Six Sigma Tips on Keeping Pharma R&D Lab Costs From Spinning Out of Control
Lab Manager magazine notes that R&D labs have had to skinny down their budgets in recent years, given the growing volatility of the pharma market. As you might expect, the majority of lab spending—over 60%—is on consumables: chemicals, life science reagents and kits, glassware, plasticware, and general laboratory supplies. Instruments and equipment make up as much as 40% of the remaining spending, with up to 27% of budgets allocated to the purchase of instruments and 13% allocated to the purchase of equipment. Instruments are the single largest expense of laboratories, with the average instrument budget totaling over $82,000 in recent years. Recently I led a team that found an effective way to use six sigma tools to keep its lab instruments and equipment costs in check — and ensure experiments weren’t being derailed by contaminated equipment. How? By using a measurement system analysis of current equipment and a careful evaluation of company and federal requirements, the team established Standard Operating Procedures (SOPs) for utilizing existing equipment in GLP analytical laboratories. There were many “ah-ha” moments during the process. One came when we took a closer look at one of the biggest challenges and expenses for any lab –clean glassware and a well-functioning lab washer system. As you can imagine, these labs go through thousands of flasks, beakers and vials in a day. The standard operating procedure stated that glassware needed to be “visually clean” for the lab washer to be certified for research lab use. But what does “visually clean” really mean? What about scratches on the glass? We learned that what looked clean to one researcher might not be considered so by another. The six sigma team members discussed the term, and came up with a standard definition upon which everyone could agree. They then tested the definition by grading a set of glassware in their own labs. After determining that everyone was now grading glassware uniformly, we then implemented the new definition as a part of the SOP. The result? Over $1 million in cost avoidance, since we didn’t have to purchase a fancy, new lab washer. Not to mention the avoidance of ruined experiments because of contaminated glassware. The team did an amazing job. This is just one simple way I’ve seen that six sigma tools can help improve pharma R&D. What have you done this week to make your lab operations better? Share your...
Read MoreLetting Go: Top 3 Tips for Terminating Pharma R&D Projects
This week Roche announced that it has pulled the plug on its diabetes drug aleglitazar, once tapped as a blockbuster hopeful. Similarly in May, Merck discontinued investigational studies of preladenant for the treatment of Parkinson’s disease. These examples of sad endings to once hopeful products happen every day in pharmaceutical operations. Having worked in project management for a large pharma company, I know firsthand that it’s never easy to terminate a project. With years of staff time and valuable resources invested, it’s hard to let it go. The decision to terminate a project can demoralize project managers and team members, and increase concerns about job security. For many reasons, managers tend to delay project termination decisions. However, delaying project termination diverts scarce R&D resources from higher potential projects. Even after a project is closed, resource diversion can still be an issue. It’s not uncommon for terminated projects – at least parts of them — to continue under the radar, because a determined researcher is convinced that the project axe decision came too soon. You would think that, given the trial-and-error nature that’s at the heart of innovative research, pharma companies would be experts at the art and science of letting go. But most would likely say they aren’t. Why? Because developing safe, effective, market-viable and FDA-approved drugs takes a really, really long time – typically 10-15 years from start to approval. (Most of the drugs on the market today were developed in the 1990s.) And second, because the majority of drugs in the early pipeline will never make it to production. On average, 60% of drugs fail during phase I, 50% fail during phase II, and 15% fail during phase III. Thus, the probability of a drug entering clinical trials making it all the way to the market is approximately 17%. Let’s face it — R&D is inherently uncertain and risky. If you lead a pharma R&D team, how can you mentor researchers in getting wiser at the art and science of letting go? This Business Week article offers some best practices from other industries: Tremors and Thrills – Check the signals you’re sending to your staff. How management reacts to a well-thought-out plan that goes south makes a big difference. Acceptance reinforces a culture of risk-taking; harsh reactions breed a culture of fear. Failure Parties – Find ways to measure performance that balance accountability with the freedom to make intelligent mistakes. Find Your Own Flaws Up Front – Reframe your team’s thinking. You should not only seek positive outcomes to prove that an experiment works, but you should also take time to try to prove yourselves wrong. Looking for those potential flaws makes failure, and the lessons that come with it, occur earlier. What have been your lessons learned in terminating projects? What has worked well for you? Share your...
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