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Drug Discovery & Development of Innovative Therapeutics Japan
Event Information
如何及早取得POC
2008年5月７日（三）～ 9日（五）
京王广场饭店 （KEIO PLAZA HOTEL）（东京）
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Tentative Agenda
Day One
Wednesday, May 7, 2008
| DAY ONE | DAY TWO | DAY THREE | |
| 8:00 | Conference Registration Begins |
| Setting the Stage for Scientific Innovation and Partnering in Drug Development |
| 9:00 | Chairperson's Welcome and Opening Remark |
| 9:05 | Will Japan Reward Innovation?
Japan rose from the ashes of World War II to become the second largest pharma market within a generation. This "miracle" was achieved because innovation was rewarded. Then price erosion and a drug lag discouraged innovation. Now various measures are and will be implemented to restore Japan's competitive position. Smart players assume they will work.
P. Reed Maurer, Chairman, aRigen, Inc., Japan |
| 9:25 | Trends and Best Practices in Global Pharma/Biotech Partnering and Licensing
As the trends in Biotech/Pharma partnering ebb and flow at an ever-increasing rate, today's licensing professionals have to be adept in the marketplace in order to execute the best deals, raising these questions: What are the latest trends, where are partnering models headed, and what do you need to know before starting the process? We will present the latest data and discuss the drivers behind the trends.
Michael G. McCully, Director and Senior Analyst, Recombinant Capital, Inc., USA |
| 9:50 | Emerging Financial Vehicles for External Innovation by Pharma
New models are emerging for early stage company financing. These include pharma-backed, option-linked venture funds, the creation of spinout companies to allow for venture-backed progression of otherwise dormant assets, the active promotion of entrepreneurship within pharma and the formation of biotech incubators. This talk will review the factors that have stimulated these developments, debate the pros and cons of the various emerging models and discuss the implications and opportunities for venture capital investors and early stage companies.
Art Pappas, Managing Partner, Venture Capital, Pappas Ventures, USA |
| 10:15 | Refreshment Break
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| R&D Strategies and Partnering Case Studies |
| | Featured Speaker |
| 10:45 | Merck's R&D Strategy, Pipeline and Approaches to Move Quickly to Clinical POC
Despite tremendous leaps of knowledge in biology and medicine and continued increases in R&D funding in the pharmaceutical sector, the number of drug approvals has not kept pace. Moreover, there are increasing pressures on the industry from consumers, physicians, payors, and regulatory agencies. To operate more effectively in this environment, Merck has taken a new approach to R&D in an attempt to make drug development faster, less risky, and less expensive.
Greg Wiederrecht, Ph.D., Vice President & Head, External Scientific Affairs, Worldwide Licensing and External Research, Merck & Co., Inc., USA |
| | Featured Speaker |
| 11:10 | Partnering Innovation: RNAi and Alnylam's Business Strategy
Alnylam is a leader in RNAi therapeutics with a comprehensive global intellectual property position and a novel drug development pipeline that addresses significant medical needs. Alnylam has broadly licensed its IP and technology to advance the field and fund proprietary R&D. This presentation describes Alnylam's scientific progress and the role that innovative partnering has played in driving the company's strategic development.
Jason Rhodes, Vice President, Business Development, Alnylam Pharmaceuticals, USA |
| 11:35 | Case Study of a Strategic Discovery Alliance Between Purdue Pharma LP and Shionogi & Co Ltd.
Purdue Pharma LP and Shionogi & Co Ltd. executed the agreement of discovery alliance in pain in 2005. There were some "Serendipity" and "Synchronicity" stories behind the discovery alliance between two firms. Details regarding impact of this alliance's strategy on both firms and steps that were taken to ensure the successful progression of the collaboration will be jointly presented.
Amy Belmear, Director, Alliance Management, Purdue Pharma LP, USA
Eiichi Yamaguchi, Deputy General Manager, License Department, Shionogi & Co., Ltd., Japan |
| 12:00 | Managing Multiple Alliances in a Changing Industry Scenario
The global pharmaceutical and biotechnology industry is looking for innovative partnering models to counter high discovery costs, low productivity and after market failures. Each company is evolving its own partnering needs and parameters. The presentation will focus on how to construct and manage seamless relationships with multiple partners in spite of them having different needs, engagement models and work culture.
