Drug & Biologics Japan
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Main Conference: Monday | Main Conference: Tuesday | Main Conference: Wednesday | Add-On
Main Conference - Plenary Session
8:50
Chairperson's Opening Remarks
Eiichi Yamaguchi, M.S. Pharm., CA-AM, Head of Licensing, General Manager, Corporate Planning and Business Development Department, Shionogi & Co., Ltd.
Eiichi Yamaguchi, M.S. Pharm., CA-AM, Head of Licensing, General Manager, Corporate Planning and Business Development Department, Shionogi & Co., Ltd.
Keynote Presentations
9:00
Leadership in Challenging Times - Current and Future Strategies for the Japanese Pharmaceutical IndustryJapan has been a miracle country with its population's remarkable longevity with only 8% medical care spending out of the GDP. But this status quo has been fading away. There are four major challenges against medical care reform. First, the rapid increase of medical care spending by a fast growing elderly population. Second, discovering how to create innovative drugs to meet unmet medical needs. Third, how to promote generic drugs and fourth, how to resolve the drug lags to US/EU. What are the important and effective medical reforms needed for patients and what are the key success factors for the Japanese pharmaceutical firms for future growth? These topics will be discussed through the presentation.
Norikazu Eiki, Chairman of the Management Board, Bayer Yakuhin, Ltd., Japan
9:50
Open Innovation - The Way Forward for Next Generation Innovation DrugsJohnson & Johnson is reinventing innovation to spur entrepreneurship and capitalize on the information-empowered age in which we live. In this presentation, we will discuss Johnson & Johnson's open innovation model, which bridges gaps between inspiration and implementation and embraces collaborations across institutions and geographies in the search for new and effective health care solutions for patients.
Joanne Waldstreicher, M.D., Chief Medical Officer, Pharmaceuticals Group, Johnson & Johnson, USA
10:30
Networking Refreshment Break with Poster and Exhibit Viewing
Innovation in Japan - Is it Still Alive? Strategies for Open Innovation to Enhance Productivity and Creativity
Featured Presentation
11:00
Presentation in Japanese
with slides in English.
Transforming Ideas into Innovation - Taking Ideas from Pharmacological Concepts to POCwith slides in English.
Japan's system for innovation has performed weakly for bioventures and pharmaceutical collaborations, but the flow of technologies and ideas generated within academia to industry is also very poor. A new approach for the transfer of promising technologies and drug candidates to pharmaceutical companies and amended system by which they may be connected will be introduced.
Tsuneaki Sakata, Ph.D., Deputy General Manager/ Visiting Professor, Strategic Planning/Cybermedia Center, Shionogi & Co., Ltd. / Osaka University, Japan
11:30
Genome Science Brings Business Innovation to Land of the Rising Sun
Most of scientific outcomes in the field of biotechnology have come to Japan, but the Japanese system is not suitable to challenge something brand-new. However, the system works well once any science is recognized to be ready for commercialization. Genome science and RNAi are innovations in terms of approach to drug discovery and development. This presentation will showcase our experiences on innovative approaches for RNAi drug, mAb, small molecule drugs and diagnostics
Yukikazu Natori, MSc., Professor, Graduate School of Science & Engineering, Tokyo Institute of Technology, Japan
Most of scientific outcomes in the field of biotechnology have come to Japan, but the Japanese system is not suitable to challenge something brand-new. However, the system works well once any science is recognized to be ready for commercialization. Genome science and RNAi are innovations in terms of approach to drug discovery and development. This presentation will showcase our experiences on innovative approaches for RNAi drug, mAb, small molecule drugs and diagnostics
Yukikazu Natori, MSc., Professor, Graduate School of Science & Engineering, Tokyo Institute of Technology, Japan
12:00
Learning from the Innovation Strategies of Emerging Asian Countries
Drying pipelines and lack of efficacy at terminal clinical stages are a real concern to the pharmaceutical industry. An increasing number of generic development and approvals to invade international market is a potential threat to market leaders. With most of the drugs going off patent the life cycle management is being achieved by way of patenting formulations, processes, technology and even the blood level profile. The future obviously is focused on biosimilars, recombinant, gene regulators and safer chemicals. The drug industry in other countries of Asia (especially India, China, Korea etc.) are managing by way of formulation innovations, fixed dose combinations and utilizing technologies (nano, liposomes, targeted therapy, NDDS). The entry of generic formulations to Japan's market is still a difficult process yet this reality may help the companies to focus more on the basic research for new drugs and challenging therapeutic areas.
Ashok Omray, Ph.D., Associate Vice President, Drug Delivery Research, USV Limited, India
Drying pipelines and lack of efficacy at terminal clinical stages are a real concern to the pharmaceutical industry. An increasing number of generic development and approvals to invade international market is a potential threat to market leaders. With most of the drugs going off patent the life cycle management is being achieved by way of patenting formulations, processes, technology and even the blood level profile. The future obviously is focused on biosimilars, recombinant, gene regulators and safer chemicals. The drug industry in other countries of Asia (especially India, China, Korea etc.) are managing by way of formulation innovations, fixed dose combinations and utilizing technologies (nano, liposomes, targeted therapy, NDDS). The entry of generic formulations to Japan's market is still a difficult process yet this reality may help the companies to focus more on the basic research for new drugs and challenging therapeutic areas.
Ashok Omray, Ph.D., Associate Vice President, Drug Delivery Research, USV Limited, India
12:30
Networking Luncheon with Poster & Exhibit Viewing
Main Conference - Concurrent Sessions
Your registration allows switching between sessions. Bring a colleague. Group/Team discounts available.
