IDCRC Newsletter: November 2024
IDCRC Admin Profile: Kellei Johnstone
Kellei has been with Emory University for over nine years, starting as a clinical research coordinator at Winship Cancer Institute and then as audit manager and research liaison with the NCI Clinical Trials Cooperative Group. Kellei joined the IDCRC as a project director in the Leadership Operations Center in March 2022. She shares that "the most impactful work I’ve done with the IDCRC has been supporting the MCDC program, as well as facilitating the creation of multiple task forces and ad hoc committees in order to provide quick responses to public health emergencies. It’s been an honor to work with so many incredibly talented leaders in infectious disease, as well as a dedicated and hard-working team within the Leadership Group."
During this time of reflection, we would like to take the opportunity to thank all of our IDCRC members and partners for their unwavering commitment and dedication to our mission and work. We are grateful for everything you do and wish you a joyous and safe holiday.
Share your news with the IDCRC!
Help us celebrate your wins! Have you or someone on your team recently been recognized for an award? Do you want to shine a spotlight on someone on your team doing excellent work? Do you have opportunities to share with the IDCRC network?
We want to hear from you! Contact us at idcrc@emory.edu for a chance to be highlighted in a future newsletter and on our website.
Register for the Annual FDA Clinical Investigator Training Course
Register today for the Small Business and Industry Assistance's (SBIA) Annual FDA Clinical Investigator Training Course! This is a free virtual course taking place from December 10-12, 2024. This is intended for all stakeholders in the clinical trial enterprise, including industry, academia, and regulators (both domestic and foreign).
About:
The primary goal of this clinical investigator training course is to provide participants with the essential knowledge and skills to conduct clinical trials effectively, ethically, and in accordance with regulatory standards. The course aims to prepare clinical investigators to conduct high-quality research that contributes to scientific knowledge and improves patient care.
Topics Covered: - Study design and protocol development
- Biostatistics and data analysis
- Ethical considerations
- Safety considerations for clinical trials
- Data management and integrity
- Regulatory requirements and compliance
- Innovations in trial design and implementation
Save the Date: 2025 IDCRC Annual Meeting
Date: April 30-May 1, 2025
Location: NIAID Fishers Lane Building
5601 Fishers Lane,
Rockville, MD, 20892
It’s Safe to Give COVID-19 and Influenza Vaccines Together
Cincinnati Children’s was the lead enroller of participants in a recent multi-site clinical trial that found it is safe to administer at the same time vaccines that can help prevent serious illness from COVID-19 and the flu.
The findings, published Nov. 6, 2024, in JAMA Network Open, support the option of getting influenza and COVID-19 vaccines together, making it easier to protect oneself against both of these respiratory viruses during the winter months. Elizabeth Schlaudecker, MD, MPH, and Mary Allen Staat, MD, MPH, of the Division of Infectious Diseases at Cincinnati Children’s collaborated on the study with colleagues at the Centers for Disease Control and Prevention and two other CDC-sponsored Clinical Immunization Safety Assessment Project sites, Duke University and Johns
Hopkins University.
IDCRC members recognized during Emory University
School of Medicine's Celebration of Faculty Eminence
Last month, Emory University School of Medicine's hosted their Celebration of Faculty Eminence, recognizing faculty accomplishments and excellence in patient care, research, education, and innovation. Congratulations to the former and current IDCRC members who were recognized!
Lifetime Service and Leadership Award:
Former IDCRC Leadership Operations Center (LOC) co-director Monica Farley, MD, received the Lifetime Service and Leadership Award. This award recognizes a faculty member’s significant service to the university through personal activities, influence, and leadership over the course of many years. Read more.
MilliPub Club:
The following IDCRC members were recognized as MiliPub Club members. They have published one or more individual papers throughout their careers that have each garnered more than 1,000 citations. Such a paper is commonly considered a “citation classic” and represents high-impact scholarship. Read more.
Infectious Diseases Research Job Openings
Notice of Special Interest (NOSI): Advancing Research Needed to Develop a Universal Influenza Vaccine – Due January 8, 2025
The purpose of this Notice of Special Interest (NOSI) is to support research that contributes to the areas of interest outlined in “A Universal Influenza Vaccine: The Strategic Plan for the National Institute of Allergy and Infectious Diseases.” The proposed research should have clear relevance to the research objectives defined in the strategic plan, which encompasses three major research areas: - Improve understanding of transmission, natural history and pathogenesis of influenza virus infection
- Characterize influenza immunity and correlates of immune protection
- Support rational
design of universal influenza vaccines
Notice of Special Interest (NOSI): Competitive Revision Supplements to Existing T32 Programs to Include Institutional Research Training in Data Science for Infectious and Immune Mediated Diseases – Due January 8, 2025
This Notice of Special Interest (NOSI) solicits competitive revision applications from existing T32 recipients to support additional training slots within the NIAID Data Science Training Program (NDSTP) for pre-doctoral data science training. Applications must propose a data science training program that will include research and mentoring opportunities, as well as coursework for pre-doctoral biomedical trainees. Through this NOSI, applicants may increase the number of training slots beyond the T32 maximum allowed; the training slots proposed via this NOSI must support trainees pursuing a data science curriculum. It is anticipated that an application will propose 2-3 additional data science training slots and 3-4 awards are expected. Centers for Accelerating Phage (Bacteriophage) Therapy to Combat ESKAPE Pathogens (CAPT-CEP) (P01 Clinical Trial Not Allowed) – Due January 29, 2025
