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Event Information

Oligonucleotide and Peptide ® Technology and Product Development Conference
February 23 - 25, 2009
Sheraton Miyako Hotel · Tokyo, Japan

Alternate Language Options:

Korean Taiwanese Chinese

Document Title

Agenda

Agenda

Pre-Conference Tutorials to Develop your Skills
Monday, February 23, 2009
| PRE-CONFERENCE TUTORIALS | DAY ONE | DAY TWO | DAY THREE |
8:00 Conference Registration Begins
Tutorial #1:
Analysis and Bioanalysis of Oligonucleotides in Support of Drug Development
 

Analysis of oligonucleotides presents many challenges due to the complexity of the molecules currently in development. This tutorial is designed to address the analytical approaches being used to meet the regulatory expectations for overall product quality and in support of preclinical (DMPK, toxicology) and clinical development. Methods to support quality control and bioanalytical studies will also be discussed.

Participants will learn:

  • Ion-pair reversed-phase LC and CE method development
  • How to resolve oligonucleotides in less than 5 minutes
  • The use of state-of-the-art LC-MS methods to characterize siRNA
  • Complexities of analysis of pegylated aptamers
  • Quantitative bioanalysis of oligonucleotides in biological fluids and tissues
  • The importance of raw material testing to ensure final product quality
  • Method transfer

Tutorial Leader: Martin Gilar, Ph.D., Principal Researcher, Waters Corp., USA
Additional Instructors:
Philip R. Oldfield, Ph.D., Scientific Director, Immunochemistry, Laboratory Sciences, Charles River Laboratories PCS-MTL, Canada
Ipsita Roymoulik, Ph.D., Senior Analytical Chemist, Quality Control, Avecia Biotechnology, USA
Yansheng Wu, Ph.D., Senior Scientist, CMC Analytical, Archemix Corp., USA

Tutorial #2:
RNA/DNA Synthesis and Purification: From Research to Commercial Scale
 

The process of oligonucleotide manufacture is a combination of sequential chemical transformations and equipment-related engineering solutions accommodating the requirements of these transformations. The course is designed to address the differences in the manufacturing of different classes of oligonucleotides as well as the different scales and equipment necessary for the transition from discovery to preclinical and clinical stages.

Participants will learn:

  • How it started and where it is now- a historical and business overview of the process - DNA, antisense, aptamers, ribozymes, RNA and more
  • The state of the art of oligonucleotide manufacture today
  • Do it yourself or outsource - the therapeutic company perspective
  • How a CMO can help - the contract manufacturer perspective
  • It is all automated - the equipment manufacturer perspective

Representatives from major CMOs, equipment manufacturers, and therapeutic companies will share their thoughts on the current state of the art of the process and the challenges they are facing. The course will conclude with a roundtable discussion.

Tutorial Leader: Lubomir Nechev, Ph.D., Director, Process Chemistry, Alnylam Pharmaceuticals, USA
Additional Instructors:
Gary Carter, Business Development Manager, Nucleic Acid Solutions Division, Agilent Technologies, Inc., USA
Patrick Foster, Director of Process Development, Avecia OligoMedicines, USA
Satya Kuchimanchi, Ph.D., Associate Director, High Throughput Synthesis, Alnylam Pharmaceuticals, USA
Thomas Rupp, Bioprocess Customer Application Support Oligonucleotides, GE Healthcare BioProcess, Sweden

