with Gerry Migliaccio, vice-president of quality; environment, health, and safety; and agility at Pfizer
What is the biggest industry challenge you're now facing?
The pharmaceutical industry is facing the same challenges as many other industries as a result of the economic situation,
plus a few unique challenges such as successfully bringing new medicines to market and changing payors' expectations. From
the pharmaceutical manufacturing perspective, I think one of our biggest challenges is securing our supply chains as they
become truly global. The challenge includes the prevention and detection of counterfeits, the prevention of product diversion,
and the prevention of intentional (i.e., criminal) adulteration.
How do you stay abreast of new developments in the industry?
I try to interact with industry colleagues and regulators as often as possible at industry association meetings, which is
where you can get a true sense of new developments from the perspective of industry and the regulatory agencies. For my daily
dose of current industry affairs, I review Dickinson's FDA Webview and several other online newsletters.
Do you see a new industry trend emerging?
I see quite a few trends in the manufacturing arena. The trend toward outsourcing will continue. Strategies widely used in
other industries such as continuous processing are taking hold in pharmaceutical manufacturing and will emerge in the coming
years. As quality by design continues to be adopted and our manufacturing processes become better understood and highly capable,
reliance on product testing will be reduced significantly.
Gerry Migliaccio will be a keynote speaker at Pharmaceutical Technology's Third Annual Conference to be held Aug. 11–12, 2009, in Philadelphia. For program details and to register, visit