Register

Tuesday, September 3

1:00 – 1:05 p.m.

 
Opening and Welcome
John Rex, M.D.
 
1:05 – 3:05 p.m. Bootcamp 1: Understanding the Potential for Antimicrobial Resistance in the Drug Discovery Process
Sponsored by:
CARB-X/Wellcome Trust/GARDP/Repair Impact Fund/JPIAMR 
Moderator: Ursula Theuretzbacher, Ph.D.
Emergence of Mutational Resistance - Threat or Myth?
Mariana Castanheira, Ph.D.–JMI Laboratories, North Liberty, IA, USA

Testing for the Potential of Emergence of Resistance
Michael Mourez, Ph.D. - Evotec, Marcy l'Étoile, Lyon, France

Improving Predictions of the Risk of Emergence of Resistance
Douglas Huseby, Ph.D. - University Uppsala, Uppsala, Sweden
3:05 – 3:25 p.m. Coffee Break 
3:25 – 5:25 p.m. Bootcamp 2: Post-Approval Economics for New Antibiotics
Sponsored by:
CARB-X/Wellcome Trust/GARDP/Repair Impact Fund/JPIAMR 
Moderator: Ryan Cirz, Ph.D.

Post-Marketing Commitments and Antimicrobial Susceptibility Test Development
Kevin M. Krause, B.S., MBA - Sr. Director of Microbiology at Achaogen, Inc. South San Francisco, CA, USA

Supply Chain Robustness, Inventory Build, and Quality Assurance
Craig Lichtenstein, MBA - Former Head of Technical Operations at Achaogen, Inc. South San Francisco, CA, USA

Rolf Wagenaar, M.S. - Formulary Process, Sales, Marketing, and Medical Affairs at CD&E Consulting LLC, Hillsborough, NJ, USA

Post-Approval Economics for New Antibiotics
Elaine Hamm, Ph.D. - Ascend BioVentures, Oklahoma City, Oklahoma, USA
5:25 – 5:30 p.m. Closing Comments 
Ursula Theuretzbacher, Ph.D.
5:30 – 8:30 p.m. Reception Networking Event 
Sponsored by: CARB-X/Wellcome Trust/GARDP/Repair Impact Fund/JPIAMR











 

 

Wednesday, September 4

7:15  – 8:15 a.m. Breakfast 
8:15  – 8:25 a.m. Opening and Welcome
Sujata M. Bhavnani, Pharm.D., M.S., FIDSA and Chair, ASM Meetings Strategy Committee, David M. Aronoff, MD, FIDSA, FAAM
8:25 – 10:25 a.m. Regulatory Updates and Case Studies of 
Anti-infective Drug Development

Moderators: Sumathi Nambiar, M.D., MPH and Marco Cavaleri, Ph.D. 

Updates from Regulatory Agencies
Edward Cox, M.D., MPH - U.S. Food and Drug Administration, Silver Spring, MD, USA

Marco Cavaleri, Ph.D. – European Medicines Agency, Amsterdam, Netherlands

Junko Sato, Ph.D. – Office of International Cooperation and PMDA, Tokyo, Japan                                                   

Case Studies on CMC, Clinical Pharmacology and Clinical Topics

Balajee Shanmugam, Ph.D. -  U.S. Food and Drug Administration, Silver Spring, MD, USA                                      

Seong H. Jang, Ph.D. -  U.S. Food and Drug Administration/Office of Clinical Pharmacology, Silver Spring, MD, USA    

Mair Powell, M.D. – Healthcare Products Regulatory Agency, Dublin, Ireland               

Arun Pradhan; CDSCO, New Delhi, India
10:25 – 10:55 a.m. Coffee Break 
10:55 – 11:55 a.m. Keynote Lecture: Beta-Lactamase Inhibitors: A Journey of Discovery
Moderator: Shampa Das, University of Liverpool, BSc, PhD

Robert A. Bonomo, M.D., – Louis Stokes Cleveland Department of Veteran Affairs Medical Center and University Hospitals, Cleveland Medical Center, Cleveland OH, USA
11:55 a.m. – 1:25 p.m.  Lunch 
1:25  – 2:55 p.m. Scientific and Regulatory Strategies for Developing Future Beta-Lactamase Inhibitors
Moderators: Keith A. Rodvold, Pharm.D., FCCP, FIDSA, and Marco Cavaleri, Ph.D.