Tutorial Schedule:
9:00 - 1:00 : with half-hour refreshment break at 10:30
1:00 - 2:00: Luncheon and Registration for Main Conference
Main Conference - Day One
Monday, February 23, 2009
| PRE-CONFERENCE TUTORIALS | DAY ONE | DAY TWO | DAY THREE |
2:00 Platinum Sponsor's Conference Welcome and Introductory Remarks
Kyle Haraldsen, Business Development Manager, Avecia OligoMedicines, USA
2:05 Chairperson's Opening Remarks
Yoshikazu Nakamura, Ph.D., Professor, Department of Basic Medical Science, Institute of Medical Science, University of Tokyo; Founder, Ribomic, Japan
  Keynotes
2:15 RNA: Science to Therapeutics
Recent achievements and discovery in biological science clearly emphasized the importance of RNA in life; the discovery of RNA interference, molecular mimicry between protein and RNA, and ribosome structure at atomic resolution. Moreover, the completed human genome project revealed, to our great surprise, the existence of a large amount of protein-noncoding RNAs (ncRNAs). This lecture overviews milestone achievements in RNA Science toward therapeutics.
Yoshikazu Nakamura, Ph.D., Professor, Department of Basic Medical Science, Institute of Medical Science, University of Tokyo; Founder, Ribomic, Japan
2:45 Peptide-Based Cancer Vaccines: A New Therapeutic Modality for Cancer
Great progress has been made in the field of tumor immunology in the past two decades and cancer vaccines have become a therapeutic option. Currently a large number of clinical trials of cancer vaccines have been carried out. Dr. Yamada will review the development of peptide-based cancer vaccines in the world and also introduce a personalized peptide vaccine for advanced cancer.
Akira Yamada, Ph.D., Professor, Cancer Vaccine Development Division, Kurume University Research Center for Innovative Cancer Therapy, Japan
3:15 Poster and Exhibit Viewing Refreshment Break Exhibit Hall Opens
Formulation and Delivery Session
  Keynote
3:45 Key Technologies for RNA Drug Discovery: RNA Delivery and Synthesis
Target-specific gene silencing by RNA interference (RNAi) is expected to play an important role in the new field of RNA therapy. Two key challenges associated with RNA drug discovery are (1) the difficulty of RNA delivery in vivo and (2) the cost and purity of synthetic RNA. This talk describes technologies that help meet these challenges.
Junichi Yano, Ph.D., Member of the Board, Research and Development, Nippon Shinyaku Co., Ltd., Japan
4:15
CASE
STUDY
Overview of Peptide Drug Formulation Advances and Selected Case Studies
An overview of recent advances of peptide drug formulations in clinical and commercial development will be presented. The growing significance and overall value of peptide therapeutics in meeting unmet medical needs in multiple key disease areas will be highlighted in several case studies. The major challenges and opportunities in peptide formulation and process scale-up for commercial manufacturing will also be discussed.
Qiang Ye, Ph.D., Associate Director, Product Development, Amylin Pharmaceuticals, Inc.
4:45 siRNA Therapeutics: Delivery into the Clinic
RNAi-based therapeutics require a broad approach involving potent siRNAs and efficient delivery. We have shown Dicer substrate siRNAs (D-siRNA) are highly active; when combined with our DiLA2 delivery platform, pharmacology has been demonstrated for metabolic, oncology, inflammatory and viral targets. These, and further advances in siRNA, meroduplex technology, and delivery options will further expand the therapeutic scope of RNAi.
Michael V. Templin, Vice President, Discovery Research and Pharmaceutical Development, MDRNA Inc., USA
5:15 Networking Reception in Poster and Exhibit Hall
Main Conference - Day Two
Tuesday, February 24, 2009
| PRE-CONFERENCE TUTORIALS | DAY ONE | DAY TWO | DAY THREE |
Concurrent Tracks
Oligonucleotide-Based Therapeutics Track
7:30 Coffee and Registration
Worldwide Advances in RNAi
8:30 Chairperson's Remarks
Dmitry Samarsky, Ph.D., VP, Technology Development, RXi Pharmaceuticals, USA
8:45 Development of a Novel RNAi Therapeutics Platform
The design and effective delivery of synthetic RNAi compounds are important factors for therapeutic applications. We will present data obtained with our proprietary rxRNA compounds, which can be up to 100 times more potent than conventional siRNAs, demonstrate nuclease resistance, and are potentially more specific for their intended targets. We will also discuss the possible mechanism of incorporation of chemically modified molecules into the RNAi machinery.
