Translational Drug Development in Asia 2007

Join us at the first Asian conference targeted to solve critical issues on bringing together biomedical science innovation with drug developments for emerging markets.

Program Highlights

Best practice sharing from Translational Research experts to leverage on the capacity for this new up and coming methodologies
Examining crucial points and challenges for warranting successful translational medicines in Asia
Forging improved understanding between basic and clinical science to achieve successful strategies in your research; and to create results rather than abstract theories.

Conference Day One: Tuesday 27 November 2007

8:30 Registration And Morning Coffee
9:00 Chairman’s Opening Speech
9:15 Translational Drug Development: An Overview Of Research To Commercialization For A Deeper Understanding Of The Issue
Identifying critical areas of developmental problems for preventive efforts
An introduction to the concept of translational medicines
Examining the role of translational research in drug and medical technological development
Dr. Brian Cao
Senior Scientific Investigator, Director, Antibody Technology Laboratory
Van Andel Research Institute

10:00 Genomic, Proteomic Approaches To Translational Medicines: Technology, Regulatory And Partnering Challenges In India
Ways to build a knowledge bank based on both ideas from biomedical research and reliable insights into the pathway to patients
Identifying knowledge gaps in your organization for more streamlined developmental processes
Expertise for aligning bench and bedside goals for more targeted research
Dr. K.Narayanasamy
Vice President and Head of Translational Research
The Center For Genomic Application (TCGA)

10:45 Break
11:15 Development Of Biomarkers For The Prediction Of Hepatotoxicity Of Pyrrolizidine Alkaloid-Containing Chinese Medicinal Herbs: A Case-Study To Demonstrate Mitigation Of Slow-Moving Drug Pipelines
It is well known that most naturally occurring pyrrolizidine alkaloids (PA) can cause hepatotoxicity. Various medicinal herbs including Chinese medicinal (CM) herbs have been found to contain toxic PAs. Although it is generally recognized that the liver toxicity induced by PA-containing CM herbs should be dose dependent, to date there are no available biomarkers for the assessment of the potential hepatotoxicity of PA-containing CM herbs. This case study will specifically cover the following:

Recent studies on several PA-containing CM herbs to develop biomarkers for the prediction of hepatotoxicity of PA-containing CM herbs
Examining the provision of translational research expertise for drug development teams
Issues related to the delivery of these molecules for mitigating glitches in your drug development pipelines
Dr. Ge Lin
Department of Pharmacology, Faculty of Medicine
The Chinese University Of Hong Kong

12:00 An In-Depth Examination Of Biomarker Validation And Preclinical Safety Studies For Optimization Of Drug Discovery Time Periods
Critical points to look out for when designing your biomarker
Exploratory approaches for a more informed selection of a biomarker for your drug development procedures
Efficacy of biomarkers and surrogate end points as predictive tools for toxicology & human safety testing for accelerated development phases
Understanding ultimately the qualification or linkage of biomarkers to clinical outcome
Dr. Ketan Patel
Research Scientist
Lilly Singapore Centre For Drug Discovery

12:45 Lunch
13:45 Understanding China’s Regulatory Landscape To Expedite Your Drug Development Processes
Role of SFDA in identifying the challenges to development
Detailing the process and criteria for setting product safety standards
Methodologies and available avenues for streamlining your product development processes with regulations
Support for projects for new medical breakthroughs and innovative tools for developing new treatments
Ms. Tao Jianhong
Deputy Chief Director
The Southern Medical Economy Research Institute SFDA

14:30 A Comprehensive Analysis Of Challenges For China CRO’s (Contract Research Organizations) To Become Western GLP Compliant For More Efficacious Drug Development Pipelines In Asia
Major obstacles to overcome for effective communication in Asia Essential check points for maintaining pharmaceutical, biotechnology, and medical device pipeline productivity
GLP compliant Protocols, SOP’s and Training Files to explore opportunities for investigative tools to better assess product safety and quality
Western GLP compliant Forms and Electronic Data Collection for elucidation of critical trends to that will expedite drug development practices
Data Collection including Clinical Observation and Histopathology for improved global integration of your drug development pipeline
Western GLP Quality Assurance compliance for ensuring drug safety and reduced attrition rates
Study reports and reporting of non-compliance issues for improved evaluation of drug attrition rates
Dr. Dean Rodwell
VP Preclinical Toxicology
Bioduro Beijing

15:15 Break
15:45 Developing Effective Collaborations With Academia In China To Tap Into Unexplored Potential
Understanding the gaps between academic centers and pharmaceutical organizations
Vital areas to look out for in creating a mutually beneficial collaboration
Examining the benefits of synthesizing data and expertise with academic centers
Dr. He Yun
Head of Medicinal Chemistry
Roche R&amo;D Center (China) Ltd

16:30 Building Critical Strategic Partnerships To Accelerate Drug R&D And Remove Bottlenecks In Translational Medicine
Avenues for collaboration among government, academia, and the private sector for more timely, affordable, and predictable access to new therapies
Points to look out for in partnership selection to complement your infrastructure and technology
Strategies to get lagging partnerships back on track
Dr. Jiang Canwen
Head
Genzyme R&D China
Senior Director
Applied Discovery Research
Genzyme Corporation

17:15 End Of Day One & Chairman’s Summary

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