Two new NCI funding opportunities with upcoming deadlines

The National Cancer Institute released two funding announcements in recent weeks that offer exciting opportunities for investigators to improve patient outcomes and contribute major breakthroughs in the field of cancer research.

Integrating Biospecimen Science Approaches into Clinical Assay Development (U01), will support research that investigates and moderates challenges facing clinical assay development due to biopsy biospecimen preanalytical variability. Biopsy collection, processing, and storage procedures can all have significant impact on the analytical performance of clinical biomarkers; false positive or negative results from the evaluation of biomarkers can directly affect patient diagnosis, treatment, and outcomes and can lead to over-treatment, under-treatment, or incorrect treatment. In addition, measurement and validation of clinically relevant biomarkers are increasingly challenging as reliance on smaller biospecimens grows and new biomarkers and analysis platforms emerge. The need to increase reliability and reduce time needed for assay development is imperative.
Eligibility: This FOA will fund a collaborative, interdisciplinary network that integrates clinical researchers with academic and private sector scientists in projects focused on preanalytical challenges presented by small biopsies. Applicant must have an assay that has been analytically validated within its intended clinical context under particular preanalytical conditions. Preliminary data should define the current status of the assay as well as justify support for optimization and usability in a clinical trial.
Application budgets are limited to $250,000 direct costs per year for up to five years.

Letter of Intent due: May 22, 2016
Full application due: June 22, 2016


NCI Clinical and Translational Exploratory/Developmental Studies (R21)
, will support exploratory/ developmental projects in the advancement of novel anti-cancer agents, diagnostic tools, and clinical approaches in treatment, symptom management, and prevention of common or rare tumors. These studies may involve considerable risk, but may lead to a breakthrough in a particular area, and/or to the development of novel techniques, agents, methodologies, models, or applications (pre-clinical or clinical). Focus areas with examples include but are not limited to:

  • Clinical Studies: Exploratory Phase I or small, non-randomized Phase II trials of new agents; Clinical studies for preliminary evaluation of safety and efficacy of imaging tools/techniques; Pilot trials of new radiation modalities
  • Correlative Studies/Biomarker Development: Studies that correlate pathology image data with cancer diagnosis and prognosis; Discovery of early validation of biomarkers elucidating mechanisms of action of cancer preventive interventions
  • Target and Agent Discovery and Development: Work that identifies new tumor or tumor micro-environment molecular or immunologic targets
  • Model Development and Analysis: Development of in vivo or in vitro models of common or rare tumors; Computational, mathematical, and animal models that can be used to assess imaging systems

Up to $275,000 in direct costs over a two year project period.

Application deadline June 19, 2016

What to do with the new NIH review criteria

As you are likely well aware, new review criteria and application instructions concerning rigor and reproducibility for many NIH and AHRQ grants go into effect May 25th. As the deadline nears for the June R01 cycle, we are getting a lot of questions about how to manage these changes. While this is still very much unsettled territory, NIH has released some clarifications and resources (as well as a graphical representation). The following represents our best intelligence to date.

First, let’s look at the new formal review criteria:

  • Is there a strong scientific premise?
  • Have the investigators demonstrated adequate plans to address relevant biological variables (in particular sex) in vertebrate animal and human research?
  • Is the research rigorous: Are there strategies presented to ensure that the approach is robust and unbiased?

To a degree, your research has always been evaluated on these criteria, but now they are explicit whereas before they were implicit. Reviewers will be asked to look at these criteria throughout the application as well as in a new one-page attachment, “Authentication of Key Biological and/or Chemical Resources.”

So, if you’re writing a grant, what are you supposed to do differently? The two primary changes are these:

  • address the new review criteria into your Significance and Approach sections
  • fill out the attachment.

Reviewers will be paying attention to the scientific premise when they evaluate your supporting data—both in the Significance section and in your preliminary data (whether you include these data in your Approach or earlier in the application). They will focus on scientific rigor and the consideration of biological variables in the Approach section.

Let’s dive a little deeper into the review criteria:

The scientific premise of the application
Here, you’re being asked to describe the strengths and weaknesses of the prior research that you’re citing—for example, an evaluation of the rigor of previous experimental design (yours or those of others). If you wrote R01 applications back in the days of the 25-page application, this requirement may remind you of the 3-page “Background and Significance” section. The reviewer instructions do state that this information will be sought after in the Significance section—but the page lengths and headings for applications have not changed. You may want to write a longer Significance section: Up to now, there’s been an evolving practice to make the Significance section—which should describe why your science and health problems are important to solve—comparatively short. The details were saved for the Approach section. The instructions for scientific premise, however, direct reviewers to evaluate this in the Significance section. Thus, we expect the form of the Significance section to evolve further.

