October 1, 2020

CTSI in the Time of COVID-19
An Interview with Deb Keeling

Deborah Chavis-Keeling, MS, is the Executive Director of Administration and Finance at the NYU–H+H Clinical and Translational Science Institute. Deb has been a part of the CTSI since its founding in June 2009, and before that at the GCRC since 2006. She is exceptionally positioned to describe how the CTSI was uniquely equipped to tackle the challenges faced through the COVID-19 pandemic.
Why and how was the CTSI uniquely prepared to handle and respond to the COVID-19 crisis?
Being uniquely qualified goes back to our history of how the institution responded to and recovered from Hurricane Sandy in 2012. NYU Langone Health (NYULH) implemented regulatory and clinical measures and looked to the CTSI to guide in the implementation. Due to this, we were able to “put the hat back on” and ramp up accordingly when the pandemic hit. Our preparedness allowed us to be more adaptable to what the particular need was that arose. Some examples of this include: (1) an in-house, institution-wide DSMB, (2) leveraging partnerships, (3) cataloging all SOPs, (4) adapting the scientific review committee to approve requests (biospecimens, data) more rapidly, (5) developing consistent GCP, (6) utilizing the SMART IRB reliance agreements for cross-collaborative projects.
How has being part of the NCATS CTSA consortium properly aligned our hub to respond to the COVID-19 crisis?
Collegiality within the consortium serves as an incredible resource, especially in this time of need. To be able to reach out to others across the US and come together to share ideas and best practices with various levels of expertise (PI, Administrative/Operational, Evaluation, Education, Informatics, Funding Community Engagement, etc.) is a tremendous benefit. We are leveraging the relationships that we’ve been establishing and cultivating for over 10 years within the consortium, our institution, and our partners:
      Consortium: Regional Tri-State Hubs (Cornell, Einstein, Columbia, Mt. Sinai, Rockefeller, Rochester, Buffalo, Rutgers, Yale) – having existing networks nationally allowed us to tap into these relationships to put together an administrative supplement with regional informatics networks across our TRICON group.
       Institution: Mulligan Vaccine Trial recruitment, which is now guided by our CTSI Community Engagement core who are leading the charge in going out to our communities in order to build trust and recruit into the trial.
       Partners: Our clinical partner, NYC Health + Hospitals (H+H), provided NYU investigators the opportunities to open up their studies to a wider audience and space. Building these relationships and trust over the years means we can leverage each other’s strengths when needs arise.
How will emergency preparedness and procedure development play a role in how the CTSI operates going forward?
It will be vital to move forward from this and not just put a band-aid on the things that need to be fixed in the short-term. We will be using the measures and procedures developed now to be ready to adapt them to anything that happens in the future. Efficiency was key to ramping up and sustaining processes during the crisis at NYULH and the CTSI played a major role in that. It is extremely important to take a step back, learn, and continually grow from what did not go right the first time so we can get it right the next time. It is also essential to hear about the relatable experiences of our peers from all levels. Dissemination of best practices and impact is also key (channel, language, POV) depending on the audience.

Doris Duke Program Announcement

The Doris Duke Charitable Foundation's Fund to Retain Clinical Scientists (FRCS) program at NYU Langone Health (NYULH) is an “extra hands” program that support our 250+ junior faculty who conduct human subjects research across NYULH's vast network of subsidiary institutions, including the NYU Grossman School of Medicine, five hospitals, emergency care locations, academic departments, and Clinical and Translational Science Institute (CTSI). The program seeks to support outstanding junior physician scientists for whom a relatively small investment over a 2-year period promises to substantially minimize the likelihood that they will change their career path owing to the demands of extraprofessional caregiving obligations. A semi-annual selection process identifies the most worthy candidates and will now be managed under the CTSI. Stay tuned for an RFA announcement coming in the Fall.

6th Annual Health Disparities Symposium: Now Virtual and CME Accredited!

The NYU-H+H CTSI, in collaboration with NYU Langone’s Department of Population Health, Office of Diversity Affairs, and the NYU-CUNY Prevention Research Center, is sponsoring the 6th Annual Health Disparities Day Symposium. The event will be held virtually over the course of the week of October 13th. Continuing medical and nursing education (CME/CNE) credits will now be offered free of charge to participants.
This year’s conference theme will focus on how we turn “Research Into Action”. As the 2019 coronavirus disease (COVID-19) pandemic has unfolded in the backdrop of continued structural racism faced by communities of color, it is more critical than ever before that research uncovering inequities in health is disseminated, translated, and actionable. Conference topics will explore a variety of health inequalities, and speakers will be encouraged to address the ways in which COVID-19 has highlighted structural inequities across time.
Dr. Mary T. Bassett, the Director of the François-Xavier Bagnoud (FXB) Center for Health and Human Rights at Harvard University, FXB Professor of the Practice of Health and Human Rights at the Harvard T.H. Chan School of Public Health, and former New York City’s Commissioner of Health from 2014 to 2018, will provide the keynote address for the event. Register here for this free, virtual event. For additional information about the event, including learning objectives, agenda, and speaker bios, please click here.

