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Tuesday, May 5

7:00 am Conference Registration and Morning Coffee

Implementing Precision Medicine 

8:00 Chairperson’s Opening Remarks

Alan T. Wright, M.D., CMO, Roche Diagnostics Corporation

8:10 Companion Diagnostics – A New Take on Medical Value

Alan T. Wright, M.D., CMO, Roche Diagnostics Corporation

Companion diagnostics are proving value by targeting, monitoring and directing personalized therapies. In the future, companion diagnostics will expand to include both biochemical and physical measurements. Testing can be discrete, periodic or continuous with analyzers that may be remote, worn or implanted. Just as advancements in biochemistry and pharmacology have driven therapeutics, innovations in measurement techniques will revolutionize healthcare.

8:35 Understanding Disease Heterogeneity, Status, Trajectory and Treatment Response to Enable Patient Stratification

Jaya Goyal, Ph.D., Director, Translational Sciences, Value-Based Medicine, Biogen Idec

9:00 Consumer Genetics: What Role in Drug Discovery and Development?

Stephen T. Furlong, Ph.D., Safety Science Lead, AstraZeneca

Genetic testing is rapidly moving from a research tool into the consumer marketplace. This presents some exciting opportunities but also some major challenges relating to how to manage, interpret and regulate this data. This presentation will provide an overview of the genetic technology now available to consumers, implications for using this genetic data in clinical trial design and drug safety, and a summary of the potential impact on the overall drug discovery and development process.

9:25 Multiplexed Biomarkers: Transitioning from Discovery to the Clinic

Robert Neely, Ph.D., Research Investigator, Bioanalytical Sciences, Bristol-Myers Squibb

With the developing need of multiple biomarkers in clinical programs, the need for multiplexed platforms has increased considerably. Multiplexing analytes will save time and sample; however, it will lead to an increase in analytical factors that will need to be assessed during method development and validation. The two most widely used platforms for multiple analyte screening are either a bead based or a planar format. This talk will focus on these platforms and highlight the technical challenges that can arise in a multiplex assay. Specifically, it will focus on the analytical rigor needed to transition from discovery to the clinic.

9:55 Sponsored Presentation (Opportunity Available)

10:10 Coffee Break in the Exhibit Hall with Poster Viewing

10:40 Precision Medicine and Biomarker Development at the NCI

Tracy Lively, Ph.D., Deputy Associate Director, Cancer Diagnosis Program, National Cancer Institute, NIH

The development of predictive markers to guide the use of emerging targeted therapeutic agents requires new approaches to both clinical trials and correlative laboratory science. This talk will present NCI’s experience with novel trial designs, the Exceptional Responders initiative and more effective approaches to the integration of biomarker development into cancer therapy trials.

11:05 Talk Title to be Announced

Carrie Brodmerkel, Ph.D., Director, Immunology Biomarkers, Johnson & Johnson

11:30 Operationally Identifying Pharmacogenetic Variants

Gregory J. Opiteck, Ph.D., Senior Principal Scientist, Merck

Merck has undertaken an enterprise change management initiative to understand the sources of complexity and cost in identifying functionally relevant PGx variation. Finding the inflection points between cost and complexity was key. Merck has now moved to a fully standardized analytical platform which delivers consistent and high quality PGx data on a time scale that is impactful to the decision-making process. Therefore, we are in keeping with a customer-centric model, while reducing demands on operational processes and information systems.

Quest Diagnostics12:00 pm Luncheon Presentation to be Announced

NGS for Biomarker Discovery and Patient Selection 

1:30 Chairperson’s Remarks

Nazneen Aziz, Ph.D., Chief Research Officer & Senior Vice President, Phoenix Children’s Hospital

1:35 Application of NGS for Biomarker Discovery and Patient Selection

Xiaolan Hu, Ph.D., Head, Clinical Genetics, Bristol-Myers Squibb

2:00 Phoenix Children’s Hospital to Address the Unmet Need: Slow Progress in Pediatric Drug Development

Nazneen Aziz, Ph.D., Chief Research Officer & Senior Vice President, Phoenix Children’s Hospital

The need for new drugs in pediatric cancer is acute. Virtually no new therapy has been introduced in the past two decades. Treatment for relapsed patients is lower than in adults yet a large number of childhood cancer patients will relapse. In stark contrast to the rapid introduction of targeted therapies in adults more effective therapies are unavailable in pediatric cancer. PCH will focus on genomic analysis to better understand disease mechanisms to develop new therapeutics for pediatric cancer.

2:25 A General Approach to the Discovery and Translation of Multi-Gene Biomarkers in Drug Discovery and Therapy

Wolfgang Sadee, Dr.rer.nat., Professor & Director, College of Medicine Center for Pharmacogenomics, The Ohio State University

Extensive genetics/genomics studies have yet to account for the estimated heritability of complex traits, including diseases and their treatments. Our discovery pipeline encompasses detailed molecular genetics of target genes – to avoid use of surrogate markers – and large-scale data analytics to reveal phenotype associations involving gene-gene-environment interactions. Discovering frequent regulatory variants in key genes often under positive selection, we are now in a position to develop clinically relevant biomarker panels, demonstrated with examples.

Theranostics Health2:50 A Novel Phospho-Proteomic Diagnostic for Patient Stratification and Therapy Selection for Breast Cancer

Glenn Hoke, Ph.D., Executive Vice President and COO, Theranostics Health™, Inc.

The TheraLink® Assay for Breast Cancer, a commercially available CAP/CLIA test, measures the proteomic signature in patient’s cancer, to provide the activation status for multiple drug targets. Designed for use in the routine clinical setting, this molecular diagnostic assay can identify which patients are more likely to respond to a particular molecularly targeted therapy. Case studies and the design of a prospective trial will be presented.

