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Wednesday, March 26

7:00am Registration (Open until 5:30pm)

8:00 Plenary Keynote Introduction
Edward G. Heidig, General Counsel and Deputy Secretary, Business, Transportation and Housing Agency

8:10 Risk Diagnosis for Disease Prevention
C. Thomas Caskey, M.D., F.A.C.P., Director and Chief Executive Officer, Brown Foundation Institute of Molecular Medicine, University of Texas Health Science Center 
There are an increasing number of presymtomatic diagnostic options which include: genetic, imaging, and analyte technology. Examples of linking a specific diagnostic to a therapeutic decision and FDA approval have fueled the activity for personalized medicine. It must be appreciated that diagnostic capacity emerges far more rapidly than an approved safe therapeutic. Thus the personalized medicine goal has a bottle neck for broad utility. A strategy of studying approved drugs for maximal efficacy is realistic and reasonable toward that goal since it is estimated that many approved drugs are effective in less than 50% of patients. These approaches will be discussed.

8:55 Disruption of the Pharmaceutical Industry: Moving from Products to Solutions
Theodore J. Torphy, Ph.D., Corporate Vice President & Head, Science & Technology, Johnson & Johnson
The pharmaceutical industry is bracing itself for a period of unprecedented challenges. This new era for our industry is being brought on by the confluence of several environmental factors, both internal and external to the industry, including; 1) non-sustainable increases in healthcare expenditures, 2) spiraling costs and decreasing productivity of R&D, 3) reimbursement driven by medical and economic outcomes, and 4) the proliferation and redistribution of healthcare outcomes information. Although all of these factors threaten to disrupt our industry, it is the evolving transparency in healthcare outcomes information that represents the most unsettling threat to our current business model, as well as the largest opportunity to transform our industry. For this transformation to take place, it is imperative that we change from an industry in which the sole mission is to provide products to one that provides broader, cost-effective solutions to areas of major healthcare needs.

9:40 Grand Opening Refreshment Break in the Exhibit Hall

11:00 Chairperson's Remarks
Paul R. Billings, M.D., Ph.D., Senior Vice President, Strategic Planning and Corporate Development, Senior Geneticist, Center for Molecular Biology and Pathology, Laboratory Corporation of America

11:10 Clinical Diagnostics and Imaging for Early Health 
Christoph Hergersberg, Ph.D., Global Research Leader, Biosciences, GE Global Research Center 
Diagnostic imaging is currently undergoing a transition from anatomical analysis and contrast towards true molecular imaging. In that respect, the connection to clinical and molecular diagnostics is becoming more and more direct and integrative diagnostic workflows seem feasible. The development of such workflows and the connection to the emerging concepts of companion diagnostics as well as outcomes analysis will be described.

11:40 Prospective Medicine: The Next Health Care Transformation 
Ralph Snyderman, M.D., Chancellor Emeritus & James B Duke Professor Medicine, Duke University and Proventys 
Health care today is largely focused on the acute treatment of disease delivered by a system that is uncoordinated, with care being sporadic and reactive. Expenditures are inefficient as they are largely for intervention in late stage chronic disease rather than prevention. This is due, in part, to the lack of effective preventative approaches, early intervention, customized therapies and coherent management. Emerging technologies in the fields of genomics, proteomics, metabolomics, metabolic imaging and informatics, as well as medical know-how are enabling a new approach to health which can mitigate these problems. Personalized, predictive, and preventative medicine will enable individuals to develop strategic health plans to avoid the diseases to which they are most susceptible. Moreover, therapy will be customized to their own needs. This has been termed 撤rospective Health Care・and is a model that uses individualized health risk assessment, personalized health planning and state-of-the紡rt predictive and tracking tools to specify the best means of disease avoidance, early intervention, and when needed, individualized therapy.

