The mission of the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) is to unite individuals with lupus and their advocates, industry, clinicians, researchers, and government stakeholders to identify and pursue the most effective ways to accelerate lupus drug development in a collaborative, pre-competitive setting.
Our Challenge
Lupus is complex.
Lupus is a heterogeneous disease – it presents many symptoms that vary from person to person, and symptoms can even change over time. This makes lupus especially difficult to diagnose and treat, which impacts patients’ quality of life and long-term survival. There have also been major challenges to the development of safe, effective, and tailored treatments to improve these outcomes.
The extraordinarily high rate of failed lupus trials has led to a consensus among experts that current endpoint measures – how safety and effectiveness of potential treatments are evaluated – and trial designs may be unable to capture meaningful data on a drug’s effects. Furthermore, physician-assessed outcome measures do not include certain outcomes that are most important to people with lupus.
Additionally, there is a continuing need to better incorporate and elevate patient voices in the current approach to lupus therapeutic development. This is especially true for minority populations who are impacted most severely by the disease. This perspective is fundamental to the ability to execute successful trials and ultimately provide benefits to people with lupus with the highest unmet need.
Our Opportunity
There is a robust pipeline of tens of lupus treatments currently being tested. There are also rich data from previous failed trials that add new insights and advance our ability to design better trials. The lupus community is ready to work in partnership with the FDA to ensure potential new lupus drugs can be effectively evaluated and rapidly approved. Together, we will deliver a modern approach that ensures safer and more effective treatment options for people living with lupus.
The Lupus Accelerating Breakthroughs Consortium Will
1
Bring the experiences, perspectives, needs, and priorities of people with lupus into the spotlight as a key partner in developing new lupus treatments.
2
Enable open collaboration between key stakeholders and regulators to develop and pursue initiatives that have the highest potential for improving the health outcomes of individuals with lupus.
3
Identify and pursue the most effective ways to accelerate lupus drug development.
4
Convene workshops, produce white papers, and publish articles that could inform updated guidance on lupus drug development.
Lupus Therapy Development
