By John StuttardIndustry Vice President, Reed ExhibitionsPharmaceutical manufacturers are under pressure as never before—not only from regulators, but also from the medical establishment, government, investors and consumers. New challenges are emerging everywhere, and many solutions are still largely unproven within such a sensitive and highly regulated environment. Yet the urgency for delivering safe, innovative products to market has never been greater.

Today, more than ever, pharmaceutical manufacturing professionals need a trustworthy, objective forum where they can discuss important issues, explore their ramifications and evaluate potential solutions. The good news is, you’ll find that forum at INTERPHEX2005.For the past 12 months, the INTERPHEX show team, along with our many sponsoring and endorsing organizations, has been working hard to develop the agenda for this year’s event. Our mission has been to identify your most pressing problems, assemble respected thought leaders and innovative solution providers, initiate discussion and facilitate productive collaboration and innovative thinking.As a result of this year-long effort, I’m proud to announce that you will see much that is new, different and exciting at INTERPHEX2005. First is our series of three Visionary Keynotes, one each day of the event. Because our aim is to encourage industry-wide discussion, these hour-long presentations are free to every industry professional at INTERPHEX, including registered attendees, conference speakers, and exhibitors and their staff.

Strong Medicine: What’s next for drug-development?

On Tuesday, April 26th, you’ll hear a prestigious panel of industry experts including a prescriber, an analyst, a researcher and an attorney share their various perspectives on what’s next in drug development. Irvin Modlin, MD, PhD., Professor, Yale University School of Medicine; Sarah W. Fuller, President of Decision Resources, Inc.; Nancy Hutson, PhD., Senior Vice President, Global Research and Development at Pfizer; Peter Barton Hutt, Esquire, Senior Counsel, Covington & Burling; and Moderator Bill Breen, Senior Writer and Northeast Bureau Chief of Fast Company magazine will discuss ways to balance the sometimes conflicting demands for safety, efficacy, urgency and profitability.

Rudy Giuliani: Leadership in challenging and uncertain times

Rudy Giuliani’s accomplishments as a tough and highly effective criminal prosecutor, followed by two terms as mayor of New York, combined with his extraordinary response to the terrorist attack of September 11th and its aftermath, reaffirmed his reputation as a courageous and compassionate leader. On Wednesday, April 27th you can hear first-hand what it’s like to lead in challenging times-and what it takes to rise to the occasion when unexpected crises arise.

Risk-Based Inspections: What’s the FDA looking for?

An FDA inspection is not something most people look forward to—and in the light of new initiatives and evolving best practices, it’s not easy to anticipate what regulators want to know, and what you should expect. On Thursday, April 28th, FDA Associate Commissioner for Regulatory Affairs John M. Taylor III will clarify the agency’s role and answer your questions as he describes what constitutes a high risk that is likely to cause an FDA inspection, and what happens when you get inspected.

A new focus on pharmaceutical facilities.

This year’s INTERPHEX also marks the debut of PharmaFacilities, the only event dedicated to the highly specialized requirements of pharmaceutical facilities. PharmaFacilities is an essential tool for ensuring that all of your critical physical assets are operating smoothly, safely and cost-efficiently.You can preview the most innovative solutions in a unique setting designed to illustrate the environment of an actual pharmaceutical production plant at the Pharmadule Facilities Resource Center, and see examples of world-class facility design at the first annual Facility of the Year Award ceremony, presented by ISPE, Pharmaceutical Processing magazine and INTERPHEX.

RFID and PAT—the proof is in the pudding.

2005 may be the year that the industry makes its first major foray into the advanced productivity solutions recommended by the FDA and demanded by such major customers as Walmart. The new Rockwell Automation Partner Pavilion and the Process Automation & Controls Pavilion are great places to begin your search for potential partners and suppliers who can help you develop and implement your PAT initiatives. Exhibiting companies offering RFID solutions include Elpro Services; Brady Corp., RFID & Brand Security Division; Creo, Inc.; Werum Software & Systems and many others. For a searchable database of all INTERPHEX2005 exhibitors, please visit www.interphex.com.

New products and new solutions.

Tour the INTERPHEX exhibits to see the newest products from more than 950 companies including Cintas, Cardinal Health, Fluor, ITT Pure-Flo, Elizabeth Companies, Fette, IMA North America, MG America, Thomas Engineering, Korsch, Marchisini and many others. Is it time to update your technical knowledge? The INTERPHEX2005 Conference offers cutting edge insights on best practices for every discipline; from manufacturing, packaging and facilities to IT and outsourcing.

INTERPHEX2005 will take place April 26-28, 2005 at the Jacob K. Javits Convention Center in New York City. For complete event details and online registration, visit www.interphex.com or call 1-888-334-8704 or 203-840-5648.