News and Updates
Cancer Consortium Pilot Funds Awarded (April 2010)
The FHCRC/UW Cancer Consortium has awarded $360,000 in Pilot Funds to Consortium investigators to support cancer-related pilot projects in calendar year 2010. Awards are for $40,000 in direct costs each.
2010 Awardees are:
Muneesh Tewari/ Jim Roberts (FHCRC): Telomerase-generated small RNAs in breast cancer
Corey Casper (FHCRC): Human Herpesvirus-8 Replication and HIV Progression in Uganda
Paul Nghiem (UW): A pharmacodynamic study of intratumoral injection of Interleukin-12 plasmid and in vivo electroporation in patients with Merkel Cell Carcinoma
Johanna Lampe (FHCRC): Metabolomics in Human Studies of Diet
Tobias Hohl (FHCRC): Visualizing Microbial Eradication During Pulmonary Infection
Eve Rodler (UW): Phase 1 Study of ABT-888 in Combination with Cisplatin and Vinorelbine for Patients with Advanced Triple Negative Breast Cancer
Savannah Partridge (UW): A novel lipophilic nanoparticle gadolinium contrast agent for lymphatic mapping and characterization by MRI
Nina Salama (FHCRC): Exploring the role of the bacterial microbiome in esophageal disease progression
Carla Grandori (FHCRC): Therapeutic Targets for Myc-Driven Cancers
The next round of CCSG Pilot Award RFA’s will be released in fall 2010 for projects beginning in January 2011. All members of the FHCRC/UW Cancer Consortium are eligible to apply.
Consortium Translational Research Infrastructure Updates (December 2009)
Clinical Trials Implementation
Recognizing the importance of an efficient clinical trial startup process to successful clinical research, the University has undertaken a major process improvement effort to reduce the time required to develop and implement industry sponsored clinical trials to an average of 90 days. Executive sponsorship for this project includes the Vice Provost for Research, the SOM Vice Dean for Research and Graduate Education, and the Executive Director of Health Sciences Administration. To date, the study startup process has been mapped to identify all components; offices responsible for each component of study startup met monthly over a nine-month period to identify bottlenecks and opportunities for improvement; and a list of recommendations was developed to improve operational efficiencies. Initial outcomes are the creation of an on-line, interactive clinical trials handbook expected to be launched in early 2010, and commitment of resources to hire a staff member who will continue to assist with implementation of the proposed recommendations. FHCRC and UW are in the process of applying for a Cancer Center Support Grant Supplement to provide additional funding to support implementation of the recommendations.
Clinical Informatics
Through a collaboration with Microsoft, the University’s Institute of Translational Health Sciences is piloting the Amalga software suite in the context of data integration and use of electronic medical record data (EMR) for research across both UW Medical Center and Harborview hospitals. Amalga is a secure, high-performance data aggregation platform that is developing integrated access to a broad array of clinical and ancillary healthcare systems at UW Medicine. This repository contains over 15 years of data exceeding 1TB of storage for over 3.5 million current and former patients of UWMC, Harborview Medical Center, and the seven UW Medicine Neighborhood Clinics. This effort represents a significant institutional commitment to building transformative information infrastructure to support clinical and translational research. Based on the successful use of the system for research over the past 18 months and the recognition of the importance of robust clinical information systems for research, UW Medicine is taking appropriate steps within the University and State procurement systems to pursue the purchase of Amalga.
Phase 1 Clinical Trials Program
FHCRC and UW have collaborated to establish a new and successful Phase I Clinical Trials Program, which has received major funding from WA state’s Life Sciences Discovery Fund. The program, directed by John Thompson (UW medical oncology), has established a skilled research and administrative team to provide support to investigators leading Phase I industry trials. Within the past year, has initiated 15 new Phase I trials of new therapeutic agents, 7 of which are open to patient accrual. The program has increased the Consortium’s visibility with industry and is expected to provide a foundation for further development of investigator-initiated studies of promising therapeutic agents. Staff from UW and FHCRC are currently developing administrative and regulatory procedures to streamline the setup of industry trials that involve faculty and/or staff from both institutions.
Industry Sponsored Agreements
The University’s Office of Sponsored Programs has actively participated in the clinical trials process improvement effort described above, and has made substantial effort to reduce the time required to negotiate contracts for industry sponsored clinical trials by establishing master agreements with biotech/pharma companies. To date, the University has established 26 master clinical trial agreements with potential study sponsors, including such major biotech/pharma companies as Merck, Pfizer, GlaxoSmithKline, Novartis, Amgen and others. As evidence of the substantial benefit of these agreements, the startup process for four recent industry sponsored clinical trials for the Phase I Clinical Trials Program (see above) were completed with a 90-day turnaround time. FHCRC has recently hired a new industry sponsored agreement analyst who will be responsible for establishing master agreements with industry.
Biospecimen Acquisition
The Consortium was awarded funding for a new Tissue Bank shared resource through the Cancer Center Support Grant. CCSG funds have been committed for purchase of a software platform that will enable existing tissue collections to be queried for potential research applications as well as provide an institutionally supported IT system for the creation of new collection; a project manager; and servers. This software will be accessible to faculty/staff at FHCRC, UW and Children’s, and implementation and maintenance will be provided through the University’s ITHS Biomedical Informatics Core. This project represents a major collaboration of the Consortium and the ITHS. Further, a plan has been developed for prospective specimen acquisition and distribution. A proposal to fund development of this phase is currently under consideration by the Life Science Discovery Fund. In addition, the University has initiated planning for a biospecimen acquisition program that would allow for the capture of discarded clinical specimens for research and will seek funding for this effort in 2010.
Consortium News
Presentation to FHCRC Admnistrative Managers Forum
On 12/3/09, the FHCRC Consortium Administrative team gave a presentation to the FHCRC Administrative Managers. This was an overview of the Consortium and the Cancer Center Support Grant, including information on current Consortium initiatives. (download slides.ppt)