Next Generation Biologics
1:50
Chairperson's Opening Remarks
Akihiko Watanabe, Ph.D., Associate Director, External Relations, Kyowa Hakko Kirin Co., Ltd., Japan
Akihiko Watanabe, Ph.D., Associate Director, External Relations, Kyowa Hakko Kirin Co., Ltd., Japan
Featured Presentation
2:00
Genome-based Antibody Drug Development: Introduction of a Japanese Government Project
From the year 2001, we have systematically established monoclonal antibodies against more than 500 human target proteins, which include all nuclear hormone receptors, many GPCRs and cancer associated proteins. These antibodies are used as diagnostics, therapeutics, and PET imaging probes. We will summarize recent development in this project.
Prof Tatsuhiko Kodama, M.D., Ph.D., Professor, Research Center for Advanced Science & Technology, The University of Tokyo, Japan
From the year 2001, we have systematically established monoclonal antibodies against more than 500 human target proteins, which include all nuclear hormone receptors, many GPCRs and cancer associated proteins. These antibodies are used as diagnostics, therapeutics, and PET imaging probes. We will summarize recent development in this project.
Prof Tatsuhiko Kodama, M.D., Ph.D., Professor, Research Center for Advanced Science & Technology, The University of Tokyo, Japan
Alternative Scaffolds
2:30
Anticalins®, A Unique Class of Binding Proteins, and Their Use as Therapeutics
Anticalins, which are derived from human lipocalins, are small 20kDa proteins with highly selective binding properties. The first clinical candidate PRS-050 (VEGF antagonist) is about to enter the clinic. Unique features such as the ability to antagonize therapeutically relevant hapten targets will be presented and come along with the broad formulation and formatting flexibility of Anticalins.
Kristian H. Jensen, Chief Operating Officer, Pieris AG, Germany
Anticalins, which are derived from human lipocalins, are small 20kDa proteins with highly selective binding properties. The first clinical candidate PRS-050 (VEGF antagonist) is about to enter the clinic. Unique features such as the ability to antagonize therapeutically relevant hapten targets will be presented and come along with the broad formulation and formatting flexibility of Anticalins.
Kristian H. Jensen, Chief Operating Officer, Pieris AG, Germany
3:00
The SH3 Domain of Fyn Kinase as a Scaffold for the Generation of New Binding Proteins
We show that the fully human Fyn SH3 domain represents a useful protein scaffold for the generation of new binding proteins called Fynomers. The single-pot Fyn SH3 library is a rich source of Fynomers binding with high affinity and specificity to a broad range of targets, thus providing useful reagents for many biochemical and biomedical applications as an alternative to more conventional IgG-based immunochemical technologies. We present experiments illustrating the usefulness and versatility of our Fynomer therapeutic platform.
Dragan Grabulovski, Ph.D., Chief Scientific Officer, Covagen AG, Switzerland
We show that the fully human Fyn SH3 domain represents a useful protein scaffold for the generation of new binding proteins called Fynomers. The single-pot Fyn SH3 library is a rich source of Fynomers binding with high affinity and specificity to a broad range of targets, thus providing useful reagents for many biochemical and biomedical applications as an alternative to more conventional IgG-based immunochemical technologies. We present experiments illustrating the usefulness and versatility of our Fynomer therapeutic platform.
Dragan Grabulovski, Ph.D., Chief Scientific Officer, Covagen AG, Switzerland
3:30
Networking Refreshment Break with Poster & Exhibit Viewing
4:00
Phylomer Libraries as A Rich Source of Potent Peptides for Therapeutic Development
Phylomers are a new class of peptide derived from biodiverse genomic fragments of archael and bacterial species. Phylomer peptide libraries can exhibit a superior quality and quantity of candidates, due to an evolutionary selection for stable structures compatible with target proteins. Phylomers have been identified with potent antimicrobial activity against clinical isolates of multidrug resistant microorganisms. In addition, potent blockers of the pro-inflammatory target CD40Ligand have been isolated with picomolar primary affinities, even before any sequence maturation.
Richard Hopkins, Ph.D., Vice President, Research, Phylogica Ltd., Australia
Phylomers are a new class of peptide derived from biodiverse genomic fragments of archael and bacterial species. Phylomer peptide libraries can exhibit a superior quality and quantity of candidates, due to an evolutionary selection for stable structures compatible with target proteins. Phylomers have been identified with potent antimicrobial activity against clinical isolates of multidrug resistant microorganisms. In addition, potent blockers of the pro-inflammatory target CD40Ligand have been isolated with picomolar primary affinities, even before any sequence maturation.
Richard Hopkins, Ph.D., Vice President, Research, Phylogica Ltd., Australia
4:30
Peptides Modulating Conformational Changes in Secreted Chaperones: from In Silico Design to Preclinical Proof of Concept
Using a computational approach, we designed peptides that modulate conformational changes in proteins known to shift between inactive and active conformations. This talk will describe the design of a peptide that targets gp96, and its validation in disease models of inflammation.
Yossef Kliger, Ph.D., Project Leader and Senior Scientist, Compugen Ltd., Israel
Using a computational approach, we designed peptides that modulate conformational changes in proteins known to shift between inactive and active conformations. This talk will describe the design of a peptide that targets gp96, and its validation in disease models of inflammation.
