Show Preview - Interphex 2007

As the world's largest and most comprehensive biotechnology and pharmaceutical conference and exhibition for manufacturing biopharmacuticals, INTERPHEX is the leading source for specifying, purchasing, partnering, and learning in the drug production industry. Over its 28-year history, INTERPHEX has adapted to sweeping changes in the market, and in turn, has helped shape the industry as we know it today. INTERPHEX provides industry and regulatory professionals with their annual dose of information on all pharmaceutical fronts.

The annual event will take place April 24-26, at the Jacob K. Javits Convention Center in New York City and will be co-located with PharmaMedDevice, a premiere event focusing on the convergence of the medical device, pharmaceutical, and biologic industries.

With over 100 cutting-edge sessions led by respected industry experts, the INTERPHEX2007 conference program is unsurpassed for up-to-the-minute, intensive education geared toward problem solving and productivity enhancement. INTERPHEX2007 is poised to deliver insight on today's hot topics such as personalized medicines, bioequivalent drugs, PAT, process development, and disposable technologies.

International participation in INTERPHEX continues to grow in line with the globalization of the industry. Over 1,000 leading global companies serving the pharmaceutical and biotechnical industries will showcase the latest lines of equipment, technologies, and services in the areas of PharmaManufacturing, PharmaSourcing and Services, PharmaIT, and PharmaFacilities. Visit www.interphex.com.

Focus Areas at INTERPHEX

Innovation Theater

The Innovation Theater will feature presentations and product demonstrations from leading exhibitors on the INTERPHEX2007 tradeshow floor. Attendees will gain an in-depth understanding of the industry's leading technologies and trends from experts in the industry, while enabling exhibitors to increase the visibility of their innovations.

Packaging Pavilion

INTERPHEX2007 will feature a Packaging Pavilion, where exhibitors can showcase the latest in packaging technologies and services. With the best and most innovative packages on display, the Package Design Showcase will provide an added draw for the Packaging Pavilion. Sponsored by Package Design Magazine, the Package Design Showcase will highlight award-winning package designs that have been selected by respected industry organizations in the areas of pharmaceutical, cosmetics, medical device, and other related industries. The Packaging Pavilion is sponsored by Packaging Digest magazine and the Healthcare Compliance Packaging Council (HCPC).

Process Automation & Controls Pavilion

The Process Automation & Controls Pavilion at INTERPHEX2007 is sponsored by Control Engineering. The pavilion features the latest automation systems, instruments, and controls to make manufacturing operations more efficient and productive. A number of leaders in automation will be featured in the Process Automation & Controls Pavilion such as Honeywell, Invensys PLC, Rockwell Automation, and Emerson Process Management.

Life Sciences Job Fair

Produced in partnership with AAPS and ISPE, INTERPHEX2007 will also feature a Life Sciences Job Fair. The Life Sciences Job Fair will provide opportunities to meet representatives from a broad range of companies who have employment and career opportunities, including exhibitors and other suppliers, pharmaceutical and biotech companies, industry recruiters, and more.

New at INTERPHEX

Bio-to-Business Program at INTERPHEX

The producers of INTERPHEX2007 announce the introduction of a Bio-to-Business program to provide small- and medium-sized biotech companies with the resources to grow their business and scale-up for production. Bio-to-Business provides an additional avenue for biotech development; it offers a targeted schedule of conference sessions, roundtables, VIP networking opportunities and special events tailored to the needs of this high-growth industry.

The early stages of development represent a critical juncture in the life of a biotechnology company. Process development, regulatory strategy, and selection of sourcing and manufacturing partners are all crucial considerations. INTERPHEX2007 aims to help biotechnology companies navigate the vast opportunities available to the industry at large.

"The Bio-to-Business program provides a balance of education, networking, and sourcing opportunities," says RJ Palermo, Event Director at Reed Exhibitions. "Biotechnology company executives will uncover technologies to speed development, gain regulatory insight, and network with potential investors to help realize full-scale production and commercialization of new drugs."

