Clinical Diagnostics and Research

Nov 11-12, 2015
52
165
67,587
 

Blah BlahWelcome to LabRoots’ 6th Annual Clinical Diagnostics & Research free online conference! The event is now available on-demand and you can attend sessions including keynotes sessions by Dr. Linda Thienpont, Katie Serrano, and Dr. Edward Watson Hook, III. Clinical diagnostics is an ever-changing field of medicine and research, challenged with combining several different scientific disciplines into one for the sake of diagnosis and treatment of human disease. Clinical diagnostics has become exciting in recent years as advances in new techniques aid in fulfilling the potential of personalized medicine.

Attendees can earn free CME and CE Credits while watching an impressive group of presenters who will discuss a range of medical, clinical and research topics including:

  • FDA regulation of Laboratory Developed Tests
  • Clinical application of LC-MS/MS
  • Clinical Next-generation Sequencing
  • Toxicology, Laboratory Test Utilization
  • Standardization of Laboratory medicine
  • New lipid lowering guidelines- helpful or harmful?
  • Clinical Genomics and Personalized Healthcare
Our virtual conference allows you to participate in a global setting with no travel or cost to you. You can participate in exactly those parts which you are interested in and be back at your desk or bench in an instant. Virtual events remove time and place restrictions and ensure that everyone who wants to participate can do so. This virtual conference also offers increased reach for the global clinical community with a high degree of interaction through live-streaming video and chat sessions.

By bringing together clinicians, researchers, medical experts and professionals from around the world, LabRoots aims to help drive collaborations and in turn, advances in clinical diagnostics, research and medicine. This complementary conference offers an amazing opportunity to benefit from interacting with a global community of like-minded colleagues from the comfort of home.

Use #BCLclinical to follow the conversation

Continuing Education
The following are continuing medical education (CME) learner objectives that attendees should be able to do as a result of participating in this activity.
  • Ability to contrast previous and newly released guidelines
  • Take action to increase partnership and collaboration with clinicians
  • Identify actions that can be taken to deliver quality results faster to clinicians
  • Better define personalized healthcare today and explain the role of companion diagnostics
  • Better describe diagnostic tools used in the patient workups
  • Better describe how the evolution of laboratory testing in health has impacted the patient
  • Identify the role of the clinical laboratory in contributing to or preventing diagnostic errors
  • Identify laboratory directed interventions that can reduce diagnostic errors
  • Describe analytical issues associated with various assays
  • Recognize the patient safety risks associated with misuse of the clinical laboratory
  • Identify several categories of commonly misused laboratory tests
  • Advise patients on the likely long term effects of certain surgery in patients with diseases
  • Explain levels of personalized medicine as it attempts to predict individual response to therapy

Speakers

(See Agenda)
Professor of Analytical Chemistry, Statistics and ...
Professor of Internal Medicine, Director of the ...
Chief of the Division of Nephrology and ...
Professor, Associated Laboratory Director ...
Professor of Medicine/Epidemiology/Microbiology ...
Senior Global Product Manager, NGS, Qiagen
Global Product Manager, NGS, QIAGEN
Chief, Division of Medical Genomics, Inova ...
Application Scientist, Agilent Technologies
Assistant Professor, Department of Pediatrics ...
Senior Manager, NGS Applications, DNASTAR
Deputy Director, Division of Chemistry and ...
Chairman of Pathology, University of Texas Medical ...
Project Lead for the Clinical Laboratory ...
Associate Director, Genetics and Solid Tumor ...
Clinical Chemistry Fellow, Department of ...
Associate Professor, University of Texas Health ...
Professor, Head of Laboratory, Microbiology and ...
Associate Professor of Pathology (Clinical) ...
Scientific Reviewer, Food and Drug Administration ...
Co-Director, Cardiovascular Laboratory Medicine ...
Professor of Endocrine Bone Research Laboratory ...
Medical Director of Cardiac Rehabilitation and ...
Director, Endocrine Laboratory, Mayo Clinic
President, Medical Technology Partners
Clinical Associate Professor, Dept of ...
Director of Clinical Chemistry, Houston Methodist ...

Clinical Diagnostics and Research

Agenda - Click below each speaker's photo to watch their Webcast

All times are Pacific Time

clinical application of lc-ms/ms-+

Nov 11, 6:00 AM - 7:00 AM PT

A Comprehensive Toxicology Screening Solution Targeted to Individual Needs

Ping Wang, PhD, DABCC, FACB

Director of Clinical Chemistry, Houston Methodist Hospital, Associate Professor, Pathology and Laboratory Medicine, Weill Cornell Medical College

Drugs of abuse toxicology testing by immunoassays is widely used clinically, but also known to be inadequate for many clinical indications. In this presentation, the speaker will outline different reasons for which the provider want clinical toxicology testing, and describe a comprehensive solution using both immunoassays and LC tandem mass spectrometry to target individual needs. The speaker will also discuss the performance details of the LC tandem mass spectrometry method. After completing this activity, the learner will be able to describe several clinical needs for toxicology testing. They will also be able to describe a comprehensive solution for clinical toxicology screening, targeted to these individual needs.
Nov 11, 10:30 AM - 11:30 AM PT

Role of LC/MS/MS spectrometry in diagnosis of various endocrine disorders

Ravinder Singh, PhD

Director, Endocrine Laboratory, Mayo Clinic

    Until recently most of the phenotypic information on congenital endocrine disorders have relied on biochemical testing of steroids, biogenic amines and peptides but is now being combined with the molecular testing.  In spite of the mutational analysis of endocrine disorders the correlation of the phenotype relies more on biochemical testing than the molecular testing.  Immunoassyas have been the methodology of choice for the analysis of steroids and amines in making diagnosis of patients affected with Cushing’s, pheochrmocytoma and congenital adrenal hyperplasia (CAH).  But very often the results from the endocrine laboratory had to be repeated with the HPLC-extraction assays to rule out the possible cross reactivities of the glucocorticoids, steroid metabolites and drugs with the antibody detecting the analyte.   In the past the use of gold standard MS technology in the clinical diagnostic labs have been limited because of labor intensive extraction, sample preparations and chromatographic separations.  Recently the use of MS/MS (tandem MS) technology in liquid and gas chromatography has revolutionized the application of MS technology in clinical laboratories.  This is due to reduction in effort for extraction and chromatography and as a result has a scope for expediting the analysis of steroids, biogenic amines and peptides for the diagnosis of various endocrine disorders. We at Mayo have implemented this technology for the routine analysis of steroids, biogenic amines and peptides. These methods not only provide reliable results for endocrine disorders but also can be used as reference methods by other laboratories and accreditation agencies.

clinical diagnostics-+

Nov 12, 7:30 AM - 8:30 AM PT

Keynote: Reconceptualizing Genital Herpes Diagnosis and Management

Edward Watson Hook, III, MD

Professor of Medicine/Epidemiology/Microbiology, Director, Division of Infectious Diseases, The University of Alabama at Birmingham, Department of Medicine, Division of Infectious Diseases

As one of the nation's most prevalent sexually transmitted infections, genital herpes represents a diagnostic and therapeutic challenge to clinicians, laboratorians and the patients they serve.  Over the past 25 years there has been increasing appreciation that the infection is widespread, impacting over 45 million Americans, and is misunderstood in terms of how the infection is transmitted from person to person, in terms of optimal diagnostic strategies, and in terms of the goals of management for infected persons.  Nucleic acid amplification tests now offer more sensitive methods for virologic testing for the virus and proper use of type-specific serological tests can be helpful in detecting infection an guiding therapeutic decision making.  This presentation will provide an overview of current genital herpes management, emphasizing the role of laboratory testing to improve diagnosis and guide therapy to control clinical manifestations of infection and reduce risk for transmission to others.
Nov 12, 1:30 PM - 2:30 PM PT

Genomics in Public Health Microbiology

Ben Howden, PhD

Professor, Head of Laboratory, Microbiology and Immunology, Director, Microbiological Diagnostic Unit, University of Melbourne

While genomics has been used as a tool for research for many years, globally there is increasing momentum to deploy microbial genomics for routine public health microbiology. This technology has potential broad application in the diagnosis, surveillance, characterisation, and source-tracking for public health pathogens. Genomics also has the potential to replace many microbial typing techniques, and allow real-time, higher resolution national and international characterisation of microbial pathogens. Early successes have been reported in some jurisdictions, including the early recognition of putative foodborne disease outbreaks that have reduced the number of human infections associated with certain contaminated food. Improved tracking of antibiotic resistant microbes through genomics also has the potential to prevent further spread of these pathogens. Significant work is still required to determine how best to transition public health microbiology to a genomics based specialty, including issues of data quality, bioinformatics pipelines, and reporting of results to end-users.

clinical genomics-+

Nov 12, 10:30 AM - 11:30 AM PT

Validation of Mass Spec Analytical Platforms and Proteomic Biomarkers: FDA perspective

Doug Jeffery, PhD

Scientific Reviewer, Food and Drug Administration Center for Devices and Radiological Health

Basic research in Proteomics has led to new understanding of proteins’ contributions to health and disease, and has also driven the advancement of powerful analytical technologies used to explore these contributions.  Translating these discoveries and technologies into in vitro diagnostic (IVD) tests presents expanded opportunities to improve patient care; however, the complexity of these technologies raises challenging questions on how to evaluate the safety and effectiveness of these tests.  Fundamental to using IVDs in the clinic is the demonstration that the tests are safe and effective—that the results claimed are accurate and precise and that the clinical interpretation of the results is supported by science.  The more complex the information gathered, the more challenging is the validation of results; therefore,  FDA will discuss the elements of clinical and analytical validation of IVDs and proteomic technologies the successful transfer of research and discovery-level assays into the clinic.

clinical next-generation sequencing-+

Nov 11, 6:00 AM - 7:00 AM PT

Clinical next-generation sequencing for precision cancer therapeutics

Christina (Tina) Lockwood, PhD, DABCC, FACB

Associate Director, Genetics and Solid Tumor Diagnostics Laboratory, Assistant Professor, Department of Laboratory Medicine, University of Washington

Next-generation sequencing has emerged as a valuable tool for generating patient-specific genetic information for clinical diagnostics and optimal selection of targeted therapies. The heterogeneous somatic mutational landscape in cancer makes NGS technologies particularly appealing due to their ability to accurately and simultaneously detect multiple mutations across many genes.  Accordingly, oncologists are increasingly recognizing the importance of mutation assessment prior to initiating therapy with targeted therapeutic agents.  Issues that must be considered with NGS include technological limitations and opportunities, bioinformatics, test validation requirements, and reporting complexities. Participants will better understand and assess current clinical NGS testing modalities, including the necessary steps required for selecting a NGS assay.  The presentation will specifically emphasize the utility of NGS testing in precision oncology with illustrative case examples.

Learning objectives:

1. Discuss the basic concepts of next-generation sequencing
2. Define the complexities of detecting somatic mutations using tumor-derived DNA
3. Describe the advantages and limitations of clinical NGS for precision oncology
 

fda regulation of laboratory developed tests-+

Nov 11, 9:00 AM - 10:00 AM PT

Keynote: FDA’s Proposed Framework for Regulatory Oversight of Laboratory Developed Tests

Katherine (Katie) Serrano

Deputy Director, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostics and Radiological Health, Food and Drug Administration Center for Devices and Radiological Health

FDA has generally not enforced applicable regulatory requirements on a group of IVD tests called Laboratory Developed Tests.  This use of “enforcement discretion” has been under review by the Agency for many years, and particularly since the Agency hosted a 2010 public meeting on this topic. This presentation will provide a general overview of IVD regulation and a discussion of the current regulatory situation for laboratory developed tests.  The presentation will further discuss FDA’s draft policy guidance for enforcement of applicable regulatory requirements for Laboratory Developed Tests which was published in October of 2014, will provide an overview of the feedback that was received from Stakeholders on this document and will discuss next steps in the guidance finalization process.
Nov 11, 1:30 PM - 2:30 PM PT

Why to validate diagnostic tests?

Wieslaw Furmaga, MD

Associate Professor, University of Texas Health Science Center at San Antonio

This lecture will provide attendees with the knowledge and skills to bring on new clinical laboratory tests in clinical chemistry and molecular diagnostics. The lecture will provide a general overview of the CLIA and CAP regulatory requirements for the implementation of new tests, including conducting test validation, discussing the analytical measurement range (as appropriate for quantitative assays), cut offs for qualitative tests and carry over identification. The lecture will discuss some examples from the areas of clinical chemistry and molecular diagnostics which are related the general principles of validation.
Nov 11, 3:00 PM - 4:00 PM PT

Proposed Rule for the Medicare Clinical Diagnostic Laboratory Test Payment System

Jerry Stringham, MBA

President, Medical Technology Partners

Medical Technology Partner’s presentation is designed highlight what Medicare is proposing to do based on the Protecting Access to Medicare Act of April 1, 2014 with regard to clinical laboratory diagnostic tests in general and Laboratory Developed Tests in particular.

This presentation’s learning objectives are to alert participants that there are:
  • Upcoming proposed changes in how Medicare proposes to pay for Clinical Diagnostic Laboratory Tests (CLDTs)
  • Key reimbursement proposals that could affect Laboratory Developed Tests (LDTs)
  • Easy ways to access the CMS source document and respond before  November 24, 2015

industry-+

Nov 11, 6:00 AM - 7:00 AM PT

Next-generation sequencing for BRCA1 and BRCA2 mutation testing

Raed Samara, PhD

Global Product Manager, NGS, QIAGEN

Cancer is complex, but recent findings are yielding a greater understanding of the disease. The tumor suppressor genes BRCA1 and BRCA2 are implicated in breast, ovarian, prostate, and other cancers.  Studying mutations along the entire length of these genes will bring us closer to winning the fight against cancer, so every base of BRCA1 and BRCA2 is important to your cancer research. QIAGEN recently launched the GeneRead DNAseq BRCA1/2 Targeted Panel covering 100% of the coding region and intron-exon junctions, enabling you to analyze every base of the BRCA1 and BRCA2 genes. This presentation will cover the development, experimental verification, NGS workflow, and data interpretation associated with the BRCA1/2 targeted DNA sequencing panel.
Nov 11, 7:30 AM - 8:30 AM PT

Keynote: Evolution of Standardization in Laboratory Medicine

Linda Thienpont, PhD, PHARM, Clinical Chemist

Professor of Analytical Chemistry, Statistics and Quality Control, Method Development and Validation; Director of the Laboratory for Analytical Chemistry ID-MS Reference Laboratory, University of Ghent, Belgium

There is agreement among clinicians that laboratory analyses are indispensable for correct diagnosis of disease, therapy, and patient monitoring. It is evident that laboratory data should be comparable and independent of measurement system, time, and location, but this is often not the case. The concept of standardization or establishment of metrological traceability has been developed to solve these challenges. Understanding the benefits of traceability of lab results in public healthcare is of increasing importance, and enables the interpretation of results against common reference intervals, development of evidence-based clinical guidelines, translation of research data into patient care and prevention activities, and the inclusion of lab data in electronic patient records. This presentation explains the standardization concept in detail, considering both defined analytes (e.g., creatinine, cholesterol, glucose) and analytes that are not unequivocally defined. One example will focus on serum TSH measurement, a typical heterogeneous glycoprotein. Potential non-commutability encountered with artificial reference materials in the standardization/harmonization process will be discussed, as will the use of large panels of clinically relevant samples to ensure commutability. Implementation in practice may be the biggest challenge, particularly in cases where the standardization process has a major impact on the values the clinical lab community is familiar with. Hence, education of all stakeholders is critical. In addition, the need for continual assessment will be demonstrated by examples.

Learning Objectives: 

1)  Identify rationale and benefit for standardization in lab medicine
2)  Describe basic design and evolution of standardization process
3)  Learn the importance of using panels of clinically relevant samples in standardization process
4)  Identify requirements to be met before standardization can be implemented
5)  Understand what is required after standardization
Nov 11, 10:30 AM - 11:30 AM PT

Agilent StreamSelect LC/MS System: Future solutions for the high throughput lab

Kevin McCann, BS

Application Scientist, Agilent Technologies

Liquid chromatography triple quadrupole mass spectrometry (LC/MS/MS) is ideally suited for the direct and rapid analysis of prepared biological samples. While analysis times can be shortened through appropriate LC method choices, a user is often interested in only a portion of the total data collected by an LC/MS system. Typically, there is time during each chromatographic separation where no compounds of interest are being analyzed by the mass spectrometer, leaving the instrument under-utilized. The Agilent StreamSelect LC/MS Solution eliminates instrument idle time and maximizes productivity using highly integrated, intuitive software that allows users to run parallel HPLC streams in a staggered fashion. This system can provide up to four times the throughput of a traditional LC/MS system while remaining compatible with existing LC/MS methods. Through this presentation, attendees will learn about the various workflows supported by the Agilent StreamSelect LC/MS system and the quantitative performance achieved with this instrument.
Nov 11, 12:00 PM - 1:00 PM PT

DNASTAR Software for Accurate Variant Detection and Validation in Targeted Gene Panel Data Sets

Matthew Keyser, MS

Senior Manager, NGS Applications, DNASTAR

DNASTAR offers an integrated suite of software for accurate assembly, alignment, and analysis of sequence data from all major next-generation sequencing platforms, supporting key workflows including targeted resequencing and variant detection. The DNASTAR gene panel workflow supports all gene panel sets from Illumina and Ion Torrent, as well as custom gene panel data sets. The efficiency of variant detection in gene panels is determined by multiple factors, including specificity of primers and probes used for gene panel design; efficiency of the sequencing technology; accuracy of assembly; accuracy of variant calling; and stringency of variant filters. When gene panel sequencing data is used in conjunction with a validated variant data set, DNASTAR software can calculate variant calling sensitivity, specificity, and accuracy. By utilizing this workflow, users can validate their entire gene panel assembly and analysis process and the speed and accuracy of DNASTAR software.
Nov 11, 1:30 PM - 2:30 PM PT

Improving Diagnostic Testing and Interpretation of Chronic Kidney Disease (CKD)

Kevin J Martin, MD, MB, BCh, FASN

Professor of Internal Medicine, Director of the Division of Nephrology, Saint Louis University School of Medicine

Diagnosis and management of CKD requires a spectrum of diagnostic tests to not only diagnose kidney function but also determine the status of other complications due to CKD, including creatinine, BUN, phosphorous, calcium, intact PTH, vitamin D, cystatin C, urinary albumin, urinalysis, EPO, and cardiac markers. In order to best assist physicians in the management of CKD, it is important that the laboratory is well versed in the specific tests used, improvements made to tests over time, and opportunities for improvement. Clinicians should know how to use tests appropriately in patient treatment across the continuum of CKD care.

Learning Objectives 
  1. Understand improvements in CKD diagnostic testing and also examine other opportunities for analytical improvement focusing on the measurement of PTH, vitamin D compounds, and bone markers. 
  2. Review case studies demonstrating the clinical application of these tests for patient management across the spectrum of CKD and ESRD.
Stuart M Sprague, DO, FACP, FASN, FNKF

Chief of the Division of Nephrology and Hypertension, and Director of Nephrology Research at NorthShore University HealthSystem and Clinical Professor of Medicine at the University of Chicago Pritzker School of Medicine

Diagnosis and management of CKD requires a spectrum of diagnostic tests to not only diagnose kidney function but also determine the status of other complications due to CKD, including creatinine, BUN, phosphorous, calcium, intact PTH, vitamin D, cystatin C, urinary albumin, urinalysis, EPO, and cardiac markers. In order to best assist physicians in the management of CKD, it is important that the laboratory is well versed in the specific tests used, improvements made to tests over time, and opportunities for improvement. Clinicians should know how to use tests appropriately in patient treatment across the continuum of CKD care.