Yossef Kliger, Ph.D., Project Leader and Senior Scientist, Compugen Ltd., Israel
5:00
Design and Clinical Application of Fusion Proteins for the Treatment of Solid Cancers
Immunotoxins combine the precision targeting of an antibody fragment with a powerful cytotoxin. VB4-845 and VB6-845, anti-EpCAM antibody fragments genetically-linked to a toxin, have been designed for loco-regional and systemic delivery strategies against solid cancers, respectively. Our clinical trial experience to-date illustrating the utility of these constructs is presented.
Glen MacDonald, Ph.D., Chief Scientific Officer and VP, Operations, Viventia Biotechnologies Inc., USA
Immunotoxins combine the precision targeting of an antibody fragment with a powerful cytotoxin. VB4-845 and VB6-845, anti-EpCAM antibody fragments genetically-linked to a toxin, have been designed for loco-regional and systemic delivery strategies against solid cancers, respectively. Our clinical trial experience to-date illustrating the utility of these constructs is presented.
Glen MacDonald, Ph.D., Chief Scientific Officer and VP, Operations, Viventia Biotechnologies Inc., USA
5:30
Networking Cocktail Reception with Poster & Exhibit Viewing
Personalized Medicine & Biomarker Strategies
1:50
Chairperson's Opening Remarks
Osamu Sato, Ph.D., Director, Head of Medical Writing Group, Clinical Data & Biostatistics Dept, R&D Division, Daiichi Sankyo Co., Ltd., Japan
Osamu Sato, Ph.D., Director, Head of Medical Writing Group, Clinical Data & Biostatistics Dept, R&D Division, Daiichi Sankyo Co., Ltd., Japan
2:00
Implementing Personalized Healthcare: Challenges and Opportunities of Pharmacogenetics in Drug Development
One of the most exciting questions in drug development today is how far the science of pharmacogenetics can be used to address the fundamental issues that the pharmaceutical industry is facing. In particular, the question of how far it is possible to use this emerging science to deliver the right treatment, to the right patient, at the right dose, at the right time is both the challenge and opportunity of using pharmacogenetics in drug development. This talk will address these questions with several real-life examples from AstraZeneca.
Hiroshi Katayama, Ph.D., Senior Scientist, Member of AstraZeneca's Personalised Healthcare Team, AstraZeneca K.K., Japan
One of the most exciting questions in drug development today is how far the science of pharmacogenetics can be used to address the fundamental issues that the pharmaceutical industry is facing. In particular, the question of how far it is possible to use this emerging science to deliver the right treatment, to the right patient, at the right dose, at the right time is both the challenge and opportunity of using pharmacogenetics in drug development. This talk will address these questions with several real-life examples from AstraZeneca.
Hiroshi Katayama, Ph.D., Senior Scientist, Member of AstraZeneca's Personalised Healthcare Team, AstraZeneca K.K., Japan
2:30
Presentation in Japanese
with slides in English.
Co-Development of Therapeutics and Diagnostic Agentwith slides in English.
The FDA and EMEA already set up a Biomarker Qualification Meeting. The PMDA in Japan held a similar meeting in April 2009. Their common and primary objectives are promotion and coordination of co-development of drugs and diagnostics using pharmacogenomics and/or biomarkers. The Invader UGT1A1 assay, which was developed earlier, is a typical example of such co-development. In this presentation, we will discuss the importance of the co-developed based upon our experience.
Atsuo Mori, Ph.D., Group Manager of Molecular Diagnostics, R&D Division, Sekisui Medical Co. Ltd., Japan
Sponsored Presentation
3:00
KINAXO's phosphoproteomics platform "PhosphoScout" enables the identification of regulated protein phosphorylation sites in response to therapeutic antibody or kinase inhibitor treatment. Using state-of-the-art quantitative mass spectrometry upt o 15,000 phosphorylation sites can be monitored in a single experiment thereby facilitating the analysis of the phosphoproteome in patient samples and animal models on a global scale. This makes "PhosphoScout" an emerging technology for drug mode of action analysis and the stratification of cancer patients receiving targeted therapies.
Andreas Jenne, Ph.D., Chief Executive Officer, KINAXO, Germany
3:30
Networking Refreshment Break with Poster & Exhibit Viewing
4:00
Stratified Medicine: A Rational Drug Development and Treatment Paradigm
In the not distant future, regulatory agencies and healthcare providers are expected to embrace the "pay for performance" model such that therapies are expected not only to be efficacious but also to have acceptable safety and toxicity profiles in each patient. As a case study, this presentation will examine the mAb space and address the critical issues related to drug development, regulatory protocols, and treatment procedures in the area of stratified medicine. In addition, this presentation will explore strategies for building an effective intellectual property portfolio in this area.
Vijay Ramakrishnan, Ph.D., Founder & CEO, PIKAMAB, Inc, USA
Janet M. McNicholas, Ph.D., Partner, K&L Gates LLP, USA
In the not distant future, regulatory agencies and healthcare providers are expected to embrace the "pay for performance" model such that therapies are expected not only to be efficacious but also to have acceptable safety and toxicity profiles in each patient. As a case study, this presentation will examine the mAb space and address the critical issues related to drug development, regulatory protocols, and treatment procedures in the area of stratified medicine. In addition, this presentation will explore strategies for building an effective intellectual property portfolio in this area.
Vijay Ramakrishnan, Ph.D., Founder & CEO, PIKAMAB, Inc, USA
Janet M. McNicholas, Ph.D., Partner, K&L Gates LLP, USA
4:30
Presentation in Japanese
with slides in English.
Chemical Screening of Circadian Clock and Personalized Medicine by Metabolomicswith slides in English.