Dmitry Samarsky, Ph.D., VP, Technology Development, RXi Pharmaceuticals, USA
9:15 TLR Mediated Immune Responses to siRNA Based Drugs
Unmodified siRNA can activate the innate immune response and elicit non-specific therapeutic effects in multiple disease models. Researchers must anticipate, monitor and control for these effects. Various techniques, including the use of chemically modified siRNA with minimal immunostimulatory capacity, facilitate accurate delineation of the mechanism of action underlying siRNA studies, enabling the development of safe and effective siRNA based drugs.
Ian MacLachlan, Ph.D., Executive Vice President and Chief Scientific Officer, Tekmira Pharmaceuticals Inc., Canada
9:45 Targeting the Gastrointestinal Tract with Transkingdom RNA Interference(tkRNAi)
Transkingdom RNAi offers a unique approach to the delivery of RNAi for the GI tract. Cequent is close to starting clinical trials with a candidate to prevent colon polyps, and is developing a preclinical candidate for Inflammatory Bowel Disease (IBD). TkRNAi is suited for target validation in the GI tract including for indications such as metabolic diseases, gastric cancer, and others.
Johannes H. Fruehauf, M.D., Ph.D., Vice President, Research, Cequent Pharmaceuticals Inc., USA
10:15 Poster and Exhibit Viewing Refreshment Break
  Featured Presentation
10:45 RNAi Therapeutic Development: Selecting the Right Lead Molecule
Over the past several years, there have been significant advances in the development of RNAi therapeutics. With these advances comes an increased understanding of the complexities of the RNAi pathway and the activities of dsRNAs. As we bring new molecules forward for clinical evaluation we must carefully evaluate their efficacy and specificity as mediators of RNAi. This talk will focus on the lead development paradigm exploited at Alnylam to identify lead candidates across various programs.
Rachel Meyers, Ph.D., Senior Director, RNAi Lead Development, Alnylam Pharmaceuticals, USA
11:15
CASE
STUDY
Design and Development Strategies for Clinical Applications of Synthetic siRNAs
Quark Pharmaceuticals' pipeline includes a synthetic siRNA licensed by Pfizer in Phase 2 clinical studies and another synthetic siRNA in Phase 1/2 studies for two renal indications. This talk will include an update on clinical studies and provide an overview of the novel chemical modifications Quark is incorporating into new development candidates to optimize stability while attenuating potential off-target effects.
James D. Thompson, Ph.D., Vice President, Pharmaceutical Development, Quark Pharmaceuticals, Inc., USA
  Technology Workshop
11:45 Waters Corporation Ion-pair Reversed Phase UPLC Separation of Oligonucleotides: Method Development
Oligonucleotides are utilized for diagnostic and therapeutic purposes. This tutorial will explain the principles of ion-pair reversed-phase LC and LC-MS and illustrate the guidelines for method development. We will review the bases of separation of single stranded and duplex species. The role of ion-pairing system on separation selectivity of native, modified and labeled oligonucleotides will also be discussed. The impact of mobile phase selection, flow rate, temperature and gradient slope on separation will be illustrated with relevant examples.
Martin Gilar, Ph.D., Principal Researcher, Waters Corp., USA
12:15 Networking Luncheon in Poster and Exhbit Hall
Updates on Oligo-Based Therapeutics in Development
1:30 Chairperson's Remarks
Ryuichi Morishita, M.D., Ph.D., Professor, Dept. of Clinical Gene Therapy, Graduate School of Medicine, Osaka University; Founder, Board Member, Anges MG Inc., Japan
1:45 In Vivo Antisense Activity of ENA Oligonucleotides
2l-O,4l-C-Ethylene-bridged nucleic acids (ENA) exhibit a binding affinity to ssRNA as high as 2l-O,4l-C-methylene-bridged nucleic acids (LNA) and have much higher nuclease resistance than LNA. Here we present a comparison of the in vivo efficacy of isosequential ENA-modified oligonucleotide with that of ISIS113715 targeted to protein-tyrosine phosphatase 1B mRNA, which increases insulin sensitivity and normalizes plasma glucose in diabetic mice.
Makoto Koizumi, Ph.D., Senior Researcher, Exploratory Research Laboratories, Daiichi Sankyo Co., Ltd., Japan
2:15 Antisense Oligonucleotide GED-0301 against Smad7 for the Oral Treatment of Crohn's Disease
