Buffalo Translational Consortium News

BNMC opens doors to neighborhood for ‘Treats, Tricks and Discoveries’

Posted on 11/01/17 at 09:36 am
Community Research Facilitator Megan Wilson-Crowley and another masked superhero at the fair

An enthusiastic crowd of at least 175 local trick-or-treaters and their families turned out for the first-ever “Tricks, Treats and Discoveries: Family Fun and Learning Fair,” held October 28 in the Educational Opportunity Center on the Buffalo Niagara Medical Campus (BNMC).

A foul and rainy Saturday afternoon, it was just the right kind of day to come inside and learn about clinical research at UB while enjoying some Halloween snacks and fun activities co-sponsored by the Clinical and Translational Science Institute (CTSI) Community Engagement core and its partner, the Patient Voices Network.

View a photo gallery here.

Volunteers from across UB’s health sciences schools and community partners set up more than a dozen tables for the event, each featuring a fun and educational learning activity and a bowl of Halloween treats. Kids received a sticker at each station to fill out their passport cards, which were entered into a drawing for a selection of donated gift baskets at the end of the day.

“The purpose of the event is to bring the university community and the surrounding community together for a day of fun and learning,” said Laurene Tumiel-Berhalter, PhD, director of Community Translational Research in UB’s Department of Family Medicine in the Jacobs School of Medicine and Biomedical Sciences and director of Community Engagement for the CTSI. “It’s an opportunity for our neighbors to learn more about clinical and translational research on the medical campus and across UB, and for UB to open its doors to the community.”

Central Study Registration and scientific review are mandatory as of November 13, 2017

Posted on 11/01/17 at 07:46 am

The UB Clinical Research Office announced that effective Monday, November 13, 2017, two new initiatives to facilitate and support clinical research across UB will be initiated: Central Study Registration (CSR) and Department/School Scientific Review. 

CSR will institute the initial single point of entry for the various processes, workflows and software platforms for clinical research at UB. The data required for several systems, once entered into the Central Study Registration Form, will flow to each system that requires the information:

  • Click Agreements
  • Click Safety
  • Click IRB
  • OnCore Clinical Trials Management System
  • Clinical Research Management System (CRMS)
  • Electronic Sponsored Projects routing form

Central Study Registration (CSR) and Department/School Scientific Review will be mandatory for:

  • All clinical research (see definition below) originating within the health sciences schools:
    • Jacobs School of Medicine and Biomedical Sciences
    • School of Nursing
    • School of Dental Medicine
    • School of Public Health and Health Professions
    • School of Pharmacy and Pharmaceutical Sciences
  • Department of Biomedical Engineering
  • Campus-wide for all clinical trials (see definition below)

The website for Central Study Registration is https://www.research.buffalo.edu/studyregistration.

Central Study Registration will be required prior to submitting your study to the IRB.  Please note the following exceptions where Central Study Registration and Scientific Review do not apply:

  • If you are submitting your protocol to the IRB for determination of 'Not Human Subjects Research
  • If you are seeking 'Exempt Status' from the IRB for your study
  • If your research is originating from a non-health science school at UB and is not a clinical trial
  • If your research does not meet the definition of clinical research and does not require IRB submission

Please note that Central Study Registration can be initiated at any point once you have decided to pursue the clinical research project.  

  • Early submission is encouraged for the reasons detailed below. 
  • Central Study Registration shall precede the submission of the study for IRB consideration in Click. Required documents can be added at any stage.
  • Central Study Registration is not retroactive. Clinical research studies already approved do not need to be entered.​

When investigators (or their team members) respond to questions within the CSR form, they will receive detailed information and links to information, forms and policies that are required to conduct research at UB and through our hospital affiliates.

Departmental/School Scientific Review will be initiated via Central Study Registration by the Clinical Research Office, and the process has been fully integrated into the Central Study Registration process.

The Clinical Research Office has extensively tested the registration process with end-users across UB and you will find it to be simple and short. Training on the system is available on a daily basis.  

Associate Director of the Clinical Research Office Kim Brunton is managing this initiative and is in charge of training. She can be reached at .(JavaScript must be enabled to view this email address) or at 888-4840. 

Please do not hesitate to reach out to Kim or Director of the Clinical Research Office Sanjay Sethi, MD, at .(JavaScript must be enabled to view this email address) or 888-4864 with any questions or concerns.  

