Fall 2015 CTSI Seminar Series: Advancing Biomedical Innovation through Translational Research and Regulatory Science

“Every day I look around the University and the Medical Center and am ‘wowed’ by the number of clinical trials, the types of new products that are being tested by our investigators here and the ingenuity of the research which is conducted by our faculty and staff.  This level of creativity along the continuum of translational research is constantly adding to the repertoire of life-saving drugs and medical devices that are available for use in patient care.”     Dr. Joan Adamo

A key objective of the University of Rochester Clinical and Translational Science Institute (CTSI) is to support creative research and training methods to drive innovation across the entire medical product development pathway. Along with this creativity comes the need to ensure medical products are safe and effective.  The FDA is the federal agency tasked with regulating drugs, biologics and devices and they must constantly update and enhance the processes to regulate these products.  There is also the need to keep up with new technologies and scientific developments.   The rapid advances in stem cell research, nanotechnology-based therapies and diagnostics, 3-D printing of tissues and organs, direct-to-consumer genetic tests, the marketing of products such as electronic cigarettes, and other developments present both opportunities and challenges for the FDA.

The academic research community has an opportunity to speed the development and approval of beneficial medical products by collaborating with the FDA, industry and other academic partners in the field of Regulatory Science.  Regulatory Science is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.  As the technology improves and the cures become more complex, the agency which regulates them needs solid, evidence-based research to improve the way products are reviewed and approved.  Additionally, the FDA and other regulatory agencies can enhance the way they interact with the public, academic institutions and industry to achieve their main mission of protecting public health.

This fall we will highlight and bring to the University of Rochester campus a panoply of Regulatory Science leaders who are currently working to address these issues.  The Fall CTSI Seminar Series “Advancing Regulatory Science and Translational Science: Research, Training and Partnerships” held on Tuesdays at 12noon in Helen Wood Hall will highlight Regulatory Science research and detail Regulatory Science training programs that are being developed both locally and in conjunction with our CTSA partners.  We will also hear from experts in industry and at the FDA about what they see as the Regulatory Science priority areas and how our research and training efforts can have the greatest impact.

The organizers of the CTSI Seminar Series, Dr. Joan Adamo and Dr. Scott Steele, will provide a kick-off presentation on Regulatory Science on Tuesday, 8 September 2015. Click here to access the full schedule.

Meliora!  The motto of the University of Rochester does not ring clearer than it does when we look to improve public health by making the process of developing and regulating safe and efficacious products ever better.

SCORE: Helping research coordinators connect and learn

by Nancy Needler, Special to the CTSI Stories Blog

Are you a research coordinator? This article is for you.

Do you know a research coordinator? Then please, pass this along.

Principal Investigators and research team members rely on coordinators every day. Coordinators impact the lives of research subjects and assist to provide the foundation behind the science data in the development of new clinical procedures, drugs, devices and technology to improve health care.

As a result, the University continues to recognize the professional role of the coordinator, and the CTSI is here to provide support.


The Study Coordinators Organization for Research & Education (SCORE) is a forum organized for coordinators where participants meet to share information, to collaborate to develop tools and practices, and to learn of University processes related to human subject research management. Providing support and regular networking opportunities for University research coordinators and staff, SCORE monthly events include presentation of resources and services needed for coordinating research, open discussions to share best practices and to discuss and identify resolutions to barriers in everyday study management activities.

To further support coordinators helping each other, a coordinator discussion listserv is also being developed. Soon coordinators will have this online forum for discussions with peers.

(This past June, SCORE, under the support of the CTSI and SON with OHSP and ACRP hosted the annual SCORE Half-Day Seminar for coordinators. The event, its 7th year, offered continuing education contact hours, was attended by 143 people, and 100% of those who responded to the evaluation rated the overall program as “good” to “excellent/high.”)

SCORE events are held monthly. Interested? Want to be engaged? What to learn what’s around the corner? Be sure you are on the SCORE distribution list – contact SCORE@rochester.edu. Protect your time now to attend future networking and educational events. To learn more, visit the SCORE website.

SCORE’s next forum event is scheduled for September 10th and will be listed on the CTSI calendar.

Research coordinator job series

Coordinators: You are special! This career is growing quickly and is recognized as a certified profession by the ACRP and SoCRA. A preparation review course is offered at the start of each year to the applicants for certification examinations. The Office for Human Subject Protection and the CTSI facilitate this successful course. Over the past 2 years, 33 students took the course, 12 of which were applications for taking the exam. All 12 applicants have passed their certification exam. The University encourages and supports recognition of your skills and experience through certification.

