Contract Pharma: Over the course of the decade HollisterStier went through several expansions, as well as the integration into Jubilant HollisterStier that Marcelo talked about. How do you manage client expectations during an expansion phase?
John Bertagnolli: Expansions are never gradual things; they more like quantum leaps of change. It'd be nice if you could view expansions as a gradual ramp up, but it never works out like that. You don't get to bring in a new group of employees and train them at a gradual pace. It's always a giant influx.
You always hope that the sum of the equation turns out to be a successful product transfer or completed project, but the one constant in the equation is going to be client expectations. They know what they want; it's not going to change dramatically based on what's going on at your site. So you have to rearrange some of the other variables in the equation so that you can "solve" for that one.
Customers, at either a planned or an instinctual level, have an idea of what their priorities are. Making sure that these are communicated to both project teams is really important. If you are struggling with resources or facility space or equipment, you're not always going to be able to hit all of their criteria at the same time. So it's important to satisfy the most important ones for the customer.
You want to be careful not to have a project schedule that goes, "I need to go from A to B to C," if, in the client's mind, there's a deliverable between B and C that's much more important than the ones at the beginning.
CP: How do you manage incoming and continuing business when you're ramping up capacity? Is it difficult to not over-promise but also not leave capacity lying unitized?
JB: You mean, "How do you level-load during quantum change?"
CP: That sounds about right!
JB: That's a challenge. Sometimes, it's not until later on in a project that you're going to be able to really understand what the total amount of work is going to be. You have an idea, based on the client's initial forecasts, what your expected volume is at the end of a transfer or a development project. But timeframes being what they are — for regulatory approval, for installing capital equipment — things can change.
You try to do a very good assessment at the beginning, but it's the mid-course corrections that are important. Sometime in the middle of a project, you have to take a look and ask, "What do we expect the end-state to be?" At that point, you should have a much better view and all the big changes should be (SHOULD) behind you. That's when you have to start projecting forward and you should have the ability to adapt to reach it.
CP: What differences do you see among client expectations based on size? I assume they're different for a large company that's already worked with you on some commercial projects than for an emerging, development-stage company that's never worked with a contract service provider.
JB: Certainly, the size of the company you're working with is going to dictate and define client expectations. The amount of infrastructure that they're used to working with, and the amount of uncertainty they're used to dealing with really play into how they view the CMO and the deliverables.
It also changes dramatically from the development stage to the commercial. A lot of times, you're going to have one group that's very development focused, a team that has one objective in mind: getting a product transferred and ready to go. When that reaches maturity, you may have a completely different team from the same company come in to manage that product. That can create a little tension. If the company you're working with has great internal communication, and the end-state has been clearly delineated for the new group and they're in accord with how they're going to work to reach that state, you're fine.
But sometimes mismatches occur, and it leads to "the project after the project." It's not just managing customer expectations, but helping to shape those expectations throughout the course of a project.
CP: What's your background and how did it prepare you for this role?
JB: I got to sit on the other side of the table for quite a while. I worked for Agilent on the outsourcing side, sending the business out to CMOs. It was really easy for me to look at those manufacturers, say, "I need this, that, and this," and believe I was their only client. But that's not the reality of it.
Most of our clients are sophisticated enough to understand that. They understand that the CMO has resources and timelines and other projects to accommodate. Fortunately, we work with a lot of good, smart clients.
When you're the person who's responsible, from the bottom-line perspective, and it's your job to make sure that this is transferred on time to meet production requirements, it can ratchet up the intensity quite a bit. Having been in that role, it made it easier for me to sit on the other side of the table here at Jubilant HollisterStier. When a client comes to me, I can gauge their level of anxiety because I've sat in their chair before.
There are a lot of unspoken expectations, so I think it's important to have that perspective. It helps you adapt and adjust without having to spell everything out.
Gil Roth has been the editor of Contract Pharma since its debut in 1999. He can be reached at email@example.com.