Learning Objectives 
  1. Understand improvements in CKD diagnostic testing and also examine other opportunities for analytical improvement focusing on the measurement of PTH, vitamin D compounds, and bone markers. 
  2. Review case studies demonstrating the clinical application of these tests for patient management across the spectrum of CKD and ESRD.
Nov 12, 9:00 AM - 10:00 AM PT

Use of a CD200R Inhibitor to Overcome Central Nervous System Tumor Induced Immunosuppression

Michael R Olin

Assistant Professor, Department of Pediatrics, Division of Hematology/Oncology, University of Minnesota

Cancer immunotherapy has demonstrated promising results. However, to date, researchers have failed to overcome the complex interplay between the immune system and the immune suppressive tumor microenvironment. Progression to a productive immune response involves passing a number of immunological checkpoints, which act as barriers for productive immunotherapies. To overcome this limitation, the FDA-approved monoclonal antibodies, ipilimumab, pembrolizumab and nivolumab, respectively, which inhibits the cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) and programmed death 1 (PD1) and programmed death 1 ligand (PD-L1) checkpoints. Both anti-CTLA4 and anti-PD1 act directly on T cells. In contrast, a third immunological checkpoint act directly on antigen presenting cells inducing T-cell tolerance. This checkpoint arises from the engagement of CD200 and it’s receptor (CD200R). CD200 is expressed in a variety of human tumors including melanoma and glioblastomas. However, it is the soluble form of CD200 that correlates with poor patient outcome. We reported that CD200 concentration significantly increased in the sera of glioma patients as their tumors progressed, which correlated with increased lineage negative myeloid derived suppressor cell (MDSC) population. We developed an inhibitor of the CD200 (CD200R antagonist) that acts directly on the CD200R on antigen presenting cells overpowering the suppressive properties of CD200. Our CD200R antagonist inhibits myeloid derived suppressor cell expansion, enhances cytokine and chemokine production significantly enhancing survival in both glioma and breast carcinoma tumor models.
Nov 12, 10:30 AM - 11:30 AM PT

Graves’ Disease Assessment: Current Trends in Laboratory Testing

Damien Gruson, PhD

Professor, Associated Laboratory Director, Saint-Luc University Hospital, Brussels, Belgium

Hyperthyroidism is an autoimmune disorder caused by the thyroid stimulating antibody (TSI), active against the thyroid-stimulating hormone (TSH) receptor, which stimulates the gland to synthesize and secrete excess thyroid hormone. It affects approximately 1.5% of the worldwide population. Graves’ disease is the most common cause of hyperthyroidism.
Fast and proper differential diagnosis of Graves’ disease is vital to initiating appropriate treatment as soon as possible. Patient history, physical examination, and diagnostic tools such as imaging and laboratory testing are necessary for proper diagnosis. Choosing the right laboratory tests and interpreting them correctly are critical components of Graves’ disease diagnosis. Currently, a variety of thyroid antibody and hormone assays are available. Understanding the differences between these tests is important to choosing the right assay.

Learning Objectives
  • Understand how clinicians diagnose and monitor Graves’ disease, and why the TSI assay is beneficial from the clinician’s point of view.
  • Learn about the differences between the TSI assay and a thyroid receptor antibody test called TRab. 
  • Review the laboratory needs for proper Graves’ disease assessment.
Nov 12, 1:30 PM - 2:30 PM PT

NGS in clinical research

Jennifer Fostel, MS

Senior Global Product Manager, NGS, Qiagen

Currently, next-generation sequencing is not only being used for basic discovery research but also in clinical settings for translational biomarker profiling and clinical research studies including inherited diseases and cancer.   Implementing a clinical-grade NGS assay is complex as it requires expertise in technology, medicine, and bioinformatics, and as a result, clinical standards for NGS are still being established by regulatory agencies and disease communities.   In addition to technical expertise, there are other strategic decisions that need to be made prior to implementing an NGS assay in a clinical environment.  These include selecting the most appropriate NGS assay for the clinical purpose, laboratory validation of the assay, and choosing a partner lab if you intend to outsource sequencing. The webinar will provide an introduction to some of these questions in NGS clinical research. 

In this webinar you will learn
1.    How NGS data differs from array or qPCR assays
2.    Strategies for NGS sequencing: WGS, WES and Targeted DNA sequencing 
3.    Considerations for validating an NGS assay for clinical use

laboratory test utilization-+

Nov 12, 6:00 AM - 7:00 AM PT

Laboratory Medicine: What should we be measuring?

Brian R Jackson

Associate Professor of Pathology (Clinical), Medical Director of Informatics, ARUP Laboratories, University of Utah, Department of Pathology

As hospitals and healthcare systems move toward value-based care, new management systems are needed to measure and improve clinical processes.  This presents both an opportunity and a challenge for laboratories to move beyond internally-facing perspectives and become better integrated into improving clinical care.  The categories of an ideal measurement system would include cost, patient benefit, and performance quality.  Each of these should be assessed at multiple layers of granularity, from executive summary down to individual item.

Learning Objectives:
  • Identify measures of cost, patient benefit and quality that can together create a comprehensive view of clinical laboratory performance
  • Identify which of these measures are feasible today versus requiring future research.
Nov 12, 10:30 AM - 11:30 AM PT

Pharmacogenetics in the Clinical Laboratory: Opportunities and Challenges

Allison Chambliss, PhD

Clinical Chemistry Fellow, Department of Pathology, Johns Hopkins University School of Medicine

Appropriate dosing of pharmaceuticals is critical to prevent sub-therapeutic efficacy or the occurrence of adverse events. However, genetic variability may significantly influence an individual’s response to a therapeutic agent. Wide genetic variability has been observed in a number of drug-metabolizing enzymes, which are responsible for the activation or inactivation of numerous drug classes. Targeted identification of specific genetic variants may assist in providing the optimal drug at the optimal dose to the correct patient. With the aid of case studies, this presentation will describe representative genetic variants that are known to influence the metabolism of commonly-prescribed medications. The presentation will also explore the current analytical platforms and challenges associated with implementing pharmacogenetic testing in a clinical laboratory environment.

Learning Objectives:

1. Describe the role of genetics in the metabolism of commonly-prescribed medications.
2. Relate genotypes of frequent drug-metabolizing variants to drug activity.
3. Discuss the advantages and disadvantages of current approaches to pharmacogenetic testing.
Nov 12, 12:00 PM - 1:00 PM PT

Keynote: Optimizing the use of laboratory testing services to improve patient diagnosis

Michael Laposata, MD, PhD

Chairman of Pathology, University of Texas Medical Branch

Diagnostic error impacts millions of US adults and children every year1,2.  Failure to order an appropriate diagnostic test and incorrect interpretation of diagnostic test results are common breakdowns in the diagnostic process3.  The Clinical Laboratory Integration into Healthcare Collaborative (CLIHC) TM, supported by the Division of Laboratory Systems at CDC, is addressing diagnostic error using several approaches.  The session will provide information on the frequency of the errors and the impact on patient outcomes.   Participants will learn about causes of diagnostic errors and strategies for reducing them.  Participants will also learn about CLIHCTM initiatives to identify gaps that exist in laboratory medicine training in medical schools and approaches being developed to promote appropriate test utilization, such as the use of test algorithms and mobile applications for test selection.    

Learning Objectives:
1)    Describe the frequency of diagnostic errors and the impact on patient outcomes
2)    Discuss healthcare system failures that may contribute to diagnostic errors 
3)    Identify at least three ways to reduce diagnostic errors 

References:
  1. IOM. Improving Diagnosis in Health Care. Institute of Medicine, 2015.
  2. Singh, H, Meyer, A., Thomas, E,. The frequency of diagnostic errors in outpatient care: estimations from three large observational studies involving US adult populations. BMJ Qual Saf, 0: 1 – 5, 2014
  3. Strategies, C. Malpractice risks in the diagnostic process. 2014
Julie R Taylor, PhD, MS

Project Lead for Clinical Laboratory Integration into Healthcare Collaborative CLIHC, Division of Laboratory Science and StandardsLSPPPO, Centers for Disease Control and Prevention (CDC)

Diagnostic error impacts millions of US adults and children every year1,2.  Failure to order an appropriate diagnostic test and incorrect interpretation of diagnostic test results are common breakdowns in the diagnostic process3.  The Clinical Laboratory Integration into Healthcare Collaborative (CLIHC) TM, supported by the Division of Laboratory Systems at CDC, is addressing diagnostic error using several approaches.  The session will provide information on the frequency of the errors and the impact on patient outcomes.   Participants will learn about causes of diagnostic errors and strategies for reducing them.  Participants will also learn about CLIHCTM initiatives to identify gaps that exist in laboratory medicine training in medical schools and approaches being developed to promote appropriate test utilization, such as the use of test algorithms and mobile applications for test selection.    

Learning Objectives:
1)    Describe the frequency of diagnostic errors and the impact on patient outcomes
2)    Discuss healthcare system failures that may contribute to diagnostic errors 
3)    Identify at least three ways to reduce diagnostic errors 

References:
  1. IOM. Improving Diagnosis in Health Care. Institute of Medicine, 2015.
  2. Singh, H, Meyer, A., Thomas, E,. The frequency of diagnostic errors in outpatient care: estimations from three large observational studies involving US adult populations. BMJ Qual Saf, 0: 1 – 5, 2014
  3. Strategies, C. Malpractice risks in the diagnostic process. 2014
Nov 12, 1:30 PM - 2:30 PM PT

Opportunities to simplify clinical lipid assessment

Howard Morris, PhD, FAACB, FFSc(RCPA)

Professor of Endocrine Bone Research Laboratory, Univ of South Australia

The assessment of serum lipid and lipoprotein levels is a common procedure which affects the management of the risk of atherothrombotic cardiovascular disease (CVD) in large numbers of patients. Traditionally, this led to interpretive comments based on fasting levels of total and HDL cholesterol and calculated or direct measurement of LDL cholesterol (LDL-C). Recent developments have encouraged a broader perspective in which lipid results are considered in the context of other clinical factors. A patient-centred approach favours the consideration of a range of clinical factors, few of which are provided on test request forms. It is increasingly appropriate for lipid results to be discussed in a consultative fashion so that these additional clinical details can be included. Nevertheless, basic lipid results often serve to frame the relevant question and encourage an iterative exchange which might lead to more detailed investigation. Furthermore, new perspectives are emerging concerning the roles of LDL-C, triglyceride, HDL cholesterol and genetic influences. This presentation will consider common scenarios such as predominant hypercholesterolaemia, mixed hyperlipidaemia, massive hypertriglyceridaemia, primary genetic dyslipidaemia and secondary dyslipidaemia. Clinical and therapeutic contexts such as secondary prevention and statin intolerance will also be discussed.
David R Sullivan, MBBS, FRACP, FRCPA

Clinical Associate Professor, Dept of Biochemistry, Royal Prince Alfred Hospital

The assessment of serum lipid and lipoprotein levels is a common procedure which affects the management of the risk of atherothrombotic cardiovascular disease (CVD) in large numbers of patients. Traditionally, this led to interpretive comments based on fasting levels of total and HDL cholesterol and calculated or direct measurement of LDL cholesterol (LDL-C). Recent developments have encouraged a broader perspective in which lipid results are considered in the context of other clinical factors. A patient-centred approach favours the consideration of a range of clinical factors, few of which are provided on test request forms. It is increasingly appropriate for lipid results to be discussed in a consultative fashion so that these additional clinical details can be included. Nevertheless, basic lipid results often serve to frame the relevant question and encourage an iterative exchange which might lead to more detailed investigation. Furthermore, new perspectives are emerging concerning the roles of LDL-C, triglyceride, HDL cholesterol and genetic influences. This presentation will consider common scenarios such as predominant hypercholesterolaemia, mixed hyperlipidaemia, massive hypertriglyceridaemia, primary genetic dyslipidaemia and secondary dyslipidaemia. Clinical and therapeutic contexts such as secondary prevention and statin intolerance will also be discussed.

new lipid lowering guidelines- helpful or harmful?-+

Nov 11, 10:30 AM - 11:30 AM PT

Reliability of LDL cholesterol: How low can we go and when are we fooling ourselves?

Jeffrey Meeusen, PhD, DABCC

Co-Director, Cardiovascular Laboratory Medicine, Mayo Clinic

Aggressive low-density lipoprotein cholesterol (LDL-C) lowering strategies are recommended for prevention of cardiovascular events in high-risk populations. Guidelines recommend a 30-50% reduction in at risk patients even when LDL-C concentrations are between 70 – 130 mg/dL (1.8 – 3.4 mmol/L). Novel PCSK9 inhibitors reduce LDL-C well below previously attainable levels. Calculation of LDL-C by the Friedewald equation is the primary laboratory method for routine LDL-C measurement. However, no recommendations have addressed the appropriate lower reportable limit for calculated LDL-C. This presentation will cover recently published data regarding the accuracy and precision of calculated LDL-C values <130 mg/dL (3.4 mmol/L).
Nov 11, 12:00 PM - 1:00 PM PT

Cholesterol Treatment Guidelines: Controversies and use in clinical practice

Michael Rocco, MD

Medical Director of Cardiac Rehabilitation and Stress Testing, Staff Cardiologist, Cleveland Clinic

In November of 2013 the AHA/ACA jointly proposed new guidelines for the management of hypercholesterolemia, the first full update in over a decade.  The charge was to create evidence based recommendations, whenever possible based on randomized clinical trials and meta-analysis of such trials. The finished product proposed a major paradigm shift in management. Still emphasizing the importance of risk assessment for determining treatment initiation, four groups were identified that would benefit from moderate or high intensity statin therapy in order to achieve cardiovascular risk reduction. Recommendations based the decision regarding moderate or high intensity therapy on the level of cardiovascular risk balanced against risks of intensive therapies. Controversies included elimination of previously proposed and long accepted LDL-C and non-HDL-C treatment goals, a new tool for risk stratification in primary prevention populations and de-emphasis of non-statin therapies. The guidelines did offer an extensive review of cholesterol altering medications and their risks and benefits, expert opinion on how to deal with statin intolerance, recommendations for the use of biomarkers/noninvasive testing in risk assessment and promised swifter integration of new data into future guidelines. However, limiting recommendations to clinical trials also may limit therapeutic recommendations for individuals falling outside these four treatment groups. Concerns were raised about both over treatment and under treatment in certain populations. A careful review of the published statement can address some of the controversies but others still exist. Newer studies with conventional therapies and recently approved therapies may soon trigger a rethinking of the guidelines particularly relative to goals for therapy and combination therapies with statins. Objectives are to review the details of the 2013 guideline, highlight the weaknesses and strengths of the guideline and discuss utilization of these recommendations in current practice.

Clinical application of LC-MS/MS

6:00 AM - 7:00 AM PT

A Comprehensive Toxicology Screening Solution Targeted to Individual Needs

Ping Wang, PhD, DABCC, FACB

Director of Clinical Chemistry, Houston Methodist Hospital, Associate Professor, Pathology and Laboratory Medicine, Weill Cornell Medical College

Drugs of abuse toxicology testing by immunoassays is widely used clinically, but also known to be inadequate for many clinical indications. In this presentation, the speaker will outline different reasons for which the provider want clinical toxicology testing, and describe a comprehensive solution using both immunoassays and LC tandem mass spectrometry to target individual needs. The speaker will also discuss the performance details of the LC tandem mass spectrometry method. After completing this activity, the learner will be able to describe several clinical needs for toxicology testing. They will also be able to describe a comprehensive solution for clinical toxicology screening, targeted to these individual needs.

Clinical Next-generation Sequencing

6:00 AM - 7:00 AM PT

Clinical next-generation sequencing for precision cancer therapeutics

Christina (Tina) Lockwood, PhD, DABCC, FACB

Associate Director, Genetics and Solid Tumor Diagnostics Laboratory, Assistant Professor, Department of Laboratory Medicine, University of Washington

Next-generation sequencing has emerged as a valuable tool for generating patient-specific genetic information for clinical diagnostics and optimal selection of targeted therapies. The heterogeneous somatic mutational landscape in cancer makes NGS technologies particularly appealing due to their ability to accurately and simultaneously detect multiple mutations across many genes.  Accordingly, oncologists are increasingly recognizing the importance of mutation assessment prior to initiating therapy with targeted therapeutic agents.  Issues that must be considered with NGS include technological limitations and opportunities, bioinformatics, test validation requirements, and reporting complexities. Participants will better understand and assess current clinical NGS testing modalities, including the necessary steps required for selecting a NGS assay.  The presentation will specifically emphasize the utility of NGS testing in precision oncology with illustrative case examples.

Learning objectives:

1. Discuss the basic concepts of next-generation sequencing
2. Define the complexities of detecting somatic mutations using tumor-derived DNA
3. Describe the advantages and limitations of clinical NGS for precision oncology
 

Industry

6:00 AM - 7:00 AM PT

Next-generation sequencing for BRCA1 and BRCA2 mutation testing

Raed Samara, PhD

Global Product Manager, NGS, QIAGEN

Cancer is complex, but recent findings are yielding a greater understanding of the disease. The tumor suppressor genes BRCA1 and BRCA2 are implicated in breast, ovarian, prostate, and other cancers.  Studying mutations along the entire length of these genes will bring us closer to winning the fight against cancer, so every base of BRCA1 and BRCA2 is important to your cancer research. QIAGEN recently launched the GeneRead DNAseq BRCA1/2 Targeted Panel covering 100% of the coding region and intron-exon junctions, enabling you to analyze every base of the BRCA1 and BRCA2 genes. This presentation will cover the development, experimental verification, NGS workflow, and data interpretation associated with the BRCA1/2 targeted DNA sequencing panel.

Industry

7:30 AM - 8:30 AM PT

Keynote: Evolution of Standardization in Laboratory Medicine

Linda Thienpont, PhD, PHARM, Clinical Chemist

Professor of Analytical Chemistry, Statistics and Quality Control, Method Development and Validation; Director of the Laboratory for Analytical Chemistry ID-MS Reference Laboratory, University of Ghent, Belgium

There is agreement among clinicians that laboratory analyses are indispensable for correct diagnosis of disease, therapy, and patient monitoring. It is evident that laboratory data should be comparable and independent of measurement system, time, and location, but this is often not the case. The concept of standardization or establishment of metrological traceability has been developed to solve these challenges. Understanding the benefits of traceability of lab results in public healthcare is of increasing importance, and enables the interpretation of results against common reference intervals, development of evidence-based clinical guidelines, translation of research data into patient care and prevention activities, and the inclusion of lab data in electronic patient records. This presentation explains the standardization concept in detail, considering both defined analytes (e.g., creatinine, cholesterol, glucose) and analytes that are not unequivocally defined. One example will focus on serum TSH measurement, a typical heterogeneous glycoprotein. Potential non-commutability encountered with artificial reference materials in the standardization/harmonization process will be discussed, as will the use of large panels of clinically relevant samples to ensure commutability. Implementation in practice may be the biggest challenge, particularly in cases where the standardization process has a major impact on the values the clinical lab community is familiar with. Hence, education of all stakeholders is critical. In addition, the need for continual assessment will be demonstrated by examples.

Learning Objectives: 

1)  Identify rationale and benefit for standardization in lab medicine
2)  Describe basic design and evolution of standardization process
3)  Learn the importance of using panels of clinically relevant samples in standardization process
4)  Identify requirements to be met before standardization can be implemented
5)  Understand what is required after standardization

FDA regulation of Laboratory Developed Tests

9:00 AM - 10:00 AM PT

Keynote: FDA’s Proposed Framework for Regulatory Oversight of Laboratory Developed Tests

Katherine (Katie) Serrano

Deputy Director, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostics and Radiological Health, Food and Drug Administration Center for Devices and Radiological Health

FDA has generally not enforced applicable regulatory requirements on a group of IVD tests called Laboratory Developed Tests.  This use of “enforcement discretion” has been under review by the Agency for many years, and particularly since the Agency hosted a 2010 public meeting on this topic. This presentation will provide a general overview of IVD regulation and a discussion of the current regulatory situation for laboratory developed tests.  The presentation will further discuss FDA’s draft policy guidance for enforcement of applicable regulatory requirements for Laboratory Developed Tests which was published in October of 2014, will provide an overview of the feedback that was received from Stakeholders on this document and will discuss next steps in the guidance finalization process.