Bio-to-Business provides select programming for all three days, including a series of specially-selected conference sessions on topics, such as PAT, process development, and disposable technologies. The event is capped with a special event and panel discussion on the topic of funding for early stage life sciences companies, which will be moderated by Life Sciences Greenhouse of Central Pennsylvania (LSGPA). The panel will be comprised of entrepreneurs, venture capitalists, angel investors, and federal funding sources, such as NIH (National Institutes of Health). Speakers will discuss the various types of funding available to biotechnology start ups, when each type is appropriate, and strategies for establishing relationships with venture capitalists and other financial sources.

Bio-to-Business attendees are also invited to the BioExecutive International Roundtable. This elucidating session will bring together key biopharmaceutical and pharmaceutical industry executives to discuss, debate, and provide insight on topics such as Big Pharma Funding, The Regulatory Curiosity of Combination Products, Intellectual Property as Strategy, and more. This invitation-only roundtable forum will take place Wednesday, April 25, and will be published in its entirety as a special supplement with BioExecutive International's June issue.

myINTERPHEXshow Online Planning Tool

INTERPHEX offers a new intelligent online tool that is available FREE of charge to everyone who registers to attend the event. Participants can use it to search for products, connect with people, and create a personalized show agenda in just a few clicks. It also provides helpful suggestions based on a participant's registration data.

Facility of the Year Award

Now in its third year, the Facility of the Year Award recognizes the global leader in facility engineering. The award is based on significant contribution to the pharmaceutical industry, project uniqueness and innovation, quality, and project management. This year only finalists (category winners) will be announced; the award will be presented at the ISPE Annual Meeting in November. Also, the competition, its category winners, and the Facility of the Year Award Winner will receive high profile attention and media coverage from ISPE, INTERPHEX, and Pharmaceutical Processing magazine. For more information, visit www.facilityoftheyear.org.

RFID Related Lectures at INTERPHEX2007

1. RF1, Apr. 24, 9:00-10:00 Pedigrees:Update on Federal and State Regulation and Effect on RFID Tagging of Products Speaker: Paul Rudolph

   Dr. Rudolf will provide an update on statutory and regulatory oversight of the pharmaceutical supply chain and how the latest developments will affect the adoption of electronic pedigrees and RFID. Special attention will be paid to the PDMA.

2. RF2, Apr. 24, 10:15-11:15 Venture Funding of RFID Start-ups Speaker: John Dwyer

   John will discuss venture funding of start-ups in the RFID space. As a former CEO, John will pay special attention to concerns of potential investors and how companies should position themselves strategically with regard to obtaining funding.

3. RF3, Apr. 24, 2:00-3:00 Update on e-Pedigree: Options for Supply Chain Partners Speaker: Robin Koh

   Robin will discuss the implementation of electronic pedigree and RFID in the pharmaceutical supply chain from the point of view of a technology supplier. He will discuss the strategic and business issues that supply chain entities need to focus on as they will adopt these technologies.

4. RF4, Apr. 24, 3:15-4:15 Real World Item-Level RFID Tagging in the Pharmaceutical Supply Chain: Pfizer's Experience with Viagra Speaker: Peggy Staver

   Peggy will discuss the real-world experience Pfizer has had with RFID tagging of Viagra and the planned tagging of Celebrex. She will discuss the business planning that went into these projects as well as implementation issues, relationship with supply chain partners, and what Pfizer has learned.

5. RF5, Apr. 25, 9:00-10:00 Pharmaceutical & Authentication Security Speaker: Joseph Pearson

   RFID can play a major role in raising confidence in the security and safety of prescription drugs by providing product supply chain pedigree and package authentication. Regulatory mandates, coupled with increased efficiencies, and EPCglobal item-level tagging requirements are well-understood deliverables. Still to be defined is the tag data security infrastructure to support these deliverables. The infrastructure must take into account the different centralized and decentralized approaches and address product security and privacy.

