AsiaTides -Peptides and Oligonucleotides 2015

Where Global Oligonucleotide and Peptide Leaders Connect to Share
Groundbreaking Science and Form Successful Business Collaborations
オリゴヌクレオチドとペプチドのグローバルリーダー達が集い、革新的な科学研究結果を共有し、事
業コラボレーションを成功させる場です
March 3-5, 2015 • Hyatt Regency Osaka • Osaka, Japan
IBC主催　第7回 Asia TIDES オリゴヌクレオチドとペプチド® 研究、技術および製品開発
2015年3月3 -5日大阪、ハイアット・リージェンシー大阪
You Asked and We Listened – AsiaTIDES is Coming to Osaka in 2015!
Media Parters: Premier Publication: Organized by:
IBC’s 7th Annual
Keynote Presentations
Transfer of exRNAs
in Cancer Metastasis
Takahiro Ochiya, Ph.D.
Chief, Division of Molecular and Cellular Medicine,
National Cancer Center Research Institute, Japan
Amylin and its Analog:
Potential Diagnostic Test
and Therapeutic Drug for
Alzheimer's Disease
Wendy Wei Qiao Qiu, M.D., Ph.D.
Associate Professor, Departments of Psychiatry
and Pharmacology, Alzheimer's Disease Center,
Boston University School of Medicine, USA
n Accelerate Your Discovery and Development Programs
by Applying Successful Strategies from 18+ Case Study and New
Data Presentations from Arrowhead, Isis, Roche, Takeda and other
Industry Leaders from not only Japan, but also USA, Europe and Asia
n Ensure a Successful Market Launch
by Utilizing Manufacturing and Analytical Strategies from Global
Experts from 8 different countries, including Avecia, Agilent,
Bachem, Ajinomoto and more
n Gain Faster Therapeutic Approval
by Hearing Guidance from Two Former FDA Officials for
Overcoming the Latest Regulatory Requirements and Challenges
n Highlight Your Expertise in Untapped Markets
by Forging Partnerships with Key Decision Makers and Academic
Leaders from Across the Globe
Register Early and Save Up to USD300! www.IBCLifeSciences.com/AsiaTIDES

Advance Your Oligonucleotide and Peptide Therapeutics Towards Commercial Success
Dear Colleagues,
Coming to Osaka in 2015, IBC’s 7th Annual AsiaTIDES is the
preeminent conference in Asia to gain the latest development
updates on preclinical and clinical peptides and oligonucleotides.
Only at AsiaTIDES can you connect with global leaders who share
their novel strategies and lessons learned to help accelerate your
oligonucleotide and peptide therapeutics to market.
Your registration at the 2015 event in Osaka gives you exclusive
access to the most up-to-date reports available only at AsiaTIDES
from not only Japanese peptide and oligonucleotide innovators,
but also their Asian and U.S. collaborators – providing you
with crucial knowledge that you can immediately apply to your
development portfolio. Additionally, our 2015 program brings
together more thought-leaders and more new data than ever
before to help you effectively meet regulatory expectations and
overcome complex product and manufacturing challenges.
So, register early and save up to USD300 and be sure to log
on to www.IBCLifeSciences.com/AsiaTIDES for program
announcements and updates.
I look forward to seeing you in March 2015 at AsiaTIDES in
Osaka: The premier meeting to accelerate your oligonucleotide and
peptide discovery and development programs towards commercial
success.
Sincerely,
Mark A. DeSorbo
Conference Producer
関係各位
2015年大阪にて開催されるIBC主催の第7回Asia TIDESは、アジに
おける最高峰のカンファレンスであり、オリゴヌクレオチドとペプチド治
療の臨床前研究と臨床研究における最新開発情報を取得できます。皆
様のオリゴヌクレオチドとペプチド治療研究の商業化を加速するため、
全く新しい戦略や教訓を共有して下さるグローバルリーダー達と知り
合えるのはAsia TIDESだけです。
2015年の大阪でのイベントに登録すると、日本のオリゴヌクレオチ
ド革新者のみならず、アジアやアメリカにいる彼らの共同研究者よ
り、Asia TIDESでしか入手できない最新レポートを入手でき、開発ポ
ートフォリオにすぐに適用可能な重要な知識を得ることができます。さ
らに、2015年のプログラムでは、今までよりも多くのオピニオンリーダ
ーとデータを一堂に集め、効率よく規制・基準を満たし、複雑な製品製
造過程の課題を克服できるようにサポートします。
早めに登録すると、最大300米ドルオフとなります。プログラム詳細情
報や最新情報に関しては、www.IBCLifeSciences.com/AsiaTIDES
にログオンして下さい。
それでは、大阪で2015年3月にAsia TIDESで皆様とお会いできること
を楽しみにしております。このプレミア会議に出席することで、皆様のオ
リゴヌクレオチドとペプチド研究および開発プログラムの商業化成功
を促進できると確信しております。
敬具
マーク・A・デソーボ
カンファレンス・プロデューサー
Main Conference • Plenary Keynote Presentations Tuesday, March 3, 2015
8:00 Registration and Coffee/Tea
9:10 Chairman’s Remarks
Mark Graham, Executive Director, Cardiovascular Disease Research,
Antisense Drug Discovery, Isis Pharmaceuticals Inc.
