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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) Recorded On: 10/23/2024

    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.

    Anne Gaelle Dosne

    Pharmacometrician

    Argenx

    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

  • Contains 2 Component(s) Recorded On: 10/09/2024

    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. This month ACoP 2013's Award winner France Mentre is our featured guest.

  • Contains 1 Component(s) Recorded On: 09/25/2024

    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.

    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 3 Component(s) Recorded On: 09/18/2024

    This is the eighth Table Talk and Encore Lecture in the Sheiner Lecture Series featuring the 2014 Lewis B. Sheiner Lecturer Award recipient Stephen Duffull.

    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.

  • Contains 1 Component(s) Recorded On: 09/16/2024

    This webinar focuses on the application of Mixed-Effects Bayesian Meta-Analysis (MBMA) and traditional Meta-Analysis (MA) in oncology drug development, particularly for immune checkpoint inhibitors in metastatic non-small cell lung cancer (mNSCLC). It highlights how these statistical techniques utilize summary-level data to make predictions and inform decision-making.

    MBMA and traditional MA are statistical techniques that leverage summary-level data to make predictions [1] and provide inference [2], and can be used to inform oncology drug development decisions. MBMA, an extension of network MA, leverages pharmacology principles using mathematical models. Oncology trials are prone to variability from varying trial designs, diverse patients with numerous treatment options, and different prior therapies. Here, we share our experience utilizing MBMA and MA of immune checkpoint inhibitors to inform decisions on development plans in mNSCLC.

    An MBMA with mixed-effects logistic regression quantified effects on ORR. MBMA with semi-parametric longitudinal mixed-effects models quantified PFS and OS Kaplan–Meier curves as a function of observed ORR and other factors. Model-based head-to-head trial simulations predicted hazard ratios (HR) for PD-1 vs PD-L1 treatments.

    MA-based matched indirect treatment comparison (ITC) evaluated PFS HR and OS HR for PD-1 vs PD-L1 treatments. This approach first matches identified studies of different drugs by important trial-level characteristics for a fair comparison, then compares efficacy or safety outcomes of the two drugs using Bucher's approach [2].

    From MBMA, correlations between ORR and OS and between ORR and PFS were established for each treatment type (i.e. PD-(L)1 monotherapy, chemotherapy, etc.), supporting use of ORR data to predict survival.

    The analyses found numerical trends in historical and simulated PFS HR and OS HR favoring PD-1 over PD-L1 inhibitors, alone or in combination.

    The MBMA- and MA-based matched ITC provided a comprehensive and consistent assessment of the relative effect for PD-1 vs PD-L1 treatments in mNSCLC. Results were used as prior knowledge to support oncology drug development under the quantitative decision-making framework at GSK.

    1. Turner et al., 2023 https://doi.org/10.1002/psp4.1...

    2. Bucher et al., 1997 https://doi.org/10.1016/s0895-...

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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.

  • Contains 4 Component(s)

    The ISOP Quantitative Systems Pharmacology (QSP) Special Interest Group held a week of one-hour presentations focusing on scientific and technical learning.

    The ISOP Quantitative Systems Pharmacology (QSP) Special Interest Group held a week of one-hour presentations focusing on scientific and technical learning. 

  • 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.