We are developing a novel oligonucleotide-based therapeutic approach for management of active Crohn's disease. The compound, named GED-0301, targets Smad7. We developed an oral dosage form of GED-0301 that affords delivery to small intestine and right colon thus achieving a "topical" effect. Toxicology and safety pharmacology in mice and non-human primates indicate that the orally administered drug is well tolerated.
Francesca Viti, Ph.D., Project Manager, Pharma Division, Giuliani S. p. A., Italy
2:45 Preclinical and Clinical Development of Second Generation Antisense Oligonucleotides
Abstract to come.
Richard S. Geary, Ph.D., Senior Vice President, Development, Isis Pharmaceuticals, Inc., USA
3:15 Poster and Exhibit Viewing Refreshment Break - Last Chance to Visit Poster and Exhibit Hall
3:45 Development of Decoy Oligonucleotide Drug
We have developed decoy ODN against NFkB, an essential transcription factor for inflammation and adhesion. Phase II trial to treat atopic dermatitis demonstrated a significant improvement of skin condition in NFkB decoy ODN compared to placebo. Moreover, we recently modified design of decoy and its structure, to overcome the short half life, low efficiency of uptake, and degradation by endocytosis.
Ryuichi Morishita, M.D., Ph.D., Professor, Dept. of Clinical Gene Therapy, Graduate School of Medicine, Osaka University; Founder, Board Member, Anges MG Inc., Japan
4:15 Development of New Type of Decoy Oligonucleotides Technology
The current type of NF-kB decoy oligonucleotides has been developed for treating atopic dermatitis, asthma, and rheumatoid arthritis by local administration. We have recently developed a hybrid decoy, which can be systemically administered, through its high affinity to the target molecule and low toxicity. It also can be manufactured more cost competitively. This technology can be applied to many transcription factors. Takefumi Gemba, Ph.D., Member of the Board, Corporate Officer & Vice President, Pharmaceutical Research, AnGes MG, Inc., Japan
  Featured Presentation
4:45 Proteomics with Aptamers: Biomarkers Galore
SomaLogic has developed a new class of aptamers to use as protein binders. Initial biomarker discovery experiments have been performed on arrays that measure, simultaneously, hundreds of proteins in plasma. Many biomarkers have been identified for several disease states, allowing "protein signatures" to be used for accurate diagnostics.
Larry Gold, Ph.D., CEO and Chairman, SomaLogic, Inc., USA
6:00 Networking Dinner in Tokyo
Join fellow attendees and speakers for an evening out in Tokyo. Space is limited and an additional fee applies. Please sign up by checking off the box on the registration form.
Worldwide Advances in Peptides & Diagnostics Track
7:30 Coffee and Registration
CMC Development and Optimization Strategies for Peptide-Based Therapeutics in Development
8:30 Chairperson's Remarks
Jesper Lau, Ph.D., Vice President, Diabetes Protein and Peptide Chemistry, Novo Nordisk, Denmark
  Keynote
8:45 Overview of Peptides Anti-Cancer Medicine and an Example of a G2 Checkpoint Abrogator CBP501
Hear an overview of the current peptides anti-cancer medicine. CBP501, which is a peptide G2 checkpoint abrogator under Phase 2 clinical study in the US, including concept of G2 checkpoint abrogation, mechanism of action and ADME profiles, will be discussed.
Takumi Kawabe, M.D., Ph.D., President, CanBas, Japan
9:15
CASE
STUDY
Discovery and Development of Liraglutide, the First Once-daily GLP-1 Analog
The history of GLP-1 (Glucagon-Like peptide-1) and the importance of pharmacokinetics will be reviewed. The main focus of the talk will be presentation and discussion of structures of GLP-1 analogs and the design of the once-daily human GLP-1 analog liraglutide. A brief overview of the clinical data for liraglutide will be given.
Jesper Lau, Ph.D., Vice President, Diabetes Protein and Peptide Chemistry, Novo Nordisk, Denmark
9:45 Clinical Trial Update on Hematide™, a Synthetic PEGylated Peptide ESA for the Treatment of Anemia
Hematide is a novel synthetic PEGylated peptide that acts as a potent erythropoiesis-stimulating agent (ESA). Clinical trials are underway to establish the safety and efficacy of Hematide after administration every 4 weeks in predialysis, dialysis, and PRCA patients. A summary of the Phase 2 results and design of the ongoing Phase 3 clinical trials for the treatment of anemia will be described.
