Director’s Update – October 2015

Every month, the CTSI Stories Blog will post excerpts from ongoing conversations with the institute’s co-directors. This month, Karl Kieburtz looks back on the grant-writing process and discusses the advantages to including so many people.KarlKieburtz

First, congratulations on being done!

Thank you! Yes, we’re done, and we’ve submitted the CTSA renewal grant application to NCATS.

This grant involved work from more than 50 people. Why did you feel it was important to include so many of us? I’m guessing that must have made it harder in some ways.

Well, I’ll answer that by giving a little background first, because what we’re actually tasked with here in the CTSI is tricky. First, we’re an institute and we’re supposed to do certain things – we’re supposed to train people, help foster collaborations, get people moving in certain research directions, and so on. And we’re supposed to do that in an organized and structured fashion.

At the same time, we’re supposed to innovate. Innovate is an easy thing to say, but innovation really requires discovery, and discovery is only possible, in my view, when you cease to be enamored with what you know. You can be standing next to someone, seeing the same thing they’re seeing, but they’re looking at it in a different way and so they make a discovery and you don’t. That’s why most innovation organizations are small. It’s a group of guys and gals off somewhere else, disconnected from a mainline organization, fiddling around.

But that perspective – not being enthralled with the rules and trying to forget what we already know – is antithetical to being structured and delivering on things that we say we’re going to deliver on. So that puts us in a difficult position of needing to deliver in an organized way, while also needing to suspend some of the rules.

So that’s tricky. We have an infrastructure grant to provide education, collaborative interaction, and  funding, but it’s tough to innovate infrastructure. I think the only way you can do it is by involving a lot of people and embracing the perspectives of others.

The easiest thing in the world to do is to write down everything you already know. The hardest thing is to listen to what everyone has to say and find a way to express the views of every person. The grant could have been written by a small handful of people just deciding what it is we should do. But, obviously, that’s not what we did.

Did it pay off? Would you do it this way again?

We came up with about a dozen innovative programs beyond what we’re doing now. And these programs weren’t prompted by the grant. They came from people talking to us – at the CTSI retreat, at the Town Hall meeting – about the new things we could try to do.

Ultimately, the actual core text and references was about 190 pages, broken into 10 different sections. Each of those sections had two or three pieces, and each of those pieces had a team of four or five people working on it. That’s what gave us that varied perspective.

If it was just Martin, Nana, and I sitting in a room, that never would have happened. It would have been easier, yes, but not as diverse.

When do you expect to get an answer from NCATS as to whether the CTSI grant will be renewed?

It should be in the next several months. Thanks to all the hard work we did, we think we’re in a good position.

Previous Director’s Updates:

September 2015 Martin Zand discusses the CTSI’s research subject engagement efforts.
August 2015Nana Bennett talks about the renewal grant that the CTSI is pursuing.
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.
More…

Director’s Update – July 2015

Director’s Update — July 2015

Every month, the CTSI Stories Blog will post excerpts from ongoing conversations with the institute’s co-directors.

Below, Karl Kieburtz circles back to the May 7 CTSI Town Hall Meeting.KarlKieburtz

For the benefit of the people who weren’t able to attend, can you give a quick recap of what was discussed at the CTSI Town Hall Meeting in May?

At the CTSI Town Hall, we asked people “What we do well here?” “What would you like to see more of?” We also asked: “If we went away, what would you miss most about us?”

We hope that by asking that last question, it’ll make people consider the CTSI in a different way. When a good innovation happens, we accommodate to our new circumstances, and the novelty becomes the new normal. You’re recording our conversation on an iPhone. Of course, right? But when that first came out, that was really cool. And when I want to start a manuscript now, I just turn on my app, I dictate to myself, it comes out in text and I email it to myself and edit it. I expect that now. But when I first did that, it was really cool.

So that’s what makes a good innovation. It comes out, gets incorporated into our lives, and then you stop being blown away by the fact that it’s there.

How does this relate to the upcoming renewal?

For the people writing the renewal, part of the effort involves going back over the past 9 years and looking at what’s happened. But because we’re in the midst of it and we take advantage of it, we don’t really stop to think that it wasn’t so long ago that we didn’t have X, Y, or Z. Things that we have now that we’ve grown accustomed to — we want to explicitly call those out and to ask people what they’d miss.

