Archive for the ‘Francis Collins’ Tag

Patient-Centered Clinical Research Network (PCOR-net)

As we all know, comparative effectiveness research is smokin’ hot right now. We are all anxious to see what PCORI funding produces in the upcoming years. In December they unveiled PCOR-net, a highly innovative, clinical data sharing network. In a recent blog post, Dr. Francis Collins (who sits on PCORI Board of Governors) stated, “This initiative will provide an unprecedented opportunity to streamline clinical trials, empower patients, and build a solid foundation for personalized medicine.” He goes on:

“PCORnet will be made up of two types of data networks: Clinical Data Research Networks (CDRNs) and Patient-Powered Research Networks (PPRNs). CDRNs include academic health centers, community hospitals, health plans, inpatient and outpatient hospitals and providers, Veterans’ Administration clinics, pediatric hospitals and providers, private electronic health record companies, and many other health care groups. Utilizing electronic medical records, all of these organizations will build patient databases and a clinical trial infrastructure that can be accessed by researchers from many different organizations (including NIH), while protecting patient privacy and confidentiality.

“As the name suggests, PPRNs are patient-oriented groups united by a certain disease or condition. The successful groups receive support from PCORnet, and are charged with outreach, expanding networks of patients, and collecting standard patient data—all of which are critical for researchers looking to recruit volunteers for a clinical trial.”

In December, PCORI distributed $93.5 million to 11 CDRNs and 18 PPRNs who will conduct pilot studies on data models over the next 18 months.

If successful, this single, overarching network has the potential to include over 100 million people across the US of all ages, ethnicities, and SES who have agreed to participate in clinical research.

Read the complete blog post here.


Significant Budget Cuts Imminent For the National Institutes of Health

Guest Blog by Luke Bouvier, PhD

In a notice issued a few days ago on February 21, the NIH released some additional details about its contingency plans if sequestration goes into effect this Friday, March 1, as scheduled.  In order to hit the mandated 5.1% budget cut, the NIH “likely will reduce the final FY 2013 funding levels of non-competing continuation grants and expects to make fewer competing awards.”  Non-competing continuation awards, which have generally been funded this year at 90% of the previous commitment level because of the ongoing budget uncertainty, may see some restoration above the current level “but likely will not reach the full FY 2013 commitment level described in the Notice of Award.”  The NIH also confirmed that in the event of the budget sequester, each of the 27 NIH Institutes and Centers will detail its own approach to meeting the reduced budget level.

Science likewise reported that a press conference held at the NIH last week confirmed the bleak budget outlook.  NIH Director Francis Collins and Senator Barbara Mikulski (D-MD) warned that the coming sequester cut of $1.57 billion to the NIH’s $31 billion budget would “slow scientific progress, delay clinical trials, and put a generation of young researchers at risk.”  Collins reported that “everything will take a hit,” though Institute directors will be able to use their discretion in allocating cuts among programs such as single-investigator grants, centers, and intramural research.  Referring to NIH staff and intramural researchers, Collins added that “we will do everything we can to try not to furlough or to lay off employees.”  Nobel Prize winner Carol Greider, chair of the Department of Molecular Biology and Genetics at Johns Hopkins University, also appeared at the press conference and lamented that the looming cuts could reduce NIH’s grant success rate from an already-low 17-18% down to 15%, which would translate to a reduction of grants in the hundreds, forcing cutbacks in biomedical labs throughout the country.  Collins confirmed that many high-scoring grant proposals have not received any funding yet at all because of the lack of budgetary clarity, adding that “some of that science is being held up as we try to figure out what resources we actually have in fiscal year ’13.”  Though few observers now believe that the sequester cuts can still be averted by March 1, Senator Mikulski, chair of the Senate Appropriations Committee, hopes that the NIH cuts will eventually be remedied in a budgetary deal to fund the federal government through the remainder of the current fiscal year.  That deal would have to be reached before the current Continuing Resolution expires on March 27, or else a government shutdown could result.

Posted February 25, 2013 by Meg Bouvier in Biomedical research, medical grant writing, medical policy writing, NIH grantwriting

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Supreme Court Ends Stem Cell Funding Challenge

Guest Blog by Luke Bouvier, PhD

On January 7, 2013, the U.S. Supreme Court declined to review Sherley vs. Sebelius, which effectively ends the legal challenge to the 2009 NIH Stem Cell Funding Guidelines.  The Guidelines, which allow funding of most stem cell research, were challenged by two researchers who work with adult stem cells, James Sherley and Theresa Deisher, as a violation of U.S. law, which prohibits the NIH from funding research in which human embryos are destroyed.  In 2010, a federal judge blocked the 2009 Guidelines, but the U.S. Court of Appeals for the District of Columbia Circuit reversed that decision in August of 2012, deferring to the NIH’s judgment that it could fund research on stem cells from embryos that are not actually destroyed during the research. The Supreme Court’s refusal to take up the case effectively upholds the Appeals Court decision and lifts the cloud of uncertainty over future stem cell research funding.

