Designing Phase I Trials for Biosimilars: Unique Challenges and Strategies

29th April, 2025

Time - 6:30 PM IST | 4:00 PM EEST | 9:00 AM EDT

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Register for webinar now!

    In this webinar you will learn about

    • Essential elements and objectives of Phase I Trials for Biosimilars
    • In-depth insights from Erythropoietin, Filgrastim, and Vedolizumab studies
    • Key Strategies for dose escalation, PK/PD assessments, and immunogenicity monitoring
    • Learn about adaptive trial designs, real-time data adjustments, and risk mitigation approaches
    • Insights into navigating global regulatory requirements and aligning study protocols with evolving guidelines

    Dr Hiren Mehta

    Dr Hiren Mehta, a Ph.D. in clinical Pharmacology with over 19 years of experience in managing clinical pharmacology functions, medical and scientific affairs. Dr. Mehta has worked with renowned companies such as Altasciences, Syneos Health, Lambda Therapeutic Research, Torrent Pharma, Cadila Pharmaceutics Ltd, and Wyeth Lederle Ltd, where he has demonstrated expertise in pharmacokinetics, pharmacodynamics (PK/PD) data analysis-reporting, and regulatory compliance

    Dr. Jatin Vadhvana

    Dr. Jatin Vadhvana, Head of the Clinical Research Department at Veeda Lifesciences, holds an MBBS degree and brings over 15 years of expertise in clinical research. With a strong foundation in basic and clinical pharmacology, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), clinical studies, and medical writing, he plays a pivotal role in advancing research excellence. Dr. Vadhvana leads a multidisciplinary team of medical doctors and clinical pharmacologists, driving innovation and ensuring the highest standards in clinical research.