DESCRIPTION AND SUMMARY
The Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) are co-sponsoring this public virtual workshop.
Discussions are planned around the following topics/areas:
- The current state of development of pathogen-directed products used to prevent healthcare-associated infections (HAIs)
- Evidence supporting decolonization and pathogen reduction (in colonized patients) as a strategy to prevent infection and transmission of antimicrobial-resistant healthcare-associated pathogens
- Antimicrobial resistance threats as potential targets for decolonization and pathogen reduction
- Challenges and potential approaches to drug development and registration of products for the prevention of healthcare-associated infections
Mr. Craig is the Director of CDC’s Antimicrobial Resistance Coordination and Strategy Unit and leads the coordination of CDC’s $180 million cross-cutting antimicrobial resistance portfolio. He is CDC’s representative on the President’s Advisory Committee for Combating Antibiotic-Resistant Bacteria (PACCARB) to align public health activities related to antimicrobial resistance across multiple federal agencies.
Dr. Guh is a U.S. Public Health Service Medical Officer in CDC’s Division of Healthcare Quality Promotion. Within this division, she leads the Clostridioides difficile infection and Multi-site Gram negative Surveillance Initiative Team within the Epidemiology Research and Innovations Branch.
Dr. Ham is the Deputy Lead of the Antimicrobial Resistance Team in CDC’s Division of Healthcare Quality Promotion where he serves as a subject matter expert on antimicrobial-resistant Gram positive bacteria. As a public health physician and epidemiologist, he oversees a broad portfolio of projects focused on the prevention of antimicrobial-resistant pathogens in healthcare settings.
Dr. Jernigan serves as Chief of the Epidemiology Research and Innovations Branch within CDC’s Division of Healthcare Quality Promotion. He has 30 years of experience in clinical infectious diseases and healthcare epidemiology research.
Dr. McDonald is currently the Associate Director for Science within CDC’s Division of Healthcare Quality Promotion. He has published extensively in healthcare-associated infections, especially Clostridioides difficile infection, and antimicrobial resistance. He has also led his division’s efforts to explore the application of microbiome science to public health.
Dr. Sexton is a microbiologist and the Team Lead for CDC’s Mycotic Diseases Branch Laboratory. He has specific subject matter expertise in the detection and control of Candida auris, including diagnostics, colonization, transmission, and environmental control.
Dr. Walters is an epidemiologist and leads the Antimicrobial Resistance Team in the Prevention and Response Branch within CDC’s Division of Healthcare Quality Promotion. Her interests include strategies to prevent the spread of multidrug-resistant organisms (MDRO), especially carbapenem-resistant Gram negative bacilli, and outbreak response.
A. Whitney Brown
Dr. Brown joined the Inova Advanced Lung Disease and Transplant Program in Falls Church, VA, in 2010 and helped create the Inova Cystic Fibrosis (CF) Center. In July 2021, Dr. Brown joined the Clinical Affairs department with a focus on supporting the Care Center network and the evolving CF care model. She continues to care for adults with CF at Inova, which energizes and informs her work at the CF Foundation.
Ms. Thomas was the first patient advocate to raise the alarm concerning methicillin-resistant Staphylococcus aureus (MRSA) infections and HAIs in 2002 before founding MRSA Survivors Network in 2003. She is a survivor of MRSA, sepsis, and Clostridioides difficile.
Dr. Bein is a senior statistician at the FDA, where he has worked for five years. He has a doctorate in biostatistics from UC Berkeley.
Dr. Carlson is a principal investigator in the Laboratory of Mucosal Pathogens and Cellular Immunology, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. His research at the FDA has focused on infections caused by the enteric pathogens, Clostridioides difficile, and vancomycin-resistant Enterococcus (VRE) species, as well as fecal microbiota transplantation (FMT) and bacteriophage therapeutics.
Dr. Duffy is the Chief of Research & Development at CARB-X, a global biopharmaceutical accelerator for the discovery and early development of products designed to prevent, diagnose, and treat bacterial infections. Most of her professional growth was with Melinta Therapeutics (founded as Rib-X Pharmaceuticals), where over 17 years she became EVP, Chief Scientific Officer and R&D site head. Erin’s formal training was at Yale University, where she completed a PhD in physical-organic chemistry and a Howard Hughes Medical Institute postdoctoral fellowship in computational structural biology.