Swapan Bhattacharya, Managing Director, TCG Lifesciences Limited, India |
| 12:25 | Luncheon |
| | Panel Discussion |
| 1:30 | Retooling the Transpacific Partnering Process: Making US-Euro-Japan Deal-Flow More Robust and Productive
- How can the process be improved?
- What deal structures are Japanese companies comfortable with and what deals do they not like?
- What are US/Euro companies looking for from a Japan deal?
- Pharma company objectives versus biotech objectives in deal-making
- Case studies of recently innovative US-Euro-Japan deals
- Why cultural "empathy" may be one of the most important factors in a successful deal
Panelists:
Davis Farmer, Chairman, MSM Protein Technologies, USA
James Egan, Chief Business Officer, ESBATech AG, Switzerland
P. Reed Maurer, Chairman, aRigen, Inc., Japan
Jim Murray, M.D., Executive Director, Hunter-Fleming Ltd., United Kingdom |
| Technologies in the Drug Development Cascade to Accelerate Quality Drugs into The Clinic |
| 2:15 | Chairperson's Remarks
Kailash Swarna, Ph.D., Executive Director, Research & Development, Amgen, Inc., USA |
| 2:20 | From Early Discovery to First-in-Human: Realities of The Post-Technology Revolution
Over the last decade, we have witnessed the near-perfect inverse correlation between record levels of technology investments and novel drugs in the clinic. Technology investments are necessary, but drying pipelines are in desperate need more rigor in discovery, and a connection to the clinic. This presentation will explore the value of enabling technologies, the process of target and lead selection, and the priorities that drive the successful launch of therapeutics.
Kailash Swarna, Ph.D., Executive Director, Research & Development, Amgen, Inc., USA |
| 2:45 | Building an Integrated Lead Optimization Operation
This presentation provides an overview of the integrated lead optimization model we have employed. The infrastructure support included implementation of an integrated local compound storage and liquid handling automated system, and set-up of the centralized automated tissue culture facility. To generate pharmacogenomically predictive results, we have incorporated multiple assay technologies. The combination of a flexible, integrated automated infrastructure support with a sophistication of the biological screening provides a basis for shortening the cycle time for generation of high quality leads.
Ilona Kariv, Ph.D., Director, Automated Lead Optimization, Merck Research Laboratories, USA |
| | Technology Workshop |
| 3:10 |  Accelerating Drug Discovery and Lead Optimization: Large Scale Transient Systems for Cell-Based Assays and Biotherapeutic Candidate Production
Mammalian cell lines that stably express drug targets for cell-based compound screens, or produce biotherapeutic drug candidates for lead selection and optimization are key tools in drug development. However, considerable investments of time and resources are required to engineer these lines. Large scale transient expression systems are increasingly employed because they significantly reduce time and costs, and provide greater flexibility. This presentation will examine the latest advances in transient cell-based assays and protein production systems.
Henry C. Chiou, Ph.D., Technology Area Manager, Research and Development, Invitrogen Corporation, USA |
| 3:35 | Refreshment Break |
| 4:05 | VelocImmune: A Novel Platform for Human Antibody Discovery
VelocImmune mice are a novel platform for the rapid discovery of antibody therapeutics using the natural mouse immune system. VelocImmune demonstrates that it is possible to humanize complex genomic loci in mice and faithfully reproduce locus expression and function. To further speed validation of antibody therapeutics in vivo, genes for antibody targets are replaced with their human equivalents in the mouse genome. This type of 'genetic humanization' of the mouse genome allows for the creation of novel disease models to analyze antibody leads which more faithfully reproduce human biology.
Sean Stevens Ph.D., Associate Director, Inflammation and Immune Diseases, Regeneron Pharmaceuticals Inc., USA |
| 4:30 | Old and New Animal Models - How Shall We Use Them Together to Support Drug Discovery
With the advancement of gene manipulation technologies, many transgenic and knockout mice have become available with the hope that these 'new' or 'gene-manipulated' animal models will enhance or speed up the drug discovery process, i.e., target validation and drug screening. This presentation will give a real example how the old and new animal models can be used together to support the drug discovery process and what key factors have to be considered when selecting and validating animal models for a particular drug discovery project.
