June 2018
News
Request a Service on the CTSC website!
https://case.edu/medicine/ctsc/
The CTSC website was recently redesigned to better promote the integration of our translational processes from discovery to clinical trials. It is our ultimate goal to bring together the discoveries of biomedical science to advance the well-being of our nation.

How can we help connect you to our resources? Request a service and we will work with you to find an answer.
Limited time offer: Health Data Matters resources are available for your research project!
On a trial basis, the CTSC is offering support from Health Data Matters for clinical and translational research needs of Case Western Reserve University Faculty.  This pilot effort will enable us to determine the resource needs for offering this service on a more widespread basis as a CTSC Core. This assistance is intended to support efforts of faculty in preparing grant submissions, for their primary research or for teaching related to clinical research.

The following are types of requests you can make from Health Data Matters:
  • Identify and procure non-PHI data sets on health outcomes and social determinants of health for residents of Cuyahoga County
  • Prepare datasets for analysis by, for example, aggregating data at a geographic level of interest or combining multiple data sets to explore relationships between socioeconomic factors and health
  • Conduct primary analysis of such datasets
  • Create interactive data visualizations (e.g. maps and charts)
  • Create stories that highlight findings in the data.
 
This offer is subject to availability of staffing. Contact Amy Sheon or Scott Frank to discuss Health Data Matters support for your project.
Effectively Implementing the Revised Common Rule
by Philip A. Cola, PhD and Madeleine Williams
Phil Cola, Associate Professor of Management in the Departments of Design and Innovation and Organizational Behavior at the CWRU Weatherhead School of Management and Madeleine Williams, Senior Director at Huron Consulting Group, presented this material as part of a presentation for the April 2018 Midwest/Southern Section meeting of the Society for Research Administrators (SRA). The presentation preceded the most recent announcement of an additional delay (see below).

On January 18, 2017 the U.S. Department of Health and Human Services (DHHS) and 15 other federal agencies issued a final rule to update the “Common Rule” regulations that safeguard individuals who participate in research. The final rule follows the September 2015 publication of the Notice of Proposed Rulemaking (NPRM). In response to concerns raised during the public comment period for the NRPM, and extensive subsequent review processes, the final rule contains a number of significant changes from the originally-proposed rule. It has been interesting to watch these developments evolve over the past three years because the Common Rule as promulgated in 1991, at 45 CFR 46, has not changed for more than 27 years. However, the past few years have brought a whirlwind of activity that has yet to be finalized. The original effective and compliance dates for the final rule was to be January 19, 2018, but this was delayed until July 19, 2018. Now, DHHS has issued another NPRM to further delay the general compliance date of the revisions to the Common Rule until January 21, 2019 1,2 .
Institutional Review Boards (IRBs) in the public and private sectors have been in the process of preparing for these pending changes. Many in the field of human subject protections are excited to have updates to this regulatory framework, but others have been anxious about implementing changes to policy, procedures and resource utilization strategies.  Changes to the effective and compliance dates have increased the uncertainty among IRB managers and administrators. This all comes at a time when Academic Medical Centers and other Research Institutions are also in the process of implementing the NIH’s Single IRB (sIRB) policy 3 , which represents additional uncertainty and challenges for implementation concurrently with the revised Common Rule.
The key changes to the existing Common Rule regulations include the following:
  1. Required additional content for informed consent documents
  2. Required use of single IRB for most multi-institutional research studies
  3. New options for the use of “broad consent” documents for research involving identifiable date or identifiable bio-specimens
  4. New categories of “exempt” human research
  5. Elimination of continuing review requirements for certain types of human research studies


[2] Williams, M., Hunter, J.M., & Kane, R. (April 23, 2018).  HHS Issues a NPRM to Further Delay the Revised Common Rule.  Huron's Clinical Research Management Briefing. Accessed May 30, 2018. https://www.huronconsultinggroup.com/resources/higher-education/hhs-delay-revised-common-rule

[3] Cola, P.A. & Williams, M. (April 27, 2018).  Implementing the NIH Single IRB Policy: Five Core Strategies.  SRA Catalyst.  Accessed May 30, 2018.    https://www.srainternational.org/publications/catalyst/201804/implementing-nih-single-irb-policy-five-core-strategies
Dahms Clinical Research Unit (DCRU) Analytical Laboratory
Do you have questions about best practices for research sample collection, processing, storage and analysis? If so, let us help!  The DCRU Analytical Core Laboratory provides consultation for and testing of research assays.  Using enzyme linked immunosorbent assays (ELISA), we test serum, plasma, saliva, urine, CSF and breast milk (and other sample types) for a variety of different analytes. Sample dilutions will be performed when appropriate.

