May  2017
News
Trial Innovation Network

In the January/February edition of our newsletter, we introduced the Trial Innovation Network as a collaborative national network that focuses on operational innovation, excellence and collaboration that will use the expertise and resources of the CTSA Program.

The Trial Innovation Network is aimed at advancing clinical trials in a better, faster, and more cost-effective way. The Trial Innovation Network is able to: 

  • Identify & track Trial Innovation Network studies
  • Pair study opportunities with Investigators
  • Assist in navigating the site selection process
  • Facilitate SOP development for local Hub team

By featuring a single IRB system, master contracting agreements, quality by design approaches, and a focus on evidence-based strategies to recruitment and patient engagement, the Trial Innovation Network helps researchers navigate the clinical trial process. 

Any full-time faculty at Case Western Reserve University can submit a proposal  to the Trail Innovation Network through the Trial Innovation Liaison Team. The CWRU Trail Innovation Liason Team consists of James Chmiel, MD, Co-Medical Director; Lara Jehi, MD, Co-Medical Director; and Project Coordinator Noreen Roman, MT(ASCP), MBA, who is the primary point of contact and can be reached at nroman@metrohealth.org or 216.778.3130.

Congratulations to the March 2017 CTSC FDA Guidance Core Utilization Pilot Awardees!
Michael Gibson, MD
University Hospitals Cleveland Medical Center
“Afatinib and Nivolumab as Treatment of Platinum- and Cetuximab-Refractory Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)”
Johnathan Sheele, MD, MPH
University Hospitals Cleveland Medical Center
“Oral Ivermectin for the Elimination of a Bed Bug Infestation”
What Type of Leader Do I Want to Be?
Congratulations to Sumita B. Khatri, MD, MS & Lisa M. Mencini, CPA, MBA who were recently published in the NEJM Catalyst! Khatri and Mencini write on the impact leadership has in healthcare professions, and the lack of focus there is on developing leadership skills within the healthcare community. They outline different styles of leadership and the impact that leadership programming, such as FLEX, has had on healthcare professionals.

Researchers: Pure Experts can connect you with other researchers!
In an effort to promote multi-disciplinary clinical and translational research, the Clinical and Translational Science Collaborative of Cleveland (CTSC) is pleased to introduce  Pure Experts, a directory of researcher expertise that enables collaboration among researchers.

This expertise portal is a key component of the CTSC's mission to catalyze new knowledge 
and discovery to enhance and improve patient care and promote better health in the community.

Pure allows you to:
  • Capture and structure your research data centrally
  • Identify funding, expertise and collaborative partners
  • Report on the reliable, validated data
  • Analyze the progress of your teams and departments
  • Showcase your accomplishments
For more information about Pure, please see the Pure Brochure.
Do you know the difference between a PMID and a PMCID?
A PMID, also known as the PubMed reference number, is a number assigned by the NIH National Library of Medicine to papers indexed in PubMed.

The PMC reference number (PMCID) is assigned when the article is deposited in "PubMed Central", a full-text repository of publications that are funded by NIH. It is the proof of compliance that you must include when submitting applications, proposals, and reports to the NIH.

Have questions? Need help? Contact the CTSC at ctsc-administrator@case.edu.

View the full compliance checklist for submitting a manuscript.

News from the PRCHN
PRCHN Seminars
Healthy Neighborhoods
5/10/17-
The Future of Food in Your Neighborhood: the foodNEST Study

5/31/17-
Tobacco Research Day
PRCHN Faculty and Staff

6/14/17-
Approach to multi-level modeling
Don Hedecker, PhD, University of Chicago

You can find more information on these seminars and other PRCHN programs   here.
For more news from PRCHN check out their  e-newsletter!

Did you miss the PRCHN webinar?
Watch a recording of the PRCHN webinar on how Prevention Research Centers (PRCs) and public health partners are reducing health disparities by implementing nutrition policies and programs that increase access to healthy food in low socioeconomic communities.The Association of State and Territorial Health Officials (ASTHO) and the Centers for Disease Control (CDC) sponsored the webinar. 

