Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a
clinical-stage biopharmaceutical company developing novel
therapeutics for the treatment of rare diseases, today announced
the appointments of Meredith Manning, M.B.A as Chief Commercial
Officer, Dairine Dempsey, Ph.D. as Vice President, Europe and
Lauren Budesheim, M.S. as Vice President of Human Resources. The
Company also announced the appointment of key advisors with Shamim
Ruff, M.S. joining as Chair of the Development Advisory Board and
James (Jim) Geraghty, J.D., M.S. as a Board Advisor.
“As we move into the next phase of Soleno’s growth, we are
delighted to welcome seasoned biopharmaceutical leaders Meredith,
Dairine and Lauren as part of our leadership team as well as Shamim
and Jim as key advisors,” said Anish Bhatnagar, M.D., Chief
Executive Officer of Soleno Therapeutics. “Together, their
wealth of industry knowledge and proven track records will
significantly strengthen our capabilities in both the U.S. and
Europe as we build towards becoming a commercial-stage company. We
look forward to leveraging their collective expertise as we advance
DCCR toward NDA and MAA filings and potential approval in
Prader-Willi Syndrome.”
Meredith Manning, M.B.A. brings over 25 years of experience in
global commercialization of biopharmaceuticals and medical devices.
Her expertise spans U.S. and global commercialization, brand
building, and go-to-market strategies for products at all lifecycle
stages, with significant experience in rare diseases. Prior to
joining Soleno, she served as President of the Americas and a
member of the U.S. Board of Directors at PharmaEssentia, where she
led the U.S. regulatory approval and commercial launch of
PharmaEssentia's first product, BESREMi®. Prior to PharmaEssentia,
Ms. Manning served as the Chief Commercial Officer at resTORbio and
as a vice president of marketing for a seven-brand hemophilia
portfolio at Baxter BioScience (now Takeda). She previously held
senior marketing and field leader roles at Vertex and Pfizer. Ms.
Manning holds an M.B.A. from the University of Chicago Booth School
of Business and a B.A. in political science from Colorado
College.
Dairine Dempsey, Ph.D., brings over 20 years of experience in
the pharmaceutical, biologic, and device industries. She has been a
consultant to Soleno since 2019. Prior to consulting, she founded
and led the start-up phase of Open Orphan, a company specializing
in orphan drugs. Prior to Open Orphan, she served as Global Vice
President, Strategic Regulatory Affairs at ICON, where she
navigated and resolved significant regulatory and compliance
challenges in clinical development and post-marketing programs
across the US, EU, and Asia. Dr. Dempsey previously spent nine
years at the Irish Health Products Regulatory Authority (HPRA)
working with both the European Medicines Agency (EMA) and the
European Commission on technical issues and policy development. She
also led the establishment of the National Health Regulatory Agency
for Pharmaceutical Products in Bahrain. She has been involved in
the successful global clinical development and post-marketing
management of over 10 pharmaceutical products across multiple
therapeutic areas, many for rare diseases. She is a board member at
Fighting Blindness and the FutureNeuro Research Centre in Ireland.
Dr. Dempsey holds a Ph.D. from the School of Pharmacy at Trinity
College and a Certificate in International Business from UCD
Smurfit Business School.
Lauren Budesheim, M.S. has over 20 years of experience and has
held a variety of positions as a Human Resources professional. She
is deeply committed to developing people and leveraging data and
technology to modernize operations and to create a strong company
culture in which employees are empowered and engaged. She
previously served as Head of People at Neurona Therapeutics, where
she built and implemented strategies, programs, and infrastructure
to develop, engage, and retain the best talent. Prior to joining
Neurona, Ms. Budesheim was Senior Director of Human Resources at
Invuity where she was instrumental in developing a strong
purpose-driven employee culture that fostered employee engagement
and development. Prior to Invuity, Ms. Budesheim was the Senior
Manager of Human Resources at Triton Container International where
she was responsible for general operations of the Human Resources
department. Additionally, she has led two successful integrations
as a result of acquisitions. She has a B.A. in Psychology from
Scripps College and a M.S. in Organizational Development from the
University of San Francisco. She also received her Senior
Professional Human Resources certification in 2008.