9:15 Transfer of exRNAs in Cancer Metastasis
The existence of circulating miRNAs and exosomes in the blood
of cancer patients has raised the possibility that disease-specific
miRNAs and exosomes may serve as a novel diagnostic marker.
Moreover, exosomes secreted from tumor cells contribute
micromanaging tumor microenvironment. We and other
groups reported that tumor-derived exosomes mediated tumor
angiogenesis and thus facilitated tumor metastasis for distant organs. Here we will
discuss importance of transfer of extracellular microRNAs (exRNAs) and their
contribution to tumor development and metastasis.
Takahiro Ochiya, Ph.D., Chief, Division of Molecular and Cellular Medicine,
National Cancer Center Research Institute, Japan
9:45 CASE STUDY / NEW DATA Amylin and its Analog:
Potential Diagnostic Test and Therapeutic
Drug for Alzheimer's Disease
Amylin is a naturally occurring peptide with important
functions in the brain, including regulating glucose metabolism.
Using Alzheimer's disease (AD) mouse models, we show here
the evidence that chronic peripheral treatment with amylin or its analog,
pramlintide, reduced the amyloid burden and lowered the concentrations
of amyloid-beta peptides (Aβ) in the brain when compared with saline
treatment. Further, behavioral tests showed that learning and memory in
these mice were improved by the treatment. Despite the fact that amylin and
Aβ share a similar secondary structure, our study indicates the therapeutic
potential of amylin type peptides for treating Alzheimer’s.
Wendy Wei Qiao Qiu, M.D., Ph.D., Associate Professor,
Departments of Psychiatry and Pharmacology, Alzheimer's Disease Center,
Boston University School of Medicine, USA
10:15 Grand Opening of the Poster and Exhibit Hall with Refreshments Sponsored by:
2 To Register, Call: (+65) 6508 2401 • Fax: (+65) 6508 2407 • E-mail: register@ibcasia.com.sg

Main Conference • Concurrent Tracks Tuesday, March 3, 2015
Oligonucleotide-Based Therapeutics in
Preclinical and Clinical Development
Peptide-Based Therapeutics in Preclinical and
Clinical Development
Sponsored by:
David L. Lewis, Ph.D., Chief Scientific Officer, Arrowhead Research Corp., USA
11:15 NEW DATA N-acetyl Galactosamine Conjugation Enhances
Potency of Second-Generation Antisense Targeting
Hepatocyte Expressed Genes
Second-generation antisense oligonucleotide (ASO) mRNA/protein potency
was increased 5-10 fold versus parent following N-acetyl galactosamine
(GalNAc3) conjugation of human apolipoprotein C-III, apolipoprotein(a)
and angiopoeitin protein-like3 ASOs in transgenic mice. GalNAc3 ASO
conjugation should significantly enhance the therapeutic index, reduce cost,
and support monthly dosing regimens for hepatocyte mRNA targets.
Mark Graham, Executive Director, Cardiovascular Disease Research,
Antisense Drug Discovery, Isis Pharmaceuticals Inc., USA
11:45 Optimization of Phosphorothioate Antisense DNA by
Controlling the Phosphorous Chirality
This presentation demonstrates that the P-chirality affects nearly all the critical
properties of the antisense drugs, from binding affinity to target RNA to
metabolic stability and RNase H activity.
Takeshi Wada, Ph.D., Department of Medicinal and Life Science, Faculty of
Pharmaceutical Sciences, Tokyo University of Science, and Department of
Medical Genome Sciences, Graduate School of Frontier Sciences,
The University of Tokyo, Japan
12:15 Luncheon in Poster and Exhibit Hall
Dr. Troels Koch, VP & CTO, Roche Innovation Center Copenhagen, Denmark
1:30 Using Dynamic Polyconjugate (DPC) Delivery Technology
in RNAi-Based Therapeutics for the Treatment of
Liver Disease
We have developed a platform technology called Dynamic Polyconjugate (DPC) for
targeted delivery of RNAi trigger molecules. Key to this technology is a reversibly
masked endosomolytic polymer. The masking chemistry prevents the polymer from
interacting with blood components and non-targeted tissues, but is hydrolyzed
in the acidic environment of endosomes allowing activation of the polymer and
release of the RNAi-trigger to the cytoplasm of the targeted cell. Attachment
of N-acetyl galactosamine moieties to the DPC enables delivery specifically to
liver hepatocytes via the asialoglycoprotein receptor. We are currently using this
technology in therapeutics designed for the treatment of chronic hepatitis B virus
infection and alpha-1 antitrypsin deficiency-associated liver disease.
David L. Lewis, Ph.D., Chief Scientific Officer, Arrowhead Research Corp., USA
2:00 Nucleic Acid Ligands with Protein-like Side Chains and Their
Application in Diagnostics and Therapeutics
This presentation discusses a new class of nucleic acid ligands with protein-like
side chains, called slow off-rate modified aptamers (SOMAmers). Their
broader chemical diversity results in higher success rate of SELEX, expanded
range of accessible epitopes, and enhancement in nuclease resistance. These
features are well-suited for large-scale proteomics, biomarker discovery and
development of new diagnostic and therapeutic agents.
