Final Agenda 

 

Molecular Diagnostics 



Day 1 | Day 2 | Day 3 | Channel Brochure PDF | Molecular Diagnostics PDF 

Recommended Pre-Conference Short Courses *  

(SC2) Roadmap for Accelerating Commercialization of Molecular Diagnostics (9am-12pm)   

(SC7) Future of Point-of-Care Platforms (2pm-5pm)   

(SC8) Smarter Studies: Designing Efficient and Rigorous Molecular Diagnostics and Biomarker Studies (2pm-5pm)   

(SC10) Business Strategies for Companion Diagnostics (2pm-5pm) 

  

*Separate Registration Required. 

 

 

 

Wednesday, February 23 

7:00 am Registration and Morning Coffee

8:00 Plenary Keynotes - Details 

9:40 Grand Opening Refreshment Break in the Exhibit Hall


KEYNOTE PRESENTATIONS 

11:00 Chairperson’s Opening Remarks

11:10 Massively Parallel Sequencing in Clinical Diagnostics

Wayne GrodyWayne W. Grody, M.D., Ph.D., Professor, Medical Genetics and Molecular Pathology, UCLA School of Medicine

The advent of massively parallel or “next generation” DNA sequencing has finally brought into reach the long-anticipated “Thousand Dollar Genome”, or the ability to sequence an individual’s entire genome at reasonable cost.  Many are predicting that this achievement will supplant the single-gene genetic testing that largely comprises molecular medicine today.  But if so, how will we handle the massive amounts of data produced, distinguish benign variants from pathologic mutations, and convey their clinical implications to doctors and patients? This presentation will review the many considerations that must be faced in developing, validating, performing and reporting these new genome-wide tests. Also considered will be the ethical dilemmas raised by this new technology, including genetic discrimination and privacy, level of government oversight, gene patent restrictions, and direct-to-consumer testing.

11:40 AdvaMed Dx: An Ally in Your Molecular Diagnostics Company’s Future

Andrew Fish, J.D., Executive Director, AdvaMed Dx

AdvaMed Dx is an advocacy organization focused on issues facing in vitro diagnostic (IVD) companies. The membership developed a strategic plan that encompasses global policy initiatives. This talk will cover the highlights of the policy initiatives for all of IVDs and those particularly important to the field of molecular diagnostics.

12:10 Genome-Era Pathology, Precision Diagnostics and Preemptive Care

Jeffrey SaffitzJeffrey E. Saffitz, M.D., Ph.D., Mallinckrodt Professor of Pathology, Harvard Medical School; Chairman, Pathology, Beth Israel Deaconess Medical Center

“Medical sequencing” will revolutionize clinical laboratory diagnostics as the foundation for the new era of personalized medicine.  However, the medical profession lags far behind the technology and business communities in recognizing and preparing for this change.  Applications of genomic technologies in medical practice must be developed and standardized through CAP-accredited, CLIA-certified clinical laboratories.  As a critical first step, we have established a first-in-the-nation pathology training curriculum in genomics and personalized medicine, and we have challenged all ACGME-accredited pathology residency programs in North America to implement a similar program by 2012.  We are also leading a discussion among pathology organizations, private insurance companies, government regulators and policymakers, and the technology community to develop a national plan to incorporate and pay for standardized genomic diagnostics in the practice of medicine.   

 

12:40 Luncheon Presentation

Miniaturized and High Sensitivity Protein Detection Assays Using High Density Multiplex NanoarraysSponsored by
Nanoink logo
 

Haris Jamil, Ph.D., Vice President, Business Development, Nano BioDiscovery 

NanoInk has developed a multiplex protein array technology for the detection and quantification of low abundance biomarkers using small sample volumes. NanoInk’s nanoarraysenables assay miniaturization with improved sensitivity. These protein nanoarrays exhibit improved detection levels over conventional assay technologies with sensitivities for target biomarkers down to the femtograms/ml range.

