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FEATURED


CELL AND GENE THERAPY MANUFACTURING COSTS LIMITING ACCESS


SYNBIO OFFERS SOLUTIONS FOR SCALE UP


CHARLES RIVER SIGNS TWO GENE THERAPY MANUFACTURING AGREEMENTS


PROTEIN DEGRADATION AND PARTICLE FORMATION CONTROL STRATEGIES


MRNA-BASED THERAPIES FACE RAW MATERIAL AND MANUFACTURING CHALLENGES

FEATURED VIDEOS

From the approval of Alzheimer’s disease drug Leqembi to Carl Icahn’s battle
over Illumina to the first CRISPR-edited therapy being approved, 2023 had more
than its share of milestones shaping drug discovery, development, clinical
trials, and commercialization. To look back at the year that is ending, and look
ahead to 2024, GEN invited CEOs of three companies to offer some valuable
perspective on the biopharma industry’s strengths and challenges, and the
strengths and challenges of their own companies.
 * Neil McFarlane, CEO of Zevra Therapeutics
 * Karen Zaderej, CEO of Axogen
 * Simon Arkell, CEO of Ryght


McFarlane assumed his current role as CEO of Zevra in October, the latest
chapter in a career stretching over 25 years of global biopharma and life
sciences experience. Just a month ago Zevra propelled itself into the commercial
phase by completing the acquisition of Acer Therapeutics for up to $91
million—$15 million plus $76 million in contingent value rights tied to
milestones. Zevra is also moving toward resubmission of its new drug application
(NDA) for Arimoclomol by year’s end, as a treatment for Niemann-Pick disease
type C (NPC), an ultra-rare, genetic, progressive and fatal neurological
disease. Zaderej joined Axogen in 2006, and has served as president, CEO, and a
board member since 2011. Seven years later, she became chairman of Axogen, a
developer of products for peripheral nerve regeneration and repair. Axogen is
headquartered in Alachua, FL, with a second corporate campus in Tampa, FL, a
global distribution facility in Burleson, TX, and a tissue processing center in
Dayton, OH. 2023 was a memorable year for Axogen. In August, it began processing
Avance® Nerve Graft at its processing center in Dayton, intended to support the
company’s long-term growth as well as a Biologics License Application (BLA)
submission planned for the first half of 2024 to transition the product into a
biologic. A month later in September, Axogen launched Axoguard HA+ Nerve
ProtectorTM (HA+), which combines a remodeling extracellular matrix base-layer
for long-term protection with a short-term resorbable hyaluronate-alginate gel
coating for enhanced nerve gliding and minimization of soft tissue attachments.
In 2024, Axogen plans to launch another product, Avive+ Soft Tissue Matrix™ in
Q1. Arkell was an Olympic pole vaulter for the Australian national team who won
several championship honors in Australia and in the U.S. before co-founding
Ryght, the developer of a generative-AI data analytics platform for biopharmas.
Based in Laguna Beach, CA, the company officially launched in June as Synthetica
Bio, and rebranded in November to reflect its focus on providing accurate and
reliable insights for driving biopharma decision-making in clinical trial
operations and commercial activities.


WHAT’S IN STORE FOR 2024? THREE CEOS LOOK AHEAD AND LOOK BACK ON “CLOSE TO THE
EDGE”

The talks, coffee hours, and networking sessions have all wrapped up from last
week’s American Society for Human Genetics (ASHG) meeting. After a few whirlwind
days in DC, the GEN team is back at home. Here, Julianna LeMieux, PhD, Deputy
Editor in Chief at GEN and Kevin Davies, PhD, GEN’s Editor at Large, are joined
by Uduak Thomas, Senior Editor at GEN, to recap their biggest takeaways from the
meeting.



THANKS DC: GEN EDITORS’ FINAL REPORT FROM ASHG

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MAGAZINE


GEN: DECEMBER 2023

The idea of community isn’t just for people. It’s for cells, too. Like people,
cells thrive in neighborhoods that are characterized by a diversity of uses and
users. In the neighborhoods we call tissues, this kind of diversity is partly
due to cellular heterogeneity, and partly due to the distribution of and
interactions among different kinds of cells. Understanding this kind of
diversity is exactly what spatial biology is all about. And because spatial
biology can reveal the hidden order that supports healthy cells and tissues, it
can also suggest remedies should cells and tissues come under attack or fall
into disorder. Spatial biology inspires both scientific and commercial activity,
as this issue of GEN reports, taking the idea of community full circle, that is,
back to people. This issue of GEN also reviews the State of Biotech 2023 and
describes developments in disciplines such as cell therapy and downstream
bioprocessing.

Read Magazine

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READ THE DIGITAL EDITION






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