Organovo Announces Appointment of Steven G. Hughes, M.D. as Chief Medical Officer
August 01 2018 - 8:05AM
Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”) today announced
that Steven G. Hughes has been named Chief Medical Officer.
Dr. Hughes is an industry veteran who brings significant experience
directing clinical development and medical affairs teams at leading
biopharma companies.
Dr. Hughes most recently served as the Chief Clinical
Development Officer at Ionis Pharmaceuticals, where he led a team
that managed the global clinical development of 25 drugs across 10
therapeutic areas including cardiovascular, metabolic, oncology and
rare diseases. Previously, he held positions as Global
Medical Lead, Oncology Clinical Development and Medical Director,
UK & Ireland at Biogen Idec. Dr. Hughes also held
numerous senior clinical development, medical affairs and
leadership positions of increasing responsibility at CSL Behring
and Sanofi. Dr. Hughes is board certified in Pharmaceutical
Medicine and received his medical degree from Imperial College,
London. He also has an MBA with distinction from Imperial
College Business School.
“Dr. Hughes brings an extensive and successful track record of
progressing cutting edge therapeutic opportunities from the
preclinical stage through to commercialization,” said Taylor J.
Crouch, CEO, Organovo. “His outstanding background
establishing the teams, processes, external expert support and
patient group advocacy in orphan diseases will be critical as we
advance our multiple Investigational New Drug (“IND”)-track liver
therapeutic tissue program in a range of medical applications aimed
at addressing serious unmet needs. As we move through fiscal
2019, his experience will be invaluable as we pursue orphan drug
designation for a second rare disease indication and commence
IND-enabling studies for treating Alpha-1-antitrypsin
deficiency. With Dr. Hughes’ guidance, our objective is to
end this fiscal year with two liver therapeutic tissue programs on
track for an IND targeted for calendar 2020.”
“I’m thrilled to join Organovo and look forward to being part of
a team that has the potential to transform the lives of people that
are fighting these rare and very serious diseases,” said Steven G.
Hughes, chief medical officer, Organovo. “I’ve been
privileged in my career to help design and steer productive drug
pipelines, shepherding many important products through complex
scientific and regulatory pathways. Organovo has a broad
range of promising opportunities in the years ahead, and I can’t
wait to dive in and get started.”
About Organovo Holdings, Inc.Organovo is a
biotech platform company that has developed a leadership position
with its revolutionary ability to 3D bioprint tissues with human
functionality. The Company is pursuing multiple IND-track
programs to develop its NovoTissues® to address a number of serious
unmet medical needs in adult and pediatric populations, initially
focusing on liver disease. Organovo’s first IND-track program
for Alpha-1-antitrypsin deficiency recently received orphan drug
designation from the FDA, and the Company expects to file its first
IND in 2020. In order to help fund its plan to initiate
multiple IND-track programs, the Company is providing access to its
ExVive™ in vitro tissue disease modeling platform to facilitate
high value drug discovery and development collaborations.
Organovo’s wholly-owned subsidiary, Samsara Sciences, provides the
Company and its clients with high quality human liver and kidney
cells for research applications. Organovo is changing the
shape of life science research and transforming medical care.
Learn more at www.organovo.com.
Forward-Looking Statements Any statements
contained in this press release that do not describe historical
facts constitute forward-looking statements as that term is defined
in the Private Securities Litigation Reform Act of 1995. Any
forward-looking statements contained herein are based on current
expectations, but are subject to a number of risks and
uncertainties. Forward-looking statements include, but are
not limited to, statements regarding the potential benefits and
therapeutic uses of the Company’s therapeutic liver tissue,
including the benefits of an orphan designation; the Company’s
expectations regarding the FDA regulatory pathway and anticipated
timelines for its regulatory filings; the potential market
opportunity for the Company’s therapeutic tissue candidates; and
customer demand for and acceptance of our disease modeling and
other in vitro tissue platforms. The factors that could cause
the Company's actual future results to differ materially from
current expectations include, but are not limited to, risks and
uncertainties relating to the possibility that the final results of
the Company's preclinical studies may be different from the
Company's studies or interim preclinical data results and may not
support further clinical development of its therapeutic tissues;
the Company may not successfully complete the required preclinical
and clinical trials required to obtain regulatory approval for its
therapeutic tissues on a timely basis or at all; risks that
competitive products may adversely impact the market opportunity
for the Company’s therapeutic tissue candidates; the
Company's ability to develop, market and sell products and services
based on its technology; the expected benefits and efficacy of the
Company's products, services and technology; the Company’s ability
to execute framework agreements involving multi-year commitments
and routine use on a timely basis, or at all; the Company’s ability
to successfully complete studies and provide the technical
information required to support market acceptance of its products,
services and technology, on a timely basis or at all; the Company's
business, research, product development, regulatory approval,
marketing and distribution plans and strategies, including its use
of third party distributors; the Company’s ability to recognize
deferred revenue; and the Company’s ability to meet its fiscal-year
2019 goals and outlook. These and other factors are identified and
described in more detail in the Company's filings with the SEC,
including its Annual Report on Form 10-K filed with the SEC on May
31, 2018. You should not place undue reliance on these
forward-looking statements, which speak only as of the date that
they were made. These cautionary statements should be considered
with any written or oral forward-looking statements that the
Company may issue in the future. Except as required by applicable
law, including the securities laws of the United States, the
Company does not intend to update any of the forward-looking
statements to conform these statements to reflect actual results,
later events or circumstances or to reflect the occurrence of
unanticipated events.
Investor & Press Contact:
Steve Kunszabo
Organovo Holdings, Inc.
+1 (858) 224-1092
skunszabo@organovo.com
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