Clinical application of LC-MS/MS

10:30 AM - 11:30 AM PT

Role of LC/MS/MS spectrometry in diagnosis of various endocrine disorders

Ravinder Singh, PhD

Director, Endocrine Laboratory, Mayo Clinic

    Until recently most of the phenotypic information on congenital endocrine disorders have relied on biochemical testing of steroids, biogenic amines and peptides but is now being combined with the molecular testing.  In spite of the mutational analysis of endocrine disorders the correlation of the phenotype relies more on biochemical testing than the molecular testing.  Immunoassyas have been the methodology of choice for the analysis of steroids and amines in making diagnosis of patients affected with Cushing’s, pheochrmocytoma and congenital adrenal hyperplasia (CAH).  But very often the results from the endocrine laboratory had to be repeated with the HPLC-extraction assays to rule out the possible cross reactivities of the glucocorticoids, steroid metabolites and drugs with the antibody detecting the analyte.   In the past the use of gold standard MS technology in the clinical diagnostic labs have been limited because of labor intensive extraction, sample preparations and chromatographic separations.  Recently the use of MS/MS (tandem MS) technology in liquid and gas chromatography has revolutionized the application of MS technology in clinical laboratories.  This is due to reduction in effort for extraction and chromatography and as a result has a scope for expediting the analysis of steroids, biogenic amines and peptides for the diagnosis of various endocrine disorders. We at Mayo have implemented this technology for the routine analysis of steroids, biogenic amines and peptides. These methods not only provide reliable results for endocrine disorders but also can be used as reference methods by other laboratories and accreditation agencies.

Industry

10:30 AM - 11:30 AM PT

Agilent StreamSelect LC/MS System: Future solutions for the high throughput lab

Kevin McCann, BS

Application Scientist, Agilent Technologies

Liquid chromatography triple quadrupole mass spectrometry (LC/MS/MS) is ideally suited for the direct and rapid analysis of prepared biological samples. While analysis times can be shortened through appropriate LC method choices, a user is often interested in only a portion of the total data collected by an LC/MS system. Typically, there is time during each chromatographic separation where no compounds of interest are being analyzed by the mass spectrometer, leaving the instrument under-utilized. The Agilent StreamSelect LC/MS Solution eliminates instrument idle time and maximizes productivity using highly integrated, intuitive software that allows users to run parallel HPLC streams in a staggered fashion. This system can provide up to four times the throughput of a traditional LC/MS system while remaining compatible with existing LC/MS methods. Through this presentation, attendees will learn about the various workflows supported by the Agilent StreamSelect LC/MS system and the quantitative performance achieved with this instrument.

New lipid lowering guidelines- helpful or harmful?

10:30 AM - 11:30 AM PT

Reliability of LDL cholesterol: How low can we go and when are we fooling ourselves?

Jeffrey Meeusen, PhD, DABCC

Co-Director, Cardiovascular Laboratory Medicine, Mayo Clinic

Aggressive low-density lipoprotein cholesterol (LDL-C) lowering strategies are recommended for prevention of cardiovascular events in high-risk populations. Guidelines recommend a 30-50% reduction in at risk patients even when LDL-C concentrations are between 70 – 130 mg/dL (1.8 – 3.4 mmol/L). Novel PCSK9 inhibitors reduce LDL-C well below previously attainable levels. Calculation of LDL-C by the Friedewald equation is the primary laboratory method for routine LDL-C measurement. However, no recommendations have addressed the appropriate lower reportable limit for calculated LDL-C. This presentation will cover recently published data regarding the accuracy and precision of calculated LDL-C values <130 mg/dL (3.4 mmol/L).

Industry

12:00 PM - 1:00 PM PT

DNASTAR Software for Accurate Variant Detection and Validation in Targeted Gene Panel Data Sets

Matthew Keyser, MS

Senior Manager, NGS Applications, DNASTAR

DNASTAR offers an integrated suite of software for accurate assembly, alignment, and analysis of sequence data from all major next-generation sequencing platforms, supporting key workflows including targeted resequencing and variant detection. The DNASTAR gene panel workflow supports all gene panel sets from Illumina and Ion Torrent, as well as custom gene panel data sets. The efficiency of variant detection in gene panels is determined by multiple factors, including specificity of primers and probes used for gene panel design; efficiency of the sequencing technology; accuracy of assembly; accuracy of variant calling; and stringency of variant filters. When gene panel sequencing data is used in conjunction with a validated variant data set, DNASTAR software can calculate variant calling sensitivity, specificity, and accuracy. By utilizing this workflow, users can validate their entire gene panel assembly and analysis process and the speed and accuracy of DNASTAR software.

New lipid lowering guidelines- helpful or harmful?

12:00 PM - 1:00 PM PT

Cholesterol Treatment Guidelines: Controversies and use in clinical practice

Michael Rocco, MD

Medical Director of Cardiac Rehabilitation and Stress Testing, Staff Cardiologist, Cleveland Clinic

In November of 2013 the AHA/ACA jointly proposed new guidelines for the management of hypercholesterolemia, the first full update in over a decade.  The charge was to create evidence based recommendations, whenever possible based on randomized clinical trials and meta-analysis of such trials. The finished product proposed a major paradigm shift in management. Still emphasizing the importance of risk assessment for determining treatment initiation, four groups were identified that would benefit from moderate or high intensity statin therapy in order to achieve cardiovascular risk reduction. Recommendations based the decision regarding moderate or high intensity therapy on the level of cardiovascular risk balanced against risks of intensive therapies. Controversies included elimination of previously proposed and long accepted LDL-C and non-HDL-C treatment goals, a new tool for risk stratification in primary prevention populations and de-emphasis of non-statin therapies. The guidelines did offer an extensive review of cholesterol altering medications and their risks and benefits, expert opinion on how to deal with statin intolerance, recommendations for the use of biomarkers/noninvasive testing in risk assessment and promised swifter integration of new data into future guidelines. However, limiting recommendations to clinical trials also may limit therapeutic recommendations for individuals falling outside these four treatment groups. Concerns were raised about both over treatment and under treatment in certain populations. A careful review of the published statement can address some of the controversies but others still exist. Newer studies with conventional therapies and recently approved therapies may soon trigger a rethinking of the guidelines particularly relative to goals for therapy and combination therapies with statins. Objectives are to review the details of the 2013 guideline, highlight the weaknesses and strengths of the guideline and discuss utilization of these recommendations in current practice.

FDA regulation of Laboratory Developed Tests

1:30 PM - 2:30 PM PT

Why to validate diagnostic tests?

Wieslaw Furmaga, MD

Associate Professor, University of Texas Health Science Center at San Antonio

This lecture will provide attendees with the knowledge and skills to bring on new clinical laboratory tests in clinical chemistry and molecular diagnostics. The lecture will provide a general overview of the CLIA and CAP regulatory requirements for the implementation of new tests, including conducting test validation, discussing the analytical measurement range (as appropriate for quantitative assays), cut offs for qualitative tests and carry over identification. The lecture will discuss some examples from the areas of clinical chemistry and molecular diagnostics which are related the general principles of validation.

Industry

1:30 PM - 2:30 PM PT

Improving Diagnostic Testing and Interpretation of Chronic Kidney Disease (CKD)

Kevin J Martin, MD, MB, BCh, FASN

Professor of Internal Medicine, Director of the Division of Nephrology, Saint Louis University School of Medicine

Diagnosis and management of CKD requires a spectrum of diagnostic tests to not only diagnose kidney function but also determine the status of other complications due to CKD, including creatinine, BUN, phosphorous, calcium, intact PTH, vitamin D, cystatin C, urinary albumin, urinalysis, EPO, and cardiac markers. In order to best assist physicians in the management of CKD, it is important that the laboratory is well versed in the specific tests used, improvements made to tests over time, and opportunities for improvement. Clinicians should know how to use tests appropriately in patient treatment across the continuum of CKD care.

Learning Objectives 
  1. Understand improvements in CKD diagnostic testing and also examine other opportunities for analytical improvement focusing on the measurement of PTH, vitamin D compounds, and bone markers. 
  2. Review case studies demonstrating the clinical application of these tests for patient management across the spectrum of CKD and ESRD.
Stuart M Sprague, DO, FACP, FASN, FNKF

Chief of the Division of Nephrology and Hypertension, and Director of Nephrology Research at NorthShore University HealthSystem and Clinical Professor of Medicine at the University of Chicago Pritzker School of Medicine

Diagnosis and management of CKD requires a spectrum of diagnostic tests to not only diagnose kidney function but also determine the status of other complications due to CKD, including creatinine, BUN, phosphorous, calcium, intact PTH, vitamin D, cystatin C, urinary albumin, urinalysis, EPO, and cardiac markers. In order to best assist physicians in the management of CKD, it is important that the laboratory is well versed in the specific tests used, improvements made to tests over time, and opportunities for improvement. Clinicians should know how to use tests appropriately in patient treatment across the continuum of CKD care.

Learning Objectives 
  1. Understand improvements in CKD diagnostic testing and also examine other opportunities for analytical improvement focusing on the measurement of PTH, vitamin D compounds, and bone markers. 
  2. Review case studies demonstrating the clinical application of these tests for patient management across the spectrum of CKD and ESRD.

FDA regulation of Laboratory Developed Tests

3:00 PM - 4:00 PM PT

Proposed Rule for the Medicare Clinical Diagnostic Laboratory Test Payment System

Jerry Stringham, MBA

President, Medical Technology Partners

Medical Technology Partner’s presentation is designed highlight what Medicare is proposing to do based on the Protecting Access to Medicare Act of April 1, 2014 with regard to clinical laboratory diagnostic tests in general and Laboratory Developed Tests in particular.

This presentation’s learning objectives are to alert participants that there are:
  • Upcoming proposed changes in how Medicare proposes to pay for Clinical Diagnostic Laboratory Tests (CLDTs)
  • Key reimbursement proposals that could affect Laboratory Developed Tests (LDTs)
  • Easy ways to access the CMS source document and respond before  November 24, 2015

Laboratory Test Utilization

6:00 AM - 7:00 AM PT

Laboratory Medicine: What should we be measuring?

Brian R Jackson

Associate Professor of Pathology (Clinical), Medical Director of Informatics, ARUP Laboratories, University of Utah, Department of Pathology

As hospitals and healthcare systems move toward value-based care, new management systems are needed to measure and improve clinical processes.  This presents both an opportunity and a challenge for laboratories to move beyond internally-facing perspectives and become better integrated into improving clinical care.  The categories of an ideal measurement system would include cost, patient benefit, and performance quality.  Each of these should be assessed at multiple layers of granularity, from executive summary down to individual item.

Learning Objectives:
  • Identify measures of cost, patient benefit and quality that can together create a comprehensive view of clinical laboratory performance
  • Identify which of these measures are feasible today versus requiring future research.

Clinical Diagnostics

7:30 AM - 8:30 AM PT

Keynote: Reconceptualizing Genital Herpes Diagnosis and Management

Edward Watson Hook, III, MD

Professor of Medicine/Epidemiology/Microbiology, Director, Division of Infectious Diseases, The University of Alabama at Birmingham, Department of Medicine, Division of Infectious Diseases

As one of the nation's most prevalent sexually transmitted infections, genital herpes represents a diagnostic and therapeutic challenge to clinicians, laboratorians and the patients they serve.  Over the past 25 years there has been increasing appreciation that the infection is widespread, impacting over 45 million Americans, and is misunderstood in terms of how the infection is transmitted from person to person, in terms of optimal diagnostic strategies, and in terms of the goals of management for infected persons.  Nucleic acid amplification tests now offer more sensitive methods for virologic testing for the virus and proper use of type-specific serological tests can be helpful in detecting infection an guiding therapeutic decision making.  This presentation will provide an overview of current genital herpes management, emphasizing the role of laboratory testing to improve diagnosis and guide therapy to control clinical manifestations of infection and reduce risk for transmission to others.

Industry

9:00 AM - 10:00 AM PT

Introducing an ancestrally diverse whole genome data set for select cohort and control research applications

Benjamin D Solomon, MD

Chief, Division of Medical Genomics, Inova Translational Medicine Institute, Associate Professor, Virginia Commonwealth University School of Medicine

Introduction and adoption of whole-genome sequencing has enabled new methods of investigation in the quest for answers in diagnostic odyssey cases as well as in the broader study of genetic diversity in affected and healthy populations. Ground breaking studies at the Inova Translational Medicine Institute (ITMI) have generated a data set of nearly 7,000 and growing fully sequenced genomes annotated with familial relationships, ancestral origin and clinical phenotypes. This data set has been the focus of a number of recent publications describing diverse applications including clinical diagnostic cases of children presenting with congenital anomalies and characterization of germline variation in cancer-susceptibility genes in a healthy population, as well as having provided the basis for an exploration of the utility of whole-genome sequencing for detection of newborn screening disorders.
Using these and other studies as examples, we will discuss the importance of having access to such an ancestrally diverse data set in understanding genetic variation and interpreting the likely clinical relevance of individual genomic variants.

Learning Objectives
  1. Appreciate the utility of whole-genome sequencing for diagnostic odyssey cases and cohort analyses
  2. Understand the value of an ancestrally diverse control data set 
  3. Apply allele frequency information in the evaluation of likely pathogenic variants for clinical significance
9:00 AM - 10:00 AM PT

Use of a CD200R Inhibitor to Overcome Central Nervous System Tumor Induced Immunosuppression

Michael R Olin

Assistant Professor, Department of Pediatrics, Division of Hematology/Oncology, University of Minnesota

Cancer immunotherapy has demonstrated promising results. However, to date, researchers have failed to overcome the complex interplay between the immune system and the immune suppressive tumor microenvironment. Progression to a productive immune response involves passing a number of immunological checkpoints, which act as barriers for productive immunotherapies. To overcome this limitation, the FDA-approved monoclonal antibodies, ipilimumab, pembrolizumab and nivolumab, respectively, which inhibits the cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) and programmed death 1 (PD1) and programmed death 1 ligand (PD-L1) checkpoints. Both anti-CTLA4 and anti-PD1 act directly on T cells. In contrast, a third immunological checkpoint act directly on antigen presenting cells inducing T-cell tolerance. This checkpoint arises from the engagement of CD200 and it’s receptor (CD200R). CD200 is expressed in a variety of human tumors including melanoma and glioblastomas. However, it is the soluble form of CD200 that correlates with poor patient outcome. We reported that CD200 concentration significantly increased in the sera of glioma patients as their tumors progressed, which correlated with increased lineage negative myeloid derived suppressor cell (MDSC) population. We developed an inhibitor of the CD200 (CD200R antagonist) that acts directly on the CD200R on antigen presenting cells overpowering the suppressive properties of CD200. Our CD200R antagonist inhibits myeloid derived suppressor cell expansion, enhances cytokine and chemokine production significantly enhancing survival in both glioma and breast carcinoma tumor models.

Clinical Genomics

10:30 AM - 11:30 AM PT

Validation of Mass Spec Analytical Platforms and Proteomic Biomarkers: FDA perspective

Doug Jeffery, PhD

Scientific Reviewer, Food and Drug Administration Center for Devices and Radiological Health

Basic research in Proteomics has led to new understanding of proteins’ contributions to health and disease, and has also driven the advancement of powerful analytical technologies used to explore these contributions.  Translating these discoveries and technologies into in vitro diagnostic (IVD) tests presents expanded opportunities to improve patient care; however, the complexity of these technologies raises challenging questions on how to evaluate the safety and effectiveness of these tests.  Fundamental to using IVDs in the clinic is the demonstration that the tests are safe and effective—that the results claimed are accurate and precise and that the clinical interpretation of the results is supported by science.  The more complex the information gathered, the more challenging is the validation of results; therefore,  FDA will discuss the elements of clinical and analytical validation of IVDs and proteomic technologies the successful transfer of research and discovery-level assays into the clinic.

Industry

10:30 AM - 11:30 AM PT

Graves’ Disease Assessment: Current Trends in Laboratory Testing

Damien Gruson, PhD

Professor, Associated Laboratory Director, Saint-Luc University Hospital, Brussels, Belgium

Hyperthyroidism is an autoimmune disorder caused by the thyroid stimulating antibody (TSI), active against the thyroid-stimulating hormone (TSH) receptor, which stimulates the gland to synthesize and secrete excess thyroid hormone. It affects approximately 1.5% of the worldwide population. Graves’ disease is the most common cause of hyperthyroidism.
Fast and proper differential diagnosis of Graves’ disease is vital to initiating appropriate treatment as soon as possible. Patient history, physical examination, and diagnostic tools such as imaging and laboratory testing are necessary for proper diagnosis. Choosing the right laboratory tests and interpreting them correctly are critical components of Graves’ disease diagnosis. Currently, a variety of thyroid antibody and hormone assays are available. Understanding the differences between these tests is important to choosing the right assay.

Learning Objectives
  • Understand how clinicians diagnose and monitor Graves’ disease, and why the TSI assay is beneficial from the clinician’s point of view.
  • Learn about the differences between the TSI assay and a thyroid receptor antibody test called TRab. 
  • Review the laboratory needs for proper Graves’ disease assessment.

Laboratory Test Utilization

10:30 AM - 11:30 AM PT

Pharmacogenetics in the Clinical Laboratory: Opportunities and Challenges

Allison Chambliss, PhD

Clinical Chemistry Fellow, Department of Pathology, Johns Hopkins University School of Medicine

Appropriate dosing of pharmaceuticals is critical to prevent sub-therapeutic efficacy or the occurrence of adverse events. However, genetic variability may significantly influence an individual’s response to a therapeutic agent. Wide genetic variability has been observed in a number of drug-metabolizing enzymes, which are responsible for the activation or inactivation of numerous drug classes. Targeted identification of specific genetic variants may assist in providing the optimal drug at the optimal dose to the correct patient. With the aid of case studies, this presentation will describe representative genetic variants that are known to influence the metabolism of commonly-prescribed medications. The presentation will also explore the current analytical platforms and challenges associated with implementing pharmacogenetic testing in a clinical laboratory environment.

Learning Objectives:

1. Describe the role of genetics in the metabolism of commonly-prescribed medications.
2. Relate genotypes of frequent drug-metabolizing variants to drug activity.
3. Discuss the advantages and disadvantages of current approaches to pharmacogenetic testing.

Laboratory Test Utilization

12:00 PM - 1:00 PM PT

Keynote: Optimizing the use of laboratory testing services to improve patient diagnosis

Michael Laposata, MD, PhD

Chairman of Pathology, University of Texas Medical Branch

Diagnostic error impacts millions of US adults and children every year1,2.  Failure to order an appropriate diagnostic test and incorrect interpretation of diagnostic test results are common breakdowns in the diagnostic process3.  The Clinical Laboratory Integration into Healthcare Collaborative (CLIHC) TM, supported by the Division of Laboratory Systems at CDC, is addressing diagnostic error using several approaches.  The session will provide information on the frequency of the errors and the impact on patient outcomes.   Participants will learn about causes of diagnostic errors and strategies for reducing them.  Participants will also learn about CLIHCTM initiatives to identify gaps that exist in laboratory medicine training in medical schools and approaches being developed to promote appropriate test utilization, such as the use of test algorithms and mobile applications for test selection.    

Learning Objectives:
1)    Describe the frequency of diagnostic errors and the impact on patient outcomes
2)    Discuss healthcare system failures that may contribute to diagnostic errors 
3)    Identify at least three ways to reduce diagnostic errors 

References:
  1. IOM. Improving Diagnosis in Health Care. Institute of Medicine, 2015.
  2. Singh, H, Meyer, A., Thomas, E,. The frequency of diagnostic errors in outpatient care: estimations from three large observational studies involving US adult populations. BMJ Qual Saf, 0: 1 – 5, 2014
  3. Strategies, C. Malpractice risks in the diagnostic process. 2014
Julie R Taylor, PhD, MS

Project Lead for Clinical Laboratory Integration into Healthcare Collaborative CLIHC, Division of Laboratory Science and StandardsLSPPPO, Centers for Disease Control and Prevention (CDC)

Diagnostic error impacts millions of US adults and children every year1,2.  Failure to order an appropriate diagnostic test and incorrect interpretation of diagnostic test results are common breakdowns in the diagnostic process3.  The Clinical Laboratory Integration into Healthcare Collaborative (CLIHC) TM, supported by the Division of Laboratory Systems at CDC, is addressing diagnostic error using several approaches.  The session will provide information on the frequency of the errors and the impact on patient outcomes.   Participants will learn about causes of diagnostic errors and strategies for reducing them.  Participants will also learn about CLIHCTM initiatives to identify gaps that exist in laboratory medicine training in medical schools and approaches being developed to promote appropriate test utilization, such as the use of test algorithms and mobile applications for test selection.    

