The Lupus Research Alliance (LRA), during the first anniversary meeting of the Lupus Accelerating Breakthroughs Consortium (Lupus ABC), proudly announced an expanded partnership with the U.S. Food and Drug Administration (FDA). This new collaboration includes the addition of the Center for Biologics Evaluation and Research (CBER), marking a significant step forward in the Consortium’s focus on pioneering engineered cell therapies for lupus.

Launched in March 2023 in collaboration with the FDA’s Center for Drug Evaluation and Research (CDER), Lupus ABC represents a groundbreaking public-private partnership. It unites individuals affected by lupus, advocates, industry leaders, clinicians, researchers, and government stakeholders. The aim is to collectively identify and pursue the most promising strategies to accelerate the development of personalized, urgently-needed treatments for those living with lupus.

The integration of CBER into the Consortium underscores a committed effort to address the complexities of engineered cell therapies, such as CAR-T cells, which have shown considerable promise in early clinical trials for treating lupus. This approach may offer a potentially curative treatment, transforming the lives of patients who currently rely on lifelong immunosuppression.

Dr. Peter Marks, Director of CBER, emphasized the transformative potential of these emerging technologies at the Lupus ABC meeting. “Patients with lupus endure severe, often life-threatening symptoms. The involvement of CBER with Lupus ABC will focus on navigating product development in a safe, efficient manner, ensuring the advancement of therapeutic innovations,” said Dr. Marks.

Teodora Staeva, Ph.D., Vice President and Chief Scientific Officer of the LRA, highlighted the importance of this collaboration. “With CBER’s expertise, alongside contributions from those with lived lupus experience and our other partners, we aim to significantly enhance the clinical evaluation and development of new therapies. We appreciate the dedicated support from both CBER and CDER in this vital initiative,” Dr. Staeva stated.

Since its inception, Lupus ABC has grown to include over 40 member groups and has initiated several key projects aimed at improving outcome measures for lupus trials. These projects include the Treatment Response Measure for SLE (TRM-SLE), the Cutaneous Lupus Erythematosus Disease Area Severity Index (CLASI), and Lupus Patient-Reported Outcomes. A new project focusing on CAR-T cell therapies will also benefit from CBER’s guidance.

Lupus, a complex autoimmune disorder, disproportionately affects women and communities of color, impacting various organs and causing significant inflammation and tissue damage. It is notoriously challenging to diagnose and treat due to its heterogeneous nature and varying symptoms over time.


About Lupus ABC:

The Lupus Accelerating Breakthroughs Consortium (Lupus ABC) is a unique public-private partnership that includes the U.S. Food and Drug Administration among its members. It is dedicated to accelerating the development of safer and more effective therapies for lupus. Lupus ABC fosters collaboration among regulators, government representatives, drug developers, academics, patient advocacy groups, and professional societies in a pre-competitive environment to address the biggest challenges in lupus drug development. Managed by the Lupus Research Alliance, more information about the Consortium can be found at

About PackGene

PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.

Related News

Related Services

Plasmids GMP Services

Multiple scales & grade of solutions of various kind of plasmids suitable for multiple treatments in a fast and cost effective way.

AAV GMP Services

Ranging from small-scale AAV production, to large-scale AAV cGMP manufacturing for animal studies.
aav icon

Technology Platforms

PackGene’s proprietary π-Alpha™ 293 AAV High-yield Platform increases AAV production by 3 to 8 times that of traditional platforms.