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THURSDAY, FEBRUARY 26    

7:00am Registration and Morning Coffee

7:20 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 Reserves; Professor, Orthopedic Surgery and Biomedical Engineering, College of Medicine, Mayo Clinic
Orthopedic Surgery and Biomedical Engineering, College of Medicine, Mayo Clinic
Tissue regeneration via tissue engineering strategies requires some combination of cells, a scaffold upon which the cells can attach and express their phenotypic function, and signaling molecules to direct the cells down the desired differentiation path. This cellular component often includes stem cells. This lecture will present current concepts regarding musculoskeletal tissue regeneration and the issues to be considered for its translation to clinical practice, as well as the unique reconstructive challenges encountered in combat injuries.

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
Raymond L. Woosley, M.D., Ph.D., President & CEO, 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. 

10:00        Sponsorship Presentations (Opportunity Available)

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
The NanoString nCounter System: A Highly Sensitive, Digital Technology for Multiplexed Measurement of Gene Expression Without Reverse Transcription or PCR Sponsored by
Sean Ferree, Ph.D., Research & Development Manager, NanoString Technologies
We describe a novel technology, the NanoString nCounter Analysis System, that captures and counts individual mRNA transcripts. Advantages over existing platforms include direct measurement of mRNA expression levels without enzymatic reactions or bias, sensitivity coupled with high multiplex capability, and digital readout.

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 Francisco
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)

EVALUATING TARGETS FOR CANCER
Shared session with Cancer Profiling and Pathways

3:55          Chairperson’s Remarks
Ulrik B. Nielsen, Ph.D., Vice President, Research, Merrimack Pharmaceuticals

4:00          Systems Optimization of ErbB-Targeted Therapeutics: Development of an Anti-ErbB3 Monoclonal Antibody
Ulrik B. Nielsen, Ph.D., Vice President, Research, Merrimack Pharmaceuticals
Computational biology is improving our understanding of complex biological systems. Using very large biological datasets of cell signaling, we have constructed detailed, mechanistic models. These may be used to predict network responses to targeted therapeutics such as monoclonal antibodies and small molecule inhibitors. Using the ErbB signaling network as an example, we will present how simulation proposed MM-121, a monoclonal anti-ErbB3 antibody, as a potentially superior approach current therapies.

4:30          Oncology Target-Disease Linkage Through Pathway Profiling
Lihua Yu, Principal Scientist, Cancer Bioscience, AstraZeneca PLC
One of the key challenges to the successful development of novel oncology agent is to identify disease settings most likely to see patient response. The explosion of molecular profiling data has provided us unprecedented opportunity to further our understanding of diseases at molecular level and to associate cancer pathways with disease subtypes. We will discuss several recent examples to illustrate how we use pathway-based approaches to establish oncology target-disease linkage.

5:00          Evaluation of Molecular Pathway Biomarkers of Novel Cancer Therapeutics
Sherry X. Yang, M.D., Ph.D, Chief of Nat’l Clinical Target Validation Laboratory, Division of Cancer Treatment and Diagnosis, National Cancer Institute
The talk will focus on the use of gene expression profiling approach for identification of molecular pathways in response to small molecule inhibitor of poly(ADP-ribose) polymerases in combination with chemotherapeutics, and to anti-angiogenesis agents. How the approach that was utilized for evaluation of cancer targets will be discussed and reviewed. In addition, validation and potential application of the identified pathway biomarkers will be discussed.

5:30          Epitomics: Individualized Immunoprofiling of Cancer-Specific Circulating Antibodies on Protein Microarrays of Tumor Associated Antigens
Michael A. Tainsky, Barbara & Fred Erb Professor of Cancer Genetics, Karmanos Cancer Institute, Department of Pathology, Wayne State University School of Medicine
The humoral immune response is an exquisite biosensor of novel proteins expressed by tumor cells. Panels of tumor antigens could provide a sensitive and specific multianalyte immunoassay for the presymptomatic of cancer. Using a high-throughput antigen cloning method, a panel of epitopes/antigens have been isolated that react with autoantibodies to tumor proteins in the serum of patients with cancer. The binding properties of these serum antitumor antibodies on microarrays and advanced bioinformatics tools led to a panel of diagnostic antigens. There are numerous advantages of employing serum antibodies as the analytes, not the least of which is the ability to readily adapt these assays to standard clinical platforms and their application to personalized immunotherapy. Early detection using panels of tumor antigens will lead to individualized interventions based on each specific immunoprofile. We envision that the early detection of cancer using immunoassays against tumor associated antigens will define a specific panel of antigens suitable for a personalized cancer vaccine for the test subject. In this fashion the earliest cancers can be eradicated with a vaccine prior to the formation of a sizable mass.

6:00          Close of Day 

Overview | Day 1 | Day 2 | Day 3 | Download Brochure | Breakout Discussions