Maximizing Potential, Minimizing Time, Cost, & Risk: Mastering 505(b)(2) Development Strategy

In the US, drug development pathways are referred to by their corresponding section in the Federal Food, Drug, and Cosmetic Act: 505(b)(1), 505(b)(2) and 505(j). A 505(b)(1) program is generally used for novel drugs that have not been previously studied or approved, while a 505(j) program is used to develop a generic form of an innovator drug.

A 505(b)(2) program must demonstrate safety and efficacy to the same standards as a 505(b)(1) program, but at least some of the information required for approval comes from studies not conducted by or for the applicant. Because of this, when the right strategy is used, a 505(b)(2) product can often be developed with less risk, in less time and at lower cost than a 505(b)(1) product while obtaining market exclusivities and patent protection afforded to 505(b)(1) but not 505(j) products.

To realize the full potential of this abbreviated pathway, it is essential to plan for and execute a credibly aggressive development strategy early on. Key stakeholders in critical areas of drug development, including regulatory, chemistry, manufacturing and control (CMC), nonclinical, commercial and clinical, must maintain seamless communication to ensure there are no gaps when it comes time to submit the New Drug Application (NDA).

Register for this webinar today to gain insights into the 505(b)(2) development strategy and how it is unique compared to other traditional drug development pathways. The featured speakers will discuss why a well-thought-out development strategy with a multidisciplinary team approach is the key to avoiding missteps and achieving success.

Speakers

William Salminen, PhD, DABT, PMP, Vice President, Regulatory Toxicology and Clinical Pharmacology, Premier Consulting

William Salminen is board-certified in Toxicology and Project Management and has over 20 years of drug development experience for an array of drug products and indications. He leads the Nonclinical/Toxicology and Clinical Pharmacology/Pharmacokinetic groups within Premier Consulting, which provide clients with nonclinical and clinical pharmacology strategies, study requirements and designs, pharmacokinetic modeling, input on regulatory submissions and addressing nonclinical and clinical issues (e.g., Clinical Holds) with regulatory authorities (e.g., US FDA). William’s key experience includes but is not limited to regulatory strategy and advice, nonclinical safety and toxicology strategy and advice, US FDA pre-IND meetings, IND applications and maintenance and NDA and BLA submissions. He has significant experience with 505(b)(2) NDAs and the unique regulatory, nonclinical and clinical strategies involved with developing drugs under the 505(b)(2) pathway.

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Seth DePuy, PhD, Manager, Regulatory Affairs, Premier Consulting

Seth DePuy is a Scientist and Mentor with over 10 years of research experience in both academia and industry and over 5 years of experience in drug development and regulatory affairs for a broad range of therapeutic areas and unique drug products and/or dosage forms. Seth is accomplished in performing thorough background research and assessing scientific and regulatory information to develop/support regulatory strategy and produce quality on-time deliverables to all stakeholders. His key experience includes (but is not limited to) regulatory strategy and support of US FDA meetings, IND applications and maintenance, expedited programs and designation applications and NDA submissions. Seth possesses significant expertise in 505(b)(2) drug development and the unique strategies required for this development pathway.

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