Learning Objectives:
1)    Describe the frequency of diagnostic errors and the impact on patient outcomes
2)    Discuss healthcare system failures that may contribute to diagnostic errors 
3)    Identify at least three ways to reduce diagnostic errors 

References:
  1. IOM. Improving Diagnosis in Health Care. Institute of Medicine, 2015.
  2. Singh, H, Meyer, A., Thomas, E,. The frequency of diagnostic errors in outpatient care: estimations from three large observational studies involving US adult populations. BMJ Qual Saf, 0: 1 – 5, 2014
  3. Strategies, C. Malpractice risks in the diagnostic process. 2014

Clinical Diagnostics

1:30 PM - 2:30 PM PT

Genomics in Public Health Microbiology

Ben Howden, PhD

Professor, Head of Laboratory, Microbiology and Immunology, Director, Microbiological Diagnostic Unit, University of Melbourne

While genomics has been used as a tool for research for many years, globally there is increasing momentum to deploy microbial genomics for routine public health microbiology. This technology has potential broad application in the diagnosis, surveillance, characterisation, and source-tracking for public health pathogens. Genomics also has the potential to replace many microbial typing techniques, and allow real-time, higher resolution national and international characterisation of microbial pathogens. Early successes have been reported in some jurisdictions, including the early recognition of putative foodborne disease outbreaks that have reduced the number of human infections associated with certain contaminated food. Improved tracking of antibiotic resistant microbes through genomics also has the potential to prevent further spread of these pathogens. Significant work is still required to determine how best to transition public health microbiology to a genomics based specialty, including issues of data quality, bioinformatics pipelines, and reporting of results to end-users.

Industry

1:30 PM - 2:30 PM PT

NGS in clinical research

Jennifer Fostel, MS

Senior Global Product Manager, NGS, Qiagen

Currently, next-generation sequencing is not only being used for basic discovery research but also in clinical settings for translational biomarker profiling and clinical research studies including inherited diseases and cancer.   Implementing a clinical-grade NGS assay is complex as it requires expertise in technology, medicine, and bioinformatics, and as a result, clinical standards for NGS are still being established by regulatory agencies and disease communities.   In addition to technical expertise, there are other strategic decisions that need to be made prior to implementing an NGS assay in a clinical environment.  These include selecting the most appropriate NGS assay for the clinical purpose, laboratory validation of the assay, and choosing a partner lab if you intend to outsource sequencing. The webinar will provide an introduction to some of these questions in NGS clinical research. 

In this webinar you will learn
1.    How NGS data differs from array or qPCR assays
2.    Strategies for NGS sequencing: WGS, WES and Targeted DNA sequencing 
3.    Considerations for validating an NGS assay for clinical use

Laboratory Test Utilization

1:30 PM - 2:30 PM PT

Opportunities to simplify clinical lipid assessment

Howard Morris, PhD, FAACB, FFSc(RCPA)

Professor of Endocrine Bone Research Laboratory, Univ of South Australia

The assessment of serum lipid and lipoprotein levels is a common procedure which affects the management of the risk of atherothrombotic cardiovascular disease (CVD) in large numbers of patients. Traditionally, this led to interpretive comments based on fasting levels of total and HDL cholesterol and calculated or direct measurement of LDL cholesterol (LDL-C). Recent developments have encouraged a broader perspective in which lipid results are considered in the context of other clinical factors. A patient-centred approach favours the consideration of a range of clinical factors, few of which are provided on test request forms. It is increasingly appropriate for lipid results to be discussed in a consultative fashion so that these additional clinical details can be included. Nevertheless, basic lipid results often serve to frame the relevant question and encourage an iterative exchange which might lead to more detailed investigation. Furthermore, new perspectives are emerging concerning the roles of LDL-C, triglyceride, HDL cholesterol and genetic influences. This presentation will consider common scenarios such as predominant hypercholesterolaemia, mixed hyperlipidaemia, massive hypertriglyceridaemia, primary genetic dyslipidaemia and secondary dyslipidaemia. Clinical and therapeutic contexts such as secondary prevention and statin intolerance will also be discussed.
David R Sullivan, MBBS, FRACP, FRCPA

Clinical Associate Professor, Dept of Biochemistry, Royal Prince Alfred Hospital

The assessment of serum lipid and lipoprotein levels is a common procedure which affects the management of the risk of atherothrombotic cardiovascular disease (CVD) in large numbers of patients. Traditionally, this led to interpretive comments based on fasting levels of total and HDL cholesterol and calculated or direct measurement of LDL cholesterol (LDL-C). Recent developments have encouraged a broader perspective in which lipid results are considered in the context of other clinical factors. A patient-centred approach favours the consideration of a range of clinical factors, few of which are provided on test request forms. It is increasingly appropriate for lipid results to be discussed in a consultative fashion so that these additional clinical details can be included. Nevertheless, basic lipid results often serve to frame the relevant question and encourage an iterative exchange which might lead to more detailed investigation. Furthermore, new perspectives are emerging concerning the roles of LDL-C, triglyceride, HDL cholesterol and genetic influences. This presentation will consider common scenarios such as predominant hypercholesterolaemia, mixed hyperlipidaemia, massive hypertriglyceridaemia, primary genetic dyslipidaemia and secondary dyslipidaemia. Clinical and therapeutic contexts such as secondary prevention and statin intolerance will also be discussed.

Clinical Diagnostics and Research

Continuing Education (CME/CE/CEU) Credits

The speakers below have been approved for CME, CE, or CEU credits. To redeem your credits, locate the presentation you watched and click on the CME/CE/CEU buttons for further direction. For more general information regarding continuing education, the processes to receive credits, and the accreditation bodies, click here.

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A Comprehensive Toxicology Screening Solution Targeted to Individual Needs
11.11.2015 | 06:00:00 AM PT
Ping Wang, PhD, DABCC, FACB
Director of Clinical Chemistry, Houston Methodist Hospital, Associate Professor, Pathology and Laboratory Medicine, Weill Cornell Medical College
Next-generation sequencing for BRCA1 and BRCA2 mutation testing
11.11.2015 | 06:00:00 AM PT
Raed Samara, PhD
Global Product Manager, NGS, QIAGEN
Keynote: Evolution of Standardization in Laboratory Medicine
11.11.2015 | 07:30:00 AM PT
Linda Thienpont, PhD, PHARM, Clinical Chemist
Professor of Analytical Chemistry, Statistics and Quality Control, Method Development and Validation; Director of the Laboratory for Analytical Chemistry ID-MS Reference Laboratory, University of Ghent, Belgium
Agilent StreamSelect LC/MS System: Future solutions for the high throughput lab
11.11.2015 | 10:30:00 AM PT
Kevin McCann, BS
Application Scientist, Agilent Technologies
DNASTAR Software for Accurate Variant Detection and Validation in Targeted Gene Panel Data Sets
11.11.2015 | 12:00:00 PM PT
Matthew Keyser, MS
Senior Manager, NGS Applications, DNASTAR
Use of a CD200R Inhibitor to Overcome Central Nervous System Tumor Induced Immunosuppression
11.12.2015 | 09:00:00 AM PT
Michael R Olin
Assistant Professor, Department of Pediatrics, Division of Hematology/Oncology, University of Minnesota
Pharmacogenetics in the Clinical Laboratory: Opportunities and Challenges
11.12.2015 | 10:30:00 AM PT
Allison Chambliss, PhD
Clinical Chemistry Fellow, Department of Pathology, Johns Hopkins University School of Medicine
Keynote: Optimizing the use of laboratory testing services to improve patient diagnosis
11.12.2015 | 12:00:00 PM PT
Michael Laposata, MD, PhD
Chairman of Pathology, University of Texas Medical Branch
Julie R Taylor, PhD, MS
Project Lead for Clinical Laboratory Integration into Healthcare Collaborative CLIHC, Division of Laboratory Science and StandardsLSPPPO, Centers for Disease Control and Prevention (CDC)

Clinical Diagnostics and Research

Speakers

Linda Thienpont, PhD, PHARM, Clinical Chemist
Professor of Analytical Chemistry, Statistics and Quality Control, Method Development and Validation; Director of the Laboratory for Analytical Chemistry ID-MS Reference Laboratory, University of Ghent, Belgium

Prof. Dr. Linda Thienpont has spent most of her career developing and validating reference measurement procedures, using isotope dilution-gas chromatography and liquid chromatography-mass spectrometry, for the analysis of many components in serum/plasma. These have included clinical chemistry analytes, steroid hormones, thyroid hormones, peptides and vitamin metabolites. By establishing metrological traceability and assessing trueness/accuracy hierarchically lower (routine) methods in laboratory medicine, she has worked with the eminent standardization and certification authorities, in addition to Chairing the IFCC Committee on the Standardization of Thyroid Hormones. She has worked in research projects with different IVD manufacturers world-wide and been involved in proficiency testing/External Quality Assessment Organizations, Accreditation Bodies and Governmental Offices. She has been involved in many educational campaigns and has published more than 168 scientific papers.

Kevin J Martin, MD, MB, BCh, FASN
Professor of Internal Medicine, Director of the Division of Nephrology, Saint Louis University School of Medicine

Dr. Martin is Director of the Division of Nephrology at Saint Louis University and Professor of Internal Medicine. He has served as Chairman of the General Medicine B Study Section of the National Institutes of Health. Dr. Martin’s clinical research interests include parathyroid hormone, Vitamin D metabolism and secondary hyperthyroidism. He has authored 230 publications in professional journals, including The New England Journal of Medicine, Kidney International, and The American Journal of Kidney Diseases and Clinical Journal of the American Society of Nephrology.

Stuart M Sprague, DO, FACP, FASN, FNKF
Chief of the Division of Nephrology and Hypertension, and Director of Nephrology Research at NorthShore University HealthSystem and Clinical Professor of Medicine at the University of Chicago Pritzker School of Medicine

Dr. Sprague is Chief of the Division of Nephrology and Hypertension, and Director of Nephrology Research at NorthShore University HealthSystem and Clinical Professor of Medicine at the University of Chicago Pritzker School of Medicine, Chicago, IL. USA. His clinical focus includes chronic kidney disease, end-stage renal failure, chronic kidney disease-mineral and bone disease, hyperparathyroidism, and osteoporosis in chronic kidney disease.

Damien Gruson, PhD
Professor, Associated Laboratory Director, Saint-Luc University Hospital, Brussels, Belgium

Professor Damien Gruson was awarded his degree of Pharmacist and later of Specialist in Laboratory Medicine from the Catholic University of Louvain, Brussels, Belgium. He joined the Department of Laboratory Medicine of the St-Luc University Hospital in 2008. He is now associated laboratory director and leading Endocrine Biology. He is also member of the research unit on Endocrinolgy Diabetes and Nutrition of the Catholic University of Louvain. Pr. D. Gruson has published numerous articles in several international peer-reviewed journals. Pr. D. Gruson is a member of the committee on distance learning of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), of the IFCC task force for young scientists (Chair between 2010 and 2012 and now consultant), a member of the division of Endocrinology of the American Association of Clinical Chemistry. Pr. D. Gruson is also a Fellow of the European Society of Cardiology.

Edward Watson Hook, III, MD
Professor of Medicine/Epidemiology/Microbiology, Director, Division of Infectious Diseases, The University of Alabama at Birmingham, Department of Medicine, Division of Infectious Diseases

Dr. Hook is a Professor of Medicine and Epidemiology at the University of Alabama, Birmingham, and Director of the STD Control Program for the Jefferson County (Alabama) Department of Health. Dr. Hook’s laboratory has emphasized diagnostic testing for Neisseria gonorrhoeae, Chlamydia trachomatis and syphilis, providing a platform for a wide variety of studies. His laboratory is one of 5 CDC-funded reference laboratories for the Gonococcal Isolate Surveillance Project which has monitored trends in gonococcal epidemiology and antimicrobial resistance in the U.S. since 1988. In addition, data generated by his laboratories have reflected collaboration with other faculty of the Infectious Diseases Division and other Departments within the School of Medicine (Obstetrics and Gynecology, Pediatrics and Microbiology) and other UAB Schools (Public Health, Social and Behavioral Sciences).

Dr. Hook’s recent work has included: studies of health behavior and behavioral interventions for STD/HIV risk reduction; assessment of STD epidemiology; clinical trials of new therapeutic agents; and clinical evaluation of new diagnostic tests for diagnosis of gonorrhea, chlamydial infection and syphilis. Major ongoing research efforts include his role as PI on a randomized trial evaluation of non-invasive screening for gonococcal and chlamydial infections in adolescents seeking care at hospital emergency rooms and as Protocol Chair for a randomized trial evaluation of azithromycin for treatment of syphilis.

Jennifer Fostel, MS
Senior Global Product Manager, NGS, Qiagen

Jennifer Fostel has her masters in Molecular and Cell Biology from University of California at Berkeley. She did her graduate research in Dr. Susan Marqusee’s lab where she analyzed the key properties of proteins from thermophilic and mesophilic microbial species. She has worked in next-generation sequencing for the last seven years, including management of clinical next generation sequencing projects for the Broad Institute of MIT and Harvard as well as NGS biomarker assay development for Takeda Pharmaceuticals oncology translational medicine. Today at QIAGEN Jennifer is a Senior Global Product Manager, covering a portfolio of universal workflow NGS library preparation products.

Raed Samara, PhD
Global Product Manager, NGS, QIAGEN

Raed Samara, PhD is a Global Product Manager for NGS technologies at QIAGEN, with a focus on pre-analytics and targeted enrichment. Prior to joining QIAGEN, he was a postdoctoral fellow at the National Cancer Institute conducting research in the field of cancer immunology with emphasis on identifying strategies to boost the efficacy of cancer vaccines. He received his Ph.D. degree from Georgetown University in tumor biology.

Benjamin D Solomon, MD
Chief, Division of Medical Genomics, Inova Translational Medicine Institute, Associate Professor, Virginia Commonwealth University School of Medicine

Dr. Solomon, an accomplished scientist and medical geneticist, is dual board-certified in pediatrics and clinical genetics through the National Human Genome Research Institute.

At Inova Translational Medicine Institute, Dr. Solomon leads the Medical Genomics division – a group of clinicians and researchers that focuses on providing genetic and genomic medical care, discovering new explanations for genetic disorders, and studying the best ways to integrate cutting-edge genomic resources into clinical practice.

Previously Dr. Solomon held positions at National Institutes of Health researching the genetic and genomic causes of both rare and common conditions, especially certain types of congenital anomalies. The author of over 70 peer-reviewed articles and book chapters, Dr. Solomon serves as an editor on a number of medical journals, has edited several medical textbooks, and is actively involved in genetic and genomic training and education.

Kevin McCann, BS
Application Scientist, Agilent Technologies

Kevin McCann is an application scientist at Agilent Technologies in Santa Clara, California where he focus on LC/MS workflows and solutions. He has contributed to the development of many analytical methods and customer collaborations as well as enabling technologies, such as the Agilent StreamSelect LC/MS system and MassHunter Examiner. Prior to his work at Agilent, Kevin was the laboratory manager of the biochemical genetics laboratory at Mount Sinai Hospital in New York where he also developed LC/MS methods for the analysis of warfarin, tamoxifen, acylcarnitine profiles, and amino acid profiles.

Michael R Olin
Assistant Professor, Department of Pediatrics, Division of Hematology/Oncology, University of Minnesota

For more than 7 years, I have dedicated my efforts to developing immunotherapy for brain tumors. We, among others, have utilized tumor cells as vaccine components, demonstrating promising results with minimal toxicity. However, progression to a productive immune response that necessitates passing a number of immunological checkpoints those act as barriers to effective immunotherapy because of “self” antigen recognition. The FDA-approved monoclonal antibodies ipilimumab, pembrolizumab and nivolumab, which inhibit the cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), programmed death 1 (PD1) and programmed death 1 ligand (PD-L1) checkpoints, respectively, can be used to partially overcome this limitation. Both anti-CTLA-4 and anti-PD1 act directly on T cells, whereas a third immunological checkpoint acts directly on antigen-presenting cells, inducing T-cell tolerance. This checkpoint arises from the engagement of CD200 with its receptor (CD200R). CD200 is expressed in a variety of human tumors including melanoma and glioblastomas. However, it is the soluble form of CD200 that correlates with poor patient outcomes. CD200 has been well characterized as immunosuppressive in multiple graft rejection models, but prior to our work its role in tumor-induced immune suppression had not been clearly defined. We reported that CD200 concentration significantly increased in glioma patients’ sera as their tumors progressed, correlating with increases in the lineage-negative myeloid-derived suppressor cell (MDSC) population. More surprisingly, we have found that CD200 is significantly upregulated on the vascular endothelial cells forming the blood-brain barrier in malignant human brain tissue but not in adjacent, apparently unaffected tissue. We are focusing our research on the development of a competitive CD200 inhibitor (a CD200R antagonist) with the goal of overcoming CD200-induced immune suppression. Our preliminary data show that the CD200R isoform activates antigen-presenting cells; we suggest that this occurs via a CD200R isoform that enhances chemokine and cytokine production required for the development of a tumoricidal response.

Matthew Keyser, MS
Senior Manager, NGS Applications, DNASTAR

Matthew Keyser is Senior Manager, NGS Applications for DNASTAR, where he has helped scientists address their sequence assembly and analysis challenges for the past seven years. Matts sole focus at DNASTAR is supporting customers in next-gen sequencing applications using DNASTARs broad software toolset. Matt helps customers with their templated and de novo assembly projects, transcriptomes, exomes, metagenomic assemblies, RNA-Seq, ChIP-Seq and numerous other unique experiments. Matt has helped hundreds of scientists optimize their workflows using DNASTARs next-gen software solutions. He has also spoken at numerous conferences and workshops regarding the capabilities of DNASTARs next-gen software tools.

Katherine (Katie) Serrano
Deputy Director, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostics and Radiological Health, Food and Drug Administration Center for Devices and Radiological Health

Katherine Serrano is the Deputy Director of FDA’s Division of Chemistry and Toxicology Devices in the Office of In Vitro Diagnostic Device Evaluation and Safety. Ms. Serrano received a Bachelor of Science degree in Biomedical Engineering and a Bachelor of Arts degree in Spanish from the University of Minnesota, Twin Cities. Before working at the Food and Drug Administration, Ms. Serrano has held positions as a regulatory affairs professional at Boston Scientific Corporation and has worked as a Biomedical Engineer at the United States National Institutes of Health supporting new programs focused on cutting edge technologies in the field of bioengineering.

Ms. Serrano joined the FDA in 2008 as a Commissioner’s fellow where she worked on various policy issues related to in vitro diagnostics. At FDA, Ms. Serrano has worked as a scientific reviewer, the Chief of the Diabetes Diagnostic Devices Branch and as the Deputy Director for the Division of Chemistry and Toxicology Devices.

Michael Laposata, MD, PhD
Chairman of Pathology, University of Texas Medical Branch

Dr. Michael Laposata is the Edward and Nancy Fody Professor of Pathology and Medicine at Vanderbilt University School of Medicine. He is the pathologist-in-chief at Vanderbilt University Hospital and director of clinical laboratories. He received his M.D. and Ph.D. from Johns Hopkins University School of Medicine and completed a postdoctoral research fellowship and residency in Laboratory Medicine (Clinical Pathology) at Washington University School of Medicine in St. Louis. He took his first faculty position at the University of Pennsylvania School of Medicine in Philadelphia in 1985, where he was an Assistant Professor and director of the hospital's coagulation laboratory. In 1989, he became Director of Clinical Laboratories at the Massachusetts General Hospital and was appointed to faculty in pathology at Harvard Medical School.

His research program, with more than 160 peer reviewed publications, has focused on fatty acids and their metabolites. His research group is focused on the study of fatty acid alterations in cystic fibrosis.

Dr. Laposata's clinical expertise is in the field of blood coagulation, with a special expertise in the diagnosis of hypercoagulable states.

Dr. Laposata implemented a system whereby the clinical laboratory data in coagulation and other areas of laboratory medicine are systematically interpreted with the generation of a patient specific narrative paragraph by a physician with expertise in the area. This service is essentially identical to the service provided by physicians in radiology and anatomic pathology, except that it involves clinical laboratory test results. In 2005, Dr. Laposata was recognized by the Institute of Quality in Laboratory Medicine of the Centers for Disease Control and Prevention for this innovation.

