Specialized Workshop F1 - Friday April 17, 2026: 7am to 5pm
"AGENDA - Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders"
| 07:00am-08:00am: | Start your day at WRIB with Continental Breakfast |
Session 1: Current Best Practices for Method Transfer & Cross-Validation
Chair: Dr. Li Yang, Pharmacologist, US FDA| 08:00am-08:20am: |
Dr. Johanna Mora, Senior Director Bioanalysis, Bristol Myers Squibb "Navigating Bioanalytical Method Transfer Challenges in Late-Stage Asset Acquisitions and Partnerships" |
| 08:20am-08:40am: |
Dr. Catherine Brockus, Director ADME External Bioanalysis & Oversight, Lilly "Objective Statistical Assessments of Cross Validation Data" |
| 08:40am-09:00am: |
Dr. Claudio Crosasso, Senior SME Bioanalysis LBA Outsourcing Operations, EMD Serono "A Case Study on Cross-Validation: Investigating Inter-Lab Bias in PK Assays for Large Molecule ADCs" |
| 09:00am-09:20am: |
Dr. Johanna Mora, Senior Director Bioanalysis, Bristol Myers Squibb
Dr. Catherine Brockus, Director ADME External Bioanalysis & Oversight, Lilly Dr. Claudio Crosasso, Senior SME Bioanalysis LBA Outsourcing Operations, EMD Serono "Panel Discussions on Current Best Practices for Method Transfer & Cross-Validation" |
| 09:20am-09:50am: | Coffee Break with Morning Snacks |
Session 2: Fit-for-Purpose Bioanalytical Methods for Rare Matrix & Radiopharmaceuticals
Chair: Dr. Fabrizio Galliccia, Head of Clinical Trial Office and GCP Senior Inspector, Italy AIFA / EU EMA| 09:50am-10:10am: |
Dr. Katty Wan, Senior Director Clinical Bioanalytics, Pfizer "Addressing Analytical Challenges of Drug Concentration Measurements in Rare Matrices to Support Clinical PK" |
| 10:10am-10:30am: |
Dr. Wenkui Li, Director Bioanalytics, Pharmacokinetic Sciences, Novartis "Fit-for-Purpose Bioanalysis of Blood and Urine by Gamma Counting in Support of Clinical Trials Involving Radioligand Therapies (RLTs)" |
| 10:30am-10:50am: |
Mr. Joseph Tweed, Associate Director Bioanalysis, Quantitative Pharmacology Group, Bicycle "The bioanalysis of Bicycle® radioconjugates: a case study of bioanalytical challenges from a preclinical assay" |
| 10:50am-11:10am: |
Dr. Katty Wan, Senior Director Clinical Bioanalytics, Pfizer
Dr. Wenkui Li, Director Bioanalytics, Pharmacokinetic Sciences, Novartis Mr. Joseph Tweed, Associate Director Bioanalysis, Quantitative Pharmacology Group, Bicycle "Panel Discussions on Fit-for-Purpose Bioanalytical Methods for Rare Matrix & Radiopharmaceuticals" |
Special Session: ASK THE REGULATORS!
| 11:10am-11:50am: |
Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Bioanalysis/BMV Regulatory Panelists:
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| 11:50am-12:50pm: | Sit-down Hot Buffet Lunch at Reunion GH |
Session 3: Enhancing Bioanalytical Performance by Capability-based Trending, CRLs Lesson Learned, Specimen Management Optimization
Chair: Dr. Yang Lu, Senior Staff Fellow, US FDA| 12:50pm-01:10pm: |
Mr. Jason (Jay) DelCarpini, Director Bioanalytics, Moderna "Setting Capability-Based Performance Expectations in Bioanalysis" |
| 01:10pm-01:30pm: |
Dr. Sekhar Surapaneni, Vice President DMPK & Clinical Pharmacology, Nimbus "Analysis of BA Issues from Recent FDA CRLs" |
| 01:30pm-01:50pm: |
Ms. Jennifer Francis, Senior Manager Sample Management, Regeneron "Optimizing Clinical Trials: A Sample Management Perspective" |
| 01:50pm-02:10pm: |
Mr. Jason (Jay) DelCarpini, Director Bioanalytics, Moderna
Dr. Sekhar Surapaneni, Vice President DMPK & Clinical Pharmacology, Nimbus Ms. Jennifer Francis, Senior Manager Sample Management, Regeneron "Panel Discussions on Enhancing Bioanalytical Performance by Capability-based Trending, CRLs Lesson Learned, Specimen Management Optimization" |
Session 4: Adapting BMV Strategies beyond ICH M10 for Different Matrices/RoA & Alternative Sampling
Chair: Dr. Anna Edmison, Senior Clinical Assessment Officer, Health Canada| 02:10pm-02:30pm: |
Dr. Kamala Bhavaraju, Head of Clinical Bioanalytics & Chief of Staff, Dr. Reddy's Laboratories "Partial Validation Strategies for Pharmacokinetic Method in Biosimilar Development : A Science" |
| 02:30pm-02:50pm: |
Ms. Yujin Wang, Senior Director DMPK & Bioanalysis, Day One Biopharmaceuticals "Case Study on Patient-Centric Sampling Applicability–Pharmacokinetics Comparison Between Mitra® Whole Blood and Conventional Plasma Samples in a Clinical Trial" |
| 02:50pm-03:20pm: | Coffee Break with Afternoon Snacks |
| 03:20pm-03:40pm: |
Mr. John Eddy, Director Bioanalytical, Lilly Dr. Quincy Carter, Advisor ADME External Bioanalysis & Oversight, Lilly "Transforming Clinical Pharmacokinetics: Validated Capillary Blood Microsampling for Monoclonal Antibody Quantification" |
| 03:40pm-04:00pm: |
Dr. Kamala Bhavaraju, Head of Clinical Bioanalytics & Chief of Staff, Dr. Reddy's Laboratories
Ms. Yujin Wang, Senior Director DMPK & Bioanalysis, Day One Biopharmaceuticals Mr. John Eddy, Director Bioanalytical, Lilly Dr. Quincy Carter, Advisor ADME External Bioanalysis & Oversight, Lilly "Panel Discussions on Adapting BMV Strategies beyond ICH M10 for Different Matrices/RoA & Alternative Sampling" |
Session 5: 2026 White Paper in Bioanalysis
| 04:00pm-05:00pm: |
Dr. Li Yang, Pharmacologist, US FDA Dr. Fabrizio Galliccia, Head of Clinical Trial Office and GCP Senior Inspector, Italy AIFA / EU EMA Dr. Yang Lu, Senior Staff Fellow, US FDA Dr. Anna Edmison, Senior Clinical Assessment Officer, Health Canada "Recommendations on BMV and Regulated Bioanalysis and Panel Discussions for 2026 White Paper in Bioanalysis" |
