Next Generation Dx Summit

Short Courses

Monday, August 18 (9:00AM-12:00PM)


SC1: Overcoming Challenges of Working with FFPE Samples (Detailed Agenda) 

W. Fraser Symmans, M.D., Professor & Director, Research Operations, Pathology, UT MD Anderson Cancer Center

Sidney W. Fu, M.D., Ph.D., Professor & Associate Director, Genomic Medicine and of Medicine, Microbiology, Immunology and Tropical Medicine, George Washington University School of Medicine and Health Sciences

Professor Beatrice S. Knudsen, M.D., Ph.D., Director, Translational Pathology, Cedars Sinai Medical Center

Biswajit Das, Ph.D., Senior Scientist (Contractor), Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, National Cancer Institute, Leidos Biomedical Research Inc.
 

  • RNA detection in cancer tissues stored in FFPE samples
  • Profiling microRNA expression
  • FFPE DNA quality control and its correlation with NGS data
  • Understanding pre-analytic effects on RNA gene expression

SC2: Leading Product Innovation - (Detailed Agenda) 

John C. Carrano, Ph.D., President and Founder, Paratus Diagnostics, LLC

  • Raising capital for your company or your project; pitching new ideas and writing a winning proposal, product development processes for FDA QSR
  • Mathematics of cost-benefit analysis to establish a value proposition
  • ISO 13485 and leadership and management techniques

SC3: NGS Data Analysis – Determining Clinical Utility of Genome Variants - (Detailed Agenda) 

Heather McLaughlin, Ph.D., MB(ASCP)CM, Instructor of Pathology, Massachusetts General Hospital and Harvard Medical School and Assistant Laboratory Director, Laboratory for Molecular Medicine, Partners HealthCare Personalized Medicine

Erica Ramos, MS, CGC, Clinical Genomics Specialist, Certified Genetic Counselor, New and Emerging Opportunities, Illumina, Inc.

Gabe Rudy, Vice President, Product Development, Golden Helix

  • Review advances in NGS such as opportunities to mine genetic data from individuals to populations
  • Identify genetic variants to link sequence data with disease
  • Explore genetic data science
  • Learn how to determine informed healthcare decisions

Monday, August 18 (2:00-5:00PM)


SC4: Microfluidics for POC: Technologies, Applications and Products - (Detailed Agenda) 

Holger Becker, Ph.D., Founder & CSO, microfluidic ChipShop GmbH

  • Understand the role of microfluidics technology in the development of new products and the current state of the markets and obstacles in the commercialization process; and the different microfabrication methods for low and high volume production
  • Learn about development strategies in product development and about examples of successful and unsuccessful microfluidic product introductions
  • Get an overview on existing microfluidics-enabled products in the POC market

SC5: NGS as a Diagnostics Platform - (Detailed Agenda) 

Madhuri Hegde, Ph.D., FACMG, Associate Professor, Human Genetics; Executive Director, Emory Genetics Lab, Emory University School of Medicine

Shashikant Kulkarni, Ph.D., FACMG, Head, Clinical Genomics; Associate Professor; Pediatrics, Genetics, Pathology and Immunology, Washington University School of Medicine

Justin Zook, Ph.D., Biomedical Engineer, NIST

  • Technical aspects, tremendous power and pitfalls of NGS
  • NGS for cancer genomic analysis and companion diagnostics
  • Risks of genetic discrimination and impacts of gene patents, government regulation, and direct-to-consumer marketing
  • Standardization of NGS assay development

SC6: Clinical Trials to Establish the Value of Diagnostic Tests: Design and Management - (Detailed Agenda) 

Adrienne Bambach, Ph.D., Manager, Scientific Affairs; Acting Director, Clinical Affairs, Nanosphere, Inc.

Anita Borek, Senior Manager, Clinical Affairs & Specimen Mgmt., Nanosphere, Inc.

Scott Powell, Clinical Marketing Manager, Nanosphere, Inc.

  • Sponsored/Investigator-Initiated-Study clinical diagnostics processes
  • Specimen Acquisition and Management—who from, how to acquire, when to acquire, what to acquire and management best practices
  • Clinical study publication planning and execution—microbiology molecular diagnostic test case presented from market development studies through clinical outcomes/cost-effectiveness studies

Monday, August 18 (DINNER 5:30-8:30PM)


SC8: Use of CLIA-Waived POC and Rapid Diagnostic Tests in Community Pharmacies - (Detailed Agenda) 

Michael E. Klepser, Pharm.D., FCCP, Professor, Pharmacy Practice, Ferris State University College of Pharmacy

Donald G. Klepser, Ph.D., MBA, Assistant Professor, Pharmacy Practice, University of Nebraska Medical Center College of Pharmacy

Allison Dering-Anderson, Pharm.D.,RP, Clinical Assistant Professor, Pharmacy Practice, University of Nebraska Medical Center College of Pharmacy

  • Community pharmacies and how it is a growth market for diagnostics
  • Legislation and state practice acts regarding the use of CLIA-waived POC and RDTs in community pharmacies
  • Developing a sustainable business using POC and RDTs in community pharmacies

SC9: Regulatory Compliance in Drug Diagnostics Co-Development (Detailed Agenda) 

Tracy Bush, Ph.D., Director & Global Coordinator, Companion Diagnostics, Regulatory Affairs, Roche Diagnostics

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

Sabah Malek, Associate Director, Global Regulatory Affairs, Eisai, Inc.

  • U.S. requirements and processes; U.S. government oversight of diagnostics, diagnostic clearance and approval pathways
  • Co-development process & timelines and integration of Rx and Dx development plansl navigating the development process and co-development examples and lessons learned
  • Diagnostics regulation in the EU, Japan, China and other complex emerging markets; developing a successful CDx global regulatory strategy

WEDNESDAY, AUGUST 20 (DINNER 6:30-8:30PM)


SC10: Regulatory & Reimbursement Issues with NGS and Other Multiplex Assays - (Detailed Agenda) 

Melina Cimler, Ph.D., Vice President, Head, Global Quality Illumina, Inc.

Danielle Scelfo, Director, Government Affairs, Genomic Health

  • Part 1: NGS applications and implications; Current regulatory pathways; Things to consider in developing NGS applications for clinical use; NGS in companion diagnostics – roles of pharma and diagnostic partners
  • Part 2: Coding, coverage, policies and payment fees for NGS assays; Medicare /CMS view; How to generate cost effectiveness data; Clinical utility data

SC11: NGS for Infectious Disease Diagnostics - (Detailed Agenda) 

Samia Naccache, Ph.D., Associate Specialist, Laboratory Medicine, UCSF

Erik Samayoa, Clinical Lab Scientist, UCSF Viral Diagnostics and Discovery Center

  • Clinical laboratory implementation of an unbiased NGS assay for pathogen detection
  • From sequence-to-answer: bioinformatics analysis of NGS data in infectious diseases
  • Other applications of NGS in infectious diseases – 16S/18S amplicon sequencing, whole-genome sequencing of bacteria and viruses, microbiome analysis, pathogen enrichment panels, host transcriptome sequencing

*Separate Registration Required

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