Christopher P. Holmes, Ph.D., Senior Director, Chemistry, Affymax, Inc., USA
10:15 Poster and Exhibit Viewing Refreshment Break
10:45 Conformationally Constrained Peptides: Templates for Drug Design and Delivery
We have found that the introduction of αλπηα, βετα - dehydroamino acids in small peptides stabilize beta turns and helical structures in longer peptides. These design principles have been used to develop peptides with antibacterial activity and antifibril actively. Small dehydropeptides also self assembled as nanotubes and also as hydrogels. These assembled structures can be developed as delivery agents for drug like molecules.
Virander S. Chauhan, Ph.D., Director, International Centre for Genetic Engineering and Biotechnology (ICGEB), India
11:15 A Novel Production System for Recombinant Polypeptides Using Corynebacterium glutamicum
We have developed a recombinant polypeptide production system by using Corynebacterium glutamicum that is used for industrial-scale amino acids production for several decades, and demonstrated that Streptomyces mobaraensis transglutaminase and other heterologous proteins could be efficiently secreted as active form. Therefore, C. glutamicum shows a potential as a host for industrial-scale recombinant polypeptide production
Yoshimi Kikuchi, Ph. D., Associate General Manager, Life Science Laboratories, Ajinomoto Co., Inc., Japan
11:45 The Generation of Bioactive Hotspot Pharmacophores for the Treatment of Disease Indications
Antyra uses high-diversity peptide libraries to generate bioactive peptides (HotSpot Pharmacophores) as drug leads. Antyra's lead candidate, ANT-429, is an IGF-1R antagonist that is indicated in many cancers. The company has additional oncology leads as well as HPs for other disease indications. Additionally, internalizing HPs have been identified having the potential to deliver biologicals such as antisense or siRNA.
Neil I. Goldstein, Ph.D., President and CSO, Antyra Inc., USA
12:15 Networking Luncheon in Poster and Exhbit Hall
Peptide Vaccines
1:30 Chairperson's Remarks
Akira Yamada, Ph.D., Professor, Cancer Vaccine Development Division, Kurume University Research Center for Innovative Cancer Therapy, Japan
1:45 Preclinical and Clinical Studies of Combination HER-2/neu and VEGF Vaccine and Therapeutic Strategies
We have tested a safe combination of HER-2 peptide vaccine which elicits antibodies in cancer patients. We have created novel molecules based on the known crystal structures of HER-2 in complex with pertuzumab, and VEGF with Avastin and VEGFR2. We have also developed retro-inverso D-amino acid VEGF peptide mimics as an anti-angiogenic therapy. This lecture will describe our vaccine strategies
Pravin T.P. Kaumaya, Ph.D., Professor of Ob/Gyn, Director, Division of Vaccine Development, The Ohio State University, USA
2:15 Clinical Development of Personalized Cancer Peptide Vaccine
Phase 1 studies of personalized cancer peptide vaccine 1TK-1 with advanced hormone refractory prostate cancer and glioblastoma patients were completed, followed by extension studies, in Japan. The results of the studies and the development plan will be discussed.
Keizo Yoshida, Ph.D., Director, Business Development, GreenPeptide Co., Ltd, Japan
2:45 Development of Peptide-Based Vaccines for the Treatment of Renal Cell Cancer (IMA901)
IMA901 is a multiple peptide vaccine containing 10 peptides for the treatment of renal cancer (RCC). The tumor-associated peptides (TUMAPs) contained in IMA901 were identified by immatics directly from primary renal cells (= primary RCC tumor tissue samples), selected regarding their over-expression in RCC and proven to be immunogenic using in vitro T-cell assays. IMA901 is now in phase II clinical development. The development of IMA901 will be presented.
Dr. Werner Stueber, Director Manufacturing & Drug Supply, Immatics biotechnologies GmbH, Germany
3:15 Poster and Exhibit Viewing Refreshment Break - Last Chance to Visit Poster and Exhibit Hall
Worldwide Updates on Diagnostics
Chairperson: Yogesh Sanghvi, Ph.D., President, Rasayan Inc., USA
3:45 Expansion of the Genetic Alphabet by Unnatural Base Pair Systems
The creation of extra, unnatural base pairs provides new systems toward the expansion of the genetic alphabet of DNA. We developed a series of unnatural base pair systems that function in replication, transcription and/or translation. The systems enable the site-specific incorporation of new components with a functional group of interest, into nucleic acids and proteins.
