Kent E. Kester, Workshop Co-chair

Vice President, Translational Medicine

International AIDS Vaccine Initiative

Alliance Director

CARB-X

• Examine the current state of rapid diagnostic development, including examples of successes and limitations of current approaches;
• Consider gaps that rapid diagnostics may be best-suited to address (e.g. tools to support targeted treatment decisions in the healthcare setting, tools to enable real-time surveillance based on routine hospital data);
• Discuss what “success” might look like in future.

Karen C. Carroll, Keynote Speaker

Director, Division Medical Microbiology & Professor of Pathology

Johns Hopkins University School of Medicine

Karen C. Carroll, Moderator

Johns Hopkins University School of Medicine

Bradley Burnam

Founder & AMR Survivor

Turn Therapeutics

Craig Whiteford

Senior Director R&D

Becton Dickinson

Tracey L. Cohen

Distinguished Visiting Scholar

Institute for Bioethics & Health Policy, University of Miami Miller School of Medicine

Susan Van Meter

President

American Clinical Laboratory Association

• Consider the unique challenges for the development of rapid point-of-care diagnostics to address antibiotic resistance;
• Discuss lessons learned from other diseases, including COVID-19, for rapid diagnostics development and use; and

• Consider generalizable applications and practical approaches to overcome barriers to the development and use/uptake of rapid diagnostics for drug-resistant bacterial infections.

Joseph Lutgring

Medical Officer, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

William “Bill” Rodriguez

Chief Executive Officer

FIND, the Global Alliance for Diagnostics

Paul Eder

Senior Scientific Officer

Concept Acceleration Program – Diagnostics

National Institute of Allergy and Infectious Disease

Paul Eder, Moderator

National Institute of Allergy and Infectious Disease

Alex Greninger

Assistant Professor and Assistant Director of the Clinical Virology Laboratories

University of Washington Medical Center

Kristian Roth

Deputy Director

Division of Microbiology Devices, FDA

David Persing

Head of R+D

Cepheid

• Consider common incentives/disincentives for the development of rapid diagnostics and new antibiotics; and
• Discuss innovative ways to foster innovation at the intersection of complementary diagnostics and drug development.

John Billington

Head of Commercial Pipeline & Health Security, Policy & Advocacy

GSK

John Billington, Moderator

GSK

Valérie Raymond-Schwartzmann

Companion Diagnostics Senior Program Director

bioMérieux

Alita Miller

Chief Scientific Officer

Entasis Therapeutics

Gregory Frank

Director, Global Public Policy

Merck

Kim Sciarretta

DRIVe Launch Office Branch Chief

Biomedical Advanced Research and Development Authority (BARDA)

• Lay out a “menu” of policy options for incentivizing the development and use of rapid diagnostics.

Mark McClellan, Moderator

Duke Margolis Center for Health Policy

Phyllis Arthur

Vice President, Infectious Diseases & Emerging Science Policy

BIO

Sarah McClelland

Health Policy Analyst

U.S. Department of Health and Human Services

Jaclyn Levy

Director, U.S. Policy

AMR Action Fund

Kevin Outterson

Professor of Law, Boston University

Executive Director, CARB-X

• Consider the health equity implications for the development and use of rapid point-of-care diagnostics in health care settings; and
• Discuss practical approaches for incorporating diversity, equity, inclusivity, and access into push and pull incentives for spurring diagnostic development.

Mother of the Late Mallory Smith

AMR Advocate

Salt in My Soul Co-author/Producer

Amanda Jezek, Moderator

Infectious Diseases Society of America

Nicholas Evans

Chair, Associate Professor

University of Massachusetts, Lowell

Daniel Bausch

Director of Emerging Threats & Global Health Security

FIND, The Global Alliance for Diagnostics

Melinda Pettigrew

Anna M. R. Lauder Professor of Epidemiology and Interim Dean

Yale School of Public Health

Anthony So

Professor of the Practice; Director, Innovation+Design Enabling Access (IDEA) Initiative

Johns Hopkins Bloomberg School of Public Health

• Discuss practical and actionable policy options to integrate rapid point-of-care diagnostics and antibiotic stewardship in healthcare settings;
• Consider the role of reimbursement, incentives, and guideline development for rapid point-of-care diagnostics in healthcare settings.

Robin Patel, Moderator

Mayo Clinic

Ritu Banerjee

Medical Director, Pediatric Antimicrobial Stewardship Program

Vanderbilt University

Carey-Ann Burnham

Chief Clinical Officer

Pattern Bioscience

Diane Flayhart

Global Program Leader

Becton, Dickinson and Company

• Based on a menu of policy options, consider practical and actionable next steps that would be most impactful for spurring the development and use of rapid diagnostics in healthcare settings; and
• Discuss practical short- and long-term opportunities for specific stakeholders to take action.

Betsy Wonderly Trainor, Moderator

CARB-X

Jean Patel

Principal Scientific Affairs, Microbiology

Beckman Coulter Diagnostics

Joseph Larsen

Vice President, Clinical Development

Locus Biosciences, Inc.

Robin Patel

ID Physician, Laboratory Director

Mayo Clinic

Ribhi Shawar

Branch Chief, Division of Microbiology Devices, Office of In Vitro Diagnostic and Radiological Health

Center for Devices and Radiological Health, FDA

Susan Van Meter

President

American Clinical Laboratory Association

Kent E. Kester, Workshop Co-chair

Vice President, Translational Medicine

International AIDS Vaccine Initiative

Alliance Director

CARB-X