Innovative Strategies and Services (ISS) Component
The ISS Component supports the mission of CTSI-CN to enable clinical and translational research by providing consultancy, support, education, and advocacy for issues related to product development and innovation. Additionally, it offers state of the art genomics/proteomics services and specialized resources to clinical and translational researchers.
The ISS component provides advice for investigators and other personnel who are moving ideas and discoveries forward into products for commercialization. Discussion topics include product development and critical path planning, regulatory and commercialization strategy, IP consultation, and project review and assessment.
The component also provides investigators with unique opportunities to participate in translational research through using a number of resources such as the Point-Person-Project (PPP). The PPP is an effort of the Pediatric Oversight Committee of the national Clinical and Translational Science Award Consortium funded by NIH to bring together private and public sponsors of drug and device trials with academic investigators with common interests in conducting clinical trials. To date, the national PPP has been successful in advancing projects in a number of relevant pediatric fields and in facilitating the conduct of important pediatric studies.
The component provides financial support through rapid deployment of funding for product development to address critical gaps for high-tech/high-cost services (genomics, proteomics, HTS, imaging) and for specific needs in product development programs. These funds are accessed through an RFA mechanism.
In conjunction with the Sheikh Zayed Institute for Pediatric Surgical Innovation, the ISS Component provides education and training focused on topics related to product development and innovation. The flagship education program is The Innovation and Product Development Certificate Program that focuses on the skills, knowledge, and insight needed to successfully participate in the innovation process and culture. The program consists of four workshops, each beginning with a panel discussion and ending with questions and answers from the audience and is offered once a year. Other workshops are offered on topics of interest on an ad-hoc basis.
Our CTSI-CN partner organization, the George Washington University, in collaboration with the National Science Foundation, University of Maryland and Virginia Tech, has introduced the DC-iCorps for investigators and entrepreneurs who are moving ideas from the lab to the market place. The program is designed to give researchers the Lean Startup skills and tools to advance down the commercialization path. The program is a combination of in person lectures/meetings held at GW, WebEx sessions and customer development interviews. The ISS component encourages researchers to participate in this program and takes a strong interest in those that do.
The component serves as a resource for product development and innovation advocacy, policy and ethics. CTSI-CN provides national leadership in these fields and the Component supports these efforts. Priority areas include product development for children including rare and orphan diseases, anticipatory medicine and personalized medicine, and safety of drugs and devices. An example of our advocacy work is the Symposium on Best Practices in Clinical Study Design for Rare Diseases held on April 29 and 30 of 2013. The two-day event featured roundtable discussions and presentations by leading experts in the field, including John McKew from the NIH/NCATS, Mark McClellan from the Brookings Institute, and Gayatri Rao from the FDA. Topics included statistical and study design challenges for rare diseases, the use of biomarkers in rare diseases, sustainability of rare disease product development and infrastructure for rare disease product development.
Genomics/Proteomics capabilities, as part of the ISS Component, is designed to support rigorous CTR investigations and training by:
- Providing state-of-the-art emerging technologies for clinical and translational research
- Offering specialized resources from design through analysis for large or small projects
- Moving high-value novel methodologies and discoveries from innovation to implementation
- Sequencing (whole exome, targeted, microbiome, RNA/miRNA)
- Illumina and Affymetrix Arrays (profiling, methylation, transcriptome, etc.)
- Mass Spectrometry (metabolomics, labeled proteomics, post-translational modifications), 2-D Gel
- Bioinformatics, Statistical Genetic Analysis
- SNP analysis, ELISA, NanoString, RT-PCR
- 3D printing, design, prototyping
- MRI, CT, US, and other modalities
- Development planning
- Funding sources
- Legal assistance
- Regulatory advice