In 2014, the University, in a collaborative initiative with stakeholders (which included coordinators, hiring managers, human resources and CTSI leadership) formalized the coordinator career path in the three-level Human Subject Research Coordinator job series. When positons need to be filled, hiring managers and human resource business partners turn to this job series. Coordinators now have a career path designed specifically for their role.

Hiring managers are using UR Connected to advertise and connect with potential new hires.  Hiring managers continue to examine the information in listed coordinator profiles and contact coordinators for available positions.  Coordinators – consider entering or updating your profiles in this connection system.

Study Coordinators – your dedication to your profession is recognized.  Your knowledge is sought to improve study management operations.  You are invited to connect and learn by participating in SCORE.  For more information contact:  Together, we can raise research coordination to the highest order.


Healthy Weight Initiative re-launches

Diana Fernandez, M.D., Ph.D., associate professor of Public Health Sciences and Pediatrics, is now heading the University of Rochester Medical Center’s Healthy Weight Initiative.

Diana Fernandez, M.D., Ph.D.

Diana Fernandez, M.D., Ph.D.

Fernandez, a nutritional epidemiologist who has spent much of her career studying obesity and weight gain, will soon begin visiting departments within the Medical Center and River Campus. The Healthy Weight Initiative will facilitate collaboration among researchers from seemingly disparate disciplines throughout the University.

“There are so many factors that affect energy balance – there’s physical activity, what we eat, DNA, culture, the economy, and so on,” said Fernandez. “we’re hoping to get people connected so we can start writing proposals that will ultimately translate into improving weight on a population level.”

The Healthy Weight Initiative is guided by three overarching concepts.

  1. Action-oriented research: The research which emerges from the initiative will be translational, and can be applied to individuals or populations.
  2. Team science: Transdisciplinary teams will collaborate to work together on projects from the very onset to develop a shared conceptual framework that integrates multiple perspectives allowing for research ‘outside the box’ that can translate more quickly to clinical practice.
  3. System thinking: The initiative will look at the interconnection of the myriad factors that contribute to a person’s weight. While complex, understanding the entire system that affects weight is vital to future breakthroughs.

The Healthy Weight Initiative grew out of a group started two years ago that organized the Obesity Research Roundtable in May 2014. That roundtable included dozens of investigators and community members, and served as the genesis for several projects including a currently-funded CTSI Incubator related to the impact of obesity and diabetes on musculoskeletal disease.

The initiative is part of the CTSI’s overarching goal of improving population health and encouraging team science. For more information, contact Diana_Fernandez@urmc.rochester.edu.

CTSI and NCDHR: How we work together

The CTSI has a unique partnership with the Rochester Prevention Research Center (RPRC): National Center for Deaf Health Research (NCDHR). RPRC/NCDHR and CTSI have collaborated in numerous ways, and the affiliation has been tremendously beneficial for the university and the community.

CTSI Stories recently spoke with Steve Barnett, M.D., director of RPRC/NCDHR, about how the partnership has evolved over the years.SteveBarnett

Tell us a little about the history of the collaboration.

Tom Pearson was the initial bridge between RPRC/NCDHR and CTSI. He was the founding director of the RPRC/NCDHR, which was established in 2004 to promote health and prevent disease with populations of Deaf sign language users and people with hearing loss through community-based participatory research.  Rochester is the ideal home for RPRC/NCDHR — Rochester has large populations of Deaf sign language users and people with hearing loss, and URMC provides care to many deaf people and people with hearing loss, their families and communities. Tom was also part of the founding leadership of the CTSI, established in 2006. Tom looked at CTSI and RPRC/NCDHR and saw synergistic opportunities, and he encouraged collaboration. The relationship between CTSI and RPRC/NCDHR grew from that encouragement.

What types of collaboration have gone on?

RPRC/NCDHR and CTSI have overlapping priorities, such as novel research methods, community and stakeholder engagement, diversity in the scientific workforce, and integrating populations that are under-represented in research. By working together — CTSI, RPRC/NCDHR, and community members — we are able to advance translational research, address disparities and promote population health at a higher level than any of us could do alone.  Some examples:

