July  2017
News
Meet Your Local Trial Innovation Network Hub Liaison Team Members
Jim Chmiel, M.D. currently serves as Co-Medical Director of the Trial Innovation Network. Dr. Chmiel has participated in multiple clinical trial networks as either Principal Investigator or Co-Investigator including the Cystic Fibrosis Foundation’s Therapeutics Development Network, Inner City Asthma Consortium, AsthmaNet, and SARP-3. He served as the Director and Chief Executive Officer of the Ohio Clinical Trials Collaborative (OCTC), a clinical trials network which was established across multiple sites in the State of Ohio as part of Governor John Kasich’s Medical Corridor Initiative.  One of his responsibilities as CEO of the OCTC was to remove barriers and develop processes to facilitate clinical trial implementation and conduct across sites. To that end, the OCTC utilized developed (some through ACTA) Master CDAs, Master Research Contracts, Master Clinical Trials Agreements, and budget templates that are used across the institutions.  Dr. Chmiel has a significant amount of experience interfacing with other CTSA hubs.  

Lara Jehi, M.D. currently serves as the Co-Medical Director of the Trial Innovation Network. She has a wide background in clinical research, with a focus on outcomes research. She has been intimately involved with the development of the Knowledge Program, an electronic health record (EHR) interfacing technology that plays an important part in this proposal, allowing her a detailed understanding of the technology. In parallel, she has served as the Associate Director of the Clinical Research Unit for the Cleveland Clinic CTSC since 2012, and is a member of the Cleveland Clinic Institutional Review Board since 2014. These experiences give her a genuine understanding of the challenges of recruiting, enrolling, and conducting multicenter clinical trials. This combination of EHR-interfacing knowledge, outcomes research expertise, and intimate involvement with the CTSC place her in a unique position to understand the relationships between the multiple hurdles complicating recruitment for clinical trials.

Noreen Roman, MT(ASCP), MBA is the Project Coordinator of the Trial Innovation Network and has several years of experience as the director of a nationally recognized start-up business, a clinical research study coordinator of three federally-funded grants, and a medical technologist. For the last 6 years, Ms. Roman has been responsible for access to the MetroHealth clinical research unit nursing and laboratory services, fiscal and operations management, continuous quality improvement and all metrics and outcomes reporting. The Trial Innovation Network (TIN) Project Manager is responsible for the day to day management of the TIN Hub Liaison Team, and has practical experience managing clinical trials and understanding the business aspects of conducting clinical trials. The Project Manager works with each site’s Research Navigator and their local investigative teams to oversee training of research staff, develop processes to improve clinical trial conduct, and ensure deployment and adherence of national and joint SOPs at the sites.
The  Trial Innovation Network  is a new collaborative initiative within the CTSA program network that leverages the resources of the 62 national CTSA program hubs to advance clinical trials in a better, faster, and more cost-efficient manner. The Trial Innovation Network assists investigators with the clinical trial process by featuring a single IRB system, master contracting agreements, quality by design approaches, and focus on evidence-based strategies to assist with recruitment and patient engagement.

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.

KL2 Scholar Graduate, Vikas Gulani, MD, PhD and Team Find Cost-effective Prostate Cancer Detection Strategy  
“Many consider MRIs to be cost-prohibitive, especially when evaluating for a common entity such as prostate cancer. This was our expectation as well, prior to doing this work, but our study found the opposite. We found that performing MRI before biopsy and using that information to alter biopsy pathways would be a strategy that would add health benefits to the patient population in a cost effective manner,” said Vikas Gulani, study advisor and associate professor of radiology, urology, and biomedical engineering at Case Western Reserve University School of Medicine, and member of both the Case Comprehensive Cancer Center and Case Center for Imaging Research.
Shirley Moore Receives 2017 Elizabeth McWilliams Miller Award for Excellence in Research
Sigma Theta Tau International (STTI) Honor Society of Nursing recently honored  Shirley M. Moore , PhD, RN, FAAN, with the 2017 Elizabeth McWilliams Miller Award for Excellence in Research.

