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Contains 1 Component(s) Includes a Live Web Event on 12/18/2024 at 12:00 PM (EST)
The 2024 MIDD Webinar Series, coordinated by Ana Ruiz and Sihem Bihorel, is a series of webinars focused on shaping the future of drug development and regulatory decision-making. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases.
Overview of the 2024 MIDD Webinar Series
The 2024 MIDD Webinar Series, coordinated by Ana Ruiz and Sihem Bihorel, is a series of webinars focused on shaping the future of drug development and regulatory decision-making. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases.
Joga Gobburu
CEO
Pumas-AI, Inc.
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.
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Contains 1 Component(s) Includes a Live Web Event on 11/20/2024 at 12:00 PM (EST)
The 2024 MIDD Webinar Series, coordinated by Ana Ruiz and Sihem Bihorel, is a series of webinars focused on shaping the future of drug development and regulatory decision-making. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases.
Overview of the 2024 MIDD Webinar Series
The 2024 MIDD Webinar Series, coordinated by Ana Ruiz and Sihem Bihorel, is a series of webinars focused on shaping the future of drug development and regulatory decision-making. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases.
Emma Hughes
Pharmacometrician
Gilead Sciences
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.
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Contains 1 Component(s) Includes a Live Web Event on 10/23/2024 at 12:00 PM (EDT)
The 2024 MIDD Webinar Series, coordinated by Ana Ruiz and Sihem Bihorel, is a series of webinars focused on shaping the future of drug development and regulatory decision-making. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases.
Overview of the 2024 MIDD Webinar Series
The 2024 MIDD Webinar Series, coordinated by Ana Ruiz and Sihem Bihorel, is a series of webinars focused on shaping the future of drug development and regulatory decision-making. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases.
Anne Gaelle Dosne
Pharmacometrician
The Janssen Pharmaceutical Companies of Johnson & Johnson
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.
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Contains 1 Component(s) Includes a Live Web Event on 09/25/2024 at 12:00 PM (EDT)
The 2024 MIDD Webinar Series, coordinated by Ana Ruiz and Sihem Bihorel, is a series of webinars focused on shaping the future of drug development and regulatory decision-making. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases.
Overview of the 2024 MIDD Webinar Series
The 2024 MIDD Webinar Series, coordinated by Ana Ruiz and Sihem Bihorel, is a series of webinars focused on shaping the future of drug development and regulatory decision-making. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases.
Rena Byrne
Senior Scientist
Metrum Research Group
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.
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Contains 1 Component(s) Includes a Live Web Event on 09/18/2024 at 4:00 PM (EDT)
This Sheiner Lecture Series revisits each of the Lewis B. Sheiner Award winner's exceptional lectures, counting back from the very first one in 2008. Each month, the series will highlight a previous award winner with two sessions: Part 1 will be a 20-minute "Table Talk" to get to know the award winners; Part 2 will be an encore presentation of the award-winning lectures.
This Sheiner Lecture Series revisits each of the Lewis B. Sheiner Award winner's exceptional lectures, counting back from the very first one in 2008. Each month, the series will highlight a previous award winner with two sessions: Part 1 will be a 20-minute "Table Talk" to get to know the award winners; Part 2 will be an encore presentation of the award-winning lectures.
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Contains 1 Component(s) Includes a Live Web Event on 09/11/2024 at 4:00 PM (EDT)
This Sheiner Lecture Series revisits each of the Lewis B. Sheiner Award winner's exceptional lectures, counting back from the very first one in 2008. Each month, the series will highlight a previous award winner with two sessions: Part 1 will be a 20-minute "Table Talk" to get to know the award winners; Part 2 will be an encore presentation of the award-winning lectures.
This Sheiner Lecture Series revisits each of the Lewis B. Sheiner Award winner's exceptional lectures, counting back from the very first one in 2008. Each month, the series will highlight a previous award winner with two sessions: Part 1 will be a 20-minute "Table Talk" to get to know the award winners; Part 2 will be an encore presentation of the award-winning lectures.
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Contains 1 Component(s) Recorded On: 08/21/2024
The 2024 MIDD Webinar Series, coordinated by Ana Ruiz and Sihem Bihorel, is a series of webinars focused on shaping the future of drug development and regulatory decision-making. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases.
Overview of the 2024 MIDD Webinar Series
The 2024 MIDD Webinar Series, coordinated by Ana Ruiz and Sihem Bihorel, is a series of webinars focused on shaping the future of drug development and regulatory decision-making. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases.
Samira Merali
Cardiovascular Therapeutic Area Head in Clinical Pharmacology and Pharmacometrics
BMS
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.
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Contains 3 Component(s) Recorded On: 07/31/2024
This is the seventh Table Talk and Encore Lecture in the Sheiner Lecture Series featuring the 2017 Lewis B. Sheiner Lecturer Award recipient Marc R. Gastonguay.
This Sheiner Lecture Series revisits each of the Lewis B. Sheiner Award winner's exceptional lectures, counting back from the very first one in 2008. Each month, the series will highlight a previous award winner with two sessions: Part 1 will be a 20-minute "Table Talk" to get to know the award winners; Part 2 will be an encore presentation of the award-winning lectures.
Marc R. Gastonguay
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.
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Contains 1 Component(s) Recorded On: 07/24/2024
The 2024 MIDD Webinar Series, coordinated by Ana Ruiz and Sihem Bihorel, is a series of webinars focused on shaping the future of drug development and regulatory decision-making. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases.
Overview of the 2024 MIDD Webinar Series
The 2024 MIDD Webinar Series, coordinated by Ana Ruiz and Sihem Bihorel, is a series of webinars focused on shaping the future of drug development and regulatory decision-making. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases.
Julia Korell
Executive Director and US Head of Pharmacometrics
Boehringer Ingelheim
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.
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Contains 1 Component(s) Recorded On: 07/19/2024
Fifteen years ago, the company formed a modeling and simulation programming team initially tasked with creating nonmem datasets, which has since expanded its responsibilities significantly. Vincent will outline the team's deliverables and future development plans, including how the role may evolve with emerging technologies.
The company established its dedicated modeling and simulation programming team 15 years ago. Initially focused on creating nonmem datasets, the team's roles and responsibilities have significantly expanded over time. Vincent will present the various deliverables produced by the team and discuss potential future developments.
Learning objectives:
- Discuss potential future development plans for pharmacometrics data programmers.
- Discuss how the role might continue to evolve in response to emerging technologies.
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