Sanford Magazine - Fall 2014

FALL 2014 | SANFORDHEALTH.ORG

The Sanford Project Progress in our pursuit for a cure

discoveries Fall 2014

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Message from Kelby Krabbenhoft How the Sanford Project is Making Progress Updates from Development & Research Events Calendar

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from Kelby Krabbenhoft I am pleased to report that a successful search for the Executive Vice President for Sanford Development and Research has concluded. There were two key parts to this search - Dave Link’s appointment as Chief Strategy Officer, and the choice of Rich Adcock as our next Executive Vice President.

Sanford Health Development & Research 1305 W 18th Street PO Box 5039 Sioux Falls, SD 57117-5039 For questions or additional information email us at discoveries@sanfordhealth.org or visit us on the web at sanfordhealth.org

Dave has assumed a role with more focus and attention to the strategic planning agenda at Sanford Health. Dave has also taken on a bigger role in working with the Sanford Trustees on matters of governance and will establish the Center for Strategic Governance and the Department of Strategic Planning at Sanford.

As Executive Vice President, Rich is overseeing Sanford Research, Sanford Health Plan, Sanford Frontiers, Sanford International Clinics and the Sanford Foundation - all critical, growing and strategically significant areas at Sanford. Rich is the former president of Sanford Frontiers and has held various executive positions with the organization since 2004.

Join me in congratulating these two dedicated Sanford family members as their remarkable leadership continues to propel Sanford at the forefront of collaboration and innovation.

Kelby Krabbenhoft President & CEO, Sanford Health

How the Sanford Project is making progress toward a discovery Since 2009, Alex Rabinovitch, MD, has been leading the way in The Sanford Project’s mission of discovering a cure for type 1 diabetes. Last month, he announced his retirement after dedicating an entire career to diabetes research. With generous support from T. Denny Sanford and Todd and Linda Broin, the work of The Sanford Project under Dr. Rabinovitch’s leadership has

come a long way in a short time to try and make the lives of those struggling with diabetes better.

Diabetes and proper insulin levels “People with type 1 diabetes, whether they be children or adults, need insulin,” says Dr. Rabinovitch. “The beta cells that produce insulin in their bodies have been destroyed by an

Cover: Todd and Linda Broin Chair and Director of The Sanford Project, Alex Rabinovitch, MD, has dedicated his entire career to diabetes research.

The Sanford Project’s REPAIR-T1D trial was supported by members of the Sanford clinical research team, including Jennifer Weiss, BS, CCRP, Clinical Research Coordinator; Carmen Sandman, BS, RN, Clinical Research Coordinator; Diane Hahn, LPN, CCRP, Director of Clinical Research Operations; Jada Johnson, BS, MS, Regulatory Specialist; and Angela Van Veldhuizen, BSN, RN, Clinical Research Coordinator.

autoimmune process. They have to inject insulin to replace that insulin that has been lost because those cells that produce it have been lost.”

This insulin is crucial to maintaining proper glucose levels in the body.

When these levels are imbalanced, complications begin to occur.

“Kidney failure, blindness, heart attack, strokes, all of those things happen if your blood glucose goes too high,” explains Dr. Rabinovitch. “And if your blood glucose goes too low, then you would be at risk for seizures or slipping into a coma.” Avoiding these problems requires injecting exactly the right amount of insulin several times each day, a quantity that changes depending on many factors including activity and food.

Steps to the perfect cure To fix this problem, ideally researchers would like to find a way to regenerate those insulinproducing cells in the body. This is what Dr. Rabinovitch refers to as the “perfect cure” where diabetic patients would no longer need to inject themselves at all. And while that is the ultimate goal, 4 | discoveries

the Sanford Project team is currently focused on how to lessen the amount of insulin that needs to be injected and prevent the problems that come from dosing that cannot be as exact as what the body should be doing on its own.

“If we can bring those insulin-producing cells up even a little bit, then you would have a contribution from your own insulin production,” says Dr. Rabinovitch. “Then you wouldn’t have to inject as much insulin and still get good blood glucose control. This would hopefully improve the life of people with type 1 diabetes. ” By having a little reserve insulin from the pancreas, the body can do fine tuning after a more approximate dose, building a cushion against the problems of both over- and under-dosing.

Clinical trial completion marks major milestone Searching for answers, The Sanford Project recently reached a major milestone and published the results of its first clinical trial just before Dr. Rabinovitch’s retirement. Called REPAIR, this phase-two trial enrolled people who had been diagnosed with type 1 diabetes within the past six months. They ranged between the ages of 11 and 36 and were from four different areas of the country, including Sioux Falls and Fargo. The 69 trial participants continued taking their insulin shots as normal, but a number of them were given something else, as well.