Bin Zhu, M.D., Ph.D, Principal Scientist, In vivo Pharmacology, Takeda Singapore Pte. Ltd., Singapore |
| 4:55 | Circulating Tumor Cells (CTCs) as Biomarkers in Preclinical and Clinical Oncology Drug Development
Circulating tumor cells (CTCs) represent a simple yet powerful biomarker in the field of oncology. Pivotal clinical trials have shown that the number of CTCs before treatment is an independent predictor of progression-free and overall survival in patients with metastatic breast cancer. Interim analyses of data from clinical trials in prostate and colorectal cancer appear to mirror data from the breast cancer trial and the most recent data will be presented. Biomarker assay development with CTCs and their incorporation in clinical trials will be discussed.
Alexander Kuklin, Ph.D., Business Unit Manager, Immunicon, Inc., USA |
| 5:20 | Close of Day One |
| 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. Check box on registration form to sign up. |
Day Two
Thursday, May 8, 2008
| DAY ONE | DAY TWO | DAY THREE | |
| 8:00 | Conference Registration |
| 9:00 | Chairperson's Welcome and Opening Remarks
Osamu Sato, Ph.D., General Manager, Head of Medical Writing Group, Clinical Data & Biostatistics Dept, R&D Division, Daiichi Sankyo Co., Ltd., Japan |
| | Keynote Presentation |
| 9:05 | Biotechnology Innovation
Today, the power of innovation is considered almost the same as the competitiveness of a nation and speed of environmental adaptation is also important that, for health care industry, producing epoch-making new biotechnology has much greater social impact than conventional block-buster types. Whether or not pharmaceutical corporations are capable of creating innovative business models would be a challenge in shifting from conventional linear innovation to demand driven innovation.
Kiyoshi Kurokawa, M.D. Ph.D., Chairman, Health Policy Institute, Japan |
| | Keynote Presentation |
| 9:40 | Translational Research and a Genomic Approach to Cell Therapy: Manipulating the Immune System for Drug Development
This presentation will discuss efforts to develop therapeutic products based on acquired immunity of T cell derived cytokine networks. It will describe recent efforts to develop innovative products based on innate immunity of dendritic cells such as antibodies, oligodeoxynucleotides and cell therapy. These developments have been supported by a translational research platform including genomics, proteomics and cell processing facilities.
Ken-ichi Arai, M.D., Ph.D., Professor Emeritus, University of Tokyo, Founding President, Asia-Pacific IMBN and President & CEO, SBI Biotech Co., Ltd./Gingko Biomedical Research Institute, Japan |
| 10:15 | Poster/ExhibitViewing and Refreshment Break |
| Biomarkers, Imaging and Translational Research to Increase Clinical Success Rates |
| 11:00 | Leveraging Academic Research Through Commercial Partnerships from Discovery to the Clinic
With a unique business model that interfaces academic government-funded target/pathway research and small molecule drug discovery with commercial partnerships, SRI Biosciences develops high quality drug candidates ready for clinical development at greatly reduced risk. From idea to IND, we incorporate translational research including biomarker studies for clinical validation. Successful scientific collaborations with Japanese partners will be showcased as examples of the power of this approach.
Nathan Collins Ph.D., Executive Director, Drug Discovery, Biosciences Division, SRI International, USA |
| | Technology Workshop |
| 11:25 |  The Value of Human Tissue Samples in the Drug Discovery Process to Increase Clinical Success Rates
Ethically collected and well characterized human tissues can be used for immunohistochemistry, in situ hybridization, gene expression, functional pharmacology, biochemical pharmacology and toxicological assays to increase confidence in target identification and validation as well as characterization of compounds leading to development of drug candidates with an increased likelihood of clinical success. Practical applications of this approach will be discussed.
Dr Julian E. Beesley, Ph.D., Principal Scientist, Managing Director of Japan, Asterand, plc, United Kingdom |
| 11:50 | Imaging in Drug Development: Study Design Using PET / fMRI
Positron emission tomography (PET)and Functional magnetic resonance imaging (fMRI) are playing an increasing role in drug development. This presentation will discuss practical applications of imaging to help achieve clinical POC, including various case studies. Discussion points will include: advantages of PET in drug development; advantages of fMRI in drug development; study design; therapeutic areas; time and cost advantages; case studies.
