Founding chair appointed to FDA
The FDA’s Center for Drug Evaluation and Research (CDER) has appointed Dr. Frank Harrell, professor of biostatistics at Vanderbilt University Medical Center, as a senior biostatistics advisor to the Office of the Center Director under the Intergovernmental Personnel Act (IPA) Mobility Program. CDER’s mission is to protect and promote public health by helping to ensure that human drugs are safe and effective for their intended use, meet established quality standards, and available to patients.
Under this appointment, Harrell will serve as a senior advisor to CDER on innovative and novel models for biostatistical analysis to facilitate the regulatory drug review in therapeutic areas with underserved populations or unmet medical needs. Harrell will advise the center on advanced approaches to drug regulatory pathways, optimization of regulatory science models, and complex statistical analysis methodologies and clinical trial designs.
The IPA Mobility Program provides for the temporary assignment of personnel between the federal government and state and local governments, colleges and universities, Indian tribal governments, federally funded research and development centers, and other eligible organizations. The program is a critical tool that allows federal agencies to access academicians or clinical experts on a part-time basis to bolster existing or new initiatives.
Harrell previously served as an advisor to the FDA CDER Office of Biostatistics from 2016 to 2020 and has been a long-time consultant to the FDA. "I am excited to serve in this important role at the request of the CDER director as part of my VUMC appointment, and look forward to contributing to making clinical trials more efficient and flexible, as well as to fostering development of statistical methods to analyze new types of patient outcomes in therapeutic clinical trials. My last two years of working with my Vanderbilt biostatistics and VICTR colleagues on the design and analysis of many high-profile Vanderbilt-led COVID-19 clinical trials has given me experience and ideas that I plan to put into use at FDA."
Celebrating our first VBSIUU cohort
Left to right: Leena Choi, Akshat Vasisht, Mary Guirguis, Rajala Bean
On Friday, July 1, the Vanderbilt Biostatistics Summer Internship for Underrepresented Undergraduates program celebrated the conclusion of its inaugural season with presentations by its participants. The above photograph (by department chair Yu Shyr) shows them in front of scientific posters about the research they performed. Mary Guirguis and Akshat Vasisht investigated "Reproducibility and Quality Control for Combination Drug Screening" in collaboration with PhD student Elisa Yazdani and faculty mentor Amir Asiaee. Rajala Bean focused on "SEPSIGN: early identification of SEPsis SIGNs in emergency department" in collaboration with faculty mentor Chris Lindsell and biostatistician Cassie Hennessy.
In addition to conducting research and attending classes on statistics and computing, the interns received professional development training from staff and faculty on topics such as writing CVs, resumes, and personal statements; creating statistical reports, posters, and oral presentations; and preparing for interviews. The program also featured lunches with department members. It was headed by Leena Choi, professor of biostatistics and vice chair of diversity and inclusion.
Bean expects to receive her bachelor's degree in health sciences in Spring 2023; in addition to her school and work commitments, she is active with Love You Like a Sister, Alpha Kappa Alpha, ThriftSmart (a Nashville store whose proceeds benefit African Leadership, the Belize Project, Mercy Community Healthcare, and New Hope Academy), and Nashville General Hospital's Food Tote Delivery program. Guirguis is a computer science student at Middle Tennessee State University; her experiences include working as a pharmacy technician at Polaris, programming a virtual reality horror project during MTSU's hackathon, and volunteering for Second Harvest. Vasisht, from Brentwood High School, is an aspiring software engineer, an American Red Cross ambassador, and a teen board member and volunteer with the John P. Holt Brentwood Library.
The internship information page will be updated when the application period for the 2023 program is about to open.
Vanderbilt Biostatistics Bulletin - May 2022 issue
The May 2022 issue of our department newsletter is now available. We have upcoming events, incoming faculty, and recent honors to celebrate!
May 16 Symposium on Implementation Research in the Learning Health System
Here are new and updated details about the upcoming Vanderbilt Symposium on Implementation Research in the Learning Health System.
The planning committee includes professor Chris Lindsell and research assistant professor Cheryl L. Gatto.
Symposium registration: https://redcap.link/IRLHSregistration2022
Abstract submission for poster reception: https://redcap.link/IRLHSpostersubmission2022
Project proposal submission for workshop: https://redcap.link/IRLHSworkshopsubmission2022
Yu Shyr inducted into AACR Academy
AACR Fellows, class of 2022. Yu Shyr is third from left in the front row.
May 16 Implementation Research Symposium
Note: this blog post has been superseded by the April 19 update about symposium opportunities.