NIH Director Francis Collins welcomed the decision, stating that “patients and their families who look forward to new therapies to replace cells lost by disease or injury, or who may benefit from new drugs identified by screening using stem cells, should be reassured that NIH will continue supporting this promising research.”  Likewise, Amy Comstock Rick, president of the Coalition for the Advancement of Medical Research, greeted the Court’s decision as “a victory for scientists, patients, and the entire biomedical research community,” noting that the NIH currently lists 198 stem cell lines on its registry, up from 21 in early 2009 when the NIH first implemented President Obama’s executive order lifting President Bush’s ban on funding for all but the most limited stem cell research.  Bernard Siegel, spokesperson for the Stem Cell Action Coalition and Executive Director of the Genetics Policy Institute (GPI), applauded the decision as “a major victory for scientifically and ethically responsible innovative research” adding that while the legal challenge to the NIH’s 2009 guidelines is now over, “we must remain vigilant against threats at state and other policy-making levels.”





NIH Will Pilot Anonymous Peer Review of Grant Applications

On December 7, the NIH Office of the Director issued a press release announcing a series of new initiates. The initiatives group under two main themes: workforce development and data & informatics.

I strongly recommend that people read the one-page press release to get a sense of the way NIH will set priorities in terms of its funding portfolios going forward. Look for new funding opportunity announcements and NIH policies addressing the issues laid out in this document in the upcoming months/years. It is also worthwhile to peruse the original recommendations given to the NIH Director by the Advisory Committee to the Director (ACD) last June, from which these initiatives derive.

Within workforce development, topics include the launch of new initiatives to provide mentored support to new researchers, training and standards for mentors, numerous initiatives to promote diversity at all levels, and increased support to grant mechanisms that foster an independent research career, such as the K99/R00. Notably, the following language appears pertaining to peer review:   Promote fairness in peer review through interventions including implicit bias and diversity awareness training for both scientific review officers and members of review panels, and piloting a program that would make grant applications completely anonymous.

Under data and informatics, they list the following:

  • Maximize the value of biomedical data through a new Big Data to Knowledge (BD2K) initiative that would create:
    • improved data and software sharing policies, catalogs of research data, and data/metadata standards development to facilitate broader use of biomedical big data
    • analysis methods and software development and dissemination
    • enhanced training for biomedical big data
    • proposed new centers of excellence
  • Launch the NIH InfrastructurePlus adaptive environment to advance high-performance computing, agile hosting and storage approaches, and modernization of the network, among other approaches.

NIH Director Francis Collins Launches Blog

I am delighted to report that Dr. Francis Collins, current NIH Director, has recently launched his own blogFrancis Collins discussing science, medicine, and public health news, and sharing biomedical research discoveries that are, in his words, “game changers, noteworthy, or just plain cool”. As many of you know I worked for FC in the late ’90s and am a big fan–his intelligence is surpassed only by his integrity. I hope you will subscribe.

(And yes, he really does ride a motorcycle.)

NIH Names New Director for the Center for Scientific Review

NIH Director Francis Collins announced yesterday tthat Richard Nakamura, Ph.D. will be the new director for the NIH’s Center for Scientific Review (CSR). Dr. Nakamura has been serving as the acting director since September 2011.

Read the full press release.

Now that NIH NCATS Is Replacing NCRR, Where Have The NCRR Programs Gone?

It has been over a year since NIH Director Francis Collins announced the creation of the National Center for Advancing Translational Science. From the NIH website:  “The goal of NCATS will be to develop new ways of doing translational research that the public and private research and development communities can adopt. Innovations that come out of NCATS are intended to cut down the time or expense needed to develop a new drug, or allow us to predict which compounds will work best and be safe earlier in development.”

CLICK HERE for more information on the mission of NCATS.

One casualty of the formation of NCATS has been the National Center for Research Resources (NCRR.) Where have the NCRR programs gone? Two have wound up at NIGMS. From a NIGMS blog post by Judith Greenberg:

“In the first major reorganization of NIGMS since 1994, we have just established two new divisions that bring together existing NIGMS programs with programs transferred to NIGMS from the former National Center for Research Resources (NCRR). These changes give us the opportunity to create synergies and strengthen efforts in areas that are central to our mission.