Watch the webinar here! (A name and email is required to watch)
Healthy Retail Initiative expands with Chronic Disease Self Management classes
The Healthy Retail Initiative is leading a new project called Chronic Disease Self Management (CDSM). CDSM is a set of classes which give individuals with a chronic disease the tools to live a healthier life.  


Darcy Freedman to Teach at OSU's Summer Program in Population Health
Associate Director of the PRCHN, Darcy Freedman, PhD, will be teaching a segment called "Promoting Social & Built Environments to Support Healthy Food Access in the Community" during Ohio State University's Summer Program in Population Health from June 21-23. 

News from the Urban Health Intiative
Urban Health Happenings

What Does Internet Access Have To Do with Health?

The Urban Health Initiative continues efforts to raise awareness of internet access and digital skills (collectively called “digital inclusion” as a fundamental social determinant of health.  Internet access, either via fixed broadband or through mobile access, has a direct impact insofar as it enables patients to communicate with their providers, track and report symptoms, view their laboratory test results and order medication refills, for example.  Smartphone-based apps can support healthy behaviors such as smoking cessation, tracking nutritional intake, encouraging physical activity and providing medication reminders.  Indirectly, internet access and skills are virtually essential for education, applying for jobs or loans, and even obtaining government benefits.  And crucial for the CTSC, internet access is increasingly essential for participation in clinical research.

Adam Perzynski and colleagues recently published an important paper documenting disparities in the uptake of MyChart, the patient portal to the Electronic Health Record at MetroHealth.  Overall uptake was lower for blacks (23.4%) and Hispanics (23.8%) versus whites (34.1%) and for patients with no or public insurance (17.4% - 26.5%) versus commercial insurance (39.3%).  But especially interesting is that patients living in neighborhoods better served with high-speed internet were considerably more likely to use MyChart than those living in less well-served neighborhoods. 

This disparity is not simply a matter of the affordability or preferences in using the internet.

Thanks to efforts of partners at community organizations we work closely with, national attention was recently drawn to an analysis that showed that one of our main local internet service providers “has systematically discriminated against lower-income Cleveland neighborhoods in its deployment of home internet and video technologies over the past decade…Because the patterns revealed by this analysis result from a decade of deliberate infrastructure investment decisions, NDIA and CYC believe they constitute strong evidence of a policy and practice of “digital redlining” by AT&T — i.e. income-based discrimination against residents of lower-income urban neighborhoods in the types of broadband service AT&T offers, and in the company’s investment in improved service.” 

Other communities are now clamoring to replicate the analysis done in Cleveland.  The first results completed show similar patterns in Dayton, Ohio.  The University of California, Berkeley just published an analysis showing statewide that the median income of household with access to AT&T’s gigabit fiber network is $32,297 higher than in areas lacking this access.  Laws regulating broadband deployment differ by state, but the deployment pattern in Ohio may violate state laws against provision of telecommunication services on the basis of race or income.   In response, a high profile attorney has issued notice of his intention to file a lawsuit on behalf of Cleveland residents who claimed to have been harmed by their lack of internet access. 

Local action to address digital inclusion

As part of its recognition of Digital Inclusion Week, Cleveland City Council is planning a hearing on Wednesday, May 10th.  The organizers have asked the Urban Health Initiative to  prepare and provide Health Data MattersLiveStories maps showing how internet access disparities compound the effects of racial segregation and poverty. 

These and other issues were explored  on Health Data Matters during the first meeting, in April, of a Public Health Data Sector workgroup meeting convened by DigitalC, and during a 2-hour workshop, also hosted by DigitalC in April, helping community and government organizations to use Health Data Matters’  LiveStories platform. 

Bringing Community Health Perspectives to Medical Innovation

Urban Health Initiative Executive Director Amy Sheon served on the planning committee for the first Cleveland Medical Capital Innovation Competition.  The April 25-26th competition included 22 professional and 5 collegiate teams selected from 180 applicants.  Amy was one of several mentors who helped teams shape the pitch they would give to judges on Day 2.  Her particular focus was on the importance of incorporating perspectives of underserved populations and of considering the population health impact of their technologies. 

A Case Western Reserve University team was among the top winners in the competition.

