The Drug Discovery and Development Program bridges the gap between basic research and clinical applications by leveraging internal and external resources to advance promising therapeutic technologies. We serve as a central hub to integrate all resources for a development campaign. Our technical, scientific, project management, and operations expertise enables us to guide cutting-edge therapies from concept to clinical study deployment. 

Advancing novel therapy discoveries to clinical studies 

Our team serves as a guide on the challenging journey from exciting research breakthrough to safe, effective patient therapy. We progress research and development campaigns to Investigational New Drug (IND) filings using internal and external technical resources as appropriate for each project, ensuring compliance with complex processes and regulations that govern translational research. 

Providing comprehensive project management from concept to clinic 

Our self-sufficient team’s scientific and operational expertise allows us to successfully steer new therapy candidates from basic research toward clinical trial initiation. We support projects at any stage of the development lifecycle to advance therapeutic campaigns as efficiently as possible.  

Collaboration Opportunities

Want to work with us? We are open to collaborations!

Reach out at FNLDDD@nih.gov for more information if you are interested in our team’s project management services. 

Managing multiple projects at various development stages 

Our team supports campaigns including proof-of-concept for new drugs, manufacturing process development, assay development, safety and toxicity studies, pre-IND studies to enable regulatory filing, and early-stage clinical trials. We support campaigns for therapeutic use of small molecule drugs, antibodies, proteins, and viral vectors.  

Project management 

Our personnel have expertise in various types of technical and operational project management. We leverage hybrid project management approaches and the strengths of our individual backgrounds to fully support drug development campaigns. 

Sourcing 

Our team understands how to properly resource projects using internal or external partnerships to drive project success. 

Mesothelioma Spheroid
Furthering a Novel Cancer Therapy

Solid tumor treatment project

Our team supports the development of a promising treatment for solid tumors using photoimmunotherapy. As part of this project, our approach to evaluate and advance the best antibody candidate has yielded beneficial results.
A single vector
Advancing New Gene Therapies

Platform Vector Gene Therapy (PaVe-GT) project

Our team supports the development of gene therapy platforms and drug candidates as part of the NIH PaVe-GT Initiative. These technologies will treat rare genetic diseases and pave the way for future breakthrough therapies.
Learn More