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MAIN CONFERENCE 

WEDNESDAY, FEBRUARY 25

7:15am Registration Open and Morning Coffee

8:45 Plenary Keynote Introduction 
Kathryn Lowell, Deputy Secretary, Life Sciences, California Business Transportation & Housing Agency

8:55 PLENARY KEYNOTE
Using Molecular Medicine to do Therapeutic Development in the Network Age
Jay M. Tenenbaum, Ph.D., Chairman and Chief Scientist, CollabRx, Inc.
A new paradigm for translational research will be described that combines the integrative and collaborative power of the Internet with personalized molecular analysis to slash the time and cost of therapy development. A key element is the creation of Health Commons, an open web-based ecosystem of researchers, clinicians, patients, pharma/biotechs, and service/technology providers that can be rapidly mobilized to develop targeted therapies for disease subclasses. This ecosystem will stimulate the same radical increase in efficiency for therapy development that ecommerce brought to business in the 1990s, ushering in a new age of collaborative, personalized medicine where every patient can afford custom therapies and discovery is driven by collectively interpreting the outcomes across all patients.

9:40 Grand Opening Refreshment Break in the Exhibit Hall

KEYNOTE SESSION
(SHARED SESSION WITH MOLECULAR DIAGNOSTICS)

11:00 Chairperson’s Remarks 
Paul Billings, M.D., Ph.D., President and Chief Executive Officer, CELLective Dx Corporation

11:10 pm Title to be Announced 
William J. Rutter, Ph.D., Chairman, Synergenics LLC

11:40 Genes for Common Disease: But What Next?
John A. Todd, Ph.D., University Chair, Medical Genetics, University of Cambridge
Technology, extensive clinical sample collections and a maturation in statistical assessment of results coincided in 2007 to trigger an avalanche of gene identification in “complex” diseases: the disorders that fill clinics and cost billions of dollars. These susceptibility genes mark and point to the etiological pathways of disease, including facilitation of disease precursors or biomarkers. The latter research, knowledge and future knowledge should lead to improved efficiency in the development of strategies to prevent disease.

12:10 MDx - From Revolution to Mainstream to Personalized Medicine
Daniel H. Farkas, Ph.D., HCLD, Executive Director, Center for Molecular Medicine
The golden age of molecular biology led to the development of tools that transformed the practice and business of laboratory medicine. Molecular pathologists and their clinical colleagues are now poised to use the tools of the 21st century, arrays, high-speed sequencing, bioinformatics and the like, to bring a new and exciting growth period to molecular diagnostics that will have dramatic effects in all areas of medicine. 

12:40 Sponsored Presentations (Opportunity Available)

1:10 Walk & Talk Luncheon in the Exhibit Hall

SUCCESS STORIES OF NOVEL TEST ADOPTION
(SHARED SESSION WITH MOLECULAR DIAGNOSTICS)

2:15 Chairperson’s Remarks 
Daniel H. Farkas, Ph.D., HCLD, Executive Director, Center for Molecular Medicine

2:20 Molecular Diagnostic Tests That Affect Diagnosis and Therapy in Myeloid Leukemias 
Adam Bagg, M.D., Director, Hematology, Department of Pathology and Laboratory Medicine, University of Pennsylvania
The laboratory diagnosis and classification of myeloid neoplasms requires the integration of a number of disparate technologies, often including morphology, histol-ogy, immunophenotyping (flow cytometry and immunohistochemistry), cytochemistry, and genetic analyses (such as conventional cytogenetics, FISH and molecular approaches); of these, genetic analyses, in particular molecular studies, provide the most prognostically-pertinent and therapeutically-relevant data. This session will highlight some of the scenarios in which molecular tests can not only refine diagnoses, but also dictate therapy as well as redefine concepts of remission.

2:50 Molecular Chimerism Analysis in Hematopoietic Cell Transplantation
Christopher Watt, M.D., Ph.D., Molecular Pathology Fellow, Department of Pathology and Laboratory Medicine, Hospital of the University of Pennsylvania
An increasing number of diseases, both malignant and non-malignant, are being treated with hematopoietic cell transplantation. Molecular chimerism analysis was developed by harnessing the power of forensic identity analysis to monitor patients following allogenic hematopoietic cell transplants. Chimerism analysis is used to evaluate the relative amounts of donor and recipient cells using DNA identity markers. How chimerism analysis was developed in a clinical molecular pathology lab and examples of how the data obtained is used for patient care will be presented.