This is a research lab with a clinical emphasis. We operate under a GLP-based quality model. Freezers, centrifuges, bio-safety hood and pipettes undergo routine maintenance and calibration.  Our quality control plan requires at least 2 levels of manufacturer’s/in-house quality controls be run in each assay and results are thoroughly reviewed before released.  If we know many assays will be run on one sample, we maintain the integrity of the samples by making additional aliquots and limiting freeze-thaw cycles.

Assay Validation testing can be performed including dilution, sensitivity, precision and accuracy testing to assure kit performance. Other services offered in conjunction with the DCRU Sample Processing lab include DNA and PBMC extraction and long term sample storage and tracking in 24/7-monitored -70 freezers. To request more information about our fee-for-service analytical and sample storage services, contact Sarah Scott ( sarah.scott@uhhospitals.org ).
What makes a good Trial Innovation Network proposal?
The Trial Innovation Network is looking for study projects with:
  • Principal Investigators who are willing to partner with the TIN through the project lifecycle
  • Innovations in operations
  • Multiple sites
  • Inclusion of many populations
  • Academic evidence to improve clinical trial design

Any full-time faculty member at Case Western Reserve University is eligible to submit a study proposal to the Trial Innovation Network through the  Trial Innovation Network Hub Liaison Team . To submit a proposal or for questions about the Trial Innovation Network, please contact Noreen Roman, Project Coordinator, at  nroman@metrohealth.org  or at
216-778-3130.
Health Informatics Update from the
Institute for Computational Biology
ICB Data Club update
The ICB Data Club special interests groups will be formally introduced to each other and oriented this summer, and groups will begin to meet independently in the fall 2018 semester. More information on ICB Data Club activities and the SIG breakdowns will appear in the ICB Summer Newsletter being released later this month. If you would like to be included on the ICB Newsletter mailing list (and have not already signed up), please send an email to  icb_info@case.edu  with the subject "Newsletter inclusion"
ICB and CWRU to host an OHDSI face-to-face meeting in Spring 2019
The leadership of the ICB and the OHDSI community have agreed to hold an OHSDI Face-to-Face meeting at CWRU in the spring of 2019. Dates are being finalized now and will be announced shortly. During this meeting, leaders and participants in the OHDSI community will gather for a two-day working session that advances and shares the work of this international group. Details on the specific areas of focus will be decided over the coming months, but input is welcome from the Northeast Ohio scientific and clinical community. Information on prior OHDSI events can be found at  www.ohdsi.org . If you are interested in participating in the OHDSI face-to-face and/or have ideas of interest, please contact  icb_info@case.edu  and we will reach back out to you.
News from the PRCHN
PRCHN Monthly Seminar Series
Mark your calendars for these upcoming PRCHN seminars:

June 13, 2018
Precision Public Health: Using Health Information Technology to Improve Our Approach to Community Health Improvement
Scott Frank, MD, MS, Director of Public Health Initiatives, CWRU

July 11, 2018
TIME Intervention
Martha Sajatovic, MD, Professor, CWRU

Seminars are held the second Wednesday of each mo nth from 12:00-1:15 pm in the PRCHN Ground Floor Conference Room, BioEnterprise Building, 11000 Cedar Avenue. Parking is available and a light lunch is served.  
 

PRCHN researchers publish three papers addressing public health concerns
“Implementing a produce prescription program for hypertensive patients in safety net clinics”
Kakul Joshi, REACH strategy coordinator and foodNEST project coordinator, and Erika S. Trapl, associate director of PRCHN and associate professor for the Department of Population and Quantitative Health Sciences
Read the full article in Health Promotion Practice .

“Challenges implementing lung cancer screening in federally qualified health centers”
Sue Flocke, associate director of PRCHN and professor in the Department of Family Medicine and Community Health
Read the full article in the American Journal of Preventive Medicine.


“We Run This City: impact of a community–school fitness program on obesity, health, and fitness”
Trapl co-authored another paper, this time with Elaine Borawski, the director and principal investigator of PRCHN and the Angela Bowen Williamson Professor of Community Nutrition. 
Read the full article in Preventing Chronic Disease.
News from the Urban Health Intiative
The Social Determinants of Health and Public Health Innovation remain strong themes for the work of the Urban Health Initiative and Health Data Matters. Health Data Matters Co-Director Scott Frank and HDM Public Health Specialist Matt Kucmanic presented their recent analysis of State Health Improvement Plans at the April 2018 Teaching Prevention Conference in Philadelphia. Key findings related to differences between state and local health improvement planning processes. On May 1, 2018, I gave a talk on Designing for the Healthcare End User at the HIMSS Health 2.0 Dev4Health Conference that was held in Cleveland. My key message was about the importance of addressing needs of those with limited technology, connectivity and skills in developing health IT.
 
