Befitting the theme of INTERPHEX, many of the discussions will focus on manufacturing processes. For example, PharmTech Editor-in-Chief Michelle Hoffman will be talking to Tim Freeman, Freeman Technology’s (Malvern, UK) director of operations, about the complexities of powder dynamics. I’ll be discussing spray drying and lyophilization with Jim Searles, director of process and product development at Aktiv-Dry (Boulder, CO), and Steve Nail, senior research scientist at Baxter Pharmaceutical Solutions (Deerfield, IL).

Reflecting our magazine’s broad scope, we’ll also be talking to attendees about issues that arise beyond the plant floor. Patricia Van Arnum, PharmTech’s senior editor, will discuss the future of process automation and control with Siemens (Berlin). And PharmTech Managing Editor Angie Drakulich will moderate a panel regarding the best ways to use radio-frequency identification to bolster supply-chain security.

Perhaps one of the most interesting features will be a question-and-answer session held on Wednesday, April 21 at 10:30, when officials of the US Food and Drug Administration will respond to audience queries about the deficiencies the agency frequently encounters in abbreviated and new drug applications. The Q&A will follow their presentation as part of the Signature Series of lectures hosted by Pharm Tech. Neither the Signature Series nor the FDA Q&A will be videotaped. If you’d like to participate in this unprecedented opportunity, please come to the exhibit floor’s main stage (which is near the registration desk).

Taped interviews will all be available on our website after the show! Check out the full preliminary program.

The SMART Container was developed for the Department of Defense for use in tracking military assets, and the US Navy is currently using it.

“Always knowing not only the location, but the contents of military containers down to the unit level at any point in transit is a major breakthrough in supply chain management for Military and Defense, and other industries that are soon to follow,” said Patrick J. Sweeney II, founder of ODIN, in a press release.

This level of visibility is a milestone for supply-chain security. Knowing the location and status of the contents of shipping containers could help the pharmaceutical industry by allowing companies to closely track assets and secure their supply chains. For those who are interested, a live example of the technology at work is currently available online.

For a commercial pilot launch, ODIN set up a website that enables visitors to track a container that left Hsinchu, Taiwan, on Apr. 16, 2009, and is en route to Denver, Colorado. Updates are sent to ODIN twice daily detailing the container’s location and the status of the contents inside. The system accounts for each of the 400 items inside and states whether the door remains closed. A detailed inventory showing each case within each pallet is also available. This is an example of the real-time updates that ODIN is receiving about this shipment. The company is also featuring a product video on You Tube.

WaveTrend’s project focused on tracking the daily movements and habits of the contestants of the UK reality show Celebrity Big Brother 2009. The show’s producers asked WaveTrend to set up a network of active RFID readers in the house and issue each contestant a personnel tag that was worn at all times. The contestants’ movements were shown on a house floorplan via a studio display that indicated each housemate with a tracking beacon. With the data gained by tracking the contestants, the show’s viewers, producers, and psychologists, could see where and with whom each contestant spent his or her time.

“We’re proud to have provided our technology to enable active RFID to make its television debut,” said Saleem Miyan, CEO of Wavetrend, in a press release. “The recognition by the Awards Panel at RFID Journal is very exciting and a great validation of the successful use of active RFID in real-time tracking.”

As the winners of the RFID Journal Awards are announced at next week’s conference in Orlando, they are sure to reveal more innovations in RFID technology and its applications.

PharmTech Talk: Can you explain the shift from a compliance-focused market to the concentration on tying supply-chain processes to business processes? Why is the shift moving away from compliance?

Pino: A year ago, compliance was the single-most important driver for supply-chain technology adoption. The economic downturn has manufacturers and distributors facing unprecedented pressure to cut costs and reduce inventory while simultaneously responding to new customer demands. Increased reliance on trading partners such as contract manufacturers, 3PLs [third-party logistics partners], and component suppliers adds additional complexity to the challenge of managing supply-chain networks.

Pharmaceutical manufacturers and suppliers are quickly recognizing that not having accurate and readily accessible information results in higher operational costs, waste, reduced revenues, damaged brand image, and competitive disadvantage. Cleaner, more reliable, error-free data is the goal for businesses in integrating supply-chain and business processes to positively impact the bottom line.

