Next Generation Dx Summit

Short Courses

Monday, August 19

MORNING SHORT COURSES 9:00 am - 12:00 pm

SC1 Overcoming Challenges of Working with FFPE Samples  -Detailed Agenda 

Moderator: P. Mickey Williams, Ph.D. (Contractor), Director of Molecular Characterization and Clinical Assay Development Laboratory (MoCha), Frederick National Laboratory for Cancer Research (tentative)

Instructors: Helen M. Moore, Program Director, Biorepositories and Biospecimen Research Branch, NCI NIH

Lynne Rainen, Ph.D., Principal Scientist, PreAnalytiX, BD

Helen Y. Wu, Ph.D., Project Leader, Genomics and Oncology, Roche Molecular Systems

Jason Lih, Ph.D. (Contractor), Principal Scientist, Molecular Characterization & Clinical Assay Development Laboratory, SAIC Frederick National Laboratory for Cancer Research, SAIC-Frederick

  • Non-formalin-based fixatives
  • Comparison of methods for preserving morphological, molecular, and protein biomarkers in tissue
  • Feasibility data from fine needle aspirates (FNA)
  • Assay development

College of American PathologistsSC2 Latest Advances in Molecular Pathology

Instructors: Jack H. Lichy, M.D., Ph.D., Chief, Pathology & Laboratory Medicine, VA Medical Center, Washington, D.C.
Christopher D. Gocke, M.D., Associate Professor of Pathology and Oncology, Director of Hematology, Molecular Diagnostics, Johns Hopkins University School of Medicine

Jennifer Morrissette, Ph.D., Director, Clinical Cancer Cytogenetics, University of Pennsylvania School of Medicine and The Children’s Hospital of Philadelphia

  • Introduction to molecular pathology methods
  • Molecular diagnostic cancer testing
  • Cytogenetic testing and microarray comparative genomic hybridization

SC3 Clinical Studies for the Development of Evidence-Based Diagnostics

Instructors: Catherine Schnabel, Ph.D., Vice President, Medical, Clinical & Regulatory Affairs, bioTheranostics, Inc.

Brock Schroeder, Ph.D., Director, Medical & Scientific Affairs, bioTheranostics Inc.

 

Development of a strong clinical program for diagnostic tests requires consideration and integration of key strategic drivers such as clinical adoption, reimbursement, & regulatory filing based on a proposed indication for use.  In considering the appropriate use of new tests, clinicians and health care policymakers must consider the accuracy with which a test identifies a patient's clinical status (clinical validity), the risks and benefits resulting from test use (clinical utility), and the medical value of the test (health economics/outcomes). This workshop will provide a basic framework for establishing comprehensive clinical evidence based on analytical validity, clinical validity, clinical utility, and health economics and effectiveness, and utilize a case study of the 92-gene assay, CancerTYPE ID to build these points.

• Clinical study designs for biomarker research/Levels of evidence
• Formulating clinical endpoints
• Framework for clinical evidence
• Data requirements for various stakeholders
• Case study

SC4 Technology Trends in the Emerging Exosomes Field   -Detailed Agenda 

Instructors: Enal Razvi, Ph.D., Biotechnology Analyst

Hannah Mamuszka, Vice President, Business Development, Exosome Diagnostics

Leonora Balaj, Ph.D., Research Fellow, Massachusetts General Hospital, Harvard Medical School

  • Challenges and opportunities in exosome research: Where are the bottlenecks?
  • Technology development in exosomes and microvesicles (EMVs)
  • Classes of EMV researchers
  • EMVs as potential biomarkers: Prognostic vs. predictive

SC5 Clinical Assay Development

Instructors: Barbara A. Conley, M.D., Associate Director, Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute

Andrea Ferreira-Gonzalez, Ph.D., Professor and Chair, Division of Molecular Diagnostics; Director, Molecular Diagnostics Laboratory, Department of Pathology, Virginia Commonwealth University

Andrew Grupe, Ph.D., Senior Director, Pharmacogenomics, Celera/Quest Diagnostics

Elaine Lyon, Ph.D., Medical Director, Molecular Genetics; Co-Medical Director, Pharmacogenomics, ARUP Laboratories; Associate Professor, University of Utah

