FINAL PROGRAM - American Society for MicrobiologyFinal Program asm.org American Society for...

Final Program

asm.orgAmerican Society for Microbiology

1752 N Street, N.W.Washington, DC 20036-2904

ASM/ASV Conference on Interplay of Viral and Bacterial Pathogens

May 1–4, 2017 | Bethesda, MD

FINAL PROGRAM

2019 ASM/ESCMID Conference on Drug Development to Meet the Challenge of Antimicrobial ResistanceSeptember 3-6, 2019 | Boston Park Plaza Boston, Massachusetts

www.asm.org/AMR

FINAL PROGRAM

Are you ready to win battle against Antimicrobial drug resistance (AMR)? Co-sponsored by the American Society for Microbiology (ASM) and the European Society for Clinical Microbiology and Infectious Diseases (ESCMID), this leading conference will provide a unique forum for you to explore the challenges, opportunities and current requirements for antimicrobial drug development for AMR.

Learn more at www.asm.org/AMR

ASM/ESCMID Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance September 6–8, 2017 • Boston, Massachusetts

Final Program

asm.orgAmerican Society for Microbiology

1752 N Street, N.W.Washington, DC 20036-2904

ASM/ASV Conference on Interplay of Viral and Bacterial Pathogens

May 1–4, 2017 | Bethesda, MD

SAVE THE DATE

JOIN US IN CHICAGO

1ASM/ESCMID Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance

AGENDA Tuesday 9/3

Wednesday 9/4

Thursday 9/5

Friday 9/6

Bootcamp 1:00 p.m. - 5:30 p.m.

Welcome Reception 5:30 p.m. - 8:30 p.m.

Light Breakfast 7:15 a.m. - 8:15 a.m. 7:30 a.m. - 8:30 a.m. 7:00 a.m. - 8:00 a.m.

Session 8:25 a.m. – 10:25 a.m. 8:30 a.m. - 10:30 a.m. 9:55 a.m. – 11:55 a.m.

Coffee Break 10:25 a.m. - 10:55 a.m. 10:30 a.m. - 11:00 a.m. 9:35 a.m. - 9:55 a.m.

Keynote Speaker 10:55 a.m. – 11:55 a.m.11:00 a.m. – 12:00 p.m. 8:20 a.m. - 9:10 a.m.

Lecture 8:00 a.m. – 8:20 a.m. 9:10 a.m. - 9:35 a.m.

Lunch 11:55 a.m. – 1:25 p.m. 12:00 p.m. - 1:30 p.m.

Session 1:25 p.m. – 2:55 p.m. 1:30 p.m. – 3:00 p.m. 9:55 a.m. - 11:55 a.m.

Coffee Break 2:55 p.m. - 3:25 p.m. 3:00 p.m. - 3:30 p.m.

Session 3:25 p.m. - 4:25 p.m. 3:30 p.m. - 4:30 p.m.

Poster Presentations/LIght Reception

4:25 p.m. - 6:25 p.m. 4:30 p.m. - 6:30 p.m.

Closing Remarks 11:55 a.m. - 12:00 p.m.

Schedule at a Glance

2 ASM/ESCMID Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance

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

Co-ChairWilliam 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 HospitalBoston, MA, U.S.

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

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 ChicagoChicago, IL, U.S. Michael Sharland, M.D.St. George's Hospital London, United Kingdom

Judith Steenbergen, Ph.D.Newtown, PA, U.S.

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


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@ASMicrobiology@ESCMID #ASMESCMID

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Follow ASM + ESCMID

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Travel AwardeesThe following Travel Awardees were selected by the ASM/ESCMIDProgram Co-Chairs on the basis of the scientific quality of their submitted abstracts.

Nicola Farrington

Tyson Hillock

Abigail C. Jackson

Gurmeet Kaur

Riza Gloria Magsino

Sabeeha Sabeeha

Anou Moise Somboro

Dhruvitkumar Sutaria

Xun Tao


General InformationREGISTRATION AND NAME BADGESASM Staff will be available at the registration desk outside of the Grand Ballroom during posted registration hours. Participants may collect name badges and program materials at the registration desk. A name badge is required for entry into all sessions and meals.

GENERAL SESSIONS All general sessions will be held in the Grand Ballroom A.

POSTER PRESENTATIONSPoster boards are located in Avenue 34 (lower level).

Posters will be available for viewing informally throughout the conference, with official poster sessions scheduled on Wednesday and Thursday.