Some of those things people might not realize come from the CTSI. There’s the Junior Faculty Academic Core Curriculum, there’s the Seminar Series, there’s SCORE, pilot funding and incubator funding, the i2b2 to REDCAP tool we developed here, the community advisory council that allows researchers to get input into the community, recruitment capabilities. So to put this question another way, what elements of your day would be different if you didn’t have some of these resources?

And to be clear, we’re not threatening to take anything away, but we just want to know what matters to folks in a way that we might not always see or might not always expect. We develop these programs and resources because we think they are relevant, but those assumptions have to be validated by the people using them. And for the renewal, it’s important that we capture a sense of what things matter to people.

So you tell us. It’s important for us to know what we are doing well and what we need to do better in the future. Please contact ResearchHelp@urmc.rochester.edu and let us know: What would miss most about the CTSI, if it wasn’t here?

[Readers may also provide feedback by visiting the CTSI Suggestion Box to respond to a very brief feedback survey.]


Previous Director’s Updates:
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.
More…

Director’s Update — April 2015

Every month, the CTSI Stories Blog will post excerpts from ongoing conversations with the institute’s co-directors.

Below, Karl Kieburtz talks about how the leadership is preparing for the Clinical and Translational Science Award renewals.Karl Kieburtz, M.D., M.P.H.

The new leadership structure has been in place for three months now. How are things going?

One of the great things about the change in leadership structure is it allows each of us to direct ourselves with more emphasis toward specific areas, and one of the things I’ve focused on is trying to understand what’s happening lately at NCATS. Right now, they’re very focused on the development of new methodologies and new technologies to increase the efficiency of clinical and translational research.

In research, there’s a very long window from discoveries in the lab to treatments in humans and actually influencing the health of the population. That’s often measured in decades. Can we get that down to a sub-decade measure by improving the tools we use? That’s NCATS’s big focus, and they’re demonstrating that focus by targeting their funding toward the new methodologies and technologies.

How are they targeting the funding?

The RFA for renewals for the CTSAs is coming out again soon, but they’re also having RFAs for three new structures. One is called a Recruitment Innovation Center (RIC), one is called a Trial Innovation Center (TIC), and the third is a Collaborative Innovation Network.

So the CTSA awards are the base awards, and they’re going to be reduced on the high end for institutions that had very large awards. Fortunately, we’re already among the smaller centers, so that shouldn’t affect us as much. But they’re likely going to use that reduction to pay for these new awards, and the way you grow your base award is by applying for one or more of these new structured grants.

Can you describe what they’re looking for in terms of RICs, TICs, and Collaborative Innovation Networks?

A RIC is responsible for new or more efficient ways to drive recruitment. Here, for example, through the National Center for Deaf Health Research, we’ve done a lot with the deaf community. So we’re thinking about whether that could be used as a model to recruit and engage with underserved communities, or communities with health disparities.

For the TIC, one example that would apply here is the work that Ray Dorsey has been doing with mobile technology. The mPower app, which is the Apple app that was highlighted recently, allows you to record your medications, record memory activities, there’s a voice activity, a measured gait activity. And that kind of tool is exactly the kind of methodology they’re looking for in terms of clinical trials, because it’s much more efficient than having people come into their research visits once a month.

For something like mPower, you can arrive at estimates of benefits faster. A lot of trials go on for a long period of time and are bigger because of there’s a lot variability of the data. But if you can get more data from fewer people, you can run trials faster, and you’re more efficient because there isn’t so much inter-individual variability. You often hear about certain advancements in research costing X billion dollars, but the reason for that cost is you’re actually amortizing all the failures in addition to the success. For every success, you might have 100 failures or 200 failures. But those 200 failures don’t happen early. They happen over the course of a trial or late in a trial. So one of my hopes is that by getting more accurate data early, you can fail earlier. It seems counterintuitive, but if you can cut off a line of study and save costs on something that’s ultimately going to fail, you can learn faster with more reliability. You can stop that trial and then put your energy into other things.

And then the Collaborative Innovation Network is when three or more CTSA hubs act collaboratively to develop something innovative which will improve the efficiency of trials.

mPower is a great example – what other strengths do we already possess here that could apply to the RFA?

