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THURSDAY, FEBRUARY 26 

7:00am Registration Open and Morning Coffee

7:20 am Plenary Keynote Introduction 

7:30 PLENARY KEYNOTE 
Tissue Engineering Strategies for Musculoskeletal Regenerative Medicine in Civilian and Military Applications
Michael J. Yaszemski, M.D., Ph.D., Brigadier General, United States Air Force, Professor, Orthopedic Surgery and Biomedical Engineering, Mayo Clinic College of Medicine

DEVELOPMENT OF DIAGNOSTICS FOR STANDARD OF CARE 
(SHARED SESSION WITH MOLECULAR DIAGNOSTICS)

8:25am Chairperson’s Remarks 
David S. Lester, Ph.D., Senior Vice President, Strategy & Corporate Development, Gene Express, Inc.

8:30 KEYNOTE PRESENTATION
Bringing the Promise of Genomics to Clinical Practice: Development and Commercialization of the Oncotype DX Breast Cancer Assay 
Steve Shak, M.D., Chief Medical Officer, Genomic Health Inc.
We all feel an urgency to improve cancer care. Patients desire individualized treatment based on their specific cancer. Physicians desire more accurate clinical predictors to guide their treatment recommendations. Payors desire better allocation of resources. The Oncotype DX Breast Cancer Assay was developed to meet the needs of patients, physicians, and payors and has become a standard in breast cancer clinical practice. Targeted therapies and new diagnostic tests are transforming the way that we understand, diagnose, and treat cancer.

9:00 The BCR-ABL qRT-PCR Assay: Status of a Molecular Diagnostic that is a Current Standard of Care
J. Milburn Jessup, M.D., Chief, Diagnostics Evaluation Branch, Cancer Diagnosis Program, DCTD, National Cancer Institute 
Newly diagnosed chronic phase Chronic Myelogenous Leukemia (CML) is the paradigm for molecular oncology with a targeted therapy that efficiently induces remissions. The BCR-ABL assay is the molecular diagnostic for CML that has a sensitivity of 1 CML cell in 105 peripheral blood mononuclear cells. Although this assay is performed in over 150 hospitals in the US, results in one laboratory are not directly comparable to those in another because the assay lacks a daily use calibrator. In this presentation the Cancer Diagnosis Program (CDP) of NCI will describe a pilot study using calibrators to harmonize the BCR-ABL assay and improve its use as a standard of care. 

9:30 Moving Biomarkers into Applications
Elizabeth Gribble Walker, Ph.D., Assistant Director, Toxicology, Predictive Safety Testing Consortium, Critical Path Institute
Biomarkers are most valuable to support decision-making during drug development when they have been “qualified for use” by regulatory scientists. The critical path initiative, through the work of consortia, has resulted in a new pathway for qualification of biomarkers and improved testing methods. Also, in the clinical phases, biomarkers can enable development of targeted therapies but the pathway for evolution of a laboratory biomarker to a clinically reliable diagnostic test is still being defined and will be discussed. 

10:30 Poster Competition Refreshment Break & Raffles in the Exhibit Hall 

11:30 Quantitative Imaging as a Biomarker of Drug Response in Lung Cancer
James L. Mulshine, M.D., Professor, Associate Provost for Research and Vice President, Director, Rush Translational Sciences Consortium, Internal Medicine, Rush University Medical Center, Chicago 
Major improvements in imaging resolution and image processing with helical computerized tomography are permitting strategic evaluation of drug response in untreated lung cancer. Using a new neoadjuvant trial structure, candidate drugs are administered for two to three weeks prior to a curative surgical procedure. CT scans and molecular evaluations of lung tissue are performed before and after drug exposure. The exposure of drugs to untreated cancer allows cross-evaluation of molecular and imaging endpoints permitting a rapid and clean evaluation of the molecular underpinning of early lung cancer. 

12:00pm Personalized Medicine – Towards an Integrated Approach to Health Care
J.W. (Hans) Hofstraat, Ph.D., Vice President Philips Research, Healthcare Strategic Partnerships 
We are at the beginning of a new era in medical care. Science-based innovations in technology, molecular biology and remote disease management, together with new business and organizational models, will enable the creation of entirely new, integrated and personalized, approaches to diagnosis, treatment and management of medical conditions. For patients, these approaches will lead to better outcomes, less traumatic experiences, and an enhanced quality of life. For healthcare providers, they will contribute to more cost-effective healthcare systems through the delivery of easy-to-use tools to healthcare professionals. Diagnostic technologies, developed in public-private partnerships, play a key role in enabling this paradigm shift in health care.