The scientific rigor of the proposed experiments
How well controlled are your experiments? What is their statistical power? The goal here is to create reproducible and unbiased results, so transparency will also be important—with the caveat that different fields will have different standards for what counts as rigorous. Well-written grants usually have this kind of information, so this may not be qualitatively different from what you have done before. If you’re curious, NIH has provided some samples of what they consider rigor (scroll down to Resources).

Consideration of relevant biological variables
Your approach will also be evaluated for how well you explain the effects of biological variables such as sex, age, weight, and underlying health conditions for vertebrate animal and human subjects research. Reviewers are being asked to focus on sex, in particular, because it has to been overlooked in much published research (for many years, by design). You are being asked to incorporate consideration of sex into both research design and analyses. And if you’re just studying one sex, you’ll need to have a compelling justification (previous literature, preliminary data, and so on). This criterion will probably cause the most confusion and angst, among grant writers and reviewers alike.

Authentication of key biological and/or chemical resources
This is the one change to the formal process, and it consists of filling out a one-page document. Here, you will explain how your key biological and chemical resources will be evaluated for their quality.

These resources should be integral to your research, and they may have properties that affect the data. They may include cell lines, specialty chemicals, antibodies, and other biologics. They may be something you created or a cell line you purchased—and even these may differ in different labs or over time. So your task is to explain how you will ensure these resources are as consistent as possible. Ideally, you are doing this already—for example, checking antibodies via Western blotting—but the difference here is that you’ll list out the process of authentication in a separate document. Applicants are being counseled to plan to independently verify even commercial resources—don’t presume that a cell line you purchased from a vendor is free of problems.

One note of caution: reviewers are being asked to look for ‘overloading’ of applications, so don’t try to put experimental detail in this document. They don’t want the data demonstrating authentication–they want to know your plans for doing this.  It may feel a bit redundant with proposed controls in the approach—the jury is out at this point in terms of whether this section will ultimately overlap with or supplement the Approach. Finally, the review of this section, at least for the time being, will not count in your overall significance score. If it’s inadequate, it will be handled administratively prior to the release of funds.

If you’re writing a career award or training grant, you can learn from the experience of others: similar changes in these applications are being drafted and are expected to go into effect in 2017. In the meantime, you can study the FAQs: there will no doubt be more questions.

Funding opportunity: Nonsurgical permanent female contraception

The Oregon Permanent Contraception Research Center (OPERM) is soliciting applications for research funding for preclinical studies of promising novel approaches to female permanent, or very long acting (>10 -20 years), contraception. A variety of funding opportunities are available.

OPERM was established at the Oregon National Primate Research Center, Oregon Health & Science University in November, 2014 through a generous grant from the Bill & Melinda Gates Foundation. The Center will provide grants for direct research costs (up to $300,000/year) and core resources (including use of the nonhuman primate model for proof-of-concept testing) designed to support early phase studies. Applications from clinicians, material scientists, social scientists, bioengineers, immunologists, and reproductive biologists and others are welcome. Proposals may involve novel targets or approaches, or the use of a new technology or innovation to address limitations or problems with previously investigated techniques. All proposals should address the target product profile of a new permanent contraception method; low cost, portability, applicability for use in low resource settings by non-physicians, single treatment, and lack of interference with normal menstrual cycles. Approaches that adapt currently approved drugs or technologies from other fields are particularly welcomed.

Applicants are required to submit a proposal outline in the specified format as a Letter of Intent by May 31, 2016. These proposal outlines will be reviewed, and selected applicants will be invited to submit a complete research proposal.

Complete details and a downloadable copy of the full Request for Proposals are available on the center’s website or by contacting the OPERM Administrative Coordinator, Keri Brown (browkeri@ohsu.edu).

Applicants are encouraged to contact the OPERM co-Principal Investigators to discuss potential projects:

Jeffrey T. Jensen, M.D., M.P.H., jensenje@ohsu.edu
Ov D. Slayden, Ph.D., slaydeno@ohsu.edu

Human Investigations Program applications due July 15

The Human Investigations Program (HIP) trains scientists in the principles of and best practices in clinical and translational research. Participants can obtain a Certificate in Human Investigations or a Master of Clinical Research degree. Enrollment in individual courses without a degree is available as well. The curriculum includes a wide variety of required courses and electives that provide the basic foundations for human investigation. Topics range from the basic science of disease to biostatistics to evidence-based medicine and beyond.