Well what you said is important, because we want to be prepared to respond for this without chasing after something we’re not good at, or that we don’t have strong interest in, or that doesn’t tie in with our strategic aims.

But we already have an emphasis in technology and methodology as demonstrated by our clinical trial methodology pillar. We didn’t know they were going to have RICs and TICs, but we have a pre-existing emphasis on that, so that’s a big advantage.

On community engagement, which fits into the RIC side, we are ahead of the game because of the Center for Community Health and our Community Advisory Group and the efforts we’ve put in to community engagement. And structurally, we’re in a great place to look at what’s happening in the community, because we have a relatively simple and contained health care system, with two major providers, and one regional health database. Most communities aren’t that centralized.

We recently joined a large network called NIPTE where producing drugs or interventional agents can be done from basic synthesis all the way out to packaging and delivering. So that’s an additional strength.

Phil Ng and Adam Tatro have developed a tool that uses i2b2 to extract from the EMR and put into a REDcap database. They just presented that recently and it got a lot of attention because most centers don’t have that, so that could be part of an application, because we’re already developing new biomedical informatics tools to help assist in making trials more efficient.

So I think we’re going to be able to tap a few strategic domains, because they resonate well with what we’ve already been doing and what we want to improve on. And there are more that I haven’t mentioned, but that’s what Martin and Nana and I are thinking about right now: Where we are well placed to apply as a center – a RIC or a TIC – or if there’s something we should apply in to be part of an Collaborative Innovation Network.


Previous directors’ updates:

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.
December 2014  – Karl Kieburtz offers his takeaways from the CTSI all-hands retreat.
November 2014 – Nana Bennett speaks to the expansion of the role of the CTSI’s Community Advisory Council.
October 2014 – Harriet Kitzman discusses the science of team science.
September 2014 – Karl Kieburtz talks about why the CTSI is beefing up its informatics team.
August 2014 – Nana Bennett discusses the new Population Health pillar.
July 2014 – Harriet Kitzman offers her takeaways from the Mini Summer Research Institute.
June 2014 – Karl Kieburtz gives an overview of the CTSI’s six pillars.

URMC joins NIPTE, strengthens pharmaceutical science and engineering

The University of Rochester Medical Center has gained admission to the National Institute for Pharmaceutical Technology and Education (NIPTE), a collaborative organization dedicated to research and education in the field of pharmaceutical science and engineering.

URMC becomes the 14th member institution of NIPTE.

Cornelia Kamp, M.B.A.

Cornelia Kamp, M.B.A.

URMC’s Clinical Material Services Unit (CMSU), a core research unit of the Center for Human Experimental Therapeutics (CHET), was the key to the university’s admission. CMSU provides investigational drug and device services for many large, multi-center clinical trials conducted at URMC and elsewhere, and acts as the central pharmacy for the National Institutes of Health’s NeuroNEXT network. CMSU also works closely with the CTSI and CHET on drug development research.

“This membership in NIPTE expands the resources available to CMSU, and to researchers at the University of Rochester,” said Cornelia Kamp, M.B.A., executive director for strategic initiatives at CMSU. “A researcher can ask us a question, and if we don’t have an immediate answer, we can work on finding a solution through NIPTE.”

There is minimal overlap of expertise within the NIPTE member organizations, as each university brings something different to the table, said Kamp. Through CMSU, URMC is able to bring expertise in back-end pharmaceutical distribution — such as packaging, labeling, kitting, and drug destruction — to NIPTE. In turn, CMSU leaders hope to gain experience from other member collaborators, which could lead to gains for Rochester researchers.

Karl Kieburtz, M.D., M.P.H.

Karl Kieburtz, M.D., M.P.H.

“Through NIPTE, we have a better chance of making or procuring certain drugs that researchers might be interested in studying,” said Kamp.

The membership could also strengthen a future application that involves the Clinical and Translational Science Award program, said Karl Kieburtz, M.D., M.P.H., co-director of the CTSI, who will serve on the NIPTE Board of Directors.

“The National Center for Advancing Translational Science is developing this vision of improving the efficiency of clinical research and focusing on clinical trials,” said Kieburtz. “So we’re looking at what strengths we have that would apply towards these various centers, and CMSU’s affiliation with NIPTE is definitely one of them.”

