Record Attendance Expected! Don't Miss IBC's 18th Annual TIDES

Register by Friday, April 15th and save $300! To save, use the code B16180BLOG100

Experts Provide Key Success Factors for Drug Development and Manufacturing:

Mixed-Incretin Receptor Biochemical Signaling at Multiple Receptors
Richard DiMarchi, Ph.D. Standiford H. Cox Professor of Chemistry, Indiana University

Drisapersen: Case Study
Robert Baffi, Ph.D. Executive VP, Technical Operations, BioMarin Pharmaceuticals

Quark's Long History of Oligonucleotide Development
Danny Zurr, Ph.D. Chairman and CEO, Quark Pharmaceuticals Inc. 

Technologies for Targeting Molecules to Sites of Diseases
John Reed MD, Ph.D Global Head of Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd.


TIDES 2016 is on pace for record attendance with 800+ global attendees expected to attend this year’s meeting, held May 9-12, 2016 in Long Beach, California – will you be there?

Register your team today and access the science, technologies and contracts you need to accelerate your oligonucleotide and peptide products through the clinic towards commercial success.

Your registration grants you access to:

• 800+ attendees representing 25 countries help you forge new business and scientific collaborations
• 100+ speaker presentations across 5 tracks provide a customized agenda of solutions for your company’s current challenges
• 70+ exhibitors demonstrate the latest products and technologies to accelerate your therapeutic to market
• 40+ poster presentations keep you abreast of cutting-edge industry and academic research

Plus, be sure to register this week to gain access to Attendee Connect powered by partneringONE, the digital networking platform that allows you to view the full attendee list, pre-schedule meetings, and send private messages to attendees before, during and after the event.

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Analytical Controls in an Evolving Technology and Regulatory Landscape

 
IBC's 18th Annual TIDES is the industry's #1 forum for oligonucleotide and peptide leaders to build successful partnerships and accelerate products from early discovery through late-stage development and commercialization. The TIDES team recently talked to Rachel Orr, Senior Scientist, GlaxoSmithKline R&D, United Kingdom for an exclusive interview that delves into analytical controls in an evolving technology and regulatory landscape, the topic of her presentation at the upcoming Oligonucleotide and Peptide Therapeutics event in Long Beach, CA.


1. What key analytical challenges do oligonucleotide developers need to overcome in order to achieve regulatory approval?

Oligonucleotides are inherently difficult to analyze - they are neither traditional, small nor large molecules, and the techniques and well established methodologies for pharmaceutical analysis are all focused on these distinct classes. In addition, there is very limited regulatory guidance when it comes to oligonucleotides, so there are no set rules to follow. There are often discussions as to whether oligonucleotide analysis should follow small molecule rules and regulations or align with biopharmaceuticals; opinions are divided.

With limited experience across the industry in marketing applications it is difficult to assess what is needed in order to gain regulatory approval and this is one of the biggest challenges in CMC oligonucleotide development. There is no recent precedence of global oligonucleotide marketing applications and as such it is difficult to ascertain what may and may not be acceptable. Close engagement with the regulators is something which helps to form strategies and controls and hopefully this will increase the likelihood of success of regulatory approvals going forwards.


2. How have advancements in technology improved the analytical process? Can you provide examples?

Since the last successful oligonucleotide marketing application there have been considerable enhancements in technologies. UHPLC is now common throughout the industry and techniques such as high resolution NMR and mass spectrometry are much more affordable and quick. These advances in technology mean that the resolution and robustness of methodologies can be much improved, however has a downside that the regulators may well expect us to present them with these improvements by first intent.

Increased understanding of non "typical" molecules throughout the industry has enabled wider thinking and collaboration between different pharmaceutical companies, with more people working together on the problem progress will inevitably come quicker. As more people engage with the concept of oligos and as technology continues to evolve, I anticipate a large shift in the way we look to control oligonucleotides analytically in coming years.


3. What are the most common mistakes that oligonucleotide drug developers encounter during CMC submissions?

Again, due to there being so few oligonucleotides which have gone through the full CMC process I think it is difficult to make too many sweeping statements, however the key issues that I have come across all stem from attempting to fit oligonucleotides into a box. Whether it is the small molecule group or the biopharmaceutical groups who take on the challenge of oligonucleotides, it is generally only a few "experts" within that team who work on the molecules. It is impossible to fit existing small or large molecule platforms onto oligonucleotides and a lot of time, resources and money can be wasted trying to do so! Due to the small pool of people working on the oligo projects it can also be challenging when it comes to elements such as wider reviews of submissions as the reviewers are not always as well informed about the challenges associated with oligonucleotide analysis. Education of these reviewers and key stakeholders is an activity that cannot be underestimated in time or importance! This emphasizes the benefits of cross-pharmaceutical company collaborations.


Want to hear more from industry experts like Rachel? See our exclusive TIDES speaker Q&A series here.

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Efficient Chemoenzymatic Peptide Synthesis (CEPS) in Water

"When peptides are ligated in water, the crude reaction mixture can immediately be loaded on the preparative HPLC column to purify the product" 

IBC's 18th Annual TIDES is the industry's #1 forum for oligonucleotide and peptide leaders to build successful partnerships and accelerate products from early discovery through late-stage development and commercialization. The TIDES team recently talked to Timo Nuijens, Ph.D., Lead Scientist, EnzyPep BV, The Netherlands for an exclusive interview that delves into the topics he plans to discuss at the upcoming Oligonucleotide and Peptide Therapeutics event in Long Beach, CA.