Application Deadline: July 15, 2016
The application involves a written component, letters of support from your department or mentor, and transcripts.  Find out more about the application process here.

HIP is based on nationally recognized competencies for clinical and translational research and operates on a policy of inclusion.  The program is open to faculty, clinical and postdoctoral fellows, and graduate students. Applicants should have a doctoral degree or be enrolled in a doctoral degree program within the OHSU Schools of Medicine, Dentistry, or Nursing or the OHSU-PSU School of Public Health.

Sponsor
HIP is supported by the Oregon Clinical and Translational Research Institute (OCTRI). Find more information about HIP at www.ohsu.edu/hip.

Erick Turner chosen as finalist for the Open Science Prize

open-science_0Erick Turner, M.D., associate professor in the Department of Psychiatry in the OHSU School of Medicine was selected as a finalist in the Open Science Prize. Turner partnered with Ben Goldacre, a British physician, academic, and science writer from the University of Oxford, and their team was one of six teams chosen out nearly 100 submissions.

The Open Science prize, a collaboration between the NIH, the UK-based Wellcome Trust, and the Howard Hughes Medical Institute, is a recently launched global competition to make both the outputs from science and the research process more accessible to the public. Turner’s project, “Unlocking the FDA trove: Making unbiased clinical trial data accessible,” was born of his desire to make the unique clinical trial data the Federal Drug Administration has collected over the years more accessible and user-friendly. Having worked at the FDA as a reviewer for drugs new to the U.S. market, he witnessed how much data never reaches traditional scientific journal articles. FDA reviews contain detailed information about the methods and protocols of clinical trials as well as complete results of a study whether the outcome is positive or negative. As such, they are generally more informative and “unspun” than what’s reported in journals. This is particularly important when assessing a drug’s efficacy. However, despite the value of these documents, they are incredibly difficult to access, aggregate, and search and are therefore rarely used by clinicians and researchers. Turner and his team want to change that.

The team proposes to produce application programming interfaces that will allow third party platforms to access, search, and present the FDA data. This innovation will enable access to complete and unbiased information which could have a significant effect on clinical decision-making globally.

Turner and his team are hard at work on their final prototype which will be submitted by Dec. 1 2016. The winner is expected to be announced in late Feb. or early Mar., 2017.

Research Week 2016 comes to a celebratory close

ResearchWeekArt2106 FNL RGBResearch Week 2016 consisted of four days full of events and activities celebrating the research taking place at OHSU . More than 400 participants took part this year, including five keynote speakers, 80 oral presenters, 124 poster presenters, 17 Three Minute Thesis competitors, 38 volunteers, 35 judges, and 24 industry professionals and School of Medicine alumni at career networking night.

The awards ceremony and reception brought the week to a celebratory close as OHSU leaders lauded the depth and breadth of this year’s programming and handed out awards to participants.

This year’s award recipients included:

Postdoc poster presentation winners
1st place: Arpita Ray, “Investigating the neuroprotective role of the glial engulfment receptor Draper in a drosophila model of Alzheimer’s disease”
2nd place: Douglas Martini, “Long-term effects of adolescent concussion history on cognition”
3rd place: Thomas Meyer, “Retrotransposon-associated differential expression of genes in macaques”

Postdoc oral presentation winners
1st place: Saurabh Thosar, “Endogenous circadian rhythm in vascular function and cardiovascular risk”
2nd place: Chelsey Dawn Kline, “Understanding the roles of antioxidants in human melanocytes and melanoma”
3rd place: Daniel Coleman, “Androgen content and BET bromodomain proteins influence enzalutamide agonism of mutant F876L androgen receptor”

