about   CII home   shop   checkout
Conference Banner


Diagnostics to Guide Antimicrobial Stewardship and Drug Development

2015 Archived Content

Diagnostics to Guide Antimicrobial Stewardship and Drug Development


Drug-resistant infections take a staggering toll in the United States and worldwide. There are several key reasons for this situation, such as dry antibacterial pipeline, misuse and overuse of existing antibiotics, and the ingenuity of microbes that manage to develop resistance to literally every and any new antibacterial agent. One of the key elements for improving antimicrobial stewardship and drug development is rapid and accurate identification of the pathogens, as well as rapid and accurate antimicrobial susceptibility testing. These CHI's inaugural Diagnostics to Guide Antimicrobial Stewardship and Drug Development conference, part of the Re-Entering Antibacterial Drug Development Summit, will provide a comprehensive overview of advanced molecular assays and approaches to enhance stewardship of existing antibiotics, to diagnose and monitor resistance, and to enable clinical development of pathogen-specific antibacterial agents.


Tuesday, November 17

12:45 Registration


DEVELOPING NEW ANTIBIOTICS WITH REGULATORY SUPPORT AND NEW DIAGNOSTICS

Shared Session between Track 2 and Track 3

1:35 Chairperson’s Remarks

Barry Eisenstein, M.D., FACP, FIDSA, FAAM, Distinguished Physician, Antimicrobials, Merck & Co., Inc.

1:45 Overcoming the Challenges of Developing New Antibiotics for Resistant Bacteria with Regulatory Support and New Diagnostics

Barry EisensteinBarry Eisenstein, M.D., FACP, FIDSA, FAAM, Distinguished Physician, Antimicrobials, Merck & Co., Inc.

In this era of increasing antimicrobial resistance and widespread dissemination of virulent pathogens resistant to most, if not all, available antibiotics, society must come up with solutions, which includes both better paths to new agents active against such pathogens and to appropriate stewardship of existing agents. A means to help on both of these key aspects is improved rapid diagnostics. Together with streamlined regulatory pathways for approval of new agents, developing new, life-saving antibiotics would thus become more feasible.

2:15 Achieving Value and Improving Patient Safety Through Innovative Methods of Antimicrobial Utilization - Experience At the Front Line of Care

Ronald NahassRonald G. Nahass, M.D., MHCM, President, ID Care

Multidrug resistance in healthcare-associated Gram-negative bacteraemia is associated with higher financial costs—a significant proportion of which are subsidized by public funding in the form of governmental subvention. More active interventions aimed at controlling antimicrobial resistance are warranted, and the results of our study also provide possible benchmarks against which the cost-effectiveness of such interventions can be assessed.

2:45 Diagnostics Update: Recent Advances in Pathogen and Antimicrobial Resistance Detection

Kimberly HansonKimberly E. Hanson, M.D., MHS, Section Chief, Clinical Microbiology, the University of Utah and ARUP Laboratories

Accurate and timely diagnosis can improve patient care and antibiotic stewardship. This session provides an overview of new and emerging diagnostic technologies for infectious diseases, with a focus on bacterial detection and drug resistance testing. The ways in which current assays may be optimally utilized along with potential barriers to the implementation of advanced technologies will be discussed.

3:15 The Economics of Modern Anti-Infectives

Rene_Russo Rene Russo, PharmD, Chief Development Officer, Arsanis, Inc.

 

 

 

3:45 Refreshment Break with Exhibit and Poster Viewing

4:15 Antibacterial Drug Development: The Role of Clinical Microbiology and the Need for Rapid Diagnostics

Grace ThorneGrace M. Thorne, Ph.D., Senior Director, Antibiotics and Rapid Diagnostics, Merck & Co., Inc.

Around the world, there is an increase in multidrug-resistant clinical pathogens, which is putting pressure on the development of new antibacterial agents. New clinical trial designs based on smaller data sets or focused on narrow spectrum agents require fast and accurate detection of the bacterial pathogen and resistance phenotypes so that enrollment of the target patient population can be met. This presentation will provide an overview of the changing landscape in antibacterial drug development and highlight current efforts to support the development of much needed rapid diagnostic tests.

