Understanding the FDA's Drug Approval Process: A primer for Deep Tech startups. A chat with Daniela Drago, Regulatory Expert, Partner @ NDA Partners

Welcome back to Deep Tech Catalyst, the channel where science meets venture! We're thrilled to welcome Daniela Drago, Regulatory Expert and Partner at NDA Partners! Today, we'll dive into the complexities of new drug approval and marketing, exploring the essential criteria required by the United States Food and Drug Administration (FDA) and tackling the challenges and risks associated with IND submissions. We'll also discuss emerging regulatory trends for 2024 and share valuable advice for those interested in pursuing a career in regulatory affairs. Let’s dive into it! Host: Nicola Marchese Guest: Daniela Drago #DeepTechCatalyst --------------------- TIMESTAMPS: (00:45) 🎙️ Introduction (02:17) 💊 FDA 101 for aspiring Deep Tech founders (04:21) ✅ Key steps for Achieving an FDA Approval for a New Drug (06:46) ❓ What Factors Indicate Whether a Drug Candidate Will Advance to the Next Stage? (09:44) 🛡️ How to Mitigate Risks in IND Submissions Before Seeking FDA Approval (11:24) 🧗 Common Challenges for Founders in IND Submissions (15:46) 🚀 Emerging Regulatory Trends to Watch in 2024 (19:32) 💼 How to Start a Career in Regulatory Affairs? ------------------------ KEY THEMES COVERED: 1. FDA 101 for Deep Tech Founders: An overview of the U.S. Food and Drug Administration's role in the approval and marketing of new drugs, including the regulatory framework, essential criteria for new drug approval, and the complexity of the drug development process. 2. Challenges in Drug Development: Insights into why bringing a new drug to the market is so difficult, highlighting the time, costs, and statistical odds against drug candidates from discovery through to clinical trials. 3. Advancing Through Drug Development Phases: A focus on the early stages of drug development, including the discovery of targets, preclinical testing, and the importance of selecting a viable drug candidate among thousands of compounds. 4. De-risking the Manufacturing Process: Discussion on ensuring the manufacturing process does not introduce additional risks into drug development, emphasizing the importance of chemistry assessments and toxicology studies. 5. Emerging Regulatory Trends for 2024: Exploration of future regulatory trends, including the advancement of digital health technologies, the expansion of gene therapies, and the challenges of a regulatory talent shortage. 6. Off-Topic - Career Pathways in Regulatory Affairs: Tips for scientists aiming to transition into regulatory roles, highlighting the need for a blend of scientific understanding, communication skills, and regulatory knowledge. ------------------------ MORE ABOUT THE SCENARIONIST: - Discover all the episodes, trends analysis, and more: https://www.thescenarionist.org/ - Stay in the loop with our latest news: https://www.linkedin.com/company/thescenarionist/ - Let’s connect: https://www.linkedin.com/in/nmarchese-md/ ------------------------ #deeptech #fda #innovation