Daniel Spasic, Chief Executive Officer, TFS Trial Form Support International AB, Sweden |
| 12:15 | Poster/Exhibit Viewing and Luncheon |
| 1:30 | Biomarker Development and Utilization for Facilitating Decisions in Oncology Clinical Trials
Biomarkers represent an evolving strategy to facilitate and improve decision-making in Oncology trials. Biomarkers are identified through multiple approaches including immunohistochemistry, genomic and proteomic profiling, etc. Biomarkers of response measure inhibition of target and/or impact on target biological pathways, whereas predictive biomarkers aid in identifying patients who are likely benefit from therapy. This presentation will discuss biomarkers developed by AstraZeneca and how they are influencing program decisions.
Sonya Zabludoff, Ph.D., Associate Director, Cancer Bioscience, AstraZeneca Pharmaceuticals, USA |
| | Technology Workshop |
| 1:55 |  Application of a Biomarker Discovery Platform for Drug Development
As the Evidence-Based Medicine (EBM) policy advocated by the FDA has become indispensable for new drug discovery/development, useful biomarkers are crucial. A model for a biomarker discovery platform applied in Japan's market will be introduced.
Toshiaki Somehara, Manager, Business Development, Wako Pure Chemical Industries, Ltd., Japan |
| 2:20 | Case Study of the Discovery of JANUVIATM (Sitagliptin), a Selective Dipeptidyl Peptidase-4 Inhibitor for the Treatment of Type 2 Diabetes
Dipeptidyl peptidase IV (DPP-4) inhibition has been validated as an alternate, oral approach to GLP-1 therapy. Initial DPP-4 inhibitors threo- and allo-isoleucyl thiazolidide were discontinued due to profound toxicity. The observation that both compounds inhibit the related proline peptidases DPP8 and DPP9 led to the hypothesis that inhibition of DPP8 and/or DPP9 could evoke severe toxicities. Thus, medicinal chemistry efforts focused on identifying a highly selective DPP-4 inhibitor for clinical development, culminating in the discovery of JANUVIA TM (sitagliptin), a highly selective DPP-4 inhibitor.
Troels Wolthers, M.D., Ph.D., Regional Director, Scientific Affairs, Diabetes Obesity AP, Merck & Co, Australia |
| 2:45 | Poster/ExhibitViewing and Refreshment Break |
| Drug Development Case Histories |
| 3:30 | Chairperson's Remarks
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| 3:35 | T-5224/R7277: An Oral Inhibitor of AP-1 for the Treatment of Rheumatoid Arthritis
The next generation of treatments for RA following the biologics is likely to consist of oral DMARDS. Roche and Toyama Chemical have entered into a licensing agreement for research and development of T-5224/R7277, a novel oral small molecule that inhibits the activity of AP-1, a transcription factor critical in the inflammatory response in RA. Data supporting the use of T-5224/R7277 in treating both the signs and symptoms and underlying joint destruction in RA will be presented.
Brian R. Wong, M.D., Ph.D., Director, Research, Inflammation, Autoimmunity & Trans plantation, Roche Palo Alto, USA
Yukihiko Aikawa, Ph.D., General Manager, Inflammation Research, Toyama Chemical Co. Ltd., Japan |
| 4:00 | The Discovery of CVT-10216, a Novel Aldehyde Dehydrogenase-2 Inhibitor, as a Potential Treatment of Alcohol Addiction
We have discovered a novel ALDH-2 inhibitor, CVT-10216 (2), that has retained the inhibition of ALDH-2, but has much improved oral bioavailability and half-life relative to daidzin 1. CVT-10216 inhibits alcohol consumption in rodent models in a dose-dependent manner at doses well below those for acamprosate and comparable to those for naltrexone, approved agents for alcohol addiction. The efficient SAR led by structure based design that resulted in the discovery of the development candidate CVT-10216 within the first 150 compounds synthesized will be highlighted in the presentation.
