CTSA PROGRAM UPDATE

April 14, 2017

2017 SPRING CTSA PROGRAM MEETING – APRIL 18TH AT OMNI SHOREHAM

UNCOVERING GRAND OPPORTUNITIES IN TRANSLATIONAL SCIENCE 

OVERVIEW

Thank you to all who have registered for the meeting! If you have not yet registered, there will be on-site registration starting at 7:30 AM. CTSACentral.org now has our full day’s agenda. The meeting will start promptly at 8:00 AM. We encourage you to come early and join us for morning refreshments. Please bring your laptops, if possible, for full participation in the breakout groups.

PURPOSE

The purpose of this meeting is to bring together thought leaders in translational science who can discuss approaches to catalyze grand opportunities in translational science where the CTSA Program can have substantial impact. The CTSA Program Meeting Planning Committee has designed this meeting to go beyond the traditional model of talks and questions to one that emphasizes idea generation and collaboration amongst all attendees

GRAND OPPORTUNITIES

Grand opportunities focus on specific gaps in current knowledge, illuminate the key issues that underlie a problem, suggest potential approaches to attack that problem, inspire creative solutions that may have profound scientific and ultimately practical implications, and hint at some promise of the final results.

Our CTSA Program community has identified four grand opportunities in translational science that are timely and relevant to our CTSA Program:

1. How can we best demonstrate the impact of our CTSA Program?
2. What innovations are necessary and timely to advance clinical and translational science?
3. What are some novel strategies to enhance recruitment in clinical trials?
4. How can we better disseminate local innovations / programs / best practices to the entire CTSA Program consortium?

Each of these four opportunities will be the area of focus for one breakout group. Each breakout group host a few short presentations followed by ample time for round-table discussions. All breakout groups will be repeated twice to allow all attendees to participate in discussing two different grand opportunities.

AGENDA, IN BRIEF

 MORNING PRESENTATIONS

The meeting will start with welcoming remarks from Dr. Petra Kaufmann and Dr. Kathleen Brady. We will then hear several presentations from members within the NCATS Division of Clinical Innovation and Office of Rare Diseases, followed by a 30-minute discussion period.

To complete the morning, our keynote presentation will feature Dr. Eric Dishman, Director of the All of Us Research Program. Dr. Dishman will give a 35-minute speech, followed by 1-2 thought-provoking questions for our CTSA Program community. We will take approximately 10-minutes to reflect on his speech and questions, and then re-convene together for a stimulating discussion period.

BREAKOUT GROUPS AND ASSIGNMENTS

Titles for each breakout group are presented in the questions above. Each group was uniquely developed by several CTSA Program leaders and NCATS Program Directors to target their specific grand opportunity. Their names and contact information will be available for your reference on April 18^th. All four breakout groups will be repeated twice from 12:45 – 2:00 PM and from 2:15 – 3:30 PM.

Those of you who responded with your breakout preferences have been placed in your 1^st and 2^nd choices. For those who did not respond, you have been assigned to a breakout group based on an algorithm designed to bring together individuals from different backgrounds and CTSA Program hubs.

All attendees will have the groups they will be participating in written on your badges. If you wish to change the group you have been assigned to, please see the Registration Desk on April 18^th.

REPORT OUTS AND DISCUSSION

The last 10-15 minutes of each breakout session will be dedicated to aggregating the different strategies that participants have identified to address the group’s grand opportunity. The NCATS Program Director(s) in each group will lead this effort with the help of 1 or more facilitators from C4 to ensure consistency and allow attendees who were unable to participate in their groups to have a clear idea of what was discussed. At 3:45 PM, NCATS Program Director(s) will have approximately 10 minutes each to report-out their group’s key ideas to the entire plenary session.

The meeting will conclude with an open discussion about grand opportunities and each group’s key ideas with CTSA Program Steering Committee members: Petra Kaufmann, Kathleen Brady, Ebony Boulware, Donald Lloyd-Jones, Tim Murphy, Jim Holmes, and Susan Smyth. All of these members were part of the CTSA Program Meeting Planning Committee, and have been influential in the review and selection of grand opportunities as well as in the planning and implementation of the breakout groups.

SOCIAL MEDIA

 TWITTER

Our twitter handle is #CTSAProgram. We will be posting limited content from our presentations and key ideas from our panel discussions from our NCATS twitter account (@NCATS_NIH_GOV). We encourage everyone at the meeting as well as those who couldn’t attend in person to post/interact with us via #CTSAProgram.

VIDEO TESTIMONIALS

Have a story to tell? We want to hear it! Specifically, we want to hear: “What does the CTSA Program mean for you, your patients, and your community?” Please visit the Hampton Room anytime during the day to share your story with us. If you are unable to visit in person but would like to contribute, you can email Amit Chaudhari a short clip (*.mpg, 4 minutes max). Selected stories may be edited, combined and/or modified in other ways to be featured online.

LINKEDIN

We have two showcase pages on LinkedIn related to the CTSA Program – (1) NCATS CTSA Program and (2) CTSA Program KL2 Scholars. Please FOLLOW US on both pages to get regular updates about our program and to support our scholars!

NOTE: We will be setting up groups on LinkedIn for collaboration amongst our CTSA Program community right after the meeting. Notes, slides, discussions, and pictures from our meeting will be posted there. Please consider joining these groups by clicking ASK TO JOIN – (1) NCATS CTSA Program PIs (limited membership), (2) NCATS CTSA Program Community, and (3) NCATS CTSA Program KL2 Scholars.

