On initiative of the TBDO, Dr. Miguel Mulet will provide an overview of cell therapy in regenerative medicine from an industrial focus and how this field illustrates particularly well, the challenges and risks of the trip from science to product during PRBB-CRG Session of Friday April 29th 2016 from 12:00-13:00. In this overview, he will touch various aspects:

• Cell therapy as a pharmaceutical product.
• How Mechanism of Action has been a moving target in parallel with product development.
• The intellectual property challenge of protecting inventions involving cells.
• Adapting biologics regulation to cell therapy.
• The long path of clinical development.
• Moving from a laboratory craft to industrial manufacturing.
• Commercialization and Market Access.

Miguel Mulet is Director of Strategy and New Projects in TiGenix, which is a leading European cell therapy company. His primary role at TiGenix is focused on aligning the functions that drive the cell therapy pipeline in Crohn’s Disease and Acute Myocardial Infarct. In addition, and besides business development activities to broaden the current pipeline, he is in charge of advancing the market readiness of the current platforms through implementation of new technologies and process improvement initiatives.