PRESS RELEASE
December 21, 2020
Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced the further expansion of its executive team with the appointments of Denelle Waynick as Chief Legal Officer and Kyle Haraldsen as Chief Technical Operations Officer. The positions will be based in the U.S. and will support Saniona’s advancement of clinical trials for Tesomet and SAN711 as well as the company’s growing U.S. presence.
“This has been a year of transformation for Saniona, evolving from a company focused on early-stage research to one capable of conducting its own mid-stage clinical trials. As we close out 2020, the hiring of Denelle and Kyle completes Saniona’s executive team in support of our current business,” said Rami Levin, President and CEO of Saniona. “As we look to 2021, our entire organization is focused on initiating Phase 2b clinical trials of Tesomet in HO and PWS, as well as advancing SAN711, the first drug candidate from our library of more than 20,000 proprietary ion channel modulators, into the clinic.”
Denelle Waynick, Chief Legal Officer, has nearly 30 years of experience advising domestic and international companies in the healthcare and life sciences industries. Most recently, Waynick served as Chief Legal Officer and Corporate Secretary at MyoKardia, where she provided strategic and practical counsel to C-suite executives in legal matters, as well as issues impacted by the regulatory and policy environment. Waynick has also worked as in-house corporate counsel at UCB, Actavis and Schering-Plough, and in corporate law as an Associate and Partner at national and regional law firms. In addition to expertise in corporate, policy, governance and litigation matters, she has served as counsel on a range of global business transactions, including mergers, acquisitions and divestments. Waynick holds a B.S. in Accounting from Rutgers, the State University of New Jersey-Newark, and a JD from Howard University School of Law.
“Saniona is a company uniquely positioned for long-term success — with both a mid-stage product in clinical development and a robust research engine to further its pipeline. I am excited about joining the team and contributing to Saniona’s robust growth,” said Waynick.
Kyle Haraldsen, Chief Technical Operations Officer, has nearly 20 years of technical operations and manufacturing experience in the biopharmaceutical industry, including in support of U.S. and E.U. product approvals. Most recently, he served as the Vice President of Technical Operations and Project Management at AMAG Pharmaceuticals, where he led the process and analytical development, manufacturing, supply chain and project management functions. During his time at AMAG, Haraldsen oversaw multiple product launches, line extensions and the integration of two development stage assets. Prior to his time at AMAG, he was the Senior Director of Manufacturing at Radius Health, where he was responsible for the developmental, operational, and budgetary oversight of CMC programs and clinical trial material in support of global Phase 3 and multinational Phase 2 clinical trials. Haraldsen also worked for contract manufacturers Avecia Biotechnology and Johnson Matthey Pharma Services. He holds a B.S. in Chemical Engineering from Northeastern University.
“As Saniona prepares to execute significant clinical trial programs, it will be essential that we have a strong technical operations function to oversee the manufacturing and supply of product in line with clinical development activities and timelines. I am eager to ensure we have the people and processes in place to support successful execution of our clinical programs, and to begin planning pre-commercial manufacturing and supply chain strategy,” said Haraldsen.
Waynick and Haraldsen will serve on Saniona’s executive committee and will report to President and CEO Rami Levin. Both positions will be based in Saniona’s office in the Boston, Massachusetts-area, U.S. Waynick and Haraldsen will start in January 2021.
For more information, please contact
Trista Morrison, Chief Communications Officer, Saniona. Office: + 1 (781) 810-9227. Email: trista.morrison@saniona.com
The information was submitted for publication, through the agency of the contact person set out above, at 14:00 CET on December 21, 2020.
About Saniona
Saniona is a biopharmaceutical company focused on discovering, developing, and delivering innovative treatments for rare disease patients around the world. The company’s lead product candidate, Tesomet, is in mid-stage clinical trials for the rare diseases Prader-Willi syndrome and hypothalamic obesity. Saniona also has a broad pipeline derived from its proprietary ion channel discovery platform, with lead candidate SAN711 entering Phase 1 studies for rare neuropathic disorders. Saniona intends to develop and commercialize its rare disease products internally. The company has out-licensed other programs, which may provide future supplemental revenue. Saniona is based in Copenhagen, Denmark and Boston, Mass., U.S. The company’s shares are listed on Nasdaq Stockholm Small Cap (OMX: SANION). Read more at www.saniona.com.
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