AsiaTides -Peptides and Oligonucleotides 2015

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Media Parters: Premier Publication: Organized by: Where Global Oligonucleotide and Peptide Leaders Connect to Share Groundbreaking Science and Form Successful Business Collaborations March 3-5, 2015 • Hyatt Regency Osaka • Osaka, Japan 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 You Asked and We Listened – AsiaTIDES is Coming to Osaka in 2015! 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 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

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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. 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。

Transcript of AsiaTides -Peptides and Oligonucleotides 2015

  • 1. Where Global Oligonucleotide and Peptide Leaders Connect to ShareGroundbreaking Science and Form Successful Business CollaborationsMarch 3-5, 2015 Hyatt Regency Osaka Osaka, JapanIBC7 Asia TIDES 201533 -5You Asked and We Listened AsiaTIDES is Coming to Osaka in 2015!Media Parters: Premier Publication: Organized by:IBCs 7th AnnualKeynote PresentationsTransfer of exRNAsin Cancer MetastasisTakahiro Ochiya, Ph.D.Chief, Division of Molecular and Cellular Medicine,National Cancer Center Research Institute, JapanAmylin and its Analog:Potential Diagnostic Testand Therapeutic Drug forAlzheimer's DiseaseWendy Wei Qiao Qiu, M.D., Ph.D.Associate Professor, Departments of Psychiatryand Pharmacology, Alzheimer's Disease Center,Boston University School of Medicine, USAn Accelerate Your Discovery and Development Programsby Applying Successful Strategies from 18+ Case Study and NewData Presentations from Arrowhead, Isis, Roche, Takeda and otherIndustry Leaders from not only Japan, but also USA, Europe and Asian Ensure a Successful Market Launchby Utilizing Manufacturing and Analytical Strategies from GlobalExperts from 8 different countries, including Avecia, Agilent,Bachem, Ajinomoto and moren Gain Faster Therapeutic Approvalby Hearing Guidance from Two Former FDA Officials forOvercoming the Latest Regulatory Requirements and Challengesn Highlight Your Expertise in Untapped Marketsby Forging Partnerships with Key Decision Makers and AcademicLeaders from Across the GlobeRegister Early and Save Up to USD300! www.IBCLifeSciences.com/AsiaTIDES

2. Advance Your Oligonucleotide and Peptide Therapeutics Towards Commercial SuccessDear Colleagues,Coming to Osaka in 2015, IBCs 7th Annual AsiaTIDES is thepreeminent conference in Asia to gain the latest developmentupdates on preclinical and clinical peptides and oligonucleotides.Only at AsiaTIDES can you connect with global leaders who sharetheir novel strategies and lessons learned to help accelerate youroligonucleotide and peptide therapeutics to market.Your registration at the 2015 event in Osaka gives you exclusiveaccess to the most up-to-date reports available only at AsiaTIDESfrom not only Japanese peptide and oligonucleotide innovators,but also their Asian and U.S. collaborators providing youwith crucial knowledge that you can immediately apply to yourdevelopment portfolio. Additionally, our 2015 program bringstogether more thought-leaders and more new data than everbefore to help you effectively meet regulatory expectations andovercome complex product and manufacturing challenges.So, register early and save up to USD300 and be sure to logon to www.IBCLifeSciences.com/AsiaTIDES for programannouncements and updates.I look forward to seeing you in March 2015 at AsiaTIDES inOsaka: The premier meeting to accelerate your oligonucleotide andpeptide discovery and development programs towards commercialsuccess.Sincerely,Mark A. DeSorboConference Producer2015IBC7Asia TIDESAsia TIDES2015Asia TIDES2015300www.IBCLifeSciences.com/AsiaTIDES20153Asia TIDESAMain Conference Plenary Keynote Presentations Tuesday, March 3, 20158:00 Registration and Coffee/Tea9:10 Chairmans RemarksMark Graham, Executive Director, Cardiovascular Disease Research,Antisense Drug Discovery, Isis Pharmaceuticals Inc.9:15 Transfer of exRNAs in Cancer MetastasisThe existence of circulating miRNAs and exosomes in the bloodof cancer patients has raised the possibility that disease-specificmiRNAs and exosomes may serve as a novel diagnostic marker.Moreover, exosomes secreted from tumor cells contributemicromanaging tumor microenvironment. We and othergroups reported that tumor-derived exosomes mediated tumorangiogenesis and thus facilitated tumor metastasis for distant organs. Here we willdiscuss importance of transfer of extracellular microRNAs (exRNAs) and theircontribution to tumor development and metastasis.Takahiro Ochiya, Ph.D., Chief, Division of Molecular and Cellular Medicine,National Cancer Center Research Institute, Japan9:45 CASE STUDY / NEW DATA Amylin and its Analog:Potential Diagnostic Test and TherapeuticDrug for Alzheimer's DiseaseAmylin is a naturally occurring peptide with importantfunctions in the brain, including regulating glucose metabolism.Using Alzheimer's disease (AD) mouse models, we show herethe evidence that chronic peripheral treatment with amylin or its analog,pramlintide, reduced the amyloid burden and lowered the concentrationsof amyloid-beta peptides (A) in the brain when compared with salinetreatment. Further, behavioral tests showed that learning and memory inthese mice were improved by the treatment. Despite the fact that amylin andA share a similar secondary structure, our study indicates the therapeuticpotential of amylin type peptides for treating Alzheimers.Wendy Wei Qiao Qiu, M.D., Ph.D., Associate