A public-private collaboration model for clinical innovation

Area of Science:

• Translational Science
• Drug Development
• Biomedical Research

Background:

• The National Center for Advancing Translational Sciences (NCATS) launched an initiative in May 2012 to foster industry-academia collaboration.
• This program aimed to advance therapeutic development by connecting pharmaceutical companies with biomedical researchers.

Purpose of the Study:

• To describe the process of establishing collaborations between pharmaceutical companies and academic researchers for novel therapeutic use development.
• To highlight how NCATS funding supported clinical trials and innovative outcome measures for proof-of-concept studies.

Main Methods:

• The initiative involved partnerships with major pharmaceutical companies providing clinic-ready experimental assets.
• Academic researchers proposed clinical trials to test new therapeutic uses for these assets.
• Funding supported nonclinical studies, Phase I and II clinical trials, and testing of innovative outcome measures.

Main Results:

• The program facilitated collaborations for testing new therapeutic uses of pharmaceutical assets.
• While not demonstrating improved Phase II clinical trial success rates, the model provided valuable research opportunities.
• The initiative supported the testing of innovative outcome measures for proof-of-concept trials.

Conclusions:

• The NIH-Industry Partnerships initiative successfully created a collaborative model between pharmaceutical companies and academic researchers.
• This collaboration model, with a focus on innovative outcome measures, has the potential to reduce patient burden and trial costs.
• The program demonstrated the value of leveraging combined strengths to advance therapeutic development and improve patient engagement.