Working Group Description
The DOTD Working Group helps HRA members identify strategies to accelerate discovery and development of drugs and other therapies in members’ areas of interest. It has two priorities:
- Share examples of collaborations and/or consortia among academic and industry partners that are catalyzing effective drug discovery, drug development, or biomarker development.
- 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:
- Effect of nonprofit accounting standards on funding models
- Working with big pharma – access to drugs on the shelf and a role for nonprofits in pharma drug development programs
- Strategies for pricing of drugs developed with nonprofit funds
- Clinical research infrastructure to subsidize drug development costs
- Metrics for drug development programs
- FDA issues: need for regulatory science; the need for EMEA-FDA harmonization
- Sharing documents such as MTAs, NDAs, research contracts, and multi-party contracts
In 2018, the Drug and Other Therapy Development Working Group is being co-chaired by:
- James Hendrix, Director, Global Science Initiatives, Medical and Scientific Relations, Alzheimer’s Association
- Steve Roberds, Chief Scientific Officer. Tuberous Sclerosis Alliance