Mastering 505(b)(2) Drug Development:Strategic Pillars & Bridging Considerations

Presented by

William Salminen Ph.D. DABT PMP VP Premier Consulting ; Seth D. DePuy, PhD Manager, Regulatory Affairs Premier Consulting

About this talk

Join us for a comprehensive webinar that delves into the intricacies of successful drug development under the 505(b)(2) pathway. In addition, this webinar will explore the strategic pillars and bridging considerations essential for mastering the art of 505(b)(2) drug development. The first part of the webinar will focus on the strategic pillars of success. We will examine the five key pillars - commercial, science, regulatory, medical, and legal intellectual property and business - that form the foundation of a successful development program. Through real-world examples and relevant questions, we will delve into commercial viability, value proposition, scientific bridging, and persuading regulatory agencies. By integrating the scientific and regulatory pillars, we will discuss how to establish a strong scientific bridge from your product to existing data or published literature, resulting in reduced development costs and accelerated time to market. Building upon the strategic pillars, the second part of the webinar will dive into bridging considerations. Bridging plays a critical role in drug development, and we will explore various strategies and scenarios where bridging can be applied. We will examine the concept of bioequivalence, comparative bioavailability, and the FDA's guidelines for bioequivalence studies. Additionally, we will discuss bridging strategies that do not require clinical data, such as bio waivers based on physiochemical properties or in vitro-in vivo correlations. Furthermore, we will explore bridging considerations related to manufacturing changes, local safety, and demonstrating consistency despite formulation modifications. Join us and master the art of 505(b)(2) drug development by leveraging strategic pillars and bridging considerations to optimize your development program and achieve regulatory approval. Please note: If we do not answer your questions during the webinar, we will follow up afterwards. Contact
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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.