Aruna Bio, Inc., a leader in the development of neural exosomes for the treatment of neurodegenerative diseases, announced the appointment of Renee Boerner, PhD, as Vice President of Regulatory Affairs. Dr. Boerner joins the company with over 25 years of experience in the pharmaceutical and biotechnology industry, including roles in research, development, compliance and regulatory affairs.

“I am pleased to have Dr. Boerner join Aruna Bio to provide ongoing strategic regulatory expertise and leadership as we move aggressively to develop our proprietary neural exosome platform both as a therapeutic and as a delivery vehicle to treat serious neurodegenerative disorders and stroke,” said Dr. Mark Sirgo, Chief Executive Officer. “Dr. Boerner’s extensive regulatory experience, particularly her work with biologics, will be instrumental as we interact with the FDA and move toward our first Investigational New Drug (IND) application.”

Prior to joining the company, Dr. Boerner was Head of U.S. Regulatory Affairs for Bavarian Nordic, Inc. where she played a critical role in the approval of the company’s first Biologics License Application (BLA) in 2019 and was responsible for all regulatory activities for the company’s immuno-oncology investigational agents. She was also instrumental in the approvals of multiple New Drug Applications (NDAs) and Marketing Applications for CNS-related indications while serving as Head of Regulatory Affairs at BioDelivery Sciences. Dr. Boerner joins Aruna Bio with over 15 years of experience in biologics, including protein, cell and gene therapy products.