Reasons for Stopping Clinical Development and the Fallout from Failure

Reasons for Stopping Clinical Developmentand the Fallout FROM Failure 

Adverse reactions are common at any stage of development and marketing, and this can cause cessation of a project. Prudent research teams have a so-called backup compound. Since the adverse reactions are common, companies insist on a backup even before considering taking a compound into clinical development. Many companies have spent years to discover a new target and went on to select Just one clinical candidate that failed, say, for some nonmechanism-related toxicity. Other companies had found better compounds for their target. Even a small company should have a backup molecule. Regrettably, many Biotechs fail to do this perhaps because they have so much conviction about the success of their principal molecule or so little time and money to develop a backup. 

Chapter 6 / About the Economics of ilget and Clinical Candidate Selection 

One needs conviction to move forward in clinical development. It bears emphasizing that one needs compassionate, courageous, and scientifically well-trained clinicians to do your clinical trials, and the strength of their conviction will help in determining how to proceed. Even if you are working through a CRO it is good to have some direct access to the physicians. The better you know them, the better chance of success. 

If you work in Big Pharma and have doubts about a candidate molecule, it is very difficult to distance yourself from it. You caimot even safely license out the compound to a third party because, in the end, people sue the company with the deepest pockets and no amount of protective paperwork will ultimately protect Big Pharma. 

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Reasons for Stopping Clinical Development and the Fallout from Failure 59... 

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