News from our Colleagues
Save the Date for NCATS Advocacy Day
June 30, 2017
NCATS will host its inaugural  NCATS Advocacy Day - Partnering with Patients for Smarter Science on  June 30, 2017, 9:00 a.m. - 4:00 p.m., at the John Edward Porter Neuroscience Research Center, National Institutes of Health, Bethesda, Maryland. The goal is to inform patients and their advocates about NCATS and its programs, identify patient needs and collectively discuss ways for enhanced patient inclusion in NCATS'  translational science activities.

Research Highlights
KL2 Scholars, Ron Hickman & Andrew Reimer, Simulate Nurse Flight Stress

Ronald L. Hickman Jr. & Andrew P. Reimer, KL2 scholars from the Frances Payne Bolton School of Nursing at CWRU, tested physiological and psychological stress levels of flight nurses with life-like flight simulators to determine the benefits for flight nurse training. Stress levels were assessed by monitoring heart rates during the simulation. A post simulation survey was completed by participants to gauge the realism of the simulator. “Although the impact of simulation on patient-oriented outcomes is unknown," the authors commented," most participants report increased confidence and feeling better prepared for actual clinical practice after simulation training."

Read the full article in AirMed & Rescue Magazine

Congratulations to the Recipients of the 2017 Faculty Distinguished Research Award! 
Congratulations to the outstanding individuals who have received the 2017 Faculty Distinguished Research Award! Read more about their time at Case Western Reserve University and their research in the daily.
Fabio Cominelli, the Hermann Menges M.D. Professor of Internal Medicine
Mark Griswold, professor of radiology
Ruth A. Keri, the Arline H. and Curtis F. Garvin MD and Constance C. Frackelton Professor in Cancer Research
Scott Shane, the A. Malachi Mixon III Professor of Entrepreneurial Studies and professor of economics
Ted Steinberg, the Adeline Barry Davee Distinguished Professor of History and professor of law
Photos are from thedaily.case.edu and are credited to Dan Milner and Anthony Gray.
Noteworthy Research
Events
Annual Department of Medicine Research Day
May 12, 2017

The Department of Medicine Research Day will be held on Friday, May 12, 2017 at the Wolstein Research Building.  Information regarding registration can be found at http://www.cwrumedicine.org/research-day .

For more information please contact Martha Salata at 844-1988 or mks18@case.edu.

CRSP 401 "Introduction to Clinical Research"
Application Deadline: May 15, 2017
Seminars will be held from July 5 - 27, 2017 in the mornings in the Wolstein Research Building.

If you would like to apply please read fully this  informational flyer and the instructions for both  Non-CRF applications and  Non-Degree applications.

For questions contact Angela Bowling (axb710@case.edu).

Save the Date! OHRP Research Community Forum
September 6-7, 2017
Northern Kentucky Convention Center, Covington, KY
The Cincinnati CTSA will be hosting a two-day human subject protection forum consisting of an academic conference and an applied workshop relevant for institutional review board (IRB) members, IRB administrators, clinical investigators, research scientists and support staff, sponsors, contract research organizations, government regulators, and members of the research community.
Representatives from the Office of Human Research Protection (OHRP) and other federal agencies as well as research experts will provide perspectives and resources for interpreting and applying human subject protections in an evolving regulatory landscape.
Tracks include:
  •          Social/behavioral research
  •          Biomedical research
  •          Innovative research
  •          Regulatory landscape
  •          Community engagement
Registration information and full agenda coming soon!

Funding Opportunities
Bill & Melinda Gates Foundation
Application Deadline: May 3, 2017

The Bill & Melinda Gates Foundation is inviting proposals for the latest round of Grand Challenges Explorations. Grand Challenges Explorations fosters early-stage discovery research to expand the pipeline of ideas for solving our greatest global health and development challenges. Launched in 2008 with an initial $100 million commitment from the foundation, Grand Challenges Explorations grants have already been awarded to more than 1200 researchers in more than 65 countries.

Applicants can be at any experience level; in any discipline; and from any organization, including colleges and universities, government laboratories, research institutions, non-profit organizations, and for-profit companies. Initial grants will be US $100,000 each, and projects showing promise will have the opportunity to receive additional funding of up to US $1 million. 

