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Updated February 2010
It is a pleasure for me to
welcome you to the Fibrocell Science, Inc. web site during
this pivotal period for the company and our lead
investigational cell therapy, azficel-T.
After serving as Fibrocell’s
Chairman of the Board since September 2009, I’m excited to
now add the title of Chief Executive Officer to my role
within the company. As CEO, I hope to leverage my broad
leadership experience in healthcare sales and
commercialization – garnered primarily through a long career
at GlaxoSmithKline – to help obtain U.S. Food & Drug
Administration (FDA) approval for azficel-T and to bring it
to market with the support structure required to ensure it
is widely available for all approved patient populations.
Our most immediate task at hand
at Fibrocell is to continue to respond to the FDA’s requests
as outlined in its complete response letter to our March
2009 biologics license application for azficel-T’s use in
the treatment of moderate to severe nasolabial fold
wrinkles. Our clinical and regulatory teams are currently in
dialogue with the FDA to help determine next steps.
Beyond that, our entire
organization is focusing on ways to expand the potential of
regenerative fibroblast cells for additional aesthetic,
medical and scientific applications. Broadly, the
regenerative effects of fibroblasts in the body include the
ability to improve skin texture through synthesizing the
extracellular matrix components, secreting collagen and
other matrix fibers, and playing a critical role in wound
healing and tissue repair.
At Fibrocell, we are proud of
our unique, streamlined manufacturing process. Azficel-T
preparation begins when a physician removes a small sample
of cells from behind a patient’s ear and sends that sample
to the Fibrocell cGMP facility. The process expands
fibroblasts into tens of millions of new cells, which are
then formulated into an autologous cellular therapy. Cells
are frozen and used for multiple treatment sessions. The
therapy is reintroduced into the patient’s skin by
injection, which we believe results in an increase in the
local fibroblast population, collagen formation and assists
the body’s own regenerative healing process.
Thank you for your interest in
Fibrocell Science, Inc. Please visit our site often so that
we can continue to provide you updates on our progress.
Sincerely,
David Pernock
Chairman & CEO
Fibrocell Science, Inc.
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