Student oral presentation winners
Brittany Alperin, “ADHD and emotion dysregulation: An issue with top-down or bottom-up processing of emotional stimuli?”
Charlie Gast, “Cancer-macrophage fusion as a mechanism for metastatic disease”
Tyler T. Risom, “Measuring and managing phenotypic heterogeneity in basal-like breast cancer to improve therapeutic control”
Christie Pizzimenti, “Context-independent effects of footshock on drug-seeking”
Courtney Brooke Betts, “Reproductive state-dependent alterations in mammary dendritic cells and a potential role for collagen”
Sharmeen Chagani, “Role of vitamin D3-vitamin D receptor (VDR) signaling in melanocyte homeostasis and UV-induced DNA damage”
Katie Tallman, “Mycobacterial enzyme profiling with chemical tools”
Cymon Kersch, “The role of αvβ3-integrin and HER2 in breast cancer metastasis to the brain”
Rebecca Hood, “Cortical activation as a mechanism of neuroprotection in a mouse model of Parkinson’s disease”
Chelsea Jenkins, “Defining the functional role of TNK2 in PTPN11-mutant JMML”

Student poster presentation winners
Mady Stovall, “Moral injury in nurse second victims: Wounded healers in the workforce”
Emily Calabro, “Post-traumatic growth’s influence on experienced ICU nurses”
Audrey Anne Drake, “Using a points of health resource map for the Medicaid population: A pilot study”
Joshua Garrison Burkhart, “ReactomeFIFusion: Discovering gene fusion events’ effects on protein-protein interactions”
Quin Denfeld, “Physical symptoms and depression interact in predicting quality-of-life in heart failure”
Paul Jones, “A case series: Optimal timing of pediatric hip spica casting in children with isolated diaphyseal femur fractures”
Patricia Ann Barfield, “Life satisfaction in children with ADHD: A mixed-methods study proposal”
Amy Rey Williams, “Effects of acute ethanol withdrawal and intoxication on the extinction and reconditioning of contextual fear memories”
Elizabeth Rosa Sunderhaus, “The role of ER stress in neuropathy target esterase-related diseases”
Michael Ha, “Micropatterned ECM-derived gelatin methacryloyl hydrogels for dental pulp regeneration”
Molly Rae Rabinowitz, “Gender disparities in small group verbal participation among first year medical students”
Ginger Keller, “Determining level, direction, and rate of change of attentional function in women with breast cancer receiving chemotherapy: A pilot study”
Wafaa BinAli, “Bring continuous back to CRRT!”
Christopher Abdullah, “Estrogen stimulates cell cycle progression dependent upon SRC kinase activity”
Ryan Mulqueen, “Characterization of Rett syndrome and wild-type neuronal methylomes by single-cell bisulfite sequencing”

Three Minute Thesis winners
1st place: Kevin Watanabe-Smith, cancer biology, “Which mutations cause cancer?”
2nd place: Kevin Burfeind, M.D./Ph.D., neuroscience graduate program, “Infiltrating leukocytes in the hypothalamus as mediators of cancer cachexia”
People’s Choice: Allison Stickles M.D./Ph.D., physiology and pharmacology, “One is the safest number”

All three winners will represent OHSU at the statewide Three Minute Thesis competition at Oregon State University, Saturday, May 21.

Ugly Data Award
The Ugly Data Award was designed to underscore the message that succeeding in science might mean failing at science—in other words, without failure, you never progress. The award is given to brave souls who put their failures out there. This year’s winners are:
Nathan Bahr
Brittany Alperin

Thank you
Thank you to all who made Research Week 2016 a success! A special thank you to the Office of the Provost, the Office of the Senior Vice President for Research, the School of Medicine, and the School of Nursing for providing both the financial and moral support needed to make Research Week a success. Special thanks also go to all our fantastic volunteers, without whom there would be no Research Week.

Newgard paper is AEM editor-in-chief pick for May 2016

Craig Newgard, M.D., M.P.H., director of OHSU’s Center for Policy and Research in Emergency Medicine, was recently recognized by Academic Emergency Medicine (AEM) for his research on gun violence mapping. Newgard et al.’s paper, “A geospatial analysis of severe firearm injuries compared to other injury mechanisms: Event characteristics, location, timing, and outcomes,” was chosen by AEM’s Editor-in-Chief Jeffrey Kline, M.D., as May’s feature.

In this study, Newgard and his team performed a secondary analysis of children and adults injured by one of four injury mechanisms (firearm, stabbing, assault, and motor vehicle collision [MVC]) who were brought to trauma centers in 10 regions of the U.S. and Canada. They then used statistics and geospatial analysis to compare the injury groups, distance from home, outcomes, and spatial clustering. What they found is that severe firearm injuries have the highest rates of serious injury, resource use, and in-hospital deaths when compared to other forms of violent and non-violent injuries. Most violent injury events occur in the patient’s neighborhood, frequently within the patient’s home, and are most common in the evening or night. And while many violent injuries cluster in lower income areas, most firearm injuries occur outside any geographic cluster, in all types of neighborhoods. These findings provide a blueprint for public health efforts to focus on the home environment in all types of neighborhoods to reduce gun violence specifically.