“The Division of Training, Workforce Development, and Diversity (TWD) merges NIGMS research training programs with activities that were previously in the Institute’s Division of Minority Opportunities in Research (MORE). It also houses the Institutional Development Award program from NCRR. Our decision to create this division was informed by input we received from many stakeholders, and it responds to key goals and recommendations of our strategic plans. Its director is Clif Poodry, who formerly directed the MORE Division.

“The Division of Biomedical Technology, Bioinformatics, and Computational Biology (BBCB) combines programs of our Center for Bioinformatics and Computational Biology (CBCB) with biomedical technology programs from NCRR. Karin Remington, who previously directed CBCB, is the director of this new division.

“You might be wondering what the reorganization will mean for your current or future funding. The amount of money allocated to programs in the new divisions will not change as a result of the reorganization or the transfer of NCRR programs to NIGMS. The review of applications will stay the same, too, as will most of the staff who manage the grants and review the applications.”


What Does the NIH FY12 Appropriations Report Actually Say?

Why should we follow the Appropriations process? Aside from the obvious reason—to know how big the pot of extramural money will be next year and to understand the government’s commitment (or lack thereof) to science funding—there is another important reason: If you know the language worked into Appropriations testimony you can strategically design your research and incorporate key language and ideas into your NIH proposal in order to improve your odds of funding. (In these competitive funding times, every little advantage helps.) So without further ado, here are some key concepts from the NIH FY12 Appropriation report:

NIH has requested $31.987B for FY12. In the cover letter for the report from the Office of the Budget, Francis Collins states: “The requested funding will enhance NIH’s ability to support research that prolongs life, reduces disability, and strengthens the economy. NIH-funded research contributes to economic growth, produces well-paying jobs, and helps to keep the United States competitive on the global stage.” He continues: “For the FY 2012 budget request, NIH has identified one major area of extraordinary opportunity and three other themes that are exceptionally ripe for investment and integral to improving the health of the American people.” The one major area of opportunity of course is the proposed highly-controversial National Center For Advancing Translational Science (NCAT), which Collins refers to as “a new paradigm for turning lab discoveries into cures and treatments through targeted investments in translational science and medicine.” The three themes that NIH has deemed “instrumental in paving the way for more rapid scientific advances across all areas of human health and disease, including global applications”:

 1) Technologies to Accelerate DiscoveryThis area focuses on genes and the environment (I guess we will see more of those FOAs), and directly lists advanced technologies such as DNA sequencing, microarray technology, nanotechnology, new imaging modalities, and computational biology.

2) Enhancing the Evidence Base For Health Care Decisions. Language here includes “comparative effectiveness” and “personalized medicine.” He also cites the new HMO Research Network, which “will bring together HMOs caring for more than13 million patients for the purpose of accelerating research in the high priority areas of epidemiological studies, clinical trials, and electronic-health-record-enabled health care delivery.”

3) New Investigators, New Ideas. Here Collins mentions two programs: “the NIH Director’s New Innovator Award, which supports new investigators with potentially high-impact projects, and the Early Independence Award, which enables our most talented young scientists to move directly from a doctoral degree to an independent research career.”

If you write NIH grants, I strongly encourage you to spend some time with the full Appropriations report put out by the NIH Office of the Budget. (click here)

The Administration requested $31.829B for NIH FY12. Here are highlights that the Administration pulled from the NIH report (and therefore deem important):

*The FY12 budget proposes to support a total of 9,158 competing Research Project Grants (RPGs), a reduction of 228 from FY10. In total, NIH projects it will support 36,582 RPGs (competing and non-competing) in FY12, an increase of 43 grants from 2010.

*The budget also proposes a 4 percent increase in stipends under the Ruth L. Kirschstein National Research Service Award (NRSA) program. The goal is to “improve NIH’s ability to attract high-quality research investigators to the field of biomedical research.” This will result in an increase in NRSA funding of $19 million over FY10, for a total of $794 million.

*The Cures Acceleration Network would receive $100 million in FY12; it is included in the budget of the Office of the Director.

*As in previous years, $300 million is transferred out of the budget of the National Institute of Allergy and Infectious Diseases (NIAID) for the Global Fund to Fight HIV/AIDS, Malaria, and TB.

*Although the budget narrative specifically mentions implementation of the National Center for Advancing Translational Sciences (NCATS), the National Center for Research Resources (NCRR) remains a line item in the FY12 budget.

*At a briefing of NIH advocates, NIH Director Francis Collins said that within the next month, the agency expects to file a budget amendment detailing the movement of NCRR programs into NCATS or other NIH institutes and centers.

*The National Children’s Study would receive $194 million, the same level as FY10; the Common Fund would receive $557 million, an increase of $13 million.

*NIH intramural research would increase by $50 million, to a total of $3.382 billion, which is approximately a 1.4 percent increase.

