Q&A with
Terry Novak, president of Norwich Pharmaceuticals

Terry Novak

Novak:
The contract manufacturing organization (CMO) industry faces a reputation issue. People think we're mediocre. There's still a stigma, a perception that Big Pharma can do drug manufacturing better than outsourcing providers. While that perception has slightly changed during the past five years, proving the case for CMO partnership remains our most time-intensive challenge. CMOs have to be as good as the customer's own manufacturing, which means delivering finished product on time, and right the first time. The greatest strength the CMO industry now has is its strong regulatory compliance. Where CMOs need to do a better job is on-time delivery. For specialty and small pharmaceutical companies, we are their internal supply, and we always have to remember that. I think a lot of CMOs have lost their customer focus due to the financial issues that have affected their businesses during the past few years.

Novak:
Drug delivery is still a hot topic. We see many companies trying to extend the patent life of an existing product before it loses exclusivity. Specifically, nanotechnology has been talked about forever, but no one has put it to commercial use yet.

Everyone is still talking about ePedigree. We were preparing for the California legislation about two years ago to force this issue into becoming a trend, and although it didn't happen, I believe it's inevitable. On the packaging end, this will be a big emerging area that we're going to have to address.

PharmTech:
What is the most common demand your clients are currently making of you?

Novak:
Lately it's been formulation development for products that are poorly soluble. They're difficult to manufacture, and outsourcing providers should be looking to solve that problem. It's an area that we've expanded into, whether it's highly potent compounds or complex controlled-release delivery. During the next few years, growth in the contract manufacturing business will be achieved by companies that can provide a quality solution to complex formulations.