Dr. Moore is the Edward J. and Louise Mellen Professor of Nursing and Associate Dean for Research in the Frances Payne Bolton School of Nursing, director of the P30 Center of Excellence in Self-Management Research (SMART Center) and co-lead of the
KL2 Scholar program in our current CTSA program. She has been instrumental in the development of the Team Science Course in the KL2 program. She is also a  PRCHN Affiliated Faculty, and the co-principal investigator of the IMPACT Study  with PRCHN Director Elaine Borawski, PhD.
Save the Date!
CTSC Education Reception
Tuesday, August 1, 2017
6-8 PM
Foundation House

RSVP: spykeb@ccf.org or 216-444-2702

Ideation Challenge: Good Questions M eet Big Data
Up to $10,000 in Prizes to be Awarded
idea_loading.jpg
The Harvard Clinical and Translational Science Center and the Crowd Innovation Library at Harvard Business School invite you to participate in a new ideation challenge:

Can you identify a human health problem that might be resolved with big data and a computational solution? Are you working on a problem that could benefit from new algorithmic solutions or improvements? Are you aware of a dataset that could be used to solve this problem or generate further ideas for solutions?

The problem must fall into the clinical and translational research realm. Topics covered might include diagnostics, therapeutics, public health, technology, or outcomes.

Eligibility: Open to the public. 
Process:  View the website for more details, and to submit your problem.
Deadline:  July 13, 2017 at 11:59pm
Multiple prizes between $500 and $1500 will be awarded, up to $10,000 in total.
Organizations Jointly Request Delay in Common Rule Compliance Dates
The Association of American Medical Colleges (AAMC) and three other organizations representing research universities have requested that the Department of Health and Human Services (HHS) delay the compliance date of the revised Common Rule by one year, to January 19, 2019, for most provisions and to January 19, 2021, for the mandate to use a single institutional review board (IRB). The rule is among those being reviewed by the new administration because of its publication date, which was just days before President Trump took office.

Ready the joint letter at:  http://tinyurl.com/y7bp2adr.
News from the PRCHN
PRCHN Seminars
Healthy Neighborhoods
July 12, 2017
If We Want to Know, We Have to Ask: The Behavioral Risk Factor Surveillance System
Lauren Bottoms, MPH, Prevention Research Center for Healthy Neighborhoods, and Andrea Martemus-Peters, MSSA, LSW, MetroHealth

There is no seminar in August.
Seminars will resume in September 2017.

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

ciCLEvia: Open Streets Cleveland
ciCLEvia (see-CLE-vee-uh) is an open streets movement. Segments of Cleveland streets are temporarily closed to cars and opened for people-powered movement such as biking, walking, dancing, and so much more.

The name ciCLEvia is derived from the ciclovias of Latin American cities such as Bogota, Colombia, where over 70 miles of streets are open to people every Sunday and holiday. ciCLEvia encourages a culture of active living and sustainable transportation while drawing on the many assets of our neighborhoods and community members to reclaim the streets where we live, work, and play.

2017 ciCLEvias include:

ciCLEvia Central:  July 16 on Community College-Quincy Avenue from E. 24th to E. 55th Streets

ciCLEvia West:  August 20 on Detroit Ave. from W. 29th to W. 67th Streets

ciCLEvia East:  September 17 East Blvd. from Superior Ave. to Ford Dr.

For more information, visit: http://ciclevia.com/
May 31st Symposium Highlights Strategies for Change in Tobacco Use in Greater Cleveland
The PRCHN and its partners hosted nearly 100 researchers, medical practitioners, community partners and community members, students, and other health professionals on May 31 for the Tobacco Research Symposium. 
News from the Urban Health Intiative
From the desk of Executive Director,
Amy Sheon, PhD, MPH

With the onset of summertime, The Cuyahoga County Board of Health has added to Health Data Matters a number of datasets of topical interest including beach water quality and availability of licensed swimming pools.  With the inevitability of winter following summer, we’ve also added flu surveillance data.  Of year-round interest are new data sets on lead levels of children and heart disease and stroke deaths by census tract.

 

Otherwise, we’re very excited about new partnerships with Cuyahoga County Community College’s Community Health Worker (CHWs) training program and with the Cuyahoga County Public Library (CCPL).  We are training CHWs  how to screen patients for digital literacy and refer them to get general skill training and assistance with accessing low cost mobile and broadband subscriptions that are available to low income individuals.  The CHWs will also work with the CCPL Branch located at MetroHealth and with other local partners including the Ashbury Senior Computer Community Center to train patients to use portals to the electronic health record.  A number of public and non-profit organizations have expressed interest in hosting CHWs to complete their practicum placements working on projects related to digital skill training.  If you are interested, please contact me.

 

Speaking of practicum placements, I’m delighted to introduce Ms. Janelle Newman, a Kent State University MPH student who is completing her practicum working with me on our various health portal training projects. Have a great summer and don’t forget sunscreen!

