OHSU Institutional Biosafety Committee policy on dual use research of concern

Recently, new U.S. government policy was implemented outlining increased oversight for dual use research of concern.

Dual use research of concern is defined as research that can, based on current understanding, be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health and safety, agricultural crops or other plans, animals, the environment, material, or national security.

In response to the change in federal regulations, the Institutional Biosafety Committee (IBC) in OHSU’s research integrity office posted a policy outlining the definition of dual use research of concern, the process for reporting, assessment and mitigation procedures, and how OHSU will meet federal reporting requirements.

This policy applies to all OHSU faculty, staff, and students who conduct clinical or basic science research involving one of the 15 high hazard agents or toxins identified in the policy. This list includes infectious agents that require biosafety level 3 or higher containment and/or botulinum neurotoxin.

Please contact the Institutional Biosafety Committee at ibc@ohsu.edu for questions about these new federal regulations, the OHSU policy, or if you are uncertain if this policy applies to your research.

MedTech Alliance one-year anniversary attracts largest crowd to date

Abhijit Banerjee, PhD, MBA, and Steve Young

Abhijit Banerjee, Ph.D., M.B.A., and Stephen Young

On Wednesday, Nov. 4, OHSU hosted its third MedTech Alliance program meeting and marked the one-year anniversary of the program launch. The meeting attracted over 150 attendees, including representatives from industry and investor groups, OHSU faculty and staff, and the Portland business and startup communities. The MedTech Alliance program allows investors, industry representatives, and community partners to stay up to date on early-stage collaboration and investment opportunities at OHSU. The goal of the MedTech Alliance is to facilitate collaborations and investment opportunities in order to advance OHSU innovations.

Speakers at the event included:

  • Michael Baker, partner of Due North Innovation spoke on behalf of Qview Health, Inc., a company that is developing an electronic peer-review system to improve hospital quality improvement programs
  • David Huang, M.D., founder of Gobiquity Mobile Health, Inc., an OHSU startup that is creating the world’s first smartphone app for the early detection and monitoring of visual disorders
  • Clyde Taylor, CEO of OregonHeart, Inc., an OHSU startup that is developing an artificial heart device with a 10-year lifespan
  • Jan van Santen, Ph.D., president and CEO of Biospeech, Inc., an OHSU startup that is developing the first English and Spanish computerized auditory rehabilitation device, called HearApp

Poster presenters and their technologies included:

  • Connor Barth, graduate student researcher in Biomedical Engineering, Fluorophores for image-guided surgery
  • Erin Gilbert, M.D., assistant professor of surgery in the Division of Gastrointestinal and General Surgery, Eliminating retained surgical items using an embedded detector system
  • Gregory Landry, M.D., vascular surgeon in the Knight Cardiovascular Institute, Remote endarterectomy device
  • John Muschler, Ph.D., research associate professor in Biomedical Engineering, Novel bioconjugates for detection and treatment of bladder disease
  • Jiri Sklenar, Ph.D., associate professor in the Knight Cardiovascular Institute, Cardiology software for visualizing patient data

The next MedTech Alliance meeting is scheduled for early 2016. For questions or inquiries regarding the MedTech Alliance program, please contact Trish Pruis, PhD, alliance manager, at pruist@ohsu.edu.

OHSU’s MedTech Alliance was founded by OHSU’s Office of Technology Transfer and Business Development and the Oregon Clinical and Translational Research Institute.

Medical Research Foundation honors top Oregon scientists, mentors

The Medical Research Foundation of Oregon has announced the recipients of its 2015 awards for scientific leadership and innovation in Oregon. The awards were presented Thursday, Nov. 12.

Established in 1942, the MRF promotes medical research achievement across the state. In addition to awarding its annual leadership and innovation honors, it administers more than $1 million in annual research funding and early investigator grants that support the work of outstanding investigators at research institutions across Oregon.

