2016 ADX
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Short Courses*


MONDAY MORNING, AUGUST 22

9:00 am - 12:00 pm

SC1: NGS Diagnostics: Technology, Regulation and Reimbursement

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

Aaron J. Schetter, Ph.D., MPH, Senior Staff Fellow, Division of Molecular Genetics and Pathology/OIR, Center for Devices and Radiological Health, U.S. Food and Drug Administration

Katherine Tynan, Ph.D., President, Tynan Consulting LLC

Barbara A. Conley, M.D., Associate Director, Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute (Tentative)

P. Mickey Williams, Ph.D., Director, Molecular Characterization & Clinical Assay Development Laboratory (MoCha), Frederick National Laboratory for Cancer Research

SC2: Method Validation According to CLSI Guidelines

Shuguang Huang, Ph.D., Associate Vice President, Biostatistics, Helomics

SC3: Translating CTCs for Clinical Use

Scott M. Berry, Ph.D., Associate Scientist, Biomedical Engineering, University of Wisconsin, Madison

Joshua M. Lang, M.D., MS, Assistant Professor of Medicine, Carbone Cancer Center, University of Wisconsin

Michael Haffner, M.D., Carbone Cancer Center, University of Wisconsin

SC4: Overcoming Challenges to Commercial Success in Molecular Diagnostics

Harry Glorikian, Healthcare Consultant


MONDAY AFTERNOON, AUGUST 22

2:00 - 5:00 pm

SC5: Establishing the Value of Diagnostic Tests

Lawrence J. Worden, Vice President and Senior Partner, Market Diagnostics International

SC6: NGS Assay Development and Validation - Detailed Agenda

Jamie Platt, Ph.D., Vice President, Genomic Solutions, Molecular Pathology Laboratory Network, Inc.

Jennifer Morrissette, Ph.D., Scientific Director, Clinical Cytogenetics Laboratory, Clinical Director, Center for Personalized Diagnostics (CPD), University of Pennsylvania School of Medicine

SC7: Digital PCR: Technologies, Quantification, and Analysis - Detailed Agenda

Alexandra Whale, Ph.D., Senior Researcher, Molecular and Cell Biology Team, Science and Innovation Division, LGC Group

SC8: Detection and Characterization of Circulating Biomarkers

Sonya Parpart-Li, Ph.D., Associate Scientist, Personal Genome Diagnostics

Additional Instructors to be Announced


MONDAY EVENING, AUGUST 22

5:30 - 8:30 pm Dinner Short Course

SC9: Practical Considerations for NGS Data Analysisand Interpretation - Detailed Agenda

Robert D. Daber, Ph.D., Director, Research and Development and Sequencing Operations, Bio-Reference Laboratories

Matthew Lebo, Ph.D., FACMG, Director, Bioinformatics, Partners Personalized Medicine; Instructor, Pathology, Brigham and Women’s and Massachusetts General Hospitals

SC10: Regulatory Compliance in Advanced Diagnostics - Detailed Agenda

Abraham Tzou, M.D., Medical Officer, Center for Devices and Radiological Health, Food and Drug Adminstration

Melina Cimler, Ph.D., Senior Vice President, Quality & Regulatory, Adaptive Biotechnologies

Pamela Swatkowski, Director, Global Regulatory Affairs, Abbott Molecular


WEDNESDAY EVENING, AUGUST 24

6:30 - 8:30 pm Dinner Short Courses

SC11: Regulatory and Reimbursement Issues with NGS and Multiplex Assays - Detailed Agenda

Živana Težak, Ph.D., Associate Director, Science and Technology, Personalized Medicine, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), Center for Devices and Radiological Health (CDRH), FDA

Girish Putcha, M.D., Ph.D., Director, Laboratory Science, Palmetto GBA (MolDX)

SC12: NGS for Infectious Disease Diagnostics - Detailed Agenda

Sneha Somasekar, Staff Research Associate, Viral Diagnostics and Discovery Center, Laboratory Medicine, University of California San Francisco

SC13: Use of CLIA-Waived Point-of-Care and Rapid Diagnostic Tests in Community Pharmacies

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

SC14: Liquid Biopsy: Clinical Applications andBusiness Considerations - Detailed Agenda

Theresa Zhang, Ph.D., Vice President, Research Services, Personal Genome Diagnostics

Divyaa Ravishankar, MS, Senior Consultant, Life Sciences, Frost & Sullivan


THURSDAY EVENING, AUGUST 25

5:00 - 8:00 pm Symposia Dinner Short Course

SC15: Preimplantation Genetic Screening and Diagnostics: A Technology Overview - Detailed Agenda

Mark Umbarger, Ph.D., Director, Research and Development, Good Start Genetics

Nathan Treff, Director, Molecular Biology Research, Reproductive Medicine Associates of New Jersey; Associate Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, Rutgers-Robert Wood Johnson Medical School; Adjunct Faculty Member, Department of Genetics, Rutgers-The State University of New Jersey

Svetlana Rechitsky, Ph.D., Laboratory Director, Reproductive Genetics Innovations


*Separate registration required for Short Courses.


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