2015 Next Generation Dx Summit

Cambridge Healthtech Institute’s Eighth Annual
Predictive Cancer Biomarkers
Pushing Discovery to Advance Clinical Translation
August 18-19, 2015 | Capital Hilton | Washington, DC


Cancer biomarkers have become an essential component of patient care. With discovery efforts ongoing, the next phase towards translation will involve validation and demonstration of clinical utility. Cambridge Healthtech Institute's Eighth Annual Predictive Cancer Biomarkers will focus on the steps needed to manage the new treatment paradigm from treating clinical symptoms to targeting genomic pathways. Focus will be given to the use of circulating tumor material to follow patients peripherally, both with known metastatic disease and post-surgery. Throughout the event, top cancer researchers will present their latest discoveries, case studies, and best practices to decrease late-stage diagnosis and improve patient outcomes.



Day 1 | Day 2 | Short Courses | Download Brochure 

TUESDAY, AUGUST 18

7:30 am Main Conference Registration & Morning Coffee


IDENTIFYING AND PRIORITIZING MARKERS

8:30 Chairperson’s Opening Remarks

Jennifer Morrissette, Ph.D., Scientific Director, Clinical Cytogenetics Laboratory; Clinical Director, Center for Personalized Diagnostics (CPD), University of Pennsylvania Perelman School of Medicine

8:40 The Vision and the Reality: One Cancer Center’s Journey toward Genomic Medicine

Jeff Boyd, Ph.D., Senior Vice President, Molecular Medicine; The Robert C. Young, MD Chair in Cancer Research; Executive Director, Cancer Genome Institute; Chief, Division of Molecular Pathology; Professor, Cancer Biology Program, Fox Chase Cancer Center

9:10 Ranking Omics Data to Discover Biomarkers

Corrado Priami, Ph.D., President & CEO, The Microsoft Research and University of Trento Centre for Computational and Systems Biology

An approach based on ranking of measurements is presented to identify patient signatures. The signature can be used to define biomarkers with respect to diseases, stratification of patients with respect to interventions or even toxicology of drugs with respect to doses and number of deliveries. I will present the approach and I’ll show examples of its application.

9:40 Databases and Case Review: An In-House Developed Program for a Mid-Sized Academic Laboratory

Jennifer Morrissette, Ph.D., Scientific Director, Clinical Cytogenetics Laboratory; Clinical Director, Center for Personalized Diagnostics (CPD), University of Pennsylvania Perelman School of Medicine

Laboratories are increasingly moving into next generation sequencing (NGS) as the costs have decreased and the technologies have become more robust. There are many choices of how to process and analyze data coming off the machine, some sequencer-specific analysis tools, commercial entities and in-house solutions. This talk will describe a laboratory developed LIMS system, covering sample management, analysis and reporting developed for identification of abnormalities in DNA and RNA used in a clinical laboratory setting.

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


CIRCULATING BIOMARKERS

10:55 Chairperson’s Remarks

Michael J. Heller, Ph.D., Professor, Nanoengineering & Bioengineering, University of California San Diego

11:00 Circulating MicroRNAs and Other Nucleic Acids in Treatment Monitoring

Anton Wellstein, M.D., Ph.D., Professor, Oncology, Georgetown University

This talk will describe the methodology of microRNA analysis from the circulation and application to treatment monitoring. Potential pathway specific findings will also be discussed.

11:30 Detection and Analysis of DNA/RNA Biomarkers from Hematological Cancer, Solid Tumors and TBI Patient Samples

Michael J. Heller, Ph.D., Professor, Nanoengineering & Bioengineering, University of California, San Diego

Fluorescent detection of ccf-DNA/RNA biomarkers from CLL, solid tumor and TBI patient blood and plasma samples (20-100ul) is achieved in 10-15 minutes using an AC dielectrophoretic (DEP) microarray. For CLL, PCR and sequencing results are comparable to “gold standard” procedures. Fragment size analysis is being carried to determine apoptotic and necrotic origins of CLL and solid tumor ccf-DNA, which may ultimately have important diagnostic value.