Looking ahead, I'm currently preparing two talks for the 2 nd Annual Artificial Intelligence in Healthcare Summit June 11-12 in San Francisco. I'll share ways that AI can support patient engagement and also discuss perils for AI due to selective lack of representation of special populations. Along with Dr. Fred Goldstein, President of Accountable Health, LLC, I'm co-Chairing a full day workshop on Social Determinants of Health for Health Care at the July 18-20 th HealthIMPACT East Summit in Washington, DC. We plan to highlight efforts underway at MetroHealth System, with Adam Perzynski and others, to screen patients for their digital connectivity, refer them to local partners to address gaps, then train patients to use digital medicine resources. Contact Amy if you are interested in obtaining a discount to the conference registration fee. Scott Frank's abstract entitled "Health Data Matters: A Platform for Teaching Health Equity and Precision Public Health through Hyperlocal Data" has been accepted as an oral presentation for the November 2018 Annual Meeting of the American Public Health Association. And I'm especially pleased that a proposed panel discussion has been accepted for the October 2018 International Association of Population Health Science Conference on "Defining Digital Skills and Connectivity as Social Determinants of Health. The conference will be held at and in conjunction with the National Academies of Science, Engineering and Medicine. We hope that this session raises awareness of the need to screen for and address digital skills and connectivity, and to recognize the growing importance of patient digital engagement to health care delivery and translational research participation.

Finally, the Health Data Matters team is pleased to welcome and introduce you to our new graduate assistant, Maher Kazimi. A student in the Master of Public Health Intensive Research Pathway Track, Maher completed training as a Physician from Zagazig University in Egypt, a Primary Care residency in Amman Jordan, and a clinical research training course at Harvard Medical School. We look forward to engaging Maher to support requests coming from CTSC-affiliated faculty for using the Health Data Matters platform.
Amy R. Sheon , Ph.D., M.P.H.
Executive Director, Urban Health Initiative
Case Western Reserve University School of Medicine
216-368-0915
@CLEhealthCUY
Upcoming Digital Health Events
See below for more details about this and other upcoming events featuring our work:

July 18-20, 2018
Washington, D.C.

HealthIMPACT is a curated knowledge-sharing network connecting and elevating the people and organizations measurably improving patient experience and outcomes. The annual summit brings together those ready to push boundaries, challenge the status quo, and take meaningful action.

Contact Amy Sheon if you are interested in obtaining a conference registration discount.

October 3-5, 2018
Washington, D.C.

IAPHS conferences feature the latest in population health science from diverse disciplines and promote exchanges about population health issues between scientists and stakeholders from policy and practice fields.

This year’s conference is hosted by the National Academies Roundtable on Population Health Improvement. The Roundtable and IAPHS are offering a  joint symposium , Population Health Science in the United States: Trends, Evidence, and Effective Policy, to be held prior to the start of IAPHS sessions, October 3, 8:15 AM – 1:00 PM.
News from our Colleagues
NIH releases first ever Strategic Plan for Data Science
binary_code.jpg
The National Institutes of Health (NIH) has released its first ever  Strategic Plan for Data Science   to capitalize on the opportunities presented by advances in data science. The plan describes NIH’s overarching goals, strategic objectives, and implementation tactics for promoting the modernization of the NIH-funded biomedical data science ecosystem.

Input received from the community and the public through the  Request for Information was incorporated into the final plan. Over the course of the next year, NIH will begin implementing its strategy, with some elements of the plan already underway. NIH will continue to seek community input during the implementation phase knowing that they share a common interest with you in maximizing the value of data generated through NIH-funded efforts to accelerate the pace of biomedical discoveries and medical breakthroughs for better health outcomes.
  
- Elaine Collier, MD
Senior Advisor, Immediate Office of Director
National Center for Advancing Translational Sciences
Join All of Us Research Program to advance precision medicine
"The future of health begins with you."

The All of Us Research Program has a simple mission: to speed up health research breakthroughs. To do this, they're asking one million people to share health information. In the future, researchers can use this to conduct thousands of health studies.

