The LRA CEO discusses his work with the organization and recent trends in Lupus R&D.
Since joining the Lupus Research Alliance (LRA) in 2015, Albert T. Roy has risen to the role of president and CEO. During that time, he’s increased the organization’s role in R&D and has helped push drugs into the Lupus treatment pipeline. He recently spoke with Pharmaceutical Executive about his work and recent trends he’s seen in the space.
What recent innovations are having a positive impact on clinical trial design for Lupus treatments?
We’re starting to see some exciting innovations that could change how clinical trials for lupus are designed in the future.
For example, the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) a public-private partnership that includes the FDA and other key lupus stakeholders, is helping move the needle on developing better outcome measures and introducing new outcome measures. We’re also seeing promising treatments on the horizon––from oral to novel therapies––which could open the door for more personalized approaches. There is also real potential with improved and innovative trial design––from inclusion in “basket” trials, shared placebo, and umbrella––that allow us to evaluate multiple therapies or diseases more efficiently.
What are some ways to increase diversity in research and reduce health inequities in this area?
There are two ways in which the LRA has focused and continues to bolster efforts: community-based outreach and recruitment efforts, and healthcare provider/patient education and engagement.
Conducting community-based outreach and recruitment can increase diversity in research and reduce healthcare inequities. Lupus Therapeutics, the clinical affiliate of LRA, is working to bridge these divides. For instance, because people of color are not well represented in clinical trials despite their greater risk and severity of lupus, Lupus Therapeutics is working on the community-based program called Project CHANGE (Community-based Health Action Network to Generate trial participation and Eliminate disparities) to ensure that any new treatments are developed, evaluated, and ultimately used by communities in greatest need.
Additionally, including peer-to-peer education and support allows for a more authentic and effective connection to drive participation. Take Patient Advocates for Lupus Studies (PALS). This program trains people with lupus who have participated in a clinical trial to provide others with lupus with the tools needed to learn about and make informed decisions about joining a clinical trial. Building that authentic connection between people with lived experience can make such a meaningful difference.
Another way to reduce healthcare disparities is through healthcare provider education and engagement, along with multi-faceted communications channels and culturally competent materials. To help people find the right provider, the Lupus Therapeutics Healthcare Provider Directory offers patients access to a curated list of lupus specialists.
How are patient-centered networks in drug development expanding trial readiness?
Patient-centered networks are expanding trial readiness by fostering trust and aligning clinical research with patient priorities.
Involving people with lupus early, and at each phase of the clinical study design and drug development process, helps ensure protocols are feasible and reflect real-world experiences. Engaging representative communities with lived experiences also helps overcome historic barriers to participation. At the same time, educating providers about these experiences increases awareness of unmet needs and willingness to consider clinical trials as standard-of-care.
Given the importance of public and private partnerships in this area, what are the current trends in partnerships?
Public Private Partnerships (PPP) in drug development have been used increasingly to facilitate collaboration across all sectors––from government to industry to NGOs. The PPP model is a mechanism to address scientific hurdles that are beyond the capacity and resources of any single organization or company.
Lupus Research Alliance, along with the broader lupus community, developed the Lupus ABC in 2023 to facilitate solutions e that would break through drug development barriers that have resulted in only three drugs ever having been developed specifically to treat lupus.
Lupus ABC provides a pre-competitive, open forum for the Food and Drug Administration, patients and patient-focused non-profits, drug developers, academic researchers, professional societies, and other government representatives to collaboratively develop and pursue initiatives that address the most pressing scientific and regulatory questions in lupus.
PPPs, like Lupus ABC, develop specific projects with agreed upon goals that stakeholders work together on. For instance, one of Lupus ABC’s first projects focused on Cutaneous Lupus Erythematosus (CLE). There are no approved mmedications for CLE, and one barrier to drug development has been that there isn’t a clear consensus on how to measure CLE outcomes in clinical trials and therefore no clear regulatory clinical development path. The Working Group studied published and unpublished data to determine if a particular clinical trial outcome could be used in CLE trials in a way that is acceptable and agreed upon by all stakeholders.
PPPs like Lupus ABC are providing an effective pathway to help stakeholders collaborate to solve drug development challenges that have previously slowed drug development and potentially kept individuals from receiving effective treatments.
