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.

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.

“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.”

URBEST opening enrollment for grad students, postdocs

Medical research training — for students and postdocs alike — is heavily geared towards an academic career path. But only 40 percent of Ph.D. holders go on to become professors, according to a 2012 study from the National Institutes of Health.

“There isn’t as much funding for PIs as anyone would like, and people are getting nervous as to what students and postdocs are going to be doing if there isn’t enough funding for them in academia,” said Tracey Baas, Ph.D.

Steve Dewhurst, Ph.D. (above, right) and Sarah Peyre, Ed.D., are the PIs for URBEST.

That’s where URBEST comes in. The program, which launched in October, is one of 17 NIH-funded BEST (Broadening Experiences in Scientific Training) programs throughout the country, and provides career training to graduate students and postdocs who are considering careers outside of academia.

BEST programs differ from institution to institution, but Rochester’s program places emphasis in two main areas.

First, URBEST is designed around self-determination theory. This means the curriculum is very flexible, allowing enrollees to dip their toe into the water or dive much deeper to obtain the experience they desire. (In order to obtain a URBEST certificate, students need to accumulate 120 “points” within the program, but those points can be accumulated in a variety of ways.)

Second, URBEST places heavy emphasis on connecting students to internships, which isn’t done at every BEST program.

“But we thought the internship would make it most attractive for both the students and for future potential employers,” said Baas, executive director of URBEST.

The program allows students to pick one of three pathways, each with its own associated coursework and internship options:

• Industry, manufacturing, and entrepreneurship (director: Paul Dunman, Ph.D.)
• Regulatory affairs, compliance, and review (director: Joan Adamo, Ph.D.)
• Science and technology policy (directors: Katrina Korfmacher, Ph.D.; Scott Steele, Ph.D.)

The program will be accepting applications for its next cohort from April 6-17. To apply, or for more information, visit the URBEST website.

Success stories: Clinical Research Center goes “above and beyond”

The Clinical Research Center (CRC), a pillar of the CTSI, plays host to numerous research studies at the University of Rochester. Charles Kamen, Ph.D., recently used the CRC for his study of psychological distress in cancer survivors.

Kamen discussed his research, and his experience at the CRC, with CTSI Stories.

Charles Kamen, Ph.D.

Tell us a little bit about your research.

I work closely with Karen Mustian, and she’s done a lot of work showing that exercise is effective in reducing side effects in people recovering from cancer. She’s shown that if you give people a home-based exercise intervention — walking regularly and increasing steps to the recommended 10,000 a day, as well as doing a resistance activity — that fatigue goes down over the course of six weeks.

I’m a clinical psychologist and I’m interested in psychological distress. So I was curious if we could use that same exercise intervention to address psychological distress in cancer survivors. I’m also interested, specifically, in psychological distress in gay and lesbian cancer survivors. There’s a lot of evidence that LGBT persons have more stress in general than heterosexual individuals do, probably because of a lifetime of discrimination and prejudice. I’ve shown in past datasets that if you look at LGBT cancer survivors, the same disparities you see in the population as a whole persist in cancer survivorship. So even in the context of cancer, which is very stressful, LGBT survivors have more stress than other cancer survivors.

So I wanted to get a group of LGBT cancer survivors, and their care partners, to come in to an intervention to see if we could study psychological stress. That’s the overall view, and that’s why I’m trying to address health disparities and psychological distress in this underserved population.

How did you come to work at the CRC?

I put together a proposal, and I got a Wilmot Cancer Center seed grant. My study is on cancer survivors and their care partners, and I’m randomizing them to have them either exercise as a pair — a dyad — or to have the survivor exercise alone. So I’m looking at whether people adhere more to an intervention when they have a partner. The thinking is that no one likes to exercise, but if you exercise with someone else, it’s going to increase the chance of you doing it. And if you exercise, that improves your immune system. So to test that, I also needed blood samples.

So there’s an exercise component, which is done in the PEAK lab, and we also need to do blood draws, and for that, one of my colleagues recommended the CRC.

What was your experience like?

The CRC went above and beyond what I expected. First, I wasn’t sure how the blood draws were going to work. I was worried that I was going to need to somehow haul the blood to a lab right away, aliquot it, and freeze it. This would’ve been tricky, because since it’s a partner study, we have two people coming in at a time. So while one person is doing the exercising with my study coordinator, I’m running the other person through the questionnaire. We would’ve needed a third person to transport, aliquot, and freeze the blood.

But the CRC was able to do all of that for me. I just brought the patient in, they drew the blood, and I took the patient down to the PEAK lab for the rest of the assessment. The CRC would spin the blood for me, aliquot it, and freeze it for me in their -20 degree freezer. Then my coordinator could come by a few days later and take it to our -80 freezer. So the convenience of that was fantastic, and I don’t know how it would’ve worked if the CRC hadn’t been able to process the blood for me.

I also knew I was going to have the participants do their physical exercises, and then I was going to have them do some questionnaires and other assessments. But I knew I was going to have to feed them before those 2 hours of other assessments, so my plan was to get yogurt and granola bars or something to offer them. But Ann Miller at the CRC told me that they have snacks there, so they could give meals to the participants. So in addition to the convenience of the blood processing, they also had meals, and we didn’t have to stock a bunch of Gogurt in the PEAK lab.

And how did the study itself go? Any results you care to share?

