Lupus Industry Council (LIC)
The mission of the Lupus Research Alliance Lupus Industry Council (LIC) is to bring industry and academia together to work collaboratively, along with the Lupus Research Alliance, to address common impediments in the pre-competitive space and accelerate shared research goals related to the development of new and improved therapies for patients with lupus.
The guiding principles of the LIC are to:
- Create new opportunities for industry to come together with the Lupus Research Alliance and academia to address shared goals
- Provide a forum for open discussion of issues related to basic/clinical research, patient care, and patient/provider education
- Foster collaboration between industry, the Lupus Research Alliance, and academia to identify and address common challenges in basic/clinical research, patient care and patient/provider education.
The LIC has completed or is currently pursuing the following projects:
Determinants of ANA Expression in Patients with Lupus Project
PIs: David Pisetsky, MD, PhD (Duke University), Peter Lipsky, MD (AMPEL BioSolutions) and Brad Rovin, MD (Ohio State University)
The goal of this study is to assess the expression of antinuclear antibodies (ANA) among patients with Systemic Lupus Erythematosus (SLE), focusing on the frequency of ANA negativity in patients with established disease.
The results of this study were published in the Annals of Rheumatic Diseases in February 2018 and a related letter was published in Arthritis & Rheumatology.
LIC-OMERACT Partnership to Advance SLE Outcome Measures
Project’s Executive Committee: Michal Abrahamowicz, PhD (McGill University ), John Esdaile, MD (Arthritis Research Centre of Canada), Peter Lipsky, MD (AMPEL BioSolutions), Rosalind-Ramsey-Goldman, MD (Northwestern University), Lee Simon, MD (SDG LLC Consulting), Vibeke Strand, MD (Stanford University)
The long-term objective of the project is to propose and then validate new outcome measure(s) for trials of new treatments in SLE by developing Multi-dimensional Response Indices (MRI) with better ‘responsiveness to change’ than the conventional outcome measures, such as SRI used in recent SLE trials. Better responsiveness to change, if confirmed by the rigorous analyses, will imply that use of MRI will increase both (a) the probability of demonstrating statistically significant benefits of new, effective treatments, and (b) the estimated treatment benefits.
The results of the development and validation of a novel lupus outcome measure called Lupus Multivariable Outcome Score (LuMOS) were presented at the 2017 ACR meeting. The further validation of this instrument, using data sets from additional trials, is ongoing.
Lupus Nephritis Biomarker Study
PIs: David Pisetsky, MD, PhD (Duke University), Brad Rovin, MD (Ohio State University), Will Pendergraft, MD, PhD (University of North Carolina), and Peter Lipsky, MD (AMPEL BioSolutions)
The goal of this project is to identify and validate biomarkers of prognosis, treatment response, and histopathology in lupus nephritis that can contribute to the development of new therapeutics.A phase 0 imaging study (the DIVINE trial) is currently underway.
The following companies are currently members of the LIC:
- Aurinia Pharmaceuticals Inc.
- Boehringer Ingelheim
- Bristol-Myers Squibb
- Eli Lilly and Company
- EMD Serono
- Equillium, Inc.
- Idorsia Pharmaceuticals
- Mallinckrodt Pharmaceuticals
- Pfizer Inc.