News from our Colleagues
Funded by NCATS, SMART IRB is designed to streamline the IRB ethical review process for multisite studies involving as few as two sites to over one hundred. With SMART IRB, institutions can agree to allow one institution to become the reviewing IRB for a study, while the other institutions “rely” on that IRB’s oversight, from initial review to study closeout. SMART IRB is poised to support a wide range of collaborative research across the nation, and is freely available to all users.

SMART IRB, which stands for the “Streamlined, Multisite, Accelerated Resources for Trials,” is the result of many years of collaboration among CTSA Program hubs and the adoption of concepts that had appeared in several regional reliance models.
NIH Extramural Nexus
Research Highlights
Q & A with Jonathan Haines, PhD
Dr. Jonathan Haines discusses the significance of data analysis on precision medicine in this month's CWRUMED360. Dr. Haines is the co-lead of the CTSC Informatics component.

Biomedical informatics is critical for the successful capture, management, analysis, and interpretation of clinical and translational data. As the research questions and the resulting data grow in size and complexity, maximizing their value requires integration of basic and clinical research at every level from cells to society. Aggregating, integrating, organizing, and harmonizing data in research-appropriate ways facilitates their successful and
widespread use. Correlating, interpreting, and sharing these data requires educating and training the workforce in all aspects of informatics. The goal of the CTSC Informatics component is to facilitate these activities through a stable, flexible, comprehensive, and user friendly biomedical informatics infrastructure.

Noteworthy Research
Events
3rd Annual Data and Life Science Collaboration and Symposium
August 3-4, 2017
Tinkham Veale University Center, CWRU

The CWRU School of Medicine along with the School of Engineering will be hosting faculty members and students from Tohoku University for a 2-day data and life science symposium at the Tinkham Veale University Center. The symposium brings together researchers from CWRU and Tohoku University to discuss and share ideas on data science in engineering and life science as well as imaging and structural biology. 


This years's sessions are: 

Big Data and Healthcare 

Big Data and Biological Complexities


A poster session will feature data science research from students, postdocs and faculty of CWRU and Tohoku University.


The SOM Office of Research Administration will provide more information soon.

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

12th Annual Cleveland Clinic Obesity Summit
September 28-29, 2017
InterContinental Hotel - Cleveland, OH
Mississppi Gulf Coast Community College - Biloxi, MS

The Cleveland Clinic Obesity Summit attracts a diverse mix of health care practitioners interested in discussing innovative solutions to the causes of obesity, preventive strategies, and therapeutic management approaches. This Summit features diverse sessions designed to engage you with colleagues as well as patient interviews, live surgeries, interactive workshops, case-based lessons, and question and answer sessions. Take advantage of the opportunity to learn from shared experts broadcast between two locations – Cleveland, OH and Biloxi, MS.

 

Who Should Attend?

Health care professionals (including physicians, nurse practitioners, nurses, physician assistants, and dietitians), researchers, hospital and corporate administrators, and others who have an interest in obesity-related fields, including endocrinology, family practice, internal medicine, pediatrics, psychiatry and psychology, bariatric surgery, and wellness. 

 

Sign up today at www.ccfcme.org/ccfobesity17


ACCREDITATION: 13.5 AMA PRA Category 1 CreditsTM


Questions? Call 216-448-8710

2017 Graft vs. Host Disease National Symposium
October 13, 2017
Grand Event Center, Columbus, OH
This conference is intended to raise awareness about the signs and symptoms of GvHD, review cutting edge approaches to prevention and treatment, and highlight and promote research to further our understanding of its cause. The symposium has  two tracks: a scientifically rigorous one for physicians and practitioners, and a survivor track that will focus on challenges faced by BMT recipients and their families. The survivor track is intended to provide both education and the opportunity for individuals to interact with national leaders in the GvHD field. The afternoon "Meet the Expert" panel provides a unique opportunity for both physicians and survivors and their families to interact during the program.

ACCREDITATION:
Physicians
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Case Western Reserve University School of Medicine and the Meredith A. Cowden Foundation. Case Western Reserve University School of Medicine is accredited by the ACCME to provide continuing medical education for physicians. Case Western Reserve University School of Medicine designates this live activity for a maximum of  5.75 AMA PRA Category 1 CreditsTM. Physicians should only claim the credit commensurate with the extent of their participation in the activity.

Nurses 
The Ohio Board of Nursing will accept at face value the number of contact hours awarded for an educational activity that has been approved for CE by a nationally accredited system of CE approval.