Kline commented on the results of Newgard’s study that show “violence occurs as a density function of people, poverty, and weapons. The most important finding is that severe interpersonal violence occurs in geographic clusters, suggesting a role for concentration of resources in these areas…No student or resident or young faculty member needs to go to Liberia to find poverty and social disaster that needs their help. They just need to go to Birmingham, Dallas-Fort Worth, Memphis, Milwaukee, Pittsburgh, Portland, San Diego, or Seattle-King County, Wash.”

This paper was co-authored by investigators from the University of Washington, OHSU (Karen J. Brasel, M.D., M.P.H., F.A.C.S.), UT Southwestern Medical Center, the University of Pittsburgh, St. Michael’s Hospital in Toronto, and the Resuscitation Outcomes Consortium.

OHSU authors’ paper on Nature Neuroscience cover

A paper co-authored by OHSU researchers is featured on the cover of May 2016’s Nature Neuroscience. The paper’s authors are Stephanie L. Padilla, Jian Qiu, Marta E. Soden, Elisenda Sanz, Casey C. Nestor, Forrest D. Barker, Albert Quintana, Larry S. Zweifel, Oline K. Rønnekleiv, Martin J. Kelly, and Richard D. Palmiter.  Ronnekleiv and Kelly are professors in the Department of Physiology and Pharmacology in the OHSU School of Medicine and senior scientists with the Oregon National Primate Research Center. Qiu and Nestor are also in the Department of Physiology and Pharmacology. The first author, Stephanie Padilla, is with the University of Washington and the Howard Hughes Medical Institute.nature cover

The study, “Agouti-related peptide neural circuits mediate adaptive behaviors in the starved state,” examines the neural basis of high-risk animal behavior when faced with starvation. Ecological studies show that prey species generally forage within familiar territory where they’re protected from predators, but when faced with starvation, these animals exhibit exploratory, food-seeking behavior. Hungry animals will aggressively defend limited food resources, but when those resources are depleted, they display less aggression toward territorial intruders, are less anxious, and will leave their protected areas to find food. Because risk assessment and territoriality require sensory processing of environmental cues,the team set out to understand the neurological influences involved in what would be considered maladaptive behavior under normal conditions.

Using circuit mapping in mice, the researchers defined a disynaptic network originating from a subset of AgRP neurons in the medial amygdala that coordinates numerous behavioral and physiological adaptations that prioritize food seeking and energy conservation under starvation conditions. They propose that AgRP neurons serve as a master switch for driving feeding behaviors and suppressing territorial aggression in response to environmental cues. The potential for AgRP neurons to orchestrate a complex behavioral response is broad so the team proposes future studies of these neurons to provide a complete profile of the starved-state behavioral response.

Upcoming class: RDA 101, May 12

Research Administration Training & Education (RATE) connects the research community with workplace learning and offers classes for research administrators and others who support research at OHSU.

A great place to start whether you or your staff are new to OHSU Research or have been around a while is RDA 101.

RDA 101: Introduction to Research Administration
Thursday, May 12
9:30 to 11:30 a.m.
Bancroft Building, room 131

Join us as we take a big-picture look at Research Administration. Meet RDA unit leaders, tour valuable web resources, and meet face to face with your contacts in OPAM, IRB, TTBD, and others.

Use your network login to enroll through Compass here. Questions? Contact Margaret Gardner.

Judges and volunteers still needed for Research Week!

ResearchWeekArt2106 FNL RGBResearch Week 2016 kicks off this coming Monday, May 2, and we’re still in need of a few oral and poster presentation judges. Specifically, we’re looking for faculty, postdocs, or researchers with expertise in:

  • Clinical and systems science
  • Cancer research
  • Imaging and advanced technology
  • Cell and molecular biology
  • Surgery
  • Informatics

Judges play a critical role in giving valuable feedback to trainees on their presentation style and content. Your support is greatly appreciated. Please register as soon as possible.

A few volunteer slots are also still open. We need a couple of poster wranglers on Monday afternoon to make sure posters are set up in the right location. We’re also in need of a few backup moderators for some of the oral presentation sessions. View the schedule and sign up here.

Thank you!
The Research Week Planning Committee

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