FAQs

What is the Lupus Accelerating Breakthroughs Consortium?

The Lupus Accelerating Breakthroughs Consortium (Lupus ABC) is a public-private partnership (PPP) with the U.S. Food and Drug Administration (FDA) and other key lupus stakeholders with the mission to identify and pursue the most effective ways to accelerate lupus drug development.

Lupus ABC provides a pre-competitive open forum for regulators, drug developers, academics, patient-focused non-profits, professional societies, and government representatives to collaboratively develop and pursue initiatives that address the most pressing drug development issues in Systemic Lupus Erythematous (SLE), Lupus Nephritis (a serious complication to lupus affecting the kidney), and Primary Cutaneous Lupus (skin-related lupus).

Why was Lupus ABC established?

SLE (lupus) is a complex, multisystem autoimmune disease predominantly affecting women and disproportionately impacting Black/African American, Native American, Hispanic/Latino and Asian populations. Ninety percent (90%) of people with lupus are female, with women of color affected at a three-times higher rate than white Americans. Lupus is a leading cause of premature cardiovascular disease, heart attack, stroke, and kidney disease among young women and is a leading cause of death in young women of color.

One of the difficulties of diagnosing and treating lupus is the variability of its symptoms. No single test exists to diagnose SLE, and it can take four to six years – and an average of three doctors – for a patient to get diagnosed. Absent of a cure, treatment is focused on preventing flares, managing symptoms, and reducing organ damage. A variety of medications are used to treat lupus, many of which have major side effects. The unpredictable nature of the disease, as well as the effects of disease activity and treatment, can severely impact the quality of life for individuals with lupus.

While the lupus drug development pipeline remains strong, with tens of therapies being tested in clinical trials, only three drugs have been approved specifically to treat lupus to date. Although the failure of most clinical trials is due to the inefficacy of the experimental drugs, the extraordinarily high rate of failed lupus trials has suggested that the current design of clinical trials and methods of measuring improvement of symptoms may be inadequate to capture meaningful readouts of a drug’s effect. Furthermore, certain outcomes that are most important to patients are not incorporated in the drug development and evaluation process.

In response to the urgent and long unmet need for lupus therapies, Lupus ABC was established as a PPP with the FDA and other key lupus stakeholders. A PPP serves as a platform for federal regulators and external stakeholders to collaborate with a shared goal of prioritizing the most crucial scientific and regulatory inquiries that can lead to significant and immediate impact on patients. The FDA has long supported the PPP model as a mechanism to address scientific hurdles that are beyond the capacity and resources of any single organization or company. 

Lupus ABC provides a unique forum, convening people with lupus, federal agencies, medical societies, advocacy groups, industry, academic clinical researchers, and scientists in a pre-competitive and collaborative setting. Its primary focus is to address the most pressing drug development issues in lupus that have the highest potential for improving the health outcomes of individuals with lupus. Lupus ABC serves to foster the cooperation required to meaningfully tackle barriers in lupus research and to give people living with lupus a voice in relevant scientific advancements.

What is the scientific framework of Lupus ABC?

Lupus ABC, which includes FDA representation, discusses and shapes the ultimate vision as well as the short- and long-term research agenda of Lupus ABC with the following goals:

• Bring the experiences, perspectives, needs, and priorities of people with lupus into the spotlight as a key partner in developing new lupus treatments.
• 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.
• Identify and pursue the most effective ways to accelerate lupus drug development.
• Convene workshops, produce white papers, and published articles that could inform updated guidance on lupus drug development.

How does Lupus ABC function?

Lupus ABC is led by two key governing bodies – the Research Committee (RC) and the Lupus Voices Council (LVC). The RC is comprised of members from industry, academic, medical, and patient communities, as well as governmental agencies including the FDA. The LVC is comprised of individuals living with lupus, their family members or care providers, and representatives of advocacy organizations. The RC incorporates input from LVC in its decisions, ensuring that the perspectives of individuals with lupus are incorporated into the work of Lupus ABC. The RC sets priorities for the Consortium and defines projects that address these priorities.

Based on Lupus ABC strategic research priorities and consensus, the RC and the LVC empanel Working Groups (WGs) and oversee their progress. The RC and LVC meet quarterly. WGs meet at a cadence defined by the individual WG to accomplish its specific objectives and milestones. Progress is reported to the RC and LVC at quarterly meetings.

Public Dissemination of Activities and Outcomes

The Lupus ABC website posts regular updates on the work of the PPP, including any work products such as summaries of any workshops and annual meetings. Regular updates specifically geared towards the community of individuals living with lupus are also provided through the website and disseminated directly to the member organizations of the PPP. Lupus ABC also seeks to disseminate information about its activities at scientific and patient-focused meetings. Scientific workshops sponsored by Lupus ABC may be open to the public.

Ethics and Conflicts of Interest

Lupus ABC complies with all applicable ethics and conflict of interest rules required by the Lupus Research Alliance (LRA) and by FDA in FDA’s Manual of Policies and Procedures at CDER Staff Participation in Public Private Partnerships and Consortia (fda.gov). See the LRA guidelines for working with industry.

Funding

Funds raised for Lupus ABC are used solely for costs of supporting Lupus ABC.

Management

Lupus ABC operations are managed by the Lupus Research Alliance.

Who can join Lupus ABC?

Membership is open to patient organizations, academic institutions, companies, federal agencies, and other entities committed to active and consistent participation in the PPP’s work to advance the development of new treatments and cures for lupus. For further information on Lupus ABC and membership, please sign up or contact LupusABCinfo@lupusresearch.org.