Modern drug development is a challenging journey that must navigate classical regulatory hurdles (Quality – Safety – Efficacy) and address various other obstacles, including a potentially intensifying competitive landscape. In certain regions, such as Europe, market access is further influenced by Health Technology Assessment Agencies (HTA). The clinical development plan (CDP) for an innovative drug mirrors a car rally, with mandatory check-points, but the optimal route to these stops can be determined by an intelligent and agile strategy through decision gates. This strategic approach can be the defining factor that sets the winner apart from others, contributing to success, especially in the early phases of drug development, and securing solid and lasting financial support from investors.

Leveraging its unique background and expertise, Bieber Dermatology Consulting (BDC) offers a spectrum of services designed to shape your clinical development strategy, integrated evidence plan (IEP), and the life cycle of your medicinal product.