Libbie Mansell Joins AskBio as SVP Regulatory Affairs
Research Triangle Park, N.C. – July 23, 2020 – Asklepios BioPharmaceutical, Inc. (AskBio), a leading, clinical-stage adeno-associated virus (AAV) gene therapy company, announced today that Libbie Mansell, PhD, MBA, RAC, has joined the company as a senior vice president to lead its regulatory affairs operations.
“Libbie’s career has spanned the development of small molecules and biologics. She has overseen nine global approvals for significant products, and she has created and led hundreds of registration and development strategies for advanced technologies that include gene and cell therapies,” said Sheila Mikhail, JD, MBA, AskBio CEO and co-founder. “Her experience will be invaluable as we continue to advance our clinical programs for Pompe disease and congestive heart failure and lay the groundwork for our preclinical portfolio in neuromuscular, CNS and other diseases. I am delighted to welcome Libbie to AskBio and look forward to her contributions.”
Dr. Mansell is an influential executive in regulatory, quality and product development who excels at translating innovative science and technology into high-quality, commercially attractive medicines for serious and rare diseases. Most recently, she 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. She has more than 30 years’ experience in strategy and product plan development, dossier and submissions development, FDA and ex-U.S. health authority negotiations, leadership of RA/QA departments, and project management. Prior to consulting, she held positions of increasing responsibility in regulatory affairs, pharmacovigilance, quality affairs and chemistry, manufacturing and controls (CMC) with several biotechnology and pharmaceutical companies, including Curis, Sigma-Tau Research, Genzyme, CombinatoRx, Millennium Pharmaceuticals and Boehringer Ingelheim Pharmaceuticals.
Dr. Mansell earned a PhD in pharmacokinetics and biopharmaceutics with a graduate minor in applied statistics from Oregon State University and an MBA in finance and international business from New York University. She has a certificate in entrepreneurship and technology commercialization from the University of Maryland and maintains a regulatory affairs certification through the Regulatory Affairs Professionals Society. She is also active in several scientific and healthcare-related organizations, including the American Society of Gene and Cell Therapy, the American Society for Clinical Pharmacology & Therapeutics, and the Drug Information Association.
“I am thrilled to join AskBio, a leader in gene therapies for rare and life-threatening diseases and a pioneer in AAV-based vector technology,” said Dr. Mansell. “It’s an honor to become part of the team and its patient-focused, science-driven approach to developing new treatments that hold the potential to fundamentally change the lives of patients and their families.”
Founded in 2001, Asklepios BioPharmaceutical, Inc. (AskBio) is a privately held, fully integrated AAV gene therapy company dedicated to developing life-saving medicines that cure genetic diseases. Its pipeline includes clinical-stage programs in Pompe disease and congestive heart failure and a diverse preclinical portfolio of therapeutics targeting neuromuscular, CNS and other diseases, as well as out-licensed clinical indications for hemophilia (Chatham Therapeutics, acquired by Takeda) and Duchenne muscular dystrophy (Bamboo Therapeutics, acquired by Pfizer). AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, UK, the company has generated hundreds of proprietary third generation AAV capsids and promoters, several of which have entered clinical testing. An early innovator in the space, the company holds more than 500 patents in areas such as AAV production and chimeric and self-complementary capsids.
This press release contains “forward-looking statements.” Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding AskBio’s pipeline of development candidates; AskBio’s goal of developing life-saving medicines aimed at curing genetic diseases; the potential benefits of AskBio’s development candidates to patients; and Dr. Mansell being well-positioned to help advance AskBio’s clinical programs.
These forward-looking statements involve risks and uncertainties, many of which are beyond AskBio’s control. Known risks include, among others: AskBio may not be able to execute on its business plans and goals, including meeting its expected or planned regulatory milestones and timelines, clinical development plans and bringing its product candidates to market, due to a variety of reasons, including the ongoing COVID-19 pandemic, possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved in a timely manner, potential disagreements or other issues with our third-party collaborators and partners, and regulatory, court or agency feedback or decisions, such as feedback and decisions from the United States Food and Drug Administration or the United States Patent and Trademark Office.
Any of the foregoing risks could materially and adversely affect AskBio’s business and results of operations. You should not place undue reliance on the forward-looking statements contained in this press release. AskBio does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.
Vice President, Communications