Dr. Laposata is the recipient of 14 major teaching prizes at Harvard, the Massachusetts General Hospital, and the University of Pennsylvania School of Medicine. His recognitions include the 1989 Lindback award, a teaching prize with competition across the entire University of Pennsylvania system; the 1998 A. Clifford Barger mentorship award from Harvard Medical School; election to the Harvard Academy of Scholars in 2002, and to the Vanderbilt University School of Medicine Academy for Excellence in Teaching in 2009; and the highest award - by vote of the graduating class - for teaching in years 1 and 2 at Harvard Medical School in 1999, 2000, and 2005.

Julie R Taylor, PhD, MS
Project Lead for the Clinical Laboratory Integration into Health Care Collaboration (CLIHC), Division of Laboratory Programs, Standards, and Services Center for Surveillance, Epidemiology, and Laboratory Services Office of Public Health Scientific Services Centers for Disease Control and Prevention

Julie received her B.S. degree in microbiology from the University of Alabama focusing on research in bacterial genetics then completed her M. S. and Ph.D. in microbiology at Auburn University where she studied immunity to bacteria and parasites. She gained experience in virology during a postdoctoral program at Emory University School of Medicine.  Throughout her years of working in the private sector in laboratory and clinical research settings, Julie has identified, developed and completed programs addressing unmet needs in health care.    Her accomplishments include patents and FDA- or USDA- licensed medical devices, vaccines, and diagnostics.  She has developed both commercial and research diagnostics for detecting antigens, antibodies and cellular immunity. Julies research experience includes the areas of virology, immunology, parasitology, mycology, genetics and oncology.  She has worked nationally and internationally with professionals from hospitals, long term and home care institutions, academic institutions, medical device and pharmaceutical industries, State Public Health Departments, the World Health Organization, and the International Organization of Standards.  She has also served as a reviewer for health care journals.  These professional partnerships have resulted in journal publications, healthcare standards, and training programs.   Julie is currently the Project Lead for the Clinical Laboratory Integration into Health Care Collaboration (CLIHC)TM from the Division of Laboratory Programs, Standards, and Services at the Centers for Disease Control and Prevention (CDC).  She coordinates programs to improve laboratory quality by enhancing the capacity, infrastructure, and capabilities of laboratories worldwide.   

Christina (Tina) Lockwood, PhD, DABCC, FACB
Associate Director, Genetics and Solid Tumor Diagnostics Laboratory, Assistant Professor, Department of Laboratory Medicine, University of Washington

Dr. Lockwood joined the Department of Laboratory Medicine as an Associate Director of the Genetics and Solid Tumor Diagnostics Laboratory at the University of Washington Medical Center in 2014. She is a Diplomate of the American Board of Clinical Chemistry and an Active Candidate of the American Board of Medical Genetics and Genomics. After obtaining her PhD at the University of Wisconsin, Dr. Lockwood completed postdoctoral fellowship training in Clinical Chemistry and Clinical Molecular Genetics at the Washington University School of Medicine in St. Louis, MO. Her interests include the development and application of molecular methods for the detection of genomic alterations in genetic disease, hematologic malignancies, and solid tumors. Dr. Lockwood has also been active in the design and implementation of educational resources related to training in genomic medicine.

Allison Chambliss, PhD
Clinical Chemistry Fellow, Department of Pathology, Johns Hopkins University School of Medicine

Allison Chambliss, PhD is a Clinical Chemistry Fellow in the Department of Pathology at the Johns Hopkins University School of Medicine. She received her B.S. in Chemical Engineering from Virginia Tech and her PhD in Chemical & Biomolecular Engineering from Johns Hopkins University. Allison’s current clinical research interests include development of rapid, targeted pharmacogenetics assays and mass spectrometry methods. Her current training areas include operation of the clinical laboratory, quality control and assurance, laboratory management, analytical methodologies, and test interferences.

Wieslaw Furmaga, MD
Associate Professor, University of Texas Health Science Center at San Antonio

I graduated from the Collegium Medicum at Jagiellonski University in Poland, and subsequently completed residency program in anatomic, clinical pathology and clinical chemistry. I have been practicing pathology in the University of Texas Health Science Center at San Antonio, Texas as a staff pathologist and medical director of clinical chemistry and molecular laboratory.

I have been serving the Instrumental Resource Committee of the College of American Pathologist (CAP) since 2008. Since 2009 I have served for the Pharmacogenomics Committee, Educational subcommittee working on Pharmacogenomics Educational Course. I was actively involved in the CLSI on a project “Method Validation by using patient’s sample”. The main scientific interest is in biomarkers for aggressive prostate cancer as well as biomarkers for monitoring the trauma patients with hemorrhagic shock.

Ben Howden, PhD
Professor, Head of Laboratory, Microbiology and Immunology, Director, Microbiological Diagnostic Unit, University of Melbourne

The Howden Laboratory, located in the Department of Microbiology and Immunology at the Peter Doherty Institute for Infection and Immunity is closely affiliated with the Microbiological Diagnostic Unit Public Health Laboratory (MDU PHL). Professor Howden is an Infectious Diseases Physician and Medical Microbiologist who is Director of the MDU PHL and Head of the Research Laboratory.

The Howden Laboratory works in close collaboration with the Stinear Laboratory, and has close links with the Infectious Diseases and Microbiology Units at Austin Hospital.

Our research uses genomics, molecular biology, epidemiology and clinical studies to addresses a broad range of issues related to invasive bacterial diseases in humans, especially those caused by staphylococci, enterococci and other antimicrobial-resistant species. Additionally, working closely with scientists in the MDU PHL, we investigate the evolution, epidemiology and spread of bacterial pathogens of public health significance such as Neisseria gonorrhoea, Listeria monocytogenes, Shigella and Salmonella spp. and Legionella spp.

Brian R Jackson
Associate Professor of Pathology (Clinical), Medical Director of Informatics, ARUP Laboratories, University of Utah, Department of Pathology

Dr. Jackson directs the Informatics Department at ARUP, including ARUP Consult®, decision support, product management, informatics software development, and ATOP® consulting. He is also the medical director for Referral Testing and an associate professor of pathology at the University of Utah. He received his BA in mathematics, his MS in medical informatics, and his MD from the University of Utah, and completed a clinical pathology residency at Dartmouth-Hitchcock Medical Center. Prior to his employment at ARUP, Dr. Jackson was a staff clinical pathologist and informaticist at Dartmouth-Hitchcock Medical Center, a product manager for a Belgium-based medical software firm, and a National Library of Medicine informatics fellow at the University of Utah. Dr. Jackson’s research interests include economic analysis of diagnostic testing and physician utilization of laboratory tests. He is certified in clinical pathology by the American Board of Pathology.

Doug Jeffery, PhD
Scientific Reviewer, Food and Drug Administration Center for Devices and Radiological Health

Senior Staff Fellow, Office of In Vitro Diagnostics and Radiological Health, Food and Drug Administration Center for Devices and Radiological Health.

I received a Bachelor of Science degree in biology from the Massachusetts Institute of Technology and a Ph.D. in biochemistry from the University of California, San Francisco. Before working at the FDA, I worked at the Novartis Institutes of Biomedical Research performing basic research in oncology target discovery.

Jeffrey Meeusen, PhD, DABCC
Co-Director, Cardiovascular Laboratory Medicine, Mayo Clinic

Dr. Meeusen received a PhD from the University of Wisconsin studying inorganic biochemistry. After graduate school he spent three years as a post-doctoral research fellow supporting Mayo Medical Laboratories esoteric test development. Dr. Meeusen’s research interests include lipid and lipoprotein testing and he is currently co-director of Cardiovascular Laboratory Medicine at Mayo Clinic.

Howard Morris, PhD, FAACB, FFSc(RCPA)
Professor of Endocrine Bone Research Laboratory, Univ of South Australia

Professor Howard Morris is Professor of Medical Sciences at the University of South Australia and a Chief Medical Scientist in Chemical Pathology at SA Pathology, Adelaide, South Australia. He is currently Vice-President of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and Chair of the IFCC-International Osteoporosis Foundation Working Group on Standardization of Bone Marker Assays. He has over 30 years experience in Clinical Biochemistry largely managing the Endocrinology laboratory of a large public pathology service. Between 2003 and 2009 he was the Director of the Hanson Institute in Adelaide, the major medical research institute in South Australia. His research investigates the pathophysiology of osteoporosis and the effects of hormones including vitamin D and dietary calcium. He was the Louis Avioli Memorial Lecturer at the 2009 Annual Scientific Meeting of the American Society for Bone and Mineral Research. He is also Chair of the South Australian Department of Health Working Party on Osteoporosis and Fracture Prevention.

Michael Rocco, MD
Medical Director of Cardiac Rehabilitation and Stress Testing, Staff Cardiologist, Cleveland Clinic

Michael Rocco, MD, is the Medical Director of Cardiac Rehabilitation and Stress Testing, Section of Preventive Cardiology, and a Staff Cardiologist, Section of Clinical Cardiology and Preventive Cardiology, in the Robert and Suzanne Tomsich Department of Cardiovascular Medicine. He also holds an appointment in the Section of Nuclear Cardiology in the Department of Molecular and Functional Imaging. He is board-certified in internal medicine, cardiology and nuclear cardiology. Dr. Rocco has a special interest in clinical cardiology, stress testing and cardiac rehabilitation, coronary artery disease, cardiac catheterization and the treatment of lipid disorders.

Dr. Rocco did his undergraduate work at Georgetown University in Washington, D.C., graduating Phi Beta Kappa and valedictorian of his class. He received his medical degree from Duke University Medical Center in Durham, N.C., where he was inducted into the Alpha Omega Alpha Medical Honor Society. He took his clinical training (internship and residency) at Brigham & Women’s Hospital in Boston. He became a Research/Clinical Fellow in Cardiology at Brigham & Women’s Hospital and at Harvard Medical School. Dr. Rocco completed the Henry J. Kaiser Fellowship Program at Harvard University, Boston, where he trained in epidemiology, biostatistics and clinical study design.

Ravinder Singh, PhD
Director, Endocrine Laboratory, Mayo Clinic

Ravinder J. Singh, Ph.D., is the director of the Mayo Clinic Endocrine Laboratory. He has a focused area of investigation that has broad applicability to the field. Dr. Singh studies the application of liquid chromatography-tandem mass spectrometry (LC-MS/MS) to clinical laboratory analysis. Many of the methods that Dr. Singh developed are now considered reference methods. They have subsequently been utilized for method standardization efforts as well as to establish clinical disease correlates, which he has published with his collaborators.

Dr. Singh's work has directly contributed to improving methods for the clinical diagnosis of Cushing's disease, pheochromocytoma and congenital adrenal hyperplasia. He continues to work to discover innovative ways to better understand the uses of LC-MS/MS in providing patients with faster and more accurate diagnoses.

Jerry Stringham, MBA
President, Medical Technology Partners

Jerry Stringham has worked as a reimbursement strategy consultant since the 1980s, when he began providing reimbursement consulting to diverse medical and pharmaceutical companies. Jerry holds a BS in mechanical engineering from the Massachusetts Institute of Technology and an MBA from Harvard Business School. He has been part of five medical device start-up organizations operating out of New England and has grown MTP’s client list to over 140 clients. Jerry founded Medical Technology Partners in 1998 to fill the growing need for business-oriented reimbursement consulting. Jerry’s experience in industry, including as a Principal in the health economics practice of a major CRO, brings expertise to new technology reimbursement challenges.

David R Sullivan, MBBS, FRACP, FRCPA
Clinical Associate Professor, Dept of Biochemistry, Royal Prince Alfred Hospital

David Sullivan is a physician and chemical pathologist in the Department of Clinical Biochemistry at Royal Prince Alfred Hospital.  This includes conjoint appointment as Clinical Associate Professor, Central Clinical School, Faculty of Medicine and Charles Perkins Centre, University of Sydney. David has a long-term interest in lipid metabolism with particular emphasis on the gene environment interactions contributing to cardiovascular disease. He has been involved in the early use of many forms of lipid-lowering intervention. He remains a national leader of efforts to improve the detection and management of severe inherited dyslipidaemia, such as that seen in Familial Hypercholesterolaemia. David has experience in several international clinical posts, including World Health Organization (WHO) Fellowship at the MRC Lipoprotein Unit, Royal Postgraduate School of Medicine, Hammersmith Hospital, London and co-ordination of international clinical studies from the WHO reference lipid laboratory in Wageningen, Netherlands. In addition to his clinical activities in Australia, he has served on numerous clinical committees including the management committees of the LIPID and FIELD trials. Current research interests are focussed on biomarkers, post-prandial metabolism and novel therapies.

Ping Wang, PhD, DABCC, FACB
Director of Clinical Chemistry, Houston Methodist Hospital, Associate Professor, Pathology and Laboratory Medicine, Weill Cornell Medical College

Dr. Ping Wang is currently the Medical Director of Clinical Chemistry at Houston Methodist Hospital and Associate Professor of Pathology and Laboratory Medicine at Weill Cornell Medical College. She is also Director of the ComACC-accredited Postdoctoral Fellowship Program at Houston Methodist Hospital. Dr. Wang was trained at Tsinghua University, University of Wisconsin-Madison and UCSF. She is board certified in Clinical Chemistry, Molecular Diagnostics and Toxicological Chemistry by American Board of Clinical Chemistry, for which she currently serves as Vice President and Chair of Examination Committee. She is a fellow of the National Academy of Clinical Biochemistry. She currently serves or had served on the boards of NACCCA, AACC LVDD division and TDM and Toxicology division. Dr. Wang has received many honors and awards including the Career Cornerstone Award, NACB Distinguished Abstract Award and AACC Outstanding Research Award. She has published over 60 peer-reviewed papers, abstracts and book chapters. Dr. Wang has over 10 years of experience directing and managing high complexity CLIA clinical laboratories, and is an expert in CLIA regulations, laboratory management to drive clinical efficiency, quality and outcome, clinical assay development, optimization and execution in a highly regulated environment. Besides clinical service and teaching, Dr. Wang’s current research interests focus on translating novel research and start-up findings into clinical diagnostic tools. She is Principle Investigator of two NIH grants, and actively collaborates with major diagnostic companies as well as start-up ventures to develop next-generation diagnostic tools.

Clinical Diagnostics and Research

Sponsors & Partners

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Siemens Healthcare Diagnostics is a global leader in in vitro diagnostics, providing healthcare professionals in hospital, reference, and physician office laboratories and point-of-care settings with the vital information required to accurately diagnose, treat, and monitor patients. Our innovative portfolio of performance-driven solutions and personalized customer care streamlines workflow, enhances operational efficiency, and supports improved patient outcomes.

More than 14,000 employees serve our 30,000 customers in 120 countries. Our customers have access to a broad portfolio with more than 900 different tests available across multiple disease states: immunoassay, chemistry, automation, hemostasis and hematology, blood gas and electrolytes, diabetes, urinalysis, and molecular. Our innovative portfolio of performance-driven solutions, unmatched test menu of more than 900 different tests, and personalized customer care streamlines workflow and enhances operational efficiency.

Our systematic, customer-centered approach to product development is constantly shaped and strengthened by listening to customers and understanding their needs. Working closely with laboratories, clinicians, and hospital administrators, we create forward-thinking products and solutions that are shaping and transforming diagnostics—improving clinical outcomes and, ultimately, helping to improve patient care.

As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of tools that help healthcare providers in the early detection, prevention, diagnosis and treatment of diseases. In Molecular Diagnostics, we are driven by a vision of working with laboratories like yours to improve the medical value you offer in virology, women's health, microbiology, and genomics and oncology. We continue to meet unmet needs through our investment in research, innovation, and scientific excellence with the goal of supporting your important role in improving patient’s lives.

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The promise of our company is in the promise that our work holds for health and life.

QIAGEN N.V., a Netherlands holding company, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research).

Agilent (www.agilent.com) is a leader in life sciences, clinical research, diagnostics and applied chemical markets. With over 11,000 employees worldwide, the company provides laboratories worldwide with instruments, services, consumables, applications and expertise, enabling customers to gain the insights they seek. Agilent’s expertise and trusted collaboration give them the highest confidence in our solutions.

Agilent focuses its expertise on six key markets, where we help our customers achieve their goals:

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• Clinical Research: Most life sciences and clinical research is done at top-tier universities, with funding from governments around the world

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs.

ImmunoChemistry Technologies, LLC provides quality laboratory services and research reagents. As a contract service laboratory, ICT specializes in custom immunoassay development, manufacturing, conjugation, lyophilization, and consulting services. ICT is focused on ELISA development and has the knowledge to develop reliable, sensitive, and specific tests. ICT offers a line of ELISA diluents including coat buffers, conjugate stabilizers, and sample diluents designed to reduce backgrounds, increase the specific signal, and improve the stability and shelf-life of the ELISA. ICT also offers a line of fluorescent reagents to measure caspase activity, apoptosis, and cell death in vitro.

For over thirty years, KMC Systems Inc. has partnered with leading and emerging medical device companies to successfully bring life science, in-vitro diagnostic (IVD), laboratory automation, surgical and therapeutic instrumentation to market. As a trusted source for medical contract manufacturing and engineering services, KMC Systems offers a centralized workforce of experts in engineering, manufacturing, quality control and supply chain management to provide world-class medical product development, design, manufacturing and depot-level field support services to our valued customers.

Our Total Product Lifecycle Management Program takes products from concept to development and design through manufacturing to post-production support. By focusing on every aspect of the medical product lifecycle, KMC is able to deliver cutting-edge innovation and proven performance every time. Download the KMC Systems Brochure to learn more about what KMC Systems can do for you.

DNASTAR, Inc. is a global software company headquartered in Madison, Wisconsin USA that has been meeting the needs of life scientists for more than 25 years. We were born out of the E. coli lab of Dr. Fred Blattner, Professor of Genetics at the University of Wisconsin, in 1984. Our early products reflected this background and association and we built a strong reputation during the Sanger sequencing years of providing outstanding desktop software for DNA and protein sequence assembly and analysis.

Agena Bioscience is a San Diego, CA based life sciences and clinical diagnostics company that recently acquired the Bioscience business of Sequenom, Inc. and is now offering the MassARRAY® System. The system is a highly sensitive, quantitative method for nucleic acid detection via MALDI-TOF mass spectrometry for high-throughput genotyping and mutation profiling for cancer and other disease research, companion diagnostics, pharmacogenomics, molecular blood group typing, epigenetics, clinical genetics, ag-bio genetics, and molecular sample identification for bio-banking.

Beckman Coulter Genomics, headquartered in Danvers, Massachusetts, sets the standard for providing expert Next Generation and Sanger sequencing services with bioinformatics solutions. Life science and healthcare businesses as well as academic and government institutions worldwide rely on Beckman Coulter Genomics to deliver the highest quality data, robust analyses and innovative thinking.

From classic to cutting-edge, Beckman Coulter Genomics has proven experience and expertise on a wide range of technology platforms, including the Illumina HiSeq 2500, Illumina MiSeq, Roche 454 GS FLX, and ABI 3730XL. Every associate at Beckman Coulter Genomics is dedicated to delivering total customer satisfaction.

At Illumina, we apply innovative technologies for studying genetic variation and function, making studies possible that were not even imaginable just a few years ago. These revolutionary tools for DNA and RNA analysis are enabling rapid advances in disease research, drug development, and the development of molecular tests in the clinic. Illumina's innovative sequencing and array technologies are fueling groundbreaking advancements in life science research, translational and consumer genomics, and molecular diagnostics.

MBL International Corporation is a leading life science company focused on providing high-quality products and solutions for life science research and clinical diagnostics.

Established in 1993 as a subsidiary of Medical and Biological Laboratories Co. Ltd, Nagoya, Japan, MBL International Corporation develops, manufactures and markets a wide range of ELISA and IFA test kits to aid in the diagnosis of autoimmune and infectious disease as well as an extensive portfolio of monoclonal and polyclonal antibodies, fluorescent and recombinant proteins, and ELISA kits for research related to allergy, apoptosis, autophagy, cancer, epigenetics, immunology, and neuroscience.

Our products are used widely in academic research institutions, pharmaceutical and biotechnology companies, government agencies, as well as hospital and reference laboratories. By providing a consultative approach, superior technical and customer support, and convenient purchasing options, MBL International Corporation partners with our customers to solve their scientific and clinical challenges.

For 60 years The Baker Company has been at the forefront of engineering, testing and production of reliable laboratory contamination control equipment. Recognized as the industry pioneer, The Baker Company maintains an unparalleled passion for helping our customers advance science, discovery, and clinical care.

