The Unloved Child Podcast
Leadership in Biostatistics: Driving FDA Approvals in Gene Therapy and Clinical Research In this episode, we speak with Srinivasa Reddy Mukkala, Vice President of Operations – Biostatistics and Statistical Programming at EPIS DATA, about the critical role of statistical leadership in regulatory success. Srinivasa has contributed to multiple FDA approvals, including breakthrough gene therapies such as ZYNTEGLO for Beta-Thalassemia and LYFGENIA for Sickle Cell Disease. He also served as statistical programming lead for NUZYRA, an FDA-approved tetracycline-class antibiotic. We explore: * The role of biostatistics and statistical programming in FDA submissions * Delivering regulatory-ready clinical trial data * The complexity of gene therapy trials * Leadership in biometrics and global operations * Career progression from pharmacist to data science executive * The future of clinical research, regulatory science, and data integrity This conversation is essential listening for professionals in biostatistics, statistical programming, clinical data management, regulatory affairs, pharmaceutical development, and life sciences leadership. If you are involved in clinical trials, gene therapy, FDA submissions, or biometrics strategy, this episode offers practical insights from someone who has helped bring transformative therapies to patients worldwide. Subscribe for more conversations with leaders shaping the future of biostatistics, clinical research, and pharmaceutical innovation.
7 episodes
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