Janssen12:00 pm NGS of Circulating Tumor Cells from the CELLSEARCH® System

Charles Saginario, Ph.D., Scientist, CRS Labs, Janssen Diagnostics


CLINICAL ANALYSIS OF NGS SAMPLES

12:30 Epigenetic Profiling of DNA Methylation to Categorize Breast Tumor Aggressiveness

Adam Marsh, Ph.D., Associate Professor, Bioinformatics and Computational Biology, University of Delaware

Women with triple-negative genotypes for the 3 common marker mutations for breast cancer are still at significant risk for this disease. We identify a suite of differentially methylated CpG sites between Normal and Tumor breast tissues that indicate a high degree of epigenetic conservation among different triple-negative patients who have developed aggressive breast tumors. Subtle epigenetic shifts in methylation status may provide a key line of evidence for assessing tumor risk and deciding between surgery or therapy.

NuGen1:00 Luncheon Presentation: Targeted NGS Analyses of Clinical Samples for SNPs, CNVs, Gene Fusions and More

Joe Don HeathJoe Don Heath, Ph.D., Vice President, Market Development Diagnostics, NuGEN

A novel approach for custom targeted sequencing of both DNA and RNA will be described. Sensitive variant detection in genomic DNA derived from fresh and FFPE tissues will be demonstrated as well as utilization of the enrichment technology as a rapid, cost-effective tool for the discovery of novel gene fusions and the detection of known, clinically-relevant gene fusions using a 500+ cancer gene screening panel.

1:30 Refreshment Break in the Exhibit Hall with Poster Viewing


PATIENT STRATIFICATION USING NGS DATA

2:00 Chairperson’s Remarks

Louis Fiore, M.D., Executive Director, MAVERIC, Boston VA Healthcare System

2:05 The Department of Veterans Affairs Precision Oncology Program

Louis Fiore, M.D., Executive Director, MAVERIC, Boston VA Healthcare System

The VA Precision Oncology Program systematically genotypes cancer patients and enrolls them into a cohort so that they can be matched to biomarker-driven clinical trials. This talk presents a collaborative model for integration of research and clinical care. The program addresses important issues such as bringing clinical trials to patients, identification of cases across a network of hospitals, sharing of clinical data with research partners and collection of patient-centered and patient-reported outcomes.

2:35 NGS for Patient Screening and Treatment Selection for NCI’s MPACT and Match Trials

P. Mickey Williams, Ph.D., Director, Molecular Characterization Laboratory (MoCha), Frederick National Laboratory for Cancer Research

3:05 Predictive Biomarkers for Targeted Cancer Therapy

Baolin Zhang, Ph.D., Senior Investigator, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration

The ability to identify the subsets of patients with molecularly defined cancers could significantly improve patient outcome. This presentation will discuss the major challenges in the discovery, qualification and regulatory review of predictive cancer biomarkers. Emphasis will be placed on the recent efforts of the US Food and Drug Administration in facilitating the joint development of therapeutic products and in vitro companion diagnostic devices (IVDs) that are essential for the safe and effective use of the corresponding therapeutic products.

KMC-ESA3:35 Automated Multimodal, High-Multiplex, Quantitative Molecular Platform Solution for Complicated Companion Diagnostics 

Lily Kong, Senior Director, Assay Development, Assay Development, Qiagen

Clinicians across multiple disciplines are asking complex questions for tailored therapies. Automated multimodal, high-multiplex, quantitative PCR is the ideal next generation of MDx. Modaplex provides precise, robust and simple solutions to meet the needs of next generation cancer diagnostics and therapeutic modalities. We will discuss how our “All in One Tube” technology makes it possible to develop unique, highly multiplexed, multimodal, quantitative and qualitative IVDs to interrogate dozens of biomarkers in one tube. Using this, drug developers can capture the full value of their therapies.

