Renova Therapeutics recruits seasoned expert to lead company’s regulatory and quality efforts
April 13, 2015
San Diego, CA – Renova™ Therapeutics, a biopharmaceutical company developing gene therapy treatments for congestive heart failure and other chronic diseases, has hired Jennifer Spinella, MT(ASCP), RAC, as Senior Vice President, Regulatory Affairs and Quality Assurance.
Spinella to lead regulatory, quality efforts
Ms. Spinella has more than 20 years of hands-on regulatory experience, from IND through registration with drugs, devices, diagnostics, biologics and gene therapy products. She has managed and supervised numerous regulatory applications in the biotech and pharmaceutical industry. Most recently, she was Vice President, Regulatory Affairs and Quality Assurance for Rare Disease Therapeutics.
“We’re thrilled to welcome Jennifer to the team,” said Jack W. Reich, Ph.D., CEO and Co-founder of Renova Therapeutics. “Her experience, especially in gene therapy, is critical to moving our pipeline of novel therapeutics forward and ensuring our transformational treatments reach the millions of patients suffering from debilitating chronic diseases.”
Ms. Spinella’s regulatory background includes gene therapies for coronary artery disease, diabetic foot ulcers and tissue injuries. She has held multiple VP- and director-level positions at various companies. Her past roles include Vice President, Regulatory Affairs and Quality Assurance of Cardium Therapeutics and as Vice President, Regulatory Affairs and Quality Affairs for InnerCool Therapies when Cardium acquired it. Before joining Cardium, Ms. Spinella was Director of Regulatory Affairs at Biogen Idec, where she was responsible for regulatory strategy and leading interactions with the U.S. FDA for the company’s autoimmune pipeline. Before joining Biogen Idec, she was Director of Regulatory Affairs at Idun Pharmaceuticals and held various regulatory positions at Elan Pharmaceuticals, Chugai Biopharmaceuticals, Dura Pharmaceuticals and Gensia Pharmaceuticals.
Prior to working in the pharmaceutical industry, Ms. Spinella was a neonatal biochemist for eight years at St. Joseph’s Hospital and Medical Center in Phoenix, AZ. She earned her B.S. in Medical Technology from the University of Nebraska College of Medicine in Omaha, NE. She obtained her Regulatory Affairs Certificate (RAC) from the Regulatory Affairs Professional Society in 2000.
“With the possibility of a gene therapy treatment for congestive heart failure and its paracrine gene therapy pipeline, Renova [Therapeutics] is on the edge of something revolutionary in the medical field,” said Ms. Spinella. “I’m tremendously excited at the chance to work on helping to bring such incredible innovation to the people who need it most.”