Professor,Departments of Psychiatry and Pharmacology, Alzheimer's Disease Center,Boston University School of Medicine, USA10:15 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: [email protected] 3. Main Conference Concurrent Tracks Tuesday, March 3, 2015Oligonucleotide-Based Therapeutics inPreclinical and Clinical DevelopmentPeptide-Based Therapeutics in Preclinical andClinical DevelopmentSponsored by:11:00 Chairmans RemarksDavid L. Lewis, Ph.D., Chief Scientific Officer, Arrowhead Research Corp., USA11:15 NEW DATA N-acetyl Galactosamine Conjugation EnhancesPotency of Second-Generation Antisense TargetingHepatocyte Expressed GenesSecond-generation antisense oligonucleotide (ASO) mRNA/protein potencywas 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 ASOconjugation 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., USA11:45 Optimization of Phosphorothioate Antisense DNA byControlling the Phosphorous ChiralityThis presentation demonstrates that the P-chirality affects nearly all the criticalproperties of the antisense drugs, from binding affinity to target RNA tometabolic stability and RNase H activity.Takeshi Wada, Ph.D., Department of Medicinal and Life Science, Faculty ofPharmaceutical Sciences, Tokyo University of Science, and Department ofMedical Genome Sciences, Graduate School of Frontier Sciences,The University of Tokyo, Japan12:15 Luncheon in Poster and Exhibit Hall1:25 Chairmans RemarksDr. Troels Koch, VP & CTO, Roche Innovation Center Copenhagen, Denmark1:30 Using Dynamic Polyconjugate (DPC) Delivery Technologyin RNAi-Based Therapeutics for the Treatment ofLiver DiseaseWe have developed a platform technology called Dynamic Polyconjugate (DPC) fortargeted delivery of RNAi trigger molecules. Key to this technology is a reversiblymasked endosomolytic polymer. The masking chemistry prevents the polymer frominteracting with blood components and non-targeted tissues, but is hydrolyzedin the acidic environment of endosomes allowing activation of the polymer andrelease of the RNAi-trigger to the cytoplasm of the targeted cell. Attachmentof N-acetyl galactosamine moieties to the DPC enables delivery specifically toliver hepatocytes via the asialoglycoprotein receptor. We are currently using thistechnology in therapeutics designed for the treatment of chronic hepatitis B virusinfection and alpha-1 antitrypsin deficiency-associated liver disease.David L. Lewis, Ph.D., Chief Scientific Officer, Arrowhead Research Corp., USA2:00 Nucleic Acid Ligands with Protein-like Side Chains and TheirApplication in Diagnostics and TherapeuticsThis presentation discusses a new class of nucleic acid ligands with protein-likeside chains, called slow off-rate modified aptamers (SOMAmers). Theirbroader chemical diversity results in higher success rate of SELEX, expandedrange of accessible epitopes, and enhancement in nuclease resistance. Thesefeatures are well-suited for large-scale proteomics, biomarker discovery anddevelopment of new diagnostic and therapeutic agents.Nebojsa Janjic, PhD, Chief Science Officer, SomaLogic, Inc., USA2:30 NEW DATA Gene Silencing Oligos: The Next Generation inGene SilencingThis presentation discusses a unique therapeutic oligonucleotide modality.Gene silencing oligonucleotides (GSOs) are composed of two single strandedoligonucleotides directed against the same target mRNA connected at their5 ends by a linker. GSOs show greater activity, potency and duration whencompared to antisense oligonucleotides (ASOs) directed against the same target.In addition, GSOs mitigate the immune response seen with second generationASOs and show no obvious signs of organ toxicity after repeat dosing.Significant work went into the SAR of GSOs demonstrates specific uniquestructural properties and provide opportunities for additional optimization ofthe drug-liker properties of GSOs. The GSOs represent a significant opportunityin exploding field of oligonucleotide therapeutics. The presentation alsoincludes exploration of the structure/activity relationship and work with theGSOs in various preclinical models.Walter Strapps, Ph.D., Executive Director of RNA Therapeutics,Idera Pharmaceuticals, USA11:00 Chairmans RemarksJrg Vollmer, Ph.D., Chief Executive Officer, Nexigen GmbH, Germany11:15 CASE STUDY / NEW DATA Design, Optimization and EarlyDevelopment of Novel Peptide Drug ConjugatesAbstract not available; please checkwww.IBCLife Sciences.com/AsiaTIDES for updates.Yvonne M. Angell, Ph.D., Director of Peptide and Protein Chemistry,Ipsen Bioscience, Inc., USA11:45 CASE STUDY Development of a Novel PeptideImmunotherapeutic for Prostate CancerWe are developing a second generation immunotherapeutic peptide vaccinefor various cancers. The peptide was designed to activate critical componentsof the cellular immune system in an antigen-specific manner. In a PhaseI prostate cancer study, both a robust immune response and correlates ofimproved overall and progression-free survival were obtained. The samepeptide gave encouraging results from a Phase II breast cancer study.Eric von Hofe, Ph.D., President, Antigen Express Inc., USA12:15 Luncheon in Poster and Exhibit Hall1:25 Chairmans RemarksEric von Hofe, Ph.D., President, Antigen Express Inc., USA1:30 PeptiDream; PDPS and the Discovery & Development ofConstrained Peptide TherapeuticsPeptiDreams proprietary Peptide Discovery Platform System (PDPS) hasproven highly effective at identifying constrained lead peptide candidates,in which such hits exhibit excellent therapeutic properties directly fromselections themselves. In addition, advanced screening