The LGBT population compared with heterosexuals do indeed have more psychological distress, more fatigue, and they actually report a little less support from their care partners. I didn’t expect that last part.

But over the course of the intervention, the distress for LGBT couples in the dyad comes down pretty sharply, and there’s an increase in the care partner support. Thanks to the pilot data I collected with the help of the CRC, I was able to successfully compete for a major career development award from the National Cancer Institute!

Meet the winner of “America’s Got Regulatory Science Talent”

Corey Hoffman, a predoctoral student in the Medical Center, was the winner of the second annual “America’s Got Regulatory Science Talent” student competition held on Feb. 10 at the Clinical and Translational Science Institute. Hoffman will soon travel to Maryland to speak with the Food and Drug Administration about his project. This competition is organized by the University of Rochester Regulatory Science program, led by Joan Adamo, Ph.D. and Scott Steele, Ph.D. and held in conjunction with the Center for Excellence in Regulatory Science and Innovation at the University of Maryland.

Hoffman recently spoke with CTSI Stories.

Tell us a little bit about your proposal.

Right now, there are certain areas in regulatory science where the FDA wants to advance science, and within each area there are a few more specific focuses. The focus that stuck out to me is a clinical one that centers on personalized medicine, and looking for new types of biomarkers.

So what we want to know is: Is there something within the human body, a protein or DNA sequence that might be different in a healthy individual than someone who might be at a predisposition for a disease or who might have a disease. And how can we identify methods for finding these and then validating them?

Can you give an example of that?

There was one study on people with leukemia, and there was a small subset of patients that had a more aggressive disease and didn’t respond to chemotherapy. So the study was asking if there was something genetic that was different in those individuals, and it showed that there was indeed a commonality. So that was the example I used in the presentation.

What I’m proposing is to take advantage of all the clinical trials being done that are using sequencing like that, and put them all into a database. This could allow others to prevent redundancies in future trials and could be a reference point for future clinical studies or basic science studies.

Very cool. In a perfect world, what do you see as the potential outcomes from this type of database?

There are two potential outcomes that I could see. The first is that you could screen a patient’s genome, so that when patients do respond well in a trial, maybe there’s a genetic element that they share. Or, if there’s a commonality in people that don’t respond, then you could screen future patients ahead of time before you even offer the treatment. That way you wouldn’t have to put them through something if you knew ahead of time that they weren’t going to respond.

Secondly, certain individuals don’t respond well to certain drugs because of how their body metabolizes the drugs. This is determined by things called CYP genes, and certain people have mutations in these genes which affect how they respond to the drug. So you could screen people for mutations in their CYP gene to give indications for drug response, and who is and isn’t a good candidate for a certain drug.

Are there any challenges you see to developing a database like this?

I think the biggest concern before a database is ever constructed is protecting the patient health information of these genetic sequences, and I think that’s something that remains unexplored. There needs to be efforts that go into de-identifying the genomes. I’m not a geneticist, but it seems possible that a certain sequence of DNA could be unique to an individual that it could tell you who that person is. So, how can we take advantage of genetic information without putting any risk to the patients? And if these genome sequences are in the database, who has access? Those are two things that need to be considered.

 

Med Center Research Associate receives NSF grant to help fight Ebola

What if everyone in Nigeria had a smartphone with an app where they could input abnormal health symptoms? What if health care workers could monitor all the information in real time, and direct resources to people and places before an Ebola outbreak got out of control?

Solomon Abiola, MS, is hoping to answer these questions, at least on a very small scale, in the next few months.

A research associate in the Medical Center, Abiola recently received a $130,000 grant from the National Science Foundation to develop a smartphone app that can track the symptoms of a population in real time. He leaves for Nigeria to begin implementing his idea in the next month.

The app works like this: A cellphone user living in a region with a dangerous epidemic downloads the program. Every morning, the app sends the person a series of questions about how they are feeling and prompts them to seek help if certain criteria are met.

“So a big component for Ebola was your temperature,” said Abiola. “The app could ask ‘Do you have a fever?’ and if you answered that your fever was 103, it would tell you to come in and get screened. That way you can get in front of a health care worker instead of waiting, which might cause you to spread your disease to your family or anyone else you encounter.”

The grant covers a field study with up to 200 participants. Health-related studies that track cellphone data in an attempt to map a population have been done before, said Abiola, but previous studies have been done retroactively, which can create legal issues and issues of informed consent.

“A lot of studies that use cellphones are doing it passively. They’ll look at the cellphone tower information or, after the fact, they’ll download a bunch of data from a carrier, which can create other obstacles because none of those users have given consent to use their data,” said Abiola, who collaborated with Henry Kautz, Ph.D., Robin and Tim Wentworth Director of the Institute of Data Science, and Ray Dorsey, M.D., director of the Center for Human Experimental Therapeutics, on the grant.

“But through this, by downloading the app, you’ll be able to give informed consent, and the app will give health care providers real-time information.”

Though the Ebola crisis is one of the more pressing global health crisis he said that the app could potentially be used to track any future outbreak, or aid in current efforts to combat malaria and HIV/AIDS. In developing countries, where health care professionals are scarce, the app could be used to direct the limited health resources into regions that need it most. But in more developed countries, it could also be used as a form of telemedicine, allowing doctors to check in on patients who live in rural areas; or aid in tracking infectious diseases within the hospital system, such as MRSA and C. diff.