Dr. Xiaolei Pan is a Senior Clinical Pharmacology & Pharmacometrics Reviewer at the US FDA with over eight years of experience across a range of therapeutic areas, including cardiovascular and kidney diseases, diabetes, endocrine disorders, infectious diseases and non-malignant hematology. Dr. Pan has reviewed 45 NDAs/supplemental NDAs and 10 BLAs/supplemental BLAs, where she has contributed to identifying and addressing clinical pharmacology and pharmacometrics-related issues, as well as benefit/risk assessments. In addition to her review responsibilities, Dr. Pan has led several regulatory science research projects and is actively involved in multiple clinical pharmacology initiatives within the FDA. Dr. Pan has published 12 manuscripts in peer-reviewed journals, including The Journal of Clinical Pharmacology, Pharmaceutical Research and Antimicrobial Agents and Chemotherapy. Dr. Pan's contributions have been recognized with the CDER Excellence in Communication Award, CDER Special Recognition Individual Award, CDER Regulatory Science Excellence Award and the OCP Excellence in Science Award. Dr. Pan earned her PhD in Pharmaceutics and a concurrent Master’s degree in Biostatistics from Virginia Commonwealth Univ and holds a Bachelor of Science in Pharmacy from Shenyang Pharmaceutical Univ, China.

Sihem Bihorel is currently a Senior Director at Merck & Co Inc. Prior to joining Merck, Sihem was an Assistant Professor at the Coll of Pharmacy at the Univ of Florida. Sihem holds Master's degrees in Immunology and in Pharmacometrics, a PharmD and a PhD. Following her PhD research conducted in the Dept of Pharmaceutical Sciences at SUNY at Buffalo, Sihem pursued a Postdoctoral Associate position, followed by a Research Assistant Professor position in the same department. Her expertise is in the end-to-end application of model-informed drug development with a variety of quantitative approaches and in various therapeutic areas. Sihem has authored numerous scientific publications in international peer-reviewed journals, book chapters and presented her work as posters, talks and webinars at various international conferences. She is also a mentor to many students, postdocs, scholars and scientists in academia, the pharmaceutical industry and the International Society of Pharmacometrics.