Upcoming CCTS Events
Setting the stage for attendees, he noted “Drugs, new and old, are very much in the news—from the need for new-antivirals to stop the spread of Zika to pricing controversies and patent extensions. Drugs and their development is central to our medical culture and our delivery of health care, which is a key reason the CCTS supports ‘productive collisions’ that facilitate identification of new therapeutic targets.” Kimberly emphasized the importance of using “state of the art methodology” in drug development, as well as the need for effective project management skills. “To find truly effective and promising medications, researchers must first learn to ask the right questions and set up the right experiments to minimize what can be a long and difficult process.” He encouraged attendees to take advantage of the expertise offered at CCTS, “with its team of experts who are deeply committed to helping you ‘sharpen your science.’”
Attendees enjoyed a rich day of networking and collaboration with trainees and scientists from many different disciplines and institutions. Keynote presentations featured speakers experienced in all aspects of drug discovery, including Drs. George Painter and Dennis Liotta from Emory Institute for Drug Development, who described the “trials and tribulations” of getting the anti-HIV drug Emtricitabine from concept to market. Other speakers included Dr. Monica Guzman, Weill Medical College of Cornell University; Dr. Jennifer Wylie, Merck; Drs. Joanne Murphy-Ullrich and Ed Acosta, UAB; Dr. Peter Cook, UAMS; Dr. Darin Jones, University of Arkansas Little Rock; Dr. Shradda Thakkar, National Center for Toxicological Research, FDA; and Dr. Randall Moreadith, Serina Therapeutics. Alabama Drug Discovery Alliance Associate Director Dr. Maaike Everts served on the colloquium’s career panel.
In addition to presentations, the colloquium featured both an oral presentation and poster competition. Congratulations to the winners, who are listed below:
Posters (voted on by anyone in attendance):
- Andrew Janssen, UAB
- Cameron Crawford, UAB
- Ujwani Nukala, UAMS
Oral (judged by five senior scientists present):
- Jeffrey McDonald, UAB
- Bhavitavya Nijampatnam, UAB
- Tie: Amanda Debrot, UAB and Jyoti Sharma, UAMS
The CCTS, in partnership with the UAB Comprehensive Cancer Center and as part of the Alabama Drug Discovery Alliance (ADDA), announced the selection of two recipients for the 2016 Drug Discovery Research Award:
Markus Bredel, MD, PhD, professor, UAB Radiation Oncology
Project: Inhibiting PTBP1 to Reduce EGFR Signaling in Glioblastoma
Javier Campos-Gomez, PhD, infectious disease research biologist, Southern Research
Project: High Throughput Screening of Small Molecules Targeting Oxylipins Production by Pseudomonas aeruginosa as Novel Candidates for Anti-Virulence Therapy
Drs. Bredel and Campos-Gomez will each receive $50,000 per year for two years to fund their research on new therapeutic targets. Southern Research will cover the cost of the researchers’ high throughput screens at its facility as well as any medicinal chemistry needs.
The two winning proposals were among the 15 pre-proposals submitted in response to the annual ADDA RFA. Of these, six applicants were invited to submit full proposals. Five of the six engaged CCTS PDQ panels to help hone their applications, a process the applicants rated highly. The ADDA Advisory Board made the final decision, which was announced last week.
“Drug discovery projects are very different in execution than hypothesis-driven research, which is why the PDQ panels were so helpful to these PIs,” noted CCTS Drug Discovery & Device Development Associate Director Maaike Everts, PhD. “The CCTS was able to assemble experienced drug discovery experts to help the applicants ‘sharpen their science’ and make sure the research was addressing the right questions in the right order, with appropriate timelines.”
Eligibility for the 2016 ADDA award was for scientists affiliated with UAB or Southern Research. Efforts are underway to explore how partner institutions can work together with Southern Research to initiate similar research initiatives and high throughput screening campaigns for novel targets of interest.
This week marked the end of our 2016 Clinical and Translational Science Training Program (CTSTP). Over the past six months, the select group of 30 trainees received more than 50 hours of didactic instruction in research project development, ethics, clinical trials, epidemiology, biostatistics, and types of clinical research including health services, genomics/informatics, behavioral, and community-based participatory research.
Trainees also participated in numerous interactive experiences, including sessions on grant writing and a mock NIH study section review of a K23 grant application. Sessions that focused on team science and patient recruitment were also well-received.
Courses were presented by research staff and faculty from across the partner network. A highlight for many trainees was the opportunity to network with clinical and translational researchers from many disciplines and meet individuals with expertise in grants, contracts, and regulatory issues.
The 2016 course was our 8th CTSTP—GoTo access was available to trainees from across the partner network. Interested in attending our next CTSTP? Email your interest and/or questions to
More than 60 attendees learned what it takes to develop a successful NIH mentored patient-oriented research career development award (K23) application. A real-world grant that initially received an impact score of 39, then improved to an outstanding, fundable impact score of 13 after the applicant worked closely with her mentors and CCTS experts to submit a revised application, served as the focus of the review.
