Bikash Chatterjee knows all about Lean Six Sigma. He’ll share that wisdom with us at Outsourced Pharma West in San Francisco, November 11-12. However, you might not notice when he’s doing it.
Chatterjee effortlessly embeds principles of his field in examples directly from our industry; they register just as effortlessly in the minds of his listeners. I learned this firsthand: Although nervous to interview the author of a book entitled “Applying Lean Six Sigma In the Pharmaceutical Industry,” because, shall we say, my questions seemed a little disorganized, Chatterjee made it an efficient process.
For example, his clear advice to the uninitiated in development outsourcing: “First of all, brace yourself for things taking longer than you are used to in your own labs. It is a scientific and business process working with a CDMO, so you must build that into your project timelines,” he says.
Chatterjee and I (a former outsourcing business development type) talked about how companies tend to hold back vital data from providers (for perceived IP concerns) on the one hand, and then rely on them for process guidance on the other.
About this he says, “I tell my clients it is most important to recognize you are in fact the experts in your field, and of your project, not the CDMO. If you want them to succeed, you need to first provide all the necessary details, structures, in-process and success metrics to operate and execute. For young companies,” he adds, “this also guarantees the outcomes you want to see obtained are actually clear in your mind.”
Clarity of purpose begets quality processes and puts everyone on the same path. “Most young companies are built on scientific excellence, with folks that are great at innovation, great at ideation, but perhaps not as good at execution,” he says. “Nonetheless, don’t go to the CDMO and ask what needs to be done for a characterization, for example. You need to be specific: ‘We need to do the following study, here are the raw materials to use, the batch size, the testing plan, execution timeline, number of samples, etc.’ If you move to a clear, standardized approach, whether you are doing pre-phase 1 or phase 3, you will have a much more efficient dialogue with whichever CDMO you select. This then allows them to provide the leadership you need from them.”
At Outsourced Pharma West, Chatterjee will bring to life the opportunities inherent for both pharma and start-ups in working with providers. “This is a very interesting format,” he says, “and after November could become the wave of the future. Most conferences get watered down by ‘approved presentations’ and company-specific introductions.”
During our conversation, Chatterjee stressed that outsourcing starts with getting your objectives straight, whether at big pharma or start-ups. “When you really analyze the need, most times engaging a contract service provider is not a cost decision in the sense many start out believing,” he says. “I look at it as a bandwidth decision first. You are either avoiding, for timing or in terms of your business plan, investment in infrastructure, or your capacity is consumed and you need this work done in parallel. So I think that practically, if you align your thinking in some sort of standardized process work-package, you will be able to cut to the chase and vet service providers more efficiently.”
“There certainly is a new thinking out there,” he adds. “If you look at annual contract pharma outsourcing surveys, it is interesting to see a shift in criteria associated with contracting a service provider. It used to be sponsors were cost centric: productivity metrics, product delivery timelines and cost of goods equations. Now it is more regulatory understanding, compliance history, ability to integrate CMC components. Things that were nice to have years ago are becoming the core criteria for selecting a CDMO.”
Before we end our conversation, Chatterjee again looked to November. “The dialogue-based element of Outsourced Pharma West will give all participants the chance to ask questions and move beyond theory to practical considerations from real implementation experience,” he said. “You should be able to take home thoughts on methodology to accomplish your particular outsourcing objectives. That is an outcome you want.”
And if the Lean Six Sigma expert agrees the conference process and procedures are in good order to precipitate the best outcomes, who’s to argue?