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Spruce Biosciences Appoints Libbie Mansell, Ph.D., M.B.A., R.A.C., as Chief Regulatory and Quality Officer
Rhea-AI Impact
(Low)
Rhea-AI Sentiment
(Neutral)
Tags
management
Rhea-AI Summary
Spruce Biosciences, Inc. (NASDAQ: SPRB) has appointed Libbie Mansell, Ph.D., M.B.A., R.A.C., as its Chief Regulatory and Quality Officer. Dr. Mansell will lead global regulatory affairs and quality strategy as the company advances its drug tildacerfont for rare endocrine disorders, including congenital adrenal hyperplasia and polycystic ovary syndrome. With over 30 years of experience in regulatory affairs, she aims to enhance Spruce's pipeline of treatments for significant unmet medical needs. CEO Javier Szwarcberg highlights her extensive expertise as a critical addition to the team.
Positive
Appointment of Libbie Mansell as Chief Regulatory and Quality Officer expected to enhance regulatory strategy.
Dr. Mansell brings over 30 years of experience in regulatory affairs, which is beneficial for advancing drug development.
Focus on unmet medical needs in rare endocrine disorders may position Spruce favorably in the market.
Negative
Potential concerns regarding continuity in leadership during critical stages of drug development.
Experience gaps if previous management had unique insights into company-specific regulatory challenges.
SAN FRANCISCO--(BUSINESS WIRE)--
Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need, today announced that Libbie Mansell, Ph.D., M.B.A., R.A.C., has been appointed Chief Regulatory and Quality Officer. Dr. Mansell will be responsible for leading the company’s global regulatory affairs and quality strategy.
“Dr. Mansell brings extensive regulatory affairs and quality expertise at precisely the right time for Spruce, as we progress tildacerfont through clinical development for adults and children with classic congenital adrenal hyperplasia and women with polycystic ovary syndrome,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “With more than 30 years of life sciences industry experience and a successful track record of managing complex drug development programs for numerous biopharmaceutical companies, Dr. Mansell is a strong addition to our executive team. We look forward to her leadership and guidance as we continue to advance our pipeline of novel treatments for patients with rare endocrine disorders.”
Dr. Mansell is a seasoned regulatory affairs, development strategy and program management professional, with over 30 years of industry experience in serious and rare diseases. She joins Spruce from Asklepios BioPharmaceutical (AskBio), where she served as Senior Vice President of Regulatory Affairs. Prior to AskBio, Dr. Mansell was Managing Director and Founder of White Oak BioPharma Solutions, a global regulatory strategy and operations consulting firm she established in 2006 to serve executive teams at a full range of companies, from startups to large companies. Prior to consulting, she held positions of increasing responsibility in regulatory affairs, pharmacovigilance, quality affairs and chemistry, manufacturing and controls with several biotechnology and pharmaceutical companies, including Curis, Sigma-Tau Research, Genzyme, CombinatoRx, Millennium Pharmaceuticals and Boehringer Ingelheim Pharmaceuticals. Dr. Mansell earned a Ph.D. in pharmacokinetics and biopharmaceutics with a graduate minor in applied statistics from Oregon State University and an M.B.A. in finance and international business from New York University.
"With multiple late-stage global clinical studies and additional pipeline programs in development for patients with significant unmet medical needs, Spruce is at an important stage in its development and I look forward to contributing to the company’s evolution,” said Libbie Mansell, Ph.D., M.B.A., R.A.C., Chief Regulatory and Quality Officer of Spruce Biosciences. “By leveraging my global regulatory affairs, quality and product development expertise, I am eager to help make Spruce’s vision – to transform the lives of those living with rare endocrine disorders – a reality for the patients and families we serve.”
About Spruce Biosciences
Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need. Spruce is initially developing its wholly-owned product candidate, tildacerfont, as the potential first non-steroidal therapy for patients suffering from classic congenital adrenal hyperplasia (CAH). Classic CAH is a serious and life-threatening disease with no known novel therapies approved in approximately 50 years. Spruce is also developing tildacerfont for women suffering from polycystic ovary syndrome (PCOS) with primary adrenal androgen excess. To learn more, visit www.sprucebiosciences.com and follow us on Twitter @Spruce_Bio, LinkedIn, Facebook and YouTube.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the impact of new management hires and promotions, the fulfillment of Spruce’s strategic business objectives, and the advancement of Spruce’s drug development pipeline. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “will,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Spruce’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Spruce’s business in general, the impact of the COVID-19 pandemic, and the other risks described in Spruce’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Spruce undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
What is the role of Libbie Mansell at Spruce Biosciences?
Libbie Mansell has been appointed as the Chief Regulatory and Quality Officer, responsible for leading global regulatory affairs and quality strategy.
What impact might Libbie Mansell's appointment have on Spruce Biosciences (SPRB)?
Her extensive regulatory experience is expected to strengthen Spruce's pipeline advancement and regulatory strategy, specifically for tildacerfont.
What are the key products Spruce Biosciences is developing?
Spruce is developing tildacerfont for treating rare endocrine disorders, including classic congenital adrenal hyperplasia and polycystic ovary syndrome.
How does Libbie Mansell's background support Spruce's goals?
With over 30 years in regulatory affairs and drug development, her expertise aligns well with Spruce's mission to address significant unmet needs in rare diseases.
