The 505(b)(2) Pathway: Getting to the Clinic Faster

Presented by

Premier Consulting - Ken Phelps, Strategic Advisor

About this talk

Use of the 505(b)(2) regulatory pathway has seen rapid growth as drug developers seek to avoid unnecessary duplication of research and get products to market faster. By making it possible to postpone or outright eliminate trial phases, the 505(b)(2) pathway offers a hybrid between the FDA’s traditional new drug application and its abbreviated new drug application processes — and the opportunity to significantly reduce development time and expense. By taking advantage of existing safety and efficacy data, the 505(b)(2) pathway often enables sponsors to reduce the number of required studies. But it’s no magic bullet: Successful use of this option requires careful design and a thorough understanding of the underlying science. In this webinar, we describe the advantages of the 505(b)(2) pathway, look at common misconceptions, and offer practical advice on its application in the real world. Topics include: Assessing your pre-IND. How do you know if your pre-IND meeting was successful? It was if you land on an approach that meets the FDA’s requirements, even if it’s not the one you initially had in mind. The development plan. It won’t materialize without a hitch, because things happen, and a lot may change. Stay close to the FDA as the plan comes together to avoid costly missteps. Simpler, shorter, less costly studies. Sponsors using the 505(b)(2) pathway often can forgo Phase 3 trials or postpone elements to the post-approval phase, when the product is already starting to generate revenue. The importance of CMC. Take care of your chemistry, manufacturing, and controls. CMC issues trigger FDA refuse-to-file letters more than any other cause.
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Premier Research is a clinical research company, dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments. As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors. Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions.