MESSAGE FROM THE DIRECTOR
Stan Gerson, MD
Director, Case CCC
Report on the NCI Board of Scientific Advisors Meeting
I would like to report on the March 4, 2013 meeting of the NCI Board of Scientific Advisors.
As Dr. Varmus has expanded upon in his recent email (please see the "Announcements" section below) the sequestration will result in an overall 5% reduction in support and 4.7% reduction in NCI funding. Since this is intended to last 10 years, the only choice of the NCI is to plan across the board reductions that are equitably spread. Dr. Varmus also indicated his intention to preserve funding for young investigators and to balance reductions. Each of us can expect to see reductions, and this includes the CCSG core grant.
At the meeting, there were presentations on two issues that are plaguing our field: reproducibility of research, and the ability to validate potential biomarkers in clinical development effort. Overall, the ability to validate potential biomarkers in other labs either using bio assays or gene profiles is poor. Some of this may relate to experimental conditions, efforts by the initiating lab to control variables, types of samples analyzed, and uniformity of tissue collection and accuracy of clinical annotation.
In response, I ask that you review recent publications from the NCI designed as guides for these sort of studies:
- 29 Criteria Items: These draft guidelines were presented on a poster at the Markers in Cancer meeting on October 11, 2012. (J Clin Oncol 30: 2012 (suppl 30; abstr 58)
- Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK): Explanation and Elaboration (PLoS Med. 2012 May; 9(5): e1001216.)
Addressing these elements in BIOMARKER validation studies will be important. In fact, at the breast cancer retreat today, there were a number of examples of how these guidelines will assist in the research effort. The NCI is rapidly moving towards requiring these to be addressed in grant applications and in publications.
From a practice vantage point, our biorepository has in place sample preparation SOPs to assist and our biostatistical groups can help with assay development and analysis of variance.
The NCI will expand the effort of the TCGA towards a deep study of certain tumors to further identify genomic drivers of cancers that were not seen in the 500 tumor samples of the TCGA. They are committing to a 10,000 tumor sample to fully characterize a genetic change if it exists.
The goal would be to identify all driver mutations at a 1% incidence to more fully characterize each tumor type. This effort would assist clarification of genetic changes linked to germline predisposition, environmental links, therapeutic selection, etc. Issues raised by this initiative include the value of the additional effort, whether the endpoint can be informative, how to improve academic cancer center access to the data, and whether this would lead to therapeutic impact.
Other issues I suggest we consider include:
- What about minority populations?
- How do mutations in stroma drive mutations in tumor heterogeneity?
- Does this approach identify the contributions of Epigenetics in cancer progression?
- What is the cause of the increased background mutation rate observed in cancers and metastatic lessons?
- How do this profile link to critical pathways?
- Have these samples captured critical minority populations?
- What is the biology of the mutations found?
- What is the cause of cancers without a driver mutation?
These studies will undoubtedly be the focus of future provocative questions and RFAs.
Message from Dr. Harold Varmus
To the NCI-supported scientific community:
As you have heard and read, the Budget Control Act (aka "sequestration") has gone into effect as of March 1st. All components of the NIH, including the NCI, are working diligently to assess the impact of this unprecedented budget reduction on our ability to manage the current research portfolio and to continue to award new and competing grants in this fiscal year. Knowing the anxiety that we all share about these developments, I am writing to report to you on our objectives, progress, and prognostications, even though a full account is not yet possible.
First, I must emphasize that we cannot provide a definitive and detailed account of our plans for the year at this time because we are currently operating on a so-called Continuing Resolution that extends only through March 27th. Funding for the rest of the fiscal year (FY2013) will depend on Congress’s ability to propose and pass appropriations measures that carry us through September 30th. This could be done through another Continuing Resolution, through a more typical appropriations bill, or through some kind of omnibus bill that bundles measures affecting many agencies.
