About the Program
The Translational Scholar Career Awards in Pharmacogenomics and Personalized Medicine (K23) address the NIH-wide goal of expanding the pool of well-trained individuals who will lead the implementation of personalized medicine. The highly selective program aims to cross-train leaders in both clinical research core competencies and modern methods required to conduct pharmacogenomics research in patient populations. The awards will train leaders to understand and integrate clinical practice, genetics and genomics, pharmacology and drug science, statistics and epidemiology and/or clinical trial design.
To facilitate cross-training in basic and clinical research in personalized medicine, the Translational Scholar Career Award program leverages the strengths of two large and successful NIH programs—the Clinical and Translational Science Award (CTSA) and the NIH Pharmacogenomics Research Network (PGRN). The Translational Scholar Career Award program is described in PA-11-009.
In addition to providing the foundation for the K23 program, a link between the CTSA program and the PGRN will also foster collaboration between basic researchers and clinically oriented ones, thereby propelling translational science.
Q. What are the CTSAs (Clinical and Translational Science Awards)?
A. The CTSA program supports a national consortium of medical research institutions that work together to enhance the efficiency and quality of clinical and translational research in the U.S. A major part of the CTSA mission is to educate, train and develop the careers of basic scientists and clinicians in order to accelerate the translation of research discoveries into current practice. See http://www.ncats.nih.gov/research/cts/ctsa/ctsa.html.
Q. What is the PGRN (NIH Pharmacogenomics Research Network)?
A. The NIH PGRN is a network of independent groups studying high-priority projects to identify and understand genomic predictors of drug responses. A major part of the mission of the PGRN is cutting-edge discovery research. See http://www.nigms.nih.gov/Research/FeaturedPrograms/PGRN.
Q. Are there special opportunities or features of this program?
A. Awardees will attend at least one CTSA trainee meeting and one PGRN open scientific meeting per year. They may also propose a rotation with the Food and Drug Administration Center for Drug Evaluation or a collaboration with industry.
Q. What are the immediate goals of the Translational Scholar Career Award program?
A. Within the next 5-6 years, this award program should begin to increase the number of successful, early stage investigators who are cross-trained in clinical and basic research approaches to personalized medicine.
Q. What will be the ultimate measures of success of the program?
A. The program will be evaluated based on the success of its awardees. Examples of successful awardees include individuals who:
- Take research and development positions in academia or industry.
- Lead pharmacogenomics-guided clinical trials in academia or industry.
- Contribute scientifically to the body of evidence leading to translation of pharmacogenomics and changes in clinical practice.
- Are selected as representatives on scientific advisory boards that make recommendations on drug usage, label changes or coverage decisions.
Applying for the Program
Q: What does an applicant need to do before applying for the Translational Scholar Career Award?
A. Each K23 award recipient must have two mentors—one from the CTSA program and one from the PGRN. Applicants should:
- Identify both a CTSA and a PGRN mentor from awards active at the time of application. Typically, the two mentors will be at the same location, but this is not required.
- Propose a way to ensure adequate project oversight and appropriate mentoring by both mentors.
- Obtain letters of support from the principal investigator of the CTSA award and from the principal investigator of the PGRN award. These letters should verify that the proposed mentors are members of and funded by the CTSA and PGRN awards, respectively. Affiliate members of the PGRN are not eligible to serve as mentors.
Q. What does the ideal candidate look like?
A. Applicants should indicate that they:
- Have a health professional doctoral degree or a clinically oriented research doctoral degree (e.g., M.D., D.O., D.D.S., D.M.D., O.D., D.C., Pharm.D., N.D. [Doctor of Naturopathy] or doctoral degree in nursing research or practice). Candidates with Ph.D. degrees are eligible if the degree is clinically oriented and they usually work as part of a team with clinical duties.
- Have a demonstrated interest in a translational career in pharmacogenomics.
- Propose a research project that is independent, builds on his/her prior training and experience, and takes advantage of the mentors’ skill sets.
- Propose individualized, didactic coursework and tailored, specialized training.
- Are in an environment that will prepare them to compete successfully for a tenure track or equivalent position in research translation by the conclusion of the career award.
Q. How can the career development funds be used?
A. Each awardee may use the funds to meet his or her own research needs. Allowable expenses include, but are not limited to: release time from clinical responsibilities; funds for travel or coursework; research project supplies; and partial support for a technician, project manager or statistician.
Q. What career stage is targeted with the K23 award?
A. The K23 is an early career stage award. The usual applicant would be an instructor or assistant professor level, pre-tenure, prior to receiving a first R01 or equivalent award. It is intended for an individual who is not yet completely independent and requires mentorship to develop into a researcher capable of earning research grant support. The announcement emphasizes cross-training, not career changing.
Q. What if an applicant is more advanced in his/her career position (e.g., associate professor level)?
A. In this situation, another K award program could be appropriate. Refer to the NIH K Kiosk for more information; see also the visual at http://grants.nih.gov/training/kawardhp.htm. There are also advanced F programs; see the Kirschstein NRSA for Individual Senior Fellows (F33, PA-11-114) at the NIH F Kiosk. Alternatively, the applicant may be ready to apply for an R01 or another independent research grant such as the R03, R21 or DP2 award.