Applications will be accepted on the following four topics:

  • Health Systems Strengthening: Ensuring Effective Health Supply Chains;
  • New Approaches for Improving Timeliness of Routine Immunizations in Low-Resource Settings;
  • Wearables and Technology for Maternal, Neonatal and Child Health Behavior Change;
  • Innovations for Integrated Diagnostics Systems;

Application Deadline: May 3, 2017

For more information visit the Grand Challenges website.

Taub Foundation
Application Deadline: May 19, 2017
The  Taub Foundation Grants Program for Myelodysplastic Syndromes (MDS) Research was created to support high-impact, innovative, translational research to understand the underlying causes of MDS and to advance its treatment and prevention.

Innovative studies with transformative potential to elucidate MDS etiology and to develop new treatments are particularly encouraged. Proposals focused on the progression of MDS to AML are not within the scope of this funding. 

The Taub Program supports independent investigators at all stages of their careers. To promote the expansion of the MDS research field collaborative efforts and proposals from young investigators and those from non-MDS fields are encourage to apply. 

Application Deadline: May 19, 2017

For more information visit the  Taub Foundation website.
Alex's Lemonade Stand Foundation
Application Deadline: May 22, 2017
Alex's Lemonade Stand Foundation evolved from the front yard lemonade stand of cancer patient Alexandra "Alex" Scott (1996-2004) into a national fundraising movement to raise awareness and find cures for all childhood cancers.

The purpose of the foundation's Reach Awards program is to advance its mission to find cures and better treatments for childhood cancers by providing support to move hypothesis-driven research into the clinic. To that end, the program supports late translational studies needed to ultimately initiate a clinical trial. Priority will be given to those research projects which, if funded, will result in the initiation of a clinical trial within two to three years. 

A successful application will identify an unmet clinical need relevant to the care of patients with pediatric cancer and describe how the work performed will allow for the translation of hypothesis-driven research to the clinic keeping broader clinical testing and implementation in view. 

Grants of up to $250,000 will be awarded over two years. 

Primary applicants may be an assistant-, associate-, or professor-level investigator with a track record of discovery, investigation, and external funding. Applicants may be an M.D., D.O., Ph.D, or M.D./Ph.D. In addition, applicants must have a demonstrated track record of pediatric cancer research and have experience in translational research. Multiple investigator applications that bring together pairs or teams of researchers with complementary expertise are encouraged.

Application Deadline: May 22, 2017

For more information visit the  Alex’s Lemonade website.
Centers for Disease Control - Racial and Ethnic Approaches to Community Health (REACH)
Application Deadline: May 23, 2017
Chronic diseases and their outcomes disproportionately impact racial and ethnic populations including African Americans/Blacks, Hispanic Americans, Asian Americans, Native Hawaiian/Other Pacific Islanders, American Indians and Alaska Natives. Attention to improving the access to high-quality nutrition, opportunities for physical activity and providing a smoke-free environment for young children are critical steps in reducing health disparities. The purpose of this FOA is to provide communities the opportunity to improve poor health, prevent chronic diseases and reduce health disparities among racial and ethnic populations with the highest risk, or burden, of chronic disease. Eligible applicants are unrestricted. Grant recipients will receive up to $1 million. 

Application Deadline: May 23, 2017

For more information visit the  Grants.Gov website.

Atomwise, Inc.
Application Deadline: June 12, 2017
Atomwise Inc seeks proposals from innovative university scientists to receive 72 potential medicines, generated specifically for their research by artificial intelligence. The Artificial Intelligence Molecular Screen (AIMS) program is designed to dramatically accelerate the race towards life-saving drugs by analyzing millions of compounds for each disease. Contributing cutting-edge AI technology and delivering physical molecules to as many as 100 labs, the program is the first of its kind.

AIMS is a streamlined program. Short applications are submitted online, and recipients will be announced three months from the submission deadline. No preliminary data is required and projects showing success can receive further support.

