multicare institute for research and innovation 2014 annual report

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2014 Annual Report

2014 Annual Report

Institute forResearch & Innovation

Advancing Medicine TodayFor A Better Tomorrow

M U LTI C A R E I N S TITUTE for R E S E A RC H & I N N OVATI O N

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The MultiCare Institute for Research & Innovation has completed another year of steady growth. Whether measured by the number of open clinical trials, investigator-initiated research studies, dedicated research staff, patients enrolled in studies, or by the geographic reach of our research, it was a truly fantastic year.

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2014 Annual Report

We are proud to be the South Sound region’s largest and most robust medical research organization, as well as one of the only community hospital-based research institutes in the region.

Some of our major milestones and accomplishments in 2014 include:

• Awarded a National Cancer Institute Community Oncology Research Program (NCORP) grant. The NCORP application was submitted in partnership with Virginia Mason and other significant collaborators and funded for five years. This grant represents another giant step forward in the evolution of our cancer research programs and demonstrates our ability to compete on a national level for increasingly scarce federal research dollars.

• Awarded a National Institute of Health (NIH) award to study the benefit of electrical stimulation of the legs to improve walking in elderly patients with arterial disease led by David Embrey, PhD, PT, Principal Investigator.

• More than doubled the number of new trials awarded and the number of patients enrolled in 2014 from prior year.

• Established two new preferred Contracted Research Organization (CRO) partnerships, ensuring direct and preferred access to exciting new trials.

• Added critical research support staff to include a clinical research manager, a clinical research administrator, a research administrative specialist, a senior administrative assistant and a second regulatory affairs coordinator.

• Hosted a successful conference with more than 80 participants from five neighboring states, featuring guest speakers from the Patient-Centered Outcomes Research Institute (PCORI).

• Successfully continued our intramural Investigator-Initiated Research program. We funded six exciting new proposals from an outstanding and competitive field of 15 submitted study ideas, and also developed plans to extend the opportunity to twice a year in 2015.

The future of research at MultiCare remains bright, a fact reflected in the enthusiasm and professionalism of the Research Institute staff, as well as the growing number of talented research investigators throughout our health care system. We hope you find this report interesting and informative. Thank you for your support and interest in our research programs!

Paul Amoroso, MD, MPH Medical Director, MultiCare Institute for Research & Innovation

Anne Reedy, MBA Director, Research & Federal Award Administration

A letter from the directors


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Connecting research to patientsThe MultiCare Institute for Research & Innovation brings cutting-edge medical research home. Through the Research Institute, a wide range of industry-sponsored and federally funded clinical studies, as well as our own investigator-led research, are available to patients right here in our community at no cost to the patient.

MultiCare offers a suite of over 65 clinical trials to cancer patients in our community. These trials provide promising new approaches for treating and preventing cancer. As new advances are being made to personalize cancer treatments, MultiCare is committed to bringing that personalized medicine to our patients.

Two such studies that are currently being led by principal investigator Jack Keech, DO, medical oncologist/hematologist, offer promising new approaches for treating cancer.

Preventing breast cancer recurrences Breast cancer affects about one and a half million women worldwide. Despite successful treatment, many breast cancer survivors experience a recurrence. The Research Institute is currently participating in a study of an investigational drug to prevent the recurrence of lymph node-positive, early-stage breast cancer in survivors with low to intermediate HER2 expression (human epidermal growth factor receptor 2, a protein that promotes the growth of cancer cells).

In this promising study, funded by Galena Biopharma, participants are injected with NeuVax™ at regular intervals. Patients will be followed for up to ten years.

NeuVax works by binding to antigen-producing cells (APCs) that travel to the lymph nodes, where they stimulate the body’s own immune system to seek out, neutralize and destroy HER2 expressing tumor cells and micro metastases wherever they occur in the body.

“Federal funding for the National Cancer Institute is being substantially reduced, so supporting the MultiCare Institute for Research & Innovation is more essential than ever...”

–Jack Keech, DO

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2014 Annual Report

Targeting molecules that make us vulnerable to cancerIn 2014, Dr. Keech brought three Novartis Signature studies of targeted cancer therapies to patients in our community through the Research Institute.

