DAY 1: Sunday, September 21, 2025

Program subject to change.

08:00 - 19:00

Registration Open

09:00 - 12:00

Concurrent Short Courses 1 & 2
09:00 - 12:00

Short Course 1 – Human Mass Balance Study – How, When, Why: From Practical Issues to Regulatory Guidance

Co-Chairs: Lei Zhang, Silver Springs, MD, USA and Dennis Heller, Certara, USA

  • Mass balance study and metabolite profiling: Design, data analysis, and interpretation
    Chandra Prakash, Agios Pharmaceuticals, USA

  • Industry application and case examples
    Ellen Cannady, Eli Lilly, USA

  • FDA guidance on human radiolabeled mass balance studies
    Zhixia Yan Danielsen, US Food and Drug Administration, USA

  • EMA’s perspectives on human mass balance studies
    Karin Fawkner, Medical Products Agency, Sweden

Short Course 2 – Implementing biomarkers and clinical probes to assess transporter-mediated drug-drug interactions

Co-Chairs: Bhagwat Prasad, Cincinnati Children’s Hospital, USA and Eva Berglund, Certara, USA

  • Strengths and weaknesses of biomarker PBPK models to assess transporter-mediated DDIs
    Hiroyuki Kusuhara, The University of Tokyo, Japan

  • Endogenous probes in practice, purpose, when in drug development, study design considerations
    Bridget Morse, Lilly, USA

  • Clinical transporter probes: Selectivity and sensitivity​
    Xiaoyan Chu, Merck, USA

  • Endogenous transporter probes from a regulatory perspective
    Xinning Yang, Ellicott City, MD, USA

12:00 - 13:00

Lunch for Short Course Attendees

Included in Short Course registration cost.

12:00 - 16:00

Council Meeting

13:00 - 16:00

Concurrent Short Courses 3 & 4

Short Course 3 – Unmasking the Hidden: A Deep Dive into “MISSED” Metabolites

Co chairs: Kevin Johnson, Inotiv, USA and Shuai Wang, Genentech, USA

  • Missing metabolites: what’s the big deal?
    Shuai Wang, Genentech, USA

  • Metabolic Outliers: When Drug Metabolism Goes Off Script
    Valerie Kramlinger, Amgen, USA

  • From Inception to Detection: Tracking Thiol Drug Metabolites
    Simone Schadt, Roche, Switzerland

  • Avoiding Missed Metabolites for Confidence at IND Submission
    Matthew Hutzler, Inotiv, USA

  • Mass Balance Study Design and Strategies For Addressing Unexpected Metabolites?
    Raman Sharma, Pfizer, USA

Short Course 4 - PBPK and PD modelling to support first-in-human predictions for challenging modalities

Co-chairs: Daniel Scotcher, University of Manchester, UK, Jaydeep Yadav, Merck, USA, and Yuching Yang, Cary, NC, USA

  • FiH dose predictions for protein degraders with PKPD modelling
    Jaydeep Yadav, Merck & Co, USA

  • Translational strategies for multi-specific antibodies (t-cell engagers) in oncology/ immunology
    Fei Hua, Certara, USA

  • Modelling of oligonucleotides and RNAi therapeutics
    Vivaswath Ayyar, GSK, USA

  • Applications and considerations of mechanistic modeling in regulatory decision process
    Yuching Yang, Cary, NC, USA

16:00 - 18:00

Focus Group Meetings

16:00 - 16:45 - Concurrent Meetings

  • Biotransformation, Mechanisms, and Pathways

  • Transporters

17:00-17:45 - Concurrent Meetings

  • Bioanalysis in ADME Science

  • Modeling & Simulation

18:00 - 18:15

Opening Session

18:15 - 19:15

Keynote: Novel Proteomics Tools Expand Knowledge on Covalent Modifications Beyond Searching Under the Streetlight

  • Nina Isoherranen, University of Washington, USA

19:15 - 21:15

Opening Welcome Reception