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Advances in molecular techniques have made it possible to profile and characterize cancer on a molecular basis. Cancer molecular markers will be compared and evaluated using deep sequencing, cancer stem cells and circulating tumor cells. Molecular markers will be assessed for their potential use in clinical settings. This field is revolutionizing cancer treatment and will lead the way to applying these techniques in other disease areas.
RECOMMENDED SHORT COURSES:
Tuesday, February 21
7:00 am Registration
9:40 Grand Opening Refreshment Break in the Exhibit Hall with Poster Viewing
IMPROVING PATIENT OUTCOMES: INTEGRATED GENE MUTATION, EXPRESSION & METHYLATION
11:00 Chairperson’s Opening Remarks
Alan Carter, President, MDx Consulting
11:10 The Science behind Wide-Scale Adoption of Genomic Analysis in the Clinic
Nicholas J. Schork, Ph.D., Director, Biostatistics and Bioinformatics, The Scripps Translational Science Institute; Professor, Molecular and Experimental Medicine, The Scripps Research Institute
The routine use of genomic information in the care of cancer patients is on the horizon due to recent advances in genomic assay development and data analysis techniques as well as the publication of several very compelling case studies. However, the actual routine implementation of genomic analysis in clinical care will require a few items that have yet to be refined. This talk will focus on the more scientific of these items and less on the regulatory and payor-provider relationship items, and include a discussion of annotating genomic alterations of relevance to a patient, matching patient genomic profiles to therapeutic profiles, and monitoring patients objectively.
11:40 DNA Methylation Profiling Defines Clinically Relevant Biological Subsets of Non-Small Cell Lung Cancer
David S. Shames, Ph.D., Scientist, Development Oncology Diagnostics, Genentech, Inc.
This presentation will discuss the discovery and development of DNA methylation biomarkers that are predictive of sensitivity to molecularly targeted agents such as erlotinib. I will talk about some promising new technology platforms that may be useful in the discovery of new biomarkers as well as how to develop quantitative methylation assays in the context of early stage drug development.
12:10 pm Methylation-Based Biomarkers for Predictive and Prognostic Use
Wim van Criekinge, Vice President, Science & Technology, MDx Health
MDxHealth's proprietary Methylation-Specific PCR (MSP) platform identifies DNA methylation-based oncology biomarkers for theranostic applications, utilizing epigenetic sensitization in combination with different next-generation based sequencing approaches. A comprehensive epigenome-wide profiling pipeline has been established. This approach combines a sensitive and specific discovery phase with a smooth transition to analytically validated assays for clinical trial testing. We have been applying these approaches in high throughput mode on samples ranging from model systems like cell-lines and xenografts to primary patient material, in cancer-types ranging from colon, lung, prostate to bladder.
12:40 Luncheon Presentation I
Multiplexing FFPE Samples in Your Lab and Achieving Meaningful Results
BJ Kerns, Senior Vice President, HTG Molecular
Learn how qNPA technology produces significant data from FFPE tissue with no extraction. Successfully quantitating multiple genes in a single well from FFPE differentiates qNPA technology from traditional gene expression methods.
1:10 Luncheon Presentation II
Miniaturized Biomarker Assays in Complex Biological Samples for Drug Discovery and Clinical Trials
Haris Jamil, Ph.D., Vice President, Research, NanoInk, Inc.
1:45 Dessert in the Exhibit Hall with Poster Viewing
2:15 Chairperson’s Remarks
2:20 Integrated Molecular Testing and the Critical Need to Engage Physicians
William G. Loudon, M.D., Ph.D., Assistant Professor, Neurosurgery, University of California Irvine; Section Chief, Neurosurgery, Children’s Hospital of Orange County
2:50 A New Paradigm for Advancing Personalized Medicine: The Contract Diagnostics Organization
Philip D. Cotter, Ph.D., F.A.C.M.G., Co-Founder, ResearchDx, LLC.
3:05 Wrap Up/Debate: Is Integration Realistic?
- No clear regulatory trajectory for such tests and considerable uncertainty
- Cost issues associated with a thorough (prospective) validation
- Availability of suitable tumor tissue
3:35 Biochip Array Technology – A Rapid Multiplex Solution for Mutation Profiling, SNP Genotyping and Pathogen Detection
Scott McKeown, Ph.D., R&D Consultant, Randox Laboratories
Biochip Array Technology is a class-leading multiplex platform, which in combination with a proprietary multiplex PCR amplification process is capable of simultaneous detection of up to 22 mutations, SNPs or pathogen biorecognition elements, with applications developed for oncology (KRAS/BRAF/PIK3CA mutation profiling), cardiovascular disease (risk SNP array) pharmacogenomics and infectious diseases (including sexually transmitted infections and respiratory pathogens). Data from clinical validation studies for a number of these arrays will be presented.