These trials are intended for patients who have not responded or have stopped responding to standard treatment and who have specific genetic alterations that may be driving the growth of their cancers. Targeted cancer therapies are drugs that interfere with specific molecules involved in the growth, progression and spread of cancer.

To participate in the drug trial, a patient must have a cancerous tumor with one of the three gene alterations being studied. Before committing to the deep gene studies required to determine a patient’s eligibility, MultiCare researchers were concerned about their patients’ ability to pay for this high-level molecular diagnostic test. The MultiCare Institute for Research & Innovation committed to pay for any additional patient costs related to these tests, thus green-lighting these promising drug trials. Today the need is even greater. If eligible, the patient takes the experimental drug orally at home and continues taking it until it no longer works for them. The Signature trials are currently in Phase II. Phase III will expand testing to larger groups of cancer patients and possibly pair targeted therapies with another investigational drug or chemotherapy.

“Federal funding for the National Cancer Institute is being substantially reduced,” Dr. Keech continues,

“so supporting the MultiCare Institute for Research & Innovation is more essential than ever, if we’re going to continue to make drug trials available in our community.”

“MultiCare Tacoma General Hospital is one of only two locations in Washington state where patients can participate in the NeuVax PRESENT study,” says Dr. Keech.

Patient Profile Kathleen Merryman Archbold Kathleen Merryman Archbold, a local columnist whose work has appeared in both The News Tribune and The Tacoma Weekly, chronicled her cancer journey in “The Lucky Woman’s Guide to Breast Cancer.” That journey began in December of 2013 when Kathleen was diagnosed with Stage IIB, non-metastatic breast cancer with lymph node involvement.

Archbold underwent a lumpectomy and a lymph node biopsy, which revealed that cancer cells had reached her lymph nodes. Treatment consisted of two rounds of chemotherapy, followed by radiation.

In January 2015 she learned of a MultiCare Institute for Research & Innovation study of NeuVax, and was accepted into the trial. (See “Preventing breast cancer recurrences.”)

As part of ongoing clinical trial, she receives CT scans, PET scans and MUGA (multigated acquisition) scans, which video her beating heart. The increased frequency of scans required for the trial led to earlier detection of suspicious spots discovered on her leg and lungs. Fortunately, the scans revealed that neither were cancerous, to Archbold’s relief.

Thus far, there has been no recurrence of cancer and she is continuing to receive her monthly shots.

Participating in clinical trials can also include additional tests and procedures that are paid for by the research sponsor. Trial participants appreciate the additional monitoring and visits, as well as education about their conditions. “Insurance doesn’t cover these costs,” says Kathleen, “so the trials of this very promising drug would not be possible without the support of the Research Institute.“

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In 2014, the MultiCare Institute for Research & Innovation continued to make impressive strides in gaining national attention—and funding—for our investigator-led research programs. In several cases, in-house pilot studies that were initially funded by grants from the Research Institute are now attracting substantial federal funding for more extensive clinical trials. This can put a promising new therapy or device on the path to FDA approval and, someday, into the hands of the people it was designed to help.

About one-third of the millions of older Americans with peripheral arterial disease (PAD) suffer intense intermittent pain in their limbs. MultiCare’s David Embrey, PT, PhD hopes to change that.

In August 2014, he was awarded a $230,000 National Institutes of Health grant to study how his functional electrical stimulation system (FES), the Gait Myoelectic Stimulator (GMES), can help reduce the pain PAD patients experience when they walk.

Joining Dr. Embrey on this study are his collaborators on the GMES prototype: Jeff Stonestreet, a Boeing electrical engineer, and Gad Alon, PT, PhD, associate professor emeritus at the University of Maryland School of Medicine and a world-renowned expert on clinical electrotherapy.

Focus on Researchers David G. Embrey, PT, PhDTaking steps to help patients

Building a cadre of researchers

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2014 Annual Report

The GMES sends electrical impulses that contract the calf and shin muscles in a precise sequence, enabling patients to walk with reduced leg pain. Dr. Embrey’s preliminary studies, which were funded by a $10,000 grant from the MultiCare Institute for Research & Innovation, showed that the device can also dramatically reduce pain in PAD patients, improving their ability to walk longer distances in comfort.

