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Bruce F. Mackler, PhD, JD, is Vice President, Regulatory Affairs for Virion Therapeutics. Over his 27-year career, Dr. Mackler has been involved in over 130 FDA IND filings and product reviews across the globe that have included biologics, drugs and medical devices. Prior to joining Virion, Dr. Mackler was formerly FDA Legal Practice Group Chairman, Fenwick & West, DC, and former VP Regulatory Affairs and Director at Immunomic Therapeutics. Bruce’s unique background allows him to couple his scientific training (M.S., Ph.D. Immunology) with practical, hands-on regulatory experience and commercial/business realities to create regulatory strategies that efficiently move technologies from the laboratory into animal and human testing, and eventual FDA marketing submissions.