1:10 Luncheon Presentation

Sponsored by
Thomson Scientific 
Scientific Knowledge or Information? – An Opportunity for Life Science Research Organizations
Colin Williams, Director, Product Strategy, Healthcare and Science, Thomson ReutersThe evolution of high throughput technologies means scientists involved in pharmaceutical and biotechnology research are drowning in information, often creating a barrier to progress. The rate of information generation, through technologies such as next generation sequencing, will continue to grow rapidly. The effective management and utility of information creates an opportunity for Life Science organizations to increase innovation and productivity. Using examples from solutions such as Thomson Reuters Integrity this session will show how tools which link expansive and diverse scientific information create knowledge which can support better decision making and create a competitive advantage in research projects for the organizations which employ them

1:45 Dessert in the Exhibit Hall

 

Translating Next-Generation Sequencing into the Clinical Laboratory: Raising the Bar 

 

2:15 Chairperson’s Remarks

Karl Voelkerding, M.D., Associate Professor, Pathology, University of Utah; Medical Director, Advanced Technology and Bioinformatics, ARUP Laboratories

2:20 Clinical Next-Generation Sequencing for Inherited Cardiomyopathies 

Birgit FunkeBirgit Funke, Ph.D., FACMG , Associate Laboratory Director, Laboratory for Molecular Medicine, Partners HealthCare Center for Personalized Genetic Medicine and Harvard Medical School

Genetic testing for inherited cardiomyopathies has been challenging due to the high level of genetic heterogeneity and high cost of traditional sequencing technologies. Next-Generation Sequencing allows one to maximize the number of genes that can be tested simultaneously while reducing the cost and turnaround time.
 

2:50 The True Value of Next-Generation Sequencing in a Clinical Diagnostics Laboratory

Madhuri Hegde Madhuri Hegde, Ph.D., Associate Professor, Genetics Laboratory, Senior Director, Emory University

Next generation sequencing is now sufficiently mature to begin implementation in a clinical laboratory setting where highly accurate data is required. We describe here the application of gene panel testing in clinical diagnostic testing for three unique panels X-linked mental retardation (93 genes), Congenital Muscular Dystrophy (13 genes) and Congenital disorders of Glycosylation (23 genes).  This presentation will discuss test validation, sequence quality, depth, accuracy, cost analysis and discuss the strength and weaknesses in the utilization of next generation sequencing in clinical testing. 
 

3:20 Bioinformatics for Clinical Next-Generation Sequencing

Karl Voelkerding, M.D., Associate Professor, Pathology, University of Utah; Medical Director, Advanced Technology and Bioinformatics, ARUP Laboratories

Processing, analyzing and interpreting next-generation sequencing data poses multiple challenges for clinical diagnostic implementation. Unique technical and quality monitoring solutions will need to be instituted to successfully translate raw sequence data into a clinical report. This presentation will describe components and examples of bioinformatic pipelines for managing next-generation sequencing data.

      Sponsored by
NuGen
3:50 RNA-Seq Studies of Naïve and Memory Human CD4+ T-cells

Steven Head, Director, NGS and Microarray Cores, The Scripps Research InstituteIn this study we describe optimized methods for RNA-Seq library preparation using the NuGEN Ovation RNA-Seq System for analysis of memory and naïve human CD4+ T-cells. We will present data describing functional pathways that distinguish memory and naive CD4 T cells in both normal donors and kidney transplant patients and how these molecular pathways reflect the intrinsic differences between these two important CD4 T-cell types in response to antigen challenge.

4:20 Reception in the Exhibit Hall (Sponsorship Available)  

5:20 Break-Out Discussions in the Exhibit Hall

Concurrent Problem Solving Break-Out Sessions are interactive, problem solving discussions hosted by a moderator to discuss a topic in depth.  The discussions are open to all attendees, sponsors, exhibitors, and speakers and provide a forum for discussing key issues and meeting potential partners. Please pick a topic of your choice and join in.  

The Value of Microarrays in Molecular Diagnostics – Under-Appreciated or Overrated?