  • Novel methods: RPRC/NCDHR researchers and community members work together to develop culturally appropriate and language accessible research methods. One example is our use of the video novella for research informed consent. RPRC/NCDHR, CTSI and community members worked together to successfully compete for an NIH supplement to CTSI to study research informed consent with Deaf adult sign language users. The research is being conducted with the Rochester Deaf community by researchers and staff with RPRC/NCDHR and the URMC Deaf Wellness Center. The use of video novellas for informed consent has applications with other populations.
  • Community and stakeholder engagement: RPRC/NCDHR works with community members and other stakeholders at all levels of the research process, from priority setting, through research design and conduct, interpretation of research findings, dissemination, and back to priority setting. RPRC/NCDHR community and stakeholder engagement has been recognized with awards locally and nationally. RPRC/NCDHR worked with CTSI to add Deaf community members to the URMC Community Advisory Council, a stakeholder group that advises CTSI, URMC and the Center for Community Health.
  • Workforce diversity: CTSI houses unique NIH-funded research training programs that connect programs at UR (including RPRC/NCDHR) with partners at Rochester Institute of Technology and its National Technical Institute for the Deaf. The goal of these programs is to increase the number of research scientists who are deaf or have hearing loss. The Rochester Bridges Program and the Rochester Partnership are the first two of these programs, and leverage local resources and expertise and national networks to create a national hub of excellence to foster the development of the next generation of research scientists who are deaf or have hearing loss.
  • Integrating populations that are under-represented in research: CTSI and RPRC/NCDHR seek to enhance diversity in research participation. Deaf sign language users and people with hearing loss comprise populations that are under-represented in research. CTSI also seeks to expand translational research across the lifespan, including increasing research participation of older adults, and expanding research with children and research that examines adult health outcomes associated with childhood conditions. RPRC/NCDHR engagement with people with hearing loss includes many older adults with acquired hearing loss. Most Deaf adult sign language users have been deaf since birth or early childhood, thus RPRC/NCDHR research with Deaf adult sign language users often examines adult health outcomes of deaf children. Some RPRC/NCDHR research methods, such as video surveys, are being adapted for use in research with young children.

What other ways do CTSI and RPRC/NCDHR work together?

Integrating populations requires environment and culture change, and CTSI works with RPRC/NCDHR to work with deaf, hard-of-hearing and hearing staff, students, faculty and community members to create research, education and patient care environments and cultures that are accessible and inclusive. We work together to raise awareness and change norms through the routine use of sign language interpreter services in CTSI meetings and presentations, and the use of captions in CTSI videos. The Saunders Research Building (SRB), the home of the CTSI and RPRC/NCDHR that opened in 2011, was designed with input from Deaf people and people with hearing loss. The layout and wall color of some SRB meeting rooms and offices are designed to enhance visually oriented communication. Some SRB meetings rooms also have induction loop systems to facilitate communication that includes people who use hearing aids.

CTSI and RPRC/NCDHR collaborate with others to support education related to population health, such as the URMC Preventive Medicine Residency Program. The URMC Preventive Medicine Residency Program is part of the CTSI Population Health pillar and is one venue for CTSI efforts to integrate healthcare and research, through training physicians in public health research and population health. RPRC/NCDHR works closely with the URMC Preventive Medicine Residency program and provides unique opportunities to learn about community engagement, public health research, and health inequities.

Connection to NIH and CDC funding programs and networks create opportunities for CTSI and RPRC/NCDHR to fund collaborative projects. Just as our connection with the NIH CTSA program created an opportunity for funding through CTSI of RPRC/NCDHR research on informed consent methods, our connections with the CDC Prevention Research Centers program [link] created opportunities to fund CTSI research through RPRC/NCDHR, such as funding that established in CTSI the coordinating center for the Global and Territorial Health Research Network.

Director’s Update – August 2015

Every month, the CTSI Stories Blog will post excerpts from ongoing conversations with the institute’s co-directors. This month, Nana Bennett discusses the recently-released Program Announcement from the National Center for Advancing Translational Sciences (NCATS) for its Clinical and Translational Science Awards (CTSA) program. The CTSI is pursuing its second five-year renewal.NanaBennett

By now, anyone who works in or around the CTSI probably knows that the NCATS has released the criteria for the new CTSA awards. What can you tell us about them?

Yes, the new RFA is out! And I’m happy to discuss it, but first, a brief bit of background for people who aren’t familiar with the history. URMC was one of the first dozen institutions to receive a CTSA award when the program launched in 2006. These are five year grants that support much of the CTSI. We’ve been renewed once – this is the second time we’re applying for renewal. In terms of total dollars, it’s one of the largest grants at URMC.

The good news is that we thought that the RFA would be similar to the one was that was released last year, and for the most part, it is. The format is a bit different — it’s actually a bit better, a bit more straightforward, than before.  We began preparing based on last year’s so we’re in relatively good shape.

It’s interesting though – taking the longer view, several things have changed and several things are similar to the CTSI as it was years ago. There used to be “key functions,” and then those were eliminated, and now we’re back to what they call “cores,” which are very similar to key functions. But there are also several key themes which are more specific than in the past.

Can you talk about those themes?

