Q&A with Rao Tatapudy, Catalent

PharmTech:

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

Tatapudy:

The productivity and efficiency of internal drug development have become big challenges in the industry. These challenges arise from the large size of a few Big Pharma companies (which results from consolidation), the emergence of several large generic-drug players, long approval times for both branded and generic products, and a short patent life for new drugs. This situation is an opportunity for global drug-development and delivery companies that support the pharmaceutical industry. By offering support for a product's entire life cycle, including preformulation, product development, clinical supplies, commercialization, analytical services, packaging services, and regulatory support, these companies can position themselves to succeed in the current environment.

PharmTech:

Do you see a new industry trend emerging?

Tatapudy:

Yes. Big Pharma is struggling with extensive talent on hand and limited product-development budgets, partly because of mergers and acquisitions, and partly because fewer and fewer new drug applications are being filed each year. On the other hand, global drug-development and delivery companies are extremely enthusiastic about the prospects for growth and innovation and have expanded their horizons to serve the entire industry across most dosage forms. In particular, because a large majority of new molecules in development are BCS class II and IV compounds with significant bioavailability challenges, highly specialized expertise in drug development, delivery, and manufacturing will be needed, and this situation will require drug innovators to work closely with specialty drug delivery companies such as Catalent.

PharmTech:

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

Tatapudy:

Our customers approach us for more products, better treatments, reliably supplied. Many customers come to Catalent for help in solving their bioavailability, solubility, and permeability challenges.