Welcome to the new era of preparedness -- and the enormity of the issues it encompasses -- from global health to terrorism, climate strategy and energy security.

Indeed, the opportunities and challenges for manufacturers can seem overwhelming.

Coming to New York City recently to take part in a conference on the new realities of risk, I couldn't help but think how much my role -- and our world -- have changed since I became President and CEO of U.S. operations for Roche in early 2001. While issues of globalization and security were a growing concern for the pharmaceutical manufacturing industry at the turn of the century, few people could have predicted how important homeland security would become, much less that I would have a seat at the table with the likes of former Secretary of State Madeleine Albright and former White House Counterterrorism Chief Richard Clarke, to discuss Roche's role in dealing with national threats. Convening private and public sector leaders to address issues was a significant step forward, but it also raised as many questions as it answered,.

Manufacturing companies have substantial responsibilities for preparing for a possible influenza pandemic. At a 2006 summit on corporate pandemic preparations, U.S. Dept. of Health and Human Services (HHS) Secretary Mike Leavitt made this point in blunt fashion when he stated: "Avian flu ... will severely test the best-laid plans ... and many companies are not making any plans at all. Those expecting the federal government to ride in and come to their rescue [will] be sorely disappointed."

As the maker of an antiviral product (Tamiflu) that is the primary intervention used by the World Health Organization (WHO) against the H5N1 flu strain, Roche was catapulted into a unique situation early on - where the stakes in dealing with the global pandemic threat were high. I welcome the opportunity to share what we've learned with fellow business leaders to help navigate this new landscape.

In 2003, when the H5N1 virus resurged in Asia and new human cases were confirmed, we began collaborating with the WHO on a rapid response protocol as well as planning measures to address a possible pandemic. The most pressing need was to help ensure availability and accessibility of Tamiflu globally. We invested in a massive scale-up of production capacity to meet rising global demand for the drug, and have since increased production ten-fold. In discussions with HHS, it was requested that Roche, a Swiss-based company, establish manufacturing of Tamiflu on American soil. We now have a complete supply chain in the U.S.

Over the past three+ years, we have brought on 17 new production partners and granted sub-licenses for manufacture of oseltamivir for mainland China, India and developing countries. Roche has also reached an agreement to provide generic oseltamivir for the African market and will offer technical know-how and clinical data to help expedite production and regulatory approvals.

While your company is probably not in the business of making a flu treatment, the threat of a pandemic certainly has a direct impact on your business. There are economic considerations that can have profound and long-term consequences and may even jeopardize your company's survival. Moreover, because a pandemic endangers the well being of a company's employees and customers, businesses must consider their moral, and often, legal obligation to take protective measures.

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