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A recent article in Chemical & Engineering News (June 19, 2006) brought back to mind some thoughts from my early career with a major pharmaceutical company. This special issue covers many different areas of the drug industry and tries to answer the question “Where does pharma go next?”

C&EN Special Issue: An Industry in Transition

I just want to comment on one item covered in the article Pharma In Flux. Here’s the pertinent part:

Wyeth, on the other hand, is among the major drug companies that have instituted a comprehensive series of targets for each stage of drug development. The plan, put in place by Robert Ruffolo, president of Wyeth Research & Development, emerged in response to Wyeth’s sagging pipeline in the late 1990s (C&EN, Feb. 16, 2004, page 22). It called for Wyeth to introduce 12 new drugs to early-stage development each year, up from an average of three in the late 1990s; to file eight Investigational New Drug Applications (INDAs) with FDA per year, up from an average of two; to begin Phase III clinical trials on at least two new candidates per year; and to market two new drugs per year.

While setting goals such as this is admirable, in my experience it has created many more problems than it solves. Being on the development side of things, what I saw was the following. Drug discovery, in order to meet these goals, would toss over the wall into the development side whatever compound they had when they approached their deadline for a drug in a given therapeutic area. They always seemed to come up with one just before the deadline. This was then developed regardless of how poor a candidate it truly was. Then, the drug discovery chemists were given bonuses and/or company-wide recognition and the process development folks left to try and figure out how to pull off the difficult feat of developing a potential commercial route to a poorly selected compound.

Now, in my experience development always managed to find a way to make the compound but that doesn’t make the process efficient. My experience was that development was not allowed input into what we would like to see in a drug candidate even though we were drug discovery’s internal customer. Now, I realize that the goals of drug discovery are different from those in development, but I do think allowing for input from development would have been useful. There were some things that were done to make the process more efficient. A development chemist went to each of the drug discovery group meetings (one of the reasons for having early development and drug discovery at the same geographic site) in order to get a heads up on what way be coming our way in the future and to learn what had been done that worked as well as what was tried that didn’t work. However, my impression was that this was a one way street with information flowing in one direction only. Any ideas and suggestions from development to drug discovery was generally met with little interest or outright skepticism. Also, the data packages that development received from drug discovery did not contain the kind of information that was needed in order to move the project forward. Much time was spent in gathering basic information that should have been made available in the transfer package but wasn’t (TLC’s with solvent systems; NMR data, etc.). In some cases, drug discovery experiments had to be repeated to get basic information . Some of this was because drug discovery did not understand what development did bit in other cases, they didn’t want to know. About the only time drug discovery embraced development was when they had a core compound identified and the kilo labs was making large amount of the core for drug discovery to make various derivatives.

What is needed is a more objective criteria of what drugs should be developed and not a focus on simply hitting certain numbers. When only numbers were talked about, I never saw drug discovery fail to meet the goal. In my 5.5 years at this major pharma company, I never did see any objective criteria developed to determine what drug candidate should be moved into development. Hopefully this is changing, but I’ve not seen any first hand evidence of this.

Technorati Tags: process development, drug development

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