What's The Skinny From Interphex 2005? Trim Production Fat

At Interphex 2005 in April, clear signs emerged that pharmaceutical manufacturing companies and their suppliers are committed to increasing productivity and reducing cost without threatening quality.

By Tom von Gunden

Soon after Interphex 2005 in New York City in April, I headed out to indulge in a bit of R&R. No, not "rock and roll"; I'm talking, of course, about "rest and relaxation." That's right — vacation. If you have ever attended the Interphex show and attempted, as I did, to take in a representative sweep of the goings-on, you'll understand my attraction to some energy-rekindling downtime. Dozens of sessions, hundreds of exhibitors, thousands of attendees — Interphex was definitely rocking. If you were there, you're probably still reeling, unsure whether it was Interphex or Ozzfest you just experienced.

But, make no mistake about my post-show activities: Even while watching scoop after scoop of pure, white sand sift between my toes on its return to the beach beneath my lounge chair, I didn't forget about the rocking. The calm, it seems, invited me to quietly reflect on the preceding storm.

So, now I'm back at the keyboard, prepared to granulate — er, crystallize — my impressions of Interphex. Considering the size and scope of the event, I had, frankly, been pondering surrender. How could I possibly offer an accurate snapshot of such a sprawling event?

OK, I confess: That was a rhetorical question. I have indeed pulled together a snapshot for you, and that snapshot could aptly be captioned with a single word: cost. The cost theme crept into nearly every session, meeting, and conversation I was in. Are we talking about the cost of drug discovery and development? Sure. That's one concern, a lingering one that seems to be escalating. As panelist Peter Barton Hutt, Esquire, reported during a keynote session on drug development, the average NDA (new drug application) cost has doubled over the last five years and now stands at $1.7 billion. And, what about the cost of managing risk and dealing with potential litigation? Yes, folks, we're talking about that, too. Risk management was echoed in conversations regarding the rise in consumer anxiety and the tightening of regulations pertaining to drug testing and safety.

But, the loudest — and, perhaps, most recently emerging — concern about cost had to do with production costs: reducing processing downtime, eliminating product waste, maximizing ROI on capital equipment purchases, getting more automation into (and, correspondingly, human error and manual-processing slowdowns out of) systems and facilities, and so on. Those kinds of concerns were top-of-mind among the process engineers, facility managers, consultants, validation monitors, and others who were making the rounds, reviewing products and services on the exhibit floor. As one vendor representative told me, "Until fairly recently, pharmaceutical companies — especially Big Pharma companies — were making enough profit from high-volume sales and comfortable margins that they tended not to worry too much about production efficiency. They worried a lot, and still do, about quality, but not so much about productivity. But, over the last five years, they've been getting squeezed. So, they're becoming more receptive to considering process changes."

Where is that squeeze coming from? Well, throughout the show, I compiled a list of factors persistently reported by people from various corners of the industry: from virtual companies to Big Pharma, from consultants to contract manufacturers. The list reflects a litany of pressures, including these prominent ones: increased consumer scrutiny, tighter and more regulations, the cost of reducing risk, the cost of process change and revalidation, a thinning of the new drug pipeline, increasing numbers of products coming off patent, the pricing of generics, global competition, and the trend away from high-volume blockbuster drugs toward low-volume specialty drugs.

Suppliers Look To Relieve Production Pain

Fortunately for cost-conscious attendees, many suppliers had arrived with "production costs" at the tops of their minds as well. They came to Interphex to present new or enhanced products and services designed to help customers tackle their cost-efficiency initiatives. You can learn about many of these products and services by visiting various vendor storefronts and product pages on Pharmaceutical Online. You'll also be getting my extended takes on innovative products and services in future articles posted in the Tom's Take section of our site.

For now, I'd like to highlight a few offerings that, cumulatively, underscore what I see as a broad-based vendor commitment to alleviating key customer pain. On the equipment side, spray nozzle manufacturer Spraying Systems introduced a modular system that allows for the quick swapping out of individual nozzles on a manifold for cleaning or replacement. What I found most compelling is that validation of one nozzle on the manifold serves as validation for all additional nozzles of the same type on the same manifold. That capability should greatly cut into the time and money users would otherwise spend on subsequent validation and revalidation efforts.

In the facilities management arena, executives from both Johnson Controls and Tour Andover Controls described hassle-saving, cash-saving offerings. In outlining Johnson Controls' energy management outsourcing services, Jeff Bredeson, director for life sciences, Americas, explained that the largest chunk of savings often comes from improving a customer's utilities usage and central plant efficiencies. "We'll typically come in and do an audit on the energy efficiency of the HVAC systems and the onsite central utility plant. We help customers by either making their existing equipment more efficient or by assisting them in retrofitting the facility with new, more energy-efficient equipment," Bredeson said. "We can maximize the value of our offerings and increase the customer's cost reduction when they outsource the operation of the facility to us. And, we guarantee the savings."

Following last year's merger of TAC and Andover Controls, the resulting entity, Tour Andover Controls, was touting its ability to offer seamless integration and centralized management of disparate systems within a facility. These include systems running on either of two commonly used data communications technologies, Lon and BACnet. According to Clive Smith, Tour Andover's industry marketing manager for life sciences, the key to achieving seamless, native integration is installing systems management tools built on open, interoperable communications platforms. Not only does such integration protect customers from the expense of building custom interconnections, it also allows for unified systems management and monitoring. "Our ability to natively integrate systems greatly streamlines the management of environments such as clean rooms," Smith explained. "For example, if your air sensors and door access controls are tied into the same monitoring system, you can more accurately and efficiently determine such things as whether a change in air quality is related to human entry through a door."

I was also intrigued by an offering that merges equipment with services, using the latter to reduce, eliminate, or delay the need for additional purchases of the former. What intrigued me the most is that the program is offered by an equipment vendor. Process equipment manufacturer Allegheny Bradford Corp., an entity within the Allegheny Bradford Family of Companies, discussed a service offering designed to help customers extend the life of their existing tanks and vessels. Available under the Allegheny Surface Technology (AST) division, the program provides preventive maintenance and refurbishment services aimed at maximizing ROI on capital equipment purchases. Utilizing various testing methods, AST does a complete assessment of a vessel's current condition. AST's refurbishment services include cleaning, weld repair, mechanical polishing, passivation, electropolishing, and component replacement. "This offering gives the processor a viable option other than to purchase new equipment," said AST President and CEO Tom Harvey. "In a matter of days, right at the customer's site, a vessel can be refurbished to the original specifications in terms of surface finish and mechanical integrity. Complete documentation and certification of repairs ensures the vessel meets the client's processing requirements as well as all safety concerns."

Again, I offer the examples above as representative illustrations of a general trend that reveals pharmaceutical suppliers increasingly honing in on the pain of customers' production costs. There were certainly plenty of other examples at the show. So, watch for continued coverage from me on this trend, as well as on other trends emerging from the supplier community.

Tom von Gunden, PhD, is editor in chief of Pharmaceutical Online, the industry's leading manufacturing Web site.