The new 18-month study, Saving Life and Limb: FES for the Elderly with PAD, builds on Dr. Embrey’s previous research.

The potential benefits of this research are enormous. When limb pain is dramatically reduced, PAD patients can walk further each day. Over time this may improve their circulation, heart and lung function, reduce excess weight, enhance their overall health, and, potentially, avoid vascular surgery.

Dr. Embrey, whose brother Paul had cerebral palsy, says these benefits extend well beyond patients with PAD pain.

“Our goal is to commercialize the GMES system so it can be used for multiple patient populations, such as adults with stroke, sports injuries and cardiac problems, and children with cerebral palsy and other neuromuscular disorders.”

Dr. Embrey’s pioneering research offers hope for peoplewho suffer from PAD and other conditions that limitmobility and impair overall health.

Peripheral Arterial Disease by the numbersApproximately:

• 8 million Americans suffer from PAD• 2.6 million have severe intermittent pain• 185,000 have pain so intense they

undergo amputation• 80,000 do not survive another

two years after amputation

Patient Profile Carl BradyCarl Brady was on a fishing trip in Idaho when the pain began.

“I couldn’t walk more than 50 yards without getting horrible cramps in my calves,” he says. “It was so bad, I had to stop for 10 minutes for the pain to subside, then walk a little, then stop again.”

In July 2014, Brady made an appointment with Felix Vladimir, MD, a MultiCare vascular surgeon. Dr. Vladimir diagnosed him with peripheral arterial disease (PAD). Treatment for PAD is typically either surgery or medication, but Dr. Valdimir offered a third option: Brady could contact Dr. David Embrey about participating in an NIH-funded study of the Gait Myoelectrical Stimulator (GMES), a promising new therapy for PAD pain.

Brady met with Dr. Embrey, principal investigator on the study, and was accepted into the trial.

“I had to wear the GMES for eight weeks and walk an hour each day, six days a week. I was able to go a mile each time without sitting down or feeling pain,” he says. “That thing works!”

Though his participation in the study ended in December 2014, Brady continues to walk around a mile a day.

“It hurts a little without the GMES, but the pain is much better than it was before,” he says, “and I am out walking again.”


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Focus on Researchers Rebecca Johnson, MD Rebecca Johnson, MD, a pediatric hematologist/oncologist and clinical geneticist at Mary Bridge Children’s Hospital, is creating awareness and leading an important effort to establish a Tacoma-based program that focuses on the unique needs of an underserved patient population: adolescents and young adults with cancer.

Dr. Johnson is working to strengthen coordination among local physicians, caregivers and other professionals so they can provide a clear pathway to the best possible care for young people with cancer. This may include referral to a fertility specialist to preserve a patient’s reproductive capabilities, to an oncologist who has special expertise with a particular kind of cancer, or transition to primary care after

treatment for appropriate follow-up care. In addition, she’s working with the hospital to expand in-hospital and community-based psychosocial support for young cancer patients, whether it’s pizza nights or support group meetings, so that young cancer patients can share their experiences and develop a community of support.

Dr. Johnson is planning a clinical research study investigating how a young cancer patient’s spiritual/religious orientation can affect his or her ability to cope with cancer. The study, which will include between 50 and 100 cancer patients, requires they complete a 30-minute questionnaire at three points after diagnosis. The goal of the study will be to better understand what the cancer experience is like for young people and to use the data to determine the kind of multidisciplinary care team required to best meet their needs.

Dr. Johnson brings a special passion to her work and empathy for young people who are struggling to cope with their illnesses. She herself was a young adult with cancer, having survived breast cancer in her 20’s and as an adult in her 40’s. The Research Institute looks forward to partnering with Dr. Johnson in the coming years to advance research in adolescent young adults with cancer.

“For the past 30 years there have not been any big improvements in cancer survival for this [adolescent/young adult] group. They actually go through worse psychological struggles… we hope to change that in our community.”

