FDA Workshop to Qualify Lupus Biomarkers

Today, representatives from the Lupus Foundation of America national office and the LFA Medical-Scientific Advisory Council (MSAC) are participating in a workshop hosted by the U.S. Food and Drug Administration (FDA) to discuss potential biomarkers for lupus. This meeting will bring together representatives of the federal government, the biotech and pharmaceutical industry, key scientific opinion leaders, as well as all lupus advocacy organizations, including the LFA.

Several LFA research grantees and a member of the LFA MSAC will be making presentations, including Dr. Ken Kalunian of the University of California, San Diego, who will present results of LFA Collective Data Analysis Initiative (CDAI), which examines data from past clinical trials of potential lupus drugs. The CDAI is a project of the LFA National Research Program, which seeks to examine the impact of background therapies on trials of potential treatments for lupus. It is unique and the first in its kind in lupus.

Biomarkers are important to lupus drug development, regulatory review and clinical practice. A biomarker is a substance, molecule, gene or characteristic that is used as an indicator of a biological state. It is often used to determine the effect of a particular therapy on a patient with lupus. Validated lupus biomarkers will have a positive impact on accelerating the drug-review process by the FDA of potential new treatments for lupus.

Biomarkers have been an important focus for the LFA's National Research Program: Bringing Down the Barriers. The LFA commissioned a study by the nationally recognized health policy research organization, The Lewin Group, to address barriers to lupus drug development. Their report, entitled "Overcoming Barriers to Drug Development in Lupus," both outlines obstacles to lupus drug development and provides recommendations for overcoming them. One recommendation from the Lewin Report was to "establish and fund a consortium to expedite the identification and validation of biomarkers for lupus", which begins with this workshop. The LFA has provided considerable funding to support the work of the Lupus Biomarkers Working Group which was studying lupus biomarkers. This FDA workshop continues that process.

The two-day meeting is a continuation of a process that began as a series of conference calls hosted by the FDA last summer with members of the lupus medical community. The calls were held to discuss the potential to identify lupus biomarkers that would qualify for the FDA's "Qualification Process." The process starts with a scientific meeting to showcase the scientific state of the art in lupus biomarkers research, review the process for biomarkers qualification at the FDA, and obtain consensus on which biomarkers to pursue for the qualification process.

With more safe treatments, people with lupus can look forward to an improved quality of life. However, biomarkers will need to be well defined and the qualification protocol developed before we can move forward.

Attending the meeting will be LFA President and CEO Sandra C. Raymond and LFA Vice President for Education and Research Leslie Miller Hanrahan. They will be providing updates during the meeting. Keep an eye out on our Twitter feed for tweets from the LFA throughout the day.

Lupus Researchers Will Examine Ways to Best Apply Findings From Lupus Mouse Model to Human Lupus

Nearly 200 lupus researchers, clinicians and representatives from government, industry, academia and nonprofit organizations involved in lupus research will gather on the campus of the National Institutes of Health to look at ways to best apply research findings from lupus mouse models to human lupus. The agenda includes presentations from twenty scientists, including discussions about new insights into lupus gained from clinical studies and animal models, advances and challenges in treating lupus, analysis of the genetics of lupus in humans and animals, and the future of lupus research and treatment.

“This meeting is bringing together researchers that are experts in mouse models of lupus and human lupus,” says Dr. Gary Gilkeson, Professor of Medicine at the Medical University of South Carolina, and Chair of the Lupus Foundation of America (LFA)’s Medical-Scientific Advisory Council. “The goal will be to review the current state of research in mouse models of lupus and how they can best be applied to human lupus in defining new biomarkers, new genes and new treatments of disease.”

This meeting on September 2-3 at the National Library of Medicine in Bethesda, Maryland is sponsored by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Allergy and Infectious Diseases (NIAID), National Cancer Institute (NCI), and NIH Office of Research on Women’s Health (ORWH). The LFA assisted with meeting planning and has helped to underwrite a portion of the expenses associated with the meeting as part of its ongoing support for research to advance the science and medicine of lupus.

During this meeting participants will discuss similarities, as well as differences, seen in human disease and animal models. Organizers are also hopeful that participants may be able to develop a consensus around the most important features of lupus and what animal models might be most useful in future studies of the disease. The LFA will report additional details of the meeting in a future issue of The Lupus Research Report. If you don’t already receive LFA’s eNewsletter you can sign up for free.

Read more about the upcoming meeting.

LFA Congratulates Dr. Joseph Ahearn for Receiving DoD Grant for Research on Lupus Biomarkers

The Lupus Foundation of America, Inc. (LFA) congratulates Joseph M. Ahearn, M.D., Associate Professor of Medicine and Co-Director of the Lupus Center of Excellence at the University of Pittsburgh, for being selected to receive a research grant from the U.S. Department of Defense’s (DoD) Congressionally Directed Peer Reviewed Medical Research Program (PRMRP). The DoD award will fund the Lupus Center of Excellence’s ongoing studies on lupus biomarkers.

Biomarkers are specific biochemicals found in the body which are structured in a way that make them useful for diagnosing a disease, measuring its progress or measuring the effects of treatment. Research on lupus biomarkers is a key area of scientific interest for the LFA.

Dr. Ahearn also is the recipient of a research grant from the LFA for a study on lupus biomarkers, "Biomarkers for Diagnosis, Monitoring and Prognosis in Pediatric Lupus." This is the first study in which biomarkers for lupus are being investigated in both adults and children. Dr. Ahearn is one of two lupus investigators to receive grants through the LFA’s newly established Michael Jon Barlin Pediatric Lupus Research Program. The LFA is the only national voluntary health organization with a research program specifically dedicated to studies on lupus in children. Read more about this research initiative and Dr. Ahearn’s research study.

Through its advocacy initiatives that began in 2003, the LFA pioneered efforts to have lupus and lupus biomarkers included as disease areas eligible for research funding through the PRMRP. The LFA made a persuasive case to DoD officials that described the relevance of lupus research to military personnel and their dependents. These efforts have opened a new source of much needed funds to support research on lupus.

Since including lupus and lupus biomarkers among the areas approved for funding, the PRMRP has awarded six grants totaling more than $6 million in new funding to support important studies. Four of the six DoD grants have specifically been awarded for studies on lupus biomarkers.

The development of new biomarkers for lupus could have profound benefits in obtaining U.S Food and Drug Administration (FDA) approval for new, safe and more tolerable therapies for lupus, not only by providing the sophisticated level of guidance needed so that these agents will work optimally, but also by simultaneously providing objective measurements to demonstrate if the new treatment is working. More targeted therapies, or even better biomarkers to guide existing treatments, will allow physicians to treat lupus while avoiding the sometimes devastating side effects caused by current methods used to control the disease.

Funding for lupus research through the DoD and all other relevant federal agencies has been a long-recognized priority for LFA advocacy efforts. Due to the changing demographics of the military population, there is an ever-increasing prevalence of lupus in military and Veterans Hospital Clinics. The LFA recognized this emerging health issue and worked to have lupus included in the PRMRP to advance research on lupus, which ultimately will help military personnel and their families affected by lupus.

To learn more, visit the DoD’s Congressionally Directed Peer Reviewed Medical Research Program’s Web site at http://cdmrp.army.mil/prmrp/

Learn more about LFA advocacy initiatives or LFA-funded research.

Watch a video interview with Dr. Joseph Ahearn, Director of the Lupus Center of Excellence at the University of Pittsburgh. Below, he discusses his LFA-supported research study, "Biomarkers for Diagnosis, Monitoring and Prognosis in Pediatric SLE."