12:10pm LOC: The Next Generation Molecular Diagnostic Device
Christopher Ko, Ph.D., Chief Operations Officer, Bio Business Planning, Samsung Advanced Institute of Technology 
The field of LOC has expanded greatly in recent years. With the potential of increased speed and portability, these LOC devices could bring substantial changes in the way diagnostic procedures are currently performed today. However, there are still many technical challenges yet to be solved for LOC devices. The most immediate need is to develop an automated sample preparation step. I will describe the current status of LOC as molecular diagnostic device. [LOC=Lab on a Chip]

12:40 Technology Spotlight (Sponsorship Available)

1:10 Walk & Talk Luncheon in the Exhibit Hall

2:15 Chairperson's Address
Challenges and Opportunities in Global Health Diagnostics
Carol A. Dahl, Ph.D., Chief of Staff, Global Health Program, Director, GlobalHealth Discovery, Bill & Melinda Gates Foundation

2:30 Diagnostics for the Developing World - Challenges and Constraints 
N. Sriram, Director, Tulip Group, Orchid Biomedical Systems 
The developing world hastheir own unique health care challenges having a huge disease burden and extreme  poverty and thus there is a high dependence upon the state for health care. Because of limited budgets, the major focus of the state health system is on treatment and often diagnostics are given the lowest priority. Even the existing diagnostic facilities are poorly equipped and lack qualified and trained staff. In rural and remote areas, diagnostic facilities do not exist. Regulation is rudimentary providing competition from low cost, low quality, ineffective diagnostic products. Hence there is a great need and potential for simple, high quality and affordable diagnostic products. Immunochromatography based Rapid Diagnostic Tests are partly meeting this requirement for some diseases. Innovative molecular diagnostic tools are seen as the future successful products.

2:50 Advancing Health Outcomes in Developing Countries Through Technology Deployment and Public-Private Sector Collaboration
Gary M. Cohen, Executive Vice President, BD Medical 
The speaker will share BD's successful experiences in helping address fundamental health needs in the developing world through development and deployment of vitally needed products in conjunction with policy and funding actions. Examples will be provided in medical device and diagnostic product categories. The presentation will include circumstances where products were specifically designed to meet unique needs that exist in developing countries, and other circumstances where existing technologies were tailored to developing world needs. The speaker is a senior executive of BD who has been personally active in improving health and laboratory practices in the developing world.

3:10 Affordability Through Sustainability ・A New Approach to Technology Innovation 
Bala S. Manian, Ph.D., Chief Executive Officer, ReaMetrix Inc. 
In addressing the healthcare of needs of the resource poor settings, the technology focus today is on the affordability and robust delivery of goods and services. Often such activities have failed to take into account the local economic factors on the ground where the solutions are delivered. Rather than approaching the problem as a philanthropic activity, is it possible to use innovation in technology development, not only to address the cost economics of service rendered, but also to generate local economic activity that can pay for those services on a sustainable basis? The objective of this talk is present some specific case studies and examples to support this thesis.

3:30 Design of Diagnostic Tools for the Surveillance of Infectious Diseases in Developing Countries
Guy Vernet, Ph.D., Scientific Director, Fondation M駻ieux 
Besides HIV, tuberculosis and malaria, many infectious diseases affect developing countries. Laboratory-based surveillance is critical and alert in case of epidemics is central to public health response. Sentinel laboratories are usually unprepared for this mission. Assays must detect, at low cost, several pathogens in a syndrome-based panel approach and instruments must be simple to use. Design of diagnostic tools for surveillance requires targeted epidemiological studies to focus on major pathogens, biomarker discovery including new pathogens, and use of highly innovative biological and instrumental technologies. Building a strong network of laboratories in industrialized and developed countries is essential to insure training of technical personnels.

3:50	Expert Panel:
WHICH TECHNOLOGIES DOES THE DEVELOPING WORLD HAVE AND HOW HAVE THEY SUCCEEDED IN REACHING THE WORLD担 POOR?

4:20 Reception in the Exhibit Hall (Sponsorship Available)

5:00 - 6:00pm Break-out Discussions in the Exhibit Hall 
Leading the Way Towards More Personalized Healthcare (PHC) in Oncology 
Moderator: Gabriele Beer, Ph.D., Diagnostics Liaison Manager ・Oncology, Roche 
Diagnostics GmbH 

• Where do we stand today in respect to targeted cancer therapy?

• What are the unmet medical needs ・how many more biomarkers do we need? 

• Who are the drivers for PHC?

• Can we afford targeted medicines and will Pharma support Diagnostics 

• Roche's strategy to lead: Driving PHC through a pharmacodiagnostic strategy 訴n house・/li>

Regulatory Routes Open to Diagnostic Products
Moderators: Lesley Rapaport MSc., LL.B., Associate Chair, Vancouver Biotechnology Practice Group, Borden Ladner Gervais LLP and Randy J. Prebula, Director of Regulatory Sciences, Hogan and Hartson, Washington, D.C.

• CLIA certification

• ASR

• Full PMA

• 510K

• European certification