NCATS CTSA Funding Opportunity

Administrative Supplements to NCATS CTSA Program KL2 Institutional Career Development Awards as part of the INCLUDE (Investigation of Co-occuring Conditions across the Lifespan to Understand Down syndrome) Project are due on November 2, 2020. This Notice of Special Interest (NOSI) announces NIH support for the professional development of early career scientists aiming to establish a career in DS-related research. By providing these scientists with career development research experiences, resources, and mentorship, the NIH intends to foster a pipeline of investigators in DS and other intellectual disabilities who will lead future research to improve the understanding of the biology of DS and support development of new treatments for health conditions experienced by those with DS. Please contact Elana Lipschitz for more details and a letter of support from the CTSI. Please see the NOSI for Application and Submission Information.

Educational Announcements

The CTSI is excited to announce several Educational RFAs coming this Fall:

The Masters of Science in Clinical Investigation (MSCI) is a two-year part-time course of study intended for NYU Medical Center or NYU CTSI-affiliated Health and Hospitals physicians and other post-doctoral level healthcare professionals and investigators in healthcare-related fields. Medical students in their third year of studies at NYU School of Medicine may apply via the dual MD/MSCI option. The program currently offers two tracks:
- Translational Research Track (post-doctoral and dual-degree options)
- Health Innovations and Therapeutics Track
Both tracks emphasize knowledge and skill building along with research accomplishment, and provide extensive career development mentoring.
The KL2 Scholars Program provides up to two years of support for partial salary, travel, training, and mentoring for scholars with demonstrated potential to attain independence as clinical and translational scientists. The fundamental goal of the program is to help and support scholars as they advance in their research careers, and to provide them with the knowledge and skills to develop into successful, independent researchers. The program emphasizes productivity, collaborative research, and career development.

Individuals holding faculty appointments as Instructor or Assistant Professor with at least one year of full-time research experience or its equivalent in clinical/translational research are eligible to apply. It is anticipated that applicants will be working towards research independence; one goal of the program is to help trainees achieve “next level” federal funding. Individuals that have already received NIH K- or R-level awards, or their equivalents from other federal agencies, are not eligible. Scholars from any unit or school in the University, or with appointments at CTSI-affiliated New York City Health + Hospitals institutions, are eligible to apply. Applicants must have the support of their research advisor/mentor and department chair or division chief, and be a U.S. citizen or permanent resident.
The TL1 Program will provide up to two years of stipend training and mentoring while emphasizing the trainees' success within their established research area. The fundamental goal of the program is to help and support trainees as they advance in their research careers, and to provide them with the knowledge and skills to eventually develop into successful, independent researchers. The program encourages productivity, collaborative research, and career development. Trainees should be actively engaged in clinical or translational research. Trainees from any unit or school of New York University (NYU), or with appointments at CTSI-affiliated NYC Health and Hospitals institutions, are eligible to apply. In rare cases funding will also be available to applicants from other universities, if their proposed mentor is an established researcher at NYU. Applicants must have the support of their research advisor/mentor and department chair, division chief, or Dean and be a U.S. citizen or permanent resident.

Please stay tuned as we release more information in the coming months!

Funding Announcements

The CTSI is excited to announce the RFA for the next round of Pilot Projects will be coming this Fall. The intent of the NYU CTSI Translational Research Pilot Project Awards is to support collaborative scientific studies for one year to enable development of preliminary data that will serve as the foundation for translational research projects that are impactful with a high likelihood of achieving their aims and therefore competitive for external peer review full-scale funding. Of particular interest are projects designed to develop new approaches to overcoming obstacles to translational research. The purpose of the Request for Application (RFA) is to support the development of collaborative T1-T3 translational research by investigators associated with the CTSI and to encourage new investigators to engage in translational research. Priority will be given to collaborations across departments/divisions and schools. Awards of up to $50,000 will be distributed to support these projects (pending funding from NCATS), beginning Spring 2021.

Criteria - The primary criteria for funding of these awards are:

Quality of the science proposed.
Impact of the proposed research on the health of New York City or other populations with particular emphasis on special populations (defined as pediatric, geriatric, minority and health disparity communities).
Potential of the applicants to acquire future independent funding for the project.
Evidence of collaborative clinical or translational research that is well positioned to lead to externally funded, high impact science
In accordance with the objectives of the CTSA, priority will be given to the development of novel technologies, methodologies and feasible approaches that stimulate inter-disciplinary collaborations that test generalizable solutions to translational research problems.

