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The Food and Drug Administration (FDA) today announced that Dr. Edward Otto has been selected to be the new Director of the Office of Cellular, Tissue and Gene Therapies within the agency's Center for Biologic Evaluation and Research (CBER). The Office of Cellular, Tissue and Gene Therapies plays a crucial role in FDA's regulation of these emerging biologic medical technologies. It was established to consolidate the agency's resources and expertise to effectively and efficiently regulate these related areas of innovative medical product development.
In announcing the appointment, Acting FDA Commissioner Dr. Lester M. Crawford said, “Dr. Otto was selected from a large and talented pool of applicants, because of his outstanding management skills and his scientific accomplishments, including gene therapy product research and development. He is uniquely qualified to lead FDA's efforts to help develop the full potential of these highly promising medical technologies." Dr. Jesse Goodman, the Director of CBER, added “Ed is not only a talented scientist and manager, but has been a well-liked leader who has worked effectively within his organizations to bring out the best in everyone while adhering to his principles and vision. We are absolutely delighted to have him join us”.
Dr. Otto received his Ph.D. in Genetics from the University of North Carolina-Chapel Hill (UNC) in 1987, and then did post-doctoral work in Genetics and Molecular Biology at both UNC and Duke University. He joined Genetic Therapy, Inc., (GTI) in 1992, ultimately becoming Chief Operating Officer. At GTI he played key management and product development roles, including development of gene therapy vectors, monitoring of gene therapy and xenotransplantation studies, and assisting in the preparation of a number of clinical studies.
In 2002 Dr. Otto became Chief Operating Officer of Intronn, Inc., where he both helped lead business development efforts and worked on development of RNA trans-splicing technologies. He and the teams he has worked with have published widely in the scientific literature, including in the journals Nature and Science.
Dr. Crawford and Dr. Goodman also thanked Dr. Joyce Frey-Vasconcells for her superb efforts and many important leadership contributions as Acting Office Director during recent months.
Dr. Otto starts his duties as Director of the Office of Cellular, Tissue
and Gene Therapies on November 14, 2004.
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