Q&A with Stuart E. Needleman, Aptuit

PharmTech:

Can you explain Aptuit's capabilities and how it integrates its services across its network?

Needleman:

We have API chemistry manufacturing and a business that does solid-state analysis (i.e., the bridge between the formula API manufacturer and formulation development). We have a sterile fill-finish business in the early phase of Phase I, proof-of-concept capabilities, small-dose, as well as a large-scale internal capability, and an R&D engine that we acquired from GlaxoSmithKline in Verona, Italy, which includes integrated drug development, discovery through to dosage form, including toxicology and chemistry.

Stuart E. Needleman

PharmTech:

What are some of the key trends influencing pharmaceutical outsourcing overall, and in the specific sectors of Aptuit services, like formulation, development, and API manufacturing?

Needleman:

There is a restructuring that will continue to go on inside big pharma as they focus on their sites, their facilities, their overheads, and their pipelines. There is some turmoil in the internal pharma R&D; and we want to make sure that we are there to serve those clients as they go through those restructurings and potentially rebalance their portfolio.

We also want to make sure we're following the pipelines of the emerging pharmaceutical companies because, again, innovation continues to come from the smaller companies. We want to make sure we meet the needs of where we see the industry going whether it's therapeutic areas, or whether it's going to be much more focused on oncology in the high potency areas. We want to make sure that we're meeting the market needs or the market demand. We also want to understand where the market is heading and be able to offer services, technologies, and capabilities to meet those needs.

For example, if it's going to be in the prefilled syringe area, we want to make sure we're making investments in that. We have created a scientific advisory board internally made up of some of our leading scientists around our network to discuss the future direction of technology, market, and commercial needs, so we're prepared to evaluate and build strategies around our clients' needs.