| October 7, 2024 | Regulated Bioanalysis Workshop | |
| October 8, 2024 | Discovery Bioanalysis and New Technologies Workshop | |
| October 9, 2024 | Mechanistic ADME Workshop |
Regulated Bioanalysis Workshop - Monday, October 7, 2024
|
Title |
Speaker |
Company |
Time |
|
Registration, Breakfast, Exhibits |
|
7:30 - 8:30 |
|
|
Workshop Introduction. |
Joseph Tweed |
Bicycle Therapeutics |
8:30 - 8:40 |
|
Session I: Regulatory and Industry Perspectives on M10 Implementation |
|||
|
Session Introduction: Nevena Mollova, Gilead; James Schiller, Merck & Joseph Tweed, Bicycle Therapeutics |
|
|
8:40 - 8:45 |
|
Recent Data Integrity Findings in Bioresearch Monitoring |
Yi-Ying Chen |
FDA |
8:45 - 9:05 |
|
Regulatory Inspections From a CRO Perspective - Ballancing guidance, SOP's and sponsor direction |
Amanda Leskovar |
Icon |
9:05 - 9:25 |
|
The Evolving Role of Bioanalytical Scientist in Drug Development Beyond ICH-M10 |
Faye Vazvaei |
Merck |
9:25 - 9:45 |
|
Plenary Talk - Lessons Learned from Regulatory Submissions Involving Endogenous Therapeutic Analyte: Do You See What I See? |
Chongwoo Yu |
FDA |
9:45 - 10:15 |
| Panel Discussion: All speakers session I | |||
|
AM Break & Exhibits |
|
|
10:35 - 10:55 |
|
Sponsor Presentation: PCR-Based Assays for Bioanalysis: Challenges and Latest Recommendations |
Carrie Vyhlidal |
|
10:50 - 11:10 |
|
Session II: Advances in Sampling Strategies and Drug Delivery Innovations |
|||
|
Session Introduction: Lori Payne, Alturas Analytics & Jeongsup Shim, Genentech |
|
|
11:10 - 11:15 |
|
Implementation of Low Volume Sampling Technologies for PK and Biomarker Analysis: Technical and Logistical Challenges and Solutions |
Xiaoyun Yang |
Genentech |
11:15 - 11:40 |
|
Accelerator Mass Spectrometry (AMS) Applications for Supporting Clinical Development |
Xiaomin Wang |
BMS |
11:40 - 12:05 |
|
Qualification of Low Energy Accelerator Mass Spectrometer and Opportunities To Increase Industry Utilization |
Stephen English |
Pharmaron |
12:05 - 12:30 |
|
Lunch, Exhibits, and Poster Viewing (1:10 pm - 1:40 pm) |
|
12:30 - 1:40 |
|
|
Vendor Presentation: Unlocking Bioanalytical Automation: Bridging Development and Practical Application |
Tom Zhang |
|
1:40 - 1:55 |
|
Session III: Advances in Drug Modalities and Emerging Technologies for Characterization |
|||
|
Session Introduction: Ang Liu, J&J; Fumin Li, Unitides Bioanalytical Lab & Darshna Jani, Moderna |
|
1:55 - 2:00 |
|
|
Plenary Talk - Application of AI in Drug Development |
Joe Rajaro |
Accenture |
2:00 - 2:40 |
|
A Novel Hybridization LC-MS/MS Methodology for Bioanalysis of siRNA |
Long Yuan |
Biogen |
2:40 - 3:05 |
|
Bioanalytical Method Case Studies Across the mRNA-LNP Therapeutic Portfolio |
Jason DelCarpini |
Moderna |
3:05 - 3:30 |
|
PM Break & Exhibits |
|
|
3:30 - 3:50 |
|
Development of Nonclinical Total Anti-Drug Antibody (ADA) Assays to Support The Reproductive Toxicology Studies for Zinpentraxin Alfa |
Audrey Arjomandi |
Genentech |
3:50 - 4:15 |
|
Navigating Challenges in the Development of Neutralizing Antibody Assays: Key Considerations and Strategies |
Nazneen Bano |
Merck |
4:15 - 4:40 |
|
Session IV: Innovation Junction: Bridging Science and Solutions in Pharma |
|||
|
Sponsor Showcase: Anthony Genovese, Alturas; Matthew Hutzler, Inotiv; Larry Elvebak, LabIntegrity |
|
|
4:40 - 4:55 |
|
Session V: Rapid Fire Poster Presentations |
|||
|
Session Introduction: Joseph Tweed, Bicycle Therapeutics |
|
4:55 - 5:00 |
|
|