“We treated them with two medicines that are safe and are used for other disorders,” says Dr. Rabinovitch. “One is used in type 2 diabetics, and the other is used as an antacid. The objective was to see if we could increase hormones GLP-1 and gastrin, as these hormones enhance insulin-producing cell survival and/or regeneration.”

The patients were treated and monitored over a 12-month period of time to keep track of insulin produced by their own bodies. Completing this trial required the development of not only the local, hands-on clinical research staff, but also a higher level of administration and monitoring to enable The

Sanford Project to conduct this study across multiple sites.

What Dr. Rabinovitch and his team found from the trial is that only some of the patients who received the two medications experienced the elevated hormone levels that were predicted to help the beta cells and preserve insulin production; and that those people who responded with higher hormone levels may have had some benefit to insulin production.

This has left The Sanford Project team hungry to learn more and find an answer to “why?” The most likely answer has to do with differences among people in how fast their bodies eliminate various drugs. This phenomenon - known as pharmacogenetics - is becoming increasingly recognized as affecting many drugs.

The next steps With results from the REPAIR trial in hand, Dr. Rabinovitch has created a solid foundation for The Sanford Project team to continue moving forward. A follow-up study is already being planned, and will build on the REPAIR trial method and infrastructure that has been developed.

Reaching this stage is very exciting for The Sanford Project team.

This pursuit of a real solution to diabetes is something Sanford Research Chief Operating Officer and Vice President David Pearce, PhD says the people in our Sanford communities can really take pride in.

diabetes by the numbers • As many as three million Americans may have type 1 diabetes.

• Each year, more than 15,000 children and 15,000 adults are diagnosed with type 1 diabetes in the U.S. That is approximately 80 people per day.

• The prevalence of type 1 diabetes in Americans under the age of 20 rose by 23 percent between 2001 and 2009.

• The rate of type 1 diabetes incidence among children under age 14 is estimated to increase by three percent annually worldwide.

• Type 1 diabetes accounts for $14.9 billion in health care costs in the U.S. each year.

-Statistics from JDRF.org

“What’s really exciting is the pace in which we are able to conduct research here in the Dakotas,” says Dr. Pearce.

“Medical research takes significant time and patience; however, Sanford’s vast footprint, combined with extraordinary investments to its research infrastructure, allows scientists to much more quickly and seamlessly bring their research from the bench to bedside.”

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updates

A study published in JAMA, co-authored by Sanford Health breast radiologist Thomas Cink, MD, focused on the impact of 3D mammography at a diverse range of sites across the United States.

Sanford Research Impact of 3D Mammography Revealed in Sanford JAMA Study Three-dimensional mammography finds significantly more invasive cancers and reduces unnecessary recalls, according to a large, retrospective study published in the Journal of the American Medical Association (JAMA) featuring data from Edith Sanford Breast Center.

The study, “Breast cancer screening using tomosynthesis in combination with digital mammography,” was led by Sarah Friedewald, MD, of Advocate Lutheran Hospital in Park Ridge, Illinois, and co-authored

by Thomas Cink, MD, a breast radiologist for Sanford Health in Sioux Falls. It focused on the impact of 3D mammography at a diverse range of sites across the United States. The study looked at nearly half a million mammograms, including 30,000 from Sanford Health.

takes just a few seconds longer and the positioning is the same, but I believe the real difference is in the enhanced information available to the doctor with a 3D image.”

Edith Sanford Breast Center in Sioux Falls has utilized 3D screening technology since 2012.

The program’s radiologists are fellowship trained in breast imaging.

Results indicated that 3D mammography lead to a 41 percent increase in invasive cancer detected, a 15 percent decrease in unnecessary recalls for false alarms and a 29 percent increase in the detection of all breast cancers.

Clinical Trial Looks for Genetic Targets in Cancer

“Three-dimensional mammography finds more of the invasive, harmful cancers and saves women the anxiety and cost of having additional screenings for what turns out to be a false alarm,” said Cink. “Women see little difference between a conventional 2D mammogram and a 3D mammogram; the exam

Sanford Health is working to enroll approximately 50 adult patients whose cancer has progressed after the first line of treatment or who have rare cancers without standard treatment options in a clinical trial

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to look for genetic information that could help customize treatment options. The Genetic Exploration of the Molecular Basis of Malignancy in Adults (GEMMA) began in May. Enrollees are consenting adult patients with advanced cancers whose disease has progressed on at least one line of therapy or who have a rare cancer with no standard treatment. DNA will be extracted from tumor samples and tested to identify targets for treatment.

