Big Ideas in 2024: Programming Medicine’s Final Frontier with Jorge Conde
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Stages & Challenges
Traditional drug development is a lengthy and complex process, often taking 10 to 15 years to bring a new medicine to patients. explains that this timeline includes three main stages: drug discovery, preclinical development, and clinical development. Each stage involves rigorous testing and validation to ensure safety and efficacy, contributing to the high costs and risks associated with drug development 1.
The reason why it's so painstaking, it's so time consuming, it's risky and expensive is because we're putting something into human beings.
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Additionally, regulatory approval from agencies like the FDA can add another one to two years to the process, further extending the timeline 1.
FDA & Regulatory
The FDA is adapting its regulatory framework to better handle the innovative nature of programmable medicines. notes that the FDA is taking inspiration from the FAA's approach to aviation safety, aiming to be both rigorous and adaptive 2. The recent approval of the first CRISPR therapy for sickle cell anemia exemplifies this shift, demonstrating a faster and more flexible evaluation process 3.
The FDA is appropriately trying to find ways to remain to retain their rigor, because, again, they have an extraordinarily high obligation to ensure safety and efficacy in patients.
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This new approach is expected to accelerate the development and approval of groundbreaking treatments, benefiting patients in need of innovative therapies 2.