CTSA PROGRAM UPDATE

June 9, 2017

CTSA PROGRAM PI WEBINAR

JUNE 28 PRESENTATION – ONE HEALTH:  A FAST-TRACK FOR TRANSLATIONAL SUCCESS

Tune in for the June 28 CTSA Program PI webinar (2:00 – 3:00 p.m. ET) to learn about the Clinical and Translational Science Awards (CTSA) One Health Alliance (COHA). CTSA Program PIs are encouraged to invite their hub’s physicians, biomedical scientists and other health professionals who would be interested to listen into this presentation.

One Health is a collaborative and interdisciplinary approach to optimizing health for humans, animals, and the environment. The Clinical and Translational Science Awards (CTSA) One Health Alliance (COHA) is a national network of the 12 veterinary schools affiliated with CTSA Program hubs. COHA leverages the expertise of veterinarians, physicians, research scientists and other professionals to advance our understanding of diseases shared by humans and animals, such as cancer, heart disease, arthritis and obesity. Conducting clinical trials in these natural animal models provides an innovative and effective approach for accelerating translational research that can ultimately benefit both humans and animals.

COHA has focused its efforts in four areas: Clinical Studies, Biorepository, Clinician-Scholar Education and Communication/Collaboration. Initiatives include optimizing translational veterinary clinical trials by refining standard operating procedures and data connectivity across the alliance. COHA pilot grants have funded a biorepository registry workshop, a translational research summit on calcium uroliths, multiple One Health sessions at national medical meetings, and a series of educational videos.

COHA’s “One Health in-a-Minute” videos showcase the synergy between the veterinary and other scientific communities. Find out more about the many opportunities for studying common diseases that naturally affect veterinary patients as models for human disease, as well as other ways that transdisciplinary teams can be a fast track to translational success.

Learn more about COHA through these One Health in-a-Minute videos:

• What is One Health?
• Chronic Pain in Companion Animals: Biological Parallels Between Companion Animal and Human Pain Disease
• Hypertrophic Cardiomyopathy: Collaborating for a Cure – Gene-Nutrient Interactions in Heart Disease
• Knights Landing One Health Clinic: A collaborative preventative and clinical health clinic addressing human and animal health in an under-served community in California

To view these videos, learn about COHA events and find out more about the 12 COHA institutions, visit https://ctsaonehealthalliance.org/.

Questions?  Contact Deborah Kochevar.

COMMON METRICS

ACTION REQUIRED: CHANGE IN NUMBER OF SCORECARD LICENSES PER HUB

During the initial implementation period, the Common Metrics Initiative paid for up to 10 Scorecard system user licenses per hub. However, very few hubs used more than three licenses.

Beginning August 1, 2017, Tufts will cover the cost of three licenses per CTSA Program hub.  Scorecard administrators should contact Ram Mahalingam and provide the name and email address of the three team members who should have the licenses, no later than Friday, June 30, 2017.

Hubs can purchase additional licenses directly from software vendor Clear Impact^TM, at a discounted price of $20/user/month. To purchase licenses, contact Michael Adrian.

Questions? Contact Samantha Jonson.

ANNOUNCEMENTS

NCATS Day – Partnering with Patients for Smarter Science

NCATS will be holding the inaugural NCATS Day on June 30, 2017 from 9:00 a.m. – 4:15 p.m. ET at the John Edward Porter Neuroscience Research Center (Building 35A) at the National Institutes of Health in Bethesda, Maryland. The purpose of the event is to inform patients and their advocates about NCATS, including its philosophy and programmatic approaches; identify patient needs; and collectively discuss ways for improved patient inclusion in NCATS’ translational science activities.

The full-day event will feature presentations, interactive activities and a poster session to provide more details about NCATS programs and initiatives. Designed for patients, families, caregivers and patient advocacy groups, the event will foster an open dialogue among patients and their advocates to discuss common translational science roadblocks, brainstorm ideas for improvement and apply that knowledge to strengthen patient and community engagement at NCATS.

Admission is free, but space is limited so be sure to register early!

Questions? Please visit the NCATS Day website.

SEEKING applicationS: Growing Gene and Cell Therapy (GGACT) Cooperative PROJECT SUPPORT

The goal of the Growing Gene and Cell Therapy (GGACT) cooperative is to support investigators to rapidly translate complex gene and cell therapies to early phase, investigator-initiated clinical trials.

GGACT has released a funding opportunity to provide support services in the areas listed below.

Support Services Available:

• IND-enabling pre-GMP process development guidance.
• Pre-GMP vector production and transduction manufacturing process and product development.
• Trial-supporting assay development/implementation.
• Regulatory pathway planning and assistance.
• Development of reliance agreements to allow rapid implementation of new protocols via a simplified IRB review process.
• Assistance in clinical trial protocol development, implementation and data management including packaging of data for potential licensing opportunities.
• Assistance in clinical trials compliance, monitoring and reporting.

A letter of intent is due July 14, 2017.  For more information and the full Request for Application, visit the Growing Gene and Cell Therapy website.

Questions? Contact Maria Suarez.

NIH NEWS

A COMPILATION OF NIH NEWS AND OPPORTUNITIES

• On June 8, the NIH launched the Next Generation Researchers Initiative (NGRI) to bolster support for early-stage and mid-career investigators to address longstanding challenges faced by researchers trying to embark upon and sustain independent research careers. For more information about the initiative, read the NIH Director’s Statement, visit the new NGRI webpage, or explore the references that informed this new initiative.
• The NIH, in collaboration with the FDA, and CMS announced the launch of a study by the National Academies of Sciences, Engineering, and Medicine that will convene a committee to review and evaluate the return of individual-specific research results from research laboratories, which are required to be returned in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA).  Find out more by checking out the NIH Office of Science Policy’s (OSP) blog post and the National Academies’ webpage on the study.
• The National Cancer Institutes’ Division of Cancer Control and Population Sciences Implementation Science Webinar Series will present “Campfire Chat on Developing Your Own Program of Research in Implementation Science – Lessons from Early-Career Investigators” on June 22 at 3 p.m. ET.  Register here!
• Review the current legislative mandates that limit the use of funds on NIH grants, cooperative agreements, and contract awards for FY 2017 in NIH Guide Notice NOT-OD-17-075.
• Find out more about additional changes to the NIH/AHRQ/NIOSH Policy on Post-Submission Materials in NIH Guide Notice NOT-OD-17-066.
• Find out more about the Authentication of Key Biological and/or Chemical Resources by checking out NIH Guide Notice NOT-OD-068, reading more about it in Mike Lauer’s blog post, and on Extramural Nexus.
• The NIH reminds recipients to submit complete, timely and accurate progress and financial reports. Check out NIH Guide Notice NOT-OD-17-074.
• The NIH will host a policy workshop on biosafety and emerging technologies.  The event will take place July 18-19, 2017, in Rockville, Maryland.  Learn more about the work workshop here.

NIH NCATS: Improving Health Through Smarter Science

Connect with us!: https://ncats.nih.gov/connect