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Molecular Diagnostics 

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Technologies for molecular diagnostics are delivering new tools to the clinical community for faster and more accurate decision making.  Learning what the demands of the community are, where the unmet medical need is, and how the assays can best perform, are critical questions to be asking.  This meeting is the key conference for molecular diagnostics showcasing technologies and criteria for success such as market access and payment.  It will encompass payers and reimbursement, emerging markets, comparative effectiveness, and benefits to clinical trial management and therapy selection for patients.  In its ninth year, this meeting will present the dynamic factors shaping the industry, and the enormous growth opportunities that exist. 


Tuesday, February 21

7:00 am Registration


PLENARY KEYNOTE SESSION  
 Sponsored by 
Hologic Molecular Diagnostics - small logo 

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

KEYNOTE PRESENTATION

11:10 The Science behind Wide-Scale Adoption of Genomic Analysis in the Clinic

Nicholas SchorkNicholas 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.

Sponsored by 
HHTG 

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.

Sponsored by 
nanoink 

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

Sponsored by 
ResearchDX 

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
Sponsored by 
Randox Pharma Services 

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.

Sponsored by 
Oxford Gene Technology 

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.


Drug, Test and Lab
 

Moderator: Mollie Roth, J.D., COO, Diaceutics 

  • How services are delivered
  • The need for real time reporting
  • Quality control and external quality assurance programs
  • Procedures for standardization
  • Making access to the test seamless and ensuring clear, standardized reporting

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)
  • Key hurdles
    • 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?
     

Clinical Utility: Where Regulatory and Reimbursement Meet 

Moderator: Mya Thomae, CEO, Myraqa

Regulations and payer policies are in constant flux, especially with regard to lab-developed tests (LDTs). In this panel, experts from both domains will discuss a strategy that rises to both challenges by emphasizing proof of clinical value.

Outsourcing FDA: Regulated Diagnostic Product Development 

Moderator: Gary Madsen, Ph.D., Biotech Resolutions, LLC

  • Share successes and failures when outsourcing product development (assay development, v&v, clinical trials, etc.) 
  • What are areas of unmet need having high potential for outsourcing activities?  Why? 
  • What areas are of the most concern when outsourcing? 
  • Are there areas that will NEVER be outsourced? 
  • Is there a trend toward more or less outsourcing of development activities?  Why? 

Translating Novel Biomarker Discoveries to the Clinical Lab 

Moderator: David Bourne, Senior Director, Business Development, Luminex Molecular Diagnostics 

  • How will stakeholders deal with the next wave of diagnostic discoveries 
  • Selecting a technology and platform, and downstream considerations 
  • LDT or IVD kit  
  • Outlook for LDT’s in the next 2 – 3 years 

Hire Right the First Time: Interview Techniques That Work

Moderator: Tara Kochis, President, Slone Partners  

  • Learn from recruiting experts
  • Must ask interview questions
  • How to probe and understand a candidate's motivation and why this matters
  • Why do people leave good jobs and how can knowing this help you retain your top talent

6:20 Close of Day



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2014 Premier Sponsors:

 Elsevier   

 

NanoString 

 

Quanterix 

 

RemedyMD 

 

Singulex 

 

Thomson Reuters