Biomedical products clinical data

Please read the attached article before participating in the Week 4 Discussion – As we are learning in this course manufacturers of new biomedical products must, for the most part, conduct a series of regulated design and product mechanism of action (termed pharmacodynamic) testing experiments.  The results of these experiments must be summarized and presented to regulatory agencies (in the United States the Food and Drug Administration) prior to being tested clinically in human populations.  In order to proceed with such testing manufacturers of proposed new biomedical products must, in the case of FDA, demonstrate that the likely benefits of using these new products outweigh the risks involved in using them.  In regulatory language this means that their safety profile must be maximized before conducting what we call First in Human or FIH studies – in many cases with biopharmaceuticals these would be Phase I studies (which we will start to look at in Week 5 of the course).

Within this context the clinical results observed when new biomedical products are utilized for the first time are not what would be suggested by the preclinical data collected, compiled and analyzed.  The attached article represents such a case study.  After reading the article, and based on what you have learned so far, is there anything more the manufacturers of TGN1412 could have done to improve the safety profile of this product candidate?  If you were a regulator at FDA would you fault the manufacturer for the adverse events observed?  Why or why not?

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