Building a cadre of researchers

–Rebecca Johnson, MD

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2014 Annual Report

Patients volunteer for clinical studies for a variety of reasons. Some want to contribute to medical science and help others with similar conditions. Others hope to improve their medical condition, gain insights into their own health or benefit from additional medical attention and testing.

“My father was also asthmatic. I hated to see him suffer, or anyone for that matter.”

“I’ve already had two strokes and hoped to prevent a third.”

“I just might learn something about my type of breast cancer.”

Why do our patients volunteer?

MIRI recognizes that feedback from study participants about their experiences is vital as MIRI strives to provide the highest quality care in research.

In 2014, the Research Institute conducted a patient satisfaction survey as an opportunity for patients to provide feedback about their overall research experiences, reasons for volunteering, visits, ease of scheduling, research staff professionalism and knowledge, and degree of feeling informed about the study and medical conditions. Eighty-one patients responded.

In 2015, study volunteers will continue to have the opportunity to provide feedback. Staff will review their comments as part of our ongoing efforts to ensure patient satisfaction among our study volunteers.

Patient satisfaction

Survey Result Highlights – 2014

Overall patient satisfaction score: 87.5% 97.5% of patients agree/strongly agree

that staff members treated them with respect 92.3% of patients agree/strongly agree that

staff responded quickly and fully to their concerns 93.8% of patients agree/strongly agree that they were extremely satisfied with their care


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The prevention and treatment of cardiovascular disease remains a focus of the MultiCare Institute for Research & Innovation. Through our collaboration with the Cardiac Study Center (CSC), which dates back to 2008, we’ve been able to bring over 30 state-of-the-art clinical trials in cardiovascular disease, hypertension, heart failure, atrial fibrillation, heart attack and high cholesterol to patients in our community.

The benefits of this collaboration are enormous. CSC cardiologist-researchers collaborate with MultiCare cardiothoracic surgeons on studies of next-gen artificial valves and electronic devices. They team with neurologists and neurosurgeons on clinical studies of stroke therapies, and they partner with our endocrinologists on the study of heart disease and diabetes, a common co-morbidity. In addition to physicians with complementary expertise, MultiCare offers access to far larger populations of patients who could benefit from participation in research studies, as well as the Research Institute’s screening, analytic and administrative capabilities.

In 2014 the Research Institute and CSC opened seven new trials in areas such as heart failure, atrial fibrillation and heart attack. Some highlights of studies that began last year are shown in the following pages.

A medication to minimize heart attack damageWe’re currently engaged in the trial of a monoclonal antibody, which has been shown to reduce inflammation after a heart attack. By reducing inflammation, the medication can minimize the damage heart attacks can cause, promoting far better outcomes for patients. This medication is not yet on the market, but is available through this Research Institute trial.

Cultivating strong partnerships

Medical imaging in catheterization laboratory

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2014 Annual Report

Personalized drug therapies In addition to our current standards of care, heart patients with a certain genetic marker can benefit from current trials exploring inhibitors which can lower LDL cholesterol. Results presented at the American Heart

Association in November 2014 and the American College of Cardiologists in March 2015 indicated that this experimental drug can improve patient outcomes. This medication is not yet on the market, but is available through this Research Institute trial.In the future, Vinay Malhotra, MD, expects the focus to remain on more individualized therapies. “Currently all atrial fibrillation patients are painted with the same brush,” says Dr. Malhotra. “We envision a time in which the patient is not only treated with a device or the typical medications, but might get additional drugs based on their genetic markers.” He also predicts that we will soon see the next generation of prosthetic valves, pacemakers and stents.Thanks to the collaboration of the Research Institute and CSC, heart patients don’t have to travel to the Cleveland Clinic or Mayo Clinic to access the latest research trials. They’re available on our doorstep.

“The MultiCare Institute for Research & Innovation is the glue that holds it all together.”

