Value & Development Consulting

Cell and gene therapy product development is complex and ever-evolving. Bringing a product from the research bench to the bedside can be a very challenging journey. A group of our experts sat down to discuss what key elements drug developers need to focus on in the early stages of their cell and gene therapy program that will set them up for future success.

Discover effective strategies to lower study complexity and mitigate amendment risk that can equate to patients having earlier access to new therapies and companies seeing significant returns on their investment in this white paper.

Utilizing innovative approaches to the 505(b)2 pathway can save companies time, money, and resources in developing their new product. This webinar will examine the benefits and challenges associated with the 505(b)2 pathway and how innovative solutions and planning in the early stages of development can help support a more streamlined and faster pathway towards approval.

The availability of these multiple FDA pathways makes it difficult to identify which pathway is appropriate for specific assets, and the timing of FDA interactions to seek approval/concurrence for the selected pathway. This webinar will provide a concise overview of these FDA initiatives and strategic regulatory guidance for selecting the optimal regulatory pathway for COVID-19 treatment development programs in the US.