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TIDES 2008Oligonucleotide and Peptide Technology and Product Development

Simon Burnell

February 1, 2008

7 Min Read

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In 2007, TIDES attracted a record number of attendees and exhibitors. More than 700 conference delegates participated — and even more are expected to attend in 2008. 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 made in the siRNA space. In addition, eight of the top 12 pharmaceutical companies have siRNA programs. The peptide category is growing twice as fast as overall pharmaceuticals, with its market size in 2007 estimated at over $3 billion and a projected growth rate of over 10% per year. There are 67 therapeutic peptides on the market, 150 in clinical trials, 400 in advanced preclinical research, 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, and 28 scientific sessions including over 100 presentations, with 13 case studies. There are two full tracks of updates on oligonucleotides and peptides in clinical and preclinical development. Hear updates on highlights of the multibillion dollar pipelines. Choose from multiple programming options to suit your specific needs. Arrive early on Sunday for a full day of courses to develop your professional skills. Attend colocated conferences on Synthetic Biology and Nucleic Acids Technologies for Diagnostics (www.IBCLifeSciences.com/synthetic).

Featured Presentations

“FDA’s Current Expectations on the Chemistry, Manufacturing and Controls of Peptide- and Oligonucleotide-Based Therapeutics” by Blair A. Fraser, PhD, director of the division of premarketing assessment in the office of new drug quality assessment in pharmaceutical sciences at the Center for Drug Evaluation and Research, US Food and Drug Administration

“Merck’s Perspective on siRNA as a Therapeutic Modality” by Alan Sachs, PhD, vice president of RNA therapeutics, Merck Research Laboratories

“Opportunities and Challenges of Developing Peptide Drugs in the Pharmaceutical Industry” by Waleed Danho, PhD, distinguished research leader in discovery chemistry, Hoffmann-La Roche Inc.

“Toward a Noncoding RNA Revolution in the Cancer Society” by George A. Calin, PhD, associate professor of experimental therapeutics, The University of Texas M.D. Anderson Cancer Center

“What Can Molecular Profiling Tell Us About the Specificity of RNA Therapeutics?” by Aimee Jackson, PhD, senior research fellow in molecular profiling, Rosetta Inpharmatics, LLC (a wholly owned subsidiary of Merck & Co., Inc)

“Companion Diagnostics: The Future Is Near” by Larry Gold, PhD, CEO and chairman, SomaLogic, Inc.

Session Topics

  • Regulatory Expectations for CMC for Peptides and Oligos

  • Patent Strategies in Light of the New Rules

  • miRNA: Opportunities and Challenges

  • Process and Analytical Development: Phase 2 and Beyond

  • Development Strategies of Leading Oligonucleotides in Clinical Development

  • Optimization Strategies of Leading Oligonucleotides in Preclinical Development

  • Development Strategies of Leading Peptides in Clinical Development

  • Optimization Strategies of Leading Oligonucleotides in Preclinical Development

Asia Featured EventPharmaceutical and Biotechnology Middle-East ExhibitionAntibody Production: Upstream and Downstream ProcessingImmunogenicity, Comparability, and Biosimilars

27–29 April 2008

Dubai International Exhibition Centre, United Arab Emerites

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Join us at Antibody Production: Upstream and Downstream Processing or Immunogenicity, Comparability, and Biosimilars and be part of the Pharmaceutical and Biotechnology Middle-East (PABME) Exhibition. Designed to be an international destination where business cultures and ideas can meet, PABME is the region’s only major exhibition accompanied by multidisciplinary conference to address the needs of global markets. The entire show will attract at least 1,600 participants from across the globe including Europe, South Asia, the Americas, and the Middle East.

A Premier Networking Platform: PABME offers an unprecedented opportunity to meet with top decisionmakers, market leaders, and new investors from across the globe as well as the Middle East region.

Ideal Blend of the Pharmaceutical and Biotech Industries: Network with similar organizations in the industry and discover new ways of developing more cost-effective and efficient methods and procedures.

Unique International Showcase: PABME will showcase a wide spectrum of products and services to cater to all businesses associated with the pharmaceutical and biotechnology industries and offer them an opportunity to find new business contacts and gain further recognition worldwide.

Antibody Production

Come to Dubai to access the practical information you need to ensure that you maintain robust and effective manufacturing processes, generating higher yields at lower costs:

A comprehensive program is formed around six session topics:

  • Production capacity, management strategy, and efficient facility design

  • Strategies for candidates and clone selection, and cell line development and engineering

  • Advances in expression and cell culture technologies

  • Analytical characterization and posttranslational modification

  • High potency immunoconjugates and antibody fragments

  • Facing the bottleneck — challenges of high upstream titers.

Learn from practical case studies and key industry insights from keynote speaker David P Humphreys, PhD, senior group leader, UCB-Celltech. Also hear from speakers representing Linde-KCA, Symphogen, Merck Serono, Lonza Biologics, Avecia Biologics, Institut Polytechnique LaSalle Beauvais, Selexis, and BioInvent International.

www.pabme.com/antibodies

Quote VIP Code: CQ3351BPI

Immunogenicity, Comparability, and Biosimilars

Equip yourself with the tools and information you need to prevent known problems and create successful systems throughout your biologics manufacturing process.