Efficient Chemoenzymatic Peptide Synthesis (CEPS) in Water
We describe a novel, organic cosolvent-stable peptide ligase (peptiligase), which couples peptide fragments with exceptional efficiency in water. Because peptiligase does not need a particular recognition motif, this novel technology is traceless and very broadly applicable. Besides fragment condensation, the enzyme is able to efficiently catalyze head-to-tail cyclization of peptides to create macrocyclics. It has also been shown to couple peptide esters efficiently to proteins. Peptiligase could be a useful tool for the (industrial) synthesis of numerous (pharmaceutical) peptides and conjugates.

In this interview, Dr. Nuijens also discusses;

• The importance of fragment condensation of peptides in water
• What the future holds for the Netherlands in the global peptide drug development market
• The factors to consider when determining the optimal synthesis strategy when screening an enzyme

Access the complete interview

Register for TIDES now and save $500 - To save, use the code B16180BLOG100

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Novel Delivery Strategies for Oligos and Peptides - $600 Savings End Friday, 1/29

Register by this Friday, January 29th and receive up to a $600 savings – Use the code B16180BLOG100 to save. Click here to register.

Recent advances in delivery strategies have paved the way for improved targeting, efficacy and patient usability for the oligonucleotide and peptide therapeutic industry. Ensure that your team is up-to-date on the latest drug delivery strategies for accelerated product development by attending IBC's 18th Annual TIDES meeting, held May 9-12, 2016 in Long Beach, California.

Register today to attend the industry's #1 forum for oligonucleotide and peptide leaders to build successful partnerships and accelerate products from early discovery through late-stage development and commercialization.

Industry Experts Present Novel Delivery Strategies for Oligonucleotides and Peptides:


Centyrins as Targeting Agents for Next-Generation Modular Therapeutics
Vadim Dudkin, Ph.D., Scientific Director, Centyrex, Johnson & Johnson

The biophysical properties of Centyrins make them ideal as targeting agents for a variety of novel delivery technologies. Centyrex is exploiting this platform via novel therapeutic applications aimed at addressing outstanding challenges in...(continue reading)
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Treatment Opportunities for Cystic Fibrosis Using Aerosolized Antisense Oligonucleotides
Shuling Guo, Ph.D., Director, Antisense Drug Discovery, Isis Pharmaceuticals

Cystic fibrosis (CF) is one of the most common life-threatening genetic diseases affecting ~30,000 people within US and ~70,000 worldwide. Lung disease is the major cause of morbidity and mortality in CF. Antisense oligonucleotides (ASOs) administered by aerosol delivery distribute broadly into...(continue reading)
________________________________________

ITCA 650 (Exenatide Delivered Continuously via a Matchstick-Size Subcutaneous Osmotic Mini-Pump) an Investigational Therapy for Type-II Diabetes
Scott Peterson, Ph.D., Executive Director, Corporate Development, Intarcia Therapeutics, Inc.

ITCA 650, an investigational therapy for T2DM currently in Phase 3 clinical trials, is an osmotic mini-pump that can subcutaneously deliver exenatide (a GLP-1 receptor agonist) for extended periods of time. This presentation will cover the technology behind...(continue reading)


For more session information, download the complete agenda.

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Announcing: TIDES 2016 Keynote Lineup | Brochure is Now Available

Download the complete TIDES event brochure now. 

IBC’s 18th Annual TIDES meeting is coming to Long Beach, CA May 9-12, 2016. TIDES is the industry's #1 forum for oligonucleotide and peptide leaders to build successful partnerships and accelerate products from early discovery through late-stage development and commercialization.

RVSP by January 29th, 2016 with code B16180LINK100 and receive $600 savings off the standard rate. Secure your best rate now.

Keynote and Featured Speakers Provide Novel Strategies to Accelerate Product Approval:

• Mixed-Incretin Receptor Biochemical Signaling at Multiple Receptors
• • Richard DiMarchi, Ph.D. Professor of Chemistry | Indiana University
• Drisapersen: Case Study
• • Robert Baffi, Ph.D., Executive VP, Technical Operations | BioMarin Pharmaceutical
• Quark's Long History of Oligonucleotide Development
• • Danny Zurr, Ph.D., Chairman and CEO | Quark Pharmaceuticals Inc.
• Technologies for Targeting Molecules to Sites of Disease
• • John Reed, M.D., Ph.D. Global Head | Roche Pharma, Switzerland

TIDES by the numbers:

• 800+ attendees representing global innovators, suppliers and thought-leaders who can expand your pipeline and grow your business
• 100+ case studies and new data presentations providing novel strategies to accelerate your product to market
• 70+ exhibitors showcasing new technologies to improve your process development, analytical and manufacturing/scale-up efforts

Sponsorship and Exhibition Opportunities
Showcase your expertise to 800+ global buyers by becoming an event sponsor or exhibitor at TIDES. A wide variety of options are available to meet your company's goals and budget. Contact Patrick Gallagher pgallagher@ibcusa.com for pricing and package details.

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