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Critical Path 2007
April 23-24, 2007
San Diego, CA

The Critical Path Initiative is the U.S. Food and Drug Administration's response to what it sees as the drug development pipeline problem of increased costs and fewer safe and effective new medical products for patients.

Register now for this conference and networking event taking place in the beautiful biotech hub of San Diego, CA. Stakeholders from industry, government and academia will engage in lively panel discussions on the latest news and present their research on Critical Path topics such as:

        - The Future of the FDA's Critical Path Initiative
        - Biomarkers and Toxicology
        - Biomarkers and Imaging Technology
        - Biomarkers and Cancer
        - Improving Clinical Trials
        - Bioinformatics and the Critical Path
        - Nanotechnology in Drug Design & Manufacturing


Register for this conference and take part in shaping 21st century medicine.

Exhibiting, sponsoring and recruiting opportunities are currently available.


SPEAKERS

FDA - INVITED

Dr. Jacques Demotes-Mainard, ECRIN, INSERM-DRCT

Imaging Biomarkers in Drug Discovery and Development: an over-reaching strategy
Giora Feuerstein, MD, Assistant Vice President, Head, Discovery Translational Medicine, WYETH RESEARCH

Pathotropically Targeted Genetic Medicine: Critical Path to Highly Advanced Medical Technologies and Nanodevices
Dr. Frederick L. Hall, President & CEO, EPEIUS BIOTECHNOLOGIES

The role of Information Technologies in Biomarker Discovery and Development
Michael Hehenberger, Ph.D., Solutions Executive, Life Sciences/Pharma Transformation, IBM GLOBAL INNOVATION, HEALTHCARE AND LIFE SCIENCES

Discovery and validation of protein biomarkers for human oral cancer
Shen Hu, Ph.D., Assistant Professor, Oral Biology and Proteomics and Member Dental Research Institute, UCLA

Mitochondrial DNA as a Biomarker
Dr. John P. Jakupciak, Biotechnology Division, NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY

Addressing the Challenge of Organizing and Correlating Diverse High Throughput Date Types
Dr. Keith Joho, Bioinformatics Consultant (Chair)

Systems Biology through Integrative Genomics
Andrew Kasarskis, Scientific Director, Genetics, ROSETTA INPHARMATICS LLC - MERCK RESEARCH LABORATORIES

Strategic Medicine: A New Approach to Breast Cancer
Michael N. Liebman, Executive Director, WINDBER RESEARCH INSTITUTE

Front-Loaded BioOncology Drug Development: A Critical Path Opportunity
Nelson L'ntshotshole Jumbe, Ph.D., BioOncology Modeling & Simulation, Dept. of Pharmacokinetics, Pharmacodynamics and Bioanalytical Assays, GENENTECH

Personalized Medicine: How will it unfold?
Linda McAllister, MD, PhD, Director, Technology Management, US Chief Technology Office, ROCHE DIAGNOSTICS

Molecular Imaging in the Era of Molecular Medicine-Requirements for Clinical Practice
Alexander J.B. (Sandy) McEwan, Director, Department of Oncologic Imaging, CROSS CANCER INSTITUTE

Accelerating the Critical Path: Applications of in silico technologies to drug discovery and development
Seth Michelson, Ph.D., Biomathematician, Modeling & Simulation (Chair)

Validation, Standardization, Acceptance and the Utilization of Imaging in Phase I/II v Ph III studies
Colin Miller, PhD FICR, SVP Medical Affairs, BIO-IMAGING TECHNOLOGIES INC.

Nanotechnology for Cancer: Opportunities and Challenges
Linda Molnar, PhD, Technical Program Manager, Center for Advanced Materials and Nanotechnology, NCI/NIH

Gene-based Tests For Personalized Medicine
Robert Morrison, PhD,, Principal, BIOINVENSION

Dr. Damian O'Connell, Executive Director, Clinical R&D, PFIZER GLOBAL RESEARCH AND DEVELOPMENT

William Ricketts, PhD, Vice President, Chief Scientific Officer, ONCOTECH INC.

Alan H. Roter, VP, Informatics, ICONIX BIOSCIENCES, INC.

Cyclodextrin-polymer nanoparticles: Enabling platform technology for chemotherapeutics
Thomas Schluep, Chief Scientific Officer, INSERT THERAPEUTICS, INC.

Patient enrichment using Systems Biology
Birgit Schoeberl, PhD, Director, Network Biology, MERRIMACK PHARMACEUTICALS

Experiences with dose finding in patients in early drug development: the use of biomarkers in early decision making.
Dr. Stefan Sultana, MD, Senior Director & Translational Medicine Leader, GU, PFIZER

Translational Biomarkers of Flux through Disease Pathways
Scott Turner, PhD, Vice President, Operations, KINEMED, INC.

Developing Theranostics: The diagnostic side of the equation
Dr. Gunars Valkirs, Senior Vice President, Biosite Discovery, BIOSITE


CONFERENCE CHAIRS

Erlinda M. Gordon, MD, Vice President, Operations and Medical Affairs, Founder and Chairman of the Board, Epeius Biotechnologies

Dr. Keith Joho, Bioinformatics Consultant

Seth Michelson, PhD, Biomathematician, Modeling & Simulation


VENUE

The Dana on Mission Bay
1710 W. Mission Bay Dr.
San Diego, CA 92109

Telephone: 619-222-6440
Fax: 619-222-4031

Special group rate available.




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