PPT-FDA Public Workshop – Variant Classification

Session 4 Future directions for data sharing standardization and establishing consistency in precision oncology Dane J Dickson MD 2 Overview Obstacles to data sharing and standards CureOne N1 Quality Improvement Registry. 1061 Rockville MD 20852 All comments should be identified with the docket number listed in the notice of availability that is published in the Federal Register For questions rega rding this document contact Michael Ortwerth at 301 796 8220 US Depart Sedative hypnotics depress or slow down the bodys functions These drugs are commonly referred to as tranquilizers sleeping pills or sedatives They were originally developed to treat medical conditions such as epileptic seizures as well as to treat a Bruce Ross. , . M.A. M.P.H.. Director, India Office. Agenda. Priorities. Challenges of globalization. cGMP. . deficiencies. Comparison. Post inspection regulatory . actions. 2. Advance Regulatory Science: the science of developing new tools, standards and approaches to assess the safety and effectiveness, quality and performance of FDA-regulated products. Cyrus Mehta, Ph.D.. President, Cytel Inc. .. Statistical research with Sebastien Irle and Helmut Schäfer, Institute of Medical Biometry, University of Marburg, Germany. Problem formulation based on collaborations with the Pfizer Inc., and M.D. Anderson Cancer Center. . Updates and Upcoming Collaborations. Agenda . COGR overview . U. pdates. Current variant numbers. BRCA Manuscript. 4. Discussion. COGR Objectives. To create Canada’s unified, open-access, clinical-grade genetic database using a commonly shared platform. Assessment. (Boston College & University of Michigan). Gabor Marth, Goncalo Abecasis, PIs. Informatics challenges for genomic analysis. Tool . building. Facilitating . analysis. . Widening. accessibility. Karchin Lab. Department of Biomedical Engineering. Institute of Computational Medicine. Johns Hopkins University. SSID: . ASHGWORKSHOP. WiFi. Password. : . ASHGWORKSHOP. Select the SSID: . ASHGWORKSHOP. October 3, 2017. Stephanie Scarmo, PhD, MPH . Outline. Legislative background. Different models for creating the list. Principles. Final list. Legislative background. Congress did not want to impose barriers to products currently on the market, and thereby legislated a presumption of safety.. -Version 11 Working Group Pagehttps//clinicalgenomeorg/working-groups/sequence-variant-interpretation/Date Approved March 18 2018Changes from v1 Clarified that confirmed/assumed is with regards to par Steven R. Bauer, Ph.D.. US Food and Drug Administration. Center for Biologics Evaluation and Research. Office of Tissues and Advanced Therapies. 1. Outline. Introduction. Challenges in Flow Cytometry. Atul Kothari, MD FIDSA. Medical Director Healthcare Associated Infections Program. Associate Medical Director Infectious Diseases Branch. Disclosures. Off label use of some FDA EUA products will be discussed. . Submit written comments to the Dockets ManagementStaff(HFA305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket Exomes. /WGS. Ramesh Nair. May 31, 2013. Outline. Types of genetic variation. Framework for variant discovery. Variant calling methods and variant callers. Filtering of variants. Structural variants. Ramesh Nair. 9/12/2012. Outline. Types of genetic variation. Framework for variant discovery. Variant calling methods and variant callers. Filtering of variants. Structural variants. 9/12/2012. Variant Calling.