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Translational Endeavors Core

 

Translational workforce development 

The overall objective of the Translational Workforce Development (TWD) module is to provide workforce members with a flexible and continuous learning environment that will lead to high quality, efficient, and effective CTR. In CTSI-CN v1.0, the workforce development portfolio was heavily targeted at the budding principal investigators through university graduate programs, the KL2 program, Pilot programs, and the METEOR program for under-represented minorities (described in the Overall Section). A mentoring support infrastructure and formal conferences provided both mentors and mentees with the tools and strategies to more effectively create an environment of professional development. In addition, a series of on-demand training programs and resources, designed for different members of the research team at varying levels of expertise, were made available through the Focus on Clinical and Translational Science (FACTS), a continuing education learning portal on the CTSI-CN website. In collaboration with the CTSI-CN v1.0 Evaluation Team, we determined that effective TWD requires not only a focus on content areas, but also targeted efforts to enhance team science and leadership aptitude within the translational workforce. Therefore, the major TWD initiatives in CTSI-CN v2.0 will focus on: 1) an expanded portfolio of on-demand training opportunities targeted at faculty and trainees, as well as staff and community members; 2) integrating a team science curriculum into our training and educational initiatives; and 3) focusing on team and leadership development within translational research teams. Given our network of multidisciplinary academic programs and our portfolio of on-line training platforms, the CTSI-CN v2.0 is well positioned to combine on-demand educational offerings with high quality consultative services that will bring together faculty expertise in translational research, team science, and leadership development to address needs within the CTSI-CN hub and the CTSA Network (see Vignette1,2). 

Aim 1:   Expand the portfolio of on-demand training tools, team development resources, and educational programs that address the knowledge, mentoring and practical needs of a broader and diverse translational
             workforce through innovative, collaborative multidisciplinary programming – EDUCATIONAL INITIATIVES. 

Aim 2:   Enhance and continuously improve the pipeline to recruit and retain qualified individuals from diverse backgrounds into translational research careers
             – PIPELINE DEVELOPMENT.

Aim 3:   Develop a Practitioner Certificate in CTR for Community-based health care providers and community stakeholders that further extends the collaborative engagement with our community partners
             – COMMUNITY ENGAGEMENT INITIATIVE.

Aim 4:   Establish a Center for Translational Science Leadership (CTSL) that provides team development and leadership consultations to new teams and their mentors for effective performance and outcomes
             – CTSA HUB INITIATIVE. 

Pilot Translational and Clinical Studies

The overarching goal of the Pilot Translational and Clinical Studies (PTC) module is to solicit, review, fund, and collaboratively facilitate the most promising nascent science from investigators at Children’s National, George Washington University, and their collaborators. This overarching goal is achieved by:

Soliciting and  supporting investigator-initiated and patient-centered proof-of-concept studies from Children’s National and GW faculty that will identify innovative approaches to diagnostics, prognostic marker development, and therapeutics;

Facilitating communication, collaboration, and effective utilization of available resources by investigators in partnership with the Open Studios forum; and

Providing faculty members new to clinical and translational research with interdisciplinary guidance, feedback, and mentoring through collaboration with the Grants Enhancement Program.

A major concern for the biomedical research enterprise is that discoveries in the laboratory move too slowly toward applications in the clinic and community. This translational gap is partially due to 1) insufficient early clinical feasibility testing; 2) inadequate development of novel methodologies and technologies; and 3) ineffective strategies to engage affected communities in discovery and implementation3,4. Without the support to develop methods, test concepts, or establish feasibility, the successful conduct of definitive evaluative research is virtually impossible. Thus, a program of “pilot study” funding is an essential underpinning of a strong CTR program. 

In the first two years of CTSI-CN v1.0, the Pilot Translational and Clinical Studies (PTC) Program was open to investigators at all stages of career development, without built-in mechanisms for mentoring early-stage
investigators. This met with limited success and return on investment (ROI). Thus, the program was completely reorganized in 2012 such that: 1) one cycle of PTC grants was offered annually (maximum of $50,000 per award), open only to early-stage investigators, and senior investigators “in transition to translation”; 2) the application process was two-staged, involving letters of intent (LOI), which were reviewed and triaged based on innovation/scientific merit to invite a subset of full applications; 3) a formal NIH-style study section was assembled to review applications with critiques provided to all applicants; and 4) all awardees were required to present their progress at 6-month intervals to the CTSI-CN Steering Committee and content experts. Prior to the reorganization, the ROI (measured as follow-on grant awards per pilot grant costs) was only 1.5 dollars of subsequent external funding per 1 dollar invested. Subsequently, the PTC ROI improved dramatically resulting in ROI of 3.9 over the v1.0 funding cycle. The program has resulted in 43 publications, 41 reports in preparation, and 33 external grant submissions (20 grants funded, 61%); and submission of 1 full patent.

Building on the successful CTSI-CN v1.0 PTC, CNHS/CRI obtained NIH/FDA support for additional pilot programs that will be awarded in collaboration with the CTSI-CN v2.0 PTC, with central coordination and expanded implementation. These new funds include a FDA-funded (2014) 5-year pediatric device pilot grant program (P50); Rare Diseases Clinical Research Center pilot program (U54, funded in 2014); and new pilots in orphan drug development funded by a $4M philanthropic gift to CNHS/CRI by the Clark Charitable Foundation in 2014 (see Optional Module #1, Orphan Products Accelerator-Innovations Incubator, OPA-II). These innovative additions, which will be administered by the PTC, will be available to CTSI-CN v2.0 investigators. Together, these combined pilot grant programs will increase the scope of research supported and the total annual funding available for pilot projects.

Aim 1:   Strengthen and expand the hypothesis-driven, investigator-initiated Discovery Research Pilot Program, emphasizing scientific rigor, the CTSI-CN v2.0 child-health CTR themes, and team science 
              – FOUNDATION FOR SCIENTIFIC DISCOVERY. 

Aim 2:   Establish a Translation-Acceleration Pilot (TAP) Program to fund studies focused on approaches to minimize barriers to translational research – REDUCING TRANSLATIONAL BARRIERS.

Aim 3:   Develop a Community-Based Research Pilot Program – COMMUNITY ENGAGEMENT INITIATIVE.

Aim 4:   Improve pilot program science and reach by providing support for grant development, rigorous peerreview and formal meetings of grantees – SCIENTIFIC SUPPORT.

More Information 

Please visit the Faculty and Staff Directory to find the faculty/staff member(s) responsible for these resources.