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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

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

Detection of ctDNA and Novel Enrichment Methods

10:10 Chairperson’s Opening Remarks

G. Mike Makrigiorgos, Ph.D., DFCI, Harvard Medical School

10:15 Ultrasensitive Measurement of Circulating Tumor DNA to Track Treatment Response and Failure

Abhijit A. Patel, M.D., Ph.D., Assistant Professor, Therapeutic Radiology, Yale University School of Medicine

We have developed an NGS-based method that uses molecular and computational error suppression techniques to enable ultrasensitive detection of ctDNA without prior knowledge of the tumor’s mutation profile. Clinical data will be presented illustrating the utility of this technology for noninvasive monitoring of changes in ctDNA with therapy and with disease progression.

10:40 Novel Methods for Enrichment of Mutations and Differentially Methylated Sequences from Liquid Biopsy Genomes

G. Mike Makrigiorgos, Ph.D., Professor, Radiation Oncology, Dana-Farber Cancer Institute, Harvard Medical School

Circulating DNA is poised to become a widely used tool for repeated assessment of cancer mutation and methylation status during the course of therapy. Removing the high excess wild type DNA fraction from circulating DNA allows enrichment of variant DNA and boosts the potential of all endpoint detection technologies, including sequencing. We present Nuclease-assisted Mutation Enrichment, NaME, a simple and powerful approach to remove wild type DNA from large gene pools simultaneously, in order to focus sequencing on clinically relevant DNA alterations. This single-step approach retains current sample preparation protocols almost unchanged and combines seamlessly with downstream technologies such as HRM, COLD-PCR, ddPCR and next generation sequencing.

11:05 Rare Mutation Enrichment Using Molecular Competition Probes and Primers

David Yu Zhang, Ph.D., Assistant Professor, Bioengineering, Rice University

Low allelic fractions of mutant DNA have potential to be powerful noninvasive cancer biomarkers for early detection and therapy monitoring, but are technically challenging to detect against a large background of similar wild type sequence. We have developed oligonucleotide probes and primers that enrich for single nucleotide variants by a median 890-fold in singleplex setting, and 40-fold in a 70-plex NGS panel setting. We envision that this technology will drastically reduce the cost of targeted sequencing and enable NGS to be used for a variety of screening and confirmatory assays.

11:30 Dynamic Changes in Circulating Tumor DNA in Urine

Hatim Husain, M.D., Assistant Professor, Medicine, Hematology and Oncology, University of California San Diego

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

Circulating Biomarkers to Diagnose and Monitor Disease

2:00 Chairperson’s Remarks

Sok Kean Khoo, Ph.D., Grand Valley State University Michigan

2:05 Clinical Biomarker Development: Well Begun Is Half Done

Xuemei Zhao, Ph.D., Principal Scientist, Translational Molecular Biomarkers, Merck

This presentation will cover: 1) pre-analytical factors have significant influence on clinical biomarker development and qualification, and 2) matrix selection is important in the accurate quantitation of clinical biomarkers.

2:30 Circulating microRNAs as Progression Biomarkers for Parkinson’s Disease

Sok Kean Khoo, Ph.D., Distinguished Associate Professor of Molecular Genomics, Department of Cell & Molecular Biology, Grand Valley State University Michigan

Parkinson’s disease is a progressive neurodegenerative disorder with symptoms and progression rate differing among patients. An accurate and sensitive biomarker to monitor progression and differentiate slow from fast progressors is urgently needed to assist trial decisions and test disease-modifying therapies. Here, we study circulating microRNAs in sera of the DATATOP cohort (early, unmedicated PD) to develop biomarkers that can predict slow/fast progressors and track disease progression.

2:55 Discovery of Circulating Biomarkers for the Early Detection of Lung Cancer

Qihong Huang, M.D., Ph.D., Associate Professor, Tumor Microenvironment & Metastasis, Wistar Institute

We recently identified AKAP4 as a highly accurate blood biomarker for lung cancer detection by an unbiased screening. When 264 lung cancers were compared with 135 controls, the area under the ROC curve (AUC) was 0.9714; when 136 Stage I lung cancers are compared with controls, the AUC is 0.9795; and when lung cancers were compared to 27 controls with histologically confirmed benign lung nodules, a comparison of significant clinical importance, the AUC was 0.9825. Follow-up studies in a small number of resected non-small cell lung cancer (NSCLC) patients revealed a decrease of AKAP4 expression post-surgical resection that remained low in patients in remission and increased with tumor recurrence. AKAP4 is a highly accurate blood biomarker for the early detection of lung cancer and differentiation of malignant from benign lung nodules.

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

4:10 miRNA as a Biomarker for Multiple Sclerosis

Roopali Gandhi, Ph.D., Assistant Professor, Neurology, Head of MS Biomarkers, Brigham and Women’s Hospital, Harvard Medical School

A major challenge in multiple sclerosis (MS) is to develop immune biomarkers that will allow a better understanding of an individual MS patient. The stable expression of miRNAs in plasma and serum makes them the ideal potential candidates to identify immune biomarkers related to MS. In this study, we found that circulating miRNAs are differentially expressed in MS compared to healthy controls and in relapsing remitting versus secondary progressive. Furthermore, we identified miRNAs that are linked to disease worsening. Our findings establish specific miRNAs as readily accessible blood biomarkers to diagnose and monitor disease in MS patients.