Peter Harmer, Ph.D., M.P.H., A.T.C

Peter Harmer, Ph.D., M.P.H., A.T.C

The Mentor Award was presented to Peter Harmer, Ph.D., M.P.H., A.T.C., associate research scientist at the Oregon Research Institute and professor in the Department of Exercise Science at Willamette University. While Harmer’s primary research focus is on fall prevention in older adults, he also studies the epidemiology of sports injuries. Harmer was recognized for inspiring students to challenge their assumptions, hold themselves to high standards and develop skills in rigorous scientific inquiry.

Judith S. Eisen, Ph.D.

Judith S. Eisen, Ph.D.

The Discovery Award was presented to Judith S. Eisen, Ph.D., professor of biology in the Institute of Neuroscience at the University of Oregon. Eisen was recognized for her seminal work in transforming the zebrafish into a groundbreaking research model for biomedical science. Eisen’s work was critical in propelling zebrafish from a local model used only by a handful of University of Oregon research laboratories to becoming one of the premier models for studying the mechanisms underlying vertebrate development, homeostasis and diseases in hundreds of laboratories in more than 30 countries around the world.

Michael S. Cohen, Ph.D.

Michael S. Cohen, Ph.D.

A Richard T. Jones New Investigator Award was presented to Michael S. Cohen, Ph.D., assistant professor of physiology and pharmacology in the Oregon Health & Science University School of Medicine. Cohen’s research program melds his background in chemistry with his postdoctoral training in cell biology and neuroscience, and has already influenced the fields of chemical biology, cell biology and pharmaceutical chemistry. Cohen developed a novel strategy that combines chemistry and genetics to identify the direct targets of a family of enzymes known as PARPs (Poly-ADP ribose polymerases) in neurodevelopment. His work may have great impact on our understanding of ADP-ribosylation in biological processes ranging from immunology to cancer.

Brad J. Nolen, Ph.D.

Brad J. Nolen, Ph.D.

A second Richard T. Jones New Investigator Award was presented to Brad J. Nolen, Ph.D., an associate professor in the Department of Chemistry and Biochemistry and the Institute of Molecular Biology at the University of Oregon. Nolen was recognized for using sophisticated biochemical and biophysical techniques to answer fundamental questions about cytoskeleton regulation. His research has significantly advanced knowledge about how living cells move and change shape, which is a fundamentally important problem in biology and biochemistry. Nolen’s work may provide the framework for new advances in treating cancers and infectious diseases.


Two-part OCTRI research forum: Clinicaltrials.gov registration, Dec. 3 and Jan. 7

Join the Oregon Clinical and Translational Research Institute, OCTRI, in a two-part research forum that addresses the Clinicaltrials.gov registration process and resources.

Clinicaltrials.gov registration Part 1: Background, registration process, and study maintenance
Presenters will discuss the reasons for clinical trials registration, which studies are required to be registered, and the processes for registering studies at OHSU.  The requirements for ongoing registration maintenance and common questions and problems will also be covered.
Presenters: Bridget Adams, Lara Fournier, and Laura Bradley
Thursday, Dec. 3, 2015
12 to 1 p.m.
Mackenzie Hall, 2201

Clinicaltrials.gov registration Part 2: Submitting results, timelines, and frequent reporting problems
Presenters will discuss how to submit study results and adverse events to Clinicaltrials.gov including: timelines, frequently encountered problems and resources.
Presenters: Bridget Adams, Lara Fournier, and Laura Bradley
Thursday, Jan. 7, 2016
12 to 1 p.m.
Mackenzie Hall, 2201

Click here for more information about the OCTRI Research Forum.

OCTRI invites all faculty and staff to discuss issues and solutions to common obstacles in conducting clinical and translational research. Do you have a clinical or translational research question? Let us know, and we’ll do our best to help during these events! Please submit questions and topic requests to Colleen Berreta.


NIH requests for information: Optimizing NHLBI trials and improving diversity in the physician scientist workforce

1) The National Heart, Lung, and Blood Institute (NHLBI) is seeking input from the clinical trials community on how to optimize the trials NHLBI supports and administers. Of particular interest are performance milestones and metrics for selection, design, planning, conduct, and management of clinical trials including timely reporting of results to enhance scientific and public health impact. Critical elements identified by the community can then be addressed in Funding Opportunity Announcements to help guide investigators in meeting performance milestones.