Atomwise develops artificial intelligence systems for drug discovery. Its groundbreaking AtomNet technology reasons like a human medicinal chemist, using powerful Deep Learning algorithms and supercomputers to analyze millions of potential treatments each day. 

Historically, discovering a single new medicine cost billions of dollars and took an average of 15 years – putting such research outside the reach of academic scientists. Atomwise helps predict the effectiveness of new drugs more rapidly, much like software used to simulate aircraft, buildings, and computer chips. 

Atomwise has already launched 27 drug discovery projects with leading research institutions. These partnerships are advancing research on diseases as diverse as Ebola, multiple sclerosis, and leukemia. Molecules predicted by Atomwise have become lead medicinal chemistry candidates and successfully treated animals in trials. 

Application Deadline: June 12, 2017

For more information visit the  Atomwise website.
Howard Hughes Medical Institute (HHMI) - 2018 HHMI Investigator Competition
Application Deadline: June 27, 2017

The Howard Hughes Medical Institute (HHMI) has announced that it seeks to appoint up to 20 new biomedical researchers through a national open competition. HHMI recently increased the standard term for HHMI investigators from five to seven years, providing longer term, flexible support as these scientists explore new research territory. The initiative represents an investment of approximately $168 million in basic biomedical research over the next seven years.

The HHMI investigator competition is open to basic researchers and physician scientists at more than 200 eligible institutions who bring innovative approaches to the study of biological problems in biomedical disciplines, plant biology, evolutionary biology, biophysics, chemical biology, biomedical engineering, and computational biology. Those selected in this competition will receive a seven-year appointment to HHMI, which is renewable pending favorable scientific review.

HHMI encourages its investigators to push their research fields into new areas of inquiry. By employing scientists as HHMI investigators—rather than awarding them research grants—the Institute is guided by the principle of “people, not projects.” HHMI investigators have the freedom to explore and, if necessary, to change direction in their research. Moreover, they have support to follow their ideas through to fruition—even if that process takes many years.

Application Deadline: June 27, 2017

For more information visit the HHMI website.

American Heart Association - Methods Validation Grants
Application Deadline: June 29, 2017

The Methods Validation Grants will focus on validating pre-existing methods including algorithms and analytic tools used to maximize the use of data in predicting outcomes. 

The purpose of the Methods Validation Grants is to identify methods to improve the integration and analysis of data within and across large and diverse datasets using cloud computing. A successful grant will include information on how the previous method or tool was used, the evaluation and validation of the proposed method, and the plan for utilizing the AHA Precision Medicine Platform http://precision.heart.org to serve the greater scientific community. 

The award seeks to test and validate:

  • new machine learning algorithms to curate and harmonize data in the cloud;
  • new natural language processing methods for electronic health records in the cloud;
  • new pipelines to enable more effective and efficient workflows for analyzing data in the cloud;
  • New pipelines for data curation in the cloud


These grants are open to all scientists. Knowledge of biology and/or computer science may be helpful. Collaboration with other scientists (in any field) is optional. Applicants are to provide proposals that adhere to the above broad objectives while specifically addressing the outlined goals. Faculty/ staff members conducting independent research at time of application. At application, principal investigator must hold an M.D., Ph.D., D.O. or equivalent terminal doctoral degree and must meet institutional requirements for grant submission. There are no field of study restrictions so long as the applicant demonstrates ability to complete the project proposal with the allotted time and money made available by the grant. Awardee must meet American Heart Association citizenship criteria and research status if at a foreign university throughout the duration of the award. Applicants are not required to reside in the U.S. for any period of time before applying for American Heart Association funding. 

Application Deadline: June 29, 2017

For more information visit the AHA website.

Little Giraffe Foundation
Application Deadline: July 14, 2017
The  Little Giraffe Foundation  is dedicated to funding neonatal research and supporting patients and parents of the NICU. The foundation is accepting Letters of Intent for 2017.

Grants of up to $10,000 will be awarded to qualified scientists, doctors, and nurses at universities, hospitals, and research institutions in support of research that addresses both the long-term and immediate health needs caused by premature birth as well as the causes of premature birth and ways to prevent it. Research subjects appropriate for support include basic biological processes governing development, genetics, clinical studies, studies of reproductive health, environmental toxicology, and social and behavioral studies. 

