PPT-Overview of Challenges in the Conduct of Interventional Trials to Address Antibacterial

21 Jan 2016 Symposium New Frontiers in Antibacterial Resistance Research John H Rex MD 20160121 AMR Research Frontiers Challenge of clinical studies 1 Senior VP and Chief Strategy Officer AstraZeneca Antibiotics Business Unit NonExecutive Director F2G Ltd and . New. Novel. Antibacterials?. How Difficult Is It to Discover New Antibacterials?. Lynn L. Silver, Ph.D.. LL Silver Consulting, LLC. Antibacterials at FDA 2000-2011. Compound. Usage. Class . Active versus . Elliot Young. Honey. Background. Background. Background. Background. Background. +. Background. Methodology. 3 honeys compared:. Processed. Unprocessed. 10+ UMF Manuka. Honey’s antibacterial qualities tested against . and . Machine Learning. Michael Charlton. ChEMBL. Physical Property Analysis. Ebejer. . et al.. (J. Cheminformatics) extracted data from . Chembl. and assigned an anti-bacterial class. Antibacterial . New. Novel. Antibacterials?. How Difficult Is It to Discover New Antibacterials?. Lynn L. Silver, Ph.D.. LL Silver Consulting, LLC. Antibacterials at FDA 2000-2011. Compound. Usage. Class . Active versus . % . survivors. Penicillin. Untreated. Days. Penicillin increased the chance of survival from 10% to 90%. Patients with. pneumonia . and bacteria . in the blood. Adapted from Austrian . et al.. Ann. Int. Med 1964; . Susan S. . Ellenberg. , Ph.D.. University of Pennsylvania. SCT/ICTMC Joint Meeting. Liverpool, UK. May 8, 2017. CLINICAL TRIALS TIMELINE. 1948: First randomized clinical trials of modern era. 1962: Amendments to U.S. Food, Drug and Cosmetic Act requiring demonstration of efficacy as well as safety. The . Clinical and Economic Value . of . an IR Practice. IR Is Modern Medicine. Through a tiny incision in the skin, interventional radiologists deliver precise, targeted treatment . Life-threatening conditions — such as cardiovascular disease, stroke or cancer — are treated less invasively than . % . survivors. Penicillin. Untreated. Days. Penicillin increased the chance of survival from 10% to 90%. Patients with. pneumonia . and bacteria . in the blood. Adapted from Austrian . et al.. Ann. Int. Med 1964; . Prof.. Nader . Alaridah. Antibacterial therapy. 2000 B.C. - "Here, eat this root.". 1000 B.C. - "That root is heathen, say this prayer.". 1850 A.D. - "That prayer is superstition, drink this potion.". CLINICAL TRIALS IN THE TWENTY-FIRST CENTURY: ONGOING CHALLENGES AND EMERGING ISSUES Susan S. Ellenberg , Ph.D. University of Pennsylvania SCT/ICTMC Joint Meeting Liverpool, UK May 8, 2017 CLINICAL TRIALS TIMELINE RADIOLOGY70 Dubois Street Newburgh NY 12550845 568-2242 WWWSTLUKESCORNWALLHOSPITALORGDr Chris Donikyan Interventional RadiologistHighlytrainedExperiencedBoardCert VERSION 1 AUGUST 2016DEVELOPED AND EDITED BYKyle J Cooper MD Minhaj S Khaja MD MBA Sravanthi Reddy MD Kate Klein MDWITH HELP AND INPUT FROM OTHER AMSER MEMBERS INTRODUCTION This document is intended Speaker. : [ ]. Date: [ ]. Venue: [ ]. A presentation by . the Canadian Association for Interventional Radiology . (. CAIR). http://www.medicine.dal.ca/departments/department-sites/radiology.html. Real life case. Table of ContentsPreamble ...............................................................................................................................................1Commitment to Protecting Resea