 | | Keynote and Featured Presentations FDA's Current Expectations on the Chemistry, Manufacturing and Controls of Peptide- and Oligonucleotide- Based Therapeutics Blair A. Fraser, Ph.D., Director, Division of Pre-Marketing Assessment I, Office of New Drug Quality Assessment, Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Opportunities and Challenges of Developing Peptide Drugs in the Pharmaceutical Industry Waleed Danho, Ph.D., Distinguished Research Leader, Discovery Chemistry, Hoffmann-LaRoche Inc. What Can Molecular Profiling Tell us About the Specificity of RNA Therapeutics? Michele A. Cleary, Ph.D., Associate Scientific Director, Rosetta Inpharmatics LLC, Merck & Co., Inc. Merck's Perspective on siRNA as a Therapeutic Modality Alan Sachs, M.D., Ph.D., Vice President, RNA Therapeutics, Merck Research Laboratories Toward a Non Coding RNA Revolution in the Cancer Society Riccardo Spizzo, M.D., Senior Research Associate, The University of Texas M.D. Anderson Cancer Center Companion Diagnostics: The Future Is Near Larry Gold, Ph.D., CEO and Chairman, SomaLogic, Inc. | | "TIDES is an excellent venue for networking with experts, clients and suppliers in the oligonucleotide and peptide fields." Sandra Carriero, Ph.D., Senior Research Scientist/Manager, Immunochemistry, Charles River Laboratories Preclinical Services Montreal Inc. "TIDES has established itself as the crossroads of peptides and oligonucleotides." Roger P. Micheli, Ph.D., Director, Technical Development, Roche Colorado Corporation "For me, the TIDES Conference is the main event for the Industrial Peptide and Oligonucleotide communities. This show gives an excellent insight into essential drug development and manufacturing topics, addresses the hottest scientific developments and introduces the most important regulatory subjects." Oleg Werbitzky, Ph.D., Head, R&D Peptides & Oligonucleotides, Lonza Valais Works, Switzerland "Diagnostic product manufacturers with a keen knowledge of the regulations associated with assay validation imposed upon the laboratory end-user will better be able to position their products to be successful in a competitive marketplace." Brian DuChateau, Ph.D., Vice President, Laboratory Operations, ConVerge Diagnostic Services "Extremely valuable conference with the ideal coverage of topics and appropriate attendees for a peptide production and delivery company…" Nozer Mehta, Ph.D., VP Biological R&D, Unigene Laboratories Inc. | |  | TIDES® 2007 attracted a record number of attendees and exhibitors. More than 700 conference delegates participated - and even more are expected to attend our 2008 event since TIDES® is the only forum that covers manufacturing, formulation, delivery, process and analytical development and overall market trends for peptide- and oligonucleotide-based therapeutics and diagnostics. A Billion Dollar Industry Over the past two years nearly $3 billion worth of deals were done in the siRNA space. In addition, eight of the top twelve pharma companies have siRNA programs. The peptide category is growing twice as fast as overall pharmaceuticals, with the market size in 2007 estimated at over $3 billion and projected growth rate more than 10% per year. There are 67 therapeutic peptides on the market, 150 in clinical phases, 400 in advanced preclinical phases, and over 100 pharmaceutical and biotech companies active in peptides. What's more, research into microRNA is exploding, resulting in novel potential therapeutic targets as well as new concerns for the safety of siRNA therapeutics. In addition, new delivery technologies are showing significant promise to move the field forward and expand potential markets. By attending you will gain access to: - 700 Attendees
- 75 exhibitors
- 28 scientific sessions including over 100 presentations
- 13 case studies
- Two Full Tracks of Updates on Oligos and Peptides in Clinical and Preclinical Development
- Updates on highlights of the multi billion-dollar pipelines
- Get the most from your investment with multiple programming options to suit your specific needs.
- Arrive early on Sunday for a full day of courses to develop your professional skills.
- Choose to attend co-located conference on Nucleic Acids Technologies for Diagnostics.
Plan now to access this exploding market by attending TIDES®. Event Highlights - Lessons learned from Genasense® and Exubera - does the promise still live? How much more do we know now? Which are the most promising new strategies and alternatives?
- microRNA - Hear updates on preclinical development programs from industry leaders and new entrants and learn what you need to know about off-target effects of microRNA targeted therapeutics, siRNA and aptamers
- NEW! Participate in a featured mid-day audience interactive discussion session. Choose from:
- Regulatory expectations for CMC featuring FDA, BfArM and international industry regulatory experts
- Patent strategies in light of the new rules - learn strategies to avoid new pitfalls
- microRNA: challenges and opportunities - learn what advantages miRNAs offer vs. siRNA - and more from a panel of experts
- NEW! Full day session on Process and Analytical Development: Phase 2 and Beyond
- Hear real-world strategies and case studies including regulatory experience from Pfizer, Roche Colorado, Archemix, The Medicines Company, Affymax, Isis and more
- Back by Popular Demand! Full day session on delivery of oligo- and peptide-based therapeutics: characterization, manufacturing, regulatory, IP and economic considerations
- Gain updates on highlights of the multi-billion dollar pipeline in two full tracks of updates on oligos and peptides in clinical and preclinical development
- Arrive on Sunday and choose from an array of courses to develop your professional skills
- NEW THIS YEAR! Online tool to pre-schedule meetings with other attendees and exhibitors
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