Thursday, April 28, 2011

Developing Drugs (and skills)

Posted by Jim Stevenson at Thursday, April 28, 2011

My non-traditional elective was in the drug industry with a consulting company called United BioSource. United BioSource works with a number of pharmaceutical companies to provide guidance and input during a drug’s development. For the most part, United BioSource positioned me with one of their clients, Esperion Therapeutics. Esperion has an interesting background – it started as a small pharmaceutical company in 1998, then was bought up (for a handsome sum) by Pfizer in 2004, and then split off once again in 2008. Esperion’s area of interest is in basic metabolism-related conditions. Their CEO, Dr. Roger Newton, was co-discoverer and champion of Lipitor while at Pfizer.

While I was working with Esperion, they were designing a Phase 2B trial for a drug they are developing. Interestingly, they were investigating the same compound for multiple indications. My work entailed reviewing literature on the actions and development of similar compounds. The published manuscripts of phase 2 trials for similar drugs were invaluable resources. For example, a power calculation needed to be performed for the phase 2 trial I was assisting with. The magnitude of effect of various biomarkers and the duration of similar trials were major considerations. Also, the study population was a major discussion point. With an unproven drug, it becomes an ethical dilemma to perform a long placebo-controlled trial in patients with active disease (as half will be on placebo therapy and half will be treated with an unproven drug).

It was a very interesting experience to learn about all of the considerations that must be made during a drug’s development. There is an incredible amount of consequences to consider with each decision. In a world where a small difference in p-values or a single rare adverse event can cost billions of dollars, there is spirited discussion about every aspect of a drug’s development. Perhaps one day I will see use of (or even use myself) the compound that I worked on this winter.

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