Bringing Practical Applications of Endogenous Biomarkers for Drug Transporters a Step Closer: Current Status and Future Perspectives
An ISSX Virtual Workshop Event | February 28 - March 1, 2024
Workshop Program-at-a-Glance
Wednesday, February 28, 2024 | 10:00 am - 2:00 pm ET (US)*
Session 1: Application of Transporter Biomarker Studies in Drug Development: Study Design, Case Studies, and Regulatory Perspectives
Co-Chairs: Drs. Xiaoyan Chu (Merck) & Hong Shen (BMS)
10:00 am - 10:15 am | Welcome and Overview on Transporter Biomarkers
10:15 am - 10:45 am | Practical Consideration on Designing Clinical Studies to Incorporate Endogenous Biomarkers to Evaluate Transporter DDI and Drive the Decision Making
Kenta Yoshida, Genentech, Massachusetts, USA
10:45 am - 11:25 am | Update from IQ OATP1B Biomarker Working Group
Bridget L. Morse, Eli Lilly, Indiana, USA
11:25 am - 11:40 am | Break
11:40 am - 12:45 pm | Case Studies: Applying Transporter Biomarker Data to Support Mechanistic Understanding of DDIs and Drive DDI Strategy and Decision-Making in Drug Development: 4 Short Presentations
Dr. Fenglei Huang, "Utilizing Endogenous Biomarkers to Streamline Assessment of Transporter-Mediated Drug-Drug Interactions: Case Studies" (18 min + 2 min Q&A)
Dr. Xiaoxing Wang, “Evaluation of the Impact of Ritlecitinib on Organic Cation Transporters Using Sumatriptan and Biomarkers as Probes” (13 min + 2 min Q&A)
Dr. Mikko Niemi, “Ticagrelor Increases Exposure to the Breast Cancer Resistance Protein Substrate Rosuvastatin” (13 min + 2 min Q&A)
Dr. Tomoki Koishikawa, The University of Tokyo Drug Transporter Biomarker Consortium Study (13 min + 2 min Q&A)
12:45 pm - 1:15 pm | Regulatory Perspectives on Transporter Biomarkers
Xinning Yang, US FDA, Maryland, USA
1:15 pm - 1:55 pm | Roundtable Discussion with Speakers and Dr. Ryota Kikuchi (AbbVie)
Moderated by Xiaoyan Chu and Hong Shen
1:55 pm - 2:00 pm | Session Closing Remarks
*Program is subject to change
Thursday, February 29, 2024 | 10:00 am - 2:00 pm ET (US)
Session 2: Novel Tools to Improve Understanding of Modulation in Transporter Function in Specific Populations
Co-Chairs: Drs. Aleksandra Galetin (University of Manchester) & Xinning Yang (US FDA)
10:00 am - 10:05 am | Welcome and Introductions
10:05 am - 10:45 am | Coproporhyrin I in Different Patient Populations – Implications on DDI Assessment
Manthena Varma, Pfizer, Connecticut, USA
10:45 am - 11:25 am | Endogenous Biomarkers for Renal Drug Transporters in Patients with Impaired Renal Function
Aleksandra Galetin, University of Manchester, Manchester, UK
11:25 am - 11:50 am | Break
11:50 am - 12:45 pm | Lightning Talks (Selected from Abstracts)
Moderated by Eva Gil Berglund and Chitra Saran
12:45 pm - 1:25 pm | Drug Transporters in Pediatrics: Ontogeny, Variability, and Clinical Significance
Bhagwat Prasad, Washington State University, Washington, USA
1:25 pm - 1:55 pm | Roundtable Discussion with Speakers
Moderated by Mitesh Patel and Aleksandra Galetin
1:55 pm - 2:00 pm | Session Closing Remarks
*Program is subject to change
Friday, March 1, 2024 | 10:00 am - 2:00 pm ET (US)
Session 3: Methods for Transporter Biomarker Identification, Liquid Biopsy, and Emerging Biomarkers of Efflux Transporters
Co-Chairs: Drs. Bhagwat Prasad (Washington State University) & Pei Feng Shawn Tan (University of Manchester)
10:00 am - 10:05 am | Welcome and Introductions
10:05 am - 10:40 am | Use of Metabolomics for Biomarker Identification and Validation
Martin Fromm, Friedrich-Alexander-Universität Erlangen-Nürnberg,
10:40 am - 11:15 am | Isolation of Exosomes/Extracellular Vesicles as Biomarkers of Transporter Expression/Activity: Challenges, Methodology and Promise
Brahim Achour, University of Rhode Island, Kingston, Rhode Island, USA
11:15 am - 11:50 am | An Update to Existing SLC Biomarkers: Evaluation of the Selectivity of Several OATP1B Biomarkers Using a Relative Activity Factor Method
Xiaoyan Chu, Merck, New Jersey, USA
11:50 am - 12:15 pm | Break
12:15 pm - 12:50 pm | Preclinical Identification and Evaluation of Riboflavin (vitamin B2) as a BCRP Biomarker
Hong Shen, Bristol Meyers, New Jersey, and Kathleen Giacomini, UCSF, California, USA
12:50 pm - 1:25 pm | Identification and Evaluation of Biomarkers for BCRP
Kathleen Giacomini, University of California San Francisco, San Francisco California, USA
1:25 pm - 1:55 pm | Roundtable Discussion with Speakers
Moderated by Bhagwat Prasad and Shawn Tan
1:55 pm - 2:00 pm | Session and Workshop Closing Remarks
*Program is subject to change