Anticipated Benefits of CSR 

The CSR form serves to identify services and streamline the processes required to reduce redundancy in our current systems and to streamline the initiation and implementation of clinical research at UB. CSR will:

  1. Provide early identification of current, new or changing university requirements needed for individual research studies to enable rapid, parallel completion of such requirements,
  2. Provide links and contacts for many of the resources UB has to offer the investigator and his/her staff for the successful initiation and completion of the study,
  3. Initiate the Departmental/School Scientific Review Process before submission to the IRB, which is considered best practice nationally at all leading research universities,
  4. Reduce redundant data entry currently required to get the same information into multiple software systems for some studies,
  5. Provide consistent data entry into each of the systems,
  6. Provide robust reporting for UB’s leadership, department chairs and deans, and hospital affiliate institutions about ongoing research within their facilities, and
  7. Initiate the routing for the Sponsor Approval Form early to facilitate research accounts establishment.

NIH Definition of Clinical Research

Patient-oriented research, including:

  • Research* conducted with human subjects* (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts* with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes:
  1.  Mechanisms of human disease, 
  2. Therapeutic interventions, 
  3. Clinical trials, or
  4. Development of new technologies.
  • Epidemiologic and behavioral studies
  • Outcomes research and health services research

NIH Definition of Clinical Trials

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. 

*The terms “research,” “human subjects” and “interacts” are defined in section 46.102 of the Federal Policy for the Protection of Human Subjects ('Common Rule').

 

Results of 2015-16 CTSI pilot studies presented at research colloquium

Posted on 10/27/17 at 02:30 pm
Steven Fliesler, PhD, co-director of the Translational Pilot Studies Program, presents tips for a successful application.

One of the main goals of UB’s Clinical and Translational Science Institute (CTSI) is to advance clinical and translational research that will improve the health and well-being of people living in Western New York, with a special emphasis on reducing the health disparities experienced by many in our community, including underrepresented minority groups and the poor.

The CTSI also seeks to encourage the kind of creative team science that reaches across disciplinary and institutional boundaries, and is most likely to produce paradigm-shifting breakthroughs.

Investigators from all eight research teams who received CTSI Translational Pilot Studies awards in the 2015-16 program year presented updates to the UB community on the results of their research at the annual Clinical and Translational Pilot Studies Research Colloquium, which was held October 12 in the Clinical and Translational Research Center (CTRC).

Grantees from the 2016-17 funding cycle also were on hand to present digital posters of their work-in-progress, the outcomes of which will be showcased at next year’s research colloquium.

From a clinical trial that tested an improved method of reducing maternal smoking to a radical new approach to preventing bacterial infections on metallic implants, research projects supported by the CTSI Translational Pilot Studies Program help to advance clinical and translational science on multiple fronts. 

"Among the goals of our program is a commitment to support research that has the greatest likelihood of gaining additional, substantive extramural funding, particularly from the NIH, NSF, and other federal agencies,” said Steven J. Fliesler, PhD, co-director of the CTSI's Translational Pilot Studies Program, a UB Distinguished Professor and Meyer H. Riwchun Endowed Chair Professor of Ophthalmology in the Jacobs School of Medicine and Biomedical Sciences.

“We provide support for innovative studies in clinical and translational research that are directly relevant to the themes and priorities of our Clinical and Translational Science Award (CTSA), especially those focused on developing new methods and technologies to solve important clinical and translational research problems, and those that will foster cross-disciplinary collaborations and mentoring relationships," said Fliesler.

Mark Ehrensberger, PhD, assistant professor of biomedical engineering in the School of Engineering and Applied Sciences and the Jacobs School of Medicine and Biomedical Sciences, presented results of his pilot study, titled A Novel Electrical Stimulation Technology Changing the Paradigm for the Treatment of Orthopedic-related Infections. Ehrensberger described how the CTSI pilot study support allowed the research to advance to the next stage when it appeared no one else would underwrite it.

This work led to a multidisciplinary, two-year, $1.1 million Office of Naval Research grant to determine whether electrical stimulation, combined with a regimen of antibiotics, can treat or prevent the development of bacterial biofilms on metallic implants. Biofilms are colonies of harmful bacteria which coat metallic implants and are frustratingly difficult to eradicate.