Lea rn more and join at the All of Us Research Program website .
NIH Extramural Nexus
Research Highlights
Newly launched Center for Therapeutics Discovery at Cleveland Clinic bridges translational research to clinical care
Cleveland Clinic has announced the formation of its new Center for Therapeutics Discovery, led by medicinal chemist Shaun Stauffer, PhD. The goal of the new center is to bridge the gap between translational research and clinical drug trials, which will accelerate discoveries to advance clinical care.

Dr. Stauffer's vision for the Cleveland Clinic center is to identify promising projects, remove risks and barriers to creating new therapeutics and form industry partnerships. He plans to create three cores: a medicinal chemistry/synthesis core, screening/target validation core, and drug metabolism pharmacokinetics core. His group will also employ computational and structural biology tools within the center to advance programs when and where appropriate. Once fully staffed, the center will be one of the largest of its kind in northeast Ohio and will become a hub of treatment-focused research in the area. 

"We are thrilled to be entering this next phase of drug discovery, which will not only help advance life-saving research but attract new business partnerships to Cleveland," said Serpil Erzurum, MD, Chair of the Lerner Research Institute and co-PI of the CTSC, where the center will be housed. "I am excited to help educate Cleveland Clinic researchers and physicians about the drug discovery process, and to help expedite the translation of basic research to cures for our patients," Dr. Stauffer added.

Rise of 'deep learning' machines offer tools for better, lower cost healthcare
The “deep learning” computers in Anant Madabhushi’s diagnostic imaging lab at Case Western Reserve University routinely defeat their human counterparts in diagnosing heart failure, detecting various cancers and predicting their strength.

But Madabhushi—even as he gladly touts three recent examples of apparent cyber superiority that played out in his lab—also dismisses any implication of a coming future when such machines replace pathologists and radiologists.

“There’s initially always going to be some wincing and anxiety among pathologists and radiologists over this idea—that our computational imaging technology can outperform us or even take our jobs,” said Madabhushi, whose center has made significant diagnostic advances in cardiovascular disease and also brain, lung, breast, prostate and head and neck cancers since opening in 2012.  

Elaine Borawski weighs in on the recent surge of dollar stores popping up in Portage County
Did you know that Dollar General stores and other dollar stores are popping up more frequently in rural areas of Portage County? One possibility is they’re filling a niche in areas that don’t have the population to support a full-service grocery store but need some local source of food, according to Dr. Elaine Borawski, director of the Prevention Research Center for Healthy Neighborhoods at Case Western Reserve University and co-lead of the CTSC Community & Collaboration component. 

“The same thing happened in the urban areas 5 or 6 years ago,” she said. She added that the definition of a “food desert,” generally described as an area with poor access to quality affordable food, is “a bit squishy.” 

Borawski said the question that remains is whether rural dollar stores can grow into establishments that offer fresh fruit, vegetables and meat, the same level of nutrition offered farther away at full-service grocery stores. “If we’re not going to get these full-service groceries, then what are the options for getting people fresh food?” she asked. “This is going to be something to watch for over the next 10 years.” 

Translational support helps develop licensed technology to better detect esophageal cancer
Case Western Reserve University and Lucid Diagnostics have signed an exclusive license agreement to commercialize a technology that quickly and accurately detects Barrett’s Esophagus, the primary precursor of esophageal cancer.

In 2012 and 2013, Drs. Nathan Berger and Amitabh Chak, partnered with the Clinical and Translational Science Collaborative (CTSC) of Cleveland to sponsor the Barrett’s Esophagus Translational Research Network (BETRNet) Pilot Grant Program. This partnership provided translational support which ultimately helped the founders' research develop the EsoCheck technology through BETRNet.   

Noteworthy Research
sepia_stacked_hands.jpg
woman_looking_face_mirror.jpg
Events
Webcast: The Role of Dissemination and Implementation (D&I) in Clinical and Translational Science
June 19, 2018, 12:00-1:00 PM
The Dissemination and Implementation (D&I) Workgroup (Collaboration Engagement Domain Task Force) within the Clinical Translational Science Award Program has organized a national webcast on Tuesday June 19, 12-1 EDT to increase knowledge within CTSA programs about the role of dissemination and implementation (D&I) in clinical and translational science.

At the end of the webcast, attendees will: 
  • know what dissemination, implementation, dissemination science and implementation science are, 
  • understand the features of D&I research studies and what makes D&I research studies different from usual clinical trials, and 
  • be able to identify funding sources for D&I research
 
If you have any questions about the webcast, feel free to contact Laura-Mae Baldwin at  lmb@uw.edu .
Cancer Stem Cell Conference
August 6-8, 2018
CWRU Tinkham Veale University Center
Cancer Stem Cell Conference (CSC 2018), hosted by the Case Comprehensive Cancer Center and National Center for Regenerative Medicine, is designed to bring together individuals working in the field of cancer stem cell research. CSC 2018 will feature renowned keynote speakers and leaders in the field. This conference is guaranteed to have cutting edge research from a variety of niches within the field.

