comparison of CAR-T PK qPCR with Flow Cytometry PK Results
Location: 217 CD
Adrienne Clements-Egan, PhD – Janssen Biotherapeutics, Janssen R&D, LLC
Sunday, Nov 3
11:30 am
Method Development Challenges for Cellular Kinetics
Location: 217 CD
Vellalore Kakkanaiah, Ph.D. – PPD Laboratories
Sunday, Nov 3
1:00 pm
Regulatory Perspectives
Location: 217 CD
Nirjal Bhattarai, Ph.D. – U.S. Food and Drug Administration
Sunday, Nov 3
1:30 pm
Overcoming Unique Challenges of Detecting Antibody Response to Transgene Expressed Proteins and Gene Editing Machinery
Location: 217 CD
Yanmei Lu, Ph.D. – Sangamo Therapeutics
Sunday, Nov 3
2:00 pm
ADA and Nab Bioanalytical Strategies for Viral Gene Therapy Delivery Vectors
Location: 217 CD
Boris Gorovits, Ph.D. – Pfizer Inc.
Sunday, Nov 3
2:45 pm
Bioanalytical Strategies for Cellular and Humoral Immunogenicity for CAR-T Cell Therapies
Location: 217 CD
Robert Dodge, PhD – Novartis
Sunday, Nov 3
3:15 pm
Panel Discussion
Location: 217 CD
Sunday, Nov 3
4:15 pm
Lessons Learned to Date and Where We Go from Here
Location: 217 CD
Jim McNally, PhD – CRISPR Therapeutics
Monday, Nov 4
8:30 am
Prologue: Innovative Bioanalytical Solutions and the Future of Bioanalysis
Location: 221 CD
Anahita Keyhani, Ph.D. – Altasciences; Olga Kavetska, Ph.D. – Pfizer Inc.
Monday, Nov 4
8:30 am
Prologue: Introduction to Innovative Bioanalytical Solutions and Future of Bioanalysis for Biomolecules
Location: 221 AB
Binodh DeSilva, Ph.D. – Bristol-Myers Squibb; Kelli R. Phillips, PhD, MBA – PPD; Lauren Stevenson, PhD – Immunologix Laboratories
Monday, Nov 4
9:00 am
Advanced Bioanalysis to Evaluate How Immunogenicity Impacts Drug Pharmacokinetics
Location: 221 AB
Roland F. Staack, Dr – Roche Pharma Research and Early Development
Monday, Nov 4
9:00 am
Symposium: Innovative Bioanalytical Solutions and Future of Bioanalysis – Biomolecular
Location: 221 AB
Kelli R. Phillips, PhD, MBA – PPD; Lauren Stevenson, PhD – Immunologix Laboratories
Monday, Nov 4
9:30 am
CAR-T: Bioanalytical Challenges and Considerations to Support Pharmacokinetic Characterization
Location: 221 AB
Tong-Yuan Yang, PhD – Janssen Research & Development LLC
Monday, Nov 4
10:00 am
Multispecific Bioanalytical Assay Strategies for Pharmacokinetic Analysis
Location: 221 AB
Kelly S. Colletti, Ph.D., MBA – Charles River Laboratories
Monday, Nov 4
10:30 am
Multiplexed PK Assay in Support of Biologics Combination Clinical Studies
Location: 221 AB
Vibha Jawa, Ph.D. – Merck / Predictive and Clinical Immunogenicity / QP2, PPDM
Monday, Nov 4
9:00 am
Quantitative Intestinal Tissue Assay of a Triphosphate Active Drug Metabolite
Location: 221 CD
Jennifer Vance, Ph.D. – AIT Bioscience
Monday, Nov 4
9:00 am
Symposium: Innovative Bioanalytical Solutions and Future of Bioanalysis – Chemical
Location: 221 CD
Olga Kavetska, Ph.D. – Pfizer Inc.; Anahita Keyhani, Ph.D. – Altasciences
Monday, Nov 4
9:30 am
Bioanalytical and Logistical Considerations in Patient Centric Volumetric Absorptive Microsampling
Location: 221 CD
Huizhi Xie, MS – Merck & Co., Inc.
Monday, Nov 4
10:00 am
Optimized Microflow LC-MS/MS Methods for the Bioanalysis of Large Molecules
Location: 221 CD
Shane Needham, PhD – Alturas Analytics, Inc.
Monday, Nov 4
10:30 am
Mass Spectrometry and the Battle from Bench to Bedside
Location: 221 CD
Daniel T. Holmes, M.D. – Department of Pathology and Laboratory Medicine University of British Columbia
Monday, Nov 4
1:30 pm
Keynote: Shaping the Future of Bioanalysis: From Innovation to Implementation
Location: 221 CD
Kevin Bateman, PhD – Merck & Co., Inc.; Faye Vazvaei, M.S. – Merck & Co., Inc.