Meeting of the Minds 2017 Annual Summit
October 23-25, 2017
Global Health Innovation Center - Cleveland, OH
The Meeting of the Minds Summit is a forward-looking conference for sharing strategies with scalable solutions in urban neighborhoods.The summit will include speakers and sessions that aim to share innovative sustainability and technology solutions between people from around the globe.

Funding Opportunities
Little Giraffe Foundation
Letter of Intent due: 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. 

For more information visit the Little Giraffe website.

Growing Gene and Cell Therapy (GGACT) Cooperative Project Support
Letter of Intent due: July 14, 2017

The goal of the Growing Gene and Cell Therapy (GGACT) cooperative is to support investigators to rapidly translate complex gene and cell therapies to early phase, investigator-initiated clinical trials.

 

GGACT has released a funding opportunity to provide support services in the areas listed below.

 

Support Services Available:

  • IND-enabling pre-GMP process development guidance.
  • Pre-GMP vector production and transduction manufacturing process and product development.
  • Trial-supporting assay development/implementation.
  • Regulatory pathway planning and assistance.
  • Development of reliance agreements to allow rapid implementation of new protocols via a simplified IRB review process.
  • Assistance in clinical trial protocol development, implementation and data management including packaging of data for potential licensing opportunities.
  • Assistance in clinical trials compliance, monitoring and reporting.

 

Questions? Contact Maria Suarez.

Ohio Development Services Agency - Ohio Opioid Abuse, Prevention, and Treatment Technology Initiative
Letter of Intent due: July 14, 2017 by 2:00pm
The Ohio Opioid Abuse, Prevention and Treatment Technology Initiative is to accelerate the development and commercialization of promising new products (or adaptations or modifications) in the categories of medical devices, diagnostics, pharmaceuticals, and health technology. They should meaningfully address one or more issues associated with the drug crisis driven by use, misuse, abuse and the addictive potential of opioids. Specifically, projects must contribute to near term tangible solutions associated with addiction prevention, treatment and overdose intervention. Technology and products that enable safe and effective treatment of acute and chronic pain without the use of opioids are encouraged. 

Proposal Deadline: August 31, 2017 by 2:00pm

For more information visit the Ohio.gov website.

Harrington Rare Disease Scholar Award
Letter of Intent due: July 19, 2017
Harrington Discovery Institute announces the call for proposals for the 2018 Harrington Rare Disease Scholar Award.

The Harrington Rare Disease Scholar Award was created to advance breakthrough research into cures for rare diseases. The program is sponsored by Takeda Pharmaceutical Company and overseen by Harrington Discovery Institute.

U.S.-based PhD or MD researchers whose discoveries show promise for translation into novel treatments for rare diseases are eligible to apply.

For more information visit the Harrington Discovery Institute 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. 

For more information visit the  NIH website.
Migraine Research Foundation
Application Deadline: July 28, 2017
The  Migraine Research Foundation, in partnership with the Association of Migraine Disorders, has issued a Request for Proposals for migraine research projects.

Grants of up to $50,000 will be awarded in support of relevant migraine research, with priority given to translational projects and projects related to migraine variants, childhood migraine, and chronic migraine. Grant funds must be used exclusively for research and directly related research equipment. Capital expenditures, administrative costs, and institutional overhead (including IRB approval, publication costs, and travel costs) will not be funded.

For more information visit the  MRF website.
Beckman Foundation accepting LOIs for Young Investigator Program
Letter of Intent due: August 14, 2017
The  Arnold and Mabel Beckman Foundation is accepting Letters of Intent for its 2017 Beckman Young Investigator grant program.

The annual program is intended to provide research support to the most promising young faculty members in the early stages of an academic career in the chemical or life sciences and to foster the invention of methods, instruments, and materials with the potential to open up new avenues of research in science. 

Projects proposed for this program should be truly innovative, high-risk, and show promise for contributing to significant advances in chemistry and the life sciences. They should also represent a departure from current research directions rather than an extension or expansion of existing programs. Proposed research that cuts across traditional boundaries of scientific disciplines is encouraged. 

Projects are normally funded for a period of four years. Grants typically range around $600,000 over the term of the project, contingent on demonstrated progress after the second year of the award. 

The BYI program is open to individual researchers within the first three years of a tenure-track position, or an equivalent independent research appointment, in an academic or nonprofit institution that conducts research in the chemical and life sciences. Candidates must be a citizen or permanent resident of the United States at the time of application. 

