Ready to guide you through nonclinical requirements applicable to 505(b)(2) products, Camargo provides its own proven methodologies and strategic support in the following areas:
- Due diligence
- Nonclinical program development
- Nonclinical protocol design
- Pre- and post-IND and IND
- Preparation and submission
A 505(b)(2) approval strategy often relies heavily on literature to establish the safety and efficacy of the new product and potentially reduce the number of studies required to support the application. Generally, an analysis of any previous U.S. approvals, published literature on the nonclinical pharmacology and toxicology of the active ingredient, and prior international marketing experience drive the nonclinical and clinical 505(b)(2) strategy.
In the nonclinical stage, it’s important to note some distinctions between 505(b)(2) and traditional development strategies.
- Since public data may be used in lieu of novel trial data, numerous nonclinical studies and safety and efficacy tests may not be necessary to achieve 505(b)(2) approval.
- Because 505(b)(2) candidates often have known safety profiles and previous demonstrations of efficacy, risk is diminished, which fosters investment appeal.
- 505(b)(2) often allows nonclinical and clinical studies to be completed in parallel, abridging the process even further.
These factors should be part and parcel of your nonclinical and clinical 505(b)(2) strategy. Awareness of published literature, existing risk-benefit profiles and opportunities to run parallel studies is critical to building and executing a robust nonclinical program to reduce short- and long-term costs.