Letter of Intent Deadline: July 14, 2017

For more information visit the Little Giraffe website.

NIH: Neoantigen-Based Therapeutic Targeting of Head and Neck Cancers (R01)
Application Deadline: July 19, 2017
The purpose of this Funding Opportunity Announcement (FOA) is to support basic and preclinical research aimed at developing novel immunotherapeutic targets for head and neck cancers (HNC), including salivary gland cancers. Research supported by this FOA will identify human HNC-specific neoantigens, and will test the utility of these neoantigens as targets for eliciting anti-tumor immune responses in affected patient populations. 

Application deadline is July 19, 2017. 

For more information visit the  NIH website.
Special Funding Opportunities
Multiple Deadlines
Notice of Intent to Publish a Funding Opportunity Announcement for the National Centers for Translational Research in Reproduction and Infertility (P50) 
(NOT-HD-17-001)

NIDA Translational Avant-Garde Award for Development of Medication to Treat Substance Use Disorders (UG3/UH3)
(RFA-DA-18-003)

Alliance of Glycobiologists for Cancer Research: Translational Tumor Glycomics Laboratories (U01)
(PAR-17-206) 

NIDCD Research Grants for Translating Basic Research into Clinical Tools (R01)
(PAR-17-184) 

National Cooperative Drug/Device Discovery/Development Groups (U01) 
(PAR-17-185) 

National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental or Substance Use Disorders or Alcohol Addiction (U19) 
(PAR-17-186) 

Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R21)
(PAR-17-187) 

Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R03)
(PAR-17-188) 

Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R01)
(PAR-17-189) 

Advancing the Science of Geriatric Palliative Care (R01)
(PA-17-225) 

Advancing the Science of Geriatric Palliative Care (R21)
(PA-17-226) 

Resource-Related Research Projects in the Epidemiology and Prevention of Pediatric Injury (R24)
(PAR-17-228)

Avenir Award Program for Research on Substance Abuse and HIV/AIDS (DP2)
(RFA-DA-18-004)

Establishment of Research Centers to Investigate the FVIII Immune Response in Patients with Hemophilia A (U54)
(RFA-HL-18-014)

Neurosurgeon Research Career Development Program (NRCDP) (K12)
(RFA-NS-17-010)

Secondary Analysis and Integration of Existing Data to Elucidate the Genetic Architecture of Cancer Risk and Related Outcomes (R01) 
(PA-17-239) 

Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R01)
(PAR-17-193) 

Core Infrastructure and Methodological Research for Cancer Epidemiology Cohorts (U01)
(PAR-17-233) 

Mechanisms and Consequences of Sleep Disparities in the U.S. (R01)
(PAR-17-234) 

Genetic Susceptibility and Variability of Human Structural Birth Defects (R01)
(PAR-17-236) 

Innovative Research in Cancer Nanotechnology (IRCN) (R01)
(PAR-17-240)

Notice of Intent to Publish a Funding Opportunity Announcement to Support Competitive Revision Applications in Regenerative Medicine Innovation Projects (RMIP) (P41)
(NOT-HL-17-507)

Changes to FOA RFA-TR-17-001 "Pre-application for the NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules (X02)"
(NOT-TR-17-015)

Collaborative Research Projects to Enhance Applicability of Mammalian Models for Translational Research (Collaborative R01)
(PAR-17-244)

NIH-Industry Program Opportunities
Multiple Deadlines

Limited Competition for NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules (UG3/UH3) 

(RFA-TR-17-002)
 

  • National Center for Advancing Translational Sciences
  • National Institute of Dental and Craniofacial Research
  • Application Receipt Date(s): September 15, 2017, by 5:00 pm local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. 
Limited Competition for NIH-Industry Program: Discovering Pediatric New Therapeutic Uses for Existing Molecules (UG3/UH3) 

(RFA-TR-17-003)
 

  • National Center for Advancing Translational Sciences
  • National Institute of Dental and Craniofacial Research
  • Application Receipt Date(s): September 15, 2017, by 5:00 pm local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. No Late applications will be accepted for this FOA.