3:20 Reimbursement Considerations and Strategies
Jeffrey A. Kant, M.D., Ph.D., Director, Molecular Diagnostics, Department of Pathology, University of Pittsburgh
What do global warming and coding/reimbursement for molecular diagnostics assays share? Complexity, uncertainty and often surprise! Following a brief re-view of the basics for coding molecular assays, I will present case examples to illustrate areas of confusion or controversy arising from technical or philosophical considerations along with difficulties and limitations associated with coverage policies promulgated by payers unfamiliar with molecular technology and its clinical applications. I will also discuss creative approaches users have adopted to deal with regulatory constraints and provide an update on emerging concepts and proposals to ‘fix’ this area.

3:50 Molecular Diagnostic Tests to Detect, Characterize and Monitor Viral Agents of Infection and Disease
Daniel Amsterdam, M.D., School of Medicine and Biomedical Sciences, University of Buffalo
During the quarter century since the beginning of the HIV pandemic, great strides have been made in understanding the progression of HIV infection and treatment of HIV disease. Paralleling these advances has been the development of several HIV testing technologies including the utilization of qualitative and quantitative molecular (nucleic acid) testing modalities. The latter additions to the testing armamentarium permit the clinical diagnostic laboratory to fulfill its role in partnering with healthcare professionals and specialists in the diagnosis, monitoring and management of HIV disease. Although molecular tests have not been historically included in routine HIV screening protocols, the strategy may change and conform to the model for other diseases of viral etiology.

4:20 Reception in the Exhibit Hall

5:00 Breakout Discussions in the Exhibit Hall
Biomarker Partnerships in Companion Diagnostics 
Moderator: Brian T. Edmonds, Ph.D., Principal Investigator, Integrative Biology/ Global External Research & Development, Lilly Corporate Center 

• Role of partners in biomarker assay development 

• How are deals structured? Who should you partner with? 

• Process of commercializing assays different from commercializing drugs 

• Use of companion diagnostics in drug differentiation, dose setting and safety profile

Value-Based Pricing for Molecular Diagnostics
Moderator: Michael Stocum, MS, Managing Director, Personalized Medicine Partners, LLC 

• Optimizing therapeutic and molecular diagnostic combinations to improve outcomes

• Evaluating where novel diagnostics may better inform treatment decisions

• Demonstrating higher efficacy and/or lower risk of side effects of therapeutic regimens

• Investigating current standard of care and where inefficiencies exist in healthcare delivery

• Generating and utilizing clinical data to inform pricing and reimbursement decisions 

Preventative Genomic Medicine
Moderator: Vance Vanier, M.D., Chief Medical Officer, Navigenics and Partner, Mohr Davidow Ventures

• The promise and current state of preventive genomic medicine

• Physician and patient interest

• Clinical data published and forthcoming

• Policy, educational, regulatory, and legal issues

Taking Account of the Limitations of Biomarker Discovery in Cancer
Moderator: Zoltan Szallasi, M.D., Senior Research Scientist, Children's Hospital, Boston, USA, Professor, Danish Technical Uiniversity, Lyngby, Denmark

• Are we ready to face the limitations of genome scale screening based biomarker discovery?

• Worst and best case scenarios: the variables are not independent and this should give us cautious hope if we know how to take advantage of it 

• Can we optimize the efficiency of genome scale screening based biomarker discovery in cancer technical and cohort design related issues

Expression Profiles for Individual Tumors
Moderator: Craig N. Giroux, Ph.D., Associate Professor, Research, Karmanos Cancer Institute, Wayne State University

• How can we best use static snapshots (gene signatures) of a moving target (dynamic tumor progression) to guide cancer treatment?

• How do we deal with tumor heterogeneity and its confounding effects on our ability to distinguish driver from passenger effects in tumor progression?

• Can we define an individual tumor expression profile (private variation) or must we settle for a sub-type classification (common variation)?

• How do we score a gene expression signature: statistical metrics or network topology?

6:00 Close of Day

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