4:45 The Contribution of Therapeutic Drug Monitoring to Clinical Trial Success and Effective Antibiotic Stewardship

Tilmann BrotzTilmann Brotz, Ph.D., Senior Director, Developmental Sciences, Achaogen

Therapeutic Drug Management (TDM) has been used in clinical practice for certain classes of antibiotics for many years, but its potential to impact clinical trial success and antibiotic stewardship has received little attention. Despite sophisticated pharmacokinetic and pharmacodynamic assessments and modeling, experimental antibiotics have failed in late stage clinical studies in part due to inadequate dosing, especially in patient populations with challenging pharmacokinetics, such as the critically ill with nosocomial, gram-negative infections. How TDM optimizes individual patient dosing in clinical trials with the potential to improve outcomes and safety will be discussed. The potential impact of TDM on health economic outcomes and prevention of the emergence of resistance in the context of antibiotic stewardship will also be highlighted.

5:15 Registration for Dinner Short Course

5:45 - 8:30 Dinner Short Course: Funding Opportunities for Antibacterial Research (Separate registration required, see page 6 for details.)

 

Wednesday, November 18

7:30 am Continental Breakfast 

 

DIAGNOSTICS TO GUIDE ANTIMICROBIAL STEWARDSHIP

8:00 Chairperson’s Remarks

Grace M. Thorne, Ph.D., Senior Director, Antibiotics and Rapid Diagnostics, Merck & Co., Inc.

8:10 Co-Presentation: Overview and Implementation of Rapid Diagnostic Tests from Blood Cultures and Their Impact on Patient Outcomes

Karen CarrollKaren C. Carroll, M.D., Director, Division of Microbiology, Department of Pathology, Professor of Pathology and Medicine, The John Hopkins School of Medicine

 

Edina AvdicEdina Avdic, Pharm.D., MBA, Clinical Specialist, Infectious Diseases, Associate Director, Antimicrobial Stewardship Program, The John Hopkins Hospital

 

Rapid diagnostic assays that can rapidly identify microorganisms and their resistance markers from blood cultures have become increasingly prevalent over the past decade. These tests have been repeatedly shown to reduce the time to effective and/or optimal antimicrobial therapy, however their performance is greatly enhanced when coupled with antimicrobial stewardship interventions. Antimicrobial stewardship teams are essential in rolling out new laboratory tests by providing education to clinicians on appropriate interpretation and guiding therapy modification in a timely manner.

9:00 Practical Utilization of Multiplex Infectious Disease Tests and Impact on Patient Care

Melissa MillerMelissa Miller, M.D., Professor, Pathology and Laboratory Medicine, Director, Clinical Molecular Microbiology Laboratory, Associate Director, Clinical Microbiology Laboratory, University of North Carolina, Chapel Hill School of Medicine

Multiplex molecular tests have made syndromic diagnostics a reality for many institutions, namely for bloodstream, respiratory and gastrointestinal infections. The implementation of these tests has the potential to greatly influence patient management and outcomes as well as laboratory and institutional cost-savings. However, practical utilization of these tests, including testing algorithms, treatment algorithms, and provider education are critical for successful implementation.

9:30 Interpreting Results: Rapid Diagnostics to Guide Antibacterial Therapy

Katherine PerezKatherine K. Perez, Pharm.D., Clinical Pharmacy Specialist-Infectious Diseases, Houston Methodist Hospital 

Rapid microbiologic tests provide opportunities for antimicrobial stewardship programs to optimize antimicrobial use and improve clinical and economic outcomes. Studies have demonstrated that rapid diagnostics benefit the individual patient by enabling timely antimicrobial tailoring, which, in turn, may lead to decreased mortality, shortened hospital stay, and lower hospitalization costs. We will review currently available rapid diagnostic tests, and, importantly, the impact of rapid results on management of antibiotic therapy.


BacterioScan10:00 Improving Patient Care and Antibiotic Development:
Applications of BacterioScans Rapid Bacterial Diagnostic Platform

Andrew Tomaras, Ph.D., Vice President, Microbiology, BacterioScan, Inc.

The BacterioScan diagnostic platform uses highly sensitive forward light-scattering of patient specimens, allowing for the robust determination of bacterial presence/absence in as little as 90 minutes. This should allow for more rapid therapeutic intervention, enable improved antibiotic stewardship campaigns, and also prove beneficial to improving clinical trial enrollment for novel antibacterial agents.