6. RF6, Apr. 25, 2:00-3:00 Improving Pharmaceutical & Life Sciences Supply Chain Visibility Speaker: Liz Churchill

   Gain understanding of how RF technology can improve visibility throughout the life sciences supply chain. The pharmaceutical supply chain is complex, with many steps involved in manufacturing and distribution. Integrating RF technology as a visibility tool enhances security and provides knowledge throughout the supply chain. During this session, we will examine how RF technology is being used today and can be used tomorrow to help achieve the ultimate goal of patient safety.

7. RF7, Apr. 24, 3:15-4:15 RFID in the Pharmaceutical Supply Chain - Security Challenges and Opportunities Speaker: Louis Parks

   Recent concerns about security have led to legislative action and disagreements about the suitability of RFID for the pharmaceutical industry. Anyone interested in using RFID tags as part of the pharmaceutical supply chain, including representatives from logistics, IT, and packaging should be asking these questions:

   • What are the security and privacy issues that are encountered when deploying RFID?
   • How valid are these concerns?
   • What options are there for providing security and protecting privacy within RFID solutions?

   Attendees will learn about security and privacy issues in deploying RFID and various current and proposed solutions including authentication and data protection methods. They will also learn how to select the right security level for their pharmaceutical RFID application.

8. RF8, Apr. 26, 9:00-10:00 Fatal Fakes: RFID-based Tracking of Pharmaceuticals to Counter Counterfeiting Speaker: David Wyld

   This session will examine the public health concerns, both globally and in the United States, caused by the rising tide of fake pharmaceuticals. The session will then look at the U.S. market specifically, examining how leading pharmaceutical companies and drug wholesalers are seeking to protect their brands, their bottom-lines, and their patients through the use of RFID to ensure the integrity and security of their product. The session will also provide an update on both state and federal efforts to legislate better pharmaceutical supply chain security. Finally, the article examines the forecasts for growth in this area, with an analysis of the future of the pharmaceutical market for RFID.

9. RF9, Apr. 26, 10:15-11:15 Network-Critical Physical Infrastructure for RFID Speaker: Viswas Purani

   RFID technology helps automate a variety of business processes, improving their efficiencies. It generates a huge volume of data that needs to be filtered, processed, and stored, and generally requires its own virtual local area network (VLAN). To gain all the promised benefits and return on investment of RFID, the network must be highly available. The network-critical physical infrastructure (NCPI) must be assessed for vulnerabilities in power, cooling, physical security, and other NCPI elements. Failing to plan for NCPI can lead to disruption of critical business processes resulting in loss of revenue and competitive advantage. Join this session to understand the RFID network, critical NCPI locations, and how to plan for its high availability.

10. SC1, Apr. 24, 9:00-10:00 Understanding 21st Century Supply Chain - New Models Across the Extended Chain Speaker: Ann Grackin

    What business innovations in the supply chain matter now? Significant changes have occurred the Supply Chain with a rich network of trading partners from biotech/research to outsourced manufacturing to distribution, etc. How will you effectively manage in this complex chain? Product availability, lean strategies, and more will be discussed.

11. SC2, Apr. 24, 10:15-11:15 Managing Distribution: Cold Chain, Connecting to Channel Partners, and Service Providers Speaker: Carla Reed

    Ensuring a quality product is delivered, what techniques and systems are used, and how to keep the chain cold.

12. SC3, Apr. 24, 2:00-3:00 21st Technology for the Global Chain Speakers: Bill McBeath, Ann Grackin, and Carla Reed

    How enablers make it happen - from planning, manufacturing, distribution, to RFID.

13. SC4, Apr. 24, 3:15-4:15 Managing Supply Chain Risk Speaker: Bill McBeath

    Supply chain risks include counterfeiting and piracy. A supply chain disruption model to help you assess these issues will be presented, along with the latest research and case studies.

14. SC5, Apr. 25, 9:00-10:00 Strategies for Removing Risk from the Biopharma Supply Chain Speaker: Eric Isom

    Sensitive biopharmaceutical products and components must be carefully managed during packaging, storage, and transportation to ensure efficacy, authenticity, and regulatory compliance. This program introduces strategies that global biopharmaceutical firms and their supply chain partners can implement to mitigate risk, maintain control, and create an efficient, cost-effective and secure supply chain.