Ichiro Hirao, Ph.D., Team Leader, RIKEN Systems and Structural Biology Center; President, TagCyx Biotechnologies, Japan
4:15 Update of Illumina's Genomic and Proteomic Technologies
Next-generation tools for the large-scale analysis of genetic variation and function have opened opportunities in personalized medicine and diagnostics. This presentation will update on: Oligator synthetic technology allowing economical synthesis of DNA molecules in highly parallel fashion; BeadArray technology of self assembled 2-micron silica bead chips; Genome Analyzer sequencing technology based on massively parallel sequencing; and VeraCode technology which uses digital holographic codes to provide a robust detection method for multiplexed assays.
Michal Lebl, Ph.D., D.Sc., Senior Director, Advanced Research, Illumina, Inc., USA
  Featured Presentation
4:45 Proteomics with Aptamers: Biomarkers Galore
SomaLogic has developed a new class of aptamers to use as protein binders. Initial biomarker discovery experiments have been performed on arrays that measure, simultaneously, hundreds of proteins in plasma. Many biomarkers have been identified for several disease states, allowing "protein signatures" to be used for accurate diagnostics.
Larry Gold, Ph.D., CEO and Chairman, SomaLogic, Inc., USA
6:00 Networking Dinner in Tokyo
Join fellow attendees and speakers for an evening out in Tokyo. Space is limited and an additional fee applies. Please sign up by checking off the box on the registration form.
Main Conference - Day Three
Wednesday, February 25, 2009
| PRE-CONFERENCE TUTORIALS | DAY ONE | DAY TWO | DAY THREE |
Market Landscape and Investment Opportunities
8:30 Co-Chairpersons' Remarks
Gary Carter, MMR, Business Development Manager, Nucleic Acid Solutions Division, Agilent Technologies, Inc., USA
Michael S. Verlander, D. Phil., Executive Vice President, PolyPeptide Laboratories, Inc., USA and India
8:45 The Oligo Therapeutics and Diagnostics Market Landscape - Innovative Technologies Lead to Rapid Growth
New technologies have driven rapid growth in the number of oligo therapeutic programs in development. A detailed view of these programs will be presented with a focus on the rapidly growing siRNA and miRNA areas. For the oligo diagnostics market a breakdown of revenues by indication and key competitors and a review of recent mergers and acquisitions will be presented.
Gary Carter, MMR, Business Development Manager, Nucleic Acid Solutions Division, Agilent Technologies, Inc., USA
9:15 Update on Peptide Market Landscape
The market for peptide therapeutics continues to expand worldwide and an increasing number of peptide drug candidates are in late stage clinical development. This is largely due to advances in manufacturing technologies, the current status of which will be reviewed. Experience with the construction of a manufacturing facility in India will also be presented.
Michael S. Verlander, D. Phil., Executive Vice President, PolyPeptide Laboratories, Inc., USA and India
9:45 Recent Trends in the Breadth of Claim Coverage of Patents Directed to Nucleotides and Peptides
As molecular biology continues to advance, patent applications for the protection of inventions in this field have increased. Patents have been issued carving out large scopes precluding future applicants, and patent authorities have become more experienced with handling applications covering these technologies. The result is evolution of the scope of patent claims in relation to disclosure.
Erika Takeuchi, Ph.D., J.D., Attorney, Ropes and Gray LLP, Japan
10:15 Networking Refreshment Break
10:45 NonGMP to GMP Scale-Up Strategy and Procedures
Development of therapeutic peptide products requires a scale-up strategy and nonGMP to GMP manufacturing procedure. Contract manufacturing organizations (CMOs) often play a key role in this area. This presentation discusses the scale-up strategy, guidelines and procedures used by pharmaceutical manufacturing to ensure that they can consistently make peptide active pharmaceutical ingredient (API) that meets quality specifications.
J.J. Jiang, Ph.D., Vice President, GMP Manufacturing, American Peptide Co., Inc., USA
  Audience Interactive Panel Discussion
11:15 Preparing and Managing a Supply Chain for Oligonucleotide and Peptide Therapeutics