The NHLBI seeks comments on any or all of the following topics:

  • Characteristics of a successful clinical trial (recognizing that a clinical trial can be assessed in a variety of ways, including but not limited to advancing science and completing a trial on time and on budget).
  • The best predictors of clinical trial completion.
  • Types of information applicants should be encouraged to include in their application to demonstrate the methodological and operational soundness of their clinical trial proposal (i.e., that the trial could realistically be completed on time, on budget, and meet its primary endpoint).
  • Performance milestones that should be addressed in clinical trial applications.
  • Meaningful metrics that could be used to assess progress toward those milestones.
  • Ways NHLBI can work with investigators to facilitate planning in advance of clinical trial applications.
  • Ways NHLBI can work with investigators to foster successful completion of their trials.
  • Ways NHLBI could engage the community when considering new approaches to the conduct and management of clinical trials (in addition to this RFI).

Please submit your comments by December 28, 2015 to NHLBIClinicalTrials@mail.nih.gov.

2) The NIH’s Physician-Scientist Workforce Working Group (PSW-WG) issued a report in June 2014 containing recommendations for strengthening this sub-set of the biomedical workforce. Since then, the Working Group recognized the PSW report does not sufficiently address diversity. A request for information on Strategies to Increase Diversity in the Physician-Scientist Workforce will be published later this month or early December 2015. The NIH will seek comments on

  • Unique trajectories
  • Barriers
  • Successful strategies to enhance PSW diversity
  • Existing successful programs

Additional information will be posted here when the full RFI is released.

AAALAC celebrates 50 years, OHSU acknowledged as long-standing partner

AAALAC International (Association for Assessment and Accreditation of Laboratory Animal Care) is marking 50 years in its role of promoting the humane treatment of animals in science by reflecting on its achievements within the fields of laboratory animal science and medicine and honoring its first accredited organizations, member organizations, and council officers. In 1965, AAALAC’s Articles of Incorporation in Illinois led to the accreditation of two organizations that set a trend for major research universities across the U.S. to embrace the accreditation program and process. Early-adopting government agencies included the National Institutes of Health and the Centers for Disease Control.

In honor of its five decades of service, AAALAC International looked back to the 50 organizations that were among the first to earn accreditation and remain steadfast participants in the accreditation program today. Listed in order in which the organizations originally received accreditation status:

  1. University of Louisville
  2. Howard University College of Medicine
  3. City University of New York, The Mount Sinai Medical Center
  4. Tufts-New England Medical Center
  5. Wake Forrest University
  6. Harvard Medical School
  7. University of Rochester, School of Medicine and Dentistry
  8. University of Kentucky Medical Center
  9. Oregon Health & Science University
  10. University of Southern California

The rest of the list can be found in the news section of the AAALAC’s website.

AAALAC International is a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. More than 950 companies, universities, hospitals, government agencies, and other research institutions in 41 countries have earned AAALAC accreditation, demonstrating their commitment to responsible animal care and use. These institutions volunteer to participate in AAALAC’s program, in addition to complying with the local, state, and federal laws that regulate animal research.

Revised instructions on K99/R00 eligibility

On November 17, the NIH issued a clarification of the eligibility guidance for investigators applying to the “NIH Pathway to Independence Award (Parent k99/R00)” as follows:

Part 2. Section III.1. Eligible Applicants

Current Instruction
Eligible Individuals (Program Director/Principal Investigator)
K99 applicants must have no more than 4 years of postdoctoral research experience at the time of the initial or the subsequent resubmission or revision application, and must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program.

Revised Instruction – changes in blue
Eligible Individuals (Program Director/Principal Investigator)
Effective with applications for the February 12, 2016, due date and beyond, K99/R00 applicants must have no more than 4 years of postdoctoral research experience as of the relevant application due date regardless of whether it is a new or resubmission application. Individuals must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program.