Dysregulation of circadian clock is associated with the onset and development of some human diseases, including sleep disorders. We identified one of the most potent period-determining processes in the clock by the chemical-biological approach. Our new knowledge will give useful information for the development of drugs that regulate circadian clock.
Hideki Ukai, Ph.D., Research Scientist, Laboratory for Systems Biology, Center for Developmental Biology, RIKEN Kobe Institute, Japan
5:00
Discovery and Validation of Therapeutically Relevant Oncology Biomarkers: HRP Approach and Genetically Defined Mouse Models
New approaches in genetically engineered models have shown great promise to capture the complexity of genomic changes seen in cancer. We have generated a population-based Human Response Prediction (HRP) approach featuring natural occurring variation in tumors derived from genetically defined mouse models of cancer. This HRP approach enables us to identify and validate biomarkers of therapeutic response in an in-vivo model.
Joerg Heyer, Ph.D., Director, Genetic Models, Translational Research, AVEO Pharmaceuticals, USA
New approaches in genetically engineered models have shown great promise to capture the complexity of genomic changes seen in cancer. We have generated a population-based Human Response Prediction (HRP) approach featuring natural occurring variation in tumors derived from genetically defined mouse models of cancer. This HRP approach enables us to identify and validate biomarkers of therapeutic response in an in-vivo model.
Joerg Heyer, Ph.D., Director, Genetic Models, Translational Research, AVEO Pharmaceuticals, USA
5:30
Networking Cocktail Reception with Poster & Exhibit Viewing
Main Conference: Monday | Main Conference: Tuesday | Main Conference: Wednesday | Add-On
Main Conference - Concurrent Sessions
Next Generation Biologics
8:30
Chairperson's Opening Remarks
Robert Lutz, Ph.D., Executive Director, Preclinical Development, ImmunoGen, Inc., USA
Robert Lutz, Ph.D., Executive Director, Preclinical Development, ImmunoGen, Inc., USA
Antibody-Drug Conjugates
8:45
Antibody-Cytotoxic Agent Conjugates for the Treatment of Cancer
ImmunoGen uses its Targeted Antibody Payload (TAP) technology to create novel oncology drugs by covalently linking proprietary small molecule cytotoxic agents to tumor-targeting mAbs. Advancements including new linkers designed to overcome multi-drug resistance, new effector molecules to tailor mechanism of action to tumor cell sensitivities, and a clinical update for the most advanced TAPs will be discussed.
Robert Lutz, Ph.D., Executive Director, Preclinical Development, ImmunoGen, Inc., USA
ImmunoGen uses its Targeted Antibody Payload (TAP) technology to create novel oncology drugs by covalently linking proprietary small molecule cytotoxic agents to tumor-targeting mAbs. Advancements including new linkers designed to overcome multi-drug resistance, new effector molecules to tailor mechanism of action to tumor cell sensitivities, and a clinical update for the most advanced TAPs will be discussed.
Robert Lutz, Ph.D., Executive Director, Preclinical Development, ImmunoGen, Inc., USA
9:15
Development of Antibody-Drug Conjugates Targeting Novel Cancer Targets
Abstract not available at time of print.
Aya Jakobovits, Ph.D., Executive Vice President and Head, R&D, Agensys, Inc., USA, a subsidiary of Astellas Pharma, Inc.
Abstract not available at time of print.
Aya Jakobovits, Ph.D., Executive Vice President and Head, R&D, Agensys, Inc., USA, a subsidiary of Astellas Pharma, Inc.
9:45
Arming Antibodies for Cancer Therapy
Highly potent cytotoxic agents are appended to antibodies using a variety of linkers. Preclinical research, involving target identification, antibody generation, modification of antibodies with drugs and their performance in efficacy and safety models will be discussed.
Paul Polakis, Ph.D., Director, Cancer Targets, Genentech, Inc., USA
Highly potent cytotoxic agents are appended to antibodies using a variety of linkers. Preclinical research, involving target identification, antibody generation, modification of antibodies with drugs and their performance in efficacy and safety models will be discussed.
Paul Polakis, Ph.D., Director, Cancer Targets, Genentech, Inc., USA
10:15
Networking Refreshment Break with Poster & Exhibit Viewing
10:45
Next Generation Anti-Cancer Biologics with Multi-Functional Targeted Payload
Monoclonal antibodies and chemotherapy combination treatment have become a clear choice to treat cancer by means of targeting cytotoxicity, modulating growth pathways and angiogenesis. A strategy to target several anti-tumor functions by a single biotherapeutic will be discussed.
Sanjay Khare, Ph.D., President, R&D, ImmunGene, Inc., USA
Monoclonal antibodies and chemotherapy combination treatment have become a clear choice to treat cancer by means of targeting cytotoxicity, modulating growth pathways and angiogenesis. A strategy to target several anti-tumor functions by a single biotherapeutic will be discussed.
Sanjay Khare, Ph.D., President, R&D, ImmunGene, Inc., USA
Immunogenicity Assessment
11:15
Preclinical Assessment and Minimization of Immunogenicity
- Immunogenicity drivers
- Regulatory guidelines: latest developments
- Strategies for preclinical immunogenicity assessment
- Lead selection and optimization
- Selected case studies
11:45
Immunogenicity Assessment of Therapeutic Biologics for Molecular Selection & Optimization and for Drug Efficacy & Safety Evaluation - Case Studies
Immunogenicity assessment helps the selection and optimization of the molecular candidates. It is also critical for the evaluation of efficacy and safety of the therapeutics during the preclinical and clinical development. Here we introduce our strategies of immunogenicity assessment during various stages of drug development using ligand-binding assays, biosensors, and biological assays.
