Research Inklings October 2013
1 2 Research INKlings October 2013 RESEARCH INKLINGS Research in Your Backyard OCTOBER 2013 Clinical Trials at MUSC making a difference In this Issue: P2 P3 P3 P4 P4 P5 P5 P6 P6 P7 P7 The Medical University of South Carolina (MUSC) announced key findings from a new report called “Research in Your Backyard.” This report from the Pharmaceutical Research and Manufacturers of America (PhRMA) focuses on clinical trials being conducted by biopharmaceutical research companies and local research collaborators throughout South Carolina. Continued on page 2 P8 P8 Research in Your Backyard FRD Recruits Executive Director Technology Transfer-Patents University Research Council Announced Advances in Technology Transfer Research Operations Coordination of Key Areas SPARC Request EPIC & SPARC Request Interface iLab Implementation NIH to Require eRA Commons for Students SCTR Scientific Retreat NIH Instructions for New Applications Research INKlings is an on-line newsletter prepared by the Office of Research Development providing research news, policy changes and other relevant information for MUSC faculty, staff and students. Research Town Hall The Associate Provost for Research, Dr. Stephen Lanier, and Associate Provost for Clinical & Translational Science, Dr. Kathleen Brady, presented “Updates on the Research Enterprise” at the Research Town Hall held on September 19, 2013. During the Town Hall, Dr. Lanier provided an update on research funding, research operations and the SmartState Centers of Economic Excellence program. He also announced the restructuring of the University Research Council to focus on strategic issues for the MUSC research program. The town hall video is available on the MUSC Research webpage or click here. Continued on page 4 2 1 Research INKlings October 2013 Research in Your Backyard: Economic Impact of Clinical Trials in South Carolina The report emphasizes that biopharmaceutical companies are a vital component to South Carolina’s economy and remain critical to patient health in the state. Cancer Center. Wayne Roper, SCBIO president, made the closing remarks. Congressman James Clyburn was a featured speaker at the conference, which took place inside the Drug Discovery Building of the James E. Clyburn Research Center. PhRMA Executive Vice President, Chip Davis served as host and facilitator for the Research in Your Backyard event. Of the aforementioned clinical trials, nearly 1,700 have targeted the nation’s six most debilitating chronic diseases: asthma, cancer, diabetes, heart disease, mental illnesses, and stroke. Nearly 300 clinical trials focusing on these six diseases are still actively recruiting patients, and all are helping to advance cutting-edge science and patient care in South Carolina. “Ending health disparities has been a priority of my service in Congress, and I am committed to From 1999 to present, South Carolina’s any effort that helps to reduce those disparities,” biopharmaceutical companies are conducting said Rep. Clyburn. “Today’s report will hopefully or have conducted more than 3,200 clinical trials raise awareness about the value of participating of new medicines in collaboration with the state’s in clinical trials so more patients across South clinical research centers, university medical Carolina may share in the benefits and the hope schools and hospitals, including MUSC. these trials can provide.” MUSC speakers included, Dr. Stephen Lanier, Associate Provost for Research, MUSC; Dr. Andrew S. Kraft, Hollings Cancer Center Director; Dr. Kathleen Brady, Director, South Carolina Clinical and Translational Research Institute (SCTR), Clinical Translational Science Award Principal Investigator; and Dr. Marvella E. Ford, Professor of Public Health Sciences, Hollings 2 For more information on clinical trials in South Carolina, please visit the South Carolina Research Studies Directory at SCresearch.org. Information provided by PhRMA 1 2 Research INKlings October 2013 Foundation for Research Development Recruits Executive Director The MUSC Foundation for Research Development (FRD) has recruited Michael Rusnak as their new Executive Director. Mr. Rusnak joins FRD with over 25 years of life science experience. Most recently, he served as the Director of New Ventures and Technology Development within the technology transfer office at the University of Rochester Medical Center. In his six-year tenure at Rochester, he led the office in life science licensing and directed the University’s Technology Development Fund and the award process. He also played a lead role in fund raising, including SBIRs and STTRs, for the Fund’s applicants, pre and post award. Mr. Rusnak established numerous collaborations to foster commercialization, further investments, and advance drug discovery including agreements with the Moulder Center for Drug Discovery Research at Temple University, the Medical Research Council in the United Kingdom, Califia Bio, Inc., and Johnson & Johnson. Previous to Rochester, he was an entrepreneur-inresidence with BCM Technologies, Inc., the venture subsidiary of Baylor College of Medicine where he was involved in starting and incubating more than five spinout companies from the medical school. Mr. Rusnak