PharmTech:
What is the biggest industry challenge you're now facing?
Varley:
Our customers want the fastest possible timeline from development to commercial manufacturing. A client might use a powder-in-capsule
for first-in-man studies, but it might not be the best dosage form if they want to scale up to commercial quantities quickly.
We then have to come up with a dosage form that's scaleable and can move into commercial production. It's a matter of balancing
speed with cost and efficiency.
PharmTech:
Do you see a new industry trend emerging?
Varley:
I think most of our customers are looking for a one-stop shop where they can go all the way from development through clinical,
scale-up, and registration batches to commercial manufacture. Metrics has a depth of experience, we're in a single facility,
and we collaborate with our development colleagues on a regular basis. In fact, I attend development-staff meetings, and they
attend the commercial-operations staff meetings. So, we maintain that contact and are involved, to some extent, in each other's
operations, so that when projects or products do cross the fence from development to commercial manufacturing, we don't expect
any surprises.
PharmTech:
Has your manufacturing department ever influenced how your development department approached a particular project?
Varley:
We do, in fact, get involved in development. If they're looking at a particular formulation that may lead us down a path where
we don't think our technology base is as strong, and we have an opportunity to influence it early in the process on the development
side, we may influence the final decision. Some of the commercial-operations individuals work on the development side, particularly
when we get to a registration-batch issue. Those development scientists also help us with the initial launch batches. We maintain
that continuity and keep the scientists involved. That continuity, again, goes a long way toward reducing the number of issues
we deal with.