Poster Presenters: 1. Simple and Sensitive Multiplexed HRMS/MS Method Development for Quantitation of PPMO and PMO in Cyno Plasma using Protein Precipitation - Abhi Shah, PepGen 2. Singlicate analysis in ligand binding assays from discovery to regulated clinical studies: Implementation strategies and benefits - Danielle Salha, AltaSciences 3. Antibody-drug conjugate bioanalysis: A case study in stability, matrix effects, and recovery - Paige Malec, Labcorp 4. Accurate and Precise Quantitation of the Pentadecapeptide BPC-157 from Human Blood Collected with the Tasso-M20 Microsampling Device and Analyzed by HPLC-MS/MS - Leslie Hvozda, Alturas Analytics |
|
|
5:00 - 5:20 |
Discovery Bioanalysis and New Technologies Workshop - Tuesday, October 8, 2024
|
Title |
Speaker |
Company |
Time |
|
Registration, Breakfast, Exhibits |
|
7:30 - 8:30 |
|
|
Workshop Introduction |
Hiroshi Sugimoto |
Takeda |
8:30 - 8:35 |
|
Session I: Emerging Analytical & Bioanalytical Platform Technology |
|||
|
Session Introduction: Hiroshi Sugimoto, Takeda & Zack Parsons, BMS |
|
|
8:35 - 8:40 |
|
Plenary Talk: Single-Cell Spatial Dissection Of The Pancreatic Tumor Microenvironment |
William Hwang |
Harvard |
8:40 - 9:20 |
|
Evaluation of Brain Region- and Cell Type-Derived Spatial Knockdown Efficacy of Oligonucleotides Using a Spatial Transcriptomics Platform |
Quishi Liu |
Takeda |
9:20 - 9:50 |
|
Bio-Digital Transformation of Proteomic Analysis |
Youhei Kosugi |
Takeda |
9:50 - 10:20 |
|
AM Break & Exhibits |
|
10:20 - 10:50 |
|
|
Basics of Machine Learning and Its Applications in Drug Discovery |
Reilly Eason |
Merck |
10:50 - 11:20 |
|
Session II: Novel Strategy to Advance Biotherapeutic Development |
|||
|
Session Introduction: Yu Tian, AbbVie & Ju Liu, Eli Lilly |
|
|
11:20 - 11:25 |
|
Measuring Endogenous and Transgene-Expressed Protein Levels in Gene Therapy Bioanalytical and Biomarker Studies - tentative title |
Milan Kothiya |
Eli Lilly |
11:25 - 11:55 |
|
Domain Specificity in the Tabs and Nabs Assay: Never too late for the characterization of ADA for multi-domain therapeutics |
Richard Hughes |
Resolian |
11:55 - 12:25 |
|
A Comparison of bDNA and RT-qPCR Methodologies for Quantitation of LNP Encapsulated mRNA |
Syed Ali |
Moderna |
12:25 - 12:55 |
|
Lunch, Exhibits, and Poster Viewing (1:40 pm - 2:10 pm) |
|
12:55 - 2:10 |
|
|
Sponsor Presentation: Build Resilience and Maintain Unparalleled Sensitivity for Long-Term Bioanalysis |
Robert Proos |
|
2:10 - 2:20 |
|
Session III: Innovation Junction: Bridging Science and Solutions in Pharma |
|||
|
Session Introduction: Hongying Gao, Innovo Bioanalysis LLC & Christopher Kochansky, Exelixis |
|
|
2:20 - 2:25 |
|
Bill Coode, KCAS Bio Tom Zhang, WWCT Peggy Teng, Medicilon Anahita Keyhani, Altasciences Tilak Chandrasekaran - Sciex Chris Bunker, Alamar Bio |
2:25 - 3:05 |
||
|
Session IV: Recent Case Study to Support New Modalities (oligonucleotides/C>)/bioanalytical |
|||
|
Session Introduction: John Wiliams, Vertex, Jonathan Josephs, Genentech & Jing Tu, GSK |
|
3:05 - 3:10 |
|
|
The Role of DMPK in non-viral Gene Therapies |
Nag Chemuturi |
Eli Lilly |
3:10 - 3:40 |
|
PM Break & Exhibits |
|
3:40 - 4:00 |
|
|
Innovative Approaches and Case Studies in the Bioanalysis of Oligonucleotide Therapeutics |
Aihua Liu |
Resolian |
4:00 - 4:30 |
|
Characterizing In Vivo Stability of Large Molecule Conjugates Using Complementary Bioanalytical Tools |
Jeff Lin |
Genentech |
4:30 - 5:00 |
|
Reception & Exhibits |
|
5:00 - 6:15 |
|
Mechanistic ADME Workshop - Wednesday, October 9, 2024
|
Title |
Speaker |
Company |
Time |
|
Registration, Breakfast, Exhibits |
|
7:30 - 8:30 |
|
|
Workshop Introduction |