For more information visit the  Beckman Foundation website.
Microsoft Azure for Research
Application Deadline: August 15, 2017
Cloud computing lets you spend more time on your research, providing all the computing you need, exactly when you need it Whether it’s a computer with more memory, a cluster with thousands of cores, a big data platform, an internet of things solution, or open-source machine learning at scale, you can achieve more using the cloud. Microsoft Azure for Research awards offer large allocations of cloud computing for your research project, and already supports hundreds of researchers worldwide across all domains.

What it is:
Azure cloud computing helps you accelerate your research by providing what you need, when you need it. The Microsoft Azure for Research program awards cloud computing time, training, and resources to help you achieve more. 

Who it’s for:
Faculty, researchers, and graduate students are qualified to submit proposals for Azure awards for research projects. Masters and undergraduate students require a faculty project supervisor to submit their proposal. 

Apply now for cloud computing resources for your research project. Proposals are evaluated every two months. 

If you have any questions about the program, please contact azurerfp@microsoft.com.

For more information visit the  Microsoft website.
Stand Up To Cancer - $10 Million Dream Team of Top Investigators
Application Deadline: September 5, 2017
Stand Up To Cancer (SU2C) , in partnership with the American Association for Cancer Research, is inviting Letters of Intent for a new $10 million Dream Team of top scientific investigators searching for new strategies to prevent or treat cancer.

Unlike other Dream Team grants offered by SU2C in recent years that focused on specific types of cancer, such as colorectal cancer or lung cancer, the SU2C Dream Team Translational Cancer Research Grant program is open to any type of translational cancer research. The program will support a single translational cancer research project that will address critical problems in patient care and deliver near-term patient benefit through investigation by a multidisciplinary, multi-institutional, collaborative Dream Team of expert investigators.

Projects may focus on particular organ sites, patient populations (such as pediatrics), or on innovative methods of treatment. Projects must be designed to accelerate the application of new preventive, diagnostic, or therapeutic approaches to the clinic that lead to patient involvement within two to three years from the beginning of the grant.

In addition, through collaboration with the leading healthcare research and innovation center, OptumLabs, the team will have the opportunity to gain access to, and to conduct research using, OptumLabs’ proprietary database of de-identified medical claims and electronic health record clinical data, analytic tools, and research support to pursue the goals of the Dream Team.

To maximize creativity, innovation, and collaboration, the Dream Team must include laboratory and clinical researchers, senior and/or young investigators, and senior scientists who have not worked together in the past.

Invited Application Deadline: January 16, 2017

For more information visit the  SU2C website.
NIH: Cellular and Molecular Biology of Complex Brain Disorders (R01)
Application Deadline: October 5, 2017
This Funding Opportunity Announcement (FOA) encourages research grant applications directed toward the discovery of the impact of alterations associated with complex brain disorders on the fundamental cellular and molecular substrates of neuronal function. 

For more information visit the Grants.Gov website.

Special Funding Opportunities & Notices
Multiple Deadlines
The NIH Common Fund Regenerative Medicine Program (RMP) Announces the Opportunity to Collaborate with the Stem Cell Translation Laboratory (SCTL) at the National Center for Advancing Translational Sciences (NCATS)
(NOT-RM-17-030)

Novel Assays for Screening the Effects of Chemical Toxicants on Cell Differentiation (SBIR R44)
(RFA-ES-17-007)

NCCIH Natural Product Phase I-IIa Clinical Trial Award (R33)
(PAR-17-318) 

NCCIH Natural Product Phase I-IIa Clinical Trial Phased Innovation Award (R61/R33) 
(PAR-17-319) 

Multidisciplinary Studies of HIV/AIDS and Aging (R21)
(PAR-17-320) 

Multidisciplinary Studies of HIV/AIDS and Aging (R01)
(PAR-17-321) 

NEI Center Core Grant for Vision Research (P30)
(PAR-17-322) 
Department of Defense
Multiple Deadlines

Recently released Fiscal Year 2017 (FY17) funding opportunities for the Congressionally Directed Medical Research Programs (CDMRP)

Parkinson's Research Program (formerly known as the Neurotoxin Exposure Treatment Parkinson's Research (NETPR))
Early Investigator Research Award


Investigator Initiated Research Award


Peer Reviewed Cancer Research Program
Career Development Award

Recently released funding opportunities for the Department of the Army - USAMRAA
DoD Military Burn Clinical Trial Award

DoD Autism Research Program, Idea Development Award

DoD Autism Research Program, Clinical Translational Research Award

DoD Autism Research Program, Clinical Trial Award