***
Vanderbilt Center for Clinical Quality and Implementation Research and the Vanderbilt CTSA/VICTR Learning Healthcare System are co-sponsoring an in-person symposium on May 16. More details are forthcoming. The planning committee includes professor Chris Lindsell and research assistant professor Cheryl L. Gatto, and there will be a poster session (submissions welcome through April 25; see the symposium webpage for guidelines).
Health & Wellness
Spring has arrived in the Northern Hemisphere. To quote the poet Tennyson, "In the Spring a livelier iris changes on the burnish'd dove." (The state flower of Tennessee is the iris.)
Spring is also a great time to set new self-care goals. The Department of Biostatistics has a long-standing relationship with Vanderbilt's Health & Wellness initiative. Senior associate Dan Byrne helped create the award-winning Go for the Gold program in 2003, and with biostatistician Ryan Moore provides support for "The Healthy Pulse," a feature that appears on the back page of each issue of Connection, which is mailed to all Vanderbilt employees.
Spotlight on Samuel Nwosu and Jubilee Tan
Lead biostatistician Samuel Nwosu was featured in the March 17 issue of the ACTIV-6 Site Newsletter, and application developer Jubilee Tan in the March 4 edition. The interviews are republished here with permission of the Duke Clinical Research Institute.
Data Coordinating Center Spotlights
Samuel Nwosu
What is your role on ACTIV-6?
Provide assistance with data management, create trial summary reports, perform data validations, and help with implementing the trial's interim analyses.
What activities or hobbies do you enjoy outside of work?
I enjoy spending time with my family, a good jog, and the occasional adventurous/extreme activity.
Why do you think ACTIV-6 is important?
This trial is at the forefront to help mitigate the spread of COVID-19 and provide a pathway to ending this global pandemic.
What drives and motivates you about working on the ACTIV-6 study?
Knowing that the work I do is part of a bigger community to assist in the fight against COVID-19. Hopefully my effort within the ACTIV-6 study will help everyone get back to some sense of normalcy
Jubilee Tan
What is your role on ACTIV-6?
I maintain and upgrade automated information systems among four roles: participants, pharmacy, the call center, and biometric analysts.
What activities or hobbies do you enjoy outside of work?
When I get off work, I usually spend time with family, watch movies, and fix some issues in open source community.
Why do you think ACTIV-6 is important?
Since COVID changed our lives two years ago, many families may have faced a very big change, not only the loss of life, but also social distancing and economic shock. This project is an opportunity to turn things around so that people can go back to life before the pandemic.
What drives and motivates you about working on the ACTIV-6 study?
This project is about helping people fight COVID, and I feel very motivated every time I think about this work that could lead to an earlier end to the pandemic.
Vanderbilt Biostatistics Bulletin - February 2022 issue
The February 2022 issue of our department newsletter is now available. We are excited about our recent accomplishments and upcoming events.
Note: the application deadline for the Vanderbilt Biostatistics Summer Internship for Underrepresented Undergraduates has been extended to March 14, and the due date for useR! abstracts is now March 15.
Spotlight on Chris Lindsell
Professor Chris Lindsell, who leads the ACTIV-6 Data Coordinating Center, was featured in the February 11 issue of the ACTIV-6 Site Newsletter, which is published twice a month by Duke Clinical Research Institute. The interview is republished here with permission.
What is your role on ACTIV-6? I am privileged to lead the Data Coordinating Center. Our team has developed an innovative way of running studies by using the research record like the medical record. The data we collect includes a mix of the information we need to find out what medicines help patients feel better faster, and all of the data needed for real time study information sharing and communications. The partnership with DCRI has allowed us to create a fully integrated system that will continue to get better as we learn from this new way of doing studies.
What activities or hobbies do you enjoy outside of work? I used to play rugby, but then I blew out my knees. Then I used to sail, but there isn’t much water in Nashville. I took up gardening but my brown thumb left me with little hope. For a while, I was a craft beer brewer and home vintner, which also had bad side effects. Pandemic isolation gave me a whole new lease on life and I got to teach myself the guitar while smoking bacon, chicken, salmon, turkey, brisket, cheese, bread, and even vegetables. This year I plan to master the art of pastry (or patience, or both).
Why do you think ACTIV-6 is important? If there is a safe medicine already available that could help people feel better faster from Covid-19, I want to know that, I think that’s important.
What drives and motivates you about working on the ACTIV-6 study? The challenge of finding a way to do research in totally different ways and solving the problem of what medicines help people feel better faster drives me. The passion, dedication, and excellence of the teams that are leading this research motivate me.
