2023 Agenda - Download Program Here
| September 26, 2023 | Regulated Bioanalysis Workshop | |
| September 27, 2023 | Discovery Bioanalysis and New Technologies Workshop | |
| September 28, 2023 | Mechanistic ADME Workshop |
Regulated Bioanalysis Workshop - Tuesday, September 26, 2023
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Title |
Speaker |
Company |
Time |
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Registration, Breakfast, Exhibits |
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7:30 - 8:30 |
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Workshop Introduction. |
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8:30 - 8:40 |
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Session I: Assessing the Current Landscape of FDA Regulations |
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Session Introduction: Lori Payne, Alturas Analytics & James Schiller, Merck |
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8:40 - 8:45 |
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Drug-Drug Interaction Assessment for Therapeutic Proteins |
Qin Sun |
FDA |
8:45 - 9:15 |
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Plenary Talk - Merck's Strategy Around Decentralized Trials, Bioanalytical Sampling and Logistics |
Melanie Anderson |
Merck |
9:15 - 9:55 |
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Session II: Advances in Sampling Strategies: A Dialogue with Joleen White and Lori Payne |
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Patient Centric Sampling in Therapeutic Development Programs |
Joleen White |
Bill and Melinda Gates Medical Research Institute |
9:55 - 10:25 |
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Space - the Final Microsampling Frontier |
Lori Payne |
Alturas |
10:25 - 10:40 |
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Sponsor Presentation:Targeted High-Resolution Mass Spectrometry: Sensitive & Precise Therapeutic Protein Target Quantification in Any Tissue |
Matt Westfall |
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10:40 - 10:55 |
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AM Break & Exhibits |
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10:55 - 11:15 |
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Session III: Emerging Modalities and New Technologies |
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Session Introduction: Darshana Jani, Moderna & Joe Tweed, Bicycle Therapeutics |
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11:15 - 11:20 |
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Evaluating a Hybrid LC-MS/MS Approach for the Quantification of siRNA Analytes |
Karan Agrawal |
Janssen Research and Development |
11:20 - 11:45 |
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Translating Preclinical Findings Into Clinical Biomarker Assays To Support The Phase I/II Study of BT7480, A Bicycle Tumor-Targeted Immune Cell AgonistTM |
Heather Cohen |
Bicycle Therapeutics |
11:45 - 12:10 |
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RT-qPCR Method Development and Validation for mRNA Analysis |
Suresh Paddigari |
Moderna |
12:10 - 12:35 |
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Lunch, Exhibits, and Poster Viewing |
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12:35 - 1:55 |
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Sponsor Showcase |
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1:555 - 2:15 |
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Session IV: Immunogenicity Applications for Various Drug Modalities |
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Session Introduction: Ang Liu, Daiichi & Fumin Li, Biollege Bioanalytical Consulting |
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2:15 - 2:20 |
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Qualification for SARS-CoV-2 Neutralization Assay |
Min Zhao |
Moderna |
2:20 - 2:45 |
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Chasing the Matrix Interference in a Bispecific ADA Assay - Divergent Target Interference Based on a Patient Geography |
Arkadeep Sinha |
Upstream Bio |
2:45 - 3:10 |
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MAPPs Assay and Key Applications at Novartis |
Anette Karle |
Novartis (Switzerland) |
3:10 - 3:35 |
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PM Break & Exhibits |
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3:35 - 3:55 |
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Session V: Rapid Fire Poster Presentations |
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Session Introduction |
Joseph Tweed |
Bicycle Therapeutics |
3:55 - 4:00 |
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Poster Presenters - Bahar Rizi, Sciex; Nevena Mollova, Gilead; Papa Makhtar Drame, Keros Therapeutics; Stephanie Pasas-Farmer, BioData Solutions; Matthew Solomon, Merck; Rama Voggu, Lapcorp |
4:00 - 4:45 |
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Reception, Exhibits, and Poster Viewing |
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4:45 - 6:15 |
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Discovery Bioanalysis and New Technologies Workshop - Wednesday, September 27, 2023
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Title |
Speaker |
Company |
Time |
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Registration, Breakfast, Exhibits |
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7:30 - 8:30 |
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Workshop Introduction |
Christopher Kochansky |
Exelixis |
8:30 - 8:40 |
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Session I: Leveraging Biomarkers & Integrating Multi-Omics for Biomarker Discovery |
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Session Introduction: Jonnathan Josephs, Genentech & Zack Parsons, BMS |
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8:40 - 8:45 |
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Plenary Talk - Quantitative Mass Spectrometry-based Multi-omics for Drug Development and Precision Medicine |
Bhagwat Prasad |
Washington State University |
8:45 - 9:25 |
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Multi-Omics Analysis of Colon Mucosa and Wall from Crohn's Disease Patients |
Liang Jin |
AbbVie |
9:25 - 9:55 |
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Mass Spectrometry CSF Proteomics and Single-cell Sequencing to Identify Novel Biomarkers in Multiple Sclerosis |
Akshaya Ramesh |
Genentech |
9:55 - 10:25 |
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AM Break & Exhibits |
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10:25 - 10:55 |
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Session II: Applications of Precision Medicine in Drug Discovery Research |
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Session Introduction: Hiroshi Sugimoto, Takeda & Yu Tian, AbbVie |
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10:55 - 11:00 |
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Development of a Targeted, LC-MS Assay to Investigate Collagen Crosslinking Dynamics in IPF Pathogenesis |
Sarah Lloyd |
AbbVie |
11:00 - 11:30 |
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NanoString-based High Throughput microRNA Biomarker Assay Development |
Saran Ayyadurai |
Takeda |
11:30 - 12:00 |
