Register today for our upcoming live webinar on Tuesday, May 11th entitled: "Accelerating Development of 505(b)(2) Drug Products: A Competitive and Alternative Strategy"
Significant industrial research is focused on the development of new products and indications for drugs that already have regulatory approval. From a patient perspective the benefits of this are multiple; improved formulations can lead to increased compliance and enhanced clinical outcomes, new routes of administration can offer greater convenience, new therapeutic indications can address unmet clinical needs. For an innovator company this repurposing of existing drugs can help manage the value of a new chemical entity (NCE) through its life-cycle, with the benefit of reduced development time, cost and risk. In addition there are also increasing examples of drug delivery technology companies moving into product development and leveraging their innovative formulation know-how to improve the clinical performance of established drugs.
In the US, the regulatory approval pathway for such products is via 505(b)(2) submissions. This allows development companies to access and leverage existing regulatory data packages on the previous NCE and supplement with additional information relevant to the new product (typically additional CMC and clinical data).
The 505(b)(2) pathway allows for both the development and FDA approval to be considerably accelerated compared to the 10-15 years for traditional NCE development with reduced expenditure. However, 505(b)(2) programs can present some unique development challenges, particularly from a CMC perspective; How can a new or improved formulation be quickly identified? How can this be optimized prior to pivotal pharmacokinetic or therapeutic equivalence studies? How can scale-up and commercialization be streamlined?
In this presentation we will discuss the 505(b)(2) framework and the various classification types, and reflect on some of the challenges, considerations, and tactics for companies pursuing this development route.
Key topics covered in this presentation include:
· The advantages of a 505(b)(2) approach
· 505(b)(2) classification types and related CMC development strategy options
· Pros and cons of traditional development vs integrated approaches
· Benefits of real-time manufacturing within Phase 1 studies to optimize formulations prior to pivotal studies
· Several in depth case studies
· Considerations when selecting a development partner