Late last year the European Medicines Agency (EMEA) granted marketing approval for the Western world’s first gene therapy product, Glybera, which is intended for the treatment of lipoprotein lipase deficiency, a rare inherited disease. The EMEA approval marks an important and significant milestone in the development of gene therapies.
Genetic Engineering & Biotechnology News conducted a video interview with James M. Wilson, M.D., Ph.D., from the University of Pennsylvania Perelman School of Medicine. Dr. Wilson is one of the co-authors of an article that appears in the June issue of Human Gene Therapy Clinical Development, a new companion journal to Human Gene Therapy published by Mary Ann Liebert, Inc., and for which Dr. Wilson serves as editor in chief. The article is entitled “Lessons Learned from the Clinical Development and Market Authorization of Glybera,” and it serves as the focus of the GEN interview, which can be found here.
“The story behind the development and final approval of Glybera is a fascinating and critical case study of a pathway that began in the discovery phase and led to product commercialization,” says John Sterling, the editor in chief of GEN who conducted the interview. “Everyone involved in any kind of therapeutic development, including gene therapy, will learn much by listening to what Dr. Wilson has to say during the interview.”