November 2, 2009

IN THIS ISSUE…

EVENTS:
Webinar Series Hosted by CTSA Administration Key Function Committee
CTSA Pharmaceutical Assets Portal: Matching Academia and Industry for Drug Repositioning, December 4, 2009
Regional West Coast Consortium Meeting, November 16, 2009
CTSA Industry Forum, February 17–18, 2010
2010 Clinical and Translational Research and Education Meeting, April 5–7, 2010
Science of Team Science Conference, April 22–23, 2010
Improving Children's Health Through Community-Engaged Research Workshop, April 23, 2010
2010 National Predoctoral Clinical Research Training Program Meeting, May 3–4, 2010
Society for Clinical Trials Annual Meeting, May 16–19, 2010
Save the Date—The 3rd Annual Clinical Research Management Workshop June 21–22, 2010

NEWS AND ANNOUNCEMENTS:
NIH Clinical Center Launches Leadership Sabbatical in Clinical Research Management
Call for Proposals—Comparative Effectiveness Research in Health Care
ResearchToolkit.org Provides One-stop Web Resource for Health Researchers
Indiana CTSI Innovation to Translation—Fast Track Symposium Summary
ResearchMatch Web Portal Recruitment Tool Launched
NCRR Announces New CTSA Fact Sheet
Recent Media Coverage

FUNDING OPPORTUNITIES:
NEW—National Institute of Drug Abuse (NIDA) Funding Opportunity Announcements
NIH Funding Opportunity Announcement, Recovery Act Limited Competition: Building Sustainable Community-Linked Infrastructure to Enable Health Science Research (RC4)
NIH SBIR STTR Omnibus Solicitation Released

FEATURES:
Scripps Translational Science Institute Works Toward Individualized Medicine: One Nucleotide, One Sensor at a Time
Committee Paves the Way for More Productive Public–Private Partnerships

ARTICLES:
Consortium Steering Committee Meeting Outlines Next Steps
University of Wisconsin-Madison Hosts First Workshop for CTSA Veterinary Clinical Research

GENERAL INFORMATION:
Consortium Committee Meeting Calendar
Updated Information on CTSAweb.org

EVENTS:

Webinar Series Hosted by CTSA Administration Key Function Committee

The Pilot Projects Best Practices Workgroup, part of the Administration Key Function Committee, encourages CTSA institutions with pilot funding programs to share strategies, tools, outcomes, and lessons learned. This working group is hosting a Webinar series, featuring specific examples from several CTSAs, on topics of interest across the CTSAs.

Please save the date for the following webinars to be conducted from 12:00 p.m.–1:00 p.m. (ET):

• November 4, 2009—Pilot Project Management Models—including an overview of their pilot funding program, project selection process, the management model utilized during the funding period, key benefits for investigators, and outcomes to date.
• January 13, 2010—Post-Funding Translational Progress—including topics such as strategies for follow-on funding, monitoring translational progress post-funding, and types of post-funding support provided to investigators.
• March 3, 2010—Financial Concerns and Solutions Regarding Pilot Program Management—including specific challenges and solutions from several CTSAs.

For more information, contact Lynn Sutton.

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CTSA Pharmaceutical Assets Portal: Matching Academia and Industry for Drug Repositioning

Join your colleagues for a half-day conference that will bring together leaders in the pharmaceutical industry, government, and research to explore current drug repositioning efforts in Bethesda Md., December 4, 2009, from 9:00 a.m. to noon.

Drug repositioning, or finding new uses for drugs originally designed for another purpose, has become more important recently as many pharmaceutical companies are seeing their drug pipelines dry up. With the high cost of drug research and development, drug repositioning offers a way to explore these previously shelved assets. The Clinical and Translational Science Award (CTSA) Pharmaceutical Assets Portal is a tool that aims to match researchers’ scientific knowledge of targets and diseases with the repositioning needs of the pharmaceutical industry to potentially increase the number of approved drugs for alternative uses.  

For more information and to register, visit the meeting Web site. This event will be videocast by the NIH.

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Regional West Coast Consortium Meeting

The next CTSA West Coast Consortium regional meeting will be held Monday, November 16, 2009, at the Prospector Square Lodge & Conference Center in Park City, Utah. 

