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.

Anne-Gaelle has been working as a pharmacometrician at J&J for 7 years. She has worked across many different therapeutic areas (including oncology, infections, and neuroscience) and across all clinical development phases. She has recently moved to leading the neuroscience PM subgroup. It is through one of her neuroscience projects that she was able to deep dive in an innovative application of IV-SC bridging based on pharmacodynamic endpoints, which was discussed within the FDA MIDD program as well as with other health authorities last year. This will be the topic we will be discussing today. 

Outside of project work and her managerial role, Anne-Gaelle is also active in fostering reproducible PMX at her company.  She also likes to be involved in methodological projects, which remind her fondly of her PhD time at Uppsala University. 

Anne-Gaelle lives in Belgium with her husband and 2 young children.

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. 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. 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.

Principal Consultant and MIDD platform science lead at Pharmetheus.

PhD in Pharmacometrics from Uppsala University.

Twenty years of drug development experience in areas such as metabolic disorders, autoimmune disease, infectious disease, hematological disorders etc.

Co-founded the consulting company Pharmetheus AB in 2012. Engaged as a strategic advisor on behalf of multiple clients and acted as the main responsible consultant for 50+ pharmacometric data analysis projects on behalf of more than 20 different clients. The projects have ranged from pre-clinical translational projects to submission ready large-scale phase III PKPD analysis. These analyses have among other things contributed to 5+ successful NDA filings.

First-hand experience with pharmacometric analysis of a wide variety of endpoints including time-to-event analysis, Markov-models, mechanism-based models for multiple linked endpoints and characterization of complex pharmacokinetics. Authored 30+ peer-reviewed articles.

Special interest in the development of methods for efficient communication regarding MIDD.