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

Date: April 20, 2022

Presenter: Ken Phelps, Strategic Advisor

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.

View the Webinar