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5:00 – 6:00pm Short Course Registration and Conference Pre-Registration

6:00 – 9:00 Dinner Short Course*

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

*Separate registration required or all access

Tuesday, May 17

7:00 am Conference Registration and Morning Coffee

Opening Plenary Session

8:00 Chairperson’s Opening Remarks

Eric H. Rubin, M.D., Vice President and Therapeutic Area Head, Oncology Early Development, Merck Research Laboratories

8:10 Next Steps in Cancer Immunotherapy

Eric H. Rubin, M.D., Vice President and Therapeutic Area Head, Oncology Early Development, Merck Research Laboratories

The presentation will focus on important next steps in the development of cancer immunotherapies, including understanding mechanisms of resistance to anti-PD-1/PD-L1 treatments, identifying optimal combinations, and identifying individual patient predictors of response or lack of response. In addition, efforts to modify existing imaging-based response classifiers, accounting for the unique mechanism-of-action of immunotherapies, will be discussed.

8:35 Big Data and the Evolution of Precision (Personalized) Medicine

George Poste, Ph.D., Chief Scientist, Complex Adaptive Systems, Professor, Health Innovation, Arizona State University

The rise of precision medicine and data intensive medicine are inextricably linked. Academia, industry and healthcare providers are ill-prepared for this data deluge which will impose profound changes in research and clinical care.

9:00 Multi-Stakeholder Progress on Biomarker Qualification

John Wagner, M.D., Ph.D., Senior Vice President & Head, Clinical & Translational Sciences, Takeda Pharmaceuticals

9:25 Coffee Break in the Exhibit Hall with Poster Viewing

Precision Medicine: Patient Stratification Strategies

10:10 Chairperson’s Opening Remarks

Rebecca Blanchard, Ph.D., Executive Director, Genetics and Pharmacogenomics, Head of Clinical Pharmacogenomics and Operations, Merck

10:15 The Impact of Genomic Research during Drug Development

Rebecca Blanchard, Ph.D., Executive Director, Genetics and Pharmacogenomics, Head of Clinical Pharmacogenomics and Operations, Merck

This presentation will highlight how pharmacogenomic research is becoming routine during drug development. Examples of routine genomic profiling strategies, specific data sets and impact on drug development strategies will be discussed.

10:40 Biomarkers for Patient Stratification and Precision Medicine: Cancer and Beyond

Jaya Goyal, Ph.D., Senior Director, Precision Medicine, Value Based Medicine, Biogen

11:05 Patient Selection Biomarkers—From the PDX Model Directly to the Clinic

Ann Kapoun, Ph.D., Vice President, Translational Medicine, OncoMed Pharmaceuticals

This presentation will cover: 1) the development of predictive biomarkers from PDX in mice to CDx in the clinic, and 2) two preclinical to clinical examples in the Notch pathway for gene and protein-based diagnostics.

ProteinSimple Large11:30 Rapid and Sensitive Analysis of Protein Biomarkers and Human Monoclonal Antibodies with Simple Plex

Gregory Marusov, Research Scientist, Simple Plex Assay Development, ProteinSimple

Standard ELISAs often exhibit poor sensitivity, analyte cross-reactivity, and poor reproducibility. To eliminate these challenges for biomarker analysis, Simple Plex offers a sensitive, low volume bioanalytical format. In this study, we evaluated Simple Plex for human cytokine screening, and measured human monoclonal antibodies for titer and pharmacokinetics. In addition, assays on the single analyte cartridge (72 samples, 1 analyte) transferred to the multi-analyte (16 samples, 4 analytes), with no loss in sensitivity or dynamic range.

12:00 pm Luncheon Presentation: Comparison of Human IL-6 Immunoassays Platforms

Maribeth Raines, Ph.D., Vice President, Laboratory Services, Laboratory Operations, Clinical Biomarkers, Research & Development, Pacific Biomarkers, Inc.

In addition to selecting the correct biomarker for clinical studies, it is also important to select the correct platform for measuring the biomarker so that it meets the needs of the study. Assay performance across various platforms was evaluated using commercial kits available for IL-6. The platforms evaluated include an ELISA kit, Aushon Ciraplex assay, MSD V-plex assay, and Erenna IL-6 Immunoassay. Results comparing the ability to detect endogenous IL-6 in serum, correlation between platforms, and other validation parameters will be discussed.

Genomic Profiling: Mutation Analysis for Personalized Therapy

2:00 Chairperson’s Remarks
Ann Kapoun, Ph.D., Vice President, Translational Medicine, OncoMed Pharmaceuticals

2:05 Clinical Genomics of Solid and Liquid Biopsies in Patients with Solid Tumors

Marc Ladanyi, M.D., Attending Pathologist and Chief, Molecular Diagnostics Service; Member, Human Oncology and Pathogenesis Program, Memorial Sloan-Kettering Cancer Center, New York

2:30 Utility of Multi-Faceted Approaches for Biomarker Discovery

Darrell R. Borger, Ph.D., Director, Biomarker Laboratory, Co-Director, Translational Research Laboratory, Massachusetts General Hospital Cancer Center

The complexity of cancer requires a multi-faceted testing approach to derive a comprehensive molecular fingerprint of a patient’s tumor. The benefits of next-generation sequencing, expression profiling, and histological techniques will be discussed in relation to their benefits in guiding treatment choices and predicting drug response.

