Wednesday, February 5, 2014

TIDES: The Industry's Premier Manufacturing, Networking and Business Event your focus is in oligonucleotide or peptide manufacturing, TIDES is the premier event to help you accelerate your process development efforts, understand regulatory expectations, and network with key industry leaders to move your business forward. Here are some of the manufacturing program highlights on this year's TIDES program:

Implement New Process Validation Guidelines

• Hear US Pharmacopeia's perspective on critical quality attributes for peptide APIs, with a focus on control strategies, regulatory expectations and compendial requirements for peptide APIs in USA and Europe.

• Attend Agilent Technologies, NASD's case study presentation demonstrating the continuous verification approach to process validation for an oligonucleotide, following the recent ICH and FDA guidances. Hear how they identified processing issues prior to process validation by implementing an early trending of processing parameters.

• In a can’t miss audience interactive panel discussion, ask your questions about the challenges and benefits that industry leaders are experiencing from the recent changes in process validation approaches, with moderator Paul McCormac of Pfizer and panelists representing FDA, Agilent, Isis, Prosensa and BfArM Federal Institute for Drugs and Medical Devices (Germany's regulatory agency).

Accelerate Your Process Development Efforts

• Understand alternatives to lyophilization by hearing new reports from Pfizer and Lonza.

• Increase final yield, improve process efficiency and reduce manufacturing costs by hearing Bachem's case study on process development through scale-up approaches for Davunetide.

• Learn how Isis utilizes its large body of platform knowledge to improve their process development and validation approaches.

• Hear about the challenges encountered during Bachem's production of bicyclic peptides.

Overcome Complicated Formulation and Delivery Challenges

• Get an unsurpassed update on formulation and delivery with a full day of presentations from Merck, Xeris, Amylin, Zosano, Peptisyntha, Informulate and Dicerna.

• Discover how Merck analyzes the physicochemical and biophysical characteristics of potential peptide drug candidates to support formulation and development risks to support preclinical and clinical studies.

• Hear the regulator’s view on CMC Challenges of Novel Delivery Systems in a Strategy Discussion Forum led by Dr. René Thürmer, Ph.D., Deputy Head Unit Pharmaceutical Biotechnology, BfArM - Federal Institute for Drugs and Medical Devices, Germany.

Efficiently Scale-Up Manufacturing

• Hear how industry leaders are thinking outside of the box for novel strategies to scale-up oligonucleotides and peptides during our panel discussion, with panelists representing Pfizer, Alnylam, PolyPeptide Group, Isis, Lonza and Ophthotech.

Understand Conjugation Technology to Advance Your Therapeutics

• Learn how Agilent's novel drug delivery and cleavable linker technology is being used to advance therapeutic oligonucleotide efforts.

• Attend a strategy discussion forum covering key objectives necessary for successful "tide" conjugation development, with focuses on advantages and limitations of various approaches and lessons learned from commercial successes.

To learn more, download our brochure.

Register with code XB14180BLOG to save 20% off of the standard rate: . If you have questions about the event, feel free to contact our group manager, Kate Devery (, or visit our webpage.

We look forward to seeing you May 12-15 in Providence, RI!

The TIDES Team

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