The people of Baker have built that reputation by taking no chances with customers’ safety and making no compromises when it comes to protecting the success of your research. Baker's laboratory products are built to order with precision craftsmanship and designed expressly for your unique application need. Our rigorous testing protocols go above and beyond what the average user would ever encounter and our quality control measures exceed industry standards. Our commitment to sustainable business practices and the development of a new generation of energy efficient products ensures that you — and your budget — will be pleased.

LI-COR first introduced scientific instruments for plant science research and quickly grew to provide scientists tools for such diverse disciplines as atmospheric research and the study of how proteins interact at the cellular level. LI-COR Biosciences is a global leader in the design, manufacture, and marketing of high quality, innovative instruments, software, reagents, and integrated systems for plant biology, biotechnology, drug discovery, and environmental research.

An extensive range of quality controls covering analytes for immunoassay, TDM, chemistry, cardiac assessment, immunology, diabetes, coagulation, hematology, blood gas, drugs-of-abuse, and infectious disease testing

CureSeq’s mission is to revolutionize next-generation sequencing in the oncology space by making it more affordable, offering faster time to results with a comprehensive solution. We offer products and services to advance your research and clinical endeavors. Turnaround time using our products is 48 hours from extraction through generating clinically relevant mutations. We have an Ultra Rapid FFPE DNA Extraction kit, which takes 15 minutes, hgDNA QC Kit, Library Panel Kits, and rapid analysis with a mutation report generated in just 10 minutes per sample. To complete your work, the user needs to purchase the sequencing kits for NGS from the vendor (Thermo Fisher, or Illumina). We are located in Brisbane, CA just by University of California San Francisco, where our technology originated.

DNA Genotek, a subsidiary of OraSure Technologies, Inc., develops products that optimize ease of collection and provide superior samples and proven performance for those requiring high-quality biological samples for nucleic acid testing. High-quality samples that are easily collected from target populations enable our customers to focus on translating their analysis and testing into significant worldwide advancements in health and science. DNA Genotek's success is based on our strong relationship with our valued customers, our innovative environment and our passion for quality.

Today, DNA Genotek products are marketed worldwide and support thousands of customers as they achieve breakthroughs in genomic research, in diagnostics laboratories, in the pharmaceutical industry, in livestock and animal genomics, and in personal genomics. Consequently, our products provide our customers with the ability to focus on solving disease, disease prevention and treatment by translating their testing into worldwide health improvements.

Helmer Scientific is an established, entrepreneurial, growth company headquartered in Noblesville, Indiana. We design, integrate, manufacture, market, and distribute specialized medical and laboratory equipment to clinical and life science customers in over 125 countries.

KRONUS® is a leading provider of immunodiagnostic reagents and test kits to the research and clinical laboratory marketplace. Since its founding in 1986, the Company has sought to provide unique and innovative products coupled with the highest level of customer service and support.

Working in partnership with several of the world's leading research and developmental scientists, KRONUS continues to focus its efforts on providing products and service of the highest quality. To that end, the Company now offers more than a dozen immunoassay test kits and related laboratory reagents useful in the assessment of various autoimmune and endocrine/metabolic disorders.

Mercodia is a world-leading developer, manufacturer and distributor of high quality immunoassay kits. We specialize in ELISA assays for clinical as well as research applications, notably within diabetes, obesity and cardiovascular disease. We offer assays applicable in both human and animal models.

Next Advance, Inc. develops and sells innovative, high-value, user-friendly laboratory instruments for molecular biologists. Designed and tested by our multi-disciplined cross-trained staff, our products automate mundane tasks, freeing scientists from repetitive, time-consuming procedures.

The Mérieux have a family tradition and a century-old commitment to the fight against infectious diseases.

Marcel Mérieux, who studied under Louis Pasteur and founded the Mérieux Institute, Dr. Charles Mérieux, Alain Mérieux and Dr. Christophe Mérieux have devoted their lives to biology with a goal of improving health worldwide. By creating bioMérieux in 1963, Alain Mérieux has carried on this family tradition.

- See more at: http://www.biomerieux-usa.com/about-us#sthash.MTYiFNuG.dpuf

DRG International, Inc. is a leading specialty medical diagnostics and equipment manufacturer, and distributor with operations in more than 110 countries. Founded in 1970, DRG International provides a complete range of products and services to the diagnostics and cardiology-related medical community. DRG International’s global headquarters is conveniently situated in Springfield, New Jersey, accessible from State Route 22 and minutes away from route I-78 and the Garden State Parkway. Only 20 miles from New York City and 80 miles from Philadelphia, PA, DRG International, Inc. is in the heart of the beautiful Tri-State Area.

The American Biological Safety Association (ABSA) was founded in 1984 to promote biosafety as a scientific discipline and serve the growing needs of biosafety professionals throughout the world. The Association's goals are to provide a professional association that represents the interests and needs of practitioners of biological safety, and to provide a forum for the continued and timely exchange of biosafety information.

CRC Press is a premier publisher of science, technology, and medical reference books, textbooks and online content, reaching around the globe to collect essential reference material and the latest advances for researchers, academics, professionals, and students. CRC Press is a member of Taylor & Francis Group, an informa business.

Our mission is to serve the needs of scientists and the community at large by working with capable researchers and professionals from across the world to produce the most accurate and up to date science, technology, and medical resources.

LabRoots is the leading scientific social networking website and producer of educational virtual events and webinars. Contributing to the advancement of science through content sharing capabilities, LabRoots is a powerful advocate in amplifying global networks and communities.

CHI is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations. CHIs portfolio of products includes Cambridge Healthtech Institute Conferences, Insight Pharma Reports, Cambridge Marketing Consultants, Barnett Educational Services, Cambridge Meeting Planners and CHIs Media Group, which includes news websites and e-newsletters including Bio-IT World and eCliniqua.

Pittcon is the worlds largest annual premier conference and exposition on laboratory science. It is organized by The Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy, a Pennsylvania not-for-profit educational corporation which is comprised of the Spectroscopy Society of Pittsburgh (SSP) and the Society for Analytical Chemists of Pittsburgh (SACP).

Clinical Diagnostics and Research

Program Committee

Click here to download the Program Committee brochure

Bruce Hollis, PhD

Bruce W. Hollis, Ph.D. received his B.Sc. and M.Sc. from the Ohio State University and subsequently his Ph.D. from the University of Guelph in 1979. Dr. Hollis then completed an Endocrine Fellowship at The Case Western Reserve University School of Medicine in 1982. Dr. Hollis was then Appointed Assistant Professor of Nutrition at Case Western and remained there until 1986 when he moved to The Medical University of South Carolina where to he is Professor of Pediatrics, Biochemistry and Molecular Biology. He is also Director of Pediatric Nutritional Sciences. Dr. Hollis has studied vitamin D metabolism and nutrition for the past 35 years and has been an NIH grant recipient for the past 30 years. His current work focuses on the vitamin D requirements during pregnancy and lactation. Dr. Hollis has in excess of 200 peer reviewed articles in this area of investigation.

Alan Maisel, MD

Dr. Alan Maisel attended University of Michigan Medical School and did his cardiology training at the University of California at San Diego. He is currently Professor of Medicine at the University and director of the coronary care unit and the heart failure program at the affiliated Veterans Affairs Medical Center. He is considered one of the worlds experts on cardiac biomarkers, and is given credit for ushering in the use of BNP levels in clinical practice around the world. He has over 300 articles in print and a large clinical and basic science lab. Dr. Maisel is also a fixture at the medical school, where he has won countless teaching awards from medical students as well as interns and residents. Dr Maisel s yearly San Diego Biomarker meeting is considered the most prestigious of its kind. Dr. Maisel is currently an Associate Editor of the Journal of American College of Cardiology. He has published two medical novel and helps to raise five children, He gave up on sleep five years ago.

Michael Holick, MD, PhD

Michael F. Holick, Ph.D., M.D. is Professor of Medicine, Physiology and Biophysics; Director of the General Clinical Research Unit; and Director of the Bone Health Care Clinic and the Director of the Vitamin D, Skin and Bone Research Laboratory at Boston University Medical Center.

Dr. Holick has made numerous contributions to the field of the biochemistry, physiology, metabolism, and photobiology of vitamin D for human nutrition. Dr. Holick has established global recommendations advising sunlight exposure as an integral source of vitamin D. He has helped increase awareness in the pediatric and medical communities regarding vitamin D deficiency pandemic, and its role in causing not only metabolic bone disease, and osteoporosis in adults, but increasing risk of children and adults developing common deadly cancers, schizophrenia, infectious diseases including TB and influenza, autoimmune diseases including type 1 diabetes and multiple sclerosis, type 2 diabetes, stroke and heart disease. He also observed the pregnant women who were vitamin D deficient were at increased risk for preeclampsia and requiring a C-section. He has written more than 300 pier reviewed articles, edited or wrote 12 books including The Vitamin D Solution and is the recipient of numerous awards including the Linus Pauling Prize in Human Nutrition.

Kamisha Johnson-Davis, PhD, DABCC, FACB

Dr. Johnson-Davis is a medical director of the Clinical Toxicology laboratory, Antifungal Testing and Immunosuppressants Testing at ARUP. Dr. Johnson-Davis received her PhD in pharmacology at the University of Utah and is board certified in clinical chemistry by the American Board of Clinical Chemistry. She completed her postdoctoral fellowship in clinical chemistry at the University of Utah, Department of Pathology, and was a postdoctoral research associate at the Center of Human Toxicology at the University of Utah. Dr. Johnson-Davis is a member of various professional societies, including the Academy of Clinical Laboratory Physicians and Scientists and the American Association for Clinical Chemistry.

Charles Cantor, PhD

Dr. Charles Cantor is a founder, and Chief Scientific Officer at SEQUENOM, Inc., which is a genetics discovery company with tools, information and strategies for determining the medical impact of genes and genetic variations.

He is also the founder of SelectX Pharmaceuticals, a drug discovery company, Retrotope, an anti-aging company, and DiThera, a biotherapeutic company.

Dr. Cantor is professor emeritus of Biomedical Engineering and of Pharmacology and was the director of the Center for Advanced Biotechnology at Boston University. He is currently adjunct professor of Bioengineering at UC San Diego, adjunct professor of Molecular Biology at the Scripps Institute for Research, and distinguished adjunct professor of Physiology and Biophysics at UC Irvine. Prior to this, Dr. Cantor held positions in Chemistry and then in Genetics and Development at Columbia University and in Molecular Biology at the University of California at Berkeley. Cantor was educated in chemistry at Columbia College (AB) and at the University of California Berkeley (PhD).

Dr. Cantor has been granted more than 60 US patents and, with Paul Schimmel, wrote a three-volume textbook on biophysical chemistry. He also co-authored the first textbook on Genomics titled 'The Science and Technology of the Human Genome Project'. In addition, he sits on the advisory boards of numerous national and international biotechnology firms, has published more than 450 peer-reviewed articles, and is a member of the U.S. National Academy of Sciences.

Peter Blume-Jensen, MD, PhD

Dr. Peter Blume-Jensen has extensive expertise in basic and translational cancer research, oncogenic signaling, and targeted oncology therapeutics drug discovery prior to joining Metamark as CSO in 2010.  From 2001 to 2008 Peter was department head at first Serono, US and later at Merck Research Laboratories, Merck & Co, Inc. where he established novel, integrated oncology drug discovery departments and programs linking therapeutics to patient responder populations. During his tenure he advanced a number of pre-clinical drug programs into the clinic, and provided translational support for clinical programs. Since 2008 he was Exec. Dir. and Vice President for External Scientific Affairs at Daiichi Sankyo Inc., served as the global 'Therapeutic Area Advisor' for Oncology, and was co-responsible for formulating a global oncology R&D strategy. He co-led the scientific M&A and due diligence resulting in the acquisition of Plexxikon (US$935M).  In 2010 he joined Metamark as CSO and 2nd employee.  Here he built and let R&D, a world-class KOL Advisory Board, and a novel, automated proteomics imaging platform for CLIA-certified cancer tests.  He designed and let 4 clinical studies culminating with the successful blinded, clinical validation of ProMark, a prognostic prostate cancer biopsy test for intact tissue.  During the initial commercial launch in Q1-2, 2014 he led Medical Affairs and training of all commercial staff.  Since June 2014, Peter has joined Xtuit Pharmaceuticals, a targeted therapeutics start-up, as CSO, and first employee.  Peter continues to serve as Chief Scientific Advisor and on the SAB for Metamark and also has joined the SAB of Veritas Gene, Inc, a NGS company.

Dr. Blume-Jensen has authored highly-cited original articles, reviews, and book chapters in Personalized Molecular Oncology. His review 'Oncogenic Kinase Signaling' in Nature is a citation classic in 'Clinical Medicine', and his work on genetically engineered cancer and male infertility mouse models has been widely portrayed on CNN and other news channels. His approaches for efficacy-predictive biomarkers have appeared on Nature Biotechnology's 'Hot patents' watch-list and in numerous Editorial highlights for Personalized Oncology. Dr. Blume-Jensen obtained his M.D. from Copenhagen, Denmark, his Ph.D. from Dr. Carl-Henrik Heldin's laboratory at the Ludwig Institute for Cancer Research, Uppsala, Sweden, and conducted his Post-Doctoral studies in Dr. Tony Hunter's laboratory at the Salk Institute, La Jolla, CA. He has consulted extensively for Biotech and Pharma on targeted therapeutics and Precision Medicine

Pinar Bayrak-Toydemir, MD, PhD

Dr. Bayrak-Toydemir is the medical director of the Molecular Genetics and Genomics Laboratories at ARUP and an associate professor of pathology at the University of Utah School of Medicine. Dr. Bayrak-Toydemir received her MD from the Ankara University School of Medicine in Ankara, Turkey, where she also received her PhD in human genetics. Subsequently, she completed her fellowship in clinical molecular genetics at the University of Utah. She is board certified in medical genetics.

Dr. Bayrak-Toydemir has focused her research efforts on understanding the molecular genetic characteristics of the Hereditary Hemorrhagic Telangiectasia (HHT) disease, an autosomal dominant vascular dysplasia. Her research aims to identify additional gene(s) that can cause HHT disease, to determine the roles of regulatory region mutations of known HHT genes, and to describe the genotype-phenotype correlation. In addition to HHT, her research aims to identify gene(s) that cause various inherited vascular malformations. She is also interested in application of next generation sequencing to molecular diagnostics.

Joan W Bennett, PhD

Joan W. Bennett has been Professor II of Plant Biology and Pathology at Rutgers University since 2006. Prior to coming to Rutgers, she was on the faculty at Tulane University, New Orleans, Louisiana, for over thirty years. The Bennett laboratory studies the genetics and physiology of filamentous fungi. In addition to mycotoxins and secondary metabolites, the focus is on the volatile organic compounds emitted by fungi. These low molecular weight compounds are responsible for the familiar odors associated with the growth of molds and mushrooms. Some of them function as semiochemicals for insects while others serve as developmental signals for fungi. The Bennett lab has tested individual fungal VOCs in model systems, with the intent of providing a physiological basis for the hypothesis that volatile mold metabolites might be involved in “sick building syndrome.” For example, 1-octen-3-ol (“mushroom alcohol”) functions as a neurotoxin in Drosophila melanogaster and causes growth retardation in Arabidopsis thaliana. In other studies, we have demonstrated that living cultures of Trichoderma, a known biocontrol fungus, can enhance plant growth in the absence of physical contact between the plant and the fungus. In addition, we are investigating the potential use of fungi and their volatiles in bioenergy research. Dr. Bennett also has an active interest in fungal genomics and has been involved in genome projects for Aspergillus flavus, A. fumigatus and A. oryzae.

In addition to running a laboratory, Dr. Bennett is Associate Vice President for the Office for the Promotion of Women in Science, Engineering and Mathematics (“SciWomen”), charged with promoting the welfare of women in science, engineering, mathematics and the health professions across the three campuses of Rutgers University at Camden, New Brunswick and Newark.

Amy K Saenger, PhD, DABCC, FACB

Dr. Amy Saenger is an Assistant Professor of Laboratory Medicine and Pathology at the Mayo Clinic College of Medicine and Director of Cardiovascular Laboratory Medicine in the Department of Laboratory Medicine and Pathology at the Mayo Clinic in Rochester, Minn. She is the Director of the Clinical Chemistry Fellowship Program and is actively involved in training fellows, pathology residents, and allied laboratory health staff. She also serves as a Director on the Commission on Accreditation in Clinical Chemistry (ComACC) board and is an Associate Editor for the journal Clinical Chemistry. Dr. Saenger received her PhD in Analytical Chemistry from the University of Minnesota. She completed her clinical chemistry fellowship training at the University of Washington and is board certified in clinical chemistry (DABCC). 

Her research has focused on cardiac biomarkers such as troponin and natriuretic peptides, as well as novel biomarkers for the detection of oxidative and cardiovascular stress, damage, and heart failure. Dr. Saenger has been honored with the AACC Outstanding Scientific Achievements by a Young Investigator Award, the NACB George Grannis Award for Excellence in Research and Scientific Publication, the Paul E. Strandjord Young Investigator Award from the Academy of Clinical Physicians and Scientists, the Strandjord/Clayson Award for Meritorious Research from the University of Washington, and the AACC Outstanding Speaker Award. She serves on several AACC committees including the Clinical Laboratory News board of editors, the Society for Young Clinical Laboratorians executive committee, and is currently past-chair of the AACC Midwest Section.

Theral Timpson

Theral is the host of Mendelspod, where he interviews thought leaders from around the life science community.  He's a regular blogger at Mendelspod and frequent speaker and emcee at life science conferences and related events.  Theral is an active mentor in Silicon Valley for those seeking careers in science and or media.  He's the President and owner of Theral Timpson Productions where he offers consulting for life science marketing, strategic planning, and conflict resolution.   Mr. Timpson has over 15 years experience establishing and growing companies in the life science industry, including President and Co-Founder of Consumer Genetics and Vice President of Marketing at Medax International.     He received training from the E. Goldratt Institute in Theory of Constraints and holds a B.A. degree in English Literature from the University of Utah.

Stephanie Willerth, PhD

Dr. Willerth currently holds a Canada Research Chair in Biomedical Engineering at the University of Victoria where she is dually appointed in the Department of Mechanical Engineering and Division of Medical Sciences. Her research group investigates how to engineer neural tissue by combining pluripotent stem cells, controlled drug delivery and biomaterial scaffolds . She has given invited talks at the Till and McCulloch Annual Meeting and at the 1st Annual British Columbia Stem Cell and Regeneration Medicine Initiative Meeting as well as presented at the 9th Annual World Biomaterials Congress in Chengdu, China. She belongs to both the Brain Research Centre (BRC) and the International Collaboration on Repair Discoveries (ICORD) - B.C. based organizations committed to treating brain diseases and disorders and finding long term treatments for the repair of spinal cord injuries respectively. Before accepting her faculty position, Dr. Willerth completed an NIH post doctoral fellowship at the University of California-Berkeley and graduate studies at Washington University.

Mark Marzinke, PhD, BABCC

Mark Marzinke, PhD, DABCC earned a Ph.D. in Biochemistry from the University of Wisconsin-Madison and subsequently completed a clinical chemistry fellowship at The Johns Hopkins University in 2012. During his clinical fellowship, Dr. Marzinke focused on the development and validation of qualitative and quantitative mass spectrometric assays for the clinical monitoring and quantitation of pain management drugs and anti-neoplastic agents, respectively. Further, he performed large scale proteomics studies aimed at the temporal identification of biomarkers expressed during ovarian cancer progression. Dr. Marzinke is currently an Instructor in the Departments of Pathology and Medicine at the Johns Hopkins University School of Medicine (JHUSOM). He serves as the Director of Preanalytics and General Chemistry in the Core Laboratory of the Johns Hopkins Hospital, where he focuses on workflow analysis and test utilization. Additionally, he is the Associate Director of the Clinical Pharmacology Analytical Lab (CPAL) at the JHUSOM, where he focuses on the development and validation of quantitative mass spectrometric methods in rare matrices to support large clinical trials. His research interests include the development, validation and implementation of assays focused on personalized medicine, including therapeutic drug monitoring and pharmacogenetic testing. Dr. Marzinke is board certified by the American Board of Clinical Chemistry.