Expert speakers deliver two days of practical case studies and advice on

  • Tackling immunogenicity throughout the manufacturing process and satisfying EMEA and FDA requirements

  • Ensuring comparability (success stories from industry plus a focus on protein aggregation and analytical method application)

  • Bringing biosimilars to market (industry insights on biosimilar characterization and successful reimbursement strategies)

Immunogenicity Highlights

  • Real-life experience with neutralizing assays

  • Latest insights on using animal models for predicting human immunogenicity

  • Full update on regulatory considerations on immunogenicity

Comparability Highlights

  • Best application of analytical methods for successful comparability programs

  • New findings on the effect of protein aggregation on comparability

  • Industry case studies on implementing successful process change

Biosimilar Highlights

  • Practical advice on incorporating reimbursement into your biosimilar production

  • Experiences and advice on best practice for the characterization of biosimilars

www.pabme.com/cib

Quote VIP Code: CQ3352BPI

The Future of Diagnostics Event Report

New medical technologies are making more sophisticated over-the-counter diagnostics available to consumers, opening the $7 billion “self/consumer-diagnostic” market for expansion. In a recent workshop, 20 diagnostic company executives and experts discussed what will change this market’s progress from steady growth to an explosion. Guests came from a variety of backgrounds and covered the spectrum of stakeholders in this field, from front-line healthcare professionals to diagnostic companies developing tests and devices.

Following short presentations from Cambridge Consultants and contributions from Robert Christenson, PhD (professor at the University of Maryland School of Medicine), and Bill Hannon (professor emeritus at the Massachusetts College of Art and Design), delegates contributed to two working groups. These groups focused on aspects of the future in the diagnostics industry. Morning sessions covered the diagnostic testing landscape, market dynamics, and lifestyle trends. In the afternoon, the groups discussed technology and its role in driving acceptance of consumer diagnostic testing.

Diagnostic companies have a key role to play in the expansion of this market. Companies need to augment their technology by providing education, perspective, and Web or local community support, all of which are in line with a consumer-driven healthcare model. Other steps toward the consumer diagnostic model must consider the following.

Market-Enabling Technologies: Novel sensing and imaging techniques to eliminate invasive sampling, printable circuit boards with optical detectors for low-cost consumer devices, and microfluidics for increased sensitivity, will transition diagnostics from the laboratory to the corner drug store.

Complete the Self-Diagnostic, Then What? Patients will need support after their diagnosis, such as online databases to track health, test interpretation help, or Web-based support communities.

New Partnerships Among Diagnostic, Retail, and Consumer-Product Companies: Will melanoma-diagnosis company partner with a skin-care company to reach new customers? Should chain pharmacies stock diagnosis-support tools as part of stocking diagnosis products?

A full conference report is available online from Cambridge Consultants (www.cambridgeconsultants.com/news_pr197.shtml). Earlier in 2007, a similar event was held that was attended primarily by stakeholders from the European diagnostics industry. This report is also available on request.

Global MeetingplaceConferences, Courses, and Events

MARCH 2008

1–7, New Orleans, LA

Pittcon Conference and Expo 2008

www.pittcon.org/index.html

3–4, Las Vegas, NV

Best Practices in Biopharmaceutical Raw Materials Testing and Vendor Qualification

http://epdweb.engr.wisc.edu/Courses/Course_Categories.lasso

3–5, Bethesda, MD

TRAC 36: Cell Line Identification and Authentication

www.biotrac.com/pages/Tracs/Trac36.html

3–7, Prague, Czech Republic

Cell Line Development and Engineering

www.informa-ls.com/celldev

5–6, London, United Kingdom

Stability Testing for Biotechnology Products

www.iir-events.com/IIR-conf/PTI/EventView.aspx?EventID=151

9–13, Berlin, Germany

Microscale Bioseparations and Methods for Systems Biology

www.msb2008.org

10–11, San Diego, CA

Technology Transfer for Biopharmaceuticals

www.ibclifesciences.com/transfer/7010.xml

10–11, San Diego, CA

Outsourcing Manufacturing of Biopharmaceuticals

www.ibclifesciences.com/outsourcing/6961.xml

10–11, San Diego, CA

Process Validation for Biologicals

www.ibclifesciences.com/process/6904.xml

12–13, San Diego, CA

Introduction to Biopharmaceutical Manufacturing

www.ibclifesciences.com

12–14, San Diego, CA

Antibody Development and Production

www.ibclifesciences.com/antibodyprod/6946.xml

17–21, Bethesda, MD

TRAC 25: Proteomics — Principles and Methods

www.biotrac.com/pages/Tracs/Trac25.html

26–28, Philadelphia, PA

Interphex 2008

www.interphex.com

31 March–1 April, Las Vegas, NV

Cleaning Validation Practices for Pharmaceutical and Biopharmaceutical Production

http://epdweb.engr.wisc.edu/Courses/Course_Categories.lasso