Module 5 Presentations

05/07/2024

Case study on developmentof legislation.

The Organisation for Professionals in Regulatory Affairs

33

'Elephant Man' clinical trial - TGN1412(1)

• In March 2006 eight healthy volunteers were selected to take part the Phase 1 trial of TGN1412, organised by the US company Parexel • Humanised monoclonal antibody therapy manufactured by German firm TeGenero • Originally intended for the treatment of B cell chronic lymphotic leukemia (B-CLL) and rheumatoid arthritis • The men aged 19 to 34 were each paid £2,000 to be given the drug in a private unit at Northwick Park Hospital in North-West London • The trial was a double-blind, randomized, placebo-controlled study, with two of the eight study subjects receiving a placebo • The drug was given by intravenous infusion, starting at 8am, with an interval of around 10 minutes between the study subjects , and each infusion lasting from 3 to 6 minutes

The Organisation for Professionals in Regulatory Affairs

TGN1412

34

17