has held senior positions in biotechnology business development with Ceros Pharmaceuticals, CombiChem and Lexicon Genetics, among others, where he was involved in over $100 million of partnering activity in the areas of drug discovery, combinatorial chemistry, and genomics. Prior to Lexicon he held various positions in marketing, sales, and project management with Baxter, Bayer, and Cetus. Mr. Rusnak received his Master’s Degree in Clinical Science/Lab Management from San Francisco State University and has a B.S. in Microbiology from St. Bonaventure University. With his diverse background in technology transfer, Mr. Rusnak promises to be an excellent choice as the new Executive Director of the Foundation for Research Development. He joins the MUSC community on October 1, 2013 and his office will be located in the Harborview Tower, Suite 909. Technology Transfer - Patents A patent is a property right granted to an inventor by the Government. This right gives the inventor the opportunity to "exclude others from making, using or selling the invention" for a term of 20 years from the date of filing the application. Since July 1, 2013, the US Patent Office has issued three new patents to MUSC. The inventors include: US 8,506,499 - Predicting Atrial Fibrillation Recurrence by Protease and Protease Inhibitor Profiling Inventors: Francis Spinale, Rupak Mukherjee, Michael Gold US 8,489,186 - Devices and Methods for Treatment of Myocardial Conditions Inventors: Francis Spinale, Rupak Mukherjee US 8,507,219 - Use of Statins to Inhibit Inflammation Inventor: Inderjit Singh 3 1 2 3 Research INKlings October 2013 Research Town Hall University Research Council Announced The University Research Advisory Committee was initially organized in 1979 to review policies, practices and strategic aspects of the University research mission with the goal of facilitating continued growth in this sector. The committee was re-organized in 1989 under the Vice President for Research and was given its present name. This year, the Associate Provost for Research, the Associate Provost for Clinical and Translational Science and the Associate Deans of the Colleges worked together with the Strategic Planning group on Technology and Innovation (Chair – Chris Davies, Ph.D.) to restructure the committee and focus on strategic issues for the MUSC research program. Its membership is defined as the Associate Deans of Research, the Director of the Hollings Cancer Center, the Chief Research Informatics Officer, the Director of the South Carolina Clinical and The Standing Operations sub-committee will provide recommendations regarding the support and administration of research operations and serve as an additional forum for faculty input into the overall research environment of the University. Advances in Technology Transfer Dr. Kathleen Brady, Associate Provost for Clinical & Translational Sciences, provided an update on our Advances in Technology Transfer, Innovation and Entrepreneurship at the Research Town Hall. For detailed information regarding this update, please watch the video of the Town Hall meeting. Center for Innovation and Entrepreneurship • Business Plans • Start-up Formation • Funding Assistance • IP Licensing • Commercial Meetings • Education & Outreach 4 Translational Research Institute (Associate Provost for Clinical and Translational Science), two at-large members and the Chair of the Standing Operations Subcommittee. Foundation for Research Development • ROI • Patent Filing • CDA's • Non-confidential Summaries 1 2 Research INKlings October 2013 Research Operations iLab Solutions research core management system implemented to provide streamlined request management, billing and invoicing, scheduling and publication tracking via a single tool. The research management portal “SPARC Request”, developed by MUSC’s SC Clinical & Translational Research Institute in collaboration with the Biomedical Informatics Center, has been expanded to include all research services and resources across the MUSC enterprise. shRNA Shared Technology Resource and Genomics Shared Resource for Next Generation Sequencing Research administration workflow (an internal review of workflow in ORSP, ORI, and ORD; external review of research administration workflow across campus) Clinical Research Operations Coordination of Key Areas At the Research Town Hall, Dr. Stephen M. Lanier, Associate Provost for Research, discussed opportunities to work together to maximize efficiency and leverage these areas in the most effective ways. A few of these areas include: Biorepository Initiative, Clinical Trials, “Omics”, Bioengineering, Technology Development, Drug Discovery, Informatics, High Performance Computing, Research Space, and Research Core Facilities. Dr. Craig Crosson, Associate Dean for Research in the College of Medicine, provided an update on the Biorepository Initiative. As one of the first steps, a Faculty Needs Assessment was conducted with 189 responses. Of those 85% indicated that a functional Biorepository is extremely important for their research with linkage to clinical data. A strategic plan was developed to create a university-wide, state-of-the-art Tissue Biorepository network that advances research, clinical