Michael Lauer, M.D., selected as NIH’s new Deputy Director for Extramural Research

Michael Lauer, M.D.

Michael Lauer, M.D.

Last week, we reported on Sally Rockey’s departure from NIH and the last of her blog postings on Rock Talk. Today, NIH director Francis Collins announced that Michael S. Lauer, M.D., will replace Rockey as Deputy Director for Extramural Research. According to Collins, Lauer “brings both research expertise and administrative skills to the job, as well as keen insights into the world of extramural research.”

Lauer has served in leadership roles and exhibited a strong commitment to health research throughout his career. He is a board-certified cardiologist and an elected member of the American Society of Clinical Investigation.  He is the current director of the Division of Cardiovascular Sciences at the National Heart, Lung, and Blood Institute at NIH and has held this position since 2009. Prior to arriving at NIH in 2007, Lauer served as the director of the Cleveland Clinic Foundation Exercise Laboratory and was vice chair of the clinic’s institutional review board. He also served as co-director of the Coronary Intensive Care Unit and director of clinical research in the clinic’s department of cardiology. Lauer also participates on various committees within PCORI, is actively involved in human subjects protection, and served as a contributing editor for the Journal of American Medical Association for seven years.

Read the full announcement to find out more about Lauer’s research interests, honors, and positions he’s held.

NIH to host webinars on grant application submission and review, Nov. 5 & 6

The NIH Center for Scientific Review (CSR) is hosting two webinars for new NIH applicants, mentors, and grant administrators. This opportunity is designed to give participants insights into the application submission and peer review processes.

The Nov. 5 webinar will focus on university research administrators. The webinar on Nov. 6 will focus on research project grants (R01s). Both sessions will run from 11 a.m. to 1 p.m. PST, which includes a 30 minute Q&A period.

The CSR experts will present on the following topics”

  • The Review of Your NIH Grant Application Begins Here
  • What You Need to Know about Application Receipt and Referral
  • How Your Application Is Reviewed
  • Key Things to Know About the NIH Grants Program
  • Jumpstart Your Career with CSR’s Early Career Reviewer Program (R01 webinar only)

Register by Oct. 29. You may submit questions for the Q&A session before or during the webinar by sending them to the moderator at AskExperts@csr.nih.gov.

Research Policy Board proposed to ease regulatory burden on research universities

More research administration news: If there’s one thing that political opponents in Washington DC can agree on, at least in theory, is that research is over-regulated. Study after study after study has shown that research faculty spend about 40% of their time performing administrative duties, many of which are related to research regulations (think effort reporting) that are perceived to get in the way of actual discovery–the thing that scientists are funded to actually spend their time on. (As an aside, the number of burden studies has also increased, and Sally Rockey once quipped to your friendly Research News editors that someone needed to do a burden study of all the burden studies.) So what’s the answer? You’ll be unsurprised to learn that a Congressionally appointed committee is recommending forming a Research Policy Board to help ease the regulatory strain on federally funded institutions. While adding another layer of regulation may seem onerous, the goal for the Board would be to streamline and harmonize existing regulations to reduce complexity. Let’s call it an experiment.

Farewell to Sally Rockey and Rock Talk

Today, September 25, is National Research Administrator Day, so what better way to commemorate than with a fond farewell to the research administrator who led the Office of Extramural Affairs at NIH for the past five years, Sally Rockey? She departs NIH to assume a new position as director of the Foundation for Food and Agriculture Research.si-sally rockey2

Highly regarded by both NIH administration and the research community, Rockey reshaped NIH partnerships and communication with the research community, all while helping steer the NIH through a volatile and challenging budget climate. During her tenure, Rockey led the focus on the biomedical research workforce, managed the successful implementation of the 2009 stimulus bill, which infused the NIH with over $10 billion, and guided her office through difficulties resulting from 2013 government shutdown.

But perhaps most notably, Rockey improved relations and opened dialogue between NIH and the biomedical research community by starting and maintaining her  Rock Talk blog. Rocky’s clear messaging and requests for input from the community made Rock Talk not only a resource for accurate, up-to-date information but also a platform for the research community to help shape funding policies.

“Rock Talk has in many ways lifted the curtain to NIH decision making,” wrote Rockey in her farewell Sept. 11 post. While not all decisions she discussed on her blog were popular, the transparency in sharing how those decisions were reached was new and appreciated by most everyone. Rock Talk generated often heated discussion (who could forget the rollout of the new biosketch format?) not only on the blog but on social media. Though the conversations were challenging and critical, they often led NIH to modify policies based on reader input.

