Linked to EAHP Statements

Section 2 - Selection, Procurement and Distribution: Statements 2.2, 2.6
Section 3 - Section 3 Production and Compounding: Statements 3.3, 3.5

Abstract

The so-called "advanced therapies" are not the future anymore. Gene therapy products such as T-VEC for melanoma are already in the market, and FDA has approved CAR-T cell therapy, a cell-based gene therapy, to treat adults with certain types of large B-cell lymphoma.

So, what's in it for hospital pharmacist? What new management strategies and processes must we implement for these products. What new skills, equipment and facilities must we have? What are the legal and regulatory constraints?

In this seminar we will describe the existing and upcoming gene and cell therapy products, and discuss management, skills and facilities needed to handle them, as well as the legal and regulatory framework applicable.

Learning objectives

After the seminar, participants should be able to:
• describe existing or upcoming gene and cell therapy products;
• describe applicable legal and regulatory requirements;
• list management, skills and facilities needed to handle these products.

Educational need addressed

Hospital pharmacists need to be aware of new therapies to be able to handle them in an appropriate manner, with the objective of ensuring safe and effective use.

Keywords: gene therapy, cell therapy, advanced therapies.