The goal of this notice of funding opportunity (NOFO) is to establish Centers for Accelerating Phage Therapy to combat ESKAPE pathogens (CAPT-CEPs). The CAPT-CEPs will be dedicated to developing preclinical assays, tools, and models and conducting essential studies that facilitate robust phage therapeutics against ESKAPE pathogens, ultimately preparing therapeutic candidates for future clinical studies. Applications are expected to include translational research projects covering multidisciplinary sciences. These projects aim to fill the gaps in phage therapeutics research and development (R&D), contributing significantly to the fight against antibiotic resistance (AR). Discovery and Development of Novel Therapeutics for Select Fungal Pathogens (R21/R33 Clinical Trial Not Allowed) – Due January 29, 2025
The purpose of this notice of funding opportunity (NOFO) is to support milestone-driven, early-stage translational research focused on drug discovery and development of novel therapeutics against select fungal pathogens including: Candida species, specifically Candida auris; Aspergillus fumigatus; Coccidioides; and Mucorales. This NOFO will use a milestone-driven, biphasic award mechanism. Transition to the R33 phase will depend on the successful completion of specific milestones during the R21 phase. Notice of Special Interest (NOSI):
Halting Tuberculosis (TB) Transmission – Due March 13, 2025; 2026
The purpose of this Notice of Special Interest (NOSI) is to highlight NIAID’s interest in accepting applications that aim to understand the critical drivers of Tuberculosis (TB) transmission at the individual and population levels in high-burden settings. Applicants are encouraged to develop effective methods to measure rates of TB transmission that rely on an increased understanding of the biomedical basis of transmission and related risk factors and to develop and assess potential interventions, including low-cost and low-tech options, to prevent TB transmission. International Research in Infectious Diseases (R01 Clinical Trial Not Allowed) – Due August 2, 2025
The purpose of this Funding Opportunity Announcement (FOA) is to support applications for high-priority, regionally relevant infectious diseases research by international investigators in resource-constrained countries. Applicant organizations must be headquartered in foreign (non-U.S.) resource-constrained countries (i.e. low-income economies, lower-middle-income economies, and upper-middle-income economies by World Bank Classification). Applicant organizations headquartered in low- and lower-middle income economy countries are particularly encouraged to apply. Eligibility status of applicant organizations will be determined by the World Bank Classification list at the time of application submission. Notice of Special Interest (NOSI): Complement in Fundamental Immunology – Due January 8, 2026
The main objective of this program is to support studies that accelerate our understanding of the roles of complement components and/or receptors in the initiation, magnitude, maintenance, and quality of immune responses involved in pathogenic infections, vaccination, post-infection sequelae, autoimmunity, allergy, or transplantation. The results of such studies will inform the development of vaccines or therapeutics that target complement components. The work to be encouraged includes studies of the roles of complement components (molecules and/or receptors) during immune responses. Global Infectious Disease Research Training Program (D43 Clinical Trial Optional) –Due August 7, 2026
This Funding Opportunity Announcement (FOA) encourages joint applications for the Global Infectious Disease (GID) Research Training programs from low- and middle-income country (LMIC) and U.S. institutions. The application should propose a collaborative training program that will strengthen the capacity of a LMIC institution to conduct infectious disease research (not including HIV/AIDS).
Advancing Research Needed to Develop a Coccidioidomycosis (Valley fever) Vaccine –Due January 15, 2026
The purpose of this Notice of Special Interest (NOSI) is to highlight NIAID’s interest in supporting research in the areas outlined in the NIAID Strategic Plan For Research To Develop A Valley Fever Vaccine. The proposed research should have clear relevance to the strategic priorities defined in the strategic plan, which encompasses three major research areas: 1) address gaps in Coccidioides basic research to support the development of a vaccine; 2) develop tools and resources to support vaccine development; 3) develop and advance vaccines to prevent coccidioidomycosis.
Notice of Special Interest (NOSI): Using Targeted Degradation of Protein and non-Protein Targets for the Development of Novel Anti-Infectives – Due July 17, 2026
The purpose of this Notice of Special Interest (NOSI) is to invite applications for research on the use of targeted protein and nonprotein degradation (e.g., RNA) as it relates to the development of anti-infective strategies against viral, bacterial, parasitic, and fungal pathogens and/or their toxins (e.g., Lethal and Edema Toxins of Bacillus anthracis). Both novel monofunctional (e.g., Molecular Glues) and hetero-bi/tri-functional (e.g., PROTAC or PROTAC-like) strategies will be considered. Notice of Special
Interest (NOSI): Research to Stimulate Development of Diagnostics, Therapeutics, and Vaccines for Herpes Simplex Virus (HSV) – Due April 6, 2027
This notice of special interest (NOSI) encourages applications which are focused on development of diagnostics, therapeutics, and vaccines for herpes simplex virus (HSV). In September 2023, the NIH released the NIH Strategic Plan for HSV Research. The strategic plan focuses on four strategic priorities: HSV virology basic research, better HSV diagnostics, strategies to address HSV treatment and cure, and research to prevent HSV infection. This NOSI focuses on furthering the development of new products for prevention of HSV infection, as well as improving the diagnosis and treatment of patients living with herpes, addressing three of these four strategic priorities.
Active Studies
Recruiting Volunteers
Fully Enrolled Studies
in Follow-up
IDCRC Concept Quick Stats
ECP Status EWG Review-In Process: 1 EMT Review: 1 Approved-moved to Prioritization: 4 Not Approved: 22 Approved-moved to Protocol development: 0 Active Study: 8 EMT Vote: 0 Study in Protocol Development: 2 Study Closed (LSLV Complete): 6 Other: 9
Please submit IDCRC news to idcrc@emory.edu for inclusion in the monthly newsletter and IDCRC.org.
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