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ddPCR Technology in Muscular Dystrophy Research to Quantify Human Skipped/Non-Skipped Transcripts |
Brijesh Garg |
PepGen |
12:00 - 12:30 |
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Sponsor Presentation: Sensitive Quantitation of Antisense Oligonucleotides in Human Plasma Using Triple Quadrupole & HR Orbitrap Based MS Methods |
Hao Yang |
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12:30 - 12:40 |
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Lunch, Exhibits, and Poster Viewing |
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12:40 - 2:10 |
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Rapid Fire Poster Presentations - Anahita Keyhani, Altasciences & Robert Plumb, Waters |
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2:10 - 2:20 |
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Session III: Advancing DMPK/Bioanalysis of PROTAC's |
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Session Introduction: John Williams, Vertex & Jeongsup Shim, Genentech |
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2:20 - 2:25 |
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Investigating Permeability for Heterobifunctional Protein Degraders |
Joe Cannon |
BMS |
2:25 - 2:55 |
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Bioanalytical Strategies for Characterization and PK Assessment of Multi-specific Antibodies |
Yuting Wang |
AbbVie |
2:55 - 2:25 |
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PM Break & Exhibits |
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3:25 - 3:55 |
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Pharmacokinetic and Pharmacodynamic Modeling of STAT3 Degraders |
Mike Weis |
Kymera Therapeutics |
3:55 - 4:25 |
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Session IV: Vendor Session - Latest Advances in LC-MS |
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Session Introduction: Hongying Gao, Innovo Bioanalysis LLC & Christopher Kochansky, Exelixis & Jonathan Josephs, Genentech |
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4:25 - 4:30 |
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Participants: Matthew Stone, SCIEX; Jerry Pappas, ThermoFisher Scientific & Ismael Zamora, Molecular Discovery |
4:30 - 5:00 |
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Closing Remarks |
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5:00 - 5:05 |
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Mechanistic ADME Workshop - Thursday, September 28, 2023
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Title |
Speaker |
Company |
Time |
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Registration, Breakfast, Exhibits |
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7:30 - 8:30 |
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Workshop Introduction |
Benjamin Johnson |
BMS |
8:30 - 8:40 |
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Session I: ADME of Select Modalities |
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Session Introduction: Nagendra Chemuturi, Eli Lilly & Cindy Xia, Renegade Therapeutics |
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8:40 - 8:45 |
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Developing Efficacious Preclinical PK/PD Strategies for Bifunctional Targeted Protein Degrader (TPD) Towards Non-Small Cell Lung Cancer (NSCLC) |
Steven Louie |
Moderna Therapeutics |
8:45 - 9:10 |
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ADME Properties of SOTORASIB, a Covalent Drug for Treatment of KRAS G12C Addicted Tumors |
Upendra Dahal |
Amgen |
9:10 - 9:35 |
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ADME and DDI Consideration of a Novel LNP Lipid Excipient |
Lei Ci |
Moderna |
9:35 - 10:00 |
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AM Break & Exhibits |
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10:00 - 10:25 |
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Sponsor Showcase and Rapid Fire Poster Presentations |
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10:25 - 10:45 |
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Session II: Unexpected ADMET Profiles in the Clinic and Investigations into Root Causes |
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Session Introduction: Benjamin Johnson, BMS & Greg Walker, Pfizer |
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10:45 - 10:50 |
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Characterization of Divergent Metabolic Pathways in Elucidating an Unexpected, Slow-Forming, and Long Half-Life Major Metabolite of Iclepertin |
Tom Chan |
Boehringer Ingelheim |
10:50 - 11:15 |
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Leveraging ADMET Data to Select Best in Class LPA1 Antagonist |
Ramola Sane |
BMS |
11:15 - 11:40 |
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Complex Metabolism of the Novel Neurosteroid, Ganaxolone, in Humans. A Unique Challenge for MIST Assessment |
William Fitch |
Stanford |
11:40 - 12:05 |
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Lunch, Exhibits, and Poster Viewing |
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12:05 - 1:20 |
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Session III: Applying Cutting-edge ADME Technologies |
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Session Introduction: Donglu Zhang, Genentech & David Stresser, AbbVie |
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2:05 - 2:10 |
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Plenary Talk - The Dynamic Free Fraction: Concept, Methodology, and Use in Clearance Predictions |
Zhengyin Yan |
Genentech |
1:25 - 2:05 |
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Speaker Introduction |
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2:05 - 2:10 |
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Revealing the Absorption Intricacies of bRo5s and PROTACs Through a Fresh Perspective on Assays and Novel Physiochemical Trends |
Edward Price |
AbbVie |
2:10 - 2:35 |
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A Novel All Human Hepatic Cell-Based Tri-Culture System for Preclinical Drug Development |
Jessica Weaver & Edward LeCluyse (Q&A) |
LifeNet Health |
2:35 - 3:00 |
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Mathematical Models to Characterize the Absorption, Distribution, Metabolism, and Excretion of Protein Therapeutics |
Dhaval K. Shah |
SUNY Buffalo |
3:00 - 3:25 |
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PM Break & Exhibits |
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3:25 - 3:45 |
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Session IV: Exploring Unconventional Biotransformation Pathways |
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Session Introduction: James Driscoll, BMS & Eric Ballard, Takeda |
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3:45 - 3:50 |
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Unusual In Vivo Metabolism of Nifurtimox |
Dieter Lang |
Bayer AG |
3:50 - 4:15 |
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Oxidation-Reduction Equilibrium of Thiol-Containing Drugs and Metabolites |
Simone Schadt |
Roche |
4:15 - 4:40 |
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Conference Closing Remarks |
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4:40- 4:45 |
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