Shaoxiong Wang, Ph.D., Senior Director, R&D, Genor Biopharma, Wison Group, China
Immunogenicity assessment helps the selection and optimization of the molecular candidates. It is also critical for the evaluation of efficacy and safety of the therapeutics during the preclinical and clinical development. Here we introduce our strategies of immunogenicity assessment during various stages of drug development using ligand-binding assays, biosensors, and biological assays.
Shaoxiong Wang, Ph.D., Senior Director, R&D, Genor Biopharma, Wison Group, China
Clinical Updates
12:15
Clinical Development of Recombinant Human HGF for Unmet Medical Needs
Kringle Pharma is a clinical-stage biopharmaceutical company established in 2001 as a spin-off venture from Osaka University in Japan. Our primary pipeline is recombinant human hepatocyte growth factor (HGF) for the following unmet medical needs: 1) skin ulcers, 2) renal failure and 3) ALS and spinal cord injury. The recent progress in the clinical development will be presented.
Kiichi Adachi, Ph.D., Executive VP, Kringle Pharma, Japan
Kringle Pharma is a clinical-stage biopharmaceutical company established in 2001 as a spin-off venture from Osaka University in Japan. Our primary pipeline is recombinant human hepatocyte growth factor (HGF) for the following unmet medical needs: 1) skin ulcers, 2) renal failure and 3) ALS and spinal cord injury. The recent progress in the clinical development will be presented.
Kiichi Adachi, Ph.D., Executive VP, Kringle Pharma, Japan
12:45
Networking Luncheon with Poster & Exhibit Viewing
Bi-Specific and Multi-Specific Antibodies
2:00
Development of the anti-IGF-IR Antibody Figitumumab
Figitumumab (CP-751,817) is a fully human IgG2 monoclonal antibody highly potent and specific against the Insulin-Like Growth Factor Type 1 Receptor (IGF-IR). Updates on the Figitumumab development program, predictive biomarkers currently employed, and the rationale for further testing of this agent in oncology will be presented.
Antonio Gualberto, M.D., Ph.D., Global Lead Clinician- Figitumumab, Oncology, Pfizer Inc., USA
Figitumumab (CP-751,817) is a fully human IgG2 monoclonal antibody highly potent and specific against the Insulin-Like Growth Factor Type 1 Receptor (IGF-IR). Updates on the Figitumumab development program, predictive biomarkers currently employed, and the rationale for further testing of this agent in oncology will be presented.
Antonio Gualberto, M.D., Ph.D., Global Lead Clinician- Figitumumab, Oncology, Pfizer Inc., USA
2:30
Application of Stable Dual-Affinity Re-Targeting (DART) for Effective Tumor Cytolysis by NK and T Cells In Vivo
Highly potent, disulfide stabilized, bispecific proteins called DART (Dual-Affinity Re-Targeting) are expressed at high levels in mammalian cells and fit into standard mAb platforms for downstream processing. In vitro and in vivo studies have demonstrated that DART proteins exhibit remarkable potency and stability, comparing favorably with other bispecific formats. Fc-containing versions have increased avidity and half-life. DART proteins that target tumor cells for highly potent re-directed killing by T or NK cells have been used to demonstrate effective B-cell depletion in vivo and efficacy in tumor xenograft models using FcR transgenic and PMBC reconstituted mice.
Syd Johnson, Ph.D., Vice President, Antibody Engineering, MacroGenics, Inc., USA
Highly potent, disulfide stabilized, bispecific proteins called DART (Dual-Affinity Re-Targeting) are expressed at high levels in mammalian cells and fit into standard mAb platforms for downstream processing. In vitro and in vivo studies have demonstrated that DART proteins exhibit remarkable potency and stability, comparing favorably with other bispecific formats. Fc-containing versions have increased avidity and half-life. DART proteins that target tumor cells for highly potent re-directed killing by T or NK cells have been used to demonstrate effective B-cell depletion in vivo and efficacy in tumor xenograft models using FcR transgenic and PMBC reconstituted mice.
Syd Johnson, Ph.D., Vice President, Antibody Engineering, MacroGenics, Inc., USA
3:00
Developing Next Generation Biologic Therapies Using Dual Variable Domain Immunoglobulin
Abstract not available at time of print.
W. Blaine Stine, Ph.D., Research Investigator, Abbott BioResearch Center, USA
Abstract not available at time of print.
W. Blaine Stine, Ph.D., Research Investigator, Abbott BioResearch Center, USA
3:30
Networking Refreshment Break with Poster & Exhibit Viewing
Developments in Stem Cell Science & Therapeutics Applications
8:30
Chairperson's Opening Remarks
Chikafumi Yokoyama, Ph.D., CEO, ReproCELL Inc., Japan
Chikafumi Yokoyama, Ph.D., CEO, ReproCELL Inc., Japan
ES Cells
8:45
Featured PresentationHuman Embryonic Stem Cell Therapy: Pathway to the Clinic
Geron Corporation is the world leader in developing human embryonic stem cell therapies. We received FDA clearance in January 2009 to initiate the world's first human clinical trial of an embryonic stem cell-based therapy in acute spinal cord injury. We will present a summary of the preclinical IND-enabling animal and in vitro work leading up to this clearance, and a discussion of the ongoing clinical protocol.