*NIH estimates it will be able to save more than $15 million in administrative costs in FY12. The agency plans to do so through such means as using technology to save study section travel costs by holding virtual peer review sessions.

To illustrate the achievements of NIH, Dr. Collins used two particularly compelling examples at the budget briefing:

*A 21-year-old diagnosed today with HIV/AIDS has a life expectancy of 70 years, thanks to the anti-retroviral         therapy made possible by NIH funding.

*Gains in life expectancy supported by NIH-funded research result in $3.2 trillion in annual savings.

NIH identified in its FY12 budget justification priority areas and initiatives related to the following diseases: autism; cancer; Alzheimer’s disease; type 1 diabetes; and HIV/AIDS.

Some scientific program areas of accomplishment or special emphasis provided by NIH include: bioinformatics and computational biology; National Technology Center for Networks and Pathways programs; epigenomics; genotype-tissue expression; global health; Gulf oil spill long-term follow-up; health economics; high-risk, high-reward investigator initiated research; the HMO research collaboratory; the human microbe project; and nanomedicine.

Posted April 27, 2011 by Meg Bouvier in Biomedical research, medical grant writing, medical policy writing

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New strategic plan for NIH obesity research seeks to curb epidemic

Today the NIH announced the release of its new strategic plan to combat obesity. The Task Force that developed the recommendations was composed of researchers, health care professionals, and the public and was chaired by the Directors of NHLBI, NIDDK, NICHD, and NCI.

Task Force recommendations include prioritizing research to:

· discover key processes that regulate body weight and influence behavior

· understand the factors that contribute to obesity and its consequences

· design and test new approaches for achieving and maintaining a healthy weight

· evaluate promising strategies to prevent and treat obesity in real-world settings and diverse populations

· use technology to advance obesity research and improve healthcare delivery

NIH’s first strategic plan for obesity was released in 2004 under Elias Zerhouni. In FY2010, NIH spent $824M on research to reduce the prevalence of obesity and its health consequences. Look for that funding level to continue even with budget cuts looming on the horizon, as NIH continues to commit itself to what is arguably the number one public health crisis in the country. One-third of adults in the US and 17% of children are obese. The most prevalent, deadly, and costly diseases in the US—heart disease, type II diabetes, and many cancers—are directly related to obesity.

This topic is near and dear to my heart (I trained as a ballet dancer, have been a runner for years, and am writing this blog upon returning from a Pilates class.) By choice, many of my grant and policy clients are exercise physiologists and I have a satisfying, ongoing business association with the American College of Sports Medicine, an organization for which I have a great deal of respect. I am delighted to see NIH reaffirm its commitment to this troubling area.

The New National Center For Advancing Translational Sciences

NIH Director Francis Collins is looking to leave his mark on the NIH: He has proposed a highly-controversial National Center For Advancing Translational Sciences (NCATS). On January 22, the New York Times reported on it.

The NIH Office of the Director responded with a document entitled “Separating Fact From Fiction”:

The five main points of the OD piece are: 1) NCATS will be assembled primarily from existing programs; 2) NCATS is not intended to be a drug company; 3) The final budget is unknown; 4) There is no plan to “cannibalize” (the word used in The Times piece) the budgets of other ICs to form NCATS; and 5) NIH remains committed to basic, translational, and clinical research.

It is a fact that it costs a tidy sum to bring a drug to market, and as a result research in the pharmaceutical industry has been declining for 15 years. Whether the government can step into that gap successfully and without damaging other research enterprises is hotly debated. Collins is quoted in The Times piece as saying, “I am a little frustrated to see how many of the discoveries that do look as though they have therapeutic implications are waiting for the pharmaceutical industry to follow through with them.”

He goes on, “There are some people that would say this is not the time to do something bold and ambitious because the budget is so tight. But we would be irresponsible not to take advantage of scientific opportunity, even if it means tightening in other places.”

Such language has many researchers deeply concerned, especially given that the NIH may be facing budget cuts in FY12. Because Congress recently expanded the powers of an NIH Director, NCATS would be realized as early as October.

Scientists aren’t the only ones who are concerned. A January 27th piece in Science magazine states that Congress has demanded answers.

And a January 28 piece in Science indicates some lack of internal support at NIH. This piece quotes Yale Chemistry Professor Scott Miller as stating, “If the reason [to create NCATS] is to derisk opportunities for industry, I think that’s quite bizarre and contrary to the entrepreneurial spirit.” James Stevens, a senior research fellow at Lilly Labs, adds, “If there is any organization that is slower and less agile than industry, it is the federal government.”

I hope that people who are involved in the biomedical research community in this country will stay informed, discuss, debate, and publicly comment on these developments.

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