Meeting 1—Virtual
April 22, 2024
CLOSED SESSION—COMMITTEE MEMBERS ONLY
| 12:30–2:35 PM | CLOSED SESSION |
OPEN SESSION
| 2:45 PM | Sponsors remarks and committee questions |
| BEN NEMSER | |
| Steven & Alexandra Cohen Foundation | |
| 3:15 PM | Federal agencies remarks and committee questions |
| LYLE PETERSEN | |
| National Center for Emerging and Zoonotic Infectious Diseases | |
| Centers for Disease Control and Prevention | |
| NADINE BOWDEN | |
| National Institute of Allergy and Infectious Diseases | |
| National Institutes of Health |
| KRISTEN HONEY | |
| Office of Assistant Secretary of Health | |
| Department of Health and Human Services |
CLOSED SESSION—COMMITTEE MEMBERS ONLY
| 4:00–5:00 PM | CLOSED SESSION |
| 5:00 PM | END OF MEETING |
Meeting 1.5—Virtual
May 14, 2024
CLOSED SESSION—COMMITTEE MEMBERS ONLY
| 12:00 PM | CLOSED SESSION |
| 3:30 PM | ADJOURN |
Meeting 2—Hybrid Workshop
July 11–12, 2024
DAY 1—THURSDAY, JULY 11, 2024
CLOSED SESSION
| 9:00 AM | CLOSED SESSION |
OPEN SESSION
| 9:30 AM | Welcome |
| KENT KESTER, Committee Chair | |
| IAVI |
Opening Session: An Overview of Challenges in Lyme IACI Research
Objectives
Framing Questions
| 9:35 AM | Patient perspective: Impact of Lyme IACI |
| Rhisa Parera | |
| Your Labs Are Normal | |
| 9:45 AM | Overview: Current status and challenges in research for Lyme IACI treatment |
| John Aucott | |
| Johns Hopkins University | |
| 10:05 AM | Building on current progress: Reflections from the HHS Tick-Borne Diseases Working Group |
| C. BENJAMIN BEARD | |
| Division of Vector-Borne Diseases | |
| Centers for Disease Control and Prevention | |
| 10:15 AM | Q&A |
| 10:45 AM | BREAK |
SESSION 1: Potential Commonalities Across Other Fields and Implications for Lyme IACI
Objectives
Framing Questions
| 11:00 PM | Autoimmune mechanisms of IACI |
| WILLIAM ROBINSON | |
| Stanford University | |
| 11:10 PM | Inflammatory responses in IACI |
| DANIEL CLAUW | |
| University of Michigan | |
| 11:20 PM | Current evidence for mechanisms of colonization and pathogenesis |
| JOHN LEONG | |
| Tufts University | |
| 11:30 PM | Elucidating pathophysiology: lessons from ME/CFS |
| AVINDRA NATH | |
| National Institute of Neurological Disorders and Stroke, NIH | |
| 11:40 PM | Discussion and Q&A |
| 12:15 PM | LUNCH |
SESSION 2: Advances in Diagnostics Research
Objectives
Framing Questions
| 1:00 PM | Current diagnostic approaches and emerging technologies |
| CHARLES CHIU | |
| University of California, San Francisco | |
| 1:10 PM | Challenges in diagnostics research |
| NANCY KLIMAS | |
| Nova Southeastern University | |
| 1:20 PM | Challenges in advancing new diagnostics development |
| RAYMOND DATTWYLER | |
| New York Medical College | |
| 1:30 PM | Challenges in regulatory considerations of new diagnostics |
| ELLIOT COWAN | |
| Partners in Diagnostics | |
| 1:40 PM | Discussion and Q&A |
SESSION 3: Strategies to Improve the Applicability of Research
Objectives
Framing Questions
| 2:10 PM | Patient-generated data |
| BETH JAWORSKI | |
| All of Us Research Program, National Institutes of Health | |
| 2:20 PM | Patient registries and biobanks for Lyme IACI |
| LIZ HORN | |
| Lyme Disease Biobank | |
| 2:30 PM | Platform trial designs toward standardization and quality across studies |
| ROGER LEWIS | |
| University of California, Los Angeles | |
| 2:40 PM | Research trials network and data sharing |
| RACHELE HENDRICKS-STURRUP | |
| Duke-Margolis Institute for Health Policy | |
| 2:50 PM | Discussion and Q&A |
| 3:20 PM | BREAK |
SESSION 4: Bridging Opportunities and Action
Session Objectives
Framing Questions
| 3:30 PM | Panel Discussion: Patient-defined priorities for research |
| Patient-centered outcomes | |