Tony Kim, MDA member of the Cardiac Study Center since 2012, Dr. Kim was formerly Director of the Heart Failure and Transplant Program at OHSU, where he also conducted basic science and translational research. He has authored numerous articles on thrombosis and heart failure and is currently principal investigator of a study using an experimental device called a vagal nerve stimulator in heart failure, which may restore failing hearts. His research partners include CSC electrophysiologist Tariq Salam, MD, and MultiCare neurosurgeon William Morris, MD.

Vinay Malhotra, MD Formerly chief fellow in cardiology at the University of Illinois, Chicago, Dr. Malhotra joined CSC in 2000. He has conducted extensive research in the treatment of atrial fibrillation and is currently principal investigator in a number of cardiac research studies, including one on an oral anticoagulant that can prevent major adverse cardiac events, including cardiovascular death, myocardial infarction and strokes in patients with coronary artery disease or peripheral artery disease.

Tariq Salam, MD Medical Director for the Electro-physiology and Atrial Fibrillation Program at MultiCare, Dr. Salam leads two National Institutes of Health (NIH) studies. He is Principal Investigator for the CABANA trial, which is exploring whether catheter ablation or drug therapy is more effective in prolonging and/or improving quality of life in older A-Fib patients. He also leads a trial of Ranolazine ICD (RAID) to establish whether or not a medication given for chest pain may also be a safer, more effective treatment for heart arrhythmia than the current standard drug therapy.

–Vinay Malhotra, MD


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MultiCare has always had a patient-centered philosophy and in July 2014, the MultiCare Institute for Research & Innovation invited PCORI representatives to Tacoma to host a one-day community workshop on patient-centered research. Over 80 health care providers, patients, community representatives, researchers and research administrators from MultiCare, Madigan Army Medical Center, University of Washington, Group Health Research Institute, the University of Fairbanks, Washington State University, the University of Utah, Providence, Swedish, Seattle Children’s, Rockwood Health System, the Metropolitan Development Council, and the Veteran’s Administration were in attendance. This was the first conference of its kind anywhere and PCORI is now hosting similar conferences across the United States.

Community health research has always focused on improving outcomes and changing practices to prevent illness and injury, and promote recovery. However, until recently, researchers often designed studies and research questionnaires without input from patients, payors, hospital decision makers, community organizations and patient advocates, such as family members. The Patient-Centered Outcomes Research Institute (PCORI) was founded in 2010 to focus on changing the way research is conceptualized and conducted, with the core mission of funding research that involves patients as partners at every step.

Bringing the patient into patient care

In addition to participating in two PCORI engagement projects related to asthma and safe sleep for infants, the Research Institute continues to explore patient-centered research and engagement, and has applied for PCORI projects in collaboration with Group Health Research Institute and the University of Washington.

Pictured from left to right: James Hulbert, Pre-Award Manager, PCORI; Tsahai Tafari, PhD, Senior Program Officer, PCORI; Suzanne Schrandt, JD Deputy Director of Patient Engagement, PCORI; Dave Hickam, MD, PhD, Program Director, Clinical Effectiveness Research, PCORI; Anne Reedy, Director, Research & Federal Award Administration; Paul Amoroso, MD, MPH, Medical Director MIRI; and Bill Robertson, President and CEO, MultiCare Health System

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2014 Annual Report

Looking forward

• Expand the infrastructure for epidemiological research capitalizing on the robust medical records system at MultiCare.

• Conduct our first annual MultiCare Institute for Research & Innovation research day to showcase the work of our investigators.

• Further increase extramural support of our research programs through successful grant applications to agencies such as NIH and PCORI.

• Expand patient access to clinical trials in dermatology, hematology, pediatric epilepsy and pediatric endocrinology.

• Increase clinical trial access within our community, measured by the number of available clinical trials as well as the number of patients enrolled.

• Develop effective, practical, patient-centered research studies for promoting health and wellbeing among members of our community.

• Support research that ultimately leads to important clinical outcomes: improvements in prevention, diagnosis and treatment that can reduce the incidence, morbidity and mortality of acute and chronic illnesses that are important to our patients.

• Foster a close relationship with academic, government and industry partners in the South Sound region and beyond.

• Expand productive business partnerships by turning inventions into products.

