What is the biggest industry challenge you're now facing? 

The biggest challenge has been the economy, the decrease of money in the market, because innovation still has been coming from smaller companies funded by venture capital. When they don't have money, they can't spend the money, therefore they can't develop drugs. At the same time, the Big Pharma companies, which is where the money is, are merging with each other. That causes slowdown in drug development, so we get fewer opportunities. 

Another challenge is determining whether too much capacity is becoming available on the market. Too much capacity can put cost pressures on contract manufacturers. 

How do you stay abreast of new developments in the industry? 

We have an internal scientific leadership team from each of the various businesses that routinely talks and shares best practices and ideas. We get the thought leaders of science around the table to discuss challenges, developments, trends, and what customers are anticipating. Inside the active pharmaceutical ingredient business, I have my own leadership team that does the same thing. That's part of our strategic planning process. We talk to customers, too, which is not to be underestimated. We ask customers what they want. 

Do you see a new industry trend emerging? 

We're handling more potent compounds, which is going to be a continuing trend. The application of analytical techniques such as ultrahigh-performance liquid chromatography also is increasing. 

Many compounds in development now are poorly bioavailable, poorly soluble, and have low permeability. Companies are seeking ways to improve these characteristics. For example, inside our toolbox, we have the capability of making amorphous dispersions to take something that you call brick dust and make it more bioavailable and more soluble. 

The industry is keeping an eye out for new drug-delivery techniques. The trend now is to try to deliver drug products under the tongue. 

API Synthesis and Manufacturing, Large Molecule

Development

Drug Delivery

Ingredients

Manufacturing

Outsourcing

Pharmaceutical Technology-11-02-2010

Stuart Needleman, president of active-ingredient development and manufacturing at Aptuit, discusses industry trends and challenges.