Mr. Georges is the Senior Vice President, Scientific & International Affairs, for the Household & Commercial Products Association (HCPA). HCPA represents member companies that manufacture and sell products used for cleaning, protecting, maintaining, and disinfecting residential, commercial, and institutional environments.
Dr. Huang is a professor in the Division of Infectious Diseases at the University of California, Irvine (UCI) School of Medicine, as well as the Medical Director of Epidemiology and Infection Prevention at UCI Health. She has led several large, randomized clinical trials involving decolonization to prevent MDRO disease and other HAIs across the continuum of care.
Dr. Kim is the Vice President of Science & Regulatory Affairs and leads the scientific team at the American Cleaning Institute (ACI), the trade association for manufacturers of soaps, hand sanitizers, cleaning products, and their chemistries.
Dr. Michele is currently the Director of the Office of Nonprescription Drugs (ONPD) in the FDA’s Office of New Drugs, Center of Drug Evaluation and Research (CDER). Among other drugs, the ONPD is responsible for regulating healthcare and consumer antiseptics. Prior to joining FDA in the Division of Pulmonary and Allergy Drug Products, she spent 10 years in industry, with clinical research experience across a variety of therapeutic areas in both commercial and development stage companies.
Dr. Smith is a clinical team leader in the FDA’s Division of Anti-Infectives in the Center for Drug Evaluation and Research where she is involved in the review and regulation of products intended for the treatment and prevention of infectious diseases.
Dr. Weinstein is the C. Anderson Hedberg, MD, Professor of Internal Medicine at Rush Medical College. He is also Chairman Emeritus of the Department of Medicine at Cook County Health in Chicago. Dr. Weinstein has been President of the Society for Healthcare Epidemiology of America, Chair of the Healthcare Infection Control Practices Advisory Committee at CDC, Board Member at the Infectious Diseases Society of America, and a voting member at PACCARB.
Dr. Caballero is the Director of Infectious Diseases at Vedanta Biosciences in Cambridge, MA. She is also the Head of Vedanta’s Multidrug Resistance Program aimed at reducing the risk of MDRO infections by promoting reduction of intestinal carriage with defined bacterial consortia.
Dr. Henn is the Executive Vice President and Chief Scientific Officer at Seres Therapeutics. He has been involved in the discovery and development of multiple microbiome therapeutics across infectious, inflammatory, and oncology indications.
Ms. Séjourné is the CEO of Da Volterra, a biotech company that develops innovative products to protect the intestinal microbiota from the deleterious effects of drugs, and in particular antibiotics and chemotherapies targeting medical needs including prevention of infections and dissemination of antibacterial resistance, and prevention of severe diarrhea and maintenance of immuno-oncology drug efficacy. She is also the founding board member of the BEAM Alliance, which represents European biotech companies involved in developing innovative products to tackle antimicrobial resistance.
Dr. Wacher is currently the head of corporate and product development at Synthetic Biologics. Dr. Wacher has nearly 30 years of experience leading corporate strategy, partnering, research, clinical development, and intellectual property programs for start-ups, small companies, and new business units within large companies.
REQUEST FOR ORAL PRESENTATIONS
NOTE: All slots for the public comments section have been filled. Thank you for your interest.
During online registration, you may indicate if you wish to present during a public comment session or participate in a specific session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. All requests to make oral presentations must be received by August 15, 2022, and must be emailed to Sunita Shukla (Sunita.Shukla@fda.hhs.gov) with the title and brief description of your topic.
We will determine the amount of time allotted to each presenter (no more than 5 minutes) and the approximate time each oral presentation is to begin. We will select and notify participants, if selected as presenters, by August 18, 2022. If selected for presentation, any presentation materials must be emailed to Sunita Shukla (Sunita.Shukla@fda.hhs.gov) no later than August 24, 2022. No commercial or promotional material will be permitted to be presented during the workshop.
All meeting materials—including agenda, panelist affiliations/disclosures, speaker slides, workshop recording, and transcript—will be posted here shortly before and/or after the completion of the workshop. Please check this site regularly for updates.
ONLINE ATTENDANCE (WEBCAST)
This virtual public workshop was webcast via Zoom.
This event has concluded.
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EVENT POINT OF CONTACT
Lori Benner and/or Antoinette Ziolkowski
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 22, rm. 6221
Silver Spring, MD 20993-0002
October 12, 2022