Title
Advance therapies
Poster
Description
Valentin Ovcharov
Faculty of Chemistry and Pharmacy, Sofia University "St. Kliment Ohridski ", Bulgaria
Faculty of Chemistry and Pharmacy, Sofia University "St. Kliment Ohridski ", Bulgaria
Subject
The development of cellular and molecular biology in recent years has led to the development of new advanced or high-tech therapies, gene therapy, cells therapy and tissue engineering. This new area of biomedicine gives hope for new therapeutic options in the treatment of diseases that currently have limited or no capacity for effective treatment. Great hopes and expectations for cellular and gene therapy and how they changed medicine and pharmacy. How many times did you ever get the market?
Only 10 of the modern therapy medicinal product approved in Europe have a lot to do with the idea that a first-class has been in place for over a decade. In fact, the reality is that it is too early to expect results and their wider penetration into medical practice. Many of these technologies are new and the technical requirements as well as the type of required quality data, preclinical and clinical trials demonstrating their quality, safety and efficacy are very specific. It often takes decades to reach the market.For example, the development of Strimvelis took more than 20 years. And for the approval of Chondrocelect in 2009, TiGenix took about nine years. Holoclare presented as an exceptional case at the beginning. Since the beginning of its research and its development in 1996 until the publication of the first clinical results is only a year later. But in fact the team developing Holoclar reports that the product has taken more than 25 years. This shows that research and development takes time and that advertising caused by media coverage and public interest (fortunately) does not speed up market access.
Key words: advance therapies, clinical trials, placing to the market
Only 10 of the modern therapy medicinal product approved in Europe have a lot to do with the idea that a first-class has been in place for over a decade. In fact, the reality is that it is too early to expect results and their wider penetration into medical practice. Many of these technologies are new and the technical requirements as well as the type of required quality data, preclinical and clinical trials demonstrating their quality, safety and efficacy are very specific. It often takes decades to reach the market.For example, the development of Strimvelis took more than 20 years. And for the approval of Chondrocelect in 2009, TiGenix took about nine years. Holoclare presented as an exceptional case at the beginning. Since the beginning of its research and its development in 1996 until the publication of the first clinical results is only a year later. But in fact the team developing Holoclar reports that the product has taken more than 25 years. This shows that research and development takes time and that advertising caused by media coverage and public interest (fortunately) does not speed up market access.
Key words: advance therapies, clinical trials, placing to the market