Eligibility:
This competition is open to all investigators at the School of Medicine, as well as to the other schools and colleges of NYU, members of NYC Health and Hospitals (H+H) with NYU faculty appointments or who are working in partnership with one or more NYU faculty investigators, and researchers at the Nathan Kline Institute. Additionally, it is open to members of the NYU CTSI Community Advisory Board in partnership with one or more NYU faculty investigators. Eligible applicants include all faculty members, senior post-doctoral research fellows and clinical fellows if they are likely to become faculty members whose proposals fit the above-listed criteria. Students, residents and beginning post-doctoral fellows are not eligible

Please stay tuned as we release more information in the coming months!

COVID Supplements at the CTSI

During the last 6 months, the CTSI has received several NIH COVID-19 Administrative Supplements:

CONTAIN COVID-19: Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients - This randomized, blinded phase 2 adaptive trial will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms between 3 and 7 days after the onset of symptoms OR within 3 days of hospitalization. A total of 300 eligible subjects will be randomized in Stage 1 of the trial to a 1:1 ratio to receive either convalescent plasma from people who have recovered from Covid-2 containing antibodies to SARS-CoV-2 or control (saline solution). Subsequent Stages of the trial will be defined after conclusions from the previous Stage. Collaborators include National Center for Advancing Translational Sceince (NCATS), Albert Einstein College of Medicine, Yale Univeristy, The University of Texas Health Science Center, Houston, The University of Texas Health Science Center at Tyler, and University of Miami.
COMPILE: Continuous Monitoring of Pooled International Trials of Convalescent Plasma for COVID-19 Hospitalized Patients - This is a supplement to our multi-site convalescent plasma trial. The consortium includes Albert Einstein College of Medicine, Johns Hopkins University, University of Miami, and Yale University, with international partner sites in Brazil, Netherlands, Spain, India, and Belgium. Please see more information here.
COMBAT: Consortium for Multisite Biomedical Analytics and Trials on COVID-19 - COMBATCOVID will bring together electronic health records (EHR) data from 7 participating institutions (see below) into a shared centralized database. As part of the COMBATCOVID effort, biospecimens data of COVID-19 patients collected by some of the participating institutions will also be shared and linked to the respective EHR data. The COMBATCOVID consortium will be responsible for transferring EHR data pertaining to participating institutions interested in contributing EHR data to the N3C database. COMBATCOVID is supported by NIH/NCATS and the CTSA Consortium Hubs. Additional participating Hub institutions include: Albert Einstein College of Medicine, Ichan School of Medicine at Mount Sinai, Rutger Biomedical/Health Sciences, State University of New York at Buffalo, University of Rochester, and Wake Forest University Health Sciences.

In the Spotlight

Updated CTSI Consultation Request

Please click here to request CTSI Consultation Services if you are looking for valuable input on research protocols, biostatistics, recruitment, community population engagement, research expertise sessions (studio), and other services.

Translational Research in Progress Seminars

Translational Research in Progress (TRIP) Seminars are now taking place every Monday through the end of the year via Zoom. For the webinar link or more information, please contact Shirley Cabrera at 212-263-2978.

Events

OCT

Translational Research in Progress (TRIP) Seminar
Featuring Emily Kawaler, PhD Student and Bo Shopsin, MD, PhD
Date: October 5, 2020
Time: 12:00 PM - 1:00 PM
Location: Virtual (Zoom)
Contact: Shirley Cabrera | 212-263-2978

OCT

Health Disparities Day Symposium

Conference theme: "Research Into Action"
Date: Week of October 6, 2020
Location: Virtual
Register Here

OCT

Translational Research in Progress (TRIP) Seminar
Featuring Speakers Nicole Perez, MSN, NP, PMHNP-BC and Emma Muinos Lopez, PhD
Date: October 12, 2020
Time: 12:00 PM - 1:00 PM
Location: Virtual (Zoom)
Contact: Shirley Cabrera | 212-263-2978

OCT

TREC Grant Writing for Translational Scientists
Series of grant-writing classes and workshops through the Fall
Date: Thursdays, from October 15 - December 10
Time: 4:00 PM - 5:00 PM
Location: Virtual (Zoom)
Register Here
For more information, contact: Daniel Cobos

OCT

Translational Research in Progress (TRIP) Seminar
Featuring Speakers Javiera P. Oyarzun, PhD (Post-Doc Fellow) and Anna Marie Josephson, PhD Student
Date: October 19, 2020
Time: 12:00 PM - 1:00 PM
Location: Virtual (Zoom)
Contact: Shirley Cabrera | 212-263-2978

OCT

Translational Research in Progress (TRIP) Seminar
Featuring Speakers Gadi Wollstein, MD and Israeli Ran, PhD
Date: October 26, 2020
Time: 12:00 PM - 1:00 PM
Location: Virtual (Zoom)
Contact: Shirley Cabrera | 212-263-2978