“DNA contains genetic information that acts as a blue print for how our bodies are made and work,” said Steven Powell, MD, a Sioux Falls oncologist and clinical researcher.

“A single change in the sequence of DNA can lead to cancer, and while we know some the genetic changes that can cause disease, we have much more to discover. We are learning that some of these changes can be targeted with new therapies. This could change the face of cancer care.”

Patients enrolled in GEMMA are screened over a period of up to two weeks to determine if they fit the study criteria. Upon enrollment, tissues are analyzed, and the patient’s case is reviewed by their physician and the Sanford Genomic Tumor Board, a panel of experts in cancer care and genetics, to determine the best course of treatment.

Next-generation sequencing technology will be used to analyze the tumor samples and provide real-time clinical information

for each patient’s care team.

Throughout the study, patients will regularly meet a research coordinator for progress updates.

Following treatment, patients will be monitored for two years.

“GEMMA patients receive treatment in line with the best in the world,” said Anu Gaba, MD, a hematologist and oncologist based in Fargo. “The experts tasked with studying a patient’s tumor provide a diverse prospective and allow for a personalized treatment regimen that will consider each person’s unique genomic composition.”

This study is the beginning of a focused effort to provide patients access to novel personalized therapies.

To complement the GEMMA study, Sanford will open several additional clinical trials that utilize novel therapies that treat genetic targets found on the GEMMA study.

$7.1 Million NIH Grant will Fund Cancer Research The National Cancer Institute (NCI) of the National Institutes of Health (NIH) has named Sanford Health an NCI Community Oncology Research Program (NCORP) community site and awarded it a five-year grant totaling more than $7.1 million to recruit participants for cancer clinical trials, quality of life studies and cancer-care delivery research.

The grant was one of 53 awarded

Sanford Health is enrolling approximately 50 adult cancer patients in a clinical trial to look for genetic information that could help customize treatment options.

under NCORP, a national network of investigators, cancer-care providers, academic institutions and other organizations that provide care to diverse populations in community-based health care practices across the country.

Sanford is among 34 community sites that will recruit participants and partner with the seven NCORP research base hubs to design and conduct multi-center cancer prevention, control and screening/ post-treatment surveillance clinical trials and studies.

Sanford, which is the only NCORP site in the Dakotas and Nebraska, will also participate in studies that explore quality of life and cancer-care delivery involving patients, practitioners and health care organizations.

“Advances in cancer care make this the appropriate time to expand the outreach of clinical trials to community-based facilities, which is where most people access care,” said David Pearce, PhD, chief operating officer and vice president for Sanford Research. “Sanford emerged as an ideal selection for NCORP because of our history of success in recruiting patients for clinical trials, infrastructure and physician volumes already in place to support an advanced cancer program and a research team capable and ready to contribute to research bases for the implementation of these trials.”

Besides the 34 community sites, including Sanford’s, NCORP contains seven research bases and 12 minority/underserved community sites. The program funding totals $93 million over five years.

NCORP replaces two previous NCI community-based clinical research programs, the NCI Community Clinical Oncology Program (CCOP) and the NCI Community Cancer Center Program (NCCCP).

Sanford was formerly a member of both the CCOP and NCCCP.

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Sanford Surgeon Appears in Two National Journals for Aneurysm Innovation Patrick Kelly, MD

A Sanford Health physician was recently published in a pair of national journals for two unique methods to treat aneurysms.

Devices invented by Patrick Kelly, MD, are highlighted in the Journal of Vascular Surgery and Vascular.

An aneurysm is an enlargement in the wall of a blood vessel that can lead to tearing and life-threatening bleeding.

“A novel endovascular debranching technique using physicianassembled endografts for repair of thoracoabdominal aneurysms,” published by the Journal of Vascular Surgery, demonstrates the effectiveness of a device that was created using off-the-shelf components. Kelly and his team built two custom grafts to seal off thoracoabdominal aneurysms, which involve the thoracic aorta and extend into the abdominal aorta. The stents were placed in 14 people with a 100 percent survival rate. The benefits

of the stent graft created by Kelly are that it could be replicated off the shelf and be safer to implant and may have more favorable flow characteristics when compared to what is currently offered in industry-sponsored clinical trials.