For more information or to register for the meeting, visit the University of Utah Center for Clinical and Translational Science Web site or contact Lynette Holman, University of Utah Center for Clinical and Translational Science.

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CTSA Industry Forum

The CTSA Public–Private Partnership Key Function Committee will organize a CTSA Industry Forum to take place on February 17–18, 2010, in the Natcher Conference Center in Bethesda, Md. The purpose of the Forum is to explore current practices and successful management models to promote efficient and effective collaboration with CTSA organizations. The goal is to streamline the development of new drugs, devices, and diagnostics to improve the public health of the nation.

For more information, contact Lili Portilla, NCRR.

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2010 Clinical and Translational Research and Education Meeting

To enhance and promote the best practices in research and education of clinical and translational research, the CTSA Education and Career Development consortium has collaborated with the Association for Clinical Research Training (ACRT) and the Society for Clinical and Translational Science (SCTS) to develop a national conference for scholars and leaders in research and education. The scholars program will take place in Washington, DC, on April 6–7, 2010, and the ACRT/SCTS joint meeting will be held on April 5–7, 2010.

For more information and to register, visit the Association for Clinical Research Training Web site.

NEWS AND ANNOUNCEMENTS:

NIH Clinical Center Launches Leadership Sabbatical in Clinical Research Management

The NIH Clinical Center has launched a Leadership Sabbatical in Clinical Research to provide clinical researchers an opportunity to gain additional knowledge and to develop their managerial and leadership skills by exposing them to the foundational elements required to manage a clinical research enterprise. It is expected that the experience will provide critical information for managing a clinical research program. With six core modules, the program targets physicians and allied health professionals, healthcare management and administrative professionals, extramural NIH staff overseeing clinical trials, and intramural NIH investigators.

More information

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Call for Proposals—Comparative Effectiveness Research in Health Care

Academic Medicine is seeking articles for a special issue examining the implications of comparative effectiveness research (CER) for academic health centers (AHCs) and how the academic medicine community should be contributing to CER.

Of interest are articles that (1) examine strategies for incorporating knowledge derived from CER into all levels of clinical practice and medical education in AHCs; (2) report key strategies to further develop the CER knowledge base to assist patients, providers and policymakers in making data-based decisions; and (3) analyze relevant policy issues that must be considered in developing and using the CER knowledge base and the implications of these issues for medical schools and teaching hospitals.

Proposals (not to exceed 300 words) and complete contact information should be submitted by January 31, 2010 to guest editor Harold Alan Pincus, M.D., here.

More information

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ResearchToolkit.org Provides One-stop Web Resource for Health Researchers

The University of Washington’s Institute of Translational Health Sciences (ITHS)—in partnership with Group Health Research Institute, Wayne State University, and Duke University—has developed a new Web site to help researchers create and sustain successful multisite research collaborations. The project team created the site, ResearchToolkit.org, to enhance the efficiency of research from start to finish, including developing research networks, launching and managing projects, and sharing study results or other products such as data sets, tools, and training resources. The “toolkit” on the Web site spans the entire lifecycle of a research project, allowing visitors to find everything from a link to regulatory training, to authorship guidelines, to templates for consent forms.

ResearchToolkit.org was developed as part of a project known as PRIMER, or Partnership-driven Resources to IMprove and Enhance Research. PRIMER was awarded to the ITHS at the University of Washington by the NCRR.

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Indiana CTSI Innovation to Translation—Fast Track Symposium Summary

Last August, Indiana Clinical and Translational Sciences Institute (CTSI) at Purdue University hosted a symposium for application of the Institute’s infrastructure for accelerating clinical and translational research to the food and nutrition industry problems. Featured were the infrastructure and processes for speedy translation of discoveries, including project development teams, pilot grants, research cores, toxicology screenings, formulations, and cGMP manufacturing that Purdue and the Indiana CTSI has developed. The goal of the program was to explore ways in which the CTSI infrastructure can address barriers to reaching the marketplace. Attendees included 24 corporate affiliates, food and nutrition industries, US Food and Drug Administration, and European Union representatives. All entry fees are used to support partnered pilot grants.