Nebojsa Janjic, PhD, Chief Science Officer, SomaLogic, Inc., USA
2:30 NEW DATA Gene Silencing Oligos: The Next Generation in
Gene Silencing
This presentation discusses a unique therapeutic oligonucleotide modality.
Gene silencing oligonucleotides (GSOs) are composed of two single stranded
oligonucleotides directed against the same target mRNA connected at their
5’ ends by a linker. GSOs show greater activity, potency and duration when
compared to antisense oligonucleotides (ASOs) directed against the same target.
In addition, GSOs mitigate the immune response seen with second generation
ASOs and show no obvious signs of organ toxicity after repeat dosing.
Significant work went into the SAR of GSOs demonstrates specific unique
structural properties and provide opportunities for additional optimization of
the drug-liker properties of GSOs. The GSOs represent a significant opportunity
in exploding field of oligonucleotide therapeutics. The presentation also
includes exploration of the structure/activity relationship and work with the
GSOs in various preclinical models.
Walter Strapps, Ph.D., Executive Director of RNA Therapeutics,
Idera Pharmaceuticals, USA
Jörg Vollmer, Ph.D., Chief Executive Officer, Nexigen GmbH, Germany
11:15 CASE STUDY / NEW DATA Design, Optimization and Early
Development of Novel Peptide Drug Conjugates
Abstract not available; please check
www.IBCLife Sciences.com/AsiaTIDES for updates.
Yvonne M. Angell, Ph.D., Director of Peptide and Protein Chemistry,
Ipsen Bioscience, Inc., USA
11:45 CASE STUDY Development of a Novel Peptide
Immunotherapeutic for Prostate Cancer
We are developing a second generation immunotherapeutic peptide vaccine
for various cancers. The peptide was designed to activate critical components
of the cellular immune system in an antigen-specific manner. In a Phase
I prostate cancer study, both a robust immune response and correlates of
improved overall and progression-free survival were obtained. The same
peptide gave encouraging results from a Phase II breast cancer study.
Eric von Hofe, Ph.D., President, Antigen Express Inc., USA
12:15 Luncheon in Poster and Exhibit Hall
Eric von Hofe, Ph.D., President, Antigen Express Inc., USA
1:30 PeptiDream; PDPS and the Discovery & Development of
Constrained Peptide Therapeutics
PeptiDream’s proprietary Peptide Discovery Platform System (PDPS) has
proven highly effective at identifying constrained lead peptide candidates,
in which such hits exhibit excellent therapeutic properties directly from
selections themselves. In addition, advanced screening systems have been
established to allow for the rapid assessment of those hits without the need for
laborious chemical synthesis, significantly shortening the time from selections
to the identification of hit constrained peptides that exhibit the desired
therapeutic candidate profile.
Patrick C. Reid, Chief Scientific Officer, PeptiDream Inc., Japan and USA
2:00 CASE STUDY / NEW DATA Targeting Key Signaling Pathways of
Cancer Stem Cells with Intracellular Peptide Therapeutics
One of the challenges in today’s treatment of cancer is tumor recurrence
and spread caused by the existence of subpopulations within a tumor with
distinct tumor-initiating powers, the cancer stem cells. Peptide therapeutics
targeting intracellular protein-protein interactions are an attractive alternative
to conventional therapies to inactivate signaling pathways in cancer stem
cells. Nexigen’s NexiTides target such pathways and have powerful in vitro
anti-cancer stemness activity and are effective in xenografted and orthotopic
models of tumor growth and metastases.
Jörg Vollmer, Ph.D., Chief Executive Officer, Nexigen GmbH, Germany
2:30 CASE STUDY / NEW DATA High Affinity Bicyclic Peptides:
Application to Payloads in Oncology
The Bicycle technology is based on repertoires of peptides displayed on
the surface of bacteriophages which can be modified with organochemical
scaffolds to create a diverse array of constrained peptides. These repertoires
have been extensively used for iterative selections to identify high affinity
binding peptides for a wide array of targets, including receptors, interleukins
and proteases. The bicycle peptides show antibody-like properties such as
low to sub-nanomolar affinities and exquisite selectivity, but in a 100-fold
smaller, chemically synthesized format. We showed that these small entities
extravasate and penetrate tumors much more rapidly and efficiently than
antibodies, thus delivering high concentrations of payloads in a very short
time. These features allow efficient tumor killing while drastically minimizing
systemic toxin exposure. Bicycle Therapeutics will present in vivo POC data
from its pre-clinical programs demonstrating the power of its technology to
deliver cytotoxic payloads to tumor cells.
Christophe Bonny, Ph.D., Chief Scientific Officer, Bicycle Therapeutics,
United Kingdom
3:00 Networking Reception in Poster and Exhibit Hall
Visit www.IBCLifeSciences.com/AsiaTIDES for up-to-date information on this event 3

Main Conference • Concurrent Tracks Tuesday, March 3, 2015 (continued)
Oligonucleotide-Based Therapeutics in
Preclinical and Clinical Development (continued)
Peptide-Based Therapeutics in Preclinical and
Clinical Development (continued)
Novel LNA and siRNA Developments
Patrick Y. Lu, Ph.D., President & CEO, Sirnaomics, Inc., USA
Featured Presentation
3:45 NEW DATA LNA Therapeutics: A Technology Perspective
The field of LNA and RNA therapeutics is undergoing rapid development.
