Dr. Gobburu is a scientist in drug development. He is best known for transforming the field of pharmacometrics into a decision-supporting science. His experience as a senior biomedical research scientist and Director of Pharmacometrics at the Food and Drug Administration (FDA) gives him unique insight into the technical, regulatory, and decision-making aspects in all phases of drug development. He obtained his BPharm and MSc in chemistry from the Birla Institute of Technology and Science, his Ph.D. in pharmaceutical sciences from North Dakota State University, and his MBA from Johns Hopkins University. Dr Gobburu co-founded Pumas-AI Inc. and Vivpro Corporation. 

Emma received her bachelor’s degree in chemistry from Mount Holyoke College. She went on to join the National Center for Advancing the Translational Science’s DMPK group. There she performed both bioanalysis as well as determined a compound’s preclinical PK profile for small molecules. Emma received her PhD from the University of California San Francisco’s Pharmaceutical Sciences and Pharmacogenomics program where her research focused on building PK/PD models for infectious diseases in special populations, primarily malaria in pregnant women.

Dr. Yuan Chen is a Senior Fellow in the Department of Drug Metabolism and Pharmacokinetics at Genentech. Dr. Chen has more than 20 years of pharmaceutical industry experience in the drug metabolism and pharmacokinetic discipline working at Genentech and Roche. She has been DMPK and project lead for many discovery and development programs in broad therapeutic areas and contributed to the clinical candidate nomination and filing of IND, NDA and BLA to the regulatory authorities. Dr. Chen’s current research focus is on physiologically based pharmacokinetic (PBPK) modeling for the prediction of human PK in different populations, drug absorption, and CYP-and transporter-mediated drug-drug interactions. She leads PBPK effort and oversight the PBPK strategy and support to discovery and development projects at Genentech, including interactions with HA on MIDD and PBPK applications in drug labeling. In addition, Yuan has been an active member on IQ PBPK expert working groups and contributed to many PBPK white papers.

Dr. Eva Gil Berglund joined Certara Drug Development Support in 2019 as Senior Director in Clinical Pharmacology and Regulatory Strategy. Eva supports companies in Clinical Pharmacology Regulatory Strategy. She has 20+ experience as Clin Pharm Reviewer and Senior Expert at the Swedish Medical Products Agency, and has been lead writer of several EU Clinical Pharmacology guidance documents including in DDIs, PBPK, Pediatrics and has been a member of the EMA Pharmacokinetics and Paediatrics EMA working parties.

Karen is Senior Vice-President, Client & Regulatory Strategy at Certara UK Limited’s Simcyp Division. Prior to this, she was the Head of PBPK Consultancy Services at Simcyp where she led a team of scientists engaged in Consultancy projects relating to the application of physiologically based pharmacokinetic (PBPK) modelling in drug development. Her work has focused on the use of PBPK models for assessment of drug-drug interactions and dosing of special populations and she is the author/co-author of more than 100 peer reviewed articles in these areas.

Anne-Gaëlle is currently working as director of CPP at argenx, a Belgium-based biotech company specialized in immunology innovation for rare diseases, after spending 8 years within Janssen’s (J&J Innovative Medecine) CPP group. Her experience in IV-SC bridging arises both through project work and through a multidisciplinary collaboration with health authorities and other pharmaceutical industries during the ACoP pre-conference workshop in 2022, which resulted in an article on the topic.

Anne-Gaëlle is a pharmacist by training and obtained her PharmD at Paris Descartes University (France) in 2011. She completed her PhD program at Uppsala University (Sweden) in 2015 in collaboration with Novartis. She is passionate about applying quantitative pharmacology principles at different stages of drug development across therapeutic areas and modalities

Rena Byrne is a Senior Scientist at Metrum Research Group, where she works on a variety of modeling and simulation projects to support MIDD in rare diseases, oncology, immunology, and diabetes. The types of analyses she works on include population PK and PD to support dose selection and filing, optimal sampling, and simulations in special populations. Her background is in biomedical engineering, and she got her start in the pharma industry as a lab scientist, supporting the discovery stage of drug development. She is certainly glad she learned about pharmacometrics early in her career and is happy to be doing meaningful and challenging work with wonderful colleagues and clients.

Dr. Marc Gastonguay has dedicated more than 30 years to science, advocacy, innovation, and education in the discipline of pharmacometrics. He is the co-founder and former CEO of Metrum Research Group, a provider of strategic biomedical modeling and simulation solutions. He currently serves the company as Entrepreneur in Residence and Chairman of the Board. Dr. Gastonguay received a BS in Pharmacy from the University of Connecticut, a PhD in Pharmacology from Georgetown University School of Medicine, and completed a Postdoctoral Fellowship at the US Food and Drug Administration. Through graduate faculty and adjunct faculty appointments, Dr. Gastonguay has advised more than 20 doctoral students and fellows in collaboration with faculty at multiple major research institutions in the U.S. Dr. Gastonguay is a founding Director and Fellow of the International Society of Pharmacometrics (ISoP), and a member of the American Society of Clinical Pharmacology and Therapeutics. Other recognitions include the ASCPT Sheiner-Beal Pharmacometrics Award, the ACCP/Bristol Myers Squibb Mentorship in Clinical Pharmacology Award, the ISoP Lewis B. Sheiner Lecturer Award, the University of Connecticut Distinguished Alumnus Award, the ISoP Innovation Award, and the Marcum CT Tech Top 40 Award (for MetrumRG). Dr. Gastonguay has published more than 75 manuscripts and 150 abstracts. His current research interests include Bayesian modeling methods, quantitative decision-making, pediatric clinical pharmacology, and rare disease drug development. He is also a strong advocate and contributor to open-science initiatives, including open-source software, open disease models and data, and open courseware.

Dr. Samira Merali is currently the Cardiovascular Therapeutic Area Head in Clinical Pharmacology and Pharmacometrics. Samira has 12 years of experience working on MIDD in infectious disease, oncology, immunology and cardiovascular disease areas across all stages of development including pediatrics. She is a PharmD by training, and subsequently completed her M.S in Pharmaceutical Sciences at the University at Buffalo and Post Doc in Clinical pharmacology and Pharmacometrics at the University at Buffalo and Novartis. During her training and her career to date, she strives to apply PK/PD modeling to inform drug development, whether it is in study design, prioritization, practicality, pediatric strategy or more recently, innovative dose/titration based posology to optimize benefit/risk while maintaining feasibility in clinical practice.