CCTS Training Academy Director Dr. David Chaplin provided an overview of an NIH study section’s goals and processes. He and the other panelists, including Drs. Karen Cropsey, associate professor, psychology and behavioral biology, and Gareth Dutton, associate professor, preventive medicine, then took turns acting as primary and secondary reviewers. Dr. Peter Smith, professor, cell developmental and integrative biology, served as the panel moderator and role played the chair of a review section.
Attendees learned about the different sections of a K23 grant and how they are scored, from initial impact score and individual criterion scores to the overall impact score given to career development awards. Panelists reviewed each section of the K23, explaining their mock scores for the candidate, career plan, research plan, mentors, and institutional environment sections. They stepped out of their roles to discuss with the audience several areas that can weaken a K23 grant: whether the number of subjects chosen is high enough to produce meaningful results and if it is clear the applicant had a firm foundation for a well-conceived power calculation; failure to thoroughly address human subjects protection; not providing a clear description of appropriate statistical analyses that will be performed; and assembling a mentor team that lacks sufficient expertise in the areas of training the applicant is seeking via the grant. By appropriately addressing these areas, K23 applicants "will greatly strengthen their grants." The panelists also described the need to address NIH’s new rigor, reproducibility, and transparency requirements, which apply to most K applications, including the 23, just as they do to R series applications.
After reviewing the initial application, the mock panel performed a similar review of the resubmission, noting areas of improvement and key steps taken by the applicant that helped significantly improve the score. As is the case for other grant mechanisms, they pointed out that all K award resubmissions are allowed an extra page and explained it should be used to highlight responses to reviewer concerns and to note any changes that may have occurred in the time between initial submission and resubmission (K award applicants are allowed up to 3 years to resubmit).
For the grant being reviewed, a pilot study (cosponsored by the CCTS) was conducted after the initial submission, producing new data that resulted in changes to the research plan, which were articulated in the extra page. The applicant had also taken advantage of the CCTS career development team, which strengthened several areas of the grant.
The panelists answered several questions after the mock review, including why the grant under review sought only four years of funding instead of five (the applicant had been awarded a K12 previously, which counted toward the five years of total K support allowed by the NIH); if IRB approval is required prior to submission (no, but it must be secured prior to the release of funding, as part of the “just-in-time” requirements in advance of award letters); how to strengthen the candidate section of an application (not impossible to do but takes time and may require new department letters, additional publications, and/or advancement along the career track); and how NIH program officers can help applicants (they can review an applicant’s grant aims prior to submission, helping to assure that the application focuses on a topic that is a priority for the funding agency, and can help interpret the summary statement afterwards).
In summary, Dr. Chaplin noted CCTS offers numerous services via its Research Commons to assist K award grant writers with research design, biostatistics, power calculation, rigor and transparency checks, the IRB process, and other grant-related stumbling blocks. He also pointed out that the application under review was one of many samples available via the CCTS Grant Library.
CCTS is grateful to its cohosts, the UAB Minority Health and Health Disparities Research Center and UAB Center for Outcomes and Effectiveness Research and Education. We also wish to thank Dr. Jessica Merlin, whose K23 application, "Development of a Behavioral Intervention for Chronic Pain in Individuals with HIV," served as the before and after model in the mock review. For those who missed this event, the video will be posted soon on the CCTS YouTube channel.
Over the course of eight weeks, trainees receive mentored research experience and attend seminars in study design, responsible conduct of research, team science, information finding and evaluation of literature, and statistics. Previous research experience is not required, but trainees are required to conduct a mentored research project and prepare a written abstract, poster, and presentation to summarize their findings. Trainees are also expected to devote full-time effort (40 hours a week) and receive a stipend.
Acceptance to the program is competitive and requires a cv, test scores (GRE, MCAT, or PCAT), official letter of academic good standing from a clinically relevant doctoral program, two letters of recommendation, and a personal statement. CCTS will announce the availability of the application for Summer Enrichment Program 2017 later this year via the CCTS Digest and its Training Grant Program webpage.
Clinical doctoral students from across the CCTS partner network, who will have completed their first year of training by summer 2017, are encouraged to apply. The eight-week program, which aims to meet a pressing national need for researchers trained to more rapidly move scientific discoveries into the clinical setting, is federally funded. As such, trainees must be U.S. citizens or permanent residents.
Congrats to this year’s Summer Enrichment Program cohort, including (l to r, back row) Christian Smith, Burkely Smith, Kevin Cofer, Chris Wren, and Alexandra Onyiego, (l to r, front row) Allie Khodadadi, Macie Enman, and Carrie Ellison. (Not pictured: Joann Hsu and Michelle Wang.)