New trends in the field influence future developments and further progress
will be linked to a reformulation of older concepts. It will be shown that, in
general, the way forward will benefit from a fresh view of the technology
space. It will be illustrated how the recent progresses in the field has enabled
renewed interest in the technology and in the deal space.
Dr. Troels Koch, VP & CTO, Roche Innovation Center Copenhagen,
Denmark
4:15 CASE STUDY / NEW DATA Advancing Novel siRNA Therapeutic
Products in Both China and USA
Sirnaomics has developed an enriched product pipeline including siRNA
therapeutic STP705 (Cotsiranib®) for Hypertrophic Scar prevention and
reduction, STP702 for “Resistent-Proof ” influenza therapeutics, and STP909
for HPV and cervical cancer treatment. The company is pushing two siRNA
therapeutic programs into clinical study in China and USA with support of
manufacturing capability, technical strength and financial resources.
Patrick Y. Lu, Ph.D., President & CEO, Sirnaomics, Inc., USA
4:45 NEW DATA Locked Nucleic Acid: Enabling RNA Therapeutics
RNA therapeutics have over the past decade developed from concept, clinic
to market. However, the development has been hampered by a too simplistic
approach to the underlying drug discovery principles resulting in unnecessary
attrition rates during development. The lessons learned have resulted in new
concepts to conduct drug discovery leading to increases in the productivity
of RNA therapeutics. Locked Nucleic Acids are recognized as a preferred
chemistry for RNA therapeutics and this will be presented in the context of
lesson learned and LNA drug discovery case stories.
Dr. Bo Rode Hansen, Vice President, Drug Discovery & Alliance,
Roche Innovation Center Copenhagen, Denmark
5:15 NEW DATA DT01: A First-in-Class DNA Repair Inhibitor Against
Advanced Cancers, From Concept to Clinic
Enhanced DNA repair activity in tumors confers resistance to treatment. A
first-in-class oligonucleotide therapeutics that mimics DNA double-strand
breaks (named “Dbait”) has been developed. It acts by jamming DNA
damage signaling that disorganizes DNA repair system and thereby inhibits
DNA repair. This presentation will describe its mechanism of action and
preclinical proofs of concept, animal toxicology and pharmacokinetics data,
and preliminary data in the first-in-human trial of DT01 - 1st drug candidate
of Dbait.
Professor Jian-Sheng Sun, CEO, DNA Therapeutics SA, France
5:45 End of Day One
Patrick C. Reid, Chief Scientific Officer, PeptiDream Inc., Japan and USA
3:45 Kisspeptin and its Agonist Analogs: From Discovery to
Clinical Studies
Abstract Not Available. Please visit
www.IBCLife Sciences.com/AsiaTIDES for updates.
Hisanori Matsui, Principal Scientist (Pharmacology), Extra Value Generation
& General Medicine Drug Discovery Unit, Pharmaceutical Research
Division, Takeda Pharmaceutical Company, Ltd., Japan
4:15 FRONTIER: A Phase 3, Pre-Hospital Peptide Therapeutic
Trial for Acute Ischemic Stroke
Abstract Not Available: Please check www.IBCLifeSciences.com/AsiaTIDES
for updates.
Dave Garman, Ph.D., Technology Officer, NoNo Inc., Canada
4:45 Late-Breaking Presentation
Ikuo Fujii, Ph.D., Professor Graduate School of Science,
Osaka Prefecture University
5:15 NEW DATA Cryptides and Their Accumulative Signaling
Mechanisms for Novel Therapeutic Targets
Many fragmented peptides are produced during maturation and degradation
processes of endogenous proteins but their physiological and/or pathological
roles are not well elucidated yet. We discovered novel bioactive peptides
derived from various mitochondrial proteins that efficiently activated
neutrophils and named such functional peptides hidden in protein structures
“cryptides.” Here I will discuss about such cryptides and their signaling
mechanisms for possible therapeutic targets.
Hidehito Mukai, Ph.D., Principal Investigator, Laboratory of Peptide Science
and Associate Professor, Graduate School of Bio-Science, Nagahama
Institute of Bio-Science and Technology, Japan
5:45 End of Day One
5:15 Networking Reception in Exhibit and Poster Hall Co-sponsored by:
Conference Language
The conference will be conducted in English without translation.
About the Organizers
This event is brought to you by the organizers of the TIDES and
EuroTIDES conferences. IBC Life Sciences, an Informa business, is your
connection to the life sciences industry. To see all of the in-depth
content IBC Life Sciences has to offer, visit www.IBCLifeSciences.com.
Making Hotel Reservations
Special room rates have been contracted with Hyatt Regency Osaka
Hotel for IBC’s delegation. To take advantage of this special rate, please
visit the conference website at www.IBCLifeSciences.com/AsiaTIDES
and select the Hotel Info Link. More information on how to reserve your
room is available there.