In her final post, Rockey says she expects the blog to continue in the spirit it was created – to “keep the conversation flowing, the research cranking, and the science hopping.”

Precision medicine enters a new phase

It takes a million people to discern the health strategies for one individual–at least, that’s the thinking behind the latest phase of the NIH’s Precision Medicine Initiative. This initiative was first proposed by NIH Director Francis Collins more than a decade ago. It became a reality this January, when President Obama announced his support of it in his State of the Union address, noting that its goal is “to bring us closer to curing diseases like cancer and diabetes, and to give all of us access to the personalized information we need to keep ourselves and our families healthier.”

To meet this challenge, Collins convened a working group to discuss how to create and manage a research cohort of more than one million Americans across the spectrum of diversity. That’s a large cohort to manage, so the group received input from a wide variety of stakeholders, and now they’ve published a report recommending the best ways to find the molecular, environmental, and behavioral factors that contribute to disease–as well as to find the most effective treatments. You can read the NIH’s statement on the Precision Medicine Initiative here, and see more at Science Insider.


Knight Cancer Institute researchers track metastasis with cell-free DNA

Researchers at the OHSU Knight Cancer Institute recently found that sequencing the fragments of tumor DNA that circulate in blood may give a more accurate picture of a patient’s metastatic cancer than can be obtained from biopsies. Paul Spellman, Ph.D., professor of molecular and medical genetics at OHSU, led the study, which showed that whole-exome sequencing of cell-free DNA can find the same clinically relevant mutations identified in DNA from tumor tissue, and it can provide additional information about the evolution of a particular patient’s disease and how best to treat it. That’s significant because drawing blood to obtain cell-free DNA is less invasive and safer for patients than taking a biopsy of tumor tissue. The “liquid biopsy” approach makes it feasible to repeatedly sample tumor DNA over the course of treatment.

Taking biopsies at multiple metastatic sites often isn’t possible, for instance, when they are located in tissues that are difficult to access. Some lesions are too small to obtain enough tissue. And because tumors often consist of genetically heterogeneous cells, a biopsy needle can miss important mutations that arose outside the sampled area. Cell-free DNA in the blood stream, released from normal and cancerous cells when they die, offers an attractive way around these problems.

Researchers elsewhere have shown that whole-exome sequencing of cell-free DNA provides information comparable to that obtained from biopsies. But in previous work, tumor DNA made up an unusually large proportion of the cell-free DNA — from 33 to 65 percent — leaving it unclear how practical the approach could be. The OHSU researchers showed that it’s feasible in more typical cases when tumor DNA makes up only a small fraction of the cell-free DNA, less than 8 percent.

The study – “Exome sequencing of cell-free DNA from metastatic cancer patients identifies clinically actionable mutations distinct from primary disease” – was published last month in the open access journal PLOS ONE.


OHSU scientists awarded major NIH grant to study substance abuse and adolescent brain development

A team of three OHSU researchers were selected by the National Institutes of Health today to receive a major grant for a long-term study tracking the effects of adolescent substance abuse on the developing brain. Damien Fair, P.A.-C., Ph.D., Bonnie Nagel, Ph.D., and Sarah Feldstein Ewing, Ph.D., were awarded one of 13 grants looking at cognitive and social development in approximately 10,000 children across the U.S. The total amount from NIH for this award is $30 million annually. logo-abcd-study

The Adolescent Brain Cognitive Development (ABCD) Study will follow approximately 10,000 9-to-10 year olds before they initiate drug use, through the period of highest risk for substance use and other mental health disorders. Scientists will track exposure to substances (including nicotine, alcohol, and marijuana), academic achievement, cognitive skills, mental health, and brain structure and function using advanced research methods.

Researchers have long hypothesized that there is a strong link between adolescent alcohol abuse and long-term harmful effects on brain development. The ABCD Study will seek to address this link, helping inform prevention and treatment research priorities, public health strategies, and policy decisions, including:

  • What is the impact of occasional versus regular use of marijuana, alcohol, tobacco, and other substances, alone or in combination, on the structure and function of the developing brain?
  • How does the use of specific substances impact the risk for using other substances?
  • What are the brain pathways that link adolescent substance use and risk for mental illnesses?
  • What impact does substance use have on physical health, psychological development, information processing, learning and memory, academic achievement, social development, and other behaviors?
  • What factors (such as prenatal exposure, genetics, head trauma, and demographics) influence the development of substance use and its consequences?

