Product development plan (PDP)


Academic spinout developing novel biologics for treatment of pulmonary diseases.


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.


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.


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