Jeff Zablocki, Ph.D., Head of Chemistry, CV Therapeutics, USA |
| 4:25 | Novel Antibodies that Engage T Cells for Cancer Treatment
This presentation will highlight a unique approach allowing antibodies the recruitment of T cells, the body's most professional killer cells. A CD19-specific BiTE antibody in phase 2 has provided clinical proof of concept for this novel platform, and BiTE antibodies binding other validated targets are in preclinical development. T cell-engaging antibodies of the BiTE class promise to significantly advance the treatment of cancer. We will also present new BiTE antibodies targeting cancer stem cells.
Patrick Baeuerle, Ph.D., CSO and SVP of R&D, Micromet, Inc., Germany |
| | Panel Discussion |
| 4:50 | Maximizing R&D Innovation and Efficiency: The Changing Role of Japan and Other Geographic Markets in a Global R&D Strategy
- Effectively managing a global portfolio strategies in lifecycle management
- Determining which programs to launch in which geographic regions
- Developing a long term strategy for operational excellence
- The role of outsourcing/partnering to complement your internal R&D
- Choosing the right therapeutic area strategy for the right market
- Blockbusters vs. more personalized/targeted therapeutics
- Making the most of Japan as part of a global R&D effort
Panelists:
Christopher R. Albani, Partner, PRTM, Japan
Patrick Keohane, M.D., VP and Head of R&D, AstraZeneca KK, Japan |
| 5:35 | Poster/Exhibit Viewing and Cocktail Reception in the Exhibit Hall |
| 6:30 | Close of Day Two |
Day Three
Friday, May 9, 2008
| DAY ONE | DAY TWO | DAY THREE | |
| 9:00 | Chairperson's Remarks
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| | Keynote Presentation |
| 9:05 | Induced Pluripotent Stem Cells in Drug Discovery and Toxicology
We have succeeded in inducing pluripotent stem (iPS) cells from adult human dermal fibroblasts by introducing four transcription factors, Oct3/4, Sox2, Klf4, and c-Myc. Human iPS cells are similar to human ES cells in morphology, proliferation, gene expression, in vitro differentiation, and teratoma formation. Patient- and disease- specific iPS cells will provide valuable tools in drug discovery and toxicology.
Shinya Yamanaka, M.D., Ph.D., Professor, Department of Stem Cell Biology, Institute for Frontier Medical Sciences, Kyoto University, Japan |
| Drug Development Case Histories |
| 9:35 | From Discovery to Lead Optimization: Case Study of An 11beta-HSD1 Program in Type 2 Diabetes
In a small molecule drug discovery program, assays and particular pharmacodynamic studies are important in profiling initial leads and improving the properties of lead molecules. 11beta-HSD1 inhibitors are potential therapies to improve insulin sensitivity in type 2 diabetes. Lead optimization requires target-specific strategies to resolve critical issues. Approaches to discover and improve 11beta-HSD1 inhibitors will be discussed.
Ming Wang, Ph.D., Scientific Director, Metabolic Disorders, Amgen, Inc., USA |
| 10:00 | Next Generation NSAID at Clinical Stage for Osteoarthritis
We have a candidate at phase II clinical study for osteoarthritis in EU, which is a dual inhibitor of Cox-2 and carbonic anhydrase for reducing cardiovascular side-effects and better efficacy than coxib such as Celebrex. We have done pre-clinical and phase I studies in the US and UK, which shows well-tolerated, safe at all dose levels, without any significant toxicity and no cardiovascular side-effects. I will present in detail the mode of action at the meeting.
Joong-Myung Cho, Ph.D., President & CEO, CrystalGenomics, Inc., Korea |
| 10:20 | Multipletargeted Tyrosine Kinase Inhibitors
Sutent® and Lapatinib® are the new multipletargeted clinically successful tyrosine kinase inhibitors in the market. Our drug discovery research modeling paradigm has led to several classes of new related inhibitors with equal or better overall potency in vitro and in vivo. This presentation will discuss discovery and preclinical data from our programs targetting VEGFR, EGFR/HER2 and Diabetes.