In a study of two patients that appeared in Vascular titled “Complete endovascular debranching of the aortic arch: A report of two cases,” Kelly used more physicianassembled grafts to successfully repair aortic arch aneurysms, which are characterized by an enlargement of the aorta just past the heart and aortic valve. The custom-made grafts restored appropriate blood flow and debranched the aneurysms in both patients. There was no treatment currently available for the two patients other than an open surgery, which neither of the patients were candidates for.

“These mechanisms for treating aneurysms become incredibly important when dealing with patients who have significant co-morbidities and cannot participate in a widearray of more invasive treatment options,” said Kelly. “In both studies, we used components already on the market to construct novel grafts

Sanford surgeon Patrick Kelly, MD, was recently published in a pair of national journals for developing two unique methods to treat aneurysms.

that proved to be quite effective.”

Kelly is a board-certified and fellowship-trained vascular and general surgeon. He holds dozens of patents or pending patents for medical devices and has served as a principal investigator for several clinical trials.

Outcome of Two-year Sanford Project Study Published The results of The Sanford Project’s first clinical trial are published in the July edition of The Lancet Diabetes & Endocrinology, revealing the outcome of a two-year study exploring the benefits of two drugs in treating type 1 diabetes.

The study is titled “Combination therapy with sitagliptin and lansoprazole in patients with recent-onset type 1 diabetes (REPAIR-T1D): 12-month results of a multicentre, randomised, placebo-controlled, phase 2 trial.”

The Sanford Project is an emerging translational research center focused on targeted diabetes research, cures and care made possible in part through the generosity of Denny Sanford and Todd and Linda Broin.

In August 2012, The Sanford Project Todd and Linda Broin Chair Alex Rabinovitch, MD, and his team announced they had reached full patient enrollment for Restore Pancreatic Insulin Response in type 1 diabetes (REPAIR-T1D). Based on a successful mouse model, the study explored if two FDA-approved drugs, sitagliptin and lansoprazole, could regenerate beta cells in humans by improving levels of GLP-1 and gastrin hormones. Type 1 diabetics experience a loss of insulin-producing beta cells and need to inject insulin into their bodies manually.

Sixty-nine participants between the ages of 11 and 36 received either the two drugs or a placebo while continuing their insulin injections.

The group receiving the drugs did not experience an improvement in insulin production, but some study participants whose GLP-1 and gastrin levels increased may have

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better preserved beta cell levels.

“While the results of our first clinical trial did not indicate a regeneration of beta cells as a result of the drugs used, it is promising that some of the participants seemed to have preserved beta cells that may have otherwise died,” said Rabinovitch.

“The next step is to design another study based on what we learned from the REPAIR trial and continue to make progress towards a cure.”

The Sanford Project team is finalizing plans for the next clinical trial involving participants from the REPAIR-TID project to better understand why responses to the sitagliptin and lansoprazole differed among participants.

“What is perhaps most remarkable about the completion of this trial is the pace in which we are able to conduct research here at Sanford because of our size and strategic investments in people and infrastructure,” said David Pearce, PhD, vice president and chief operating officer for Sanford Research. “The results have left The Sanford Project team both anxious and prepared to learn more about why patients reacted differently to the two drugs that were utilized in this clinical trial.”

The Sanford Project Identifies Potential Biomarker Alexei Savinov, MD, PhD

A team of Sanford Project researchers led by Alexei Y Savinov, MD, PhD, recently published an article titled “Nardilysin-dependent proteolysis of cell-associated VTCN1 (B7-H4) marks type 1 diabetes development” in Diabetes. The study highlights the potential of a specific protein, soluble V-set domain-containing T cell activation inhibitor-1 (sVTCN1), as a new type 1 diabetes biomarker and the enzyme nardilysin (NRD1) as a possible target for treatment of the disease.

The results of The Sanford Project’s first clinical trial were published in the The Lancet Diabetes & Endocrinology, authored by Sanford Project scientist Kurt Griffin, MD.

Utilizing a mouse model and samples from human type 1 diabetes patients, Savinov and his team discovered that a loss of V-set domain-containing T cell activation inhibitor-1 (VTCN1) and an increase in sVTCN1 levels occurred in parallel to the natural development of type 1 diabetes.

Furthermore, the loss of VTCN1 was mediated by the enzymatic action of NRD1, demonstrating its possible utility as a therapeutic target.

“Recent studies have indicated that VTCN1 is a molecule capable of inhibiting T-cell activation, which is thought to underlie the development of type 1 diabetes,” said Savinov.

