Do's and Don’ts for Managing Pharma Contract Manufacturing Alliances

Lisa Cozza, Executive Director, Manufacturing Alliances at Human Genome Sciences, joins Andrea Charles from Pharma IQ, to discuss lean manufacturing and the do's and don'ts of managing pharma contract manufacturing alliances.

Pharma IQ: Lisa, what got you interested in lean manufacturing in the first place?

L Cozza: I used to work for Lonza Biologics in Portsmouth, New Hampshire, and the concepts of lean were introduced to us there. Contract manufacturing has very small margins relative to some of the pharmaceutical companies, so we’re always looking at ways to improve the business processes and reduce errors. Lean manufacturing addresses those two things very well. So that’s where I was first introduced to lean manufacturing and saw the benefits. From there, I brought it, with the assistance of a consultant, to Human Genome Sciences.

Pharma IQ:  What’s the biggest challenge bio-pharmaceutical companies have in applying a lean approach to their manufacturing or other operations?

L Cozza:  Hands down, the number one challenge facing any company - doesn’t matter what company - is that every company thinks they’re different and exempt from the principles of lean. Employees will say, but we’re this type, or we’re that type, we don’t fit in that type of lean concept. They believe their situation has nuances that will prevent them from finding gains in applying these concepts. So buy-in is number one, and then management support is usually right alongside of that as the number two reason that the approach isn’t adopted easily.

At first, there’s usually a cheerleading team of early adopters who believe and will strive for change, but when push comes to shove and you actually have to make the changes, people start realising that this is in my backyard and I don’t like it. That’s when the resistance comes in and probably 70% of the programmes fail the first time through.  Buy in at all levels early is critical to making these programmes stick.

Pharma IQ: What kinds of things are companies typically finding when they begin looking at their manufacturing in an effort to become lean?

L Cozza:  The first thing management will ask is how can we save money and reduce errors. So they look at inventory turns. and they’ll look at process timing to see if they can get more capacity utilisation out of the facilities or laboratories. They look at turnaround times to set just in time practices for process equipment, not just for raw material supplies.. An example we often see early is waste within the autoclaved goods area.  Extensive quantities of clean and autoclaved glass and equipment inventory sit on shelves expiring every two weeks and then go back into the washer again unused, This is a just in time process improvement lean easily corrects.
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Another example is to look at the equipment for ways to error-proof. Poke yoke, it’s called. It’s error-proofing places or processes where people make chronic errors, Lean says, maybe it’s not the person, maybe it’s the way we’re asking them to do it. So those are the easiest places to start with improvements. 

Pharma IQ: What would be your top tips for ensuring a team follows lean manufacturing processes successfully?

L Cozza:  Well, you have to have champions from top to bottom, so it grows organically. Get the folks on the floor to be the ones making the suggestions.  Then you have to have the most senior person responsible for the area supporting it as well. These initiatives do require funding, time and resources, and they need to be provided in order for these ideas to happen.  Again, buy in from top to bottom.

Once the processes are modified and documents are changed, processes are now by default improved. The changes become routine. We’ve changed the way we do it, so now we do it this way. You have SOP’s and training to make the transitions.  In manufacturing once the change is made, you have to do it that way, right, because it’s GMP. So what’s nice is, once you get through the challenge of 1: how do we make the change, and then 2: making the change, following through consistently is usually a default because many operations are in a regulated environment.

Pharma IQ:  And what would be your dos and don’ts for managing contract manufacturing alliances?

L Cozza:   I manage our contract manufacturing alliances here at HGS, and each one is different.  Each partner is looking to you for different reasons and different skill sets, and their own parent company has different skills as well. So the challenge is finding out what they’re really after and what they really want from you, and then trying to fill the gap as much as possible.  There’s always going to be a conflict, there’s always going to be a disagreement on how to proceed on things, however understanding why they are with you in the first place helps.

Once you learn what is driving the disagreement and figure out why a particular person may push one way or another, it is easier to find common ground.  It’s not that either party  is right or wrong. Sometimes, you have to really dig in to find out what’s really driving the request, or our own resistance in making a change. So trying to understand the partner as much as you can and being an advocate, I think, for the partners.  Internally, you’ll see lots of roadblocks, lots of resistance and occasionally, poor performance. Being a strong alliance manager requires that you have to address that internally, leading without line management authority.

Pharma IQ:  How do you approach risk-management within contract manufacturing?

L Cozza:  If you’re talking about process risk management, we have a tech transfer group - that takes the process and looks at it and says, okay, what could go wrong at this step, and what kind of risk mitigation strategies do we put in place? Examples may be One, do we buy extra equipment or, two, do we have extra inventory, or, three, do we have enough time to correct or steer the ship in case X happens? The other type of risk management is more on the business side of these relationships. That’s much more complicated and much more difficult to navigate, and it’s usually case by case. I’d say that’s where I spend most of my time – on the business risk side.

Pharma IQ:  And are there any new strategies that you’re particularly excited about for improving the contract manufacturing client provider relationship?

L Cozza:  The point I made earlier about finding out what’s driving behaviour – I think that’s just the most important thing. Sometimes I get caught up in my own stereotypical thoughts and my own background clouds my opinions.  When that happens, you need to quickly recognize that and step up from it.  I’ve got 25 years of Biopharmaceutical experience between Lonza, a company once Genetics Institute, now Pfizer, and now with Human Genome Sciences, so that experience is what shades my viewpoint.  Sometimes a client requests something you just never experienced so  you have to get past those thoughts and get to why. – you know, what’s driving their concern, what is the information that’s feeding this fear/expectation for the client, so we (the CMO) can understand it.  Trying to keep both sides from getting defensive is the big challenge. People don’t ask for things or do things on purpose to create tension between the client and the provider , so let’s get to the root cause and see if we can find a compromising solution. In a way, the lean concepts apply here as well!

Pharma IQ:  And another big question for you: How do you see the bio-pharmaceutical contract manufacturing industry evolving in the next five years?

Lisa Cozza:  Contract manufacturing is just such a big part of the industry now.  It’s been growing and will continue to grow.  Smaller companies just do not have the capital anymore to be able to build and, therefore, their best solution is to use contract manufacturing.  In addition,  contract manufacturers have demonstrated that they’re the experts in their field.  They know manufacturing, they know how to navigate the regulatory environment better than any start-up company could. I consider it a strong industry and it’s going to continue to grow.  I do think competition is forcing the hand of some smaller players in the field, but in general, many companies will continue to thrive.

Pharma IQ:  You are planning on attending the 13^th Annual Contract Manufacturing for Pharmaceutical and Biotech Conference.  What do you hope to gain from being there?

Lisa Cozza:  I’ve been in the industry for a long time. .

By attending conferences like this, I pick up ideas and strategies for how I can improve my performance and perspectives which apply to broader areas of the business that might be more applicable to me going forward, so that’s usually why I attend. 

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