3:50 Sponsored Presentation (Opportunity Available)

4:05 Refreshment Break in the Exhibit Hall with Poster Viewing


CHALLENGES AND SOLUTIONS FOR NGS LABS

4:50 PANEL DISCUSSION:

Moderator: Robert D. Daber, Ph.D., Director, Research and Development and Sequencing Operations, Bio-Reference Laboratories

Panelists: Avni B. Santani, Ph.D., Assistant Professor, Clinical Pathology, University of Pennsylvania School of Medicine; Scientific Director, Molecular Genetics Laboratory, The Children’s Hospital of Philadelphia

Helen Fernandes, Ph.D., Director, Molecular Pathology, Pathology & Laboratory Medicine, Weill Cornell Medical College

  • Selecting genes for new panels
  • Informatics and analysis
  • Building clinical infrastructure ensure action on mutations

5:50 Wine & Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing

6:50 Close of Day

Day 1 | Day 2 | Short Courses | Download Brochure 

WEDNESDAY, AUGUST 19

7:15 am Registration

7:30 – 8:25 Problem-Solving Breakout Discussions with Continental Breakfast


TRANSLATIONAL STRATEGIES AND CASE STUDIES

8:25 Chairperson’s Opening Remarks

Robert D. Daber, Ph.D., Director, Research and Development and Sequencing Operations, Bio-Reference Laboratories

8:30 Utility of Implementing Clinical NGS Assays as Standard of Care in Oncology

Helen Fernandes, Ph.D., Director, Molecular Pathology, Pathology & Laboratory Medicine, Weill Cornell Medical College

The presentation will address the practical processes that need to be adopted for a NGS-based assay to be run in a routine clinical laboratory. The topics will address specific challenges encountered from the preanalytical to the analytical and postanalytical phases of the process. Details on achieving libraries with optimal quality from various types of specimens will be discussed. Factors that affect the implementation of the analytical process and the variability encountered in the interpretation of variants will be highlighted. Strategies for recognizing and dealing with the barriers will be included.

9:00 Development and Implementation of Clinical NGS Testing: Assay Development and Informatic Challenges

Robert D. Daber, Ph.D., Director, Research and Development and Sequencing Operations, Bio-Reference Laboratories

As genomic technologies continue to advance and new bio-markers emerge, rapid NGS assay development becomes critical in the age of Precision Diagnostics. Here we will discuss emerging methods to capture important biological markers and their associated informatic challenges during both the development and implementation phases.

9:30 Implementation of Clinical Exome Sequencing

Avni B. Santani, Ph.D., Assistant Professor, Clinical Pathology, University of Pennsylvania School of Medicine; Scientific Director, Molecular Genetics Laboratory, The Children’s Hospital of Philadelphia

With the advent of next generation sequencing (NGS), diagnostic laboratories are faced with unprecedented challenges in incorporating this technology in the clinical setting. This presentation will provide a comprehensive overview on the key considerations for implementation of clinical exome sequencing including resource allocation, assay development, compliance, bioinformatics, data management, analysis and interpretation of data.

Vela Diagnostics10:00 Presentation to be Announced

10:30 Coffee Break in Exhibit Hall with Poster Viewing


PLENARY KEYNOTE SESSION: Click here for details 


12:40 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:25 Refreshment Break in the Exhibit Hall with Poster Viewing

1:50 Chairperson’s Opening Remarks


2:00 KEYNOTE PRESENTATION: Monitoring the Cancer Genome in Plasma Using Circulating Tumor DNA

Nitzan Rosenfeld, Ph.D., Senior Group Leader, CRUK-CI, University of Cambridge; CSO, Inivata, Ltd.

Circulating cell-free tumor DNA (ctDNA) can be used to probe cancer genome dynamics via plasma samples. When a biopsy is unavailable, ctDNA can be used as a ‘liquid biopsy’ to assess sensitivity and resistance to targeted therapies. Quantification of ctDNA is informative for cancer prognosis, response or relapse. If cancer progresses, cancer evolution can be studied noninvasively by genome-wide analysis of ctDNA in plasma.


3:00 Close of Predictive Cancer Biomarkers


Day 1 | Day 2 | Short Courses | Download Brochure 

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2015 Brochure

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Premier Sponsor

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