Shamim Ruff, M.S. brings more than 25 years of experience in the
biopharmaceutical industry, with expertise in both domestic and
international regulatory affairs spanning early and late
development across multiple therapeutic areas. She is currently the
Chief Regulatory Affairs Officer and SVP, Head of Quality Assurance
at Stoke Therapeutics and until recently, she served on the Board
of Directors of Reata Pharmaceuticals until their acquisition by
Biogen. Prior to Stoke, she served as Chief Regulatory Affairs
Officer at Sarepta Therapeutics, where she built the company’s
regulatory affairs and quality organizations and was responsible
for leading and defining the regulatory strategy for the company’s
rare and infectious disease pipelines. Prior to Sarepta, Ms. Ruff
served as Vice President, Head of Regulatory Affairs Oncology at
Sanofi-Genzyme, leading the global, European and CMC regulatory
affairs teams. She has also held increasing senior regulatory roles
at Amgen, Abbott and AstraZeneca. She holds a bachelor’s degree in
chemistry and biology from the University of Leicester, UK, and a
master’s degree in analytical chemistry from the University of
Loughborough, U.K.
James Geraghty, J.D., M.S. is an industry leader with over 30
years of strategic and leadership experience focused on the
development and commercialization of innovative therapies. Mr.
Geraghty serves as the Chairman of the Board of Directors for
Orchard Therapeutics plc, Pieris Pharmaceuticals, Inc., and OMass
Therapeutics. He is also a member of the Board of Directors for
Voyager Therapeutics, Inc., and Fulcrum Therapeutics, Inc. He
served as an entrepreneur-in-residence at Third Rock Ventures from
2013 to 2016. Prior to Third Rock Ventures, he served as Senior
Vice President, North America Strategy and Business Development at
Sanofi, which he joined upon its acquisition of Genzyme. During his
20-year tenure at Genzyme, Mr. Geraghty held pivotal roles such as
Senior Vice President of International Development, President of
Genzyme Europe, and founding president and CEO of Genzyme
Transgenics. He holds a J.D. from Yale Law School, M.S. from the
University of Pennsylvania and a B.A. from Georgetown
University.
About Soleno Therapeutics, Inc.Soleno is
focused on the development and commercialization of novel
therapeutics for the treatment of rare diseases. The company’s lead
candidate, DCCR extended-release tablets, a once-daily oral tablet
for the treatment of PWS, recently completed its Phase 3
development program to support a planned NDA submission. For more
information, please visit www.soleno.life.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of Section
21E of the Securities Exchange Act of 1934, as amended. All
statements other than statements of historical facts contained in
this press release are forward-looking statements, including
statements regarding the timing of any regulatory process or
ultimate approvals and determining a path forward for DCCR for the
treatment of PWS. In some cases, you can identify forward-looking
statements by terms such as "may," "will," "should," "expect,"
"plan," "anticipate," "could," "intend," "target," "project,"
"contemplates," "believes," "estimates," "predicts," "potential" or
"continue" or the negative of these terms or other similar
expressions. These forward-looking statements speak only as of the
date of this press release and are subject to a number of risks,
uncertainties and assumptions, including the risks and
uncertainties associated with market conditions, as well as risks
and uncertainties inherent in Soleno’s business, including those
described in the company's prior press releases and in the periodic
reports it files with the SEC. The events and circumstances
reflected in the company's forward-looking statements may not be
achieved or occur and actual results could differ materially from
those projected in the forward-looking statements. Except as
required by applicable law, the company does not plan to publicly
update or revise any forward-looking statements contained herein,
whether as a result of any new information, future events, changed
circumstances or otherwise.
Corporate Contact:Brian RitchieLifeSci
Advisors, LLC212-915-2578
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