At present, our Continuing Resolution provides funds to the NCI for the first six months of this fiscal year (October 1 - March 27) at 0.62% above last year’s level for the same time period. Under these circumstances, as in many other years that have begun with Continuing Resolutions, we are paying both new and continuing grants at about 90% of expected levels — a conservative measure that acknowledges our uncertainty about the rest of the year. Even in this especially difficult year, we anticipate increasing the funding level for those awards (by an amount still to be ascertained) once our funding for the full year has been determined. As I have described in earlier messages and as is detailed on the NCI's web site, we continue to evaluate our applications for new and renewing grants by a careful combination of peer and programmatic review. I urge you to visit the site to see the outcomes of that process for the past two years.
One of the guiding principles in our plans for adapting to sequestration is to maintain the number of competitive awards — new grants and renewals — at levels similar to that achieved in the past few years (over 1000 grants, with success rates of 13 to 14 percent). These are, of course, fewer grants than we would like to make, and the grant sizes are often smaller than they should be. Moreover, to achieve this goal, we need to make reductions, modest but significant, in virtually all of our extra- and intramural programs, including non-competitive (type 5) grant renewals, cancer centers, and research contracts. In addition, we do not expect to reduce salaries, place employees on furlough, or take other drastic steps in making these adjustments. Yet in the plan we envision, we hope to protect, as best we can, the potentially most vulnerable parts of our community: fully trained scientists who are applying for their first grants, experienced investigators who are renewing their grants and maintaining their research teams, and the trainees we will need for cancer research in the future.
I intend to send you more details about plans for FY2013 once budgets for the rest of the year have been defined. But I want you to know that those of us working on your behalf at the NCI are making every effort to sustain the functionality of our research enterprise in difficult times.
CASE CCC IN THE NEWS
Referring Colorectal Cancer Patients to Genetic Counseling for
Cancer Network - Mar 5, 2013
The results of this study were published in the Journal of Clinical Oncology by Charis Eng, MD, PhD, The Sondra J. and Stephen R. Hardis ...
Specialized Program of Research Excellence in Gastrointestinal Malignancies (GI SPORE)
All Faculty members are invited to submit outlines for pilot projects to be funded by the NIH P50 GI SPORE. Proposals must be submitted through CTSC Webgrants. Please note that a SPORE project must be directed toward translational research of a GI malignancy. At least one specific aim should involve either direct patient contact or the study of patient derived tissue samples.
Deadline: April 1
Barrett's Esophagus Translational Research Network (BETRNet)
All Faculty members at participating institutions are invited to submit applications for Individual and/or Cross BETRNet pilot projects of up to $50,000 to be funded by the U54 BETRNet. Note that a BETRNet project must be directed toward translational research related to Barret'’s Esophagus. At least one specific aim should involve either direct patient contact or the study of patient derived tissue samples.
Deadline: May 10
Computational Genomic Epidemiology of Cancer Postdoctoral Training Program
The Case CCC invites applications to its 2-3 year NCI-funded Computational Genomic Epidemiology of Cancer Postdoctoral Training Program. The program combines a mentored cancer research project designed by the fellow in collaboration with their mentors with a specialized curriculum of formal didactic training and individualized longitudinal curriculum.
This program is designed to prepare trainees for careers as independent investigators engaged in research at the intersection of cancer research, genetics, epidemiology, biostatistics and computer science. Cancer researchers obtaining training will have the skills vital to decipher the complex pathways comprising genetic and environmental risk factors for disease, and will ultimately be able to provide clinicians and their patients with valuable information for the prevention and treatment of cancer.
Candidates with an MD, PhD, or MD/PhD degree, strong quantitative skills, and an interest in a career in genetics research are encouraged to apply.
PREVIOUSLY ANNOUNCED OPPORTUNITIES
Childhood Brain Tumor Foundation
Case CCC ACS IRG
Case CCC Protocol Specific Research Support (PSRS)
International Union Against Cancer (UICC) International Cancer Technology Transfer Fellowships
NIH BULLETIN – Notices and Funding Opportunities
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