Center for Biologics Evaluation and Research
Joins Consortium to Accelerate Engineered Cell Therapies for
Lupus
BETHESDA, Md., April 16,
2024 /PRNewswire/ -- The Lupus Research Alliance
(LRA), founder and administrator of the Lupus Accelerating
Breakthroughs Consortium (Lupus ABC), announced today at the
Consortium's first anniversary meeting an expanded partnership with
the U.S. Food and Drug Administration (FDA) with the inclusion of
the Center for Biologics Evaluation and Research (CBER). The
addition of CBER to Lupus ABC will enhance the Consortium's focus
on engineered cell therapies, a promising new area in lupus
therapeutic development. Lupus ABC was launched in collaboration
with the FDA Center for Drug Evaluation and Research (CDER) in
March 2023.
Lupus ABC is a first-of-its-kind public-private partnership
(PPP) uniting individuals with lupus and their advocates, industry,
clinicians, researchers, and government stakeholders to
collaboratively identify and pursue the most effective ways to
accelerate the development of urgently needed personalized
treatments for people with lupus.
The field of engineered cell therapies in lupus is an exciting
and rapidly evolving area of research of significant interest to
individuals living with lupus. While questions of long-term
durability, safety and effectiveness continue to be examined, early
clinical results with CAR-T cells in lupus offer much promise, and
hope for a potentially curative treatment approach. CBER's
participation in Lupus ABC will help facilitate the creation and
deployment of patient-focused tools and approaches in the
development of CAR-T cell and other engineered cell therapies and
ensure a focus on the most pressing questions for advancement of
the field.
As keynote speaker at the Lupus ABC meeting, Peter Marks, M.D., Ph.D., Director of CBER
commented, "Patients with lupus experience many debilitating
manifestations and require lifelong immunosuppression. CBER shares
the excitement and enthusiasm around the transformative potential
of emerging technologies such as CAR-T therapies to address an
unmet medical need for patients with this serious, potentially
life-threatening condition. We look forward to collaborating with
Lupus ABC to shepherd the product development plans in a safe
manner."
"We are delighted to have the Center for Biologics Evaluation
and Research join Lupus ABC at this important juncture in the
development of engineered cell therapies for lupus to help us
accelerate their clinical evaluation," said Teodora Staeva,
Ph.D., Vice President, and Chief Scientific Officer, LRA. "CBER's
engagement, along with that from people with lived lupus
experience, industry, clinicians, and other federal partners, will
provide urgently needed guidance for the field to enable improved
lupus outcomes. We are grateful to both CBER and CDER for their
commitment to this important effort."
Since its establishment less than a year ago, Lupus ABC has made
robust progress through building a strong community of more than 40
member groups and launching three projects focused on
different outcome measures for lupus trials— including Treatment
Response Measure for SLE (TRM-SLE), Cutaneous Lupus Erythematosus
Disease Area Severity Index (CLASI), and Lupus Patient-Reported
Outcomes. The fourth project, centering on CAR-T cells, will
include essential representation from CBER. Importantly, the voices
of people living with lupus were considered in establishing each of
the Lupus ABC projects and will continue to be central to the
activities moving forward.
Lupus is a complex, potentially life-threatening autoimmune
disorder that disproportionately impacts women and communities of
color. Lupus can affect the joints, skin, brain, lungs, kidneys,
and blood vessels, causing widespread inflammation and tissue
damage in the affected organ. A heterogenous disease, lupus affects
each person differently and its effects can change over time,
making it one of the most difficult diseases to diagnose and treat.
Black/African American, Native American, Hispanic/Latino and Asian
populations are two to three times more likely than white Americans
to be diagnosed with lupus.
About Lupus ABC
The Lupus Accelerating Breakthroughs
Consortium (Lupus ABC) is a public-private partnership (PPP) that
includes the U.S. Food and Drug Administration (FDA) and other key
lupus stakeholders, dedicated to accelerating the development of
safer and more effective lupus therapies. Lupus ABC convenes
regulators, other government representatives, drug developers,
academics, patient advocacy groups, and professional societies to
collaboratively develop and implement strategies that tackle the
most pressing challenges in lupus drug development in a
pre-competitive forum. The direction and priorities of the Lupus
ABC are determined with input from its members. Lupus ABC is
managed by the Lupus Research Alliance. For more information,
visit LupusABC.org.
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SOURCE Lupus Research Alliance