service, and education. A Clinical Trials Task Force was established to address how to streamline operations. Dr. Patrick Flume, professor and director of the Pulmonary Medicine division, is leading this effort. He identified the priorities and they include training, financial best practices, website navigation, clinical research space, subject remuneration, consistent leadership, Epic for research, and record storage. Dr. Rick Schnellmann, Associate Dean for Research, Professor and Chair of the Department of Pharmaceutical Sciences in the SC College of Pharmacy, discussed the Drug Discovery platform. The resource provides expertise for assay development, chemical libraries, and instrumentation for screening. Most recently, a strategic plan is considering our research foci strengths and new leadership to move this area forward. Research Town Hall Web-based workflow system to be put in place for IACUC and IBC, protocol tracking platform and reports now in place for IRM With faculty contributions, MUSC is moving forward with these key areas. 5 1 2 Research INKlings October 2013 SPARC Request: An Enterprise-wide Research Solution SPARC Request, developed by MUSC’s CTSA, the South Carolina Clinical & Translational Research Institute (SCTR) in collaboration with the Biomedical Informatics Center (BMIC), has been expanded to include all research services and resources across the MUSC enterprise, creating a MUSC “One Stop Shop” research management portal. The portal facilitates development of research proposals, marketing of MUSC’s robust research support services, and catalyzes collaborations with the community and other institutions. SPARC Request provides an electronic solution to locate, price, and request research services and resources. This enhanced support facilitates streamlined and accurate research proposal development, budgeting, implementation, and study conduct. SPARC Request also supports billing compliance and Medicare coverage analysis, sharing of study documents and communications between investigators and service providers, and tracking and invoicing of services provided for research studies. The latest version of SPARC Request contains many new features developed from feedback provided by our research community. SPARC Request has the capacity to interface with other MUSC systems to realize operational efficiencies. SPARC Request is a national “WIN” for MUSC, and a Record of Invention has been filed for this unique research management system. Multiple CTSA consortium institutions are adopting and implementing the system. To list your research services and resources and/or to schedule a presentation or demonstration of the SPARC Request system, please contact the SCTR SUCCESS Center at email@example.com. Announcing the Epic and SPARC Request Interface We are excited to announce that MUSC will be implementing research functionality in Epic July 1st, 2014. An interface has been built between SPARC Request and Epic to simplify and streamline the process of setting up research studies in Epic. Utilizing the user-friendly functionality in SPARC Request, study information will be pushed from SPARC Request to Epic to: create an Epic study record for associating patients to the study, create the Epic study calendar to manage study billing, and define Epic user rights to allow study staff access to Epic. The benefits of this interface include: reduction of duplicative data entry, consolidated user dashboard to manage all protocols & services, tools to support billing compliance, and enhanced patient safety. Prior to go-live (July 2014), SCTR will assist researchers in setting up their active studies in the SPARC Request and Epic Systems. This will be done with the use of a partially prefilled spreadsheet sent to investigators by the SPARC Request Team. If you receive a spreadsheet, please complete the required information and return it to Caleb Hund at firstname.lastname@example.org. This will ensure your study information is correctly entered into both systems. Epic will allow investigators to associate their study participants with a research study in the electronic record (a requirement for compliance with the False Claims Act) and will include investigational medications in the record for the benefit of other clinicians. This functionality increases patient safety, provider communication, and billing accuracy for research studies and third party payers. For more information and/or to schedule a presentation/demonstration of the Epic research functionality and SPARC Request system, and related interface, contact SCTR SUCCESS Center. 