Histogen Appoints Moya Daniels as Executive Vice President and Head of Regulatory, Quality and Clinical Operations
Histogen Inc. (NASDAQ: HSTO) has appointed Moya Daniels as the new Executive Vice President and Head of Regulatory, Quality, and Clinical Operations. Moya brings over 30 years of experience in biotechnology, specializing in cell and gene therapy. Previously, she held leadership roles at SanBio and Orchard Therapeutics, contributing to regulatory strategies and quality assurance. Histogen aims to advance its pipeline of therapeutic candidates, leveraging Moya's expertise. This leadership change is deemed crucial for the company's clinical progress and for enhancing regulatory oversight.
- Moya Daniels brings over 30 years of experience in biotechnology, enhancing Histogen's leadership team.
- Her expertise in cell and gene therapy aligns with Histogen's focus on innovative therapeutics.
- Moya's track record includes successful regulatory development at SanBio, signaling potential advancements for Histogen.
- No significant industry experience gaps highlighted from the departure of prior executives.
- Potential risks associated with leadership transition may disrupt ongoing clinical programs.
SAN DIEGO, Oct. 19, 2020 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, today announced the appointment of Moya Daniels as Executive Vice President and Head of Regulatory, Quality and Clinical Operations.
“I am pleased to have Moya join the Histogen team at this important time as we continue to progress our pipeline candidates in the clinic,” said Richard W. Pascoe, President and Chief Executive Officer of Histogen. “Moya has over 30 years of experience in the biotechnology and pharmaceutical industries and most notably has extensive expertise in the cell and gene therapy field. Moreover, Moya brings an impressive track-record to Histogen as an industry leader which will complement our existing senior management team.”
Ms. Daniels most recently served as Senior Vice President of GMP Quality at SanBio, where she successfully led the CMC regulatory development and GMP Quality function in support of the planned Japan commercialization of their lead product candidate. Prior to SanBio, Ms. Daniels was the Senior Vice President of Regulatory Affairs and Global Quality Assurance at Orchard Therapeutics, where she led the company’s CMC regulatory and GXP quality strategy and was part of the team that led the in-licensing of GSK’s rare disease gene therapy portfolio. Prior to joining Orchard, Ms. Daniels served as Vice President of Regulatory Affairs and Quality Assurance at Fate Therapeutics, Inc, where she led the development of the global regulatory strategy and quality assurance function and was interim head of Clinical Operations. Moya led development of the global regulatory strategy, quality, and global clinical operations at Osiris Therapeutics, which led to the approval of Prochymal®, the first approved allogeneic cell therapy indicated for the treatment of pediatric steroid refractory acute Graft Versus Host Disease in Canada and New Zealand. Ms. Daniels also held a senior leadership position at Macrocure as Vice President of Global Regulatory Affairs and currently serves as a Scientific Advisory Board member for Indapta Therapeutics.
“I am energized by Histogen’s leadership team and scientists and look forward to working with them to advance the company’s technology through clinical development. Histogen’s proprietary manufacturing process that generate biological materials that stimulate a patient’s own stem cells to activate and regenerate tissue is truly unique,” said Ms. Daniels. “Histogen’s focus on developing potential first-in-class restorative therapeutics is perfectly aligned with my industry experience and scientific passion.”
About Histogen
Histogen Inc. is a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function. Histogen’s innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells. Histogen’s proprietary, reproducible manufacturing process provides targeted solutions across a broad range of therapeutic indications including hair growth, dermal rejuvenation, joint cartilage regeneration and spinal disk repair. For more information, please visit www.histogen.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss our future operations and our ability to successfully initiate and complete clinical trials, obtain clinical trial data and achieve regulatory milestones and related timing; the nature, strategy and focus of our business; the sufficiency of our cash resources and ability to achieve value for our stockholders; and the development and commercial potential and potential benefits of any of our product candidates. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of ours that could differ materially from those described in or implied by the statements in this press release, including: the uncertainties associated with the clinical development and regulatory approval of our product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; the potential that earlier clinical trials and studies of Histogen’s product candidates may not be predictive of future results; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase its costs and expenses; the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all; and the ability to attract and retain key personnel. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including those risks discussed in our filings with the Securities and Exchange Commission. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events, or circumstances or otherwise.
CONTACT:
Susan A. Knudson
Executive Vice President & CFO
Histogen Inc.
ir@histogen.com
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