C Jimmy Lin, MD, PhD, MHS

Jimmy Lin, MD, PhD, MHS, is a 2012 TED Fellow and Founder & President of Rare Genomics Institute, the world's first platform to enable any community to leverage cutting-edge biotechnology to advance understanding of any rare disease. Partnering with 18 of the top medical institutions, such as Harvard, Yale, Johns Hopkins, and Stanford, RGI helps custom design personalized research projects for diseases so rare that no organization exists to help. Dr. Lin is also a medical school faculty member at the Washington University in St. Louis and led the computational analysis of the first ever exome sequenching studies for any human disease at Johns Hopkins. He has numerous publications in Science, Nature, Cell, Nature Genetics, and Nature Biotechnology, and has been featured in Forbes, Bloomberg, Wall Street Journal, Washington Post, and the Huffington Post.

John Quackenbush, PhD

John Quackenbush received his PhD in 1990 in theoretical physics from UCLA working on string theory models. Following two years as a postdoctoral fellow in physics, Dr. Quackenbush applied for and received a Special Emphasis Research Career Award from the National Center for Human Genome Research to work on the Human Genome Project. He spent two years at the Salk Institute and two years at Stanford University working at the interface of genomics and computational biology. In 1997 he joined the faculty of The Institute for Genomic Research (TIGR) where his focus began to shift to understanding what was encoded within the human genome. Since joining the faculties of the Dana-Farber Cancer Institute and the Harvard School of Public Health in 2005, his work has focused on the use of genomic data to reconstruct the networks of genes that drive the development of diseases such as cancer and emphysema.

Leigh Anne Swayne, PhD

Leigh Anne Swayne is a basic cell and molecular neurobiologist. After training in Canada and France, she started her independent research lab in January 2011 in the Division of Medical Sciences at the University of Victoria, in Victoria, BC Canada. Leigh Anne's work focuses on the role of ion channels in shaping postnatal neurogenesis. She combines biochemistry, proteomics, cell biology, electrophysiology, and microscopy to understand how ion channels direct this postnatal developmental process. Her lab's  ultimate goal is to find effective ways of boosting brain repair following injury or disease.

Ross J Molinaro, PhD, MT(ASCP), DABCC, FACB

Ross J. Molinaro, PhD, MT(ASCP), DABCC, FACB is an Assistant Professor in the Department of Pathology and Laboratory Medicine at Emory University. He received his PhD in Clinical Chemistry and Molecular Medicine from Cleveland State University and completed the ComACC training program at Emory as the first recipient of the AACC Past-Presidents’ Scholarship. He currently serves as the Medical Director of the Core Laboratory at Emory University Hospital Midtown and co-Director of the Emory Clinical Translational Research Laboratory. Ross also teaches various aspects of laboratory medicine to medical students, pathology residents and fellows, clinical chemistry fellows, and medical technology students.

Ross joined the AACC in 2005 and is a member of the Proteomics and Clinical Translational Science Divisions. Ross is currently a committee member of the Society for Young Clinical Laboratorians (SYCL). He is also a member of the Professional Practice Review Course Curriculum Organizing Committee and the Clinical Chemistry Trainee Council Executive Committee as the Exam Questions Vault Coordinator. In addition, Ross serves as an American Society for Clinical Pathology (ASCP) Board Liaison to the Clinical Chemistry Examination Committee, and a member of the Board of Governors as the ASCP/AACC Member Representative. With over 40 publications and book chapters, his interests reside in the practice and standardization of mass

spectrometry in the clinical laboratory and expanding the knowledge base of clinical chemistry and laboratory medicine for medical students and those practicing in different healthcare disciplines.

Wieslaw Furmaga, MD

Director, Clinical Chemistry Laboratory University Hospital Director, General Laboratory Cancer Treatment Research Center Director, Proteomics Laboratory UTHSC at San Antonio Interim Director, Molecular Laboratory UTHSC at San Antonio Associate Director, Mycology Laboratory UTHSC at San Antonio I graduated from the Collegium Medicum at Jagiellonski University in Poland, and subsequently completed residency program in anatomic, clinical pathology and clinical chemistry. I have been practicing pathology in the University of Texas Health Science Center at San Antonio, Texas as a staff pathologist and medical director of clinical chemistry and molecular laboratory. I have been serving the Instrumental Resource Committee of the College of American Pathologist (CAP) since 2008. Since 2009 I have served for the Pharmacogenomics Committee, Educational subcommittee working on Pharmacogenomics Educational Course. I was actively involved in the CLSI on a project “Method Validation by using patient’s sample”. The main scientific interest is in biomarkers for aggressive prostate cancer as well as biomarkers for monitoring the trauma patients with hemorrhagic shock.

George Fritsma, MS, MT

George Fritsma is an associate professor in Laboratory Medicine of the Department of Pathology at the University of Alabama at Birmingham.

Prof. Fritsma manages www.fritsmafactor.com, “The Fritsma Factor, Your Interactive Hemostasis Resource,” a clinical coagulation educational resource and blog. The Fritsma Factor is sponsored by Precision BioLogic, Inc, Dartmouth, Nova Scotia, Canada.

Prof. Fritsma is the continuing education editor for the Clinical Laboratory Science Journal and a member of the American Association for Clinical Chemistry publications committee. He is co-editor of Hematology Clinical Principles and Applications, 4th edition, 2012, and he is and co-author of Quick Guide to Renal Disease Testing, 2011; Quick Guide to Venipuncture, 2010; Quick Guide to Coagulation 2nd Edition, 2009; and Quick Guide to Hematology Testing, 2007, all available from the ASCLS bookstore.

Prof. Fritsma is a 40-year member of the American Society for Clinical Laboratory Science and a member of the International Society for Thrombosis and Haemostasis. He holds a bachelor’s degree in biology and chemistry from Calvin College, Grand Rapids, Michigan, a Masters in Medical Technology from Wayne State University, Detroit, and advanced course work from the University of Illinois at Chicago.

R. Claudio Aguilar, Ph.D.

Dr. Aguilar obtained his PhD degree in Immunochemistry from the School of Pharmacy and Biochemistry, University of Buenos Aires, Argentina. Dr. Aguilar pursued his post-doctoral training at the National institutes of Health in Bethesda, MD in the lab of the well-known cell biologist Dr. Juan Bonifacino. In 2005, after a period as Associate Research Scientist at The Johns Hopkins University (in Dr. Beverly Wendland lab), Dr. Aguilar joined the Faculty of the Department of Biological Sciences at Purdue University. There, his group studies the mechanisms linking endocytosis and signaling in health and disease. In order to pursue its research goals, the Aguilar lab routinely use biophysical, biochemical and genetic approaches.

Joely Straseski, PhD, MS, MT(ASCP), DABCC

Dr. Straseski is a medical director of endocrinology at ARUP Laboratories and an assistant professor of pathology at the University of Utah School of Medicine. She received her PhD in pathology and laboratory medicine and a Master’s degree in bacteriology from the University of Wisconsin-Madison, where she also served as a postdoctoral associate in the Department of Pathology. Dr. Straseski completed a postdoctoral fellowship in clinical chemistry at the Johns Hopkins Medical Institutions in Baltimore, Maryland. She has previously been awarded the Past-President Scholarship by the American Association for Clinical Chemistry, as well as a Distinguished Abstract Award from the National Academy of Clinical Biochemistry. Dr. Straseski is board certified in clinical chemistry by the American Board of Clinical Chemistry.

Christoph H. Borchers, Ph.D.

Dr. Borchers received his B.S., M.S. and Ph.D. from the University of Konstanz, Germany. After his post-doctoral training and employment as a staff scientist at NIEHS/NIH/RTP, NC and he was the director of the Duke – UNC Proteomics Facility and held a faculty position at UNC Medical School in Chapel Hill, NC (2001-2006). Since then Dr. Borchers is Associate Professor at University of Victoria (UVic), Canada and the Director of the UVic – Genome Proteomics Centre. His research is centred around the improvement, development and application of proteomics technologies with major focus on techniques for quantitative targeted proteomics for clinical diagnostics.

Vincent Mauro, Ph.D.

Dr. Mauro is an Associate Professor in the Department of Neurobiology at the Scripps Research Institute in La Jolla, California. He is also a co-founder and lead scientist of Promosome, a biotechnology company focused on bioproduction enablement and DNA vaccines. In addition, Dr. Mauro is a Senior Fellow in Experimental Neurobiology at the Neurosciences Institute in San Diego, California.

Prior to moving to The Scripps Research Institute, Dr. Mauro received his Ph.D. at McGill University in Montreal, Quebec, and continued his studies as a postdoctoral fellow at The Rockefeller University in New York City.

Dr. Mauro studies both fundamental and applied aspects of translational control mechanisms. His basic research is focused on understanding how eukaryotic mRNAs recruit ribosomes, how ribosomes subsequently locate initiation codons, and how ribosomes regulate the translation of specific subsets of mRNAs. Dr. Mauro's applied studies build on his basic research. These applied studies have led to the identification of Translational Enhancer Elements (TEEs) and the generation of synthetic translational enhancers.

Deanne Taylor, MS, PhD

Dr. Taylors background is in biophysics, bioinformatics, computational biology and structural biology with emphasis on human genetics and translational medicine. She obtained her Ph.D. in Biophysics from the University of Michigan, Ann Arbor, and completed a postdoctoral fellowship at Pfizer in Ann Arbor. She had worked in the pharmaceutical industry at EMD-Serono, transitioning into clinical and basic research by moving to Harvard School of Public Health and then to clinical research at RWJ/Rutgers. She also served several years as the Program Director of the Graduate Program in Bioinformatics at Brandeis University, where she still occasionally teaches a course in Computational Systems Biology.

Her main areas of research are in the development of mathematical and computational methods to better understand biological variation and the genetic contribution to disease, coupling clinical information with high-dimensional biomedical data from next-gen sequencing, microarray, PCR, and proteomics experiments. Some of her immediate research interests are in development of methods to better classify effects of genetic variation within interacting systems through effects in gene function and contributions to disease, developing mathematical genotype representations of variation in populations, and using machine-learning techniques to build classifiers in translational medicine research. Her scientific contributions were acknowledged with the rest of the Divisions research team at the 2010 ASRM meeting when the REI division received the ASRM Prize Paper Award, where her contribution was in building databases, systems and validated methods for high-throughput genotype analyses .

Ariel Louwrier PhD

Successful Senior Scientific Business Executive with demonstrated expertise growing markets, revenues, product pipelines and expanding technical organizations into new business opportunities. Educational and business management experience in global markets, with quantified success in moving technical businesses into new international arenas. Multi-lingual fluency enables in depth penetration into new organizations relating with all levels of employees. Author of numerous peer-reviewed articles, and holder of several patents.

Pierre-Antoine Gourraud, PhD, MPH

Pierre-Antoine Gourraud is a former student of the Ecole Normale Suprieure de Lyon in France. After receiving an M.P.H. from University Paris XIII in 2002, he got his Ph.D. in Immunogenetic Epidemiology and Public Health from Toulouse University in 2005. He relocated to the United States to do his postdoctoral research in Neuroimmunogenetics of multiple sclerosis at UCSF in 2009 and joined the UCSF faculty in 2011. Dr Gourraud has established numerous research collaborations with investigators from all over the world: He develops bioinformatics resources at the National Center for Biotechnology Information (Immunogenetics markers: HLA, KIR, Microsatellites). At UCSF, he performs new generation of MS genetic association studies using massive sequencing technologies in various genetic ancestry backgrounds and continues developing software dedicated to translational digital medicine. His recent efforts have focused on the MS Bioscreen, a tablet-based navigation-system that integrates multiple dimensions of patient information including clinical evolution, therapeutic treatments, brain imaging, genomics and biomarker data.

Cynthia Bowman MD

Dr. Cynthia Bowman has been a broad based general pathologist for over 30 years. She graduated with a BA in Chemistry from St. Olaf College, received her MD from Vanderbilt University Medical School, and trained for 6 years at the University of California, San Francisco as a surgery intern and then anatomic and clinical pathology resident. She worked as an emergency room physician during training and has always had a clinical perspective in her practices. She has worked in California, Maine, Massachusetts, New York and Australia as an anatomic and clinical pathologist and laboratory medical director in small, mid-sized, tertiary and academic medical centers. She is currently Medical Director at Enzo Clinical Laboratories, a commercial reference laboratory and bioscience company in the NY metropolitan area, and in that capacity collaborates with the development and integration of molecular services into clinical testing. She has been active in national laboratory organizations, especially the College of American Pathologists, where she was chair of the Point of Care Testing Resource Committee. In that capacity she guided the introduction and was the senior editor of a web-based POCT toolkit as a resource for laboratory director leadership in POCT. She has also written and edited multiple educational pieces for the laboratory community as part of the CAP Excel Survey program and in 2012 she was awarded a Life Time Achievement Award by the CAP. She has spoken at AACC and CAP meetings and currently serves on several CLSI document development committees. She is currently chair of an International Federation of Clinical Chemistry POCT task force work group addressing the use of glucose meters in critical care patients. Her professional commitment has always been to integrate and translate pathology and laboratory medicine services into effective clinical care. She has dedicated her efforts in POCT as part of that vision to collaborate with all stakeholders and involve laboratory services as part of the continuum of care. She enjoys evaluating technology and integrating it into laboratory services.

Ottavio Arancio MD, Ph.D

Dr. Ottavio Arancio received his Ph.D and M.D. from the University of Pisa (Italy). From 1981 to 1986 he took residency training in Neurology at the University of Verona (Italy). Dr. Arancio has held Faculty appointments at Columbia University, NYU School of Medicine and at SUNY HSCB. In 2004 he became Faculty member of the Dept of Pathology & Cell biology and The Taub Institute for Research on Alzheimer’s Disease and the Aging Brain at Columbia University. His honors include the “G. Moruzzi Fellowship” (Georgetown University), the “Anna Villa Rusconi Foundation Prize” (Italy), the “INSERM Poste vert Fellowship” (France), the AHAF centennial Award (2007), the Zenith Award (2007), the Margaret Cahn Research Award (2008), and the Edward N. and Della L. Thome Memorial Foundation Award.

Dr Arancio is a cellular neurobiologist who has contributed to the characterization of the mechanisms of learning in both normal conditions and during neurodegenerative diseases. During the last ten years he has pioneered the field of mechanisms of synaptic dysfunction in Alzheimer’s disease. Dr. Arancio’s laboratory has focused primarily on events triggered by amyloid protein. These studies, which have suggested new links between synaptic dysfunction and amyloid protein, are of a general relevance to the field of Alzheimer’s disease both for understanding the etiopathogenesis of the disease and for developing therapies aiming to improve the cognitive symptoms.

Eric Gluck, MD, JD

Dr. Eric H. Gluck received his doctoral degree in medicine from New York Medical College in Valhalla, New York. He completed his residency at Beth Israel Medical Center in New York City and a pulmonary fellowship at the University of Utah School of Medicine in Salt Lake City, Utah. Dr. Gluck currently serves as the director of Critical Care Services at Swedish Covenant Hospital in Chicago, Illinois, and as a professor of medicine at Finch University of Health Sciences at the Chicago Medical School. Dr. Gluck is a fellow of the Society of Critical Care Medicine, American College of Chest Physicians, and the Chicago Institute of Medicine. He is a member of the American Thoracic Society, Society of Sigma Xi, Alpha Omega Alpha, and the American Society of Law, Medicine, and Ethics. He has delivered numerous lectures and co-authored many articles in the field of pulmonary critical care.

Josip Blonder, MD

Dr. Blonder leads the Clinical Proteomics Group at the CRTP/FNL. FNL is a Federally Funded Research and Development Center operated by Leidos Biomedical Research, Inc., for the National Cancer Institute (NCI). In 1978, Dr. Blonder received his M.D. at the Rijeka University School of Medicine, Croatia. In 2000, through Associated Western Universities, Dr. Blonder was awarded a post-doc fellowship in proteomics at the Pacific Northwest National Laboratory (PNNL), Richland, WA (Advisor: Dr. Richard D. Smith). At the PNNL, his research was focused on studying cell surface proteins using mass spectrometry (MS)-based proteomics. In 2002, Dr. Blonder joined FNL (formerly NCI-Frederick) where he continues to develop and apply MS-based proteomics to cancer research. Since 2006, he has led the Clinical Proteomics Group, extending his research on development of shotgun proteomics for in-depth profiling of membrane proteins found at the cell surface of cancer cells. In parallel, he worked on methodology for cancer biomarker and drug target discovery using precision proteomics for targeted profiling of clinical tissue and blood specimens. His group was the first to optimize the immunodepletion of abundant proteins from clinical tissue homogenates. Currently, Dr. Blonder is leading the effort towards molecular mapping of the KRAS cell surface as a part the RAS program. This program is spearheaded by the FNL as a national mission to attack RAS-driven cancers. Dr. Blonder brings unique combination of his expertise in medicine, clinical proteomics, and pathway analysis, focusing his research on the development of innovative approaches for molecular profiling of cancer cell lines, body fluids and tissue specimens. He is an editor of BMC Cancer and a lecturer at the Foundation for Advanced Education in the Sciences at NIH. Since 2002, Dr. Blonder has authored over 50 scientific publications in areas of biological mass spectrometry, clinical proteomics and cancer research.

Szczepan Baran, VMD, MS

Dr. Szczepan Baran is Head of Innovative Animal Technologies and Training at Novartis Institutes for Biomedical Research. He also serves in the following capacities: Adjunct Associate Professor in the Department of Pathology at Wake Forest University School of Medicine; Course Director for Online Masters in Laboratory Animal Science at the Drexel University; Director at Large for the Academy of Surgical Research and as a member of Clinical and Laboratory Standards Institutes Document Development Committee. Past experiences include: President & COO of the Veterinary Bioscience Institute; Chair and Co-chair on various laboratory animal science program committees; special volunteer position at the National Cancer Institute Laboratory of Genomic Diversity; and faculty at Delaware Valley College.

Dr. Baran earned a Bachelor of Science degree in Animal Science from the University of Delaware, a Veterinary Medical Doctorate from the University of Pennsylvania and a Master of Science degree from the University of Washington. His research interests include embryonic stem cells, the development and validation of online surgical training programs, and the development and validation of rodent laparoscopic procedures. Dr. Baran has established a freezing protocol for NHP ES cells, which has increased their survival from 5% to over 90%. Additionally, he was a contributing team member in the development of one of the first canine embryonic stem cell lines.

Dr. Baran’s current work centers on the refinement and development of surgical and biomethodology training programs including efficiency and objective competency and proficiency assessment. He has also demonstrated various refinements, which have led to increasing rodent surgical procedure efficiencies. He is currently writing a rodent laparoscopy and colonoscopy book, which will be the first one of its kind.

Agnieszka Lichanzka Ph.D.

Agnieszka is currently a Staff Scientist and Laboratory Manager at TessArae, LLC in Sterling, VA, USA. She obtained her PhD at the University of Queensland in Australia in a field of biochemistry, and subsequently worked as a post-doctoral fellow at Queen's University of Belfast, University of Queensland and Institute for Molecular Biosciences. Since 2005 until 2008 she held a continuing appointment as a lecturer in a School of Dentistry at the University of Queensland and established her own laboratory in area of functional genomics and metabonomics. She has over 10 years of experience in molecular biology, genetics, genomics, biochemistry, microbiology and metabonomics. In addition she has experience as a science writer. Recently Agnieszka served on the Council of the Australian Society for Biochemistry and Molecular Biology and is still active in the society. Currently she is working on novel diagnostic assays for infectious diseases using microarray re-sequencing technology.

Tatjana Matejic, PhD, D(ABMLI)

Dr. Matejic is the founder of Biotech Expertise where she provides scientific and technical consulting services to biotech companies on development of functional assays reflective of mechanisms of drug action in the context of disease pathology, in vivo studies, and biomarkers.  She is an immunologist by training (Ph.D. in immunology, board certification in medical diagnostic immunology by the American Board of Medical Laboratory Immunology) with more than two decades of industrial experience working in research and development of Biotech/Pharma companies ranging from start-ups to multinational pharmaceutical corporations, Pfizer being the most recent one.  During her long career in industry she led and mentored diverse teams of scientists and contributed to all stages of project and product development from scientific idea to commercial product of diverse portfolio of biologics. She was recognized as a leader in development and implementation of strategies for evaluating biological function of therapeutic candidates. She contributed to efforts of interdisciplinary drug development teams to successfully advance numerous early and late stage clinical programs and a few commercial products across multiple therapeutic areas and disease targets. She also conducted technical diligence for transition of pipeline projects from discovery to development phase, as well as for technology assessment for in-licensing opportunities.