Beta-Lactamase Inhibitors (BLI) with Intrinsic Activity Versus Stand-Alone BLI Product    
David M. Livermore, B.Sc., Ph.D. –  Norwich Medical School, University of East Anglia, Norwich, United Kingdom

Dose Selection of Beta-Lactamase Inhibitors: PK-PD Issues and Suppression of Resistance
Brian VanScoy, B.S. – Institute for Clinical Pharmacodynamics, Inc., Schenectady, NY, USA

Drug Development Program for a Stand-Alone Beta-Lactamase Inhibitor    
Jeff Loutit, MBChB – Qpex Biopharma, Los Altos, CA, USA

Drug Development Program for a Beta-Lactamase Inhibitor With Intrinsic Activity
David Friedland, M.D., MBA – Wockhardt    
San Mateo, CA, USA


Regulatory Perspectives for The Development of Beta-Lactamase Inhibitors  
Sumathi Nambiar, M.D. – U.S. Food and Drug Administration
Silver Spring, MD, USA 


Mair Powell, M.D. – Healthcare Products Regulatory Agency, Dublin, Ireland    
2:55 – 3:25 p.m. Coffee Break 
3:25 – 4: 25 p.m. Young Investigator Lecture 
PK/PD Murine Infection Models: Focus on Study Elements, Variability, and Interpretation of Results

Alexander J. Lepak, M.D. - University of Wisconsin School of Medicine and Public Health, Madison, WI , USA

Moderators: Paul G. Ambrose, Pharm.D., FIDSA and Mair Powell, M.D.
4:25 – 6:25 p.m. Poster Presentations with Light Reception 

Thursday, September 5

7:30 – 8:30 a.m. Breakfast 
8:30 – 10:30 a.m. Overview of CARB-X Model – More Than Just the Money

CARB-X Accelerator: Ways of Working with CARB-X
Kevin Outterson, JD, LLM - CARB-X, Boston, MA, USA

Panel I: CARB-X Funded Product Developers
Panel: Discussion of the Benefits of CARB-X Beyond the Funding 

Moderator: Maria Uria-Nickelsen, Ph.D.

Martin Everett, Ph.D. - Antabio, Labège, France

Michael P. Bevilacqua, M.D., Ph.D. - Amicrobe, Inc., Carlsbad, CA, USA

Anand Anandkumar, Ph.D. - Bugworks Research, Inc., Bangalore, Karnataka, India

Zachary Zimmerman, Ph.D. - Forge Therapeutics, San Diego, CA, USA 

Jeanette Mucha, B.S. – SciBac Inc., Burlingame, CA , USA
  Panel ll: CARB-X Global Accelerators Network Panel: Discussion of How the Needs of the Product Developers are Identified and Addressed
Moderator: Rich Lawson, Ph.D.

Silke Alt, Ph.D., German Center for Infection Research (DZIF), Braunschweig, Germany

Chris George, MS - RTI International, Research Triangle Park , NC, USA 

Joanna Wiecek, Ph.D. - Wellcome Trust, London, United Kingdom 

Jennifer Osborn, Ph.D. - Foundation for Innovative New Diagnostics (FIND), Shoreline, WA, USA

Anita Sheoran, Ph.D. - NIAID/NIH, Rockville, MD, USA
10:30 – 11:00 a.m. Coffee Break 
10:45 a.m. – 11:00 a.m.  ASM Update
11:00 a.m. – 12:00 p.m.  Keynote Lecture: Combination Therapy for Serious Gram-Negative Bacterial Infections is the Future
Moderator: Sujata M. Bhavnani, Pharm.D., M.S., FIDSA

George L. Drusano, M.D. - Institute for Therapeutic Innovation, University of Florida, Lake Nona, FL, USA
12:00 – 1:30 p.m. Lunch 
1:30 – 3:00 p.m. Pre-Clinical and Clinical Considerations for the Development of Antifungal Agents
Moderators: Sujata Bhavnani, Pharm.D., M.S., FIDSA and William Hope, BMBS, FRACP, FRCPA, Ph.D.

Overview of the US and EU Regulatory Frameworks for Development of New Antifungal Drugs
Sumathi Nambiar, M.D.  - U.S. Food and Drug Administration, Silver Spring, MD, USA 

Mair Powell, M.D. - Healthcare Products Regulatory Agency, Dublin, Ireland               

Use of Biomarkers for Development of Antifungal Agents
Francisco Marty, M.D. - Harvard Medical School and Brigham and Women’s Hospital, Boston, MA, USA

Development of New Experimental Models for Antifungal Agents
Tom Patterson, M.D. - UT Health San Antonio, San Antonio, TX, USA

Specific Challenges in Developing New Antifungal Agents for Drug Resistant Disease
David Angulo, M.D. – Scynexis, Jersey City, NJ, USA
3:00 – 3:30 p.m.  Coffee Break 
3:30 – 4:30 p.m.  Young Investigator Lecture 
Geographic Differences in Enrollment and Microbial Etiology in Clinical Trials of Antibacterial Drugs, 2001-2017

Stephen Bart, Ph.D. – U.S. Food and Drug Administration, Silver Spring, MD, USA
Moderators: Edward Cox, M.D., MPH, and Jeff Loutit, 
MBChB
4:30 – 6:30 p.m. Poster Presentations with Light Reception 

Friday, September 6

7:00 – 8:00 a.m. Breakfast 
8:00 – 8:20 a.m. Lecture: The Role of WHO in R&D Priority Setting to Combat Antimicrobial Resistance                                              
Moderator: William Hope, BMBS, FRACP, FRCPA, Ph.D.