The 13 grants issued today will fund a Coordinating Center, a Data Analysis and Informatics Center, and 11 research project sites. OHSU will serve as one of the 11 research project sites, where all three scientists will serve as principal investigators. In addition, Fair will serve as a co-investigator for the Data Analysis Center.

CRAN is comprised of NIDA, NIAAA and the National Cancer Institute. Other NIH collaborators in this project are the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute of Mental Health, the National Institute on Minority Health and Health Disparities, the National Institute of Neurological Disorders and Stroke; and the Office of Behavioral and Social Sciences Research.

NIDA has a special section on its website related to the current state of the science on substances and brain health.

NIH funding policy on use of human pluripotent cells in regenerative medicine

The field of regenerative medicine continues to expand, seeking potential therapies for replacing, rejuvenating, or engineering human cells to restore function. This line of research often involves the use of human pluripotent cells – “master” stem cells with the potential to produce any cell or tissue in the body and also capable of self-renewal. Work in this field has led researchers to consider introducing pluripotent cells to early-stage animal embryos to grow human tissue and organs. Given the bioethical considerations and NIH’s current Guidelines for Human Stem Cell Research, which renders certain stem cell research ineligible for NIH funding, the NIH will not fund research in this area until a thorough examination of the science has been undertaken.

See the full announcement for further details on how this policy, effective Sept. 23, 2015, impacts current funding, as well as proposals already under review that include Research Involving Introduction of Human Pluripotent Cells into Non-Human Vertebrate Animal Pre-Gastrulation Embryos.

NIH-funded core facilities – future directions and OHSU’s model

As you know, Sally Rockey has stepped down from her position at NIH where she steered the Office of Extramural Research for five years. During Rockey’s tenure, she launched a blog, “Rock  Talk,” that lent transparency to NIH decision making and allowed the research community to voice their opinions. In her last few Rock Talk postings, Rockey shared some insights and updates on current NIH priorities and resources including a discussion on NIH-supported core facilities.

Rockey affirmed NIH’s commitment to continued support for core facilities and stressed the importance of these cores as hubs of innovation at research institutions. As part of this commitment, NIH co-hosted a “Workshop on Enhancing Efficiency of Research Core Facilities” with the Association of Biomolecular Research Facilities in March of this year. The workshop focused on identifying best practices, existing challenges, and suggested standards moving forward.

The primary outcome of the meeting was a set of recommendations for NIH and research institutions to consider. Among them was that institutions each develop a core strategic plan that facilitates coordination among all core facilities and encourages core resource sharing between institutions. One of the first steps in developing these strategic plans is to take inventory of what cores exist and where duplicate services occur within NIH’s funded portfolio. NIH’s goal is to identify these inefficiencies, work with institutions to consolidate multiple similar cores into a single facility, and centralize administrative components (billing, tracking, etc.) via integrated information systems. As such, institutions are encouraged to develop inventories of their core facilities both internally and across institutions or within a geographic region.

OHSU is already aligned with NIH’s vision: our institution has long been an innovator in developing shared resources to support our research enterprise.  OHSU’s University Shared Resources (USR) program is widely recognized as an exceptional example of centralization borne of collaboration and participation of multiple stakeholders. Director Andy Chitty has been asked to speak about the program’s structure, governance, and incentives approach (some good news about pilot funding will be announced soon, so stay tuned) at many conferences. OHSU also takes a leadership role with the Association of Biomolecular Resource Facilities professional organization. Andy Chitty is president of our regional chapter, and OHSU hosted this year’s Western Association of Core Directors conference with more than 110 in attendance.

For more information, a full report on the workshop can be found here and the NIH Office of Extramural affairs published FAQs that address NIH policies and considerations about cores.


OCTRI Design Studio: Get feedback on your project from senior faculty

Are you submitting a career development K award? Or your first R01? A similar major grant?

The Oregon Clinical and Translational Research Institute has an opportunity for basic and clinical scientists to present their research and get constructive feedback from OHSU scientists to improve their chances of success. The OCTRI Design Studio has helped many OHSU researchers improve their aims and identify important areas of improvement before submitting awards.

The Design Studio has openings at three scheduled meetings for this

  • Tuesday, Oct. 13, 12 to 2 p.m., location TBD
  • Tuesday, Nov. 10, 12 to 2 p.m., location TBD
  • Tuesday, Dec. 8, 12 to 2 p.m., location TBD

Please check the OCTRI Design Studio page for updated locations. OCTRI’s Design Studio has been a great opportunity for basic scientists as well as clinical scientists at all levels of training. To learn more about the Design Studio or presenting please contact Karen McCracken.

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