CTSI revamps leadership structure

The Clinical and Translational Science Institute has reorganized itself to broaden the range of expertise among the institute’s top leadership.

Karl Kieburtz, M.D., M.P.H., senior associate dean for clinical research at the School of Medicine and Dentistry, who has served as director of the CTSI since October 2013, has been joined by Nancy M. Bennett, M.D, M.S,., and Martin S. Zand, M.D., Ph.D., and the trio are serving as the Institute’s co-directors.

MartinZand

Martin S. Zand

KarlKieburtz

Karl Kieburtz

NanaBennett

Nancy M. Bennett

The leadership change became effective on January 1.

“Karl has enormous experience in clinical trials, Nana brings her community perspective and population health expertise, and Martin brings informatics and data science, as well as a basic science background,” said Stephen Dewhurst, Ph.D., vice dean for research at the School of Medicine and Dentistry. “So they have different clinical interests, research interests and expertise, and put together, they make an extraordinarily broad and effective leadership group.”

This team approach is becoming increasingly common within the Clinical and Translational Science Award network. In Rochester, the diverse skill sets of the three co-directors allows for CTSI leadership to encompass the research spectrum, starting with basic science discovery and continuing through clinical trials and implementation on the population level.

“It really does bridge the molecules to populations theme that we’re trying to express. And the truth is, no single person can bridge all that — it has to be a transdisciplinary, multidisciplinary effort,” said Kieburtz. “So we’re doing it the leadership level, and showing that you can lead an institute effectively with a team.”

For the past year, Bennett served as a CTSI co-director alongside Kieburtz and Harriet Kitzman, Ph.D., but in a more limited capacity. Now her role comes with increasing importance, as the CTSI recently placed a renewed emphasis on improving the health of the population as a whole.

“As we try to accentuate the theme of population health in the CTSI, the new leadership structure will make it much easier for me to contribute in a meaningful way,” said Bennett.

Zand, meanwhile, brings informatics expertise, paramount when it comes to analyzing the big data needed for impactful research into population health.

“We want to use data science to identify questions that we’re not asking and identify data we don’t yet have. This will allow us to be in that space of discovery,” said Zand. “That way, we can translate data into real clinical and community interventions that improve the health of a population as a whole.”

The new structure also fosters an environment that will allow the CTSI to more easily integrate with several other centers within the university. Kieburtz also has strong ties to the Center for Human Experimental Therapeutics, Bennett heads the Center for Community Health, and Zand is the director of the Rochester Center for Health Informatics and co-director of the Center for Biodefense Immune Modeling.

In terms of operations, Kieburtz will remain the CTSI’s liaison to university leadership and to the National Center for Advancing Translational Sciences (NCATS), while Bennett will be the main interface with the community through the Center for Community Health, and focus on overall CTSI strategy and developing the population health science theme for the CTSI.

Zand will take on integrating informatics activities throughout the Medical Center and the newly created Institute for Data Science, have responsibility for the CTSI’s day-to-day operations, and will lead the grant-writing process when NCATS releases its call for renewal applications.

Director’s Update – September 2014

Every month, the CTSI Stories Blog will post excerpts from ongoing conversations with the institute’s co-directors.

Below, Karl Kieburtz discusses the CTSI’s growing biomedical informatics team and how it can support university researchers.

Karl Kieburtz, director of the CTSI

Karl Kieburtz, director of the CTSI

On the growing need for biomedical informatics:

One thing we focus on in the CTSI is population health, meaning the overall health of a city, a county, a region, and so on. And we want to know, when we do something — when we educate people, when we develop new programs, when we open Strong West — does it make any difference? Does the population do any better?

Nana Bennett talked a little bit about this last month, but right now, there are a lot of agencies that collect health information on the population, and could potentially answer that question. We do it, the other health agencies in town do it, Rochester RHIO (Regional Health Information Organization) does it, the Finger Lakes Health Systems Agency does it. We all have databases. But it’s almost like they’re different bank accounts: The information is structured in different ways and lives in different places, and the data collected is everything from how much people are using hospitals, to vaccination rates, to transmission of infectious diseases, to obesity rates.

So we have a lot of different numbers, a lot of data, but we don’t always have a ton of usable information from that data. The only way to truly understand it is to establish some common rules around it, so people are comfortable with others going into the databases and pulling data out.

