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Biotech / Medical : T/FIF, a New Plateau
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To: Biomaven who wrote (1240)7/4/2002 7:19:42 PM
From: Miljenko Zuanic  Read Replies (1) of 2243
 
Peter,

I think that it is common practice in drug development process one can not start large pivotal trials without long term animal toxicology study or good PK/PD studies. If safety issues emerge after pivotal trial is completed one need scientific explanation, sometimes going back to animal studies, or PK/PD study, or drug-drug interactions, or… is necessity.

I believe that we do have constant dialog between FDA and drug developers. Quality of this dialog is what makes difference at end. In ALKS (J&J) and SEPR case I do not have true picture whom to blame for failure, or “Not Approvable”. Maybe true story will come out?

Do you think that FDA will ask for additional animal data (or any other data) if there is no connection with human results? FDA does not dictate every issue in drug development process. They do help with recommendations and suggestions. They are not perfect, far from that. Why companies have outside consultants, regulatory department, and all other technical support?

SCIO’s Natrecor story is typical one. Sloppy clinical results and you are going back. Do it right and we are with you.

Do they balance candidate safety with medical needs?
In majority of cases safety issue bar is for those who will abuse drug, not for those who are in real medical needs. Unfortunately second ones suffer because of the first.

Miljenko
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