The Rare Disease Community has developed the Drug Development model
When a new drug or device is brought to market in collaboration with disease-specific lived-experience experts the process becomes known as community-based drug development.
In 2012, the biopharmaceutical industry began investing into the development of patient advocacy-based partnerships to assist in the creation of "patient-centric" messaging for the commercial stage of drug development. Theoretically, the partnership between the advocacy and industry landscapes was supposed to improve the drug development process and inject the patient voice into the process. However, advocacy-based campaigns are not designed to partner lived-experience experts with drug developers.
As a result, burdensome clinical trials fail to deliver on unrealistic endpoints. The biopharmaceutical industry has been losing billions on poorly designed studies, wasteful recruitment campaigns, out-of-touch adherence strategies, incorrect indication choices and the ultimate decision of shutting down a study to shelve an otherwise viable product.
As the biopharmaceutical industry continues to lose money following this ancient drug development model, the people of the rare disease community have taken matters into their own hands and have evolved the drug development continuum.
FRAXA Research Foundation's Drug Development Initiative (DVI) is the first community-based drug development program.
Rare Love Ventures (RareLove.life) is the first rare disease community-based business center, developed in partnership with RAM's rare360 program.
Community-based activists, lived-experience experts, community-focused industry stakeholders and community-focused advocacy professionals are all encouraged to contact RareLove.life to learn more.