Co-Moderators:
David Konys, Vice President, Manufacturing Operations, Alnylam Pharmaceuticals, USA
Qiang Ye, Ph.D., Associate Director, Product Development, Amylin Pharmaceuticals, Inc., USA
Panelists:
Chris Bai, President & CEO, AmbioPharm, Inc., USA
Kris S. Choi, General Manager, Marketing & Business Development, Samchully Pharmaceutical Co., Ltd., Korea
Ahmad Hasan, Ph.D., Director, Manufacturing & Process Development, Thermo Scientific Genomics, (representing Nucleic Acids Technologies), USA
Shawn Lee, Ph.D., President and CEO, CPC Scientific, USA and China
Stacie Schroeder, Vice President, Sales, Bachem Americas, USA
Dr. Andreas Wolter, Managing Director, Sigma-Aldrich Biochemie GmbH, Germany
Additional panelists to be announced

Ask your questions to the panelists who will address topics including:

  • Raw material supply chain and partnership with vendors
  • Role / necessity of quality agreements with vendors of critical raw materials
  • Customer supplied raw materials vs. commercial suppliers
  • Adherence to viral safety compliance
  • Monitoring quality, quantity and cost
  • Established vs. emerging suppliers - implications
  • Aligning product clinical phase with necessary/recommended regulatory controls over supply chain
11:45 Technology Workshop
IBC's Technology workshops offer supplier and service companies the opportunities to present product and service offers directly to the audience at the conference. For more information on presenting a technology workshop at this meeting, please contact:
Asia: Catherine Wong, Phone: 65-6835-5128, email: catherine.wong@ibcasia.com.sg
US/Europe: Sherry Johnson, Phone: +1-508-614-1451, email: sjohnson@ibcusa.com
12:15 Networking Luncheon
1:30 Investment and Licensing Opportunities: Start-Up Showcase
Four emerging drug development and technology companies will give 15-minute updates on their business plan, technology, and partnering objectives.
Moderator: Gary Carter, MMR, Business Development Manager, Nucleic Acid Solutions Division, Agilent Technologies, Inc., USA
For more information on how to present in the start-up showcase, please see the guidelines.
  Early confirmed presenter:
DNA Therapeutics Develops a New Concept in Cancer Therapy via Targeting to DNA Double Stand Break Repair by Signal Interfering DNA (siDNA)
We designed and synthesized signal interfering DNA (siDNA) that mimic DNA double-strand breaks to hijack the repair complex far from its cognate substrate, damaged DNA on chromosomes. This work provides evidence to support a DNA repair mechanism-targeting approach for an innovative cancer treatment by a new class of oligonucleotide-based therapeutics.
Prof. Jian-Sheng Sun, CEO, DNA Therapeutics SA, France
2:30 Networking Business Card Exchange with Refreshments
Regulatory Updates
3:00 Chairperson's Remarks
G. Susan Srivatsa, Ph.D., President, ElixinPharma, USA
3:15 Review of Oligonucleotide Products by US and European Regulatory Agencies: An Industry Perspective
The complex and diverse nature of oligonucleotides currently in development (antisense, aptamers, DNA decoys, siRNA, etc.) is posing unprecedented challenges in meeting the regulatory requirements for drug quality. This presentation provides a historical overview and evolution of the US and European regulatory agencies' review practices of such oligonucleotide products. Also highlighted are emerging trends in the industry to meet current expectations for the characterization and quality control of oligonucleotide drug candidates entering clinical development.
G. Susan Srivatsa, Ph.D., President, ElixinPharma, USA
3:45 International Experience with Peptide-Based Therapeutics
The number of peptides used in clinical trials or approved for marketing continues to increase. Those peptide Active Pharmaceutical Ingredients (API) must be manufactured under cGMP regulations. This presentation will highlight the typical specification of peptide drug substance and CMC components and development. In addition to the GMP requirement per FDA CFR 210 and 211, relevant ICH guidance will be reviewed.
Shawn Lee, Ph.D., President and CEO, CPC Scientific, USA and China
4:15 Regulatory Requirements for Diagnostic Oligo Manufacturing: The Value of GMP Compliance
Oligonucleotides are critical components of molecular diagnostic assays. Assay performance will vary with variations in oligo quality. Consistent performance is assured when oligos are produced following Good Manufacturing Practices in compliance with the requirements of FDA's QSR (21CFR820) and IVD Directive 98/79 EEC. This presentation will discuss the value of GMP compliance from regulatory, quality, risk management, and financial perspectives.
Peter Haima, Ph.D., Manager IVD Services, Eurogentec S.A., Belgium
4:45 Close of Asia TIDES

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