Gene Pennello, Ph.D., Team Leader, Division of Biostatistics, U.S. Food and Drug Administration

  • Assessment of the analytical and clinical performance of biomarker assays
  • Translating NGS applications from a research environment to a standardized test offering in a clinical reference laboratory
  • Providing clinical value beyond existing tests on traditional platforms
  • Infrastructure to interpret and report results
  • Consequences of hardware, software and reagent updates
  • Validation of laboratory-developed tests
  • NCI Clinical Assay Development Program

AFTERNOON SHORT COURSES 2:00 - 5:00 pm

SC6 Circulating Tumor Cells and Cancer Stem Cells from Research to Clinic   -Detailed Agenda 

Moderator: Marek Malecki, M.D., Ph.D., President, Phoenix Biomolecular Engineering Foundation; Visiting Professor, University of Wisconsin, Madison

Instructors: Minetta C. Liu, M.D., Associate Professor, Department of Oncology and Department of Laboratory Medicine and Pathology, Mayo Clinic Cancer Center

Avraham Rasooly, Ph.D., Chief, Disparities Research Branch, NCI NIH

Abraham Tzou, Medical Officer, FDA CDRH

Patrick Morris, Ph.D., Perkins Coie LLP

  • Isolation of living cells
  • Molecular profiling
  • Clonal expansion
  • IP aspects
  • Patient’s rights and ethical concerns
  • Cancer stem cells
  • Liquid biopsy

SC7 Applications of Detection Theory in Diagnostics   -Detailed Agenda 

Instructor: John C. Carrano, Ph.D., President, Carrano Consulting, LLC

  • Applying basic principles of detection theory
  • ROC curve trends and interpretation
  • Application of cost-benefit analysis to product choice
  • Decision tree and systems level analysis

SC8 Next-Generation Sequencing as a Diagnostics Platform

Instructors: Jamie Platt, Ph.D., CGMBS, MB (ASCP), Director, Advanced Sequencing, Quest Diagnostics, Nichols Institute

Shashikant Kulkarni, M.S. (Medicine), Ph.D., FACMG, Head, Clinical Genomics; Medical Director, Cytogenomics and Molecular Pathology; Associate Professor of Pediatrics, Genetics, Pathology and Immunology, Washington University School of Medicine

Nazneen Aziz, Ph.D., Director, Molecular Medicine, Transformation Program Office, College of American Pathologists

  • The landscape of next-generation sequencing and challenges for clinical applications
  • Advances in application of next-generation sequencing to cancer diagnostics
  • Development of laboratory standards for next-generation sequencing as a clinical tool

SC9 Regulatory Compliance in Drug-Diagnostics Co-Development

Instructors: Pamela L. Swatkowski, Director, Regulatory Affairs, Abbott Molecular, Inc.

Maham Ansari, MS, RAC, Consultant, Strategic Regulatory Services OptumInsight (UnitedHealth Group)
Debra Rasmussen, Senior Director, Regulatory Affairs, Johnson & Johnson

  • U.S. requirements and processes
  • U.S. government oversight of diagnostics, diagnostic clearance and approval pathways
  • Co-development process & timelines
  • Integration of Rx and Dx development plans
  • Navigating the development process
  • Co-development examples and lessons learned
  • Approval path for devices ex-U.S. and more

DINNER SHORT COURSE 5:30 - 8:30 pm

SC10 Regulatory and Reimbursement Issues with Multiplex Molecular Assays/Next-Generation Sequencing

NGS in Clinical Space:  Regulatory Considerations
Melina Cimler, Vice President, Quality & Regulatory Affairs, Illumina, Inc.