More information

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ResearchMatch Web Portal Recruitment Tool Launched

ResearchMatch is an electronic volunteer recruitment registry designed to allow individuals from anywhere in the country an opportunity to securely self-register and express an interest in being prospectively considered for participation in research studies, including clinical trials. This disease-neutral, Web-based recruitment tool complements existing successful participant recruitment strategies employed throughout the CTSA. ResearchMatch is an effort involving the majority of the CTSA Consortium.

For more information, contact info@researchmatch.org.

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NCRR Announces New CTSA Fact Sheet

A new, updated CTSA Fact Sheet describing the CTSA program and consortium is now available at CTSAweb.org.

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Recent Media Coverage

Read CTSA institutional and consortium news and media coverage at the CTSAs in the News page on CTSAweb.org.

Funding Opportunities:

NEW—National Institute of Drug Abuse (NIDA) Funding Opportunity Announcements

RFA-HG-09-014—Comparing Design Approaches for Sequencing Disease-Associated Regions Found in Genome-Wide Association Studies (U01)

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NIH Funding Opportunity Announcement, Recovery Act Limited Competition: Building Sustainable Community-Linked Infrastructure to Enable Health Science Research (RC4)

A new American Recovery and Reinvestment Act-funded opportunity aimed at supporting the development, expansion, or reconfiguration of infrastructures needed to facilitate collaboration between academic health centers and community-based organizations for health science research was issued on Friday, September 18, 2009. In this community research infrastructure program, NIH establishes the role of Community Research Associate (CRA), who will be a community representative and serve as a primary liaison facilitating communication and collaboration between the academic health center and the local community. Applicants must identify at least one CRA.

Full announcement

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NIH SBIR STTR Omnibus Solicitation Released

For CTSAs interested in forming or collaborating with a small business to do biomedical research, the NIH, Centers for Disease Control and Prevention, Food and Drug Administration, and Administration for Children and Families 2009-2 Omnibus Solicitation of the SBIR/STTR Grant Applications and SF 424 (R&R) Application Guide for SBIR/STTR Grant Applications are now available. The solicitation consists of:

• Parent funding opportunity announcement (FOA) for SBIR
• Parent FOA for STTR
• Narrative descriptions of the programs and research topics (PDF)

The due dates for CY 2009 are April 5, August 5, and December 5. AIDS and AIDS-related applications are due May 7, 2009, September 7, 2009, and January 7, 2010.

More information

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FEATURES:

Scripps Translational Science Institute Works Toward Individualized Medicine: One Nucleotide, One Sensor at a Time The genetic information that makes us unique also contributes to our health. Scripps Translational Science Institute (STSI) is striving to translate the latest advances in genomics into the clinical setting. The Genome in the Clinical Setting: An Individualized Medicine Springboard Scripps Health, one of the major participants in STSI, was the first site to implement systematic genotyping for patients undergoing coronary stenting to evaluate genotype impact on platelet function and clinical outcome. Patients are now routinely evaluated for genetic mutations that may correlate with clinical response to the anti-clotting drug clopidogrel treatment. Recognizing these mutations will help guide potential changes in dosage or drug for individual patients. Good Health and Preventive Medicine Instead of focusing solely on disease, STSI focuses on disease prevention over a lifetime, or “healthspan.” For its Wellderly study, STSI has collected DNA from more than 750 healthy elderly people (aged 80 years and older) who have no history of chronic illness or need for medications. By genotyping and sequencing these remarkable individuals, precise mechanisms that promote healthspan may be identified. Another preventive medicine project, the Scripps Genomic Health Initiative (a joint venture between Scripps Health, Navigenics, Affymetrix and Microsoft) aims to determine whether personal genomic testing can improve health by motivating people to make positive lifestyle changes (e.g., improving exercise and nutrition or avoiding substance use or abuse) or to seek medical evaluation for potential illness. Nearly 5,000 participants have now received a genome-wide scan of more than 1 million markers, with a comprehensive analysis of their individual genetic predispositions for health conditions and a description of steps to prevent, delay, detect, or diagnose such conditions in their early stages. STSI is also providing participants with extensive ancestry information based on genomic markers. Ultimately, follow-up assessments will evaluate the psychological outcomes of individualized genetic knowledge. Wireless Medicine: The Next Frontier Although pills and bandages that sense your health and send a message to your doctor may sound like an idea from a science fiction movie, biosensors exist now but have not yet been validated for clinical use. An outgrowth of STSI, the West Wireless Health Institute (a partnership between Scripps Health, the Gary and Mary West Foundation, and Qualcomm) was established to develop and implement noninvasive wireless sensors that allow for remote real-time monitoring of physiologic metrics (e.g., vital signs, blood glucose). The effort represents an opportunity to combine biologic data from genomic and physiologic data via wireless sensors. Grooming the Next Generation STSI is committed to supporting up-and-coming scientists. In conjunction with the Kellogg School at The Scripps Research Institute, STSI offers a master’s degree in clinical investigation and a graduate course in translational research for Scripps Health physicians-in-training and predoctoral scientists interested in pursuing careers in molecular medicine. Innovative research is also supported via pilot/methodological study awards. To date, STSI has funded 15 projects in the fields of autism, cancer, cardiology, and osteoporosis, to name just a few. Data generated from these pilot projects have been used in subsequent NIH proposals. Committee Paves the Way for More Productive Public-Private Partnerships The Public-Private Partnerships Key Function Committee (PPP KFC) seeks to streamline the development of new drugs, devices, and diagnostics to improve the public health of the nation. The group will host a CTSA Industry Forum on February 17–18, 2010, at NIH’s Natcher Conference Center in Bethesda, Md., to explore current practices and successful management models for promoting efficient and effective collaboration with CTSA organizations. To ensure key stakeholder views are represented at the meeting, the planning team has engaged leaders from pharmaceutical companies, biotechnology firms, the venture capital community, and private foundations for input that will inform the agenda. A recent planning meeting involving industry and CTSA representatives concluded that the “big picture” discussion should identify the large initiatives and barriers that industry, academia, foundations, and government should address. The forum also provides an opportunity to identify resources that these sectors can share, such as curricula on drug development, toxicology and safety, translational and clinical research training, and entrepreneurial development of staff. Participants in the planning meeting hoped the forum could be the first step toward a formal mechanism for ongoing collaboration across sectors, particularly between industry and academia. CTSA Portal Project Seeks to Marry Pharmaceutical Companies and Academic Resources About 14,000 pharmaceutical compounds have reached Phase II and III clinical trials, but the Food and Drug Administration has approved only about 2,800 compounds over the past 60 years. The rest are referred to as “shelved assets.” The PPP KFC’s Pharmaceutical Assets Portal Project, funded by an NCRR supplemental grant, offers a pathway for academic researchers to access the thousands of drugs with an established clinical safety profile for translational research. As a result, it’s likely that more drugs would be approved for new indications. Because the information about shelved assets is not directly available, the portal establishes a way to obtain this information using two indirect routes. First, portal participants could identify a drug of interest for their particular research and apply to participating pharmaceutical companies for more information. Second, the portal would cluster the CTSA researchers according to their interests in particular targets or diseases so that they could form project teams and match their expertise with companies’ drug candidates for repositioning. The portal has already led to a successful match between Pfizer and the NIH Chemical Genomic Center. On December 4, NCRR, the National Cancer Institute (NCI), and the NIH Clinical Center will host a Drug Repositioning Symposium with representatives from CTSAs, industry, and NIH discussing the CTSA portal and various drug repositioning initiatives across the NIH campus. Expanding Partnership Opportunities The PPP KFC aims to educate CTSA sites about possible funding opportunities through the NIH’s Small Business Innovative Research (SBIR) program that can help meet public–private partnership goals. NCI is hosting an SBIR forum in the New York City area, and nearby CTSA sites are invited to participate. The Biotechnology Industry Organization (BIO) invited the PPP KFC to plan a panel discussion for the Translational Research Forum of the BIO International Conference in Chicago, May 3–6, 2010.

