| | | | Bridging Development and Regulation in CGT with Halloran Consulting Group's Monika Swietlicka | On Cell & Gene: The Podcast, Erin Harris speaks with Monika Swietlicka of Halloran Consulting Group about the top regulatory hurdles facing cell and gene therapy developers. From manufacturing challenges to clinical trial design and FDA expectations around gene editing, Swietlicka shares key insights. She also discusses the growing importance of early quality planning, comparability strategies, and real-world evidence—especially critical for rare disease treatments with limited trial data. |
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| | | On this week's Business of Biotech, Michelle Werner, CEO at Alltrna, talks transfer RNA (tRNA) therapy with host Ben Comer and guest co-host Anna Rose Welch, editorial and community director at Advancing RNA. Werner explains why a single engineered tRNA therapy has the potential to treat "hundreds, if not thousands," of rare genetic diseases, and how her own child's rare disease diagnosis shaped her career and approach to drug development. Werner also discusses Alltrna's use of AI and machine learning for drug optimization, the company's planned use of basket trials, and more. |
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| | | Evolving Data Review With AI | AI is transforming clinical data review by automating processes and enhancing efficiency. Discover the stages of evolution emphasizing automation, regulatory alignment, data analysis, and human oversight. |
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