GAINESVILLE- September 1, 2020- Rescue Hearing Inc., a team of visionary, internationally recognized physicians, scientists, and bioengineers focused on developing new gene therapies to eliminate hearing loss, announced the addition of Drug Manufacturing and CMC Advisor Mike Zdanowski today.
“Mike is a seasoned drug manufacturing professional with a track record of developing biologics and interacting with regulatory agencies,” RHI CEO and Founder Jim Ayala said. “Mike will have a key role in developing our RHI100 drug product for our preclinical and clinical studies. RHI is honored to have Mike join our team.”
Mike Zdanowski joins RHI with more than 25 years in the Pharmaceutical and Biotech industries, and 15 years in Cell Therapy including early-late stage clinical, BLA, and commercial launch and production. Prior to RHI, Zdanowski was Senior Vice President of Biopharmaceutical Operations at Meteor Therapeutics, Inc where he was responsible for process development, analytical method development, manufacturing, Quality Control, and general operations. Previously, he was also Vice President of GMP Operations at the New York Stem Cell Foundation where Zdanowski was an executive leader of various projects designed to deliver Phase 1 stem cell therapies to the clinic. From 2007 to 2013, Zdanowski was Director of Operations at the New York Blood Center where he was responsible for the management of a 115-person team, a $20 million human umbilical cord blood stem cell production division. Throughout his career, Zdanowski has gained extensive experience in Program Management, Operations, Manufacturing, Clinical Operations, Process Development, Quality Assurance, and Systems, Quality Control, Regulatory Affairs, Facilities Engineering, Validation and Qualification, Supply Chain, Storage and Distribution, and General Management.
Mr. Zdanowski will be advising the development of RHI’s initial gene therapy product, RHI100. His advisory activities will include CMC and regulatory agency documentation, cGMP and GLP manufacturing, and the CMO vendor selection process.
About Rescue Hearing Inc.
Rescue Hearing Inc. combines the top physicians and researchers with cutting-edge technologies in gene therapy and diagnostics to develop a diversified asset portfolio for patients with hearing loss.