OHSU librarian selected for NLM/AAHSL leadership fellows program

Stephanie Kerns 2The National Library of Medicine and the Association of Academic Health Sciences Libraries has named Stephanie Kerns, M.L.S., associate university librarian for information and research services for the OHSU Library, to its jointly sponsored leadership fellows program. The program prepares emerging leaders for director positions in academic health sciences libraries through a year-long mentoring relationship with a director of another library and a curriculum focused on developing leadership knowledge critical to enhancing the value of libraries in their institutions. Kerns is one of 10 fellows and mentors from academic health sciences libraries across the U.S. who will begin their program in November.

In her current role, Kerns provides leadership, vision, and management for the OHSU Library’s liaison, education and outreach programs, library service desk, and collections services. She was previously the head of information and access services at the Hirsh Health Science Library at Tufts University in Boston, and served as education and outreach and curriculum librarian at the Galter Health Sciences Library at Northwestern University in Chicago. She has also worked Pepperdine University, California State University, University of Southern California, and Georgetown University. Kerns is an active member of the Medical Library Association, having served as chair of the educational media and technology section, and currently serving on the MLA Technology Advisory Committee. Kerns received her bachelor’s and master’s degrees from Indiana University in Bloomington.

Since the NLM/AAHSL leadership fellows program began in 2002, 27 fellow graduates have assumed director positions. Read more about the leadership fellows program here.

NIH update on Precision Medicine Initiative Cohort Program

NIH Director, Francis Collins, released a statement on November 17, 2015 about progress made toward establishing a national research cohort that will be involved in  implementing the President’s Precision Medicine Initiative (PMI). The cohort will consist of roughly one million volunteers from all walks of life who will share genetic data, biological samples and diet/lifestyle information to lay the scientific foundation for precision medicine.

According to Collins, the following has already been accomplished since mid-September of this year:

  • The first set of funding opportunities has been announced. These projects aim to build a solid infrastructure for the PMI Cohort Program, including establishing a coordinating center, biobank, communication framework, network of healthcare provider organizations, and participant mobile technologies. Additional funding is available to develop a pilot program to inform the creation of the enrollment component of the cohort.
  • The initial PMI Cohort Program Advisory Panel has been established. This panel consists of a group of outside advisors who will provide on-going guidance and oversight of the cohort, while contributing to the evolution of the program’s vision, goals, and operations. Additional members will be added over time.
  • A nationwide search for a permanent director of the PMI Cohort Program is well underway. Dr. Josephine Briggs, Director for the National Center for Complementary and Integrative Health will continue to serve as interim until a permanent director has been found.
  • PMI Privacy and Trust Principles were recently issued by the White House Office of Science and Technology Policy to ensure privacy is built into the foundation of the Initiative.

Pending Congressional appropriations, NIH will begin enrollment in 2016. Learn more about the PMI and track updates here.

Who’s new at OHSU? Marina Guizzetti, Ph.D.

Marina Guizzetti, Ph.D., is an associate professor in the Department of Behavioral Neuroscience at OHSU and a research biologist with the Portland VA Health Care System. Her research focuses on the neurodevelopmental effects of alcohol on the developing brain, specifically looking at Fetal Alcohol Spectrum Disorders.

Marina Guizzetti and family

Marina Guizzetti and family

Where are you from originally?
I’m from northern Italy and also where I was educated. I got my degree at the University of Pavia just south of Milan. This is the same university from which Camillo Golgi, who won the Nobel Prize in 1906 for his work on the structure of the nervous system, graduated and worked for most of his career. Among other things, he discovered a technique for staining brain tissue he called “reazione nera” (black reaction) that’s still in use today. I completed my Ph.D. at the University of Milan. In 1994, I moved to Seattle to do my postdoc at the University of Washington. I was there for six years as a postdoc and another 10 years as a research scientist. I then moved to the University of Illinois in Chicago to take a position as associate professor and was there for about five years before coming to OHSU in February.

What brought you to OHSU?
My predecessor in this position retired, and I was approached by the VA and OHSU’s Department of Behavioral Neuroscience to replace her, as our research was well aligned. The department has a very large program on alcohol research, and I have been working in this field since I came to the U.S. in 1994. It was a good fit.