4:35 Sifting Treasure from Trash: Mining for Extracellular RNA Markers of Cardiac Remodeling

Saumya Das, M.D., Ph.D., Assistant Professor, Medicine, Harvard Medical School

In this talk we will examine the discovery and validation of novel extracellular RNA biomarkers as prognostic biomarkers that play a functional role in cellular processes important for cardiac remodeling. The challenges of using next-generation sequencing platforms for discovery and the concept of validation based on biology will be further developed.

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

Circulating Tumor DNA as Biomarkers and Diagnostics

8:25 Chairperson’s Remarks

Matthias Holdhoff, M.D., Ph.D., Assistant Professor, Oncology, Johns Hopkins University School of Medicine

8:30 Prognostic Relevance and Genetic Profile of Circulating Tumor Cells and Circulating Tumor DNA in the Late Stage of Small Cell Lung Cancer Patients

Huifeng Niu, Ph.D., Director, Translational Medicine, Takeda Pharmaceuticals

Small cell lung cancer (SCLC) is an aggressive subtype of lung cancer associated with poor survival outcomes. A greater understanding of the molecular profile of this disease is essential for development of novel targeted therapies. As SCLC is rarely treated by surgery and few specimens are available for molecular characterization, there is a need for a readily available, noninvasive method to characterize biomarkers. We undertook a single center prospective study in patients with relapsed refractory (R/R) SCLC for profiling circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA). We measured CTC counts and quantified circulating DNAs from twelve R/R SCLC patients. Moreover, we profiled CTCs or ctDNA from these patients and identified various genetic alterations including gene amplifications. Our results suggest that CTCs and ctDNA can serve as a valuable liquid biopsy for genetic profiling of SCLC patients which may inform treatment options and disease progression, and provide valuable tools for identification of prognostic or predictive biomarkers.

8:55 Cell-Free Biomarkers in Malignancies of the CentralNervous System

Matthias Holdhoff, M.D., Ph.D., Assistant Professor, Oncology, Johns Hopkins University School of Medicine

Tumors of the central nervous system pose a specific challenge in the implementation of cell-free biomarkers due to the presence of the blood-brain barrier (BBB). This session will provide an overview of the clinical need for novel biomarkers for brain cancers, and strategies to bypass BBB-related limitations, including CSF-based approaches, will be highlighted.

9:20 Circulating Tumor DNA: Applications and Challenges

John Simmons, Manager, Research Services, Personal Genome Diagnostics

This talk will discuss novel applications of ctDNA analysis in clinical and pharmaceutical research settings and highlight the major challenges encountered. Recent studies have demonstrated that ctDNA can be effective pharmacodynamic and early response markers for drug development.

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

10:45 Circulating Tumor DNA for Monitoring Diffuse LargeB-Cell Lymphoma

Mark Roschewski, M.D., Clinical Scientist, Lymphoid Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health

Molecular monitoring of treatment response for diffuse large B-cell lymphoma (DLBCL) with circulating tumor DNA offers advantages over conventional methods such as imaging scans. This lecture will highlight emergent technologies that have shown great promise for monitoring treatment in DLBCL, including rational applications and future directions of potential research.

11:10 Liquid Biopsies in the Realm of DNA Methylation as Biomarkers for Monitoring Cancer Relapse

Bodour Salhia, Ph.D., Assistant Professor, Integrated Cancer Genomics, Translational Genomics Research Institute

In the last few years, circulating cell-free (cf)DNA has attracted attention for clinical use in the context of risk prediction, prognostication and prediction of response to chemotherapy in human cancer. The presence of tumor-specific alterations is thought to be the best criterion to assess the tumoral origin of cfDNA. Various types of DNA alterations have been reported in cfDNA, including point mutations, microsatellite instabilities, loss of heterozygosity and DNA methylation. Specifically, aberrant DNA methylation is among the earliest and most chemically stable molecular alterations in cancer, making it a potentially useful biomarker for early detection or risk prediction. Several groups including ours have now reported the detection of tumor-associated methylation changes in cfDNA extracted from plasma or serum. We are specifically interested in the use of circulating DNA methylation biomarkers for the prediction of cancer metastasis in the early stage setting.

11:35 Patient Stratification in Liver Cancer Using Minimally Invasive Biomarkers

Augusto Villanueva, M.D., Ph.D., Assistant Professor, Liver Diseases, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai

Molecular therapies in liver cancer are not selected based on predicted biomarkers of response, and tissue is no longer required for liver cancer diagnosis. This talk will discuss how novel blood-based biomarkers (ctDNA and CTCs) can improve prognosis prediction and treatment allocation in liver cancer patients.

12:00 pm Close of Conference