Thomas Okarma, M.D., Ph.D., President & CEO, Geron Corporation, USA
Geron Corporation is the world leader in developing human embryonic stem cell therapies. We received FDA clearance in January 2009 to initiate the world's first human clinical trial of an embryonic stem cell-based therapy in acute spinal cord injury. We will present a summary of the preclinical IND-enabling animal and in vitro work leading up to this clearance, and a discussion of the ongoing clinical protocol.
Thomas Okarma, M.D., Ph.D., President & CEO, Geron Corporation, USA
9:15
Open Chromatin and Pluripotency in ES Cells
An open chromatin largely devoid of heterochromatin is a hallmark of ES cells. Using an RNAi screen for novel regulators of pluripotency, we found a highly expressed chromatin remodeler Chd1, that is required to maintain the open chromatin state of mouse ES cells. Moreover, Chd1 is also necessary for ES cell pluripotency. We further show that Chd1 is important in the context of induced reprogramming, to form iPS cells.
Alexandre Gaspar-Maia, Eli and Edythe Broad Center, UCSF (USA)/ University of Coimbra, Portugal
An open chromatin largely devoid of heterochromatin is a hallmark of ES cells. Using an RNAi screen for novel regulators of pluripotency, we found a highly expressed chromatin remodeler Chd1, that is required to maintain the open chromatin state of mouse ES cells. Moreover, Chd1 is also necessary for ES cell pluripotency. We further show that Chd1 is important in the context of induced reprogramming, to form iPS cells.
Alexandre Gaspar-Maia, Eli and Edythe Broad Center, UCSF (USA)/ University of Coimbra, Portugal
Epigenetics and Stem Cells
9:45
Stem Cells as the Cause and Cure Of Diseases
From the standpoint of clinical applications, a stem cell has the two different features; the cause and cure of diseases. Epigenetic vulnerability of a stem cell is the root cause of chronic diseases. This feature also limits the standardization of cell based medicine. This talk will discuss the basic problem underlying the stem cell technology from the viewpoint of epigenetics.
Kazuhiro Sakurada, Ph.D., Senior Researcher, Sony Computer Science Laboratories, Inc., Japan
From the standpoint of clinical applications, a stem cell has the two different features; the cause and cure of diseases. Epigenetic vulnerability of a stem cell is the root cause of chronic diseases. This feature also limits the standardization of cell based medicine. This talk will discuss the basic problem underlying the stem cell technology from the viewpoint of epigenetics.
Kazuhiro Sakurada, Ph.D., Senior Researcher, Sony Computer Science Laboratories, Inc., Japan
10:15
Networking Refreshment Break with Poster & Exhibit Viewing
iPS Cells
10:45
Generation of Functional Organs from iPSCs
We have developed an in vivo method to generate an organ using mutant mice in which development of a certain organ is genetically precluded. Injection of iPSCs into Sall1-/- blastocysts for kidney and Pdx1-/- blastocysts for pancreas, in both models, defective cells were totally replaced and kidneys and pancreas were formed almost entirely by injected iPSC-derived cells.
Hiromitsu Nakauchi, M.D., Ph.D., Professor and Director, Division of Stem Cell Therapy, Center for Stem Cell Biology and Regenerative Medicine, Institute of Medical Science, University of Tokyo; and Japan Science Technology Agency, ERATO, Nakauchi Stem Cell and Organ Regeneration Project, Japan
We have developed an in vivo method to generate an organ using mutant mice in which development of a certain organ is genetically precluded. Injection of iPSCs into Sall1-/- blastocysts for kidney and Pdx1-/- blastocysts for pancreas, in both models, defective cells were totally replaced and kidneys and pancreas were formed almost entirely by injected iPSC-derived cells.
Hiromitsu Nakauchi, M.D., Ph.D., Professor and Director, Division of Stem Cell Therapy, Center for Stem Cell Biology and Regenerative Medicine, Institute of Medical Science, University of Tokyo; and Japan Science Technology Agency, ERATO, Nakauchi Stem Cell and Organ Regeneration Project, Japan
11:15
Presentation in Japanese
with slides in English.
A Marker for the Tumor Transformation of Human Induced Pluripotent Stem Cellswith slides in English.
Though researchers try to find marker for tumor transformation of human induced pluripotent stem (iPS) cells by using human iPS cells, they fail to find it. However, we could understand that maintaining higher expressions of p21 than p53 was necessary in order to prevent the tumor transformation of the cells.
Hisashi Moriguchi , MPH, Ph.D., Professor, Research Center for Advanced Science and Technology, The University of Tokyo, Japan
11:45
Generating Feeder-Free iPS Cells, Their Characterization and Differentiation to Neuronal Pathways for Modeling Parkinson's and Alzheimer's Diseases
Here we report the first generation of feeder-free iPS cells from human fetal fibroblasts using a polycistronic vector. We also compared and contrasted the iPS cells/clones produced under both feeder-free and feeder-full environments and their direct differentiation to neuronal pathways. A rapid production of such iPS cells from patients that are predisposed to Parkinson's and Alzheimer's diseases can help to develop in vitro models for studying these diseases and for future regenerative medicine.
Kuldip Sidhu, Ph.D., Associate Professor, Director, Stem Cell Lab, Chair, Stem Cell Biology, Faculty of Medicine, University of New South Wales, Australia
Here we report the first generation of feeder-free iPS cells from human fetal fibroblasts using a polycistronic vector. We also compared and contrasted the iPS cells/clones produced under both feeder-free and feeder-full environments and their direct differentiation to neuronal pathways. A rapid production of such iPS cells from patients that are predisposed to Parkinson's and Alzheimer's diseases can help to develop in vitro models for studying these diseases and for future regenerative medicine.