systems have beenestablished to allow for the rapid assessment of those hits without the need forlaborious chemical synthesis, significantly shortening the time from selectionsto the identification of hit constrained peptides that exhibit the desiredtherapeutic candidate profile.Patrick C. Reid, Chief Scientific Officer, PeptiDream Inc., Japan and USA2:00 CASE STUDY / NEW DATA Targeting Key Signaling Pathways ofCancer Stem Cells with Intracellular Peptide TherapeuticsOne of the challenges in todays treatment of cancer is tumor recurrenceand spread caused by the existence of subpopulations within a tumor withdistinct tumor-initiating powers, the cancer stem cells. Peptide therapeuticstargeting intracellular protein-protein interactions are an attractive alternativeto conventional therapies to inactivate signaling pathways in cancer stemcells. Nexigens NexiTides target such pathways and have powerful in vitroanti-cancer stemness activity and are effective in xenografted and orthotopicmodels of tumor growth and metastases.Jrg Vollmer, Ph.D., Chief Executive Officer, Nexigen GmbH, Germany2:30 CASE STUDY / NEW DATA High Affinity Bicyclic Peptides:Application to Payloads in OncologyThe Bicycle technology is based on repertoires of peptides displayed onthe surface of bacteriophages which can be modified with organochemicalscaffolds to create a diverse array of constrained peptides. These repertoireshave been extensively used for iterative selections to identify high affinitybinding peptides for a wide array of targets, including receptors, interleukinsand proteases. The bicycle peptides show antibody-like properties such aslow to sub-nanomolar affinities and exquisite selectivity, but in a 100-foldsmaller, chemically synthesized format. We showed that these small entitiesextravasate and penetrate tumors much more rapidly and efficiently thanantibodies, thus delivering high concentrations of payloads in a very shorttime. These features allow efficient tumor killing while drastically minimizingsystemic toxin exposure. Bicycle Therapeutics will present in vivo POC datafrom its pre-clinical programs demonstrating the power of its technology todeliver cytotoxic payloads to tumor cells.Christophe Bonny, Ph.D., Chief Scientific Officer, Bicycle Therapeutics,United Kingdom3:00 Networking Reception in Poster and Exhibit HallVisit www.IBCLifeSciences.com/AsiaTIDES for up-to-date information on this event 3 4. Main Conference Concurrent Tracks Tuesday, March 3, 2015 (continued)Oligonucleotide-Based Therapeutics inPreclinical and Clinical Development (continued)Peptide-Based Therapeutics in Preclinical andClinical Development (continued)Novel LNA and siRNA Developments3:40 Chairmans RemarksPatrick Y. Lu, Ph.D., President & CEO, Sirnaomics, Inc., USAFeatured Presentation3:45 NEW DATA LNA Therapeutics: A Technology PerspectiveThe field of LNA and RNA therapeutics is undergoing rapid development.New trends in the field influence future developments and further progresswill be linked to a reformulation of older concepts. It will be shown that, ingeneral, the way forward will benefit from a fresh view of the technologyspace. It will be illustrated how the recent progresses in the field has enabledrenewed interest in the technology and in the deal space.Dr. Troels Koch, VP & CTO, Roche Innovation Center Copenhagen,Denmark4:15 CASE STUDY / NEW DATA Advancing Novel siRNA TherapeuticProducts in Both China and USASirnaomics has developed an enriched product pipeline including siRNAtherapeutic STP705 (Cotsiranib) for Hypertrophic Scar prevention andreduction, STP702 for Resistent-Proof influenza therapeutics, and STP909for HPV and cervical cancer treatment. The company is pushing two siRNAtherapeutic programs into clinical study in China and USA with support ofmanufacturing capability, technical strength and financial resources.Patrick Y. Lu, Ph.D., President & CEO, Sirnaomics, Inc., USA4:45 NEW DATA Locked Nucleic Acid: Enabling RNA TherapeuticsRNA therapeutics have over the past decade developed from concept, clinicto market. However, the development has been hampered by a too simplisticapproach to the underlying drug discovery principles resulting in unnecessaryattrition rates during development. The lessons learned have resulted in newconcepts to conduct drug discovery leading to increases in the productivityof RNA therapeutics. Locked Nucleic Acids are recognized as a preferredchemistry for RNA therapeutics and this will be presented in the context oflesson learned and LNA drug discovery case stories.Dr. Bo Rode Hansen, Vice President, Drug Discovery & Alliance,Roche Innovation Center Copenhagen, Denmark5:15 NEW DATA DT01: A First-in-Class DNA Repair Inhibitor AgainstAdvanced Cancers, From Concept to ClinicEnhanced DNA repair activity in tumors confers resistance to treatment. Afirst-in-class oligonucleotide therapeutics that mimics DNA double-strandbreaks (named Dbait) has been developed. It acts by jamming DNAdamage signaling that disorganizes DNA repair system and thereby inhibitsDNA repair. This presentation will describe its mechanism of action andpreclinical proofs of concept, animal toxicology and pharmacokinetics data,and preliminary data in the first-in-human trial of DT01 - 1st drug candidateof Dbait.Professor Jian-Sheng Sun, CEO, DNA Therapeutics SA, France5:45 End of Day One3:40 Chairmans RemarksPatrick C. Reid, Chief Scientific Officer, PeptiDream Inc., Japan and USA3:45 Kisspeptin and its Agonist Analogs: From Discovery toClinical StudiesAbstract Not Available. Please visitwww.IBCLife Sciences.com/AsiaTIDES