PharmTech Talk: What are your customers saying that indicates there is a shift?

Pino: Rather than implement supply-chain execution systems to meet a government or retailer generated mandate, customers are looking to “do more with less.” Of course the importance of compliance for manufacturers and suppliers remains, but the primary focus is on optimizing supply-chain execution, visibility and control. Customers are looking to reduce costs and labor requirements and streamline supply-chain operations immediately, and they are really focusing on near-term benefits with long-term benefits as a secondary focus.

PharmTech Talk: How is this approach different?

Pino: The difference is the level to which supply-chain execution systems are automated and integrated with business systems and processes, and how quickly companies are expecting implementations to yield return-on-investment (ROI). Manufacturers and suppliers are focused on spending money on projects that deliver near term ROI and cut costs quickly.

PharmTech Talk: How is the economy affecting your clients’ positions and options for supply-chain optimization?

Pino: Businesses are focused on the “here and now” and positioning themselves to be stronger and more competitive coming out of the economic downturn. Customers are searching for ways to leverage existing ERP [enterprise resource planning] investments and extending them through the supply chain with automated data-collection technology. By unlocking large stores of data and integrating this information throughout the supply chain, enterprises are targeting a more efficient operational environment both inside and outside the four walls. The clear objective is to optimize the existing business and supply-chain infrastructure holistically, in a timeframe adapted to the changing market.

In addition to the economic factors, this change in focus on ROI and seeing compliance as a secondary concern could be because the legislation is not yet in place. California’s ePedigree implementation requirements, thought to be a trial-run for a national standard once it was put into action, has been delayed from 2009 to 2011 and now to 2015. After the delay was announced, PharmTech discussed the implications and future of the implementation deadline with Arvindh Balakrishnan, vice-president of the Life Sciences Industry Business Unit at Oracle.

In the meantime, the US Food and Drug Administration is working to “develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs,” under Section 913 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), titled “Assuring Pharmaceutical Safety.” The agency is considering RFID, nanotechnology, encryption technologies, and other track-and-trace or authentication technologies in the development of its standards. FDA’s deadline is March 2010.

The Generic Pharmaceutical Association (GPhA) supported the legislation and welcomed the extra time for manufacturers to comply. “This implementation deadline will help manufacturers to determine the most cost-effective and efficient approach to establishing an electronic track and trace system,” said GPhA President and CEO Kathleen Jaeger in a press release. She explained that generics are not usually counterfeit targets because of their low costs. “To keep the price of medicines affordable, our task is to create a system that would not lead to less competition, delayed access and higher costs for consumers,” she said.

When California announced earlier this year that the 2009 deadline would be pushed back to 2011, respondents in a PharmTech poll said they appreciated the extra time. Now, companies have four additional years to figure out how to implement serialization and ePedigree technology.

Another reason GPhA commended the new legislation is because it does not outline specific technology requirements needed to achieve compliance. “The law is technology neutral, in that it does not dictate a particular technology for serialized pedigree, but allows the manufacturer to determine the most suitable technology solution-this is critical for our industry,” Jaeger said.

But some see the lack of technology standards as a problem. Companies are afraid to spend money to implement a system that won’t work with any other company’s approach. “The 2015 delay will provide all manufacturers with sufficient time for full compliance. However, the industry reluctance is based on lack of a standard that everyone can work toward and know that their investment will serve all states,” said Andre Pino, vice-president and chief marketing officer at Acsis, a provider of supply chain security solutions.

Many states have been watching California’s initiatives in order to consider implement similar requirements. It’s also possible that California’s plan could be adopted as a national standard. “We think that the state of California would have been better served by issuing a call to the pharmaceutical industry to develop a standard that could be used as a template for all states to adopt,” Pino said, adding, “We think a federally developed plan would serve the public and the industry best.”

Despite California’s leadership in developing the serialization and ePedigree requirements, a standard may ultimately be set at the federal level. Section 913 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), titled “Assuring Pharmaceutical Safety,” describes FDA’s plan to “develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs.” The agency will examine RFID, nanotechnology, encryption technologies, and other track-and-trace or authentication technologies. FDA’s deadline is March 2010.