• Further develop our entrepreneurial financial model reflecting best practices of both private and public institutions while capitalizing on local opportunities to serve our patients and community.

The MultiCare Institute for Research & Innovation offers opportunities for researchers across MultiCare’s many disciplines to collaborate on improving the health of our community, and provides the considerable resources to make their work possible. With the ongoing support of the community, our goals for the next several years are to:

MIRI: 2014 at a glanceOur staff Our studies

Types of studies

36 667

124 15

53 185

73 12

Investigators involved in research

Active cooperative group (NCORP/COG) patients

Federally sponsored Cooperative group studies Intramural awards

Dedicated research staff members

Active patients on industry sponsored studies

Industry-sponsored studies PI-initiated studies


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Thank you

Our Research Institute Assigned Staff

Paul Amoroso, Gigi Bakken, Janey Barnhart, Josy Combs, Jessica Ebert, Tiffany Edwards, Samantha Elliott, Katy Garrison, Shannon Harris, Rosemary Hadcox, Karyn Hart, Colleen Hiebert, Lyndi Hennings, Emily Hoyle, Courtney Lumsden, Michelle Maxin-Wells, Jarrod Monroe, Kelly Mulligan, Bethann Pflugeisen, Heather Perdue, Roslyn Pierce, Justin Platts, Denise Quinn, Stacie Rebar, Anne Reedy, Jessica Rowden, Laurel Rutledge, Dalia Sherif, Angela Silva, Jami Smith, Tonya Stigger, Lisa Strasbaugh and Shirley Warner. We would also like to recognize the outstanding support of our grants accountant Cheryl Lovelace who directly supports the work of the federal grants office through our Finance Partnership.

2014 Research Oversight Committee

The Research Oversight Committee supports the functioning of the MultiCare Institute for Research & Innovation by approving goals and objectives, reviewing performance and outcomes, and providing general guidance and strategies. Members include:

Paul Amoroso, MD, MPH (chair); Will Barnes, RPh, MPH; Chris Bredeson, MBA; Linda Kaye Briggs; David Embrey, PhD; Ron Graf, MD; Holly Byrne; John Lenihan, MD; Vinay Malhotra, MD; Shelly Mullin, RN; Michael Raff, MD; Les Reed, MD; Anne Reedy, MBA; Sheila Renton, DVM; John Rieke, MD; Debra Seguin, RN, MN; Brad Van Duker, MD; and George Williams, MD, MMM.

Research Funding Committee

The Research Funding Committee, now in its third year, provides expert scientific and programmatic review of all our donor-supported investigator-initiated research proposals.

Current and recent members include:

Michael Raff, MD (Chair); Catherine Brown; Wendy Fitch; Ron Graf, MD; Megan Kilpatrick; Eugene Lapin, MD; Anne Reedy, MBA; John Rieke, MD; and Doug Sutherland, MD.

Grants Steering Committee

Paul Amoroso, MD (chair); Les Reed, MD (executive sponsor); Lois Bernstein (executive sponsor); Veronica Hooper, MD; Kevin Murray, MD (co-chair); Tim Holmes; Anna Loomis; Toni Foster, RN. Ad-hoc members: Harold Moscho; Jason Mitchell; Laird Pisto; Theresa Boyle; Claire Spain-Remy, MD, MMM; Sue Miller.

Community Support

Due entirely to the generous philanthropic support of our community, we are in the midst of our third year of our intramural research funding program. This program was made possible by funds raised at the 2012 Rock the Foundation event, but equally important are the donations, large and small, which continue to come in directly from the community and from employee payroll deductions. Thank you to our many generous donors!

MultiCare Leadership

Finally, we would like to thank the MultiCare senior leadership for their support and stewardship in facilitating a patient-focused research program at MultiCare.

The success enjoyed by the MultiCare Institute for Research & Innovation in 2014 was the result of outstanding contributions of many individuals, including our dedicated employees, the members of the Research Oversight Committee, the Research Funding Committee, the Grants Steering Committee, our research investigators, our very generous community donors, research sponsors and our highly supportive MultiCare leaders.

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2014 Annual Report

36% Oncology 13% Cardiovascular