Travel/Visa Information
PLEASE NOTE: Visas are required for some nationalities to travel to Japan
for this conference. Please contact your travel agent and/or the Japanese
Consulate/Embassy in your country for exact details and visa application
procedures as soon as possible. Visa processing times can vary.
Call for Posters
Limited space is available for poster presentations at this event. If
you have new results/data on topics relevant to this conference, we
encourage you to submit a poster abstract for consideration. To present
a poster, complete the conference registration form and submit poster
title and one page poster abstract online at www.IBCLifeSciences.com/
AsiaTIDES by January 30, 2015. See registration form for poster fees.

Main Conference Wednesday, March 4, 2015
8:00 Networking Coffee and Tea
DDS (Drug Delivery Systems and Strategies
for Peptides and Oligonucleotides)
Bruce Morimoto, Executive Director, Applied Translational Medicine,
Celerion, USA
9:00 NEW DATA Lipid Nanoparticles for Therapeutic Delivery of
miRNA-Targeting Oligonucleotides
miRNA dysregulation plays a critical role in tumor development and resistance
to therapy. miR mimics and antimiR oligos have potential therapeutic
applications. A series of lipid nanoparticle formulations have been developed
for therapeutic delivery of these oligonucleotide agents in leukemia and in lung
cancer. We have shown in animal models that miR-29b mimics can inhibit
xenograft tumor growth and extend the survival of leukemia engrafted mice.
Lipid nanoparticles loaded with antimiR-21 have been shown to effectively
modulate miR-21 targets in vitro and in vivo, and to inhibit tumor growth in a
xenograft model. Lipid nanoparticle-based delivery of miR-modulating oligos
has great promise for clinical translation for cancer therapy.
Robert J. Lee, Ph.D., Professor of Pharmaceutics, Division of Pharmaceutics,
OSU College of Pharmacy, The Ohio State University, USA
9:30 CASE STUDY Intranasal Drug Delivery: Drug Development
Considerations
Intranasal route of administration is attractive for small molecules, peptides,
oligonucleotides and even proteins. The nasal epithelium has a large surface
and is highly vascularized which can result in rapid absorption and drug
onset. The nasal route represents a non-invasive means of delivery and
is amenable to peptide drugs as it avoids gastric degradation and hepatic
first-pass metabolism. This presentation will go through drug product
characterization and highlight aspects which are unique to nasal drugs.
The challenges with nonclinical dose administration, determination of the
maximum tolerated dose, and methods for pharmacokinetic evaluation will
be discussed using case examples.
Celerion, USA
10:00 Networking Refreshment Break
10:40 Chairman’s Opening Remarks
Bruce Morimoto, Executive Director, Applied Translational Medicine, Celerion,
USA
10:45 CASE STUDY / NEW DATA Block Copolymer-Based Nanosystems for
siRNA and Oligonucleotide Delivery
This presentation features supramolecular nanosystems assembled from charged
block copolymers for siRNA and oligonucleotide delivery. Focus will be on
the systemic delivery systems aiming to target intractable cancer, including
pancreatic cancer. Tumor penetrability of nanosystems will be a critical point to
be discussed particularly in this presentation.
Kazunori Kataoka, Ph.D., Professor, Department of Bioengineering, School of
Engineering, University of Tokyo
11:15 NEW DATA Probing Structural Requirement of Triantennary
N-Acetylgalactosamine for Hepatic Targeting of Antisense
Oligonucleotides
A summary of our effort to identify simpler GalNAc clusters with specific
emphasis on lowering molecular weight and ease of synthesis for Gapmer
antisense therapeutics will be presented.
Thazha Prakash, Ph.D., Senior Research Fellow, Isis Pharmaceuticals, USA
12:15 Networking Luncheon in Poster & Exhibit Hall
1:25 Chairwoman’s Remarks Paula Lorence, VP Business Development & Project Management, Nitto Denko Avecia, USA
Featured Presentation: Manufacturing and Analytical Strategies for Peptides and Oligos
1:30 Purification of Synthetic Oligodeoxynucleotides and Peptides Using a Readily Scalable Catching by Polymerization Approach
Synthetic oligonucleotides and peptides have received increasing attention for drug discovery but their purification is very expensive. To lower the purification costs,
we have developed an innovative catching by polymerization approach where a simple polymerizable group is attached to either the failure sequences or the full-length
sequences but not to both and purification is achieved by simple washing and extraction process.
Durga P. Pokharel, Ph.D., Post-Doctoral Research Fellow, Michigan Technological University, USA
Main Conference • Concurrent Tracks
Manufacturing and Analytical Strategies
for Oligonucleotides
Sponsored by:
2:00 Rapid Synthesis of Oligonucleotides for Research and
Preclinical Studies
Abstract not available; please check www.IBCLifeSciences.com/AsiaTIDES
for updates
Rowshon Alam, Group Leader, SSOU, Nitto Denko Avecia, Inc., USA and Japan
Tatsuya Konishi, Process Development, Group Leader, Nitto Denko Avecia, Inc.,
USA and Japan
2:30 First Manufacturing Results from the Next Generation
OligoProcess Synthesizer
Dr. Huseyin Aygün, Ph.D. CSO, BioSpring GmbH, Germany
for Peptides
2:00 Large Scale Manufacturing of Synthetic Peptides
Latest development in large scale manufacturing of synthetic peptides will
be presented. The talk will consider both chemical processes as well as
engineering aspects of large scale SPPS and downstream manufacturing.