Kuldip Sidhu, Ph.D., Associate Professor, Director, Stem Cell Lab, Chair, Stem Cell Biology, Faculty of Medicine, University of New South Wales, Australia
12:15
From iPS Cells to Viable Fertile Mice
We report the generation of multiple iPS cell lines that are capable of generating viable, liveborn progeny through tetraploid complementation. We demonstrate the practicality of using iPS cells as useful tools for the characterization of cellular reprogramming and developmental potency, and confirm that iPS cells can attain true pluripotency similar to that of ES cells.
Fanyi Zeng, M.D., Ph.D., Professor and Associate Director, Shanghai Institute of Medical Genetics, Shanghai Jiao Tong University, China
We report the generation of multiple iPS cell lines that are capable of generating viable, liveborn progeny through tetraploid complementation. We demonstrate the practicality of using iPS cells as useful tools for the characterization of cellular reprogramming and developmental potency, and confirm that iPS cells can attain true pluripotency similar to that of ES cells.
Fanyi Zeng, M.D., Ph.D., Professor and Associate Director, Shanghai Institute of Medical Genetics, Shanghai Jiao Tong University, China
12:45
Networking Luncheon with Poster & Exhibit Viewing
1:50
Cellular Origami: Challenges and Opportunities for Stem Cell Science
If ES cells can be thought of as flat pieces of paper, then iPS cells are flat pieces of paper with the remnant creases of previous forms. We are getting better at unfolding and refolding the paper, reliably, safely and accurately but challenges still exist.
Chikafumi Yokoyama, Ph.D., CEO, ReproCELL Inc., Japan
If ES cells can be thought of as flat pieces of paper, then iPS cells are flat pieces of paper with the remnant creases of previous forms. We are getting better at unfolding and refolding the paper, reliably, safely and accurately but challenges still exist.
Chikafumi Yokoyama, Ph.D., CEO, ReproCELL Inc., Japan
2:15
Biological and Chemical Approach to Controlling Cell Fate: Tools and Technologies
Stephen Chang, Ph.D., Founder & CSO, Stemgent
Stephen Chang, Ph.D., Founder & CSO, Stemgent
Stem Cells in Drug Discovery
2:40
Drug Discovery Targeting Neural Stem Cells
Using neural stem cells derived from human stem cells or iPS cells, one can generate large amount of human neural cells with high quality and consistency that allows target validation and proof of principle studies be carried out in human cell systems at scale and convenience previously thought impossible. We are discovering tool compounds with potential of inducing differentiation of neural stem cells to neurons and oligodendrocytes. These tool compounds will help us identify genes and pathways important for neuroregeneration and unravel novel drug targets for neurodegenerative diseases. More importantly, these tool compounds will also help us to assess the feasibility of neural repair in appropriate preclinical models of degenerative diseases.
Zhong Zhong, Ph.D., Director, Lead Discovery, GlaxoSmithKline R&D, China
Using neural stem cells derived from human stem cells or iPS cells, one can generate large amount of human neural cells with high quality and consistency that allows target validation and proof of principle studies be carried out in human cell systems at scale and convenience previously thought impossible. We are discovering tool compounds with potential of inducing differentiation of neural stem cells to neurons and oligodendrocytes. These tool compounds will help us identify genes and pathways important for neuroregeneration and unravel novel drug targets for neurodegenerative diseases. More importantly, these tool compounds will also help us to assess the feasibility of neural repair in appropriate preclinical models of degenerative diseases.
Zhong Zhong, Ph.D., Director, Lead Discovery, GlaxoSmithKline R&D, China
3:05
Human Cancer Stem Cells as a Platform for Drug Discovery
Cancer stem cells (CSCs) are the sub-populaton of undifferentiated tumorigenic cells responsible for the initiation, maintenance and spreading of tumors and should, therefore, represent the preferential target of effective therapies aimed at eradicating tumors. The analysis of basic biological parameters concerning CSCs may provide important information to determine their prognostic value in a clinical setting. This presentation will present in-vitro and in-vivo cancer stem cell assays for a variety of different tumors and sub-types.
Giorgio Stassi, M.D., Member, TriStar Technology Group, LLC., USA
Cancer stem cells (CSCs) are the sub-populaton of undifferentiated tumorigenic cells responsible for the initiation, maintenance and spreading of tumors and should, therefore, represent the preferential target of effective therapies aimed at eradicating tumors. The analysis of basic biological parameters concerning CSCs may provide important information to determine their prognostic value in a clinical setting. This presentation will present in-vitro and in-vivo cancer stem cell assays for a variety of different tumors and sub-types.
Giorgio Stassi, M.D., Member, TriStar Technology Group, LLC., USA
3:30
Networking Refreshment Break with Poster & Exhibit Viewing
Main Conference - Joint Session
Keynote Presentation
4:00
Roche's Restructuring Strategies to Drive Creativityand Innovation in Research & DevelopmentAs a global leader in the pharmaceutical and diagnostic businesses Roche has pioneered the introduction of innovative personalised healthcare solutions, such as the breast cancer drug Herceptin. In this talk we shall be examining the strategies behind this success, with specific focus on the steps Roche is now taking to ensure a continued flow of differentiated healthcare solutions for patients.
Gianni Gromo, M.D., Ph.D., Global Head Metabolic & Vascular Disease Area, F. Hoffmann-La Roche, Switzerland
4:45
Close of Day Two
6:00
Networking Dinner in Tokyo
Join fellow attendees and speakers from the Drug & Biologics Japan and AsiaTIDES for a memorable evening out in Tokyo. Space is limited and an additional fee applies. Please check box on registration page to join the dinner.