10:15 Penicillin Allergy Skin Testing: A Core Element of an Antibiotic Stewardship Protocol
James_WolfeJames D. Wolfe, M.D., Clinical Professor of Medicine, Stanford University School of Medicine, Vice-President, Scientific Affairs, AllerQuest, LLC
Application of the penicillin allergy skin test, PRE-PEN®, in the 10% of the population labeled as penicillin allergic demonstrates that >85% of history-positive patients are skin test negative and can receive penicillin products without acute reactions. This finding is highly relevant to antibiotic stewardship since penicillin allergy is significantly associated with increased use of more potent antibiotics, more serious infections, increased antibiotic resistance and greater hospital costs, and is the major reason for the inappropriate use of Vancomycin. Our research efforts to produce the next generation penicillin skin test kit containing all relevant penicillin determinants will be highlighted.

10:40 Coffee Break with Exhibit and Poster Viewing

COLLABORATIVE EFFORTS AGAINST MULTIDRUG RESISTANCE

Shared Session between Track 2 and Track 3

11:20 We are the World: How Pharmaceutical Industry Can Contribute to Antimicrobial Stewardship

Elizabeth_HemsenElizabeth D. Hermsen, PharmD, Head, Global Antimicrobial Stewardship, Merck

We must come together. Collaboration between multi-sector stakeholders, including pharmaceutical industry, is needed in order to achieve the shared antimicrobial stewardship goals of minimizing and preventing inappropriate antimicrobial use, improving patient outcomes, and combating the development of resistance. This presentation will provide examples of how pharmaceutical industry can and should play a role in meeting these goals through antimicrobial stewardship education, implementation, research, and advocacy.

11:50 Panel Discussion: Mastering Antimicrobial Stewardship with the Help of Molecular Diagnostics

Moderator: Grace M. Thorne, Ph.D., Senior Director, Antibiotics and Rapid Diagnostics, Merck & Co., Inc.

Panelists: Elizabeth D. Hermsen, PharmD, Head, Global Antimicrobial Stewardship, Merck
Katherine K. Perez, Pharm.D., Clinical Pharmacy Specialist-Infectious Diseases, Houston Methodist Hospital and Houston Methodist
Melissa Miller, M.D., Professor, Pathology and Laboratory Medicine, Director, Clinical Molecular Microbiology Laboratory, Associate Director, Clinical Microbiology Laboratory, University of North Carolina, Chapel Hill School of Medicine
Karen C. Carroll, M.D., Director, Division of Microbiology, Department of Pathology, Professor of Pathology and Medicine, The John Hopkins School of Medicine
Edina Avdic, Pharm.D., MBA, Clinical Specialist, Infectious Diseases, Associate Director, Antimicrobial Stewardship Program, The John Hopkins Hospital
 

ID Genomics12:20 pm Luncheon Presentation: Rapid Clonal Diagnostics: Getting Personal with Pathogens at the Point of Care

Sokurenko_EvgeniEvgeni V. Sokurenko, M.D., Ph.D., Founder and Chairman, ID Genomics, Inc; Professor, Department of Microbiology, University of Washington, Seattle

The vast majority of human pathogens are clonal in nature, i.e. their species are comprised of a limited number of genetically related 'crime families', most with distinct antibiotic susceptibility profiles. ID Genomics develops high-resolution molecular tests that determine the infecting strain's sub-species clonal identity directly from patient urine or other specimens. When combined with a comprehensive database consisting of hundreds of clonal-level antibiograms, this diagnostic approach reduces drug-bug mismatches multi-fold at the point-of-care.

12:50 Session Break

 

PATHOGEN-DETECTION AND SUSCEPTIBILITY TESTING BREAKTHROUGHS

1:10 Chairperson’s Remarks

Douglas WeibelDouglas B. Weibel, Ph.D., Associate Professor, Biochemistry, Chemistry, and Biomedical Engineering, University of Wisconsin, Madison

 

1:15 GenePOC: A Novel Rapid (<1h) Point-of-Care Molecular Diagnostics System to Rapidly Identify Microbes and Their Resistance Genes

Michel BergeronMichel G. Bergeron, M.D., Director and Founder, Centre de recherche en infectiologie (CRI) of Université Laval

Antimicrobial stewardship requires proper detection and identification of pathogens and their resistance genes. The long turnaround time required by central laboratory testing precludes efficient evidence-based diagnosis and therefore forces physicians to rely on empirical prescriptions of broad spectrum antibiotics. Such a long diagnostic cycle also bias the pharmaceutical industry toward developing broad spectrum antimicrobials which eventually will select for resistance. A cost-efficient and simple to use close-to-patient technology (lab on a chip) such as the sample to answer molecular diagnostics platform created at Université Laval and now being developed by GenePOC in Quebec City will rapidly assist clinicians for the diagnosis of infectious diseases and guide the smart use antimicrobials for optimal patient management. The GenePOC point-of-care system will also facilitate the design of clinical trials for targeted antimicrobials as it would timely and cost-effectively select only the eligible patients infected by the organisms against which the novel drug candidate is active.