Lei Zhang, Ph.D., Group Leader, Drug Discovery, Shanghai Hengrui Pharmaceutical Co., China |
| 10:40 | Poster/Exhibit Viewing and Refreshment Break |
| 11:15 | Clinical Trial Activities: New Class of Oncology Products
Mebiopharm has developed a new class of tumor-targeting drugs via transferring(Tf)-Tf-receptor interaction. The phase 1 study conducted in the U.S. of MBP-426 has demonstrated clinical benefit in refractory cancer patients, and safety and efficacy of MBP-426 have been proved. Mebiopharm's strategy to develop and commercialize oncology products most efficiently and rapidly will be presented.
Tadashi Fujisawa, Chief Executive Officer, Mebiopharm Cp., Ltd., Japan |
| 11:35 | NanoCarrier: Nanoparticles for Drug Delivery and Discovery
NanoCarrier is working on the design of advanced micellar nanoparticles for drug delivery and discovery using its proprietary processes. NanoCarrier's leading micellar nanoparticle formulations have exhibited many advantageous characteristics. The results of Phase-I clinical trials for paclitaxel formulation indicated good efficacy/safety profiles. Also a cisplatin-based new platinum entity has shown good efficacy/safety results in pre-clinical and Phase-I clinical studies.
Hiroyuki Hanada, Executive Advisor, NanoCarrier, Japan |
| 11:55 | Discovery and Validation of Novel Kinase Drug Targets for Cancer
Kinases have been extensively studied for their key roles in cancer cell signaling. Inhibitors of various kinases are in clinical development. GNI researchers in Shanghai have identified a new set of kinase drug targets, which are implicated in cell cycle control. siRNA was used to demonstrate that inhibiting the kinases may lead to reduced cancer cell proliferation and transformation. Through collaboration, the company is in the process of developing small molecule compounds for potential new cancer therapy.
Jun Wu, Ph.D., Executive Managing Director and CSO, GNI Ltd and Shanghai Genomics Inc., China |
| 12:20 | Development of Inhibitors of Aurora and Other Tumor-promoting Kinases for Cancer Therapy with Strategies for Early Proof-of-concept Establishment
The Aurora kinases play key roles in the progression of cell cycle and the regulation of mitosis. Compounds that also inhibit other key kinases involved in angiogenesis and metastasis might offer greater therapeutic advantages. Here we report the design, development, and establishment of early proof-of-concept studies, for novel small-molecule inhibitors that potently inhibit Aurora A, VEGF-R and c-SRC. These inhibitors belong to three distinct chemotypes, display potent anti-proliferative activities, and induce apoptosis in a number of tumor cell lines in vitro and in vivo.
Murali Ramachandra, Ph.D., Vice President, Preclinical Biology, Aurigene Discovery Technologies Ltd., India |
| 12:45 | Poster/Exhibit Viewing and Luncheon |
| | Panel Discussion |
| 1:45 | Enhancing Industry-Academic-Biotech Collaborations in Drug Development
- Can/will pharmas turn to Japanese biotechs as partners to increase drug/diagnostic pipelines?
- Barriers to partnerships between pharmas and Japanese biotechs: perspectives from both sides.
- Can direct investment from pharmaceutical companies compensate for the freeze in public equity financing for Japanese biotechs?
- Personnel flows from Japanese pharmas to Japanese biotechs: enough to sustain an industry?
- Why should pharmas bother with Japanese biotechs if they can pursue translational research directly with university laboratories?
- How much innovation with applications in drug/diagnostic discovery is coming out of Japanese universities?
Panelists:
Robert Kneller, M.D., Professor, Research Center for Advanced Science and Technology, University of Tokyo, Japan
Kenji Tsujimoto, Ph.D., Senior Manager, Investment & Advisory Dept., Nomura Research & Advisory Co., Ltd, Japan
Takumi Kawabe, M.D., Ph.D., President and CEO, CanBas Co. Ltd., Japan
Patrick C. Reid, Ph.D., Chief Technology Officer, PeptiDream, Inc., Japan
Yosuke Ozawa, President and CEO, Japan Tissue Engineering Co., Ltd., Japan |
| The Next Generation of Therapeutics: Antibodies, Stem Cells And RNAi |
| 2:30 | Chairperson's Remarks
James W. Larrick, M.D., Ph.D., Managing Director, Panorama Research, Inc., USA |
| 2:35 | Can Next Generation Therapies Address the Apparent Paucity of Druggable Targets?
