Lupus Research Alliance Collaborates with the FDA to Launch Public-Private Partnership

Lupus Research Alliance Collaborates with the FDA to Launch PublicPrivate Partnership image

The Lupus Research Alliance (LRA) announced the launched of Lupus Accelerating Breakthroughs Consortium (Lupus ABC), a public-private partnership. The goal of the partnership is to bring people with lupus together in collaboration with the FDA, other federal agencies, medical societies, industry, academic clinical researchers, and scientists to overcome scientific hurdles that are beyond the capacity of any single entity and to advance the development of urgently needed, personalized treatments for lupus.  

“Public-private partnerships such as Lupus ABC can play a critical role in addressing gaps in drug development in a collaborative, precompetitive setting," FDA Principal Deputy Commissioner Janet Woodcock, MD, said in a news release. "We appreciate the Lupus Research Alliance convening this consortium and bringing together the diverse expertise and perspectives of patients, researchers, regulators, and industry to tackle the most pressing issues in improving therapies for individuals with lupus.” 

Lupus is a complex, potentially life-threatening autoimmune disorder that disproportionately impacts women and communities of color. Lupus can affect the joints, skin, brain, lungs, kidneys, and blood vessels, causing widespread inflammation and tissue damage in the affected organ. A heterogenous disease, lupus affects each person differently and its effects can change over time, making it one of the most difficult diseases to diagnose and treat. Black, Hispanic/Latino, Asian, and Native American populations are two to three times more likely than white Americans to be diagnosed with lupus.  

“The clinical development of lupus therapies has long faced major challenges with only three drugs approved specifically for the disease in nearly 70 years. Lupus ABC offers the exciting opportunity to change that by providing a unique forum to address collaboratively scientific and clinical barriers. Inspired by the success of other FDA Public Private Partnerships, the Lupus ABC will enable the faster delivery of new and improved therapies for people with lupus,” said Teodora Staeva, PhD, Vice President and Chief Scientific Officer, LRA. “We are grateful to the FDA for their commitment and support in establishing this crucial partnership.”  

The Lupus Accelerating Breakthroughs Consortium will provide a forum for the lupus community to define common barriers impeding successful drug development and take actions that will have the greatest and most immediate impact on advancing therapeutic development for lupus. Initially, these efforts will focus on finding ways to:  

  • Better evaluate the impact of potential treatments by refining existing measurement tools that clinical research has shown may not always adequately assess a drug’s effectiveness. 
  • Fully incorporate the patient voice into the drug development process by optimizing patient-reported outcome measures, enabling recognition of the impact of potential treatments on specific symptoms that matter most to patients. 

“The Lupus Accelerating Breakthroughs Consortium will, for the first time, truly give people who live with lupus and their caregivers a platform where they can be heard and involved in the treatment development process directly with all stakeholders,” said Veronica Vargas Lupo, co-lead of the Consortium’s Lupus Voices Council. “As someone who has lived with the disease for many years and knowing the wide range of symptoms that those of us with lupus experience, having a voice in this process is immensely important. It is so critical for our perspectives to be considered when designing clinical trials and measuring outcomes to develop tailored therapies in lupus.”   

For more information about the Consortium, visit  

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