In the name of the Program Planning Committee, welcome to this 2020 PDA global conference that will include live simulcasts of select sessions for both the European and the US audience!
For the 12th time, PDA Europe will be hosting this two-day event that aims to support all stakeholders in the development and bringing to the market of novel and effective cell and gene therapies, as well as tissue-engineered products.
The rise of tissue engineering at the turn of the century led health authorities around the world to consider the need for specific legislation to clarify how they would be regulated.
The EU first defined cell and gene therapy products as medicines in 2003 (Directive 2003/63/EC), but did not specifically address tissue engineering.
This perceived gap was filled through Regulation (EC) 1394/2007 which defined tissue engineering by function not structure and required all ATMPs to be approved by the European Medicines Agency (EMA).
Today, with fifteen ATMPs approved, there is a real sense that ATMP approvals are building momentum, especially immunotherapies such as CAR-T.
Yet already, the use of viral transduction of cells may give way to new technologies such as gene editing, bringing new scientific, legal, and ethical challenges.
Having been the catalyst for new regulation, how has tissue engineering evolved since the turn of the century, and are the challenges being met?
These questions and other issues common to all personalized therapies and medicinal products such as comparability, particulates, advancements in automation, and development of commercial manufacturing strategies will be covered by our panel of international speakers.
Dayue Chen, PhD
Christopher Bravery, PhD
Advanced Biologicals, Chair