“We found that degradation of VTCN1 and consequent elevation of sVTCN1 levels seemed to have correlated to early appearance and the aggressive pace of the disease.”

Savinov is an associate scientist with The Sanford Project, which is part of the Children’s Health Research Center at Sanford Research. His lab studies how autoimmune T cells are activated during type 1 diabetes development, home to the target organ and destroy their beta cell targets.

BioID Method Receives National Attention Kyle J. Roux, PhD

A June edition of the Proceedings of the National Academy of Sciences of the United States of America features the work of Sanford Research’s Kyle J. Roux, PhD, who developed a system to identify interactions between living cells called BioID. Roux’s study, “Probing nuclear pore complex architecture with proximity-dependent biotinylation,” demonstrates the utility of BioID (proximity-dependent biotinylation) for application in cell research.

Through the fusion of an enzyme to a protein, BioID allows researchers to monitor the proximity and interactions between proteins in living cells, providing insight into the underlying mechanisms of disease. BioID advances the rate at which scientists can characterize proteins and their interactions, helping in the design of therapies for human application.

In this most recent study, Roux and his team used BioID to explore the sanfordhealth.org | 9

Thousands of youth and adults once again attended the “It’s All About Science Festival” this summer at the Sanford Research Center.

organization of the nuclear pore complex, a large subcellular structure that regulates molecular transport between different compartments of the cell. They also measured the labeling distance of BioID. “We gained a better understanding of the architecture of the nuclear pore and further demonstrated BioID as a valuable tool for exploring the organization of large protein assemblies,” said Roux.

“Furthermore, determining the labeling radius of BioID allows for the rational application of this method and enables more meaningful data interpretation.”

Roux is a scientist in the Children’s Health Research Center at Sanford Research. In August, he received a five-year, $1.52 million grant from the National Institutes of Health to further develop BioID.

Science Festival Attracts Thousands Thousands of youth and adults once again attended the “It’s All About Science Festival” in June at the Sanford Research Center. The goal of the event, which was convened by Dakota Sciences and Dakota State University in 2011, is to promote and encourage a science-based community. The festival celebrated the exploration of science, technology, engineering and mathematics for the third year in a row.

The event was planned and staffed by a core committee from industry, non-profit, educational and business organizations and was chaired by Sanford Research’s Jill Weimer, PhD. Two nationally renowned headline stage performances were featured this year, Docktor Kaboom! and Bubbleology, as seen on the Discovery Channel. The Sanford Underground Research Facility also did a live broadcast for the third year.

Sanford Health is the event’s host and lead sponsor. The event has

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experienced a significant increase in community support with 12 additional major sponsors including Sanford Health Foundation, 3M, Lawrence & Schiller, SD EPSCoR, Raven Industries, First Premier Bank, Northwestern Energy, South Dakota NASA Space Grant Consortium, Best Western Ramkota Hotel, SD BioTech Association, South Dakota State University, SDN Communication and US Bank.

Collaborative Research Center for American Indian Health Announces Pilot Grant Projects The National Institutes of Health (NIH) has selected five research projects for funding as part of the Collaborative Research Center for American Indian Health (CRCAIH) and its pilot grants program.

Now in its second year, the CRCAIH’s pilot grant program was created to fund cutting-edge transdisciplinary research to address health disparities experienced by American Indians in South Dakota,

North Dakota and Minnesota.

In September 2012, Sanford Research and a broad base of partners received a $13.5 million grant from the National Institute on Minority Health and Disparities to create the CRCAIH. The research center has now supported a total of 10 pilot grant awards across the region to explore issues in American Indian health.

“Each project was reviewed by an expert external review panel based on scientific merit and community involvement,” said Amy Elliott, PhD, principal investigator for the CRCAIH and director and senior scientist for Sanford Research’s Center for Health Outcomes and Prevention. “We were overwhelmed by the level of quality and competitiveness in the program.”

The pilot projects were selected based on five major scoring criteria, including purpose, priorities and significance; scientific approach; innovation and potential for future funding; investigators and environment; and collaborative relationships. Proposals were reviewed by eight transdisciplinary minority health researchers from across the United States and Canada with expertise in a diverse set of fields, such as health sciences, public health, ethnic studies, nursing, sociology and epidemiology.

Walking forward American Indian survivorship physical activity pilot • Heather Peters, PhD, University of Minnesota-Morris Culturally based curriculum, wicozani and suicidal ideation in Dakota youth • Ursula Running Bear, PhD, University of Colorado-Denver Multilevel context of healthrelated quality of life in northern plains tribes

Second-annual CRCAIH Summit Promotes Transdisciplinary Research on American Indian Health The Collaborative Research Center for American Indian Health (CRCAIH) held its secondannual summit in June at the Sanford Center in Bemidji.