A case study will be discussed.
Daniel Samson, Ph.D., Director API Manufacturing, Bachem, Switzerland
2:30 Characterization of Degradation Impurities in API or
Formulated drugs: Example of a beta-Aspartic Isomer
Identification by Complementary Analytical Methods
ADeep characterization of degradation impurities is a challenge in the
analytical laboratory. In this real-life case study, we supported a customer for
the characterization of a drug product. An unexpected degradation impurity
was detected and identified, with the help of orthogonal HPLC methods, small
scale purification, Edman sequencing, and mass spectrometry sequencing.
Didier Monnaie, Analytical Development Group Leader, or David Cosquer,
Mass Spectrometry Specialist, Analytical Development, Lonza, Belgium

Main Conference Wednesday, March 4, 2015 (continued)
for Oligonucleotides
for Peptides
3:30 Late-Breaking Presentation from Agilent
Abstract not available; please check www.IBCLifeSciences.com/AsiaTIDES
for updates
4:00 AJIPHASE®; Novel & Practical Solution Phase
Oligonucleotides Synthesis for Large Scale Manufacturing
AJINOMOTO’s original liquid-phase technology AJIPHASE® initially
developed for peptide manufacturing has been successfully applied to
oligonucleotide synthesis.This presentation will describe the novel and
practical liquid-phase approach for synthesis or manufacturing of two types
of oligonucleotides, DNA/RNA-type oligonucleotides and Morpholino
oligonucleotides. Several examples of liquid-phase oligonucleotide synthesis
had been reported in the literatures; however, most of them were fit only for
short length oligos in terms of yield and quality. Here, we developed ‘one-pot’
elongation cycle and optimized several factors of the reaction condition to
obtain highly pure oligonucleotide in a large scale.
Satoshi Katayama and Daisuke Takahashi, Research Institute for Bioscience
Products & Fine Chemicals, Ajinomoto Co. Inc., Japan
4:30 You Have Developed a Process – Now What? Key Elements
& KPIs to Consider When Setting Up Successful Technology
Transfers at Different Stages of the Product Lifecycle
Pre-tech transfer activities are critical in ensuring success of the tech transfer
process and clear, specific communication is essential before, during, and
after the tech transfer process. You must have the appropriate skill sets and
competencies in place with all of your upstream / downstream partners so that
you have understood any constraints and agreed on the scope of the work and
acceptable parameters months before the tech transfer actually begins.
Jayant Aphale, Ph.D., MBA, Senior Vice President, Technical Operations,
Sarepta Therapeutics, USA
5:00 Forced Degradation of Phosphorothioate Oligonucleotides
Forced degradation studies are an important component of drug development.
Forced degradation studies may be used to determine the inherent stabilities
of drug substances and drug products and to develop an understanding of
degradation pathways and degradation products. The main degradation
pathways, the structures of degradation products and the inherent stabilities
of synthetic phosphorothioate oligonucleotides exposed to a variety of
physical and chemical insults will be presented.
Daniel Capaldi Ph.D., Vice President, Analytical and Process Development,
Isis Pharmaceuticals, Inc., USA
5:30 Close of Day 2
3:30 Quantifying Sequence and Structural Features of
Protein–RNA Interactions
We quantified the contribution of both sequence- and structure-based
features as indicators of RNA-binding propensity using a machine-learning
approach. Several novel and modified features enhanced the accuracy of
residue-level RNA-binding propensity beyond what has been reported
previously. We constructed a web server called aaRNA that implements
the proposed method and demonstrate its use in identifying putative RNA
binding sites.
Singling Li, Ph.D., Specially Appointed Researcher, Systems Immunology
Laboratory, Immunology Frontier Research Center (IFReC),
Osaka University, Japan
4:00 Methods for Peptide Thioester Preparation
Chemical ligation technique is widely used for protein synthesis. The
ligation methods, such as thioester method and native chemical ligation,
have been developed based on the use of peptide thioesters as building
blocks. We have developed methods for preparation of the peptide
thioesters based on an intramolecular N to S acyl shift reaction at a thiol
containing residue of peptides.
Turo Kawakami, Ph.D., Associate Professor, Institute for Protein Research,
Osaka University, Japan
5:00 Molecular Hiving Technology as a Strategy for the
Manufacturing of Peptides
Molecular Hiving Technology™ is innovative, hydrophobic tagged Liquid
Phase Peptide Synthesis (LPPS) that integrates the key advantages of both
LPPS and Solid Phase Peptide Synthesis (SPPS). Sekisui Medical has been
developing this technology since 2010. Recent progress has allowed Sekisui to
carry out a synthesis with a substantial increase in crude purity and reduction
in consumables. This has resulted in faster lead times, a more efficient
downstream process and considerable reduction in costs. Examples of this
will be given in the presentation. This presentation will also include case
studies (all unpublished data) for the synthesis of synthetically challenging
oligopeptides (e.g. C-terminal modified cyclized). All candidates were
synthesized obtaining a high yield and crude purity, followed by an excellent
final purity after the purification process.