1:45 RNA-Based Diagnosis of Antibiotic Resistance

Deborah HungDeborah Hung, M.D., Ph.D., Co-Director, Infectious Disease Program, Broad Institute & Associate Professor, Department of Molecular Biology, Harvard Medical School

Rapid diagnostics to rapidly identify a pathogen and provide drug susceptibility is critical for preparedness against bioterrorism. In particular, the need to generate real-time drug susceptibility patterns is mounting in the face of increasing natural antibiotic resistance and the possibility of engineered multi-drug resistant bioterrorist pathogens. The detection of RNA expression signatures can serve as such a diagnostic platform.

2:15 Rapid DNA-Based Detection of Bacteria at the Point-of-Care Using a Portable Degas-Driven Microfluidic System

Douglas WeibelDouglas B. Weibel, Ph.D., Associate Professor, Biochemistry, Chemistry, and Biomedical Engineering, University of Wisconsin, Madison

We have developed a rapid, low cost, and disposable point-of-care platform for identifying pathogens. The technology consists of five integrated components and is designed to be small enough to fit into a shirt or coat pocket, takes approximately 30 minutes to convert a sample into actionable data, and can detect and identify bacteria, RNA viruses, and DNA viruses.

2:45 Use of Open Array Technology to Screen Clinical Specimens for Genes Associated with Multiple Drug Resistant Organisms

Donald StalonsDonald R. Stalons, Ph.D., Vice President, Operations; Laboratory Director, Diatherix Laboratories

This presentation will describe a molecular panel to detect genes that code for resistance to antibacterials commonly used in empirical antibiotic coverage strategies for a variety of serious infections. Primers that are used in our assays have been engineered to be inclusive for the detection of gene subsets in a particular antibiotic class; e.g. TEM and SHV types that code for resistance to several molecular Class A beta lactam antimicrobials. The ability to quickly and reliably detect the common genes that code for resistance to beta lactam, macrolide, and fluoroquinolone antibacterials in a clinical specimen can have a significant impact on antibiotic selection in the patient’s treatment and how they are managed in the healthcare setting.

 

TRACKING MULTIDRUG RESISTANCE

Shared Session between Track 2 and Track 3

3:20 Centers for Disease Control and Prevention (CDC) Data to Support Antibiotic Resistance (AR) Research, Development, and Innovation

Denise CardoDenise M. Cardo, M.D., Director, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, CDC

The emergence and spread of AR threatens the life-saving benefits antibiotics have provided over the past decades. AR Infections can affect people in all communities and healthcare settings. CDC surveillance data include resistance trends, populations at risk, and additional information that will help target clinical trials and support implementation of new diagnostic testing. CDC isolate bank will support research and development of new options for testing and treatment. Private-public partnership is critical to combat AR.

3:50 Battling Multidrug-Resistant Organisms in US Hospitals

Michael CalderwoodMichael S. Calderwood, M.D., Assistant Professor of Medicine, Harvard Medical School; Associate Director of Antimicrobial Stewardship Program, Brigham and Women’s Hospital

Dr. Calderwood will review hospital prevention and surveillance strategies for combating the selection and spread of multidrug-resistant organisms (MDROs), clinical cases where novel therapies are needed, and a discussion about hospital and provider approaches to novel antimicrobial drugs developed for the treatment of MDROs. The goal of this session will be to identify niches where drug development is needed and to better understand the clinical landscape in terms of MDROs in the hospital setting.

4:20 Close of Summit



Track 1 | Track 2 | Track 3




For more details on the conference, please contact:
Marina Filshtinsky, M.D.
Senior Director, Conferences
Cambridge Healthtech Institute
Phone: 781-972-5496
Email: mfilshtinsky@healthtech.com  


For exhibit & sponsorship information, please contact:
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-5412, Fax: (781) 972-5470
email: cbenton@healthtech.com  

Download Conference & Course Catalog

CHI Catalog March 2018 - August 2018 Cover