The CRCAIH promotes research partnerships with tribal communities, research institutions and health

care entities to develop innovative and transdisciplinary research to improve American Indian health.

The event featured presentations from researchers and public health experts on topics like indigenous research, data management and substance abuse. The schedule also included a keynote speech from Spero Manson, PhD, a distinguished professor of public health and psychiatry, director of the Centers for American Indian and Alaska Native Health and associate dean for research at the University of Colorado.

“Our goal is to enhance the knowledge and competence of participants by providing an update on the latest strategies and impact of transdisciplinary research in tribal communities,” said Amy Elliott, PhD, CRCAIH convenor and director of Sanford’s Center for Health Outcomes and Prevention Research.

“This event gathers a reputable group of presenters with a diverse set of perspectives and expertise.”

Billy Mills, (Lakota) Pine Ridge - the only American ever to win an Olympic Gold Medal in the 10,000 meter race – made an appearance at CRCAIH’s annual summit and talked about his 50-year struggle with diabetes. He is pictured here with Amy Elliott, PhD, CRCAIH’s convener and director of the Center for Health Outcomes and Prevention at Sanford Research.

Researchers from the first round of pilot grants, which were announced last summer, are currently finalizing data collection and analysis. Results are expected to be available this fall.

The following projects were selected for funding: • Emily Griese, PhD, Sanford Research Impact of residential treatment on American Indian maternalchild health outcomes • MaryLou Mylant, PhD, South Dakota State University American Indian pilot study on caregiving attachment and health of young children • Daniel Petereit, MD, Rapid City Regional Hospital

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In September 2013, Sanford Research and its partners received a $13.5 million grant--the largest in its history--from the National Institutes of Health’s National Institute on Minority Health and Disparities to create the CRCAIH.

Kruer Selected for Doris Duke Clinical Research Grant Michael Kruer, MD

A pediatrician and scientist at Sanford Health has received a grant totaling more than $500,000 to support his research on pediatric movement disorders. Michael Kruer, MD, is the recipient of a three-year Clinical Scientist Development Award from the Doris Duke Charitable Foundation (DDCF).

DDCF awarded more than $8 million in grants through the Clinical Scientist Development Award and the Clinical Research Mentorship programs, which aim to strengthen the clinical research field by providing opportunities that help advance the careers of young scientists. The Clinical Scientist Development Award is a prestigious award provided to promising young clinician investigators to support them early in their research careers and allow them to build upon promising early findings relevant to human health.

Kruer practices as a pediatric neurologist in the Sanford Children’s Specialty Clinic and the Sanford Children’s Hospital but also runs a lab at the Children’s Health Research Center. His laboratory studies the molecular and cellular basis of movement disorders and degenerative diseases in children.

His project selected for funding is titled “New insights into molecular mechanisms driving pediatric movement disorders.”

“The Children’s Health Research Center is actively looking for ways to better understand the basis of pediatric diseases like the

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Sanford pediatric neurologist, Michael Kruer, MD, is the recipient of a three-year Clinical Scientist Development Award from the Doris Duke Charitable Foundation.

movement disorders my lab studies,” said Kruer. “I believe Sanford’s support of pediatric translational research made my project an attractive choice for the DDCF.” A past recipient of the Child Neurology Foundation’s Shield Award, last summer Kruer was chosen by the National Institutes of Health for a five-year, $860,000 grant to study genetic forms of juvenile Parkinson’s disease and dystonia.

Since 1998, the DDCF has awarded 235 Clinical Scientist Development Awards totaling more than $101 million.

New Test Increases Sensitivity of HPV Detection in Cancer John Lee, MD

Results from a Sanford Research and Chronix Biomedical pilot study demonstrating the utility of a new cancer panel to detect previously undetected viral and cancer mutations were reported in a poster presentation titled “Detection of novel HPV mutations and chromosomal number imbalance (CNI) in oropharyngeal

and laryngeal cancer using nextgeneration sequencing (NGS)” at the American Society of Clinical Oncology annual meeting in Chicago.

The panel identified human papilloma virus (HPV) sequences undetected by conventional laboratory tests as well as new unreported HPV mutations. It is estimated that each year there are approximately 30,000 cases of HPV-associated cancers in the United States.

