A Novel and Innovative Model-Based Approach to Identify the Approved Posology for Mavacamten in Obstructive Hypertrophic Cardiomyopathy (HCM)
Recorded On: 08/21/2024
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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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