Population health is a major one for us. NCATS has been tasked with improving and speeding the impact of research on improving health as a whole, and that’s why our overarching theme here at the CTSI is “from molecules to populations.” We want to help advance basic research – research at the molecular level – and help facilitate its growth and translational potential so that it can be used to improve human health across a population.

In order to span that full spectrum, team science is vital – and that’s another key theme.  Science has reached the point where it’s very difficult for a single investigator to take a discovery all the way from the bench to the bedside to community. In addition, input from community stakeholders is critical to science being responsive to the greatest health challenges facing our nation. Quality and efficiency of research is an important theme – we must show how the URMC can contribute to the national network of CTSAs in ways that speed and improve the conduct of research.

And another key theme is innovative education. Our CTSI educational programs are innovative in content and process. We recently launched a doctorate program called, “Infection and Immunity: From Molecules to Populations” which is specifically designed to train scholars in interdisciplinary research – combining the basic sciences and the population health sciences.  While this is not part of the CTSI, it dovetails with it and is illustrative of our approach.

How many people are working on the renewal grant? What else are we doing to prepare?

The three CTSI co-directors – Karl Kieburtz, Martin Zand, and I – are leading the renewal efforts, but we have more than 50 people involved in the process. We’ve engaged people across the university to ask for feedback and/or contributions to the grant-writing process, and we’ve also asked a group of internal and external experts to review the application before it goes out.

Our deadline is mid-September, so things may be a little frantic for the next 5 or 6 weeks. But we are confident that when we’ve finished the process, we’ll have made a strong case to NCATS for renewal.

Previous Director’s Updates:
July 2015 – Karl Kieburtz seeks feedback in the wake of the CTSI Town Hall meeting.
June 2015 – Martin Zand gives an overview of what will likely be different about the next CTSA renewal application.
May 2015 – Nana Bennett discusses the enhanced role of the Strategic Leadership Group.
April 2015 – Karl Kieburtz talks about how the leadership is preparing for the Clinical and Translational Science Award renewals.
March 2015 – Martin Zand introduces himself and discusses his interest in informatics and population-based research.
February 2015 – Nana Bennett discusses the CTSI’s Seminar Series on population health.
January 2015 – Harriet Kitzman reflects on her time as a CTSI co-director.

Scholar Spotlight: Madeline Beach

Madeline Beach is currently working towards an M.S. in Applied Statistics through the Center for Quality and Applied Statistics at Rochester Institute of Technology. She’s then hoping to continue on to a Ph.D. in Biostatistics or Statistics, and is interested in working in the field of mental health, with a focus on quality of life and depression among the Deaf and geriatric populations. She is one of three scholars currently in the program, which is a joint venture between the University of Rochester and Rochester Institute of Technology — thanks to the folks at RIT for allowing us to use their video! Learn more at http://www.deafscientists.com.

If you’d like to see your research featured in the CTSI blog, email Sean_Dobbin@urmc.rochester.edu.

UR CTSI Advances Statistical Analysis of DNA Methylation Data

Dr. Dongmei Li, Biostatistician and Associate Professor, and Dr. Timothy Dye24710, Director of CTSI Bioinformatics and Professor, led a team of scientists to evaluate the statistical methods used to analyze DNA methylation data. Their paper was recently published in BMC Bioinformatics and has been noted by the genomics and biostatistical fields. DNA methylation is a cellular process for altering the chemical structure of DNA and is used by cells to regulate gene expression. Hypermethylation of gene promotors has been associated with cancer and some cancer therapies reverse hypermethylation. The ability to perform large-scale examinations of DNA methylation through microarrays paired with robust statistical analyses will allow investigators to accurately interpret data and identify methylation patterns attributable to disease. However, there are many biostatistical tools to choose from for DNA methylation analysis and it is not known how each method performs. Drs. Li and Dye compared the false discovery rate, power and stability of six commonly used statistical approaches: Wilcoxon rank sum test, Kolmogorov-Smirnov test, permutation test, 4270empirical Bayes method, t-test, and bump hunting method. They used two publically available data sets to validate their results, the United Kingdom Ovarian Cancer Population Study dataset and a rheumatoid arthritis dataset. They found that all biostatistical tests performed equally when using medium or large samples sizes (12-24 samples). However, in small data sets (3-6 samples) the bump hunting method and empirical Bayes method performed better.

“This work has received a lot of attention because the use of DNA methylation analysis for investigating disease states in the genome is rapidly expanding” says Li.

Citation: Li D, Xie Z, Pape ML, Dye T. An evaluation of statistical methods for DNA methylation microarray data analysis. BMC Bioinformatics. 2015 Jul 10;16:217. doi: 10.1186/s12859-015-0641-x. PubMed PMID: 26156501; PubMed Central PMCID: PMC4497424.