Session 1: Application of Transporter Biomarker Studies in Drug Development: Study Design, Case Studies, and Regulatory Perspectives

Co-Chairs: Xiaoyan Chu, Merck, Rahway, New Jersey, USA & Hong Shen, Bristol Myers Squibb, Princeton, New Jersey, USA

Why Drug Metabolites Can be Important; Examples of Active and Toxic Metabolites 

Kenta Yoshida, Genentech, South San Francisco, California, USA

Update from IQ OATP1B Biomarker Working Group

Bridget L. Morse, Eli Lilly, Indianapolis, Indiana, USA

Case Studies: Applying Transporter Biomarker Data to Support Mechanistic Understanding of DDIs and Drive DDI Strategy and Decision-Making in Drug Development

     Utilizing Endogenous Biomarkers to Streamline Assessment of Transporter-Mediated Drug-Drug Interactions: Case Studies

     

Fenglei Huang, Boehringer Ingelheim, Ridgefield, Connecticut, USA

     Evaluation of the Impact of Ritlecitinib on Organic Cation Transporters Using Sumatriptan and Biomarkers as Probes

       

Xiaoxing Wang, Pfizer, Vienna, Virginia, USA

     Ticagrelor Increases Exposure to the Breast Cancer Resistance Protein Substrate Rosuvastatin

     

Mikko Niemi, University of Helenski, Helenski, Finland

     Pharmacokinetic Drug-drug Interaction Study Using Cimetidine and Dolutegravir to Elucidate Predictive Performance of the Endogenous Biomarkers for OCT2 and MATEs in Healthy Volunteers

     

Tomoki Koishikawa, University of Tokyo, Tokyo, Japan

Regulatory Perspectives on Transporter Biomarkers

Xinning Yang, US FDA, Silver Spring, Maryland, USA

Roundtable Discussion with Speakers