Q. What if an applicant is more advanced in his/her experience (e.g., has some prior cross-training or a number of publications in the field)?
A. If an applicant has considerable research experience, including a significant publication record, he/she may be relatively advanced even if still a junior faculty member. Such individuals should consider requesting a shorter duration of support, as long as they still require a mentored experience in order to become completely cross-trained. Those with substantial preliminary data should consider applying directly for an independent grant mechanism.
Q. What is the ideal research project?
A. The research project must be patient-oriented. This is defined by NIH as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena), for which an investigator interacts directly with human subjects. It does not include basic research that has clinical implications.
Patient-oriented research projects can focus on topics like:
- mechanisms of human disease,
- therapeutic interventions,
- clinical trials, or
- the development of new technologies.
Studies falling under Exemption 4 for human subjects research are not included in this definition.
Q. Are multiple PIs allowed?
A. No. Multiple PIs are not allowed because this award is focused on an individual’s career development.
Q. Can an applicant who has another K award switch into this program?
A. No. The announcement states that principal investigators holding (or who have held) any of the following awards are not eligible: research project (R01); program project (P01); center grants (P50); FIRST Awards (R29);, subprojects of program projects (P01) or center grants (P50); and other K01, K07, K08, K22, K23 or K25 grants.
Q. What is the citizenship and residency status requirement?
A. An applicant has to be a U.S. citizen or a permanent resident (green card holder) at the time that the award is made. Individuals on temporary or student visas are not eligible.
Q. What amount of effort is required?
A. K23 awardees must spend a minimum of 9 person-months (75 percent of full-time professional effort) conducting health-related research. They may use the remaining time on clinical, teaching or other research pursuits and activities consistent with the objectives of the award.
Q. How will applications be assigned to the NIH institutes and how will they be reviewed?
A. Applications will be assigned to NIH institutes or centers based on established referral guidelines. They will be evaluated for scientific and technical merit by appropriate scientific review groups in accordance with NIH peer review procedures. Because the NIH institutes differ in their established practices, some applications could be reviewed by initial review groups (study sections) at NIH’s Center for Scientific Review, while others could be reviewed in individual NIH institutes by committees assembled by that institute’s scientific review office.
Overlap with K Awards and R Awards
Q. If an applicant has received an institutional career development award (KL2 or K12), is he or she eligible for the Translational Scholar Career Award in Pharmacogenomics and Personalized Medicine (K23) award?
A. Yes, but there are some caveats. Current and former recipients of KL2 or K12 support may apply for the K23 only if they have had no more than 3 years of KL2 or K12 support by the time the K23 is awarded. The combined total of KL2 (or K12) plus K23 support must not exceed 6 years.
Q. If an applicant has received an individual career development award (K01, K07, K08, K22, K23, K25 or equivalent grants) is he or she eligible for the Translational Scholar Career Award in Pharmacogenomics and Personalized Medicine (K23) award?
A. No. If an applicant has already received an individual career development award from NIH, he or she is not eligible for the Translational Scholar Career Award.
Q. What should an applicant anticipate if he or she wants to apply for an R01 grant?
A. Awardees of individual K23s may apply for R01 support at any time during their K award, and if the R01 is awarded, they can keep both the R and the K and decrease their percent effort to as low as 50 percent effort on the K, but only during the last 2 years of the K award; see NIH Guide Notice http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-08-065.html. The purpose of this policy is to prevent awardees from immediately applying for an R award successfully (which would imply they never needed the career development award).
We welcome inquiries about this funding opportunity. Contact information for each participating NIH component is listed below.
National Cancer Institute (NCI)
Susan Lim, Ph.D., Cancer Training Branch, Center for Cancer Training
National Institute on Drug Abuse (NIDA)
Joni Rutter, Ph.D., Division of Basic Neuroscience and Behavioral Research
National Institute of General Medical Sciences (NIGMS)
Rochelle M. Long, Ph.D., Division of Pharmacology, Physiology, and Biological Chemistry
National Institute of Nursing Research (NINR)
David Banks, Ph.D., Office of Extramural Programs
National Center for Advancing Translational Sciences (NCATS)
Heng Xie, M.D., M.P.H., Ph.D., Division of Clinical Innovation
Food and Drug Administration (FDA)--Center for Drug Evaluation and Research
Although the FDA is not formally participating in this initiative, K23 awardees are encouraged to engage in scientific exchange with the FDA. Awardees may participate with FDA by serving as visiting lecturers, engaging in voluntary exploratory data submissions (VXDS) of their research and meeting with regulatory scientists in various FDA offices including the Office of Clinical Pharmacology, Office of Translational Sciences and others. Rotations at the FDA allow K23 awardees to learn more about therapeutic product research and oversight. It might also be possible for K23 awardees to undertake special projects associated with the FDA.
Issam Zineh, Pharm.D., M.P.H., Office of Clinical Pharmacology