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Products are filtered by different dates, depending on the combination of live and on-demand components that they contain, and on whether any live components are over or not.
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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. 

  • 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.

  • 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.

  • 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.

  • Contains 1 Component(s) Includes a Live Web Event on 08/21/2024 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.

    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.

  • Contains 1 Component(s) Includes a Live Web Event on 07/31/2024 at 12:00 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.

  • Contains 1 Component(s)

    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.

  • 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.
  • Contains 3 Component(s) Recorded On: 06/26/2024

    This is the sixth Table Talk and Encore Lecture in the Sheiner Lecture Series featuring the 2018 Lewis B. Sheiner Lecturer Award recipient David Z. D'Argenio.

    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.

    David Z. D’Argenio

    David Z. D'Argenio is Professor of Biomedical Engineering at the University of Southern California and the inaugural holder of the Chonette Chair of Biomedical Technology. He is also an Adjunct Professor in the Department of Pharmaceutical Sciences at the University at Buffalo, SUNY. Professor D'Argenio has been a member of the Biomedical Engineering Faculty at USC since 1979. He is a Fellow of the American Institute for Engineering in Medicine and Biology, AAPS and ISoP. From 2003‐2008, he served on the US FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. He has served as Chairman of the Department of Biomedical Engineering at USC from 1996‐2003. He has been a visiting scientist at St. Jude Children's Research Hospital, the Institute of Biomedical Engineering, CNR, Padova, Italy, and at the University of Halle‐Wittenberg, Halle, Germany. His awards include the Lewis B. Sheiner Award from ISoP and the Gerhard Levy Distinguished Lectureship, Univ. at Buffalo, SUNY. Since 1985 he has co‐directed the Biomedical Modeling and Simulations Resource at USC, an NIH supported center that develops advanced modeling methods for studying biomedical systems. His research involves the development of methodologies for model informed discovery, development, and precision use of medicines with applications in oncology, infectious and metabolic diseases. He has also led the development of the open source ADAPT software system for pharmacometrics and quantitative systems pharmacology.

  • Contains 1 Component(s)

    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.

    Martin Bergstrand

    Principal Consultant and MIDD Platform Science Lead

    Pharmetheus

    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.