HARRY LEDEBUR - AXONOVA MEDICAL LLC

Harry’s career has centered on civilian and military medicine with over 18 years of product development, operations and strategy-related experience as a VP/C-level executive and entrepreneur in biotechnology. During that span he has done the following. Led cross-functional product and platform development programs from discovery to human proof of concept, commercial launch and/or divestiture. Developed translational, manufacturing, clinical and regulatory strategies for biologics, cellular therapies, tissue-engineered products and diagnostics. Developed R&D pipelines and led gap, competitive and resource assessments. Created and executed de novo start-up and M&A-driven growth strategies as well as corporate growth, turnaround and expansion strategies. Secured funding for new and established ventures/programs from investors, strategic partners and federal agencies. Established a track record of transactions including corporate M&A, asset divestitures and acquisitions, strategic and B2B agreements, university licenses, CDMO contracts, and sponsored research programs. Had full P&L responsibility for budgets in excess of $20 million and a staff of 80. He has a strong track record of leading and supervising development efforts for biologics, cellular therapies and tissue-engineered products. He is familiar with all facets of preclinical and clinical development for these products including discovery and translational research, drug pharmacology, manufacture under cGMP, GLP safety/toxicology and biocompatibility studies, QdD and design control, clinical development and regulatory affairs. In addition to his accomplishments, he is an empowering and team-orientated leader with a demonstrated ability to inspire results as well as guide organizations. Throughout his career, he has shown the ability to hire, mentor and develop high-performing milestone-driven teams to advance programs and products to a value inflection point. Moreover, he is a proven builder of relationships who can effectively create, communicate and implement a vision for all stakeholders.