Just this year, we’ve seen California’s deadline go from 2009, 2011, and now 2015. On the question of another possible delay, Pino said, “Without a national or industry standard it is possible that another delay could occur.”

How long will industry be in limbo waiting for someone to make the first move when it comes to standards? And in the meantime, how much counterfeiting will go unchecked?

As Alien Technology CEO George Everhart said in his presentation, “RFID has come of age.” He predicts that 2008 will be a huge year for the industry, and reported that Q4 2007 sales jumped dramatically. Everhart said that at this year’s show, he wasn’t hearing as much about issues with the technology, but more about ROI and solutions. Increasing partnerships between vendors and an increase in vendor choices are also helping the industry’s rapid growth, he said.

From what I heard from various attendees, it’s an exciting time because the technology has matured to the point where the focus is shifting toward using RFID to solve problems. People said that even just a few shows ago, the details of the technology were still being worked out. I heard things like, “Two years ago, this application was unthinkable because it was too expensive.” Now, costs have come down, performance has gone up, and customers across all industries are embracing RFID technology.

In a presentation titled “RFID—A World of Benefits, A Universe of Possibilities,” Ray Martino, CTO of Enterprise Mobility at Motorola, echoed these ideas of the industry’s growth and expansion. RFID is moving forward, and he expressed his frustration with naysayers who question the state of the industry and technology. His answer: “RFID is exactly where it should be.” As he explained, emerging technologies start out in small, vertical, closed-loop systems and then broaden across the market as the technology matures. RFID has “crossed that chasm,” Martino says, and will soon extend across multiple enterprises and bigger markets. “When you think about RFID today, it’s no more ‘Will it work?’ ‘When will it work?’ It just plain works,” Martino said.

Does it work for your organization? How is RFID used in your company, or, if it’s not currently used, has implementation been discussed?

I’ll be focusing on the pharmaceutical track, learning about the latest breakthroughs, product announcements and trends in RFID’s use in compliance, track-and-trace, anticounterfeiting, and more. New products like tags, readers, and tracking systems have already been announced, and I’m excited see demos and find out more. Here are just a few examples: Alien Technology will demonstrate the “Intelligent Tag Radar,” which can provide information about the velocity and position of RFID tags in addition to the contents of tag memory; Lexmark’s “RFID UHF Option” allows customers to turn an existing Lexmark T64x series printer into an RFID printer that prints, programs and verifies RFID tags while continuing to serve as an office printer; ODIN technologies will release the “EasyMonitor” suite, designed to automate the RFID infrastructure such as readers, printers, handhelds and peripherals; and Zebra Technologies will show its on-demand RFID printing/encoding products and line of RFID “smart” labels and tags.

Winners of this year’s RFID Journal Awards will be announced at the conference, including awards for “Best RFID Implementation,” “Best Use of RFID to Enhance a Product or Service,” and “Most Innovative Use of RFID.” The final award, “Best in Show,” goes to the company that shows off the best new product or service. Ten finalists have been chosen, nine have been revealed: American RFID Solutions, Intermec, Lexmark (for its “RFID UHF Option”), NCR, Omni ID, Pramari, Reva Systems, Skyetech, Wirama, and Company X (to be announced).

Stay tuned for updates from the show!

The first, “The Role of Industrial Automation in Qualified & Non-Qualified Building Automation Solutions,” discussed the importance of a validated environment. Joe Evans of Rockwell Automation said in his presentation that ”QBAS” is the big buzzword right now. Treating this the same way you treat your process can be beneficial when it comes to validation–you only have to vaildate one system if you use a common platform.

The second session, “Results of Serialized 2D Barcoding Pilot to Support Item-Level Track & Trace,” described a joint venture between Catalent, Secure Symbology, and Biogen that used 2D barcoding technology at the item, case, and pallet level to revamp Biogen’s packaging and data integration processes. 2D barcoding was chosen in this project over RFID tagging because the product is a biologic, and the effects (if any) of this technology on biologics are not known. The speakers, John Vignola of Catalent and Richard Smith of Secure Symbology, fielded several questions on this topic. They said some independent labs have reported finding temperature variations when biologics were exposed to radio frequencies used in the tags. They also said the US Food and Drug Administration is currently reviewing this situation to make sure using RFID will not damage pharmaceutical products.