Institute for International Research

Keynote Presentations Steven I. Gutman, M.D., Director, Office of In Vitro Diagnostic, Device Evaluation and Safety, CDRH, U.S. Food and Drug Administration Nucleic Acid Technologies for Diagnostics - FDA Perspectives on Why the Tortoise Won the Race Petra Kaars-Wiele, Ph.D., Senior Director, International Regulatory Affairs and Affiliate Compliance, Diagnostic Division, Abbott Laboratories, Germany Increasing International Challenges in Regulatory and Compliance for Diagnostic Products Ichiro Hirao, Ph.D., Team Leader, Nucleic Acid Synthetic Biology Research Team, RIKEN Genomic Sciences Center (GSC); President, TagCyx Biotechnologies, Japan Unnatural Base Pair Systems for DNA/RNA-Based Biotechnology Ask your questions to U.S. and international regulatory experts from FDA, Beckman-Coulter, Cepheid, Veridex, and Genentech during an audience interactive panel discussion Hear new reports on microRNA - emerging biomarkers and a new bead-based multiplex assay to gain new ideas for your future products Plan for the future of diagnostics by seeing cutting-edge technologies including molecular imaging, designing multiplex STR genotyping assays, ferrocene DNA oligos, technologies for MRSA and more… Learn how to advance your business plan by hearing Nanosphere's report on the launch of Verigene®, an update on PCR licensing from Roche and tips on how to qualify suppliers

If you are a manufacturer of IVD diagnostics and/or of a nucleic acid technology, this event was designed for you! IBC's Nucleic Acids Technology for Diagnostics conference has become the leading forum for suppliers and end-users to forge collaborations and discuss the technological, regulatory, operational and business considerations surrounding the manufacturing of IVD's. Meet with all of the players that are involved in development, application and validation of methods for synthesis, modification, purification and characterization of any type of oligonucleotide for IVD and therapeutic applications.

Benefit from exceptional presentations on recent U.S. and international regulatory developments from FDA and industrial specialists. Learn management insights and important business trends in the IVD market. Profit from this unique blend of presentations dealing with promising new technologies and scientific developments together with business and regulatory considerations - critical for anyone active in the development of IVD products.

This is your chance to attend and learn all you need to know to access this multi-billion dollar market from sessions in which you will:

• Gain a comprehensive update on U.S. and international regulatory developments including audience interactive panel discussion with FDA and industry and agency experts
• Understand the future of collaborative development and validation of companion diagnostics through a report from Genzyme
• Uncover strategies for test method validation from Roche Molecular Diagnostics, Converge Diagnostic Services and AcroMetrix
• Hear inside stories on the two biggest recent launches: Veridex's GeneSearch™ BLN Assay and Nanosphere's Verigene®

In addition, this meeting will be held concurrently with IBC's TIDES 2008 Oligonucleotide and Peptide® Technology and Product Development Conference. As an added benefit, you are invited to attend all TIDES® networking opportunities featured in the exhibit hall showcasing 75 suppliers and the opportunity to network with 700+ participants. Please visit www.IBCLifeSciences.com/TIDES for more information.

New for 2008: Pre-Schedule Meetings with Other Attendees!
This year for the first time ever at Nucleic Acids Technologies for Diagnostics, the event will feature an online partnering system and community that will enable you to connect with other attendees prior to the conference and arrange one-to-one meetings on-site. There will be a select number of meeting areas at the conference venue to hold your meetings, which can be reserved in advance using the system. More information and access will be available within 6-8 weeks prior to the conference.