Join fellow attendees and speakers from the Drug & Biologics Japan and AsiaTIDES for a memorable evening out in Tokyo. Space is limited and an additional fee applies. Please check box on registration page to join the dinner.
Main Conference: Monday | Main Conference: Tuesday | Main Conference: Wednesday | Add-On
Main Conference
Molecularly Targeted Cancer Therapies - A New Paradigm in Cancer Drug Development
8:30
Chairperson's Opening and Session Introductory Remarks
Thomas Chan, M.D., Chief Scientific Officer, ArQule, Inc., USA
Thomas Chan, M.D., Chief Scientific Officer, ArQule, Inc., USA
8:45
Application of Engineered Antibodies to Treat Cancer
Nobuo Hanai, Ph.D., VP, Head, Development Division, Kyowa Hakko Kirin Co. Ltd., Japan
Nobuo Hanai, Ph.D., VP, Head, Development Division, Kyowa Hakko Kirin Co. Ltd., Japan
9:15
Challenges in Drug Discovery Against Kinase Targets
Peter Blume-Jensen, M.D., Ph.D., Vice President, External Scientific Affairs, Daiichi-Sankyo Co. Ltd., Japan
Peter Blume-Jensen, M.D., Ph.D., Vice President, External Scientific Affairs, Daiichi-Sankyo Co. Ltd., Japan
9:45
Making of Glioma-Initiating Cell Models and Searching for Potential Therapeutic Targets
It has been demonstrated that malignant tumors contain cancer-initiating cells (CICs or cancer stem cells) which self-renew, are tumorigenic, and are resistant for anti-cancer therapies, suggesting that CICs are crucial targets for therapy. Using glioma-initating cell models, we have characterized them and found potential targets. This presentation will present recent progress and discuss next steps.
Toru Kondo, Ph.D., Team Leader, Laboratory for Cell Lineage Modulation, RIKEN Center for Developmental Biology, Japan
It has been demonstrated that malignant tumors contain cancer-initiating cells (CICs or cancer stem cells) which self-renew, are tumorigenic, and are resistant for anti-cancer therapies, suggesting that CICs are crucial targets for therapy. Using glioma-initating cell models, we have characterized them and found potential targets. This presentation will present recent progress and discuss next steps.
Toru Kondo, Ph.D., Team Leader, Laboratory for Cell Lineage Modulation, RIKEN Center for Developmental Biology, Japan
10:15
Networking Refreshment Break
10:45
Identification of A Novel P13K Inhibitor Identified by JFCR39 Cancer Cell Line Panel
Takao Yamori, Ph.D., Chief of Division of Molecular Pharmacology, Cancer Chemotherapy Center, Japanese Foundation for Cancer Research, Japan
Takao Yamori, Ph.D., Chief of Division of Molecular Pharmacology, Cancer Chemotherapy Center, Japanese Foundation for Cancer Research, Japan
11:15
Clinical Development of ARQ 197, A Selective Small Molecule C-Met Inhibitor
Brian Schwartz, M.D., Chief Medical Officer, ArQule, Inc., USA
Brian Schwartz, M.D., Chief Medical Officer, ArQule, Inc., USA
11:45
Non-Functional P2X7 - A Potential Pan Cancer Marker
P2X7 acts as an apoptopic receptor. This receptor has been found in a non-functional form in all human and animal tumor types investigated to date. All patients in each tumor type showed expression of the non-functional receptor as do all human and animal tumor cell lines.
Angus Gidley-Baird, Ph.D., CEO and Chief Scientific Officer, Biosceptre International Limited, Australia
P2X7 acts as an apoptopic receptor. This receptor has been found in a non-functional form in all human and animal tumor types investigated to date. All patients in each tumor type showed expression of the non-functional receptor as do all human and animal tumor cell lines.
Angus Gidley-Baird, Ph.D., CEO and Chief Scientific Officer, Biosceptre International Limited, Australia
12:15
Close of Drug & Biologics Japan conference
(Luncheon will be provided for those attendees who have signed up for the optional add-on: AsiaTIDES plenary session starting at 1:30pm).
Optional Add-On: AsiaTIDES Plenary Session
1:30
Chairperson's Remarks
G. Susan Srivatsa, Ph.D., President, ElixinPharma, USA
G. Susan Srivatsa, Ph.D., President, ElixinPharma, USA
1:45
Regulatory Considerations in the Development of RNAi Therapeutics
Saraswathy (Sara) V. Nochur, Ph.D., Vice President, Regulatory Affairs, Alnylam Pharmaceuticals, Inc., USA
Saraswathy (Sara) V. Nochur, Ph.D., Vice President, Regulatory Affairs, Alnylam Pharmaceuticals, Inc., USA
2:15
Considerations for the CMC Development of Oligonucleotides in Complex Delivery Systems
G. Susan Srivatsa, Ph.D., President, ElixinPharma, USA
G. Susan Srivatsa, Ph.D., President, ElixinPharma, USA
2:45
Development of Peptide-Based Cancer Vaccines up to Phase II - Regulatory Challenges and Opportunities
Peter Lewandrowski, Ph.D., Director and Head of CMC, immatics biotechnologies GmbH, Germany
Peter Lewandrowski, Ph.D., Director and Head of CMC, immatics biotechnologies GmbH, Germany
4:45
Close of AsiaTIDES®
For detailed abstracts and more info on this session, please visit www.IBCLifeSciences.com/AsiaTIDES
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