•         Next generation sequencing applications and implications

•         Current regulatory pathways

•         Overview of things to consider in developing NGS applications for clinical use

•         NGS in companion diagnostics – roles of pharma and diagnostic partners

Overview of the Molpath CPT codes
Victoria Pratt, Ph.D., FACMG, Director, Pharmacogenetics Laboratory, Indiana University School of Medicine

•        Difference between Tier 1 and Tier 2

•        How NGS fits in new MolPath CPT codes

•       Overview of how to obtain a CPT code

Biographies:
B. Melina Cimler, Ph.D.
Melina Cimler is Vice President of Quality & Regulatory Affairs at Illumina Inc., leading Illumina's quality, regulatory and government affairs organizations.  She has over 24 years of experience in the FDA-regulated diagnostic industry leading regulatory, quality systems, clinical affairs, research, and product development organizations.  She has been very actively engaged in global regulatory, government affairs, due diligence and alliance collaborations.
Prior to joining Illumina, Dr. Cimler served as president of PandiaDx Consulting, where she provided regulatory and compliance guidance for the development of in vitro diagnostic products and medical devices.  Previously, she held leadership positions in quality, regulatory and government affairs at Beckman Coulter Inc.  She also served in senior quality and regulatory roles at Abbott Molecular, Gen-Probe Inc., and C.R. Bard.  Dr. Cimler holds a Ph.D. in Pharmacology from the University of Washington.
Victoria M. Pratt, PhD, FACMG
Dr. Pratt is a Medical and Clinical Molecular Geneticist board-certified by the American College of Medical Genetics.  She is currently Director of the Pharmacogenetics Laboratory at Indiana University School of Medicine.  Prior to joining Indiana University, she was Chief Director, Molecular Genetics, for Quest Diagnostics Nichols Institute. Dr. Pratt served on the U.S. Secretary of Health and Human Services Advisory Committee on Genetics, Health and Society for the Oversight of Genetic Testing and the Advisory Committee on Hereditary Disorders in Newborns and Children.  She also participated in the preparation of the Morbidity and Mortality Weekly Report for Best Practices in Molecular Genetic Testing for the Centers for Disease Control and Prevention (CDC).  Dr. Pratt continues to serve on the CDC’s GeT-RM program for reference materials for Molecular Genetics.  She is currently serving on the Institute of Medicine’s Roundtable on Translating Genomic-Based Research for Health and the American Medical Association’s (AMA’s) Molecular Pathology Current Procedural Terminology (CPT) Advisory committee.  Dr. Pratt graduated with a Ph.D. in Medical and Molecular Genetics from Indiana University School of Medicine, Indianapolis, IN in 1994.  Her fellowship training was in Ph.D. Medical and Clinical Molecular Genetics at Henry Ford Hospital, Detroit MI. 

Wednesday, August 21

DINNER SHORT COURSES 6:30-8:30 pm

SC11 Use of Matrix-Assisted Laser Desorption Ionization Time of Flight Mass Spectrometry in Clinical Microbiology

Instructor: Robin Patel, M.D., Chair, Division of Clinical Microbiology, Consultant, Divisions of Clinical Microbiology and Infectious Diseases; Professor of Microbiology and Medicine, College of Medicine, Mayo Clinic

  • Adoption in the clinical laboratory
  • Comparison of available systems
  • Strengths and limitations

SC12 New Dealmaking Strategies in Companion Diagnostics
Instructors: Jorge Leon, Ph.D., President, Leomics Associates, Inc.
Matthew J. Hawryluk, Ph.D., Director, Business Development , Foundation Medicine, Inc.
• Deals between pharma and diagnostics in discovery, development and commercialization
  Needs from pharma
  Deliverables from diagnostics and the desired outcomes
  Average costs and financial structures
• Ingredients necessary to create the ideal type of pharma/diagnostics deals in order to increase the value for the diagnostic partners and to maximize the outcomes for the pharma partners

SC13 The Future of Point-of-Care Diagnostics

Instructors: Keith F. Batchelder, M.D., CEO, Genomic Healthcare Strategies

Peter S. Miller, COO, Genomic Healthcare Strategies

  • Why pharma will have to find new POC approaches to make companion diagnostics succeed
  • Near-patient testing – What are the business and technology implications?
  • New partnering opportunities for POC companies
  • Why the old business models won’t work
  • The wild cards – Consumer product companies