Drug and Other Therapy Development

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:

  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

 Plans for 2019:

  • Identify one or two additional co-chairs
  • Queue up at least one collaboration or consortium involving an HRA member(s) for presentation and discussion as a case study at a members’ meeting
    • If multiple consortia/collaborations are identified, establish a webinar series of brief presentations and summaries as case studies
  • Further curate the toolkit of toolkits

Co-Chairs

In 2018, the Drug and Other Therapy Development Working Group is being co-chaired by:

  • Steve Roberds, Chief Scientific Officer. Tuberous Sclerosis Alliance
  • Another co-chair is needed!