3:50 Integrated Biomarker Discovery: Multi-Method Approach to Enable Early Biomarker Success
Graham Speight, Ph.D., Head of Genomic Biomarkers, Oxford Gene Technology
How high throughput biomarker discovery can enable richdatasets for rapid proof of concept, analysis and validation.
4:20 Reception in the Exhibit Hall (Sponsorship Available)
5:20 Breakout Discussions in the Exhibit Hall
Concurrent problem solving breakout discussions, open to all attendees, speakers, sponsors, and exhibitors, provide a forum for discussing key issues and meeting potential collaborators. Plan to take part and explore these topics in-depth. Please pick a topic of your choice, find your table and join in
Cancer, a Molecular Pathology
Moderator: Harry Glorikian, Scientia Advisors
Has the time come where we can treat cancer for what it is – a molecular disease rather than an anatomic malady?
Enabling technologies (e.g., NGS)
Regulators – Following its recent guidance on companion diagnostics, could the FDA approve a molecular indication (e.g., EML4/ALK cancers vs. NSCLC with EML4/ALK)?
Reimbursers – How should novel diagnostics –or off-label drug use in the interim– be reimbursed?
Pharma – Can pan-cancer clinical trials be developed?
Impact of potential changes in cancer care
On the FDA – How will the organization react?
On pharma and emerging diagnostics players – How will they build a sustainable business model?
Maximizing Results Despite Small Sample Size
Moderator: David A. Eberhard, M.D., Ph.D., Associate Professor, Comprehensive Cancer Center and Research Associate Professor, Pathology & Lab Medicine, University of North Carolina, Chapel Hill
Sample quantity and quality: fit-for-purpose, tradeoffs, QC
Aligning sample, assay and intended result
Sample preparation to maximize results
Assay techniques/platforms that maximize results
From Data to Diagnosis: NGS in the Clinic
Moderator: Fuad Gwadry, Bioinformatics Consultant
Adoption of WGS in the Clinic: Hurdles and Potential Solutions
Moderator: Katherine Tynan, Business Development & Strategic Consulting, Tynan Consulting LLC
Developments in Diagnostics: Enabling Personalized Medicine
Moderator: Harald Kraushaar, Ph.D., Vice President & Head of Business Development, BioSciences, Sony DADC
Genomic testing: LDTs and IVD diagnostics
Microarrays vs. whole genome sequencing
Is sensitivity a driver for new diagnostics for PM?
Unmet needs and upcoming solutions
Innovative Techniques for Characterization of CTCs
Moderator: John F. Zhong, Ph.D., Assistant Professor, Pathology; Director, Bioinformatics, Gene Therapy Laboratories, University of Southern California School of Medicine
Which cell is a CTC
Define CTC with biomarker, DNA mutation or transcriptome
Heterogeneity of CTC population
Dynamic changes of CTC population for treatment evaluation
Challenge of CTC molecular analysis
CTCs: Value for Diagnostics, Therapeutics, and Cancer Personalized Medicine
Moderator: Enal Razvi, Ph.D., Biotechnology Analyst
CTCs in various cancer types, their origin, and role in metastasis
CTC isolation and characterization tools & technologies
CTCs in cancer personalized medicine: diagnostic and therapeutic optimization
Emerging trends and themes in the CTCs marketplace
Characterization of CTCs
Moderator: Yvon E. Cayre, M.D., D.Sci., Professor, Pierre and Marie Curie University; CSO, ScreenCell
“Lost in Translation” – How to Turn Candidate Biomarkers into Validated Diagnostic Tests?
Moderator: Yuling Luo, Ph.D., Founder, President & CEO, Advanced Cell Diagnostics, Inc.
What are the current and new ways to validate biomarkers?
What are the main issues in analytical and clinical validation of biomarker assays?
What are the issues with various sample sources (e.g. blood, tissue) for biomarker analysis?
What is the impact of cellular and tissue context on biomarker analysis and clinical utility?
What is the impact of quantitation on biomarker analysis and clinical utility?
How simple and robust should a clinical diagnostic test be?
6:20 Close of Day
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