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. 

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.

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. Julia Korell is an Executive Director and US Head of Pharmacometrics at Boehringer Ingelheim with over 10 years of experience in pharmacometrics and MIDD. She currently leads a team of 8 pharmacometricians that supports over 20 drug development projects across Boehringer Ingelheim’s Inflammation portfolio with MIDD strategies and deliverables from the start of clinical development up to submission and beyond.

As a German native, Julia studied Pharmacy at the University of Freiburg im Breisgau, followed by a PhD in Pharmacometrics at the University of Otago, New Zealand, under the supervision of Prof. Stephen Duffull, and a Postdoc at the University of Uppsala, Sweden, working with Dr. Jakob Ribbing and Prof. Mats Karlsson. She previously worked as a pharmacometrics consultant at Model Answers Pty Ltd in Brisbane, Australia, before joining Boehringer Ingelheim in 2016.