Barry O’Connor, Research Scientist, Sekisui Medical Co Ltd., Japan
5:30 Close of Day 2
Main Conference • Concurrent Tracks Thursday, March 5, 2015
8:00 Networking Coffee and Tea
Regulatory Considerations for Peptides
and Oligonucleotides
David T. Lin, Ph.D., Senior Consultant, Biologics Consulting Group, Inc.,
USA
9:00 US Regulatory Development and Review Perspectives for
New and Generic Peptide Drugs
This session will provide a regulatory overview of the requirements for
new and generic peptide drugs. The presentation will include a discussion
of the review process in FDA for peptide products with respect to a new
peptide as compared to a generic peptide product. Regulatory requirements
and expectations between new and generic peptide products are similar so
differences will be discussed. To understand these regulatory requirements
case studies will be presented that outline development strategies for new
dosage forms and delivery systems.
David Lin, Ph.D., MBA, Senior Consultant, Biologics Consulting Group, Inc.
(former acting Division Director, Office of New Drug Chemistry,
CDER, U.S. FDA), USA
Duu-Gong Wu, Ph.D., Director, Regulatory Consulting/Senior Consultant,
PPD, USA (former Deputy Division Director, Office of New Drug Chemistry,
CDER, U.S. FDA, USA)
10:00 Update on the Regulatory Expectations for the Quality of
Oligonucleotide Products
The complex and diverse nature of oligonucleotides currently in development
is posing unprecedented challenges in meeting the regulatory requirements
for drug quality. This presentation provides a historical overview and
evolution of the US, European and other regulatory agencies’ review practices
of oligonucleotide products. Also highlighted are emerging trends in the
industry to meet current expectations for the characterization and quality
control of oligonucleotide drug candidates from preclinical to late stage
clinical development.
G. Susan Srivatsa, Ph.D., President, ElixinPharma, USA
10:30 Oligonucleotide Therapeutics One Step Closer
Oligonucleotide therapeutics continues to advance toward approval and
yet there still remain some critical questions. The early challenges have
been met and now to obtain more approvals it will be necessary to address
new issues. Identifying these issues and their solutions is the key to future
regulatory approvals.
Art Levin, Ph.D., Executive Vice President, Research and Development,
Avidity NanoMedicines, USA
11:00 AsiaTIDES Closes and Post-Conference Workshops Begin

Post-Conference Workshops Thursday, March 5, 2015
Workshop #1: Impurities in Oligonucleotides:
Sources, Analysis and Control
Workshop Leaders: Thomas Rupp, Thomas Rupp Consulting, Germany
G. Susan Srivatsa, Ph.D., President, ElixinPharma, USA
With the market approval of three oligonucleotide drugs and the advancement
of a myriad of oligonucleotide programs to late stage development, there is an
increased interest on the topic of impurities in synthetic oligonucleotides. Due to
their inherent complexity, synthetic polymers such as peptides and oligonucleotides
are specifically excluded from the scope of the ICH Q3A impurities guideline. This
workshop will present current regulatory strategies for the control of impurities
through discussions of the sources, methods of analysis and control.
11:00 Welcome and Opening Remarks
Thomas Rupp and G. Susan Srivatsa
11:15 Practical Considerations for the Implementation of Quality
Criteria for Amidite Starting Materials (TBD)
12:00 Networking Lunch
1:15 Impurities Formed During Synthesis and
Downstream Processing
Thomas Rupp, Thomas Rupp Consulting, Germany
2:00 Application of Risk Assessment in Development of Testing
Strategies for Non-Oligonucleotide Impurities
Emma Wright, Nitto Denko, USA
2:45 CMC Considerations for the Control of Impurities in
Oligonucleotides
G. Susan Srivatsa, Ph.D., ElixinPharma, USA
3:30 Safety Considerations for the Control of Impurities in
Oligonucleotides
Mike Templin, SNBL, USA
4:15 General Discussion and Close of Workshop
Gold Sponsor
Current Practices in Peptide Therapeutics
This course will cover the main topics of manufacturing, formulation and regulatory
strategies for peptide therapeutics.
11:00 Evolution of Peptide API Specifications from
IND to NDA
Robert Hagopian, Director of Business Development,
PolyPeptide Group, USA
11:30 Scale-Up Manufacturing Case Study: Considerations of
Transition from Solid-Phase to Solution-Phase Synthesis
Celerion, USA
12:00 Networking Lunch
1:15 Development of a Stable Lyophilized
Peptide Formulation
Dave Garman, Ph.D., Technology Officer, NoNo Inc., Canada
1:45 Regulatory Trends and Strategy for Peptide Products
Duu-Gong Wu, Ph.D., Director of Regulatory Consulting/Senior Consultant,
Global Regulatory Consulting, PPD, USA
2:00 General Discussion and Close of Workshop
Sponsors and Exhibitors
Driven by Excellence, Guided by Experience. When you partner
with Avecia, (www.Avecia.com) you will be working with the leading
oligonucleotide CMO. Avecia offers the most extensive process
validation experience in the oligo industry. As a member of the
Nitto Denko Corporation (www.nitto.com), Avecia is committed to
the future of the oligonucleotide market. We offer our customers oligo manufacturing capacity in
two separate facilities (MA and OH). Our Cincinnati facility also provides expanded pre-clinical oligo
services (OliGROW), as well as small molecule expertise and production. Our aim is to leverage our
wealth of experience, to ensure we exceed our customer’s expectations. Avecia has the stability and
vision required for the long-term success of your oligo program.