Nagendra Chemuturi |
Eli Lilly |
8:30 - 8:40 |
|
Session I: Role of NonCYP Enzymes in DDI |
|||
|
Session Introduction: Raman Sharma, Pfizer & Nagendra Chemuturi, Eli Lilly |
|
|
8:40 - 8:45 |
|
Uncertainties and Opportunities in Predicting Non-CYP Mediated Drug Metabolism |
Sandhya Subash |
WSU |
8:45 - 9:10 |
|
Mitigation Strategies for Drug-Induced Liver Injury (DILI) - Still an Aspiration? |
Kaushik Mitra |
Janssen |
9:10 - 9:35 |
|
Recent Advancements in Predicting CYP-Independent Metabolism |
Jasleen Sodhi |
Septerna |
9:35 - 10:00 |
|
AM Break & Exhibits |
|
|
10:00 - 10:25 |
|
Rapid Fire Poster Presentations 1. Overcoming Challenges in LC- High-Resolution Mass Spectrometry (HRMS) Method Development for Quantitation of PPMO and PMO in Human Urine - Shaoxia Yu, PepGen 2. Stable Isotope Labeling by Amino Acid in Culture (SILAC) Approach for the Detection of Trapped Reactive Metabolites in Plated Hepatocytes - Chris Bode, Pharmaron 3. Closing the Translational Gap in Drug Development: Human Multi-Tissue Chip Platform for Predictive and Mechanistic Preclinical Studies - Shiny Rajan, Javelin Bio 4. Metabolism of 14C-retatrutide following subcutaneous administration in healthy male participants - Ravikanth Veluri, Eli Lilly |
|
|
10:25 - 10:45 |
|
Session II: PK/PD Challenges of New Modalities: ADCs, in vivo Gene Therapies, and PROTACs |
|||
|
Session Introduction: Sara Shum, Orna Therapeutics & Hongbin Yu, Boehringer Ingelheim |
|
10:45 - 10:50 |
|
|
Preclinical To Clinical Translation of ADCs Using PK/PD Modeling |
Minu Pilvankar |
Boehringer Ingelheim |
10:50 - 11:15 |
|
Empirical PK/PD Modeling of Novel In Vivo CRISPR/Cas9 Genome Editing Therapies |
Adam Amaral |
Intellia |
11:15 - 11:40 |
|
Addressing ProtacTM ADME Challenges |
Stefanus Steyn |
Pfizer |
11:40 - 12:05 |
|
Lunch, Exhibits, and Poster Viewing (12:35 pm - 1:00 pm) |
|
12:05 - 1:20 |
|
|
Plenary Speaker Introduction |
|
|
1:20 - 1:25 |
|
Plenary Talk - Prospects for New Approach Methodologies and Complex In Vitro Models to Reduce, Refine and Replace Animals in Drug Safety Testing |
Terry Van Vleet |
AbbVie |
1:25 - 2:05 |
|
Session III: The importance of tracking missing metabolites/new technologies (covalent drugs) |
|||
|
Session Introduction: Eric Ballard, Takeda & Donglu Zhang, Genetech |
|
|
2:05 - 2:10 |
|
A "Missing” Trazpiroben Metabolite Observed as the Most Abundant Metabolite in Human Plasma and Urine |
Sean Zhu |
Takeda |
2:10 - 2:35 |
|
Human ADME Characterization of Linerixibat Reveals Unusual Pharmacokinetic Properties: Implications for Clinical Development |
Maciej Gliszczynski |
GSK |
2:35 - 3:00 |
|
PM Break & Exhibits |
|
|
3:00 - 3:20 |
|
Impact of Missing Metabolites During Lead Optimization in Drug Discovery |
Joyce Liu |
Genentech |
3:20 - 3:45 |
|
Session IV: New Approaches to in Vitro ADME Assays for Improved Drug-Drug-Interaction and Clearance Predictions |
|||
|
Session Introduction: Benjamin Johnson, BMS |
|
|
3:45 - 3:50 |
|
Prediction of Aldehyde Oxidase Mediated Clearance: Recent Progress in Quantitative Translation |
Prakash Bolleddula |
iTeos Therapeutics |
3:50 - 4:15 |
|
Predicting Clinical Drug-Drug Interactions of Cytochrome P450 Time-Dependent Inhibitors - How Successful Are We? |
Elaine Tseng |
Pfizer |
4:15 - 4:40 |
|
Hepatocyte Uptake and Loss Assay (HUpLA): Proof-of-Concept of an All-in-One System for Same Day Measuring Hepatic Influx, Egress, and Metabolic Clearance Based on the Extended Clearance Concept |
Julia Pauly |
AbbVie |
4:40 - 5:05 |
|
Conference Closing Remarks |
|
5:05- 5:10 |
|