In the study, researchers applied advanced next-generation sequencing (NGS) techniques to identify tumor-associated mutations in 10 laryngeal and oropharyngeal cancer patients who underwent standard chemo-radiation therapy. As a control, two samples from relapsing respiratory papillamatous patients were analyzed. The single-blinded study looked at biopsied DNA from patients who were either positive or negative by conventional HPV testing. The new test identified HPV sequences in six of the samples of which conventional testing only identified four. The new test agreed with conventional testing in the other five samples that were negative for HPV sequences. Additionally, the new test identified mutations

to the HPV sequences previously unreported on HPV databases.

Further, the chromosome number imbalance discovered was consistent with oropharyngeal cancers.

Analyzing a patient’s cancer for genetic mutations is the basis for predicting treatment outcomes using various cancer drugs and protocols.

Currently, most cancer mutation panels focus on less than 1 percent of the cancer genome with limited predictive value. The preliminary finding from this study is the basis for a larger planned study designed to match these viral and cancer mutations to clinical outcomes using a vastly expanded panel. By using a more extensive mutation panel, the accuracy of genetic testing should be vastly increased for predicting optimal treatment decisions.

“These powerful new technologies are allowing us to better understand the role of viruses in cancer and the ability to make better treatment decisions patient-by-patient,” said John Lee, MD, a physician scientist at Sanford and principal investigator of the study. “In the next study, we plan to follow up using a blood-based

liquid biopsy to determine in realtime the efficacy of the treatment.”

“Current technology uses limited amounts of data to make important treatment decisions. This new technology greatly expands the amount of medically critical data we can use to increase the accuracy of treatment decision-making.

This new cancer panel has the potential to significantly enhance patient care while greatly reducing the cost to the healthcare system,” said study lead-author Howard B. Urnovitz, PhD, chief executive officer of Chronix Biomedical.

“This new comprehensive genetic cancer panel will make a major contribution with great benefit for cancer patients because accurate prediction of treatment efficacy can guide therapeutic options, which can be confirmed in weeks through a liquid biopsy,” said Professor Ekkehard Schütz, MD, PhD, chief technology officer of Chronix Biomedical.

Sanford Health Foundation Childhood Cancer Awareness We’ve all been touched by cancer in some way. Perhaps most heartwrenching is watching a child deal with the disease, not only because of the struggles it creates for the child and his or her immediate family, but because it affects their extended family, friends, classmates and neighbors as well.

During September, Sanford Children’s Hospitals across the Sanford Health enterprise recognized Childhood Cancer Awareness Month to raise awareness and funds for pediatric oncology services in their respective hospitals and clinics. The goal is to make a difference in the lives of childhood cancer patients, childhood cancer survivors and their families.

Special events and campaigns were celebrated in different areas across Sanford Health. In Fargo, Childhood Cancer Awareness was highlighted during the 61for61 fundraiser and Minnesota State

Sanford ENT specialist, John Lee, MD, is the principal investigator of a study in partnership with Chronix Biomedical to detect novel HPV genetic mutations.

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In August, the Ghana minister of health and Sanford jointly announced plans to build more than 300 clinics across Ghana.

University-Moorhead students organized an event as well.

and they really appreciate having support from so many people.”

bring health care to millions of additional people across Ghana.

In Sioux Falls, a new campaign — Brave Kids Bold Cures — debuted to support pediatric oncology services at Sanford Children’s Hospital, South Dakota’s only children’s oncology group hospital.

To learn more about the Childhood Cancer Awareness special events or to make a gift, please visit sanfordhealthfoundation.org.

This new relationship is intended to assist the Ghanaian government in improving maternity care and reducing the infant mortality rate.

This new agreement will give Sanford International Clinics the opportunity to add more than 300 clinics in Ghana by 2020 and is expected to serve 4.5 million patients annually over the same time period.

The Sanford Health Foundation encouraged everyone to wear gold ribbons, the childhood cancer international symbol, and reach out to their friends and family to organize their own events to raise money and awareness throughout the month of September to display unity in the fight against this disease.

“It’s so inspiring to see kids help other kids fight cancer during Childhood Cancer Awareness Month,” said Kim Haiar, Sanford Health Foundation director of annual giving. “These young patients fight such a hard battle

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Sanford International Clinics Ghana Minister of Health and Sanford Jointly Announce Plans to Build More than 300 Clinics Across Ghana Honorable Kwaku AgyemangManu, Ghana’s minister of health, and Kelby Krabbenhoft, president and CEO of Sanford Health, jointly announced the Ministry of Health and Sanford have joined together in a public-private partnership to

“It’s encouraging to see the positive contributions that Sanford is committed to making with our health care system to complement the public sector,” said Dr. Ebenezer Appiah-Denkyira, director general of Ghana Health Services.

