Client:

‍Academic spinout developing novel biologics for treatment of pulmonary diseases.

Problem:

‍The company had many preclinical programs in parallel. They needed guidance on how to prioritize them, select lead indication and execute effectively on a limited budget with aggressive timelines.

Solution:

We formed a project-focused team of experienced drug developers, regulatory,CMC/manufacturing advisors, and project managers. The team developed a detailed, custom drug development plan (PDP) to IND. The client engaged us on a monthly retainer basis to then execute on that plan through our network of vendors. We also assisted the company in meeting with the FDA for the pre-IND meeting.

Results:

By engaging Radyus on a monthly retainer basis ensured wholistic product development planning and effective execution of the novel therapeutic modality. The company is now entering IND-enabling studies.

Related Radyus Services:

‍+ Product development plan (PDP)

+ Monthly FTE retainer model

+ Pre-IND meeting coordination

+ Regulatory and manufacturing advisory