What is the primary focus of your research?
Since my time at the University of Washington, my work has focused on the cellular mechanisms involved in the neurodevelopmental effects of alcohol on the developing brain underlying Fetal Alcohol Spectrum Disorders, or FASD. In utero alcohol exposure causes a wide range of developmental effects including Fetal Alcohol Syndrome at the most extreme end of the spectrum.

While I’m now working in the Department of Behavioral Neuroscience, I’m actually a cell biologist by training and love the mechanistic aspect of neuroscience research. I’m particularly interested in glial cells and their role in modulating neuronal development and function. The word glia is derived from ancient Greek and literally means “glue.” When these cells were first discovered, they were thought to do nothing other than keep neurons in place. But in the last 20 years, we’ve come to realize that they play a major role in brain physiology and pathology and are involved in a number of functions that, in the past, were considered neuron functions. Genomic studies of neurological disorders show that many of the genes that are mutated and change are glial genes. So, big changes occur in these cells, and it appears they have a role in the pathology of alcoholism and other conditions.

I study one particular glial cell type, astrocytes, that we now know are involved in the regulation of neuronal development. When we characterized the proteins released by these cells by proteomics, we identified many extracellular matrix proteins. During brain development, astrocytes release both extracellular matrix components that inhibit neuronal development (i.e. axonal and dendrite extensions) in certain directions and extracellular matrix components that promote neuronal development in other directions in temporary and spatially specific patterns. These components contribute to the formation of the proper network architecture. Later, in order for synaptogenesis to occur, astrocytes modify the factors they release. What we found is that when you treat the astrocytes with alcohol, you have a dysregulation of proteins being released, leading to inhibited neuronal development. Furthermore, when alcohol is removed from the astrocytes after treatment, the dysregulation persists. Astrocyte-mediated dysregulation of neuronal development has been reported also in other neurodevelopment disorders such as Down syndrome, fragile X syndrome, and Rett syndrome. The specific effects are different, but dysregulation of astrocyte function is common to several neurodevelopmental disorders.

For a diagnosis of FAS, growth retardation, neurodevelopmental dysfunction, and specific facial dysmorphic characteristics need to be present. However, even in the absence of these facial characteristics, heavy prenatal alcohol exposure can cause permanent cognitive and behavioral dysfunction. We know that alcohol affects brain development throughout gestation. We also know that binge drinking can be more destructive than lower levels of constant exposure. When alcohol exposure is milder or happens later in pregnancy, some of the physical characteristics associated with FAS may not be present or may disappear with age, making FASD particularly difficult to diagnose. While FAS is an official medical diagnosis, FASD is not. This means people suffering from it aren’t always eligible for government assistance, and yet these individuals may be severely impacted. Many of them have low cognition, extremely poor judgment, a tendency to abuse alcohol or other substances, and sadly, sexual disinhibition, which leads to pregnancies in young women who also drink. And the cycle continues. It’s very sad.

Does your research address treatment or prevention?
I have a program that looks at supplementation of choline during alcohol exposure in the rodent equivalent of  the third trimester of human gestation to see if it improves outcomes as other studies have indicated. I’m looking at the mechanisms by which choline may improve the effects of alcohol on the fetus. We have shown that ethanol affects DNA methylation in astrocytes. In this study, we explore whether epigenetic changes in DNA methylation induced by ethanol in astrocytes can lead to reduced neuronal structural plasticity and behavioral anomalies. Choline can modulate the epigenetic processes of DNA and histone methylation, but also it is a common dietary supplement that is safe to take by pregnant women and infants/children. Therefore, choline represents an ideal potential treatment to prevent and/or ameliorate the effect of excessive alcohol drinking during gestation.

What do you like to do for fun?
Well, work and family take a lot of time. What we have been enjoying is taking small trips around Oregon. We like to cook, and my favorite thing to make, because I like to eat it, is homemade gnocchi. So, we like to hike and we like to eat. My husband wants to try a new restaurant every week because the food in Portland is so fantastic. We’re delighted to be here!

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