Moderator: Shabbir  M.  Moochhala, Ph.D., Associate Professor, Distinguish Member of the Technical Staff, Defence Medical & Environmental Research Institute, DSO National Laboratories, Singapore

  • Microarrays are widely applied today:
  • From human genotyping to small molecule drug screening
  • From expression profiling to high-throughput toxicological assessments
  • Can microarrays be applied beyond the laboratory, closer to the point of need?
  • Growth areas that leverage on microarray technology
  • Consumer genetics
  • Pharmaceutical drug screening
  • Biomarker discovery
  • Others
  • Commercial opportunities, surveying market trends

Project Management in the Development of an in vitro Diagnostic in a Changing Global Environment

Moderators:  Diane Ward, Ph.D., Senior Director and David Kern, M.B.A., Senior Director, Myraqa, Inc.

  • It's not just the science, the process matters
  • Managing a system
  • Where project management can add value in an IVD environment
  • Alliance management and strategic partnerships

Introducing New Technologies to the FDA

Moderators:  Mya Thomae, RAC, CQA, Founder and CEO, and Lianne McLean, Senior Director, Myraqa, Inc.

  • Is it too early to meet with the FDA to discuss our new technology?
  • Intended use statements
  • Regulatory strategies:  510(k) vs. PMA?
  • Removing the barriers to commercial success

"Do We Have a 'Business Model Problem" or a "Reimbursement Problem" for High Value Diagnostics?

Moderator Katherine Tynan Ph.D., Tynan Consulting LLC

  • What impact does test complexity have on market entry point? 
  • Which delivery mechanism is best, IVD kit or service? 
  • What is the most appropriate sales channel, laboratory or treating physicians? 
  • Who or what are the barriers to adoption? 
  • How will these business factors impact reimbursement? 

Next-Generation Sequencing for Carrier Testing 

Moderator: Stephen Kingsmore, M.B., Ch.B., B.A.O., D.Sc., CSO, National Center for Genome Resources 

  • What is your title and employer name? 
  • How many diseases do you think should be tested for carrier status in general US populations? 
  • At what age do you think carrier testing should ideally be performed in general US populations? 
  • What should be the cost of comprehensive carrier testing? 
  • What do you think are the principal bottlenecks to implementation of comprehensive carrier testing in general US populations? 
  • Do you have another question that you would like us to discuss? 

Targeted Resequencing versus Whole Genome Sequencing 

Moderator: Karl Voelkderding, M.D., Associate Professor, Pathology, University of Utah; Medical Director, Advanced Technology and Bioinformatics, ARUP Laboratories 

Next Generation Sequencing is being applied to multi-gene panels, exomes and whole genomes in clinical research and diagnostics. Each strategy has different cost considerations and complexity of data analysis and interpretation.  

  • What clinical conditions are multi-gene panels being developed for and implemented in clinical laboratories? 
  • How is exome sequencing being applied to discover causative genes for Mendelian disorders? 
  • In what clinical scenarios would whole genome sequencing be applied versus whole exome sequencing? 
  • What consent and counseling approaches should be considered and implemented when using whole exome and genome sequencing in clinical research? 


How Will Consumer Products Companies Make Use of Genomics?

Co-Moderators: Peter S. Miller, Chief Operating Officer, and Keith F. Batchelder, M.D., Chief Executive Officer, Genomic Healthcare Strategies

  • Discussion of some early indications from major companies
  • Some successes and failures so far
  • Discussion of how new markets will be different
  • Where will the next entries be?

Emerging Stakeholders in Personalized Diagnostics

Moderator: Harry Glorikian, Managing Partner, Scientia Advisors

  • Personalized medicine is becoming a critical component of healthcare delivery
  • Current stakeholders are increasingly active and interested in the benefits offered by personalized medicine
  • Emerging stakeholders are creating value-driven services that will impact the future direction of personalized medicine

Discussion on Getting Federal Funding to Develop Early Stage Diagnostic Platforms

Moderator: Mark David Lim, Ph.D., Support to DARPA/Defense Sciences Office, Strategic Analysis, Inc.

  • Landscape of federal funding opportunities for developing novel platform biomedical technologies
  • Funding mechanisms
  • Discussions for engaging program staff

6:20 Close of Day



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2015 MMTC Final Agenda 

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