Visit the   conference website   for more information. 
Big Data Neuroscience Workshop 2018
September 6-7, 2018
Cleveland, OH
The annual Big Data Neuroscience (BDN) workshop, organized by the Advanced Computational Neuroscience Network (ACNN) and funded by the National Science Foundation (NSF), brings together researchers in neuroscience, computer science, statistics, and related disciplines to focus on managing Big Data, enhancing data sharing, incorporating high performance computing, and using provenance metadata to support reproducible neuroscience research.

The workshop will feature keynote and invited talks together with lightning talks, poster sessions, and panel discussion focused on translational neuroscience.

Travel Scholarships
We will support a number of travel scholarships for students, post-doctoral scholars, and young investigators that will include travel and lodging. We encourage early registration at:

Deadline for submission of travel scholarship applications is August 15, 2018. Please note NSF travel scholarships is available only to US residents.

Call for Posters and Lightning Talks
This year the BDN workshop will feature awards for the three top-ranked posters/lightning talk (5 minutes) abstracts! Please submit your poster/lightning talk abstracts during registration at:

Deadline for submission of poster/lightning talk abstracts is August 5, 2018.

Funding Opportunities
Gates Foundation: Universal Flu Vaccine Development Grant Challenge
Application Deadline: June 22, 2018
The objective of this Grand Challenge initiative is to identify novel, transformative concepts that will lead to development of universal influenza vaccines offering protection from morbidity and mortality caused by all subtypes of circulating and emerging (drifted and shifted) Influenza A subtype viruses and Influenza B lineage viruses for at least three to five years. It is envisaged that such a universal influenza vaccine would address the threat from both seasonal and pandemic influenza, thus alleviating the need for annual seasonal influenza vaccination campaigns, averting significant global morbidity and mortality, and better preparing the world for the next influenza pandemic.

Projects also should engage scientists across a variety of disciplines, including those new to the influenza field; demonstrate innovative thinking by incorporating concepts or technologies not currently being used within/addressed by the influenza vaccine field; and present concepts and strategies that are “off the beaten track,” significantly radical in conception, and daring in premise. Grantees will have access to a wide-range of Gates Foundation-funded resources and technology platforms to support their projects.

In addition, the program will consider concept proposals related to use of DNA/RNA based delivery of longer acting universal influenza monoclonal antibody for passive prophylaxis or use of such monoclonals for exploring appropriate epitopes for universal influenza vaccine.

The program intends to fund pilot awards of up to $2 million over two years, with the anticipation that one or more pilot projects, on demonstration of promising proof-of-concept data (e.g., from animal models), may be invited to apply for a full award up to $10 million. Full awards would be intended to fund IND-enabling and clinical studies.

National Institute of General Medical Sciences Application Deadline: June 29, 2018
In order to ensure research that is reproducible, unbiased, and validated, the NIH's National Institute of General Medical Sciences (NIGMS)has reissued a funding opportunity announcement to support the development of training modules to enhance data reproducibility up to $250,000 for three years. The three new areas the reissue is emphasizing are:

1) How scientific culture, organization, and incentives influence the rigor and reproducibility of biomedical research,
2) Good laboratory practices and record keeping, and
3) Advanced experimental design and analysis.

Children's Leukemia Research Association
Application Deadline: June 30, 2018
The Children's Leukemia Research Association , also known as the National Leukemia Research Association , was founded in 1965 to support research efforts focused on finding the causes of and a cure for Leukemia. To that end, CLRA is seeking applications from investigators for promising research projects in the area of childhood leukemia.

Grants of up to $30,000 will be awarded to promising projects focused on isolating the causes of and finding a cure for childhood leukemia. Funding from other sources is permissible, but CLRA funding objectives should not duplicate those of other sources.

Any doctor at the PhD or MD level involved in research on finding the causes of and/or a cure for leukemia may apply. 

For more information visit the  Children’s Leukemia Research Association website .
NIH Funding Opportunities and Notices
Following in their long traditions of helping to support important scientific research, the National Institutes of Health and the Department of Health and Human Services have released information on new grant and award programs that we encourage members to take advantage of.

Notices, Requests for Applications, and Program Announcements:
Department of Defense