Submissions of new drug applications (NDAs) for new molecular entities (NMEs) have slowed to a trickle and can not possibly replace the plethora of recent blockbuster patent expirations. Regenerative "medicines" such as stem cells and designer antibodies and siRNA technologies are promising next generation therapies that can help bridge this "druggability gap". Recent work from our laboratory focuses on "Antibody-enhanced Regenerative Medicine". Adult stem cells "ARMed" by bispecific antibodies mediate significant tissue repair vs. unarmed stem cells. Efforts to move this technology rapidly into the clinic will be described.
James W. Larrick, M.D., Ph.D., Managing Director, Panorama Research, Inc., USA |
| 2:55 | Novel Strategies for Rapid Demonstration of Clinical Efficacy
Young biotech companies seldom have luxury of time or of money. Therefore, clever strategies to rapidly demonstrate clinical Proof-of-Concept (POC), must be adopted. We show our strategy to get rapid POC with a human, anti-Pseudomonas antibody in two clinically 'difficult' indications: Cystic Fibrosis, and Ventilator Associated Pneumonia. We also show an equally novel clinical strategy to gain POC with anti-inflammatory, anti-GM-CSF antibodies by testing them in several indications, including Rheumatoid Arthritis and Severe Asthma.
Mark R. Alfenito, Ph.D., Executive Vice President, Corporate Development, KaloBios Pharmaceuticals, USA |
| 3:20 | Translational Medicine Using Human Stem Cells
Differences in pharmacological effects between animals and humans can be an obstacle to the selection of appropriate drug candidates for development. Techniques which allow translation of the knowledge obtained from animal experiments to clinical application are vital for the improvement of drug development productivity. This presentation will summarize the present progress on human stem cell technologies which could be used to establish in vitro and in vivo assay systems that mimic the biologically true state in human subjects.
Kazuhiro Sakurada, Ph.D., Operating Officer and Head of Research Center Kobe, Bayer Yakuhin Ltd. and Head of Regenerative Medicine, Global Drug Discovery, Bayer Schering Pharma AG, Japan |
| 3:45 | Poster/Exhibit Viewing and Refreshment Break |
| 4:15 | ADCC and CDC Enhancement Technology for Next-Generation Therapeutic Antibodies
We have established a robust and stable method for enhancement of antibody-dependent cellular cytotoxicity (ADCC) activity of antibodies, named Potelligent technology. Potelligent dramatically enhances ADCC activity of an antibody in vitro and increases antibody potency and efficacy. We also created a method for enhancement of Complement-dependent cytotoxicity (CDC) activity of antibodies called Complegent technology. Application of these technologies has now started for the development of the next generation of more effective therapeutic antibodies.
Kenya Shitara, Ph.D., Director, Antibody Business Office, Pharmaceuticals Business Unit, Kyowa Hakko Kogyo Co. Ltd., Japan |
| 4:40 | Development and Optimization of Novel RNAi Therapeutics Platforms
Parameters for the design of therapeutic synthetic RNAi triggers including sequence, length and end structure will be discussed. Data will be presented demonstrating the delivery of RNAi compounds to the mouse liver and other tissues with nanotransporters, generating knockdown at doses of 1 mg/kg. Additional data will demonstrate silencing of SOD1 in the spinal column in a mouse ALS model. Lastly, the RNAi validation of RIP140 as a target gene for obesity will be described.
Dmitry Samarsky, Ph.D., VP, Technology Development, RXi Pharmaceuticals Corp., USA |
| 5:05 | Accelerating Antibodies to the Clinic: Drug-like Antibody Fragments for Local Therapies
Antibody fragments normally lack drug-like properties. Due to a novel and proprietary selection procedure, ESBATech has selected drug-like antibody fragments that qualify for direct therapeutic application without the need for further protein stabilization. This opens new therapeutic routes of applications for protein therapeutics that will be illustrated on a local inflammatory indication.
Dominik Escher, Ph.D., Chief Executive Officer, ESBATech AG, Switzerland |
| 5:30 | Close of Conference |
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