THANK YOU

 THANK YOU to the numerous individuals who helped plan our Spring 2017 CTSA Program Meeting!  We hope to see you all on April 18^th at Omni Shoreham for an exciting and interactive meeting about grand opportunities in translational science.

Questions?  Contact Amit Chaudhari.

FUNDING OPPORTUNITY

ADMINISTRATIVE SUPPLEMENTS TO CTSA PROGRAM HUBS TO DEVELOP BEST PRACTICES FOR SIRB IMPLEMENTATION (FY17)

The Clinical and Translational Science Awards (CTSA) Program involves multi-site clinical research and may not be currently using a single Institutional Review Board (sIRB).

The National Institutes of Health Office of the Director (NIH OD) is responsible for the allocation of funds, which are appropriated annually, to support bioethics, research, training, and translation. To this end, FY2017 funds have been allocated to support approximately 10-11 administrative supplements (~300K/award) for infrastructure development at CTSA Program hub institutions expected to follow the “NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research” (NOT-OD-16-094  and NOT-OD-17-027). The NIH sIRB policy will apply to applications and proposals submitted on or after September 25, 2017 and the Common Rule requirement for the use of sIRBs for cooperative research is anticipated to be effective on January 20, 2020.

NCATS is therefore soliciting requests from CTSA Program hub institutions with current NIH-funded award(s) for one year of supplemental support to cover direct costs for the development of costing models, business processes, system changes, and efficient procedures and tools needed to facilitate sIRB review for multi-site research. In addition to being within the scope of the award, administrative supplement requests will need to describe plans to:

• Continue the proposed activities after the period of supplemental support, and
• Share any information, methods, resources, or products developed using these funds widely and without charge to other institutions, via publications, presentations, and workshops.

Awardees that submit requests that, in combination, cover multiple recognized sIRB infrastructural needs with supplemental requests from other institutions may be considered more favorably in funding decisions. All requests must include a detailed description of the proposed activities. The following is a list of examples of activities that could be proposed to assist institutions in implementing sIRB review:

• Development and/or testing of infrastructure/technologies for computer tracking of human subjects protocols, secure records retention, electronic protocol submission, adverse events across multiple research sites for sIRB use.
• Development of methods for confidential and secure data storage and sharing systems for all stages of research across multiple research sites for sIRB review and use.
• Strategies to coordinate sIRB approval of consent forms and other activities used at relying sites in multi-site clinical research.
• Optimization of systems for coordinating across research sites conducting multi-site clinical research for sIRB review.
• Development of tools for strengthening continuing sIRB reviews for multi-site research.

A meeting of grantees who receive supplemental funding will be held in the Washington D.C. area approximately one year after receiving an award, at which time recipients will share successful strategies, modalities, and processes for sIRB review. Funds should be budgeted for travel by PI(s) and/or other relevant individual(s) with significant day-to-day involvement in the activities performed under the administrative supplement request. Institutions should use their expanded authorities to extend the funds in order to charge meeting travel costs. At the conclusion of the meeting, participants will develop a final report to be posted on the NIH website, which describes promising and widely applicable approaches for modifying and enhancing institutional IRB infrastructure to allow for efficient and effective sIRB review of multi-site studies.

Budgets should not exceed $300,000, but need to reflect the actual needs of the proposed project. As stated above, F&A costs will not be covered. All program-related expenses must be justified as specifically required by the proposed activities and must not duplicate items generally available from other sources at the applicant or collaborating institutions.

Submission information:  Requests must be submitted on or before COB local time June 2, 2017.  Applicants are instructed to cite PA-16-287 Administrative Supplements to Existing NIH Grants and Contracts when submitting their proposal.  It is recommended for applicants to discuss proposed projects with their NCATS/DCI Program Director prior to submission.

Questions? Contact via email Philip J. Brooks, Ph.D. or by phone (301) 443-0513.

NCATS + ELI LILLY EXTERNSHIP OPPORTUNITY

ROUND 2 ANNOUNCEMENT

This is an opportunity for an externship in clinical and translational sciences at Eli Lilly and Company for scholars, trainees and investigators who are supported by the National Center for Advancing Translational Sciences (NCATS) – Clinical and Translational Science Award (CTSA) Program. The externship at Eli Lilly, a large pharmaceutical company, will support the training and education of participants in techniques and principles needed for translational research. Education and training will be team oriented, and in areas of mutual interest for the trainee/scholar and Eli Lilly. Scientific, theoretical and practical knowledge will include an appreciation of translational and commercialization challenges in developing and bringing a biotechnology or pharmaceutical product to patients.

This externship opportunity is open to CTSA Program trainees, scholars or investigators supported by CTSA Program hub award funds.

For more information, please visit the NCATS website.

Questions?  Contact Joan Nagel.

ANNOUNCEMENTS

ALL OF US RESEARCH PROGRAM (PRECISION MEDICINE INITIATIVE)

The All of Us Research Program Data and Research Center (DRC) is working to prospectively design a research platform that allows the broad research community to use All of Us Research Program data in a secure environment. In an effort to begin exploring design needs for this researcher space, DRC is soliciting input from the research community. Participate in this information gathering exercise here.

Questions? Contact Celecia Scott.

NIH NCATS: Improving Health Through Smarter Science

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