Q&A with John Plachetka, POZEN

PharmTech:

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

John Plachetka

Plachetka:

The biggest challenge that POZEN sees in the healthcare industry is bringing novel therapies to market in a way that is efficient and affordable to customers, yet also meets FDA's development guidelines. The traditional Big Pharma model has become obsolete. It has stifled innovation and led to a decline in the approval of novel drugs and the continued rise of healthcare costs. POZEN's business model is designed to avoid some of the pitfalls of traditional drug development and commercialization. The company works under compressed timetables, compared with larger pharmaceutical companies, and uses an in-source model that employs a small expert team that leads the drug-development and commercial strategies, while working closely with strategic partners.

PharmTech:

Do you see a new industry trend emerging?

Plachetka:

One current trend that we see in the industry is in the development of novel combination therapies. POZEN has been researching how to best integrate existing medicines to achieve superior outcomes since I founded the company in 1996. We believe that the benefits of many gold-standard medicines today are not fully realized because of tolerability, safety, or efficacy concerns for certain patient types. Recently, FDA and the industry have begun to recognize the potential of integrated therapies, and FDA is evaluating how to update development guidance. POZEN is currently developing a family of products to maximize the benefits of aspirin by reducing its associated gastrointestinal damage.

PharmTech:

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

Plachetka:

We hold close, strategic relationships both in and outside of the pharmaceutical industry and frequently participate in conferences and seminars. We regularly read medical journals and industry trade publications. To remain in touch with the demands of our customers, we actively conduct market research.