Posters should be mounted each morning of the assigned session by 8:30 a.m. and should be removed immediately following the formal presentation on the same day. Posters not removed may be discarded.

To see the full abstracts and presentation day, please visit www.asm.org/AMR.

NETWORKING MEALS AND SOCIAL EVENTSRegistration includes the Reception Networking Event on Tuesday; breakfast on Wednesday, Thursday and Friday; light lunch on Wednesday and Thursday; and Poster Receptions on Wednesday and Thursday.

CERTIFICATE OF ATTENDANCEParticipants will receive an email after the conference with the instructions to download and print a certificate of attendance. Your badge number will be required to access your certificate.Note: Certificates of Attendance do not list session information.

CAMERAS AND RECORDINGS POLICYTaking photographs or video of projected images in the session room with any device is prohibited. Photographs of posters are only allowed after receiving the presenter’s permission. Report any violations to a member of the ASM staff. CHILD POLICYChildren are not permitted in session rooms, poster sessions, conference meals, or social events. Please contact the hotel concierge to arrange for babysitting services in your hotel room.


Scientific ProgramTuesday, September 31:00 p.m. – 1:05 p.m. Opening and Welcome Grand Ballroom John Rex, M.D.

1:05 p.m. – 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, U.S.

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 p.m. – 3:25 p.m. Coffee Break Outside of Grand Ballroom

3:25 p.m. – 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, Achaogen, Inc., South San Francisco, CA, U.S.

Supply Chain Robustness, Inventory Build, and Quality Assurance Craig Lichtenstein, MBA, former head of Technical Operations at Achaogen, Inc., South San Francisco, CA, U.S. Rolf Wagenaar, M.S., Formulary Process, Sales, Marketing,andMedicalAffairs,CD&EConsultingLLC, Hillsborough, NJ, U.S.


Scientific Program

Post-Approval Economics for New Antibiotics Elaine Hamm, Ph.D., Ascend BioVentures, Oklahoma City, Oklahoma, U.S.

5:25 p.m. – 5:30 p.m. Closing Comments Ursula Theuretzbacher, Ph.D.

5:30 p.m. – 8:30 p.m. Reception Networking Event Grand Ballroom B Sponsored by CARB-X/Wellcome Trust/GARDP/Repair Impact Fund/JPIAMR

Wednesday, September 47:15 a.m. – 8:15 a.m. Breakfast Outside of Grand Ballroom

8:15 a.m. – 8:25 a.m. Opening and Welcome Sujata M. Bhavnani, Pharm.D., M.S., FIDSA and Chair, ASM Meetings Strategy Committee, DavidM.Aronoff,MD,FIDSA,FAAM

8:25 a.m. – 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, U.S.

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

Junko Sato, Ph.D.,OfficeofInternationalCooperation and PMDA, Tokyo, Japan

Case Studies on CMC, Clinical Pharmacology and Clinical Topics

Balajee Shanmugam, Ph.D., U.S. Food and Drug Administration/OfficeofClinicalPharmacology, Silver Spring, MD, U.S.

Seong H. Jang, Ph.D., U.S. Food and Drug Administration/OfficeofClinicalPharmacology, Silver Spring, MD, U.S.


Scientific Program

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

10:25 a.m. – 10:55 a.m. Coffee Break Avenue 34, Lower Level

10:55 a.m. – 11:55 a.m. Keynote Lecture: Beta-Lactamase Inhibitors: A Journey of Discovery Moderator: Shampa Das, University of Liverpool, BSc, Ph.D.

Robert A. Bonomo, M.D., Louis Stokes Cleveland DepartmentofVeteranAffairsMedicalCenterand University Hospitals, Cleveland Medical Center, Cleveland, OH, U.S.

11:55 a.m. – 1:25 p.m. Lunch Outside of Grand Ballroom

1:25 p.m. – 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, U.S.

Drug Development Program for a Stand-Alone Beta- Lactamase Inhibitor JeffLoutit,MBChB, Qpex Biopharma, Los Altos, CA

Drug Development Program for a Beta-Lactamase Inhibitor With Intrinsic Activity David Friedland, M.D., MBA, Wockhardt, San Mateo, CA, U.S. Regulatory Perspectives for the Development of Beta- Lactamase Inhibitors Sumathi Nambiar, M.D., U.S. Food and Drug Administration, Silver Spring, MD, U.S.