The main focus of the public-private partnership is to improve access in peri-urban and rural areas and

allow patients to access primary care services closer to home.

Kojo Taylor, president of Sanford International Clinic-Ghana, believes this new relationship will make a significant impact.

“Much of the rural population in Ghana does not have access to basic care,” said Taylor. “The addition of these clinics will greatly change the scope of health care across the nation.

Thousands of families will no longer be forced to travel for basic services.”

Sanford International Clinics first formed a relationship with the Ghana Ministry of Health when it opened a clinic in Cape Coast in January 2012. Since that time, Sanford has opened four additional clinics in Mankessim, Kasoa, Kojokrom and Adenta. Sanford clinics have treated more than 180,000 patients in Ghana.

“Our work with the Ministry of Health has the potential to create thousands of clinics in Ghana,” said Jim Slack, Sanford Health vice president of Sanford International Clinics. “It is our intent to give the people of Ghana greater access to physicians and health care services, and we are most appreciative of the good working relationship we have with the minister of health.”

Sanford Partners to Form Modern Medical Facility in Ghana Sanford International Clinics is collaborating to establish a modern medical facility in the community of Akyawkrom. The George and Angelina Owusu Medical Center is expected to open in August 2015.

The facility will open as a 10,000-square-foot facility.

Sanford will be responsible for staffing and operations.

The integrated health system’s relationship in Ghana has been successful, in part, due to its expertise in rural health care. Sanford is the largest, rural, not-for-profit health care system in the United States.

Ghana’s economy is dependent on agriculture with 50 percent of the nation’s gross domestic product coming from the industry. Sanford’s domestic footprint sprawls more than 200,000 square miles, more than double the size of Ghana.

in rural areas where there is a lack of permanent health care infrastructure.

In many cases children and families are asked to travel two to four hours to receive basic health care services.”

Sanford International Clinics was established following an unprecedented gift of $400 million to Sanford Health from South Dakota businessman and philanthropist Denny Sanford. Sanford Health promised his gift would fund several initiatives, including establishing a network of Sanford clinics around the world in communities in need of expanded access.

In addition to the current clinics in Ghana, Sanford International Clinics will open a location in Kunming, China, later this year. Those are supported by domestic sites in Oklahoma, California and Oregon.

Sanford also is pursuing projects at several other locations worldwide.

“In the developing nation of Ghana, health care is supported by the government in urban areas,” says Sanford International Clinic-Ghana President Kojo Taylor. “However, much of the population and need is Sanford International Clinics is collaborating to establish a modern medical facility in the community of Akyawkrom.

The George and Angelina Owusu Medical Center is expected to open in August, 2015. Sanford Executive Vice President of Marketing and Public Policy Cindy Morrison, Sanford International Clinic Vice President Jim Slack, and Sanford International Clinic Executive Director Matt Von Holland visited Sanford partners in Ghana this summer.

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events

give.

October 9: The Sanford PROMISE Community Lecture Series “Diabesity” and the Developmental Origin of Disease Michelle Baack, MD, Physician/Children’s Health Research Center Associate Scientist, Sanford Research 5:30-6:30 p.m.

November 13: The Sanford PROMISE Community Lecture Series The Science of the Urban Jungle Kelly Sweet, BA, Producer and Wildlife Consultant 5:30 – 6:30 p.m.

If you are interested in providing philanthropic support for any of the research or major initiatives featured in this publication, please contact the Sanford Health Foundation. Thank you.

November 21: 7th Annual Denny Sanford Pediatric Symposium Emerging Paradigms in Pediatric Medicine Sanford USD Medical Center, Schroeder Auditorium

Sioux Falls Region: (605) 328-5700

December 11: The Sanford PROMISE Community Lecture Series

Fargo Region: (701) 234-6246

Use of Motivational Interviewing to Address Risky Health Behaviors Jessica Hanson, PhD, Center for Health Outcomes and Prevention Research Associate Scientist, Sanford Research 5:30 – 6:30 p.m. * Unless otherwise noted, all events will be located at the Sanford Center, 2301 East 60th Street North, Sioux Falls, SD 57104

Bismarck Region: (701) 323-8450 Bemidji Region: (218) 333-5515 foundation.sanfordhealth.org Edith Sanford Breast Cancer Foundation: (855) 463-3484

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