Sarah Paulin, Ph.D. – World Health Organization, Geneva, Switzerland
8:20 – 9:10 a.m. Keynote Lecture: Investor Sentiment: How Did We Get Here and Is There A Way Out?
Moderator: William Hope, BMBS, FRACP, FRCPA, Ph.D.

Alan Carr, Ph.D. - Needham & Company, New York, NY , USA
9:10 – 9:35 a.m. Lecture: Creating A Sustainable Antibiotics R&D Ecosystem
Moderator:
William Hope, BMBS, FRACP, FRCPA, Ph.D.

Jeremy Knox, MSc – Wellcome Trust, 
London, United Kingdom
9:35 – 9:55 a.m. Coffee Break 
9:55 a.m. – 11:55 a.m. The Road from Pre-Clinical to Clinical for Non-Traditional Therapies
Moderators: Sujata Bhavnani, Pharm.D., M.S., FIDSA and Judith Steenbergen, Ph.D.

Development of BH01, a Peptide Lysin for the Treatment of Acinetobacter Infections 
Chandrabali Ghose, Ph.D. - Bioharmony Therapeutics, New York, NY, USA

Development of Exebacase (Lysin CF-301), a Direct Lytic Agent with Potent Activity Against Staphylococcus aureus
Cara Cassino, M.D. - ContraFect Corporation, 
Yonkers, NY, USA

    
Development of CAL02, Liposomes Engineered to Neutralize a Broad Spectrum of Virulent Effectors
Samareh Azeredo da Silveira Lajaunias, Ph.D. - Combioxin SA, Geneva, Switzerland

Development of ABX01, Immunotherapy Targeting Multi-Drug Resistant Gram-Negative Bacteria
Mike Westby, BSc, Ph.D. - Centauri Therapeutics Ltd., Sandwich, Kent, United Kingdom

Development of a Multi-Mechanistic Antibody Targeting P. aeruginosa
Antonio DiGiandomenico, Ph.D. - AstraZeneca
Gaithersburg, MD, USA
11:55 – 12:00 p.m. Closing remarks
William Hope, BMBS, FRACP, FRCPA, Ph.D. 

Continuing Education

Target Audience
This conference has been approved to offer a maximum of 18.25 AMA PRA Category 1 Credit(s)™.  If you will be claiming Continuing Medical Education (AMA PRA Category 1 Credit(s) ™), an administrative fee of $50.00 is required through the registration site. If you previously registered, click on the registration link to access your registration record. The CME question is located near the bottom of the Contact Information page.

This activity is intended for Physicians, Pharmacists, Pharmaceutical Companies, Microbiologist, Clinical Researchers, Antibacterial Drug Developers, Regulatory Officers academia who want to gain insights into the aspect of drug development.

Statement of Need
This international conference will provide a forum for the meaningful exchange of ideas dealing with Antimicrobial drug resistance (AMR) over three-and one-half days. New antimicrobial drug development is increasingly viewed as a priority by National and International bodies. There are relatively few agents in developmental pipelines and a paucity of identified microbiological targets that can be exploited for drug development.

Educational Activity Learning Objectives
Upon completion of this course, the participants should be able to:
  • Articulate the pathogenesis of viral diseases and the biology of the viruses that cause them;
  • Develop an improved ability to perform and interpret diagnostic virology tests; and
  • Apply methods of antiviral therapies and vaccination strategies.
Accreditation Statement
This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of The France Foundation and the American Society for Microbiology. The France Foundation is accredited by the ACCME to provide continuing medical education for physicians.

This meeting is being held in cooperation with European Society for Clinical Microbiology and Infectious Diseases (ESCMID) and CARB-X.

Credit Designation

Physicians
The France Foundation designates this live activity for a maximum of 18.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Diplomates of the American Board of Medical Microbiology, Diplomates of the American Board of Medical Laboratory Immunology, and Registrants of the National Registry of Certified Microbiologists who are MDs and DOs may earn AMA PRA Category 1 Credits™ toward recertification. All other Diplomates and Registrants may claim Participation. Each professional should claim credit commensurate with their level of participation in the activity.

Other CE Licenses
You may obtain a Participation Statement of Credit by completing the activity evaluation. This is a detailed statement that documents your participation in the activity.