Silver Sponsors
Agilent’s Nucleic Acid Solutions Division offers
industry leading experience to efficiently
advance your lead oligo candidates from
clinic to market with a common goal of patient health and safety. With Agilent, you always have
peace of mind by partnering with a company that has the financial resources, stability and vision
required for long-term success. Contact us at: pdl-boulderinfo@agilent.com and find out why
the world’s most revolutionary biotech companies and their Big Pharma partners are choosing
Agilent Technologies to develop and commercialize their oligo APIs.
Established in 1981, ChemGenes, an ISO9001 certified
company, has consistently provided the highest quality
Phosphoramidites and Solid Supports in the market and
continues to lead the industry in oligonucleotide reagent manufacturing. Our Massachusetts
facility is setup for Bulk Therapeutic Grade phosphoramidite production for GMP grade
oligonucleotide manufacturing. Additionally, ChemGenes carries the widest variety of modified
phosphoramidites and supports currently used in oligonucleotide synthesis including Microarray
Technology, Oligonucleotide Therapeutics, Oligonucleotide Based Probes and other areas of
Nucleic Acid research. ChemGenes remains devoted to providing you with invaluable customer
service and comprehensive technical support.
Bronze Sponsors
Bachem specializes in the manufacture of peptides and complex
small molecules as APIs as well as innovative biochemicals for
research purposes. We offer technical consultancy, comprehensive regulatory affairs support,
and dedicated project management from drug development through commercial scale cGMP
production. Headquartered in Bubendorf, Switzerland with affiliates in Europe and the U.S.
GeneDesign offers contract manufacturing of various
therapeutics and diagnostics oligonucleotide including
PEGylation, peptide conjugation and ligand conjugation from screening use to hundreds gram
GMP manufacturing with sterilized condition. With our widely experience and challenge to the
new technology area, we can contribute to your successful oligo therapeutics development.
We have launched new miRNA Inhibitor called “S-TuD” and miRNA mimic as a research tools and
started novel liquid phase oligonucleotide synthesis.
Workshop #2:
For more than 16 years, BioSpring has been providing
manufacturing and analytical services for the oligonucleotide
market. We manufacture an entire range of unmodified and
modified oligonucleotides from mg to multi-kg quantities for the use in therapeutic
(GMP) and diagnostic applications (ISO 13485 certified), molecular biology, and
research and development. In addition, we have a dedicated analytical team and
employ state of the art techniques for fully testing and characterizing oligonucleotides
and oligonucleotide containing products. For additional information, contact us via
email: info@biospring.de.
Session Sponsors
Spotlight Presentation Sponsor
Exhibitors (As of October 16, 2014)
Networking Reception Co-Sponsor
Literature Sponsor Refreshment Break Sponsor
Would you like to reach the AsiaTIDES audience?
• Meet face-to-face with top-notch researchers and executives from
pharmaceutical and biotechnology companies
• Showcase your latest technology to our targeted audience of key
decision-makers
• Build invaluable relationships and form new partnerships
that give you a competitive advantage in the US, Europe and Asia-Pacific
• Gain international exposure through our specialized marketing campaign
• Network with international players in the industry
For sponsorship and exhibiting opportunities, contact:
Sherry Johnson: sjohnson@ibcusa.com • Tel: +1 (508) 614-1451

Save Up To USD300
with the Early Bird Rates!
AsiaTIDES – Oligonucleotide and Peptide® Research, Technology and Product Development
See grid below for group discounts
for companies registering
3 or more attendees
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 PHONE:
RESERVE YOUR PLACE TODAY!
Industry Rates On or before
Dec. 19, 2014
On or before
Jan. 23, 2015
On or before
Feb. 13, 2015
+65 6508 2401
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Standard Rate
After Feb. 13, 2015
o Main Conference + Workshop* USD1999 USD2099 USD2199 USD2299
o Main Conference + Workshop* Group Rate
(3+ from same company) USD1799 USD1889 USD1979 USD2069
o Main Conference Only USD1699 USD1799 USD1899 USD1999
o Main Conference Only Group Rate
(3+ from same company) USD1529 USD1619 USD1709 USD1799
*Select one Workshop: o Workshop #1: Impurities in Oligonucleotides: Sources, Analysis and Control
o Workshop #2: Current Practices in Peptide Therapeutics
Academia/Government Discounts – 40% Savings: Academic and government employees are eligible for over 40%
savings compared to the industry fees. Rate extended to full-time employees of government, universities and
university-affiliated hospitals who have NO affiliation to a for profit entity. See website for details.
Present a Poster o USD125 - Commercial o FREE - Academic
Please tell us your primary area of interest: o Oligonucleotides o Peptides
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