Monday, Nov 4
1:30 pm
Keynote: The Challenges of Conducting Infectious Disease Clinical Trials in Low Income Countries: The reality of bioassays that can work under a tree
Location: 221 AB
Russell Weiner, Ph.D. – Bill & Melinda Gates Medical Research Institute; Joleen T. White, Ph.D. – EMD Serono
Monday, Nov 4
3:00 pm
Early Bioanalytical and PK/PD support of Oligonucleotide Discovery ProgramsEarly Bioanalytical and PK/PD support of Oligonucleotide Discovery Programs
Location: 303
Xiao S. Hu, Ph.D. – Wave Life Sciences; Susovan Mohapatra, PhD – Wave Life Sciences
Monday, Nov 4
3:00 pm
Nucleic Acid-Based Therapeutics: Discovery, Development, & Delivery - Bioanalytics
Location: 303
Vibha Jawa, Ph.D. – Merck / Predictive and Clinical Immunogenicity / QP2, PPDM
Monday, Nov 4
3:30 pm
Bioanalytical Considerations in Support of a Gene Therapy Product from Discovery to Clinical - A Case Study
Location: 303
Mark H. Ma, Ph.D. – Alexion Pharma
Monday, Nov 4
4:00 pm
Pharmacokinetic and Immunogenicity Analysis of a siRNA Nanoparticle Drug Product
Location: 303
Uma Kavita, Ph.D. – Bristol-Myers Squibb
Monday, Nov 4
4:30 pm
An RT-qPCR Assay to Detect Gene Integration Post Gene Editing
Location: 303
Marina Falaleeva, Ph.D. – Sangamo Therapeutics
Tuesday, Nov 5
8:30 am
Prologue: Introduction to Advances in Precision/Personalized Medicine and Biomarkers – Biomolecular
Location: 221 AB
Joel Mathews, Ph.D. – Ionis Pharmaceuticals; Yan Ni, PhD – Regeneron; Ramakrishna (Rama) Boyanapalli, Ph.D. – Wave Life Sciences
Tuesday, Nov 5
8:30 am
Prologue: Overview of Precision Medicine and Biomarkers to Better Understand Patients, Disease, and Clinical Outcome – Chemical
Location: 221 CD
Yuanxin Xu, Ph.D. – Alnylam Pharmaceuticals Inc.; Eric Fluhler, PhD – Bioanalytical Compliance Associates, LLC
Tuesday, Nov 5
9:00 am
Exosome-based Proteins: Emerging Biomarker Type from Liquid Biopsies
Location: 221 AB
Yan Zhang, Ph.D. – Bristol-Myers Squibb
Tuesday, Nov 5
9:00 am
Symposium: Advances in Precision/Personalized Medicine & Biomarkers – Biomolecular
Location: 221 AB
Jaya Goyal, Ph.D. – Wave Life Sciences; Yan Ni, PhD – Regeneron
Tuesday, Nov 5
9:30 am
Characterization of Human Plasma Extracellular RNA Biomarkers by RNA-seq
Location: 221 AB
Thomas Tuschl, PhD – The Rockefeller University
Tuesday, Nov 5
10:00 am
Translating New Technologies into Precision Medicine and Diagnostic Sphere for Huntington's Disease
Location: 221 AB
Ramakrishna (Rama) Boyanapalli, Ph.D. – Wave Life Sciences
Tuesday, Nov 5
10:30 am
Biomarker Assay Considerations from Exploratory Endpoint to Companion Diagnostic: How to Ensure Program Success
Location: 221 AB
Kristina McGuire, PhD – Regeneron
Tuesday, Nov 5
9:00 am
A Methylated Protein Biomarker Method to Assess Target Engagement: From Proteomic Screen to Clinical Support
Location: 221 CD
Tim Sikorski, Ph.D. – GlaxoSmithKline
Tuesday, Nov 5
9:00 am
Symposium: Advances in Precision/Personalized Medicine & Biomarkers – Chemical
Location: 221 CD
Yuanxin Xu, Ph.D. – Alnylam Pharmaceuticals Inc.; Eric Fluhler, PhD – Bioanalytical Compliance Associates, LLC
Tuesday, Nov 5
9:30 am
A Reagent-free Sensitive LC-MS/MS Assay to Quantify Myostatin as a Target Engagement and Pharmacodynamic Biomarker
Location: 221 CD
Jiang Wu, PhD – Takeda
Tuesday, Nov 5
10:00 am
Novel In-Sample Calibration Curves for Liquid Chromatography-Tandem Mass Spectrometry Bioanalysis
Location: 221 CD
Huidong Gu, M.S. – Bristol-Myers Squibb
Tuesday, Nov 5
10:30 am
Leveraging Real-World Data in Rare Diseases: Longitudinal Data Sets as “Virtual Natural History”
Location: 221 CD
Frederick J. Derosier, D.O. – Covance
Tuesday, Nov 5
9:00 am
Advancing Mass Spectrometric Techniques to Study the Disposition of Small Molecules in the Brain
Location: 304
Timothy J. Garrett, Ph.D. – University of Florida, Department of Pathology
Tuesday, Nov 5
9:00 am
The Journey to Developing Tissue and Organ Specific Therapies - Bioanalytics
Location: 304
Steve Lowes, Ph.D. – Q Squared Solutions
Tuesday, Nov 5
9:30 am
Bioanalysis of Small Molecule Drugs and Biotherapeutics in Tissues: Scientific Drivers, Technologies and Challenges
Location: 304
Luca Ferrari, ChemD – F. Hoffmann - La Roche
Tuesday, Nov 5
10:00 am
The Bioanalytical Challenges of Determining Released and Encapsulated-Drug Exposures from Tumor-Targeting, Polymeric Nanoparticles
Location: 304
Christopher L. Holliman, PhD – Pfizer Inc.