3:20 Refreshment Break in the Exhibit Hall with Poster Viewing

4:10 Utility of Targeted NGS Panels for Cancer in an Academic Molecular Pathology Laboratory

Helen Fernandes, Ph.D., Associate Professor, Pathology and Laboratory Medicine, Weill Cornell Medical College

The utility of targeted next-generation sequencing-based assays for identification of genomic variants has made significant advances in the field of molecular oncology. Testing panels and platforms have enabled clinical molecular pathology laboratories to expand their testing menu to include NGS assays that can provide information for a more reliable prediction of personalized cancer therapies. Additionally, the assays can identify relevant genes that may have implications for enrollment of the patient in clinical trials. This presentation will focus on the issues involved for optimal performance and implementation characteristics of assays for the identification of somatic variants in solid tumors in an academic molecular pathology laboratory.

4:35 Clinical Impact of NGS Multi-Gene Panels in Diagnosis and Management of Hereditary Cancer Syndromes

James M. Ford, M.D., Associate Professor, Medicine (Oncology) and Genetics, and Director, Stanford Clinical Cancer Genomics Program, Stanford University School of Medicine

Next-generation sequencing-based panels assaying multiple hereditary cancer risk genes are entering clinical use; however, little is known about their yield or effect on clinical management of patients. We have sequenced germline DNA samples from over 400 patients with personal and family histories of breast and ovarian cancer, but without BRCA1/2 mutations, and found ~10% carry potentially pathogenic mutations in other cancer susceptibility genes. Challenges include return of genetic information to patients, clinical management, screening and risk-reducing interventions in individuals with mutations in moderate-penetrance genes and high-penetrance genes in non-syndromic families, and incidental findings.

5:00-6:00 Welcome Reception in the Exhibit Hall with Poster Viewing

5:30 Short Course Registration

6:00-9:00 pm Dinner Short Course*

SC1: Fit-for-Purpose Biomarker Assay Development and Validation 

*Separate registration required

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Wednesday, May 6

7:30 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

Predictive Cancer Biomarkers for Targeted Therapy 

8:25 Chairperson’s Remarks

8:30 Use of Biomarkers for Decision-Making in Breast Cancer Therapy

Dennis J. Slamon, M.D., Ph.D., Chief, Hematology & Oncology, The David Geffen School of Medicine, University of California, Los Angeles

8:55 The Impact of Multiplexed Genotyping in Directing Cancer Care and a Role for Combining Genotype with Histology for Biomarker Discovery

Darrell R. Borger, Ph.D., Director, Biomarker Laboratory, Massachusetts General Hospital and Harvard Medical School

Our laboratory has conducted clinical genotyping in a large academic hospital for 7 years, and we have started to evaluate its impact on expanding targeted therapy options for cancer patients. With the integration of next-generation sequencing technologies, more complex genotypes are now being identified. Subsequently, the integration of histological testing may provide important perspective into the biological function of unknown variants and the ability to identify new biomarkers of response.

9:20 Sponsored Presentations (Opportunities Available)

9:50 Coffee Break in the Exhibit Hall with Poster Viewing

10:45 Genomic Markers Associated with Pathologic Complete Response and Resistance in Triple Negative Breast Cancer

Christos Hatzis, Ph.D., Assistant Professor, Medicine, and Director, Bioinformatics, Breast Medical Oncology, Yale University School of Medicine

Efforts to develop transcriptional predictors of chemotherapy sensitivity in triple negative breast cancer (TNBC) have been met with limited success due to the heterogeneity of this disease. We explored whether genomic differences in the exomes of extremely chemotherapy sensitive and highly chemotherapy resistant TNBC cases could provide clues of chemosensitivity. Although a few genes show response-associated mutational patterns, the chemoresistant cases appear to have higher mutational load and subclonal heterogeneity, suggesting that higher DNA diversity may be associated with chemotherapy resistance. Interestingly, resistant tumors show characteristic mutational spectrum shifts that may suggest heterogeneous branch evolution. These broad measures of genomic diversity could show promise as markers of resistance to chemotherapy.

11:10 Comprehensive Translational Research to Identify Predictive Biomarkers of Lenvatinib in the Preclinical and Clinical Study

Yasuhiro Funahashi, Ph.D., Senior Director, Biomarkers and Personalized Medicine, Eisai

This presentation will cover: 1) systems biology to identify biomarker candidates for Lenvatinib using the cancer cell line panel, 2) translational research to test biomarker candidates in multiple Phase II trials, and 3) biomarker correlative analysis in Phase III trial.

11:35 Identification of Independent Primary Lung Tumors and Intrapulmonary Metastases Using DNA Junctions

George Vasmatzis, Ph.D., Assistant Professor, Laboratory Medicine and Pathology, Mayo Clinic

Distinguishing independent primary tumors from intrapulmonary metastases in non-small-cell carcinoma remains a clinical dilemma with significant clinical implications. Using next-generation DNA sequencing, we developed a chromosomal rearrangement-based approach to differentiate multiple primary tumors from metastasis. Tumor specimens from patients with known independent primary tumors and metastatic lesions were used for lineage test development, which was then applied to multifocal cases. Lung tumors predicted to be independent primary tumors based on different histologic subtype did not share any genomic rearrangements. In cases of lung primary tumor and paired distant metastasis, shared rearrangements were identified in all cases, emphasizing the patient specificity of identified breakpoints. Concordance between histology and genomic data occurred in the majority of cases. Discrepant cases were resolved by genome sequencing. A diagnostic lineage test based on genomic rearrangements from mate-pair sequencing demonstrates promise for distinguishing independent primary from metastatic disease in lung cancer.

12:00 pm Close of Conference

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