15. SC6, Apr. 25, 2:00-3:00 Pursuing the Perfect Order in Pharma: Transaction Life Cycle Management and Supply Chain Compliance Speaker: Scott Wheelwright

    An effective supply chain starts with the goal of achieving the perfect order. The synchronization of information among suppliers, retailers, logistics providers, and other partners is critical when optimizing the transaction lifecycle to deliver the perfect order. Starting from the case of the $5 million truckload of inventory expiring on the dock before it was turned back, this workshop takes the participant from this and other pharma supply chain nightmares including expensive compliance fines and inventory mishaps.

16. SC7, Apr. 25, 3:15-4:15 Clinical Trials Supply Chain Optimization Speaker: Vladimir Shnaydman

    Optimization of drug delivery supply chain is one of most challenging problems in clinical trial planning. Multiple interrelated factors contribute to its complexity, such as:

    • Multiple unique investigator sites distributed geographically with a variety of schedules,
    • Uncertainty of patients' accrual rate,
    • Expensive clinical materials of limited quantity,
    • Significant shipping costs, and
    • Expiration period.
      The presented technique based on optimization approach enables to answer the following questions:
    • How do I minimize production, storage, and shipping costs?
    • How do I optimize manufacturing and delivery schedule, inventory level for each site, and shipment size?
    • How do I minimize wastage of clinical materials?
17. SC8, Apr. 26, 9:00-10:00 Security and Integrity in Chain of Custody Hand-off Related to Drug or e-Pedigree Speaker: Sanjay Ahuja PhD

    This presentation will provide information on the chain of custody commands that are directly linked to supply chain security, including: how to remedy on the elements of volume of dispense, the recall scenario, the mismatch between the lot number and expiry dates, the inaccurate transmittal of information, managing information received from a previous custodian, and the perception of the customers on the chain of custody issues. The presentation specifically provides information on how the chain of custody elements relate to the supplier, the pharmaceutical manufacturer, the distribution centers, the pharmacy, and the end-user customer. Stress is on the intricacies of chain of custody handoffs and what security protocols can be implemented that provide assurance for a seamless handoff. Elements of the infrastructure are provided for high-integrity and high-availability of the information during the chain of custody sequence.

Bill Cook, Chair and CEO, Cook Group Inc.

What's Next: Where Devices and Medicine Go From Here... Tuesday, April 24, 11:30

Bill Cook, Chair and CEO of the Cook Group Inc., will survey the challenges and potential presented by one of the life science industry's fastest-growing segments - the convergence of drug and device technologies. With his unique perspective of growing device and biotech companies, Mr. Cook explores the partnership strategies, innovative approaches to R&D, investment, and regulatory issues needed to create winning combination products that will transform healthcare.

The Cook Group, Inc., and its biotechnology subsidiary, Cook Pharmica, were founded in Bloomington, Indiana, on $1,500 invested capital by Bill Cook and his wife Gayle as its only employees. The company has since become a conglomerate with manufacturing facilities throughout the world. The firms manufacture cardiovascular, critical care, diagnostic and interventional products, extruded and injection-molded plastics, stainless steel tubing, urological equipment, OB/GYN devices, and endoscopic instruments.

G. Steven Burrill, CEO, Burrill & Co.

Innovation, Integration and Exploration: The Future of the Life Science Industries Wednesday, April 25, 11:30

G. Steven Burrill, CEO of Burrill & Co., has championed the growth and prosperity of the biotechnology industry and life science industries for 40 years. One of the industry's original architects, he continues to be an industry leading expert and visionary. Building on this history, he will present statistics, predictions, and visions for the future. Mr. Burrill will explore how scientific advances, technological convergence, and expanding global markets will continue to transform the life sciences industries and open up new frontiers for personalization and commercialization.

Burrill & Company is a San Francisco-based private merchant bank focused exclusively on life science companies (biotechnology, pharmaceuticals, healthcare, related medical technologies, agricultural technologies, animal health, and nutraceuticals). Its business revolves around three core activities: strategic partnering, spinouts, and venture capital investment.