David Carpentieri, MD

Dr. Carpentieri is a Medical Staff Member at Large, Pathology, Phoenix Children's Hospital and is Assistant Professor of Clinical Pathology and Pediatrics, University of Arizona and Assistant Professor of Pathology, Mayo Medical School.  His affiliations are with the American Association for Clinical Chemistry (AACC), the Childrens Oncology Group (COG), Society for Pediatric Pathology (SPP), and the International Society for Biological and Environmental Repositories (ISBER).

Timothy Harris, PhD

Since June 2011, Dr. Harris has served as the Senior Vice President of Translational Medicine at Biogen Idec. Dr. Harris has served as the Director of the Advanced Technology Program at SAIC Frederick since 2007 and Chief Technology Officer for SAIC Frederick since 2008. Prior to holding these positions, he served as the President and Chief Executive Officer of Novasite Pharmaceuticals Inc. from January 2005 to September 2006. Prior to that, he served as Chief Executive Officer for Structural GenomiX, Inc., a drug discovery and development company focused on innovative cancer therapeutics from 2003 to 2004 and as its President and Chief Executive Officer from 1999 to 2003. Dr. Harris started his career in biotechnology in 1981 as a group leader in Molecular Biology at Celltech Group and from 1989 to 1993 was Director of Biotechnology at Glaxo Group Research in the U.K. From 1993 until 1999, Dr. Harris was Chief Scientific Officer and Vice President of Research and Development at Sequana Therapeutics Inc. in San Diego, which became Axys Pharmaceuticals, Inc. in 1998 and was subsequently acquired by Celera Genomics. During the past five years, Dr. Harris has served on the board of directors of Dendreon Corporationration and he currently serves on the boards of directors of Origen Therapeutics, Inc. and Gyrasol Technologies and is Chairman of the Scientific Advisory Board of Bionomics Inc. in Australia.

Antonio Baines, PhD

Dr. Antonio T. Baines is an Associate Professor in the Department of Biology at North Carolina Central University (NCCU) and an adjunct professor in the Department of Pharmacology in the School of Medicine at the University of North Carolina (UNC) Chapel Hill. He earned a bachelors degree in biology from Norfolk State University and a doctorate in pharmacology and toxicology from the University of Arizona. Afterwards, Dr. Baines accepted a postdoctoral fellowship at UNC in pharmacology and radiation oncology under Drs. Channing Der and Adrienne Cox. His research focused on understanding the role of the Ras oncogene as a molecular target in pancreatic cancer oncogenesis. In August 2006, Dr. Baines accepted a tenure-track faculty position at NCCU where he currently teaches and conducts research as a cancer biologist. Also, he mentors high school, undergraduate, and graduate students in his laboratory. Pancreatic cancer is the 4th most common cause of cancer deaths in the United States with a high mortality rate and very limited treatment options. The overall focus of Dr. Baines research program is to identify and validate novel molecular targets in pancreatic cancer which can be targeted by potential cancer therapeutics. Additionally, his lab aims to understand the role of these molecular targets in the development and progression of normal cells transforming into cancer cells of the pancreas. Currently, Dr Baines studies the functional significance of the oncogenic Pim kinase family in pancreatic cancer growth and development. He hypothesizes that inhibition of these enzymes will be an effective approach for antagonizing the aberrant growth of pancreatic carcinoma. In addition to working with colleagues in academia, he collaborates with various pharmaceutical companies that are developing Pim inhibitors. Results from his studies will allow for critical validation of these kinases as novel therapeutic targets for pancreatic cancer treatment. Dr. Baines research has been funded by NIH and other grant sources. He has presented his research at various national scientific meetings such as the Society of Toxicology and the American Association for Cancer Research. In addition, Dr. Baines has given invited research seminars at universities such as Duke University, UNC-Chapel Hill, North Carolina Agricultural and Technical (A&T) State University, Indiana University, North Carolina State University, University of Missouri-Kansas City and Massachusetts Institute of Technology (MIT).

Daniel Irimia, MD, PhD

Dr. Irimia is an Assistant Professor in the Department of Surgery at the Massachusetts General Hospital, Shriners Hospitals for Children in Boston, and Harvard Medical School.  He is leading a research program that is focused on studying the roles of cellular migration in health and disease.  Dr. Irimia is interested in probing the role of cancer cell migration during cancer invasion and tumor metastasis.  He is also very interested in understanding how the ability of white blood cells to move and protect against microbes is being affected during the systemic inflammation responses after burn and trauma injuries.  For this research, he is employing the most advanced microscale technologies which enable us to design new tools and measure cell migration with better precision than ever before.

Fred Russell Kramer, PhD

Fred Russell Kramer is Professor of Microbiology and Molecular Genetics at the New Jersey Medical School, and has been a Principal Investigator at the Public Health Research Institute for the past 25 years. He graduated from the University of Michigan in 1964 and received his doctorate from the Rockefeller University in 1969. He was on the faculty of the Department of Genetics and Development at Columbia University College of Physicians and Surgeons for 17 years and has been a Research Professor and Adjunct Professor in the Department of Microbiology at New York University School of Medicine for the past 24 years.

Martin Latterich, PhD

The discovery of proteinaceous disease biomarkers and their clinical validation is critically important for the enablement of molecular diagnostics and ultimately, precision medicine. In spite of the importance of biomarkers, research done in the last two decades has yielded limited success in enhancing the repertoire of protein biomarkers of disease. This apparent dichotomy is in large part due to the fact that the process from discovery to validation is complex and involves a multidisciplinary collaboration across clinical, biochemical and biophysical disciplines and that that many initiatives sought to identify unique markers for a given disease with perfect correlation. Recent advances in better biomarker discovery strategies, clinical sampling and sample storage, better sample preparation methods that consider the inherent instabilities associated with clinical specimens, better discovery methods and analytical instrumentation suited for assay validation and clinical assays together promise to generate better panel tests for disease biomarkers of clinical significance.

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Dr. Latterich has nearly 20 years of academic and commercial and leadership experience and features an accomplished research career focused on the proteomics-based discovery of novel biomarkers in oncology, respiratory disease and neurodegenerative disorders. Martin is currently CSO at BioScale, a Lexington, MA, based biotechnology corporation commercializing a novel acoustic biomarker quantification platform. Most recently Martin served as a Professor at the Proteogenomics Research Institute for Systems Medicine in San Diego, where his laboratory used proteomics and genomics to discover novel biomarkers of cancer and degenerative disease though a systems biology approach that includes proteomics. He is also the CSO, co-founder and a board member for the non-profit Nicholas Conor Institute for Pediatric Cancer Research. Martin's work at the institute included designing new technologies to enable the better treatment of children with cancer, using personalized medicine technology to match their unique genetic make-up and tumor physiology to available treatment options. He previously served on the faculty of the University of Montreal, McGill University and the Salk Institute. His grant-funded work has been recognized by the 2003 Tier I Canada Research Chair, the 1998 Pew Scholar Award and the 1997 Basil O'Connor Starter Scholar Award. Dr. Latterich also held senior management positions at several biotechnology companies, including Diversa and Illumina, where he headed the proteomics initiatives. He has made significant contributions to the field of cell biology, clinical biomarker discovery, proteomics and genomics. Among his recent discoveries are biomarkers for cancer, respiratory disease and neurodegenerative disorders. Dr Latterich has edited one book on RNAi, is author on over 34 publications in leading scientific journals and is listed on numerous patent applications. Martin is Editor-in-Chief of the scientific journal Proteome Science. He has served on several national and international study sections. He was a postdoctoral fellow in molecular and cell biology in the laboratory of Dr. Randy Schekman at the HHMI and University of California, Berkeley. Dr. Latterich earned his Ph.D. in cell biology and a B.Sc. in biochemistry and molecular biology from Durham University, U.K.

Judd Moul, MD, FACS

Judd W. Moul is James H. Semans, MD Professor of Surgery, Division of Urologic Surgery, and Director of the Duke Prostate Center, Duke Cancer Institute at Duke University Medical Center. Prior to joining Duke, he was Professor of Surgery at the Uniformed Services University of the Health Sciences (USUHS) in Bethesda, Maryland and an attending Urologic Oncologist at the Walter Reed Army Medical Center (WRAMC) in Washington, DC. In addition, he was Director of the Center for Prostate Disease Research (CPDR); a Congress-mandated research program of the Department of Defense based at USUHS and WRAMC. In 2004, he completed a 26-year U.S. Army career, retiring as a full Colonel in the Medical Corps, and became Chief of the Division of Urologic Surgery at Duke. Serving as Chief from 2004 to 2011, he brought innovation and growth to the program. Most notably, he started the Duke Prostate Center, expanded the urology residency training program through a novel collaboration with the Department of Defense and was able to maintain Duke Urology as a top 10 program in the nation throughout his tenure. Dr Moul completed his Urologic Oncology Fellowship at Duke University and graduated Summa Cum Laude from Pennsylvania State University. He earned his medical degree from Jefferson Medical College, where he was elected to Phi Beta Kappa and Alpha Omega Alpha. Dr Moul currently serves on the editorial boards of Prostate Cancer, Prostate Cancer and Prostatic Diseases, BJU International, American Journal of Mens Health, Brazilian Journal of Urology, World Journal of Urology, and Oncology REALTIME. He has published over 500 medical and scientific manuscripts and book chapters and has lectured at national and international meetings. He has appeared on ABC, NBC, CNN, PBS, and other media as a prostate cancer authority. Honors and awards received have included the American Medical Associations Young Physicians Section Community Service Award for his national involvement in prostate cancer patient support groups, the Sir Henry Welcome Research Medal and Prize from the Association of Military Surgeons of the United States, the prestigious Gold Cystoscope Award by the American Urological Association, the Baron Dominique Jean Larrey Military Surgeon Award for Excellence, the Order of Military Medical Merit from the Surgeon General at the US Army, and the Castle Connolly National Physician of the Year award.

Kathryn Wellen, PhD

Dr. Kathryn Wellen received a PhD from Harvard University in 2006 and performed postdoctoral work at the University of Pennsylvania from 2006-2011.  In 2011 she joined the Department of Cancer Biology at the University of Pennsylvania as an Assistant Professor.  She is a 2012 Pew Scholar in the Biomedical Sciences and is a recipient of a 2012 Forbeck Scholar Award.  Her laboratorys research focuses on elucidating links between cellular metabolism and signaling, with a current emphasis on metabolic regulation of the epigenome.

Howard Morris, PhD, FAACB, FFSc(RCPA)

Professor Howard Morris is Professor of Medical Sciences at the University of South Australia and a Chief Medical Scientist in Chemical Pathology at SA Pathology, Adelaide, South Australia.

He is currently Vice-President of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and Chair of the IFCC-International Osteoporosis Foundation Working Group on Standardization of Bone Marker Assays. He has over 30 years experience in Clinical Biochemistry largely managing the Endocrinology laboratory of a large public pathology service. Between 2003 and 2009 he was the Director of the Hanson Institute in Adelaide, the major medical research institute in South Australia. His research investigates the pathophysiology of osteoporosis and the effects of hormones including vitamin D and dietary calcium. He was the Louis Avioli Memorial Lecturer at the 2009 Annual Scientific Meeting of the American Society for Bone and Mineral Research. He is also Chair of the South Australian Department of Health Working Party on Osteoporosis and Fracture Prevention.

Alan Wright, MD

Dr. Wright is the Chief Medical Officer at Roche Diagnostics Corporation in Indianapolis, Indiana. Prior to joining Roche, Dr. Wright served as Senior Vice President of Health Improvement Strategies for Miraca Life Sciences. He was the Vice President for Product Strategy and Business Development for Resolution Health, a privately held analytics and intervention company serving the managed care market place. Until 2005, Dr. Wright was chairman and CEO of Star Pharmaceuticals, a generic pharmaceutical company he founded in 2002, serving the needs of the urological community. Previously, he was Senior Vice President and Chief Science Officer of Caremark . Dr. Wright also served as Senior Vice President and Chief Medical Officer for AdvancePCS.

Dr. Wright graduated magna cum laude with a Bachelor of Science degree from Pennsylvania State University. He received his medical doctorate from the University of Pennsylvania and completed his residency in internal medicine at Temple University in Philadelphia. While at Temple he served as Chief Medical Resident from 1985 to 1986 and completed his Masters of Public Health degree at Johns Hopkins School of Hygiene and Public Health. Dr. Wright is a member of several journal editorial boards. He is a member of the American Medical Association and American College of Physicians. He is also certified as a diplomat to the American Board of Internal Medicine and the National Board of Medical Examiners.

Anthony Grace, PhD

Dr. Anthony A. Grace is a Distinguished Professor of Neuroscience and a Professor of Psychiatry and Psychology at the University of Pittsburgh in Pittsburgh, PA. He received his Ph.D. from Yale University School of Medicine with Dr. Benjamin S. Bunney and had postdoctoral training with Dr. Rodolfo Llinas in the Department of Physiology and Biophysics at New York University School of Medicine. Dr. Grace has been involved in translational research related to the dopamine system for over 30 years. His early work pioneered the mode of action of antipsychotic drugs, and the identification and characterization of dopamine-containing neurons, and was the first to provide a means to quantify their activity state and pattern in a way that is the standard in the literature. His current work involves novel treatments for schizophrenia and its prevention, the role of dopamine in anhedonia and affective disorders, and the mode of action of ketamine and novel antidepressant drugs. Dr. Grace has received several awards for his research, including the Paul Janssen Schizophrenia Research Award and the Lilly Basic Scientist Award from the International College of Neuropsychopharmacology, the Efron Award from the American College of Neuropsychopharmacology, as well as a NIMH MERIT award, a Distinguished Investigator Award from the National Alliance for Research in Schizophrenia and Depression, the Judith Silver Memorial Investigator Award from the National Alliance for the Mentally Ill, a Fellow of the American Association for the Advancement of Science, and appointment as a Distinguished Professor of Neuroscience at the University of Pittsburgh. He is also a past member of the governing council of the American College of Neuropsychopharmacology and is on the editorial board for numerous leading journals in the field.

Ulrich Hengst, PhD

Dr. Ulrich Hengst studied biochemistry at the Ruhr University Bochum, Germany, and conducted his graduate research at the Friedrich Miescher Institute for Biomedical Research in Basel, Switzerland, in the group of Prof. Denis Monard. In 2003 he received his PhD from the University of Basel. For his postdoctoral training, Dr. Hengst joined the laboratory of Samie R. Jaffrey, MD, PhD at the Weill Cornell Medical College in New York, NY. In Dr. Jaffreys group, he investigated the role of axonally localized mRNAs for axonal development leading to the identification of the first examples of specific mRNAs that are translated in axons in response to extracellular signaling molecules and that mediate growth cone collapse and axon elongation, respectively.

In 2009, Dr. Hengst joined the Department of Pathology and Cell Biology and the Taub Institute for Research on Alzheimers Disease and the Aging Brain at Columbia University Medical Center in New York, NY, as an Assistant Professor. He has successfully established new research projects addressing the role of local protein synthesis in Alzheimers disease and neurodevelopment.

Paul Mathews, PhD

Dr. Paul J. Mathews received his bachelors degree from the University of Oregon where he studied invertebrate behavioral plasticity in the lab of Dr. Nathan Tublitz. He received his Ph.D. in neuroscience from the University of Texas at Austin under the mentorship of Dr. Nace Golding. Dr. Mathews work focused on understanding how the biophysical properties of specific voltage-gated ion channels in an auditory brainstem nuclei contribute to their capacity to make sub-millisecond computations necessary for low frequency sound localization. For the past several years Dr. Mathews has been working at UCLA under the mentorship of Dr. Tom Otis where he is currently working to uncover the cerebellar circuit mechanisms that underlie motor learning and memory. To do this Dr. Mathews is utilizing a multifaceted approach that includes both in vitro and in vivo electrophysiology, optogenetics, advanced optics, histology, and behavioral manipulations to make links between cerebellar circuit activity and motor output in rodent models. He is currently on the job market looking for a tenured track assistant professor position.

Ahmad Salehi, MD, PhD

Ahmad Salehi, M.D., Ph.D. is a Clinical Associate Professor at the Department of Psychiatry and Behavioral Sciences, Stanford Medical School and the Director of the Translational Laboratory at the VA Palo Alto Health Care System in California. He obtained his MD in Tehran, Iran and then moved to the Netherlands Institute for Brain Research, in Amsterdam to get his PhD. While he was there, he was selected as the best junior scientist in the field of Alzheimers disease in the Netherlands. After finishing his graduate studies and 3 years of postdoc in Amsterdam, he moved to Stanford Medical School. First as a postdoc, and then as a Senior Research Associate, he worked on mechanisms of failed axonal transport in mouse models of Down syndrome. For almost a decade, he was the Director of Stanford Brain Bank. Since 2009, Dr. Salehi has moved to the Department of Psychiatry and Behavioral Sciences at Stanford. In December 2010, he received the World Technology Award in the field of Biotechnology for his innovative work on the use of mouse models of Down syndrome. During his carrier, Ahmad has been involved in publication of a large number of papers from which several have appeared on the cover of Science, Cell: Stem Cell, Science Translational Medicine, Neuroscience and Bio-behavior Reviews, and Biological Psychiatry (twice).

Katerina Venderova, PharmD, PhD

Dr. Katerina Venderova obtained her master's and doctorate degrees in pharmacy, and her PhD in Toxicology from Charles University in the Czech Republic. She then received a fellowship from the Parkinson Society Canada and pursued her postdoctoral training at Toronto Western Research Institute (2 years), and subsequently at University of Ottawa in Canada (5 years), where she studied genetics of Parkinson's disease, mechanisms of neuronal death and cell signaling in the basal ganglia. Dr. Venderova joined Pacific in 2011.

Sihe Wang, PhD DABCC FACB

Dr. Sihe Wang is Section Head and Medical Director of Clinical Biochemistry and Director of Clinical Biochemistry Fellowship Training Program, Cleveland Clinic, Cleveland, Ohio. He also chairs the clinical chemistry integration effort for the Cleveland Clinic Health System which includes 1 Florida hospital, 8 community hospitals and 18 family health centers in Northeast Ohio. Additionally, he is Clinical Chemistry Professor, Cleveland State University. Prior to his current position, Dr. Wang was Assistant Professor at Northwestern University; Director, Clinical Chemistry Laboratory and Referred Testing Laboratory, Children’s Memorial Hospital, Chicago, Illinois. Dr. Wang is a diplomate of the American Board of Clinical Chemistry (DABCC) and a fellow of the National Academy of Clinical Biochemistry (FACB).

Dr. Wang is a member of several professional organizations, including the American Society for Mass Spectrometry and the American Association for Clinical Chemistry (AACC). He served as chair of AACC Northeast Ohio Section in 2008 and 2009 and the president of North American Chinese Clinical Chemistry Association (NACCCA) 2008-2009. Currently he serves as the historian for NACCCA, the treasurer for the Pediatric and Maternal Fetal Division of AACC, the delegate for AACC Northeast Ohio section, commissioner for The Commission on Accreditation in Clinical Chemistry (ComACC), and a member of AACC's Strategies Online Editorial Advisory Board. The AACC presented him with the 2005, 2008, and 2010 Clinical Chemist Recognition Award. He is also the recipient of the 2006 Lemuel J. Bowie Young Investigator Award for the Chicago Section of the AACC. Dr. Wang has authored over 140 journal articles, book chapters, and abstracts. He also serves on several editorial boards of peer reviewed journals.

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Attendees

Wilma Buffolano
Arthur Besteman
Christopher Heist
Michelle Vincent
Manuel Menendez
Husheng Yang
Felicia Buck
Raymond Baez
Rosemary McGeary
Alice Marcy
Hao-Chun Chiang
Rajesh Kumar
Eunjoo Kim
Alexander Aristarkhov
Jennifer Ellis
Narayan Krishnaswami
Bernard China
Vijai Agnihotri
Julio Del Hierro
Laura Edwards
frederick golec
Dolores Fabbro
Muhammad Tariq Gazdar
Frank Adamo
Joseph Rantus