Carl Denny
About Carl Denny
Carl Denny is a seasoned Senior Vice President of Regulatory Affairs with over 20 years of experience in Chemistry Manufacturing and Controls (CMC) and regulatory affairs, specializing in gene therapies and mRNA products.
Carl Denny: Senior Vice President, Regulatory Affairs
Carl Denny currently holds the position of Senior Vice President of Regulatory Affairs. With an extensive career spanning over 20 years in the field of regulatory affairs and Chemistry Manufacturing and Controls (CMC), he brings a depth of expertise to his role. His responsibilities include the oversight of regulatory strategies and ensuring compliance with global regulations for pharmaceutical products.
Carl Denny's Expertise in Chemistry Manufacturing and Controls (CMC)
Carl Denny has over 20 years of experience in Chemistry Manufacturing and Controls (CMC), a critical area in the pharmaceutical industry that involves the study and regulation of various elements, such as the manufacturing process, analytical methods, and product stability. His experience in this area allows him to provide comprehensive oversight and ensure that pharmaceutical products meet stringent quality standards.
Carl Denny's Role in Gene Therapy and mRNA Product Registration
Throughout his career, Carl Denny has been involved in the registration of innovative gene therapies and mRNA products. Notably, he played a key role in the registration of AMONDYS 45 (casimersen) and Zolgensma (onasemnogene abeparvovec-xioi), an AAV-based gene therapy. These contributions underscore his proficiency in facilitating the regulatory approval process for cutting-edge treatments.
Carl Denny's Career Path Across Leading Pharmaceutical Companies
Carl Denny has held multiple roles with increasing responsibility at several major pharmaceutical and healthcare companies. His career includes significant positions at Sarepta Therapeutics, Inc., AveXis, Inc., GE Healthcare, Takeda Pharmaceuticals, Catalent Pharma Services, Abbott Laboratories, and Eli Lilly. Each of these roles has contributed to his extensive knowledge and experience in regulatory affairs and CMC.