2:55 p.m. – 3:25 p.m. Coffee Break Avenue 34, Lower Level

3:25 p.m. – 4: 25 p.m. Young Investigator Lecture PK/PD Murine Infection Models: Focus on Study Elements, Variability, and Interpretation of Results Moderators: Paul G. Ambrose, Pharm.D., FIDSA and Mair Powell, M.D.

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

4:25 p.m. – 6:25 p.m. Wednesday Poster Presentations with Light Reception Avenue 34, Lower Level

Thursday, September 57:30 a.m. – 8:30 a.m. Breakfast Outside of Grand Ballroom

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

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

Panel I: CARB-X Funded Product Developers Panel Moderator: Maria Uria-Nickelsen, Ph.D.

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

Michael P. Bevilacqua, M.D., Ph.D., Amicrobe, Inc., Carlsbad, CA, U.S.

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

Zachary Zimmerman, Ph.D., Forge Therapeutics, San Diego, CA, U.S.

Jeanette Mucha, B.S., SciBac Inc., Burlingame, CA, U.S.

Scientific Program


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, U.S.

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

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

Anita Sheoran, Ph.D., NIAID/NIH, Rockville, MD, U.S.

10:30 a.m. – 11:00 a.m. Coffee Break Avenue 34, Lower Level

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, U

12:00 p.m. – 1:30 p.m. Lunch Outside of Grand Ballroom

1:30 p.m. – 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 U.S. and EU Regulatory Frameworks for Development of New Antifungal Drugs Sumathi Nambiar, M.D., U.S. Food and Drug Administration, Silver Spring, MD, U.S.


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

Scientific Program


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

Specific Challenges in Developing New Antifungal Agents for Drug Resistant Disease David Angulo, M.D., Scynexis, Jersey City, NJ, U.S.

3:00 p.m. – 3:30 p.m. Coffee Break Avenue 34, Lower Level

3:30 p.m. – 4:30 p.m. Young Investigator Lecture Geographic Differences in Enrollment and Microbial Etiology in Clinical Trials of Antibacterial Drugs, 2001-2017 Moderators:EdwardCox,M.D.,MPHandJeffLoutit, MBChB

Stephen Bart, Ph.D., U.S. Food and Drug Administration, Silver Spring, MD, U.S.

4:30 p.m. – 6:30 p.m. Thursday Poster Presentations with Light Reception Avenue 34, Lower Level

Friday, September 67:00 a.m. – 8:00 a.m. Breakfast Outside of Grand Ballroom

8:00 a.m. – 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 a.m. – 9:10 a.m. Keynote Lecture: Investor Sentiment: How Did We Get Grand Ballroom Here and is There a Way Out? Moderator: William Hope, BMBS, FRACP, FRCPA, Ph.D.

Alan Carr, Ph.D.,Needham&Company,NewYork,NY, U.S.

Scientific Program


9:10 a.m. - 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 a.m. - 9:55 a.m. Coffee Break Outside of Grand Ballroom

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, U.S.

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

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, U.S.

11:55 a.m. – 12:00 p.m. Closing remarks William Hope, BMBS, FRACP, FRCPA, Ph.D.

Scientific Program


TARGET AUDIENCEThis 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 OBJECTIVESUpon 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 STATEMENTThis 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 Ameri-can 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 Micro-biology and Infectious Diseases (ESCMID) and CARB-X.

CREDIT DESIGNATIONPhysicians 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.

Continuing Education


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

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

CLAIM CREDITS USING CE.ASM.ORGHow to claim credits:

• 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 Single Sign On (SSO) 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(s) you attended and are claiming credits for. Choose what type of credit you would like to claim. The 2019 ASM/ESCMID Conference offers one type 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)™.

• Certificate of Participation (no credit provided)

• 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 com-mercial interest. TFF and ASM resolve all conflicts of interest to ensure indepen-dence, objectivity, balance, and scientific rigor in all their educational programs. Furthermore, TFF and ASM seek to verify that all scientific research referred to, re-ported, 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 improve-ments in health care and not those of a commercial interest.

ActivityStaffDisclosuresThe 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 USETFF and ASM require CME faculty (speakers) to disclose when products or proce-dures being discussed are off label, unlabeled, experimental, and/or investigational, and any limitations on the information that is presented, such as data that are pre-liminary, 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 DISCLOSUREYour 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 pro-duced 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.


Notes

Sponsored by

AcknowledgementsThe Program Committee and the American Society for Microbiology acknowledge the following companies for their support of the 2019 ASM/ESCMID Conference

on Drug Development to Meet the Challenge of Antimicrobial Resistance.

All logos are the property of their respective owners.

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