RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--StrideBio, Inc., a leading developer of novel adeno-associated viral (AAV) based gene therapies, today announced the expansion of its leadership team with the appointments of Ariane Hamaide, as Vice President, Strategy and Operations, Mike Havert, Ph.D., as Vice President, Regulatory Affairs, Sandra Lueken, as Vice President, Quality Operations, and Jodi Wolff, Ph.D., M.S.S.W., as Vice President, Patient Engagement & Advocacy.
“We are very excited to welcome Ariane, Mike, Sandra and Jodi to StrideBio in these critical leadership roles necessary for our long-term success. Following our recently announced Series B financing, these key additions ensure StrideBio has the right capabilities in place as we advance our pipeline of next-generation gene therapies to the clinic,” said Sapan Shah, Ph.D., Chief Executive Officer, StrideBio, Inc. “The diverse backgrounds and extensive accomplishments of these new team members reflects StrideBio’s focus on building a world-class gene therapy company with a mission to bring novel treatments to patients.”
Ariane Hamaide most recently served as Vice President, Corporate Development at Cellectis where she piloted core strategic initiatives and prepared the company for early commercial operations. Previously, she spent over five years at The Boston Consulting Group as a Project Leader where she led early commercialization and U.S. launch preparations for a large immuno-oncology company’s autologous CAR-T cell therapy and supported several European pharmaceutical companies. Ariane also served in the French military and earned a Commando military medal. She received a M.Sc. in Strategic Management from HEC Paris and a M.Sc. in Management of Innovation from École Polytechnique.
Mike Havert, Ph.D., most recently served as Senior Director, Regulatory Science, Chemistry Manufacturing and Controls (CMC) at bluebird bio, where he engaged with the FDA on multiple regulatory submissions and managed cross-functional teams supporting FDA-related activities. Previously, Mike worked in CBER’s Gene Therapy branch as a Biologist/CMC reviewer for 15 years where he helped guide the development of a number of different advanced therapies. His accomplishments at FDA include serving as BLA Review Chair, championing the release of guidance documents, and working toward different global harmonization efforts. He also worked as a Clinical Trial Specialist at Technical Resources International, and as an adjunct faculty member at Northern Virginia Community College. At the beginning of his career, Mike completed postdoctoral fellowships at Johns Hopkins University and the National Institutes of Health. Mike received his undergraduate degree from Boston University and graduate degree from the University of Wisconsin – Madison.
Sandra Lueken most recently served as Vice President, Quality Operations at KBI Biopharma, Inc. where she was responsible for strategic planning and oversight of Quality initiatives, including technical operations, staff management, system implementations, standards and procedures, and leadership support for contract manufacturing. Previously, Sandra served as Senior Director, Quality Assurance at AstraZeneca Biologics (MedImmune) and as Director of Quality at Baxter Pharmaceutical Solutions, LLC., for five years each. Prior to Baxter, she held positions of increasing responsibility in the pharma industry at Hollister-Stier, Ventana Medical Systems, Systems Integration Drug Discovery Company and the Jerry L. Pettis Memorial VAMC in Mineral Metabolism Research. Sandra has extensive experience in pharmaceutical quality systems and regulatory compliance, having supported four biologic approvals. Sandra received her B.A. in Biochemistry from the University of Arizona and an MBA from the University of Arizona’s Eller Graduate School of Management.
Jodi Wolff, Ph.D., M.S.S.W., most recently served as Head of Global Patient Advocacy at Santhera Pharmaceuticals where she established and maintained patient advocacy initiatives throughout lifecycle development of early and late-stage therapies for rare diseases. She previously served as Director of Clinical Services for the Muscular Dystrophy Association where she spent fourteen years in positions of increasing responsibility. She also serves as a Retreat Director for the Jett Foundation’s Camp Promise summer program. Jodi served as a program supervisor at Arizona State University, the University of Arizona, and Indiana University in the departments of Social Work and Psychoeducational Studies. She received her Ph.D. in Rehabilitation from the University of Arizona and her M.S.S.W. from the University of Wisconsin.
Founded in 2015 based on the groundbreaking research of Mavis Agbandje-McKenna, Ph.D., and Aravind Asokan, Ph.D., StrideBio, Inc., is a fully integrated gene therapy company focused on creating best-in-class genetic medicines with life-changing or curative potential for children and adults. Our proprietary structure-inspired adeno-associated viral (AAV) vector engineering platform (STRIVE™) creates unique and differentiated capsids that overcome current limitations of first-generation gene therapies. Key targeted improvements include reduced seroprevalence, improved tropism for specific cell types, liver de-targeting and increased gene transfer efficiency, with the potential for improved safety and reduced doses in the clinic. StrideBio is advancing a robust pipeline of gene therapy candidates enabled by these novel engineered capsids, initially focused on genetically defined CNS and cardiovascular disorders. Combined with our genetic construct design expertise and in-house manufacturing capability at a 1000L scale, we are well positioned to advance novel best-in-class AAV gene therapies. StrideBio is based in a state-of-the-art 40,000-square-foot facility in Research Triangle Park, N.C., which houses our offices, research labs and in-house AAV manufacturing facilities. For more information, please visit www.stridebio.com or follow us on LinkedIn.