ICTR. The ICTR Studio. A new initiative for moving research ideas forward. The Johns Hopkins Institute for Clinical and Translational Research

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1 The Johns Hopkins Institute for Clinical and Translational Research The ICTR Studio A new initiative for moving research ideas forward Carol Kobrin, PhD ICTR Research Studio Director Manager Navigator Supported Services July 14, 2014

2 Background 1. The Research Studio is based on the idea of a Master Class A Master Class offers advanced instruction, taught by an expert in a particular discipline 2. The Studio setting, highlights the collaborative and creative aspects of a Master Class

3 What is the ICTR Studio? The Studio is a place to go for help with higher level questions about preclinical or clinical research projects: Am I asking the right scientific questions to achieve the greatest impact in the field? Is my research program designed to answer these questions? Are the proper resources and tools being used to efficiently gather and manage data?

4 What is the ICTR Studio? How is the traditional Studio concept applied to ICTR Studio? 1. The Studio is a multidisciplinary service center that brings investigators together with the experts and resources needed to address their questions Experts are identified from throughout the Johns Hopkins medical research community, but external consultants are included when needed 2. Studios are disease agnostic but customized for each protocol or project 3. Studios are one stop shops where experts across diverse disciplines all meet together with the investigator in a single setting to provide coordinated assistance 4. The Studio is an ongoing process that continues to work with the investigator and help make any necessary adjustments to keep the project on schedule.

5 How does the Studio Work? 1. Initial contact with Carol Kobrin or a Navigator to request a Studio Consultation Specific questions or needs are discussed 2. Carol Kobrin, the Navigators and Charlie Flexner (ICTR Studio Deputy Director) all work with the investigator to identify the appropriate consultants for the Studio The Navigators contact all consultants, confirm their interest and availability, and conduct all follow-up communication to ensure they have all the information that they need to participate Generally speaking consultants are invited 3. Depending on the investigator s and the consultants availabilities, Studios can generally be scheduled within 3 weeks of being requested Studios are minutes in length

6 How does the Studio Work? 4. Interim preparation for the Studio is required by both the investigator and consultant Studios are modeled after FDA meetings with sponsors, which require participants come ready to work with minimal meeting time devoted to background presentations. The Navigators work with Investigators to prepare a Briefing Package containing all pertinent background information and have it ready for distribution to the consultants no later than 1 week before the Studio. Consultants must have the time to develop a working knowledge of the information in the Briefing Package. 5. Other Navigator preparations for the Studio: Assist with addressing any IP issues that may arise (i.e. confidentiality disclosures, etc.) Arrange for Conference Room to accommodate the number of participants Arrange for Audio recording of the Studio proceedings

7 How does the Studio Work? 5. Other Navigator preparations for the Studio (contd.): Arrange for Teleconferencing ability (only if needed) Order light refreshments for participants Assist participants from outside of Hopkins or the East Baltimore questions with logistical issues (i.e. directions, parking, etc.) Coordinate all communications between investigator and consultants, prior to the Studio 6. During the Studio, the Navigator: Ensures that all disclosures are made (i.e. audio and/or video recording, data confidentiality reminders, etc.) Distributes copies of the Briefing Package for ready reference Tracks time to assure all the investigator s questions are answered

8 How does the Studio Work? 7. After the Studio, the Navigator: Forwards all Audio /Video Files to the investigator, which are not further distributed without their explicit permission Distributes evaluations to consultants and investigators to assess Studio Performance Maintains contact with the investigator to determine if any additional effort is required by the Navigators or the Studio to address unanticipated problems which may arise during the course of the project.

9 How can the Studio be Used? Application Writing a more competitive grant application Available Studio Support Increase overall impact by assisting with : 1. Identifying the most relevant scientific questions which should be asked 2. Identifying the most appropriate resources and/or tools which should be used for generating, collecting, managing and analyzing data 3. Improved presentation and grantsmanship skills

10 How can the Studio be Used? Application Designing a translational research program around a promising laboratory observation Available Studio Support Comprehensive consideration of preclinical and clinical factors by assisting with : 1. Establishing whether or not there is a clinical need 2. Addressing Intellectual Property Issues and potential for commercialization 3. Proactively thinking about satisfying institutional and external regulatory requirements to avoid lengthy delays in product development

11 How can the Studio be Used? Application Creating preclinical or clinical protocols Available Studio Support Increase the overall impact as well as the ability to quickly and efficiently complete the study by assisting with : 1. Identifying the most relevant scientific questions which should be asked 2. Determining that the data being collected is answering these questions or achieving the purpose of the study 3. Identifying the most appropriate resources and/or tools which should be used for generating, collecting, managing and analyzing data 4. Establishing whether or not the study complies with all applicable institutional and external regulatory requirements

12 Closing Remarks Benefits of the Studio Feedback is systematic and immediate Brings together groups of experts from diverse fields throughout the Johns Hopkins translational research community Valuable time is saved when multiple meetings are no longer necessary for the investigator with each individual consultant Helps translational researchers conceptualize research that is innovative yet feasible, and then supports the study to maximize its impact

13 More Information about the Studio 1. Please see our website: -services/the-studio/ 2. Contact Carol Kobrin at: ICTR Navigators at : ICTR_Navigators@jhmi.edu.