12:30 Luncheon Presentation (Sponsorship Available) or Lunch on your own

1:30 Plenary Keynote Introduction

1:40 PLENARY KEYNOTE
Engineering Cells to Death
James A. Wells, Ph.D., Professor and Chair of Pharmaceutical Chemistry, and Professor of Cellular & Molecular Pharmacology, University of California, San Francis-co
Apoptosis, or programmed cell death, represents an ultimate fate decision in cell biology. This process is critical for cellular differentiation and remodeling of tissues, and for anti-viral and anti-tumor defense. The study of apoptotic pathways has important ramifications for determining what is critical for cellular homeostasis, and for the development of potential anti-cancer therapeutics. A distinct molecular feature of apoptosis is the widespread but controlled cellular proteolysis, that is predominantly mediated by eight members of the caspase family of cysteine proteases. These enzymes are like demolition experts that cleave protein targets critical for cellular life. We have designed new enzymes, and antibodies, and small molecules to study and activate individual caspases and the proteins they cleave. For example, a robust proteomic method for global profiling of proteolysis (“degradomics”) in cells has been developed. Key to this is an engineered enzyme, subtiligase, that permits selective labeling and enrichment for the protein N-termini created as a result of proteolysis. Using this approach we have already identified >300 caspase substrates from Jurkat cells that were induced to undergo apoptosis by treatment with the chemotherapeutic agent etoposide. The proteins fall into a wide range of functional classes, and reveal much about the molecular components, logic, and timed sequence of events that drive a cell from life to death. We believe these engineered enzymes and proteomic approaches will be useful for characterizing the proteolysis of apoptosis induced by various agents or in different cell types, and will be generally useful for dissecting protease signaling pathways.

2:25 PLENARY KEYNOTE
The Brave New World of Personalized Medicine: The Experimental Man Project, One Man Takes the Ultimate High-Tech Exam
David Ewing Duncan, Chief Correspondent, NPR Talk’s “Biotech Nation” and Best Selling Author “Masterminds”
This focus of this presentation will be on "Creative Disruptions", and will demonstrate the walking scientific response to the question: "Can they really do that?" The most important and controversial topics of today’s scientific research will be discussed, from stem cells and synthetic biology, to rising drug prices and reforming the FDA. Recently, there has been attention on science’s most significant story: a species’ potential to self-evolve. As the founder of the independent BioAgenda Institute for Life Science Studies and, more recently, as the founder of the new Center for Life Science Policy at UC Berkeley, the passion for what comes next after new technologies appear will be explored -- what happens in business, politics, science, philosophy, the media, the arts, and to society as a whole.

3:05 Ice Cream Refreshment Break in the Exhibit Hall with BEST OF SHOW AWARDS Last Chance for Viewing Exhibits & Posters

NEXT WAVE OF ASSAYS FOR PERSONALIZED MEDICINE
(SHARED SESSION WITH MOLECULAR DIAGNOSTICS)

3:55 Chairperson’s Remarks
Brian T. Edmonds, Ph.D., Research Advisor, Global External Research & Development, Lilly Corporate Center

4:00 New Generation Predictive Multiplexed Gene Expression Diagnostics: Case Studies in Non-Hodgkin’s Lymphoma
Bruce Seligmann, Ph.D., Founder, Board Member and Chief Science Officer, R&D, High Throughput Genomics
Precise measurement of gene expression levels using the multiplexed qNPA™ assay can reliably distinguish differences in gene expression levels of 10% to 20% (1.1- to 1.2-fold differences), even from (fresh or archived) formalin fixed paraffin embedded (FFPE) tissue samples. This precision has enabled a new generation of diagnostic. Case studies will be presented describing the steps of identifying a predictive signature and then translating this into a simple diagnostic score for predicting survival risk in Non-Hodgkin’s Lymphoma (NHL) following different treatment modalities.

4:25 A Simple Colorimetric “Dipstick” Test for Molecular Diagnosis of a Broad Range of Molecules Based on Functional DNA Nanotechnology
Yi Lu, Ph.D., Professor, Chemistry, University of Illinois at Urbana-Champaign
Recent advance in nanotechnology has produced a number of nanomaterials with high sensitivity for molecular diagnostics, while progress in functional DNA biology made it possible to obtain DNAzyme and aptamers that can bind a broad range of target molecules with high selectivity. By combining the benefits of both fields, we have demonstrated a simple, sensitive and selective “dip-stick” test by immobilizing DNAzymes and aptamer functionalized gold nanoparticle aggregates onto a lateral flow device.

4:50 Improving Early Disease Detection with Single Molecule Counting Technology
John Todd, Ph.D., Vice President, R&D, Singulex, Inc.
The Erenna Immunoassay System is based on novel technology that integrates microparticle (MP) immunoassays and single molecule counting (SMC). Implementation of this new technology enables measurement of biomarkers with unprecedented levels of sensitivity and precision, providing access to valuable new diagnostic information and expansion of current assay capabilities. We have successfully used the IA to quantify baseline levels of oncology biomarkers from healthy individuals, which were previously considered intractable with other systems, demonstrating the utility of this novel technology.

5:15 Comprehensive Highly Multiplexed Single-Tube Liquid Bead Microarray Assay for Constitutively Activated
Tyrosine Kinases enables personalized therapy in Chronic Myeloproliferative Disorders
German Pihan, M.D., Director, Hematopathology, Pathology, Beth Israel Deaconess Medical Center
We have developed and implemented an assay capable of detecting the majority if the fused, point mutated or tandem duplicated tyrosine kinases known to play a key pathogenic role in a group of disorders classed under the rubric chronic myeloproliferative diseases or neoplasms.

5:40 Integration of Clinical and Pan-Omic Findings to Predict Course of Disease
Marti Jett, Ph.D., Chief, Department of Molecular Pathology, Walter Reed Army Institute of Research
Exposures of animal models to pathogenic agents has provided a continuum of pan-omic information that can be integrated with clinical findings. The composite that emerges has enabled us to begin to identify predictors of impending illness. Most importantly, we identify molecular branchpoints that correlate with severity of disease progression. Some of these pathways have the potential to serve as therapeutic targets.

6:05 Close of Day 

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