Claim Credits using ce.asm.org

  • Keep your badge! You will need your registration confirmation number or badge ID to claim your credits.
  • Login to the ASM CE Portal with your ASM Sign On user name and password. If you do not have a user name and password, select the “Need Help Logging In?” link.
  • Once logged in, you will be directed to your “My Activities” page.
  • Click on the “Claim Credits for Live Meetings” button on the right side of the screen.
  • Select “2019 ASM/ESCMID Conference” from the Available Activities table.
  • On the Activities Overview Page, scroll to the bottom of the page to enter your badge ID. The badge ID may be obtained from your printed badge or from your emailed confirmation letter.
  • Select which session you attended and are claiming credits for. Choose what type of credit you would like to claim. 2019 ASM/ESCMID Conference offers four types of continuing education credit. Please choose the certificate that is applicable to your needs:
    • Continuing Medical Education for physicians AMA PRA Category 1 Credit(s)
    • Participation
  • Answer evaluation questions and submit.

Disclosure Policy
In accordance with the ACCME Standards for Commercial Support, The France Foundation and ASM require that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any commercial interest. TFF and ASM resolve all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all their educational programs. Furthermore, TFF and ASM seek to verify that all scientific research referred to, reported, or used in a CME/CE activity conforms to the generally accepted standards of experimental design, data collection, and analysis. TFF and ASM are committed to providing learners with high-quality CME/CE activities that promote improvements in health care and not those of a commercial interest.

Activity Staff Disclosures 
The planners, reviewers, editors, staff, CME committee, or other members at The France Foundation who control content have no relevant financial relationships to disclose.

The planners, reviewers, editors, staff, CME committee, or other members at ASM who control content have no relevant financial relationships to disclose.

Faculty disclosures will be available at the activity.

Disclosure of Unlabeled Use
TFF and ASM require CME faculty (speakers) to disclose when products or procedures being discussed are off label, unlabeled, experimental, and/or investigational, and any limitations on the information that is presented, such as data that are preliminary, or that represent ongoing research, interim analyses, and/or unsupported opinion. Faculty in this activity may discuss information about pharmaceutical agents that is outside of US Food and Drug Administration approved labeling. This information is intended solely for continuing medical education and is not intended to promote off-label use of these medications. TFF and ASM do not recommend the use of any agent outside of the labeled indications. If you have questions, contact the Medical Affairs Department of the manufacturer for the most recent prescribing information. 

Media Disclosure
Your registration, attendance at, and/or participation in this meeting constitutes consent to being photographed, videotaped, or recorded during the meeting by The France Foundation, its educational collaborators, or anyone authorized on behalf of these organizations.  You further authorize, without any compensation paid to you, the use of any photographs, videos, or recordings that contain your likeness, image, or voice in any educational, informational, commercial, or promotional materials produced and/or distributed by The France Foundation, its educational collaborators, or anyone authorized by these organizations, as well as on any Internet sites maintained by any of these entities. Images/recordings used for these purposes will not be sold, and no personal information about you or the subject (other than event location and date) will be included in the production of any material. 

Disclaimer 
The France Foundation and ASM present this information for educational purposes only. The content is provided solely by faculty who have been selected because of recognized expertise in their field. Participants have the professional responsibility to ensure that products are prescribed and used appropriately on the basis of their own clinical judgment and accepted standards of care. The France Foundation and ASM assume no liability for the information herein.

Program Committee

Co-Chair
Sujata M. Bhavnani, Pharm.D., M.S., FIDSA       
Institute for Clinical Pharmacodynamics, Inc.       
Schenectady, NY

Co-Chair
William Hope, BMBS, FRACP, FRCPA, Ph.D.                   
University of Liverpool   
Liverpool, United Kingdom
              
Maiken Cavling Arendrup, M.D., Ph.D., DMSci 
Statens Serum Institut/Copenhagen University Hospital Rigshospitalet/University of Copenhagen             
Copenhagen, Denmark

Marco Cavaleri, Ph.D.                            
European Medicines Agency       
London, United Kingdom

Herman Goossens, M.D.
University Hospital Antwerp       
Edegem, Belgium

David Hooper, M.D.        
Massachusetts General Hospital 
Boston, MA        

 



Sumathi Nambiar, M.D., MPH      
U.S. Food and Drug Administration         
Washington, D.C.            

John H. Rex, M.D.                
F2G, Limited.     
Eccles, United Kingdom

Jesús Rodríguez-Baño, M.D., Ph.D.                          
Hospital Universitario Virgen Macarena 
Seville, Spain

Keith A. Rodvold, Pharm.D., FCCP, FIDSA             
University of Illinois at Chicago   
Chicago, IL          

Michael Sharland, M.D.
St. George's Hospital      
London, United Kingdom

Judith Steenbergen, Ph.D.
Newtown, PA      

Ursula Theuretzbacher, Ph.D.                                
Center for Anti-Infective Agents 
Vienna, Austria