The current standard of care for chronic implant infections involves surgical replacement of the infected hardware. In addition to the toll it takes on the patient, this method carries a heavy price tag.

Qiaoqiang Gan, PhD, associate professor in the Department of Electrical Engineering, School of Engineering and Applied Sciences, presented Highly Sensitive and Portable Surface Plasmon Resonance System for Lung Cancer Early Detection, his pilot study that was instrumental in helping to land a $1 million National Science Foundation (NSF) grant announced in September.

In collaboration with Dr. Yun Wu, PhD, assistant professor from the Department of Biomedical Engineering, Gan and Wu’s pilot study data provided proof-of-concept that a biosensor to detect lung cancer developed by the multidisciplinary team was at least as accurate, if not more accurate, than the current industry standard, but is also capable of being miniaturized to the point that it can be implanted under a patient’s skin.

“Our preliminary results were used in the application for this NSF grant,” said Gan, “although the proposal contains many other elements which go beyond our CTSI seed project.” The team working on development of the sensor includes UB engineers working with Intel Corp. and Garwood Medical Devices.

The next phase of the research, headed up by Josep Jornet, PhD, assistant professor of electrical engineering in the School of Engineering and Applied Sciences and the grant’s principal investigator, will seek to determine whether the miniature sensor can be connected via cellphone to a doctor’s office, allowing patients living in remote locations to monitor themselves.

Xiaozhong Wen, MD, PhD, a research assistant professor in the Division of Behavioral Medicine, UB Department of Pediatrics specializing in maternal and child health, enrolled 48 pregnant women who smoke in Pilot Study on Pediatric Obesity Prevention by Maternal Smoking Cessation in Pregnancy and Lactation, a clinical trial with two aims: first, to test an innovative method of smoking cessation in pregnancy and lactation and, second, to try to reduce the risk of childhood obesity due to maternal smoking.

Although children born of women who smoke during pregnancy often have low birth weight, paradoxically, they quickly catch up to their peers born to non-smoking mothers and often surpass them in weight gain. In fact, maternal smoking during pregnancy is one of the best predictors of pediatric obesity, which can be the forerunner of many other health problems such as type 2 diabetes and cardiovascular disease.

By far, most women who smoke during pregnancy come from socioeconomically disadvantaged backgrounds. Eighty-six percent of the women in Wen’s study were recruited from two of the City of Buffalo’s chronically underserved neighborhoods: 58 percent from the city’s East Side and 14 percent from the West Side. About 70 percent of the women in Wen’s program were African American, Hispanic or Native American. More than 60 percent of the women were single and more than 70 percent unemployed. About 80 percent had a high school diploma or lower level of education. 

Not only does Wen’s diverse cohort of patients show that it’s possible to sign volunteers from populations that are traditionally difficult to recruit, results of the study also demonstrate how participants in clinical studies and their families who are experiencing health disparities can reap tangible health benefits through their participation.

Most of the participants (63 percent) in Wen’s study were able to stop smoking successfully during pregnancy, which was found to significantly improve their baby’s birth weight. Early results also show that maternal quitting smoking cessation during pregnancy seems to prevent the kind of rapid infant weight gain which is a risk factor for later obesity.

Andrew Gulick, PhD, from the Hauptman-Woodward Medical Research Institute (HWI) and UB’s Department of Structural Biology, presented Development of High-throughput Assay for Inhibitors of Aerobactin Synthesis. Gulick led a multi-institutional team of researchers from UB’s Jacobs School of Medicine and Biomedical Sciences and HWI on a novel project which targets a hypervirulent strain of the bacterium Klebsiella pneumonia, which causes outbreaks in hospitals and long-term care facilities, and which is also demonstrating increasing antimicrobial resistance, making it a genuine double-threat “super bug.”  

The team’s approach, essentially, is to starve the bacteria of the iron it requires at a critical phase of its life cycle. Data collected in the pilot phase helped the team win a National Institutes of Health (NIH) Research Project Grant Program RO1 grant.

Jill Kramer, DDS, PhD, of UB’s Department of Oral Biology, School of Dental Medicine, is the principal investigator on Analysis of the Source and Significance of IgM in Sjögren’s Syndrome. Sjögren’s syndrome (SS) is an autoimmune disease characterized by dry eyes and a dry mouth. Kramer’s team is seeking to determine the role that a certain class of autoantibodies (IgM) plays in the course of the disease, since it is not currently known whether IgM is primarily pathogenic or protective in SS. 