Tuesday, Nov 5
10:30 am
RNAi Therapeutic Development on Liver Specific Targeting
Location: 304
Ju Liu, PhD – Alnylam Pharmaceuticals Inc.
Tuesday, Nov 5
1:30 pm
Keynote: Open Science in Medicine: From Ideology to Methodology
Location: 221 CD
Lara Mangravite, Ph.D. – Sage Bionetworks
Tuesday, Nov 5
1:30 pm
Keynote: Precision Medicine: Hype and Reality, from Biomarkers to Wearables
Location: 221 AB
John Wagner
Wednesday, Nov 6
8:30 am
Prologue: Historical and Current Perspective of the FDA Bioanalytical Method Validation Guidance – Chemical
Location: 221 CD
Patrick J. J. Faustino, PhD – U.S. Food and Drug Administration; Eric J. Woolf – Merck & Co., Inc.
Wednesday, Nov 6
8:30 am
Prologue: Introduction to Dialogue on Emerging Regulatory Guidelines and Experience – Biomolecular
Location: 221 AB
Susan Kirshner, Ph.D. – U.S. Food and Drug Administration; Lynn A. Kamen, Ph.D. – Genentech, Inc.
Wednesday, Nov 6
9:00 am
ADA Validation Testing and Reporting Harmonization Recommendations
Location: 221 AB
Joao Pedras-Vasconcelos, PhD – U.S. Food and Drug Administration
Wednesday, Nov 6
9:00 am
Symposium: Dialogue on Emerging Regulatory Guidelines and Experiences – Biomolecular
Location: 221 AB
Lynn A. Kamen, Ph.D. – Genentech, Inc.
Wednesday, Nov 6
9:30 am
Evolution of Nab Assays - Emerging Modalities
Location: 221 AB
Haoheng Yan, M.D., Ph.D. – U.S. Food and Drug Administration
Wednesday, Nov 6
10:00 am
Challenges and Insights to Assess Immunogenicity Risk of I-O Therapeutics
Location: 221 AB
Jochem Gokemeijer – Bristol-Myers Squibb
Wednesday, Nov 6
10:30 am
Current and Future States of Bioanalysis in Biosimilar Development
Location: 221 AB
Olanrewaju Okusanya, PharmD, MS, BCPS – US Food and Drug Administration
Wednesday, Nov 6
9:00 am
A Surveillance Perspective on Bioanalytical Method Validation
Location: 221 CD
Arindam Dasgupta, PhD – U.S. Food and Drug Administration
Wednesday, Nov 6
9:00 am
Symposium: Dialogue on Emerging Regulatory Guidelines and Experiences – Chemical
Location: 221 CD
Eric J. Woolf – Merck & Co., Inc.; Patrick J. J. Faustino, PhD – U.S. Food and Drug Administration
Wednesday, Nov 6
9:30 am
A Regulatory Science Perspective on Bioanalytical Method Validation: FDA Regulatory Research
Location: 221 CD
Diaa Shakleya, Ph.D. – U.S. Food and Drug Administration; Jinhui Zhang, Ph.D. – U.S. Food and Drug Administration
Wednesday, Nov 6
10:00 am
OGD Perspective on Bioanalytical Method Validation
Location: 221 CD
Suman Dandamudi, PhD – U.S. Food and Drug Administration
Wednesday, Nov 6
10:30 am
Panel: Science-based Perspectives for Advancing the Application of Bioanalytical Method Validation
Location: 221 CD
David N. Powers, Ph.D. – U.S. Food and Drug Administration; Nilufer Tampal, PhD – U.S. Food and Drug Administration
Wednesday, Nov 6
1:30 pm
Keynote: Regulatory Perspective on Biomarker Qualification and Impact on Drug Development
Location: Stars at Night B1
Chris Leptak – U.S. Food and Drug Administration
Wednesday, Nov 6
4:00 pm
Panel Discussion: Immunogenicity and Biomarker Regulatory Science Discussion Panel
Location: Stars at Night Ballroom B1
Susan Kirshner, Ph.D. – U.S. Food and Drug Administration; Joao Pedras-Vasconcelos, PhD – U.S. Food and Drug Administration; Haoheng Yan, M.D., Ph.D. – U.S. Food and Drug Administration; Chris Leptak – U.S. Food and Drug Administration; Nirjal Bhattarai, Ph.D. – U.S. Food and Drug Administration; Olanrewaju Okusanya, PharmD, MS, BCPS – US Food and Drug Administration
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