6 1 2 Research INKlings October 2013 iLab Implementation The Office of the Associate Provost for Research and the College of Medicine have begun implementation of the iLab Solutions Core Facility Management software, an online system to streamline the process of ordering and billing for core service requests. The initial roll-out involves five of our core facilities: § § § § § Cell & Molecular Imaging Flow Cytometry Lipidomics Mass Spectrometry Proteogenomics Additional cores facilities will be implemented over the next several months. On October 1st the integration between iLab and MUSC will go-live. This means all researchers will be required to provide a grant account (UDAK) number when requesting service(s) or reservation(s) from a core facility. (The iLab system will be populated with grant funds associated with a PI lab. If you are a member of a laboratory but do not have independent funding you will register under the PI whose grants support your work.) Below is information to assist you in registering in iLab so that you will be recognized in the system when you wish to use a core facility. Members of your laboratory who use core facilities are also able to make requests in iLab, but must be initially approved by you as a member of your lab. Therefore, you may receive email requests from your lab members wishing to be associated with your lab in the iLab system. The request email will have specific instructions on how to approve the request. In order to gain access to your funds, you will need to begin logging into iLab at the following web address: https://musc.ilabsolutions.com. iLab has integrated with MUSC’s Active Directory but a one-time registration is necessary to set up an account to place service requests. As a first-time user, log in with your NetID and password, select your PIs laboratory, and enter your phone numbers. Your Department Manager will receive an email with the request and approve you as a lab member and assign UDAK/Project numbers for you to use. A few tips: 1. You will be required to supply payment information on all reservations and/or requests when working with the core facilities. 2. If you do not have access to any payment information please contact your department financial manager to resolve this. 3. iLab works best in Firefox or Chrome browser. The URL is https://musc.ilabsolutions.com If you have any issues with the registration process or working with the core facilities via iLab please contact email@example.com. NIH to Require eRA Commons IDs for Graduate and Undergraduate Students NIH has issued a notice regarding a new requirement for all graduate and undergraduate students who participate in NIH-funded projects for at least one person month or more to obtain an eRA Commons user ID. Beginning October 18, 2013, the NIH PHS 2590 and RPPR forms will be modified to prompt for this information. The newly revised instructions and forms will be available on October 18, 2013 at NIH Forms & Applications. Beginning October 18, a warning will be generated when an RPPR is submitted that lists individuals in a graduate or undergraduate student role who have not established an eRA Commons ID. You may read the full notice here: NOT-OD-13-097. Please contact your assigned Grant Administrator in ORSP or call 792-3838 for assistance. 7 1 2 Research INKlings October 2013 SCTR Scientific Retreat The South Carolina Clinical & Translational Research Institute (SCTR) invites you to attend the 2013 Scientific Retreat on Comparative Effectiveness/Patient Centered Outcomes Research. Comparative effectiveness research is designed to inform health-care decisions by providing evidence on the effectiveness, benefits, and harms of different treatment options. The evidence is generated from research studies that compare drugs, medical devices, test surgeries, or ways to deliver health care. This scientific retreat will be held on October 29, 2013 in the Bioengineering Building Auditorium. Dr. Ann Bonham, Chief Scientific Officer, Association of American Medical Colleges, will provide the keynote address. For more information or to register, please contact Dr. Dayan Ranwala, SCTR Science Program Manager, at 843-7921498 or visit the SCTR website. Learn more about the PatientCentered Outcomes Research Institute NIH Issues New PHS 398 Forms and SF424 (R&R) Instructions Required for Applications Due on or after 9/25/2013 The National Institutes of Health has announced the availability of new application instructions and forms for paper-based PHS 398 applications and new Application Guide instructions for electronic SF424 (R&R) applications. The new application instructions and forms must be used for applications for due dates on or after September 25, 2013. All PHS 398 paper application submissions intended for due dates on or after September 25, 2013, must use the new 8/2012 version of the PHS 398 instructions and forms. As NIH announced in Notice NOT-OD-13-074 in May, applications using electronic forms will transition to new forms identified with a Competition ID of FORMS-C. Application instructions for FORMS-C are now available. Applicants must return to the FOA or the reissued Parent Announcement to download the new application forms for due dates on or after September 25, 2013. • Any application submitted using incorrect application forms (including applications that have an incorrect mix of old and new forms) may be delayed and may not be reviewed. • If you have already created an electronic application using the previous application forms (FORMS-B), you can use the ‘transform’ tool ( package (FORMS-C). • ) in Cayuse to update to the current form If you are unsure of which forms to use, please review the FOA or the Parent Announcement to confirm that you are using the correct version of the forms. Please contact your assigned Grant Administrator in ORSP or call 792-3838 for assistance.