This takes a tremendous amount of effort. The business section of the New York Times recently had a piece on big data, and it talked about how 50 to 80 percent of the time spent with big data is just spent getting the data together — reconciling different data sets. And when I read that I said, “Of course! That’s what we’re doing here!”

On how we’re doing it:

Bioinformatics isn’t one of our pillars — it’s actually part of the foundation of the CTSI, and we think it’s important enough that we’re creating a faculty position in the CTSI around it. We’ve hired Dongmei Li, who will join us shortly, and she will be the first faculty member who is actually based in the CTSI.

Dr. Li will join Tim Dye, who got here in January; Jack Chang, who got here in June; Meg Demment who started in August; as well as Kathleen Holt, who is joining shortly; and Adam Tatro, who has been our EMR (Electronic Medical Record) expert for a while. Carrie Irvine and Amanda Davin in Academic IT are also part of the team.

So we’re going to be a robust resource for people who are looking to sort through nearly any kind of big data. Whether it’s small, in-house research projects that use the EMR, or a project that looks at patient information across populations and across datasets, or something as big as national utilization data of Medicare — we can help with all of that. And that’s what we want people to know.


Previous director’s updates:

August 2014 – Nana Bennett talks about the new Population Health pillar.
July 2014 – Harriet Kitzman offers her takeaways from the Mini Summer Research Institute.
June 2014 – Karl Kieburtz gives an overview of the CTSI’s six pillars.

“Promoting” team science — URMC on the leading edge

During the lunch break at the Mini Summer Research Institute in mid-June, Beau Abar, Ph.D. and KL2 scholar, sat at a table in the Saunders Research Building lobby, swapping ideas with Harriet Kitzman, Ph.D., co-director of the CTSI.

“As a younger researcher, I want to be a team player, because the best science seems to come from strong collaborations,” said Abar. “But the best way to move up is to win those grants on your own — to be the P.I., to be the lead author. How can one do both?”

“That’s an issue that we talk about all the time,” acknowledged Kitzman.

As it turned out, the university was only weeks away from implementing updated tenure and promotion criteria specifically designed to reward talented team scientists for their contributions to collaborative research groups.

JeffLyness

Jeffrey M. Lyness, M.D.

The new policies, which went into place on July 1, allow recognition for scientists who lead a defined portion of the work done by collaborative teams. Department chairs are encouraged to ask referee letter-writers to comment specifically about the unique role on the team played by such scientists. These materials are given serious weight in tenure and promotion considerations.

This allows talented team scientists to further their careers, even if they are not always in roles such as principal investigators for grants or lead authors for publications.

“Science has gotten too complicated and requires too many different types of expertise for one person. These days, groundbreaking science of almost every discipline happens in collaborative teams,” said Jeffrey Lyness, M.D., senior associate dean for academic affairs. “Tenure systems, however, were established to recognize the achievement of an individual, and in team science not everyone can be first author, senior author, P.I., or co-P.I.”

The new system, which was established following ample input from faculty across the Medical Center, received overwhelming support from department chairs before it was put into place.

Outside organizations have appreciated the changes, too: When Lyness exchanged emails about the new system with the staff of Ann Bonham, Ph.D., Chief Scientific Officer at the Association of American Medical Colleges, he received word that the university’s policies were on the “leading edge” in this area.

Karl Kieburtz, director of the CTSI

Karl Kieburtz, director of the CTSI

Since its inception, the CTSI has also played a lead role in supporting team science. Co-director Kitzman is currently working with several others within the Institute to learn more about what traits or characteristics make one team of researchers more successful than another. The Institute’s largest grant, the Incubator Program, is specifically designed to support research efforts that involve multiple investigators or departments.

“Translation of discoveries at the bench into care — maybe that hasn’t gone so well because people are pursuing individual awards,” said Karl Kieburtz, M.D., M.P.H., director of the CTSI. “So people may need to be educated about the benefits of team science and rewarded for that interdisciplinary approach.”

The various efforts are supportive of an environment that many faculty say sets the university apart from other academic institutions.

“Collaboration has always been key to the culture here. It’s part of what I loved about the school as a student, and part of why I came back as a faculty member,” said Lyness. “As Dean Taubman has noted publicly, our faculty turnover rate is low compared to our peer institutions, and I think that’s because of our culture.”