for updates.Hisanori Matsui, Principal Scientist (Pharmacology), Extra Value Generation& General Medicine Drug Discovery Unit, Pharmaceutical ResearchDivision, Takeda Pharmaceutical Company, Ltd., Japan4:15 FRONTIER: A Phase 3, Pre-Hospital Peptide TherapeuticTrial for Acute Ischemic StrokeAbstract Not Available: Please check www.IBCLifeSciences.com/AsiaTIDESfor updates.Dave Garman, Ph.D., Technology Officer, NoNo Inc., Canada4:45 Late-Breaking PresentationIkuo Fujii, Ph.D., Professor Graduate School of Science,Osaka Prefecture University5:15 NEW DATA Cryptides and Their Accumulative SignalingMechanisms for Novel Therapeutic TargetsMany fragmented peptides are produced during maturation and degradationprocesses of endogenous proteins but their physiological and/or pathologicalroles are not well elucidated yet. We discovered novel bioactive peptidesderived from various mitochondrial proteins that efficiently activatedneutrophils and named such functional peptides hidden in protein structurescryptides. Here I will discuss about such cryptides and their signalingmechanisms for possible therapeutic targets.Hidehito Mukai, Ph.D., Principal Investigator, Laboratory of Peptide Scienceand Associate Professor, Graduate School of Bio-Science, NagahamaInstitute of Bio-Science and Technology, Japan5:45 End of Day One5:15 Networking Reception in Exhibit and Poster Hall Co-sponsored by:Conference LanguageThe conference will be conducted in English without translation.About the OrganizersThis event is brought to you by the organizers of the TIDES andEuroTIDES conferences. IBC Life Sciences, an Informa business, is yourconnection to the life sciences industry. To see all of the in-depthcontent IBC Life Sciences has to offer, visit www.IBCLifeSciences.com.Making Hotel ReservationsSpecial room rates have been contracted with Hyatt Regency OsakaHotel for IBCs delegation. To take advantage of this special rate, pleasevisit the conference website at www.IBCLifeSciences.com/AsiaTIDESand select the Hotel Info Link. More information on how to reserve yourroom is available there.Travel/Visa InformationPLEASE NOTE: Visas are required for some nationalities to travel to Japanfor this conference. Please contact your travel agent and/or the JapaneseConsulate/Embassy in your country for exact details and visa applicationprocedures as soon as possible. Visa processing times can vary.Call for PostersLimited space is available for poster presentations at this event. Ifyou have new results/data on topics relevant to this conference, weencourage you to submit a poster abstract for consideration. To presenta poster, complete the conference registration form and submit postertitle and one page poster abstract online at www.IBCLifeSciences.com/AsiaTIDES by January 30, 2015. See registration form for poster fees.4 To Register, Call: (+65) 6508 2401 Fax: (+65) 6508 2407 E-mail: [email protected] 5. Main Conference Wednesday, March 4, 20158:00 Networking Coffee and TeaDDS (Drug Delivery Systems and Strategiesfor Peptides and Oligonucleotides)8:55 Chairmans RemarksBruce Morimoto, Executive Director, Applied Translational Medicine,Celerion, USA9:00 NEW DATA Lipid Nanoparticles for Therapeutic Delivery ofmiRNA-Targeting OligonucleotidesmiRNA dysregulation plays a critical role in tumor development and resistanceto therapy. miR mimics and antimiR oligos have potential therapeuticapplications. A series of lipid nanoparticle formulations have been developedfor therapeutic delivery of these oligonucleotide agents in leukemia and in lungcancer. We have shown in animal models that miR-29b mimics can inhibitxenograft tumor growth and extend the survival of leukemia engrafted mice.Lipid nanoparticles loaded with antimiR-21 have been shown to effectivelymodulate miR-21 targets in vitro and in vivo, and to inhibit tumor growth in axenograft model. Lipid nanoparticle-based delivery of miR-modulating oligoshas 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, USA9:30 CASE STUDY Intranasal Drug Delivery: Drug DevelopmentConsiderationsIntranasal route of administration is attractive for small molecules, peptides,oligonucleotides and even proteins. The nasal epithelium has a large surfaceand is highly vascularized which can result in rapid absorption and drugonset. The nasal route represents a non-invasive means of delivery andis amenable to peptide drugs as it avoids gastric degradation and hepaticfirst-pass metabolism. This presentation will go through drug productcharacterization and highlight aspects which are unique to nasal drugs.The challenges with nonclinical dose administration, determination of themaximum tolerated dose, and methods for pharmacokinetic evaluation willbe discussed using case examples.Bruce Morimoto, Executive Director, Applied Translational Medicine,Celerion, USA10:00 Networking Refreshment Break10:40 Chairmans Opening RemarksBruce Morimoto, Executive Director, Applied Translational Medicine, Celerion,USA10:45 CASE STUDY / NEW DATA Block Copolymer-Based Nanosystems forsiRNA and Oligonucleotide DeliveryThis presentation features supramolecular nanosystems assembled from chargedblock copolymers for siRNA and oligonucleotide delivery. Focus will be onthe systemic delivery systems aiming to target intractable cancer, includingpancreatic cancer. Tumor penetrability of nanosystems will be a critical point tobe discussed particularly in this presentation.Kazunori Kataoka, Ph.D., Professor, Department of Bioengineering, School ofEngineering, University of Tokyo11:15 NEW DATA Probing Structural Requirement of