ARTICLES:

GENERAL INFORMATION:

Consortium Committee Meeting Calendar

November 2009

Monday	Tuesday	Wednesday	Thursday	Friday
2 CTSA Consortium Meeting CTSA Consortium Child Health Oversight Committee 11:30 a.m.–1:00 p.m. Democracy I, Room 803 NIH coordinators Steven Hirschfeld Mary Purucker	3 CTSA Consortium Meeting Enhancing Consortium-Wide Collaborations 11:00 a.m.–12:00 p.m. NIH coordinator Elaine Collier CTSA Consortium Meeting Administration—Grants Management 1:00 p.m.–2:00 p.m. NIH coordinators Elaine Collier Iris Obrams Sylvia Parsons CTSA Consortium Meeting Administration Key Function Committee 3:00 p.m.–4:00 p.m. NIH coordinators Elaine Collier Iris Obrams Sylvia Parsons CTSA Consortium Meeting Evaluation—Definitions 4:30 p.m.–5:30 p.m.	4 CTSA Consortium Meeting Administration—Pilot Projects Best Practices 12:00 p.m.–1:00 p.m. NIH coordinator Sylvia Parsons CTSA Consortium Meeting Informatics—Human Studies Database 1:00 p.m.–2:00 p.m. CTSA Consortium Meeting Communications— Operations Group 3:00 p.m.–4:00 p.m.	5 CTSA Consortium Meeting Enhancing Consortium-Wide Collaborations 11:00 a.m.–12:00 p.m. NIH coordinator Elaine Collier	6 CTSA Consortium Meeting Informatics—Directors and Group Leads 1:00 p.m.–2:00 p.m.
9 CTSA Consortium Meeting Clinical Research Management—Contracts 2:00 p.m.–3:00 p.m. NIH coordinator Lili Portilla CTSA Consortium Meeting Clinical Research Management—IRB 2:00 p.m.–3:00 p.m. NIH coordinators Daniel Rosenblum Donna Jo McCloskey	10 CTSA Consortium Meeting CTSA Consortium Executive Committee 1:00 p.m.–2:00 p.m. NIH coordinators Anthony Hayward Iris Obrams	11 CTSA Consortium Meeting Community Engagement— Outcomes of Community Engagement 11:00 a.m.–12:00 p.m. CTSA Consortium Meeting Informatics—Human Studies Database 1:00 p.m.–2:00 p.m.	12 CTSA Consortium Meeting Evaluation—Shared Resources 3:30 p.m.–4:30 p.m. CTSA Consortium Meeting Evaluation—Shared Resources 3:30 p.m.–4:30 p.m.	13 CTSA Consortium Meeting Community Engagement— Operations Group 11:00 a.m.–12:00 p.m. CTSA Consortium Meeting Clinical Research Management Group 3:00 p.m.–4:00 p.m. NIH coordinators Fred Ognibene Daniel Rosenblum CTSA Consortium Meeting CTSA Consortium Child Health Oversight Committee—Pediatric Drugs and Devices 4:00 p.m.–5:00 p.m. NIH coordinator Mary Purucker CTSA Consortium Meeting Enhancing Consortium-Wide Collaborations 4:00 p.m.–5:00 p.m. NIH coordinator Elaine Collier
16 CTSA Consortium Meeting Enhancing the Health of Our Communities and the Nation—4A Community Engaged Research Workgroup 11:00 a.m.–12:00 p.m. CTSA Consortium Meeting T1 Translational Research 3:00 p.m.–4:30 p.m. NIH coordinators Doug Sheeley Lili Portilla Renee Joskow Susan Old CTSA Consortium Meeting Enhancing the Health of Our Communities and the Nation—4B Comparative Effectiveness Workgroup 4:00 p.m.–5:00 p.m. NIH coordinators Anthony Hayward Jody Sachs	17 CTSA Consortium Meeting CTSA Consortium Steering Committee 1:00 p.m.–2:00 p.m. NIH coordinators Anthony Hayward Iris Obrams CTSA Consortium Meeting Public-Private Partnerships—Aggregating Intellectual Property and Resources 3:00 p.m.–4:30 p.m.	18 CTSA Consortium Workshop Methodologies to Set Priorities for Child Health Clinical Research 8:00 a.m.–5:00 p.m. Natcher Auditorium NIH coordinators Steven Hirschfeld Mary Purucker CTSA Consortium Meeting Community Engagement—Outcomes of Community Engagement 11:00 a.m.– 12:00 p.m. CTSA Consortium Meeting National Clinical and Translational Research Capability 12:00 p.m.–1:00 p.m. NIH coordinators Daniel Rosenblum Renee Joskow CTSA Consortium Meeting Informatics—Human Studies Database 1:00 p.m.–2:00 p.m. CTSA Consortium Meeting Public-Private Partnerships—Agreements 3:00 p.m.