2:55 Identification of Patient Subgroups through the Analysis of Blood RNA Profiling Data

Dipen Sangurdekar, Ph.D., Scientist, Computational Biology and Genomics, Biogen

Analysis of peripheral blood RNA collected from the placebo arm of Phase III clinical trial subjects has revealed distinct patient subgroups that share distinct gene expression patterns. These results have the potential to be developed into clinical diagnostic assays that could help guide treatment for medically important diseases.

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

4:10 Gene Expression Profiling of Distinct Non-Small Cell Lung Carcinoma Subclasses Defined by Immunohistochemistry for VEGF Receptors

Timothy R. Holzer, Ph.D., Senior Research Scientist, Diagnostic and Experimental Pathology, Eli Lilly and Company

4:35 Utility of Implementing Clinical NGS Assays as Standard of Care in Oncology

Andrea Ferreira-Gonzalez, Ph.D., Professor and Chair, Division of Molecular Diagnostics, Director, Molecular Diagnostics Laboratory, Department of Pathology, Virginia Commonwealth University

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

5:30 Short Course Registration

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

SC2: Circulating Tumor Cells: Biomarkers for Personalized Oncology

*Separate registration required or all access

Wednesday, May 18

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

Biomarkers to Predict Response to Therapy

8:25 Chairperson’s Remarks
Jason Baum, Ph.D., Director and Diagnostic Project Lead, Companion Diagnostics, Merrimack Pharmaceuticals

8:30 Use of Epigenetic Markers as Markers for Response in Clinical Trials

Jeffrey Waring, Ph.D., Director, Pharmacogenetics and Pharmacogenomics, Abbvie

8:55 Development of a Drug-Response Modeling Framework to Identify Cell Line-Derived Translational Biomarkers that Can Predict Treatment Outcome

Hyunjin (Gene) Shin, Ph.D., Scientist, Translational Medicine, Takeda Pharmaceuticals

Parexel9:20 Extending Precision Medicine Beyond Oncology

Arlene Hughes, Senior Director, Genomic Medicine, Clinical Research Services, PAREXEL

Medicine developers and academic researchers have successfully applied safety pharmacogenomics to identify risk factors for serious adverse events associated with specific medicines. Identification of actionable efficacy predictors has been more limited, particularly outside of oncology. This presentation will highlight the feasibility and value of a more systematic application of efficacy pharmacogenomics across therapy areas to aid medicine development decision making and improve patient outcomes.

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

10:45 Alpha E is the Target for Etrolizumab Treatment for Inflammatory Bowel Disease and May Predict Responses to Treatment

Teresa Ramirez Montagut, Ph.D., Scientist, Development Sciences, Genentech

Etrolizumab, an anti-b7 mAb that targets the integrins a4b7 and aEb7, has shown efficacy in patients with moderate-to-severe ulcerative colitis (UC). Recent data indicates a potential role for aEb7 cells in the pathogenesis of IBD as these cells are high producers of inflammatory cytokines and cytolytic granules, and reside at the epithelial layer of small and large bowel tissue. In the EUCALYPTUS UC Phase II clinical trial, the aE component of aEb7 was identified as a biomarker that may predict responses to etrolizumab treatment. Confirmation of this data in the currently ongoing Phase III UC and CD clinical trials of etrolizumab may be important for delivering the first clinically validated predictive biomarker in IBD.

11:10 The Use of Biomarkers to Identify Mechanisms of Resistance and Restore Sensitivity: The Example of the Bispecific Antibody MM-141 (Istiratumab)

Jason Baum, Ph.D., Director and Diagnostic Project Lead, Companion Diagnostics, Merrimack Pharmaceuticals

Understanding why certain patients are insensitive to standard therapies represents a key unmet medical need. By identifying markers of chemo-resistance, we can then look to restore sensitivity using targeted therapies. MM-141 (istiratumab), an investigational bispecific antibody, co-targets IGF-1R and ErbB3; the co-development of both blood and tissue-based diagnostic tests will be discussed.

11:35 Genomic Markers of Response to Anti-HER2 Therapies in Breast Cancer

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

Anti-HER2 therapies have resulted in significantly improved survival outcomes for HER2-positive breast cancer patients. However, effective markers of response to single or dual blockade agents have not yet been identified. We have used whole exome sequencing of a large HER2-positive clinical cohort to identify critical pathways that are associated with better response and improved survival from dual HER2 blockade when mutated.

12:00 pm Close of Conference