| LORRAINE JOHNSON | |
| LymeDisease.org | |
| Patient participation in research and data collection | |
| WENDY ADAMS | |
| Bay Area Lyme Foundation | |
| Bridging between funder and patient priorities | |
| TIMOTHY SELLATI | |
| Global Lyme Alliance | |
| 4:00 PM | Funder perspective |
| LEITH STATES | |
| Office of the Assistant Secretary for Health, HHS |
| 4:10 PM | Industry perspective |
| MATT TINDALL | |
| FlightPath Biosciences | |
| 4:20 PM | Regulatory perspective |
| STACIE HUDGENS | |
| Clinical Outcomes Solutions | |
| 4:30 PM | Discussion and Q&A |
Day 1 Wrap-Up
| 4:55 PM | Final Remarks |
| KENT KESTER, Committee Chair | |
| IAVI | |
| 5:00 PM | ADJOURN DAY 1 |
DAY 2—FRIDAY, JULY 12, 2024
CLOSED SESSION
| 9:00 AM | Committee meets in closed session |
| 3:30 PM | ADJOURN MEETING |
Meeting 3—Virtual
August 12-13, 2024
DAY 1—MONDAY, AUGUST 12, 2024
CLOSED SESSION
| 9:00 AM | Committee meets in closed session |
OPEN SESSION
WELCOME
| 9:45 AM | Welcome and opening remarks |
| KENT KESTER, Committee Chair | |
| CEPI |
SESSION 1 Moving toward Treatments: Remaining Questions in Lyme IACI Research
Session Objective:
| 9:50 AM | Evidence for central nervous system involvement in Lyme IACI |
| BRIAN FALLON | |
| Lyme and Tick-Borne Diseases Research Center | |
| Columbia University Vagelos College of Physicians and Surgeons | |
| 10:00 AM | Pathogen persistence and host immune response |
| MONICA EMBERS | |
| Tulane School of Medicine | |
| LINDA BOCKENSTEDT | |
| Yale School of Medicine | |
| 10:20 AM | Microbiome dysbiosis |
| ILHEM MESSAOUDI POWERS | |
| University of Kentucky, College of Medicine | |
| 10:30 AM | Discussion: Clinician perspective on challenges in clinical diagnosis and treatment outcomes |
| RAVINDRA GANESH | |
| Post COVID Care Clinic at Mayo Clinic | |
| RYAN HURT | |
| Mayo Clinic | |
| LISA SANDERS | |
| Yale New Haven Health Systems Long COVID Consultation Clinic |
| 10:45 AM | Open discussion with committee |
| 11:30 AM | BREAK |
CLOSED SESSION
| 12:00 PM | Committee meets in closed session |
| 2:00 PM | ADJOURN DAY 1 |
DAY 2—TUESDAY, AUGUST 13, 2024
OPEN SESSION
WELCOME
| 9:00 AM | Welcome and opening remarks |
| KENT KESTER, Committee Chair | |
| CEPI |
SESSION 2 Health Equity Considerations for Future Research Agenda
Objectives:
| 9:05 AM | Underserved populations |
| ROBERTA DEBIASI | |
| Children’s National Research Institute | |
| BETHANY ALCAUTER | |
| National Center for Farmworker Health |
| 9:25 AM | Additional risk factors in developing Lyme IACI |
| Host risk factors including sex differences | |
| MICHAL TAL | |
| Massachusetts Institute of Technology | |
| Role of environmental exposures | |
| ESTHER MELAMED | |
| University of Texas at Austin, Dell Medical School | |
| Co-infections and potential interplay of immune responses | |
| EROL FIKRIG | |
| Yale School of Medicine | |
| 9:55 AM | Open discussion with committee |
| 10:15 AM | BREAK |
CLOSED SESSION
| 10:30 AM | Committee meets in closed session |
| 2:30 PM | ADJOURN |
Meeting 3.5—Virtual
September 10, 2024
CLOSED SESSION—COMMITTEE MEMBERS ONLY
| 2:00 PM | CLOSED SESSION |
| 5:00 PM | ADJOURN |
Meeting 4—Hybrid
October 1–2, 2024
DAY 1 | TUESDAY, OCTOBER 1, 2024 (all times EDT)
CLOSED SESSION—COMMITTEE MEMBERS ONLY
| 10:00 AM | CLOSED SESSION |
| 5:00 PM | ADJOURN |
DAY 2 | WEDNESDAY, OCTOBER 2, 2024 (all times EDT)
CLOSED SESSION—COMMITTEE MEMBERS ONLY
| 9:00 AM | CLOSED SESSION |
| 3:00 PM | ADJOURN |
Meeting 5—Virtual
November 6, 2024
CLOSED SESSION—COMMITTEE MEMBERS ONLY
| 1:30 PM | CLOSED SESSION |
| 5:30 PM | ADJOURN |
Meeting 6—Virtual
January 7, 2025
CLOSED SESSION—COMMITTEE MEMBERS ONLY
| 2:00 PM | CLOSED SESSION |
| 5:00 PM | ADJOURN |