TriantennaryN-Acetylgalactosamine for Hepatic Targeting of AntisenseOligonucleotidesA summary of our effort to identify simpler GalNAc clusters with specificemphasis on lowering molecular weight and ease of synthesis for Gapmerantisense therapeutics will be presented.Thazha Prakash, Ph.D., Senior Research Fellow, Isis Pharmaceuticals, USA11:45 Late-Breaking Presentation12:15 Networking Luncheon in Poster & Exhibit Hall1:25 Chairwomans Remarks Paula Lorence, VP Business Development & Project Management, Nitto Denko Avecia, USAFeatured Presentation: Manufacturing and Analytical Strategies for Peptides and Oligos1:30 Purification of Synthetic Oligodeoxynucleotides and Peptides Using a Readily Scalable Catching by Polymerization ApproachSynthetic 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-lengthsequences 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, USAMain Conference Concurrent TracksManufacturing and Analytical Strategiesfor OligonucleotidesSponsored by:2:00 Rapid Synthesis of Oligonucleotides for Research andPreclinical StudiesAbstract not available; please check www.IBCLifeSciences.com/AsiaTIDESfor updatesRowshon Alam, Group Leader, SSOU, Nitto Denko Avecia, Inc., USA and JapanTatsuya Konishi, Process Development, Group Leader, Nitto Denko Avecia, Inc.,USA and Japan2:30 First Manufacturing Results from the Next GenerationOligoProcess SynthesizerDr. Huseyin Aygn, Ph.D. CSO, BioSpring GmbH, Germany3:00 Networking Refreshment BreakManufacturing and Analytical Strategiesfor Peptides2:00 Large Scale Manufacturing of Synthetic PeptidesLatest development in large scale manufacturing of synthetic peptides willbe presented. The talk will consider both chemical processes as well asengineering aspects of large scale SPPS and downstream manufacturing.A case study will be discussed.Daniel Samson, Ph.D., Director API Manufacturing, Bachem, Switzerland2:30 Characterization of Degradation Impurities in API orFormulated drugs: Example of a beta-Aspartic IsomerIdentification by Complementary Analytical MethodsADeep characterization of degradation impurities is a challenge in theanalytical laboratory. In this real-life case study, we supported a customer forthe characterization of a drug product. An unexpected degradation impuritywas detected and identified, with the help of orthogonal HPLC methods, smallscale purification, Edman sequencing, and mass spectrometry sequencing.Didier Monnaie, Analytical Development Group Leader, or David Cosquer,Mass Spectrometry Specialist, Analytical Development, Lonza, Belgium3:00 Networking Refreshment BreakVisit www.IBCLifeSciences.com/AsiaTIDES for up-to-date information on this event 5 6. Main Conference Wednesday, March 4, 2015 (continued)Manufacturing and Analytical Strategiesfor OligonucleotidesManufacturing and Analytical Strategiesfor Peptides3:30 Late-Breaking Presentation from AgilentAbstract not available; please check www.IBCLifeSciences.com/AsiaTIDESfor updates4:00 AJIPHASE; Novel & Practical Solution PhaseOligonucleotides Synthesis for Large Scale ManufacturingAJINOMOTOs original liquid-phase technology AJIPHASE initiallydeveloped for peptide manufacturing has been successfully applied tooligonucleotide synthesis.This presentation will describe the novel andpractical liquid-phase approach for synthesis or manufacturing of two typesof oligonucleotides, DNA/RNA-type oligonucleotides and Morpholinooligonucleotides. Several examples of liquid-phase oligonucleotide synthesishad been reported in the literatures; however, most of them were fit only forshort length oligos in terms of yield and quality. Here, we developed one-potelongation cycle and optimized several factors of the reaction condition toobtain highly pure oligonucleotide in a large scale.Satoshi Katayama and Daisuke Takahashi, Research Institute for BioscienceProducts & Fine Chemicals, Ajinomoto Co. Inc., Japan4:30 You Have Developed a Process Now What? Key Elements& KPIs to Consider When Setting Up Successful TechnologyTransfers at Different Stages of the Product LifecyclePre-tech transfer activities are critical in ensuring success of the tech transferprocess and clear, specific communication is essential before, during, andafter the tech transfer process. You must have the appropriate skill sets andcompetencies in place with all of your upstream / downstream partners so thatyou have understood any constraints and agreed on the scope of the work andacceptable parameters months before the tech transfer actually begins.Jayant Aphale, Ph.D., MBA, Senior Vice President, Technical Operations,Sarepta Therapeutics, USA5:00 Forced Degradation of Phosphorothioate OligonucleotidesForced degradation studies are an important component of drug development.Forced degradation studies may be used to determine the inherent stabilitiesof drug substances and drug products and to develop an understanding ofdegradation pathways and degradation products. The main degradationpathways, the structures of degradation products and the inherent stabilitiesof synthetic phosphorothioate oligonucleotides exposed to a variety ofphysical and chemical insults will be presented.Daniel Capaldi Ph.D., Vice President, Analytical and Process Development,Isis Pharmaceuticals, Inc., USA5:30 Close of Day 23:30 Quantifying Sequence and Structural Features ofProteinRNA InteractionsWe quantified the contribution of both sequence- and structure-basedfeatures as indicators of RNA-binding propensity using a machine-learningapproach. Several novel and modified features enhanced the accuracy ofresidue-level RNA-binding propensity beyond what has been