Fraser Sim, PhD, Department of Pharmacology and Toxicology, Jacobs School of Medicine and Biomedical Sciences, was the principal investigator on Inducing Myelin Repair by Antagonism of Muscarinic Receptor Type-3, a pilot study looking to identify a potential new site for future drug development for treating multiple sclerosis (MS) and other serious neurological disorders. Rates of MS in Western New York are twice the national average, according to the National MS Society, and Sim’s innovative approach could one day provide relief to the more than 3,000 people in the region suffering from this debilitating disease.

Thomas Szyperski, PhD, a UB distinguished professor in the College of Arts and Sciences’ Chemistry Department, presented Multi-class Modeling of Metabonomics Data for the Detection of Early Stage Ovarian Cancer, a cross-institutional, interdisciplinary project for the screening of high-risk Epithelial Ovarian Cancer (EOC) populations.

Ovarian cancers often escape detection until too late due to the absence of symptoms and effective tests. The approach established in the pilot study is to generate profiles that discriminate between blood samples from healthy women and those from women with benign or malignant tumors.

In addition to UB’s Department of Chemistry in the School of Arts and Sciences, the team includes members from the Department of Biostatistics in the School of Public Health and Health Professions, and Roswell Park Cancer Institute’s Department of Gynecologic Oncology.

Xuefeng Ren, MD, PhD, in the Department of Epidemiology and Environmental Health, School of Public Health and Health Professions, presented Inheritable Epigenetic (DNA methylation) Biomarkers and Actions of Arsenic Exposure in its Carcinogenic Activity.

Opening remarks of the 2017 Research Colloquium were delivered by Timothy F. Murphy, MD, SUNY Distinguished Professor and director of the CTSI. Co-directors of the Translational Pilot Studies Program Steven J. Fliesler, PhD, and Brahm H. Segal, MD, provided an introduction to the program, and Fliesler closed out the session with a presentation, “Program Overview and Tips for Success in Obtaining CTSA Pilot Studies Funding.”

Look for the next request for proposals (RFP) in the summer of 2018.

The CTSI Translational Pilot Studies Program is supported by the NIH and partners in the Buffalo Translational Consortium:

  • UB Office of the Provost
  • UB Office of the Vice President for Research
  • UB Office of the Vice President for Health Sciences
  • Roswell Park Cancer Institute
  • Dean of the Jacobs School of Medicine and Biomedical Sciences
  • Dean of the School of Dental Medicine
  • Dean of the School of Pharmacy and Pharmaceutical Sciences
  • Dean of the School of Engineering and Applied Sciences
  • Dean of the School of Public Health and Health Professions
  • Dean of the School of Nursing

 

CTRC Seminar Series 2017-18

Posted on 10/20/17 at 10:56 am

SCHEDULE

Seminars held first Thursday of the month

4:00 p.m.

Rooms 5019 A & B

Clinical and Translational Research Center (CTRC)

875 Ellicott Street, Buffalo, NY 14203

Pre-reception at 3:30 p.m. in the 5th floor atrium featuring  a Music is Medicine performance

------------------------------

ACADEMIC YEAR 2017-18

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November 2

Therapeutic Strategies to Promote Cardiac Myocyte Survival and Regeneration in Ischemic Heart Disease

Brian Weil, PhD

Department of Physiology and Biophysics, Jacobs School of Medicine and Biomedical Sciences

--------------------------

January 4

Title TBD

Rabi Yacoub, MD

Department of Medicine, Jacobs School of Medicine and Biomedical Sciences

--------------------------

February 1

Title TBD

Husam Ghanim, PhD

Department of Medicine, Jacobs School of Medicine and Biomedical Sciences

--------------------------

March 1

Women in Science Month

Jennifer K. Lang, MD

Department of Medicine, Jacobs School of Medicine and Biomedical Sciences

--------------------------

April 5

Title TBD

Ravi Aalinkeel PhD

Department of Medicine, Jacobs School of Medicine and Biomedical Sciences

--------------------------

May 3

Title TBD

Andrew Talal, MD, MPH

Department of Medicine, Jacobs School of Medicine and Biomedical Sciences

--------------------------

June 7

Title TBD

Supriya Mahajan, PhD

Department of Medicine, Jacobs School of Medicine and Biomedical Sciences

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