Community Description

The Therapeutic Development Learning Community (formerly the Drug and Other Therapy Development [DOTD] Learning Community) helps HRA members identify strategies to accelerate discovery and development of drugs and other therapies in members’ areas of interest. It has two priorities:

1. Share examples of collaborations and/or consortia among academic and industry partners that are catalyzing effective drug discovery, drug development, or biomarker development.
2. Curate and share a “toolkit of toolkits” to enable member organizations to more easily identify and access existing and up-to-date resources relevant to DOTD working group goals.

This group focuses on issues specifically related to drug and other therapy development such as:

• Sharing documents such as MTAs, NDAs, research contracts, and multi-party contracts
• Working with big pharma – access to drugs on the shelf and a role for nonprofits in pharma drug development programs
• Metrics for drug development programs
• FDA issues: need for regulatory science; the need for EMEA-FDA harmonization
• Clinical research infrastructure to subsidize drug development costs
• Effect of nonprofit accounting standards on funding models
• Strategies for pricing of drugs developed with nonprofit funds