Hoang Nguyen, PhD: Lupus Research Alliance Announces Partnership With FDA, Lupus Community

In an interview with HCPLive, Hoang Nguyen, PhD, Director of Scientific Partnerships at the Lupus Research Alliance (LRA), discussed the recent partnership between the LRA, the US Food and Drug Administration (FDA), and the lupus community. The collaboration, titled the Lupus Accelerating Breakthroughs Consortium (Lupus ABC), is the first public-private partnership designed to advance lupus discoveries and highlight patient perspective in drug development.

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HCPLive: Can you tell me a bit about how and why Lupus ABC was created?

Hoang Nguyen, PhD: In 2014, the Congressional Lupus Caucus asked the National Institutes of Health (NIH) to come up with an action plan for lupus research. The NIH then convened different stakeholders in the lupus field to gather their input, resulting in the publication of an action plan for lupus research in 2015. The plan suggested that it would be beneficial for the lupus community to have different ways to collaborate for all different stakeholders. At the Patient-Focused Drug Development (PFDD) program in 2017, the needs of patients were brought to the forefront, including the lack of incorporation of patient perspectives in the drug development evaluation process. The idea of collaboration with all different stakeholders, including regulators, arose from discussions with the LRA Advisory Board and the Lupus Industry Council. The LRA then took the lead and asked different stakeholders to join in this effort with the FDA to create the Lupus ABC.

HCPLive: What roles do the LRA and the FDA play in this partnership?

HN: The FDA has assigned 3 liaisons to be part of the Lupus ABC, but they are non-voting and will only offer insights on the regulatory aspect of the projects that the community will come up with. The LRA is the convener and brings together all different stakeholders. The Lupus ABC has 2 governing bodies: the Lupus Voices Council and the research committee. The Lupus Voices Council consists mostly of people with lupus and their advocates who will define what projects they want the Lupus ABC to focus on and bring that perspective to the research committee. The research committee is composed of clinicians, scientists, and people with an interest in lupus research and will define the highest priorities for the lupus community and the biggest challenges in developing new drugs. They will also define working groups. The FDA will be involved in every step of the process to provide input in real time.

HCPLive: What scientific opportunities for progress or upcoming initiatives are being planned?

HN: The first meeting of the Lupus ABC will be on April 16th and 17th, where the community will decide on the challenges they think are most important. There are no specific projects yet, as it depends on the decision of the research committee. However, 2 initiatives that are being planned are to look at patient-reported outcomes and how to improve ways to enroll patients and measure the outcomes. One of the major challenges in the field is how to measure the efficacy of drugs, as patients have different symptoms, and it's hard to measure the symptoms and determine if a drug works. One area that Lupus ABC will focus on is finding ways to divide patients effectively into subgroups so that they can be enrolled in the appropriate clinical trials most fitting for their symptoms.

HCPLive: In your opinion, how will Lupus ABC help patients, researchers, and clinicians?

HN: I believe that Lupus ABC will be instrumental in bringing together patients, researchers, and clinicians to work collaboratively on finding solutions to advance lupus drug development. With Lupus ABC, patients are at the same table with researchers, and this helps to ensure that their perspectives and priorities are heard and considered.

HCPLive: How long will this initiative last?

HN: While there is no set end date for Lupus ABC, each project that a working group or research committee takes on will have defined deliverables and timelines. This ensures that progress is being made towards resolving the challenges facing the lupus community.

HCPLive: Is there anything else that we haven't discussed that you think our audience should know?

HN: I would like to emphasize that Lupus ABC is a long-term collaboration that will require effort and time from everyone involved. While we are optimistic for the future, the hard work is still ahead of us. We are encouraged by the responses from the groups that have joined, and we want to make sure that everyone stays engaged to ensure that progress is made in advancing lupus drug development. The FDA has recognized the challenges faced by the lupus community and is committed to working together to overcome them. This is just the beginning of a unique opportunity to collaboratively find solutions to advance lupus drug development.

This transcript was edited for clarity.