–4:30 p.m.	19 CTSA Consortium Workshop Methodologies to Set Priorities for Child Health Clinical Research 8:00 a.m.–5:00 p.m. Natcher Auditorium NIH coordinators Steven Hirschfeld Mary Purucker CTSA Consortium Meeting SGC 1 Champions of Change—Metrics, Analysis, and Mapping Subgroup 12:00 p.m.–1:00 p.m. NIH coordinator Donna Jo McCloskey CTSA Consortium Meeting Regulatory Knowledge—Clinical Trial/Study Registration Tracking 1:00 p.m.–2:00 p.m. CTSA Consortium Meeting Evaluation—Social Network Analysis 3:00 p.m.–4:00 p.m.	20 CTSA Consortium Meeting Community Engagement Key Function Committee 12:00 p.m.–1:00 p.m. Democracy I, Room 1037 NIH coordinator Donna Jo McCloskey CTSA Consortium Meeting Enhancing Consortium-Wide Collaborations 3:00 p.m.–4:00 p.m. NIH coordinator Elaine Collier
23 CTSA Consortium Meeting Enhancing the Health of Our Communities and the Nation 11:00 a.m.–12:00 p.m. NIH coordinator Donna Jo McCloskey CTSA Consortium Meeting Clinical Research Management—Contracts 2:00 p.m.–3:00 p.m. NIH coordinator Lili Portilla CTSA Consortium Meeting CTSA Consortium Child Health Oversight Committee—Pediatric Research Ethics 2:00 p.m.–3:00 p.m. NIH coordinator Mary Purucker CTSA Consortium Meeting Communications— Media/Public Relations 3:00 p.m.–4:00 p.m. CTSA Consortium Meeting Public-Private Partnerships Key Function Committee 3:00 p.m.–4:30 p.m. NIH coordinators Lili Portilla Gregory Evans CTSA Consortium Meeting CTSA Consortium Child Health Oversight Committee—Rare Diseases 4:30 p.m.–5:30 p.m. NIH coordinator Mary Purucker	24 CTSA Consortium Meeting CTSA Consortium Executive Committee 1:00 p.m.–2:00 p.m. NIH coordinators Anthony Hayward Iris Obrams CTSA Consortium Meeting Biostatistics/ Epidemiology/Research Design - Evaluation 4:00 p.m.–5:00 p.m.	25 CTSA Consortium Meeting Informatics—Data Repositories 1:00 p.m.–2:00 p.m. CTSA Consortium Meeting Informatics—Human Studies Database 1:00 p.m.–2:00 p.m. CTSA Consortium Meeting Informatics—Human Studies Database 1:00 p.m.–2:00 p.m. CTSA Consortium Meeting Training & Career Development of Clinical/Translational Scientists 3:00 p.m.–4:00 p.m. NIH coordinator Carol Merchant	26	27 CTSA Consortium Meeting Informatics—Operations Group 12:00 p.m.–1:00 p.m. CTSA Consortium Meeting Regulatory Knowledge Group 2:00 p.m.–3:00 p.m. NIH coordinator Jody Sachs
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*Please note that the meetings and events listed in this newsletter are provided for your information. If you wish to participate, please contact the NIH coordinator.

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Updated Information on CTSAweb.org

The CTSAweb.org home page, in keeping with the Web site’s role of ensuring access to CTSA resources, enhancing communication, and encouraging sharing, features:

• Streamlined navigation menus organized around specific audience needs.
• Links to updated strategic goal committee (SGC) and key function committee (KFC) “landing” pages.
• New regional consortia pages.
• Highlight boxes for consortium strategic goals, featured institutions, and consortium news.
• A refocused communication toolkit tailored to the needs of consortium members, which includes a CTSA slide set, logo, and banner.
• A new CTSA Fact Sheet describing the CTSA program and consortium.
• A new media resource page for reporters and editors and more.

The CTSA Web systems help desk e-mail is help@CTSAweb.org. Please contact the help desk if you have questions regarding the CTSA systems, including CTSA Wiki and password questions.

Read archived CTSA e-Newsletters on the CTSAweb.org CTSAs in the News page.

We hope you find this newsletter helpful and informative. If you have any questions or comments, or to unsubscribe, please contact Kameha Kidd, Division of Clinical Research Resources, NCRR.