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Therapeutic Class Overview: New avatars of microbes super bugs a growing threat worldwide

February 2014 | 12 pages | ID: N7E1F643327EN
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Novel approaches to treat infection is growing as the need is urgent! Misuse/overuse of antibiotics accelerated antimicrobial resistance (AMR) and has resulted in the emergence of “super bugs” which are posing life threatening challenges world wide. Many of the advances in medical treatment like cancer therapy; organ transplants etc. would go waste if the ability to fight infections during the treatment were not available. If that fails, the gains made in life-improving modern medical advantages will be lost creating a situation of - “one step forward two step back”. Novel approaches are immediately required to combat these “super infections” warranting need for new classes of antibiotics and other preventive/therapeutic approaches.In this report We discuss -

The evolution and global dissemination of AMR Unmet need in the critical setting esp. Gram Negative infections and CRE. Pipeline of novel targets being used to develop new drugs to treat infections and resistance. Pipeline of select drugs in mid and late clinical stage of development Alarming Facts about AMR Steps being taken by the regulatory authorities WW to address the issue and encourage novel therapeutics in this therapy area. Developing Countries - /ROW - Trends in pathogens and resistance Role of diagnostics and preventive approach.
INTRODUCTION EVOLUTION AND GLOBAL DISSEMINATION OF ANTI MICORBIAL RESISTANCE (AMR)

How has the Problem Manifested to Such an Alarming Level?
Microbial Evolution has Outpaced Innovation!
Hitch Hiking and Globe Trotting by “Bad Bugs”

UNMET NEED IN THE CRITICAL SETTING

Running Out of Drugs to Treat Serious Gram-Negative Infections
Carbapenem-resistant Enterobacteriaceae (CREs)
Evolution of CRE
Spreading the Bug

NEED OF THE HOUR - NEW TARGETS - NEW ANTIBIOTIC CLASS

Pipeline of novel targets being used to develop new drugs to treat infections and resistance.
Pipeline of select drugs in mid and late clinical stage of development

ALARMING FACTS ABOUT AMR - CDC ALERTS

ACTION BY REGULATORY BODIES – TO ACCELERATE DRUG DEVELOPMENT AND THREAT AWARENESS - US

The GAIN Act
Breakthrough Therapies Designation Europe
Draft guidance “Expedited Programs for Serious Conditions––Drugs and Biologics”
Strategic Research Agenda

DEVELOPING COUNTRIES - /ROW - TRENDS IN PATHOGENS AND RESISTANCE

ROLE OF DIAGNOSTICS AND PREVENTIVE APPROACH


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