reportedpreviously. We constructed a web server called aaRNA that implementsthe proposed method and demonstrate its use in identifying putative RNAbinding sites.Singling Li, Ph.D., Specially Appointed Researcher, Systems ImmunologyLaboratory, Immunology Frontier Research Center (IFReC),Osaka University, Japan4:00 Methods for Peptide Thioester PreparationChemical ligation technique is widely used for protein synthesis. Theligation methods, such as thioester method and native chemical ligation,have been developed based on the use of peptide thioesters as buildingblocks. We have developed methods for preparation of the peptidethioesters based on an intramolecular N to S acyl shift reaction at a thiolcontaining residue of peptides.Turo Kawakami, Ph.D., Associate Professor, Institute for Protein Research,Osaka University, Japan4:30 Late-Breaking Presentation5:00 Molecular Hiving Technology as a Strategy for theManufacturing of PeptidesMolecular Hiving Technology is innovative, hydrophobic tagged LiquidPhase Peptide Synthesis (LPPS) that integrates the key advantages of bothLPPS and Solid Phase Peptide Synthesis (SPPS). Sekisui Medical has beendeveloping this technology since 2010. Recent progress has allowed Sekisui tocarry out a synthesis with a substantial increase in crude purity and reductionin consumables. This has resulted in faster lead times, a more efficientdownstream process and considerable reduction in costs. Examples of thiswill be given in the presentation. This presentation will also include casestudies (all unpublished data) for the synthesis of synthetically challengingoligopeptides (e.g. C-terminal modified cyclized). All candidates weresynthesized obtaining a high yield and crude purity, followed by an excellentfinal purity after the purification process.Barry OConnor, Research Scientist, Sekisui Medical Co Ltd., Japan5:30 Close of Day 2Main Conference Concurrent Tracks Thursday, March 5, 20158:00 Networking Coffee and TeaRegulatory Considerations for Peptidesand Oligonucleotides8:55 Chairmans RemarksDavid T. Lin, Ph.D., Senior Consultant, Biologics Consulting Group, Inc.,USA9:00 US Regulatory Development and Review Perspectives forNew and Generic Peptide DrugsThis session will provide a regulatory overview of the requirements fornew and generic peptide drugs. The presentation will include a discussionof the review process in FDA for peptide products with respect to a newpeptide as compared to a generic peptide product. Regulatory requirementsand expectations between new and generic peptide products are similar sodifferences will be discussed. To understand these regulatory requirementscase studies will be presented that outline development strategies for newdosage 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), USADuu-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 ofOligonucleotide ProductsThe complex and diverse nature of oligonucleotides currently in developmentis posing unprecedented challenges in meeting the regulatory requirementsfor drug quality. This presentation provides a historical overview andevolution of the US, European and other regulatory agencies review practicesof oligonucleotide products. Also highlighted are emerging trends in theindustry to meet current expectations for the characterization and qualitycontrol of oligonucleotide drug candidates from preclinical to late stageclinical development.G. Susan Srivatsa, Ph.D., President, ElixinPharma, USA10:30 Oligonucleotide Therapeutics One Step CloserOligonucleotide therapeutics continues to advance toward approval andyet there still remain some critical questions. The early challenges havebeen met and now to obtain more approvals it will be necessary to addressnew issues. Identifying these issues and their solutions is the key to futureregulatory approvals.Art Levin, Ph.D., Executive Vice President, Research and Development,Avidity NanoMedicines, USA11:00 AsiaTIDES Closes and Post-Conference Workshops Begin6 To Register, Call: (+65) 6508 2401 Fax: (+65) 6508 2407 E-mail: [email protected] 7. Post-Conference Workshops Thursday, March 5, 2015Workshop #1: Impurities in Oligonucleotides:Sources, Analysis and ControlWorkshop Leaders: Thomas Rupp, Thomas Rupp Consulting, GermanyG. Susan Srivatsa, Ph.D., President, ElixinPharma, USAWith the market approval of three oligonucleotide drugs and the advancementof a myriad of oligonucleotide programs to late stage development, there is anincreased interest on the topic of impurities in synthetic oligonucleotides. Due totheir inherent complexity, synthetic polymers such as peptides and oligonucleotidesare specifically excluded from the scope of the ICH Q3A impurities guideline. Thisworkshop will present current regulatory strategies for the control of impuritiesthrough discussions of the sources, methods of analysis and control.11:00 Welcome and Opening RemarksThomas Rupp and G. Susan Srivatsa11:15 Practical Considerations for the Implementation of QualityCriteria for Amidite Starting Materials (TBD)12:00 Networking Lunch1:15 Impurities Formed During Synthesis andDownstream ProcessingThomas Rupp, Thomas Rupp Consulting, Germany2:00 Application of Risk Assessment in Development of TestingStrategies for Non-Oligonucleotide ImpuritiesEmma Wright, Nitto Denko, USA2:45 CMC Considerations for the Control of Impurities inOligonucleotidesG. Susan Srivatsa, Ph.D., ElixinPharma, USA3:30 Safety Considerations for the Control of Impurities inOligonucleotidesMike Templin, SNBL, USA4:15 General Discussion and Close of WorkshopGold SponsorCurrent Practices in Peptide TherapeuticsThis course will cover the main topics of manufacturing, formulation and regulatorystrategies for peptide therapeutics.11:00 Evolution of Peptide API Specifications fromIND to NDARobert Hagopian, Director of Business Development,PolyPeptide Group, USA11:30 Scale-Up Manufacturing Case Study: Considerations ofTransition from Solid-Phase to Solution-Phase SynthesisBruce Morimoto, Executive Director, Applied Translational Medicine,Celerion, USA12:00 Networking Lunch1:15 Development of a Stable LyophilizedPeptide FormulationDave Garman, Ph.D., Technology Officer, NoNo Inc., Canada1:45 Regulatory Trends and Strategy for Peptide ProductsDuu-Gong Wu, Ph.D., Director of Regulatory Consulting/Senior Consultant,Global Regulatory Consulting, PPD, USA2:00 General Discussion and Close of WorkshopSponsors and ExhibitorsDriven by Excellence, Guided by Experience. When you partnerwith Avecia, (www.Avecia.com) you will be working with the leadingoligonucleotide CMO. Avecia offers the most extensive processvalidation experience in the oligo industry. As a member of theNitto Denko Corporation (www.nitto.com), Avecia is committed tothe future of the oligonucleotide market. We offer our customers oligo manufacturing capacity intwo separate facilities (MA and OH). Our Cincinnati facility also provides expanded pre-clinical oligoservices (OliGROW), as well as small molecule expertise and production. Our aim is to leverage ourwealth of experience, to ensure we exceed our customers expectations. Avecia has the stability andvision required for the long-term success of your oligo program.Silver SponsorsAgilents Nucleic Acid Solutions Division offersindustry leading experience to efficientlyadvance your lead oligo candidates fromclinic to market with a common goal of patient health and safety. With Agilent, you always havepeace of mind by partnering with a company that has the financial resources, stability and visionrequired for long-term success. Contact us at: [email protected] and find out whythe worlds most revolutionary biotech companies and their Big Pharma partners are choosingAgilent Technologies to develop and commercialize their oligo APIs.Established in 1981, ChemGenes, an ISO9001 certifiedcompany, has consistently provided the highest qualityPhosphoramidites and Solid Supports in the market andcontinues to lead the industry in oligonucleotide reagent manufacturing. Our Massachusettsfacility is setup for Bulk Therapeutic Grade phosphoramidite production for GMP gradeoligonucleotide manufacturing. Additionally, ChemGenes carries the widest variety of modifiedphosphoramidites and supports currently used in oligonucleotide synthesis including MicroarrayTechnology, Oligonucleotide Therapeutics, Oligonucleotide Based Probes and other areas ofNucleic Acid research. ChemGenes remains devoted to providing you with invaluable customerservice and comprehensive technical support.Bronze SponsorsBachem specializes in the manufacture of peptides and complexsmall molecules as APIs as well as innovative biochemicals forresearch purposes. We offer technical consultancy, comprehensive regulatory affairs support,and dedicated project management from drug development through commercial scale cGMPproduction. Headquartered in Bubendorf, Switzerland with affiliates in Europe and the U.S.GeneDesign offers contract manufacturing of varioustherapeutics and diagnostics oligonucleotide includingPEGylation, peptide conjugation and ligand conjugation from screening use to hundreds gramGMP manufacturing with sterilized condition. With our widely experience and challenge to thenew 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 andstarted novel liquid phase oligonucleotide synthesis.Workshop #2:For more than 16 years, BioSpring has been providingmanufacturing and analytical services for the oligonucleotidemarket. We manufacture an entire range of unmodified andmodified oligonucleotides from mg to multi-kg quantities for the use in therapeutic(GMP) and diagnostic applications (ISO 13485 certified), molecular biology, andresearch and development. In addition, we have a dedicated analytical team andemploy state of the art techniques for fully testing and characterizing oligonucleotidesand oligonucleotide containing products. For additional information, contact us viaemail: [email protected] SponsorsSpotlight Presentation SponsorExhibitors (As of October 16, 2014)Networking Reception Co-SponsorLiterature Sponsor Refreshment Break SponsorWould you like to reach the AsiaTIDES audience? Meet face-to-face with top-notch researchers and executives frompharmaceutical and biotechnology companies Showcase your latest technology to our targeted audience of keydecision-makers Build invaluable relationships and form new partnershipsthat 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 industryFor sponsorship and exhibiting opportunities, contact:Sherry Johnson: [email protected] Tel: +1 (508) 614-1451Visit www.IBCLifeSciences.com/AsiaTIDES for up-to-date information on this event 7 8. Save Up To USD300with the Early Bird Rates!AsiaTIDES Oligonucleotide and Peptide Research, Technology and Product DevelopmentSee grid below for group discountsfor companies registering3 or more attendeesMail the attached registration form with your cheque toIBC Asia (S) Pte Ltdc/o Informa Regional Business Services111 Somerset Road, TripleOne Somerset #10-06, Singapore 238164Venue & Hotel InformationHyatt Regency Osaka1-13-11 Nanko-Kita, Suminoe-KuOsaka, Japan, 559-00345 Easy Ways To RegisterTel: +81 6 6612 1234 Fax: +81 6 6614 7800Email: [email protected] must be received 10 business days prior to the event.To take advantage of discounts with an expiry cut-off date,registration and payment must be received by the cut-off date. Payments by USD bank draft or cheque should be made infavour of IBC Asia (S) Pte Ltd and mailed to:IBC Asia (S) Pte Ltdc/o Informa Regional Business Services111 Somerset Road, TripleOne Somerset #10-06,Singapore 238164Attn: The Accounts Receivable Team Payment by telegraphic transfer in USD must be made to:IBC Asia (S) Pte LtdA/C No.: 260-457866-178 (USD)The Hongkong and Shanghai Banking Corporation Limited,21Collyer Quay, HSBC Building, Singapore 049320Bank Swift Code: HSBCSGSGBank Code: 7232 Payment by Credit Card (AMEX, VISA or MASTERCARD)Please provide your Card Number, Name of Cardholder,Expiry Date and Signature and send it by fax to +65 6508 2407.Important NotePlease quote the name of the delegate, event title and invoicenumber on the advice when remitting payment. Bank chargesare to be deducted from participating organisations ownaccounts. Please fax your payment details (copy of remittanceadvice, cheque or draft to +65 6508 2407).Attendance will only be permitted upon receipt of full payment.Participants wishing to register at the door are responsibleto ensure all details are as published. IBC assumes no furtherliability or obligation, beyond the refund of the paid registrationfee, in the event of postponement or cancellation by IBC.Registration Substitutions/CancellationsShould you be unable to attend, a substitute delegate is welcomeat no extra charge. Cancellations must be received in writing atleast 10 business days before the start of the event, to receive arefund less 10% processing fee per registration. The companyregrets that no refund will be made available for cancellationnotifications received less than 10 business days before the event.IBC reserves the right to cancel or alter the content and timing ofthe program for reasons beyond its control and will NOT be heldaccountable for any costs incurred by the participants. Speakersare subject to change without prior notification.Data ProtectionThe personal information entered during your registration/order, or provided by you, will be held on a database and maybe shared with companies in the Informa Group in the UK andinternationally. Occasionally, your details may be obtained fromor shared with external companies who wish to communicatewith you offers related to your business activities. If you do notwish your details to be used for this purpose, please contact ourDatabase Department at Email: [email protected], Tel:+65 6508 2400 or Fax: +65 6508 2408.If undelivered, please return to:111 Somerset RoadTripleOne Somerset #10-06, Singapore 238164Tel: +65 6508 2400 Fax: + 65 6508 2408This label contains your priority booking code. To expedite registration, please do not remove label. If you have alreadyreceived a copy of this brochure, we apologise. For reasons of confidentiality, your full particulars were not available to IBCAsia (S) Pte Ltd for deduplication prior to mail drop. PHONE:RESERVE YOUR PLACE TODAY!Industry Rates On or beforeDec. 19, 2014On or beforeJan. 23, 2015On or beforeFeb. 13, 2015+65 6508 2401FAX:+ 65 6508 2407Standard RateAfter Feb. 13, 2015o Main Conference + Workshop* USD1999 USD2099 USD2199 USD2299o Main Conference + Workshop* Group Rate(3+ from same company) USD1799 USD1889 USD1979 USD2069o Main Conference Only USD1699 USD1799 USD1899 USD1999o 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 Controlo Workshop #2: Current Practices in Peptide TherapeuticsAcademia/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 anduniversity-affiliated hospitals who have NO affiliation to a for profit entity. See website for details.Present a Poster o USD125 - Commercial o FREE - AcademicPlease tell us your primary area of interest: o Oligonucleotides o PeptidesMultiple Bookings Discount pricing is applicable to groups of 3 or more delegates from the same organisationregistering for the same event, at the same time. Fee stated is the discounted price PER DELEGATE. Only onediscount applies; either the early bird rate OR special rate OR group rate. All fees stated include luncheons,refreshments and complete set of documentation. It does not include the cost of accommodation and travel.Registration fees are subject to the prevailing government tax.Name: Dr/Mr/Ms___________________________________________________ E-Mail______________________________________________________________Job Title___________________________________________________________ Mobile no__________________________________________________________Department_______________________________________________________ Company___________________________________________________________Address____________________________________________________________ Post Code__________________________________________________________Tel________________________________________________________________ Main Business/Activity______________________________________________Name & Title of Approving Manager________________________________ Name & Title of Training Manager_ _________________________________Please tick: o I enclose my Cheque/Draft payable to IBC Asia (S) Pte Ltdo I am paying by bank transfer (copy attached)o Payment by Credit Card: o Amex o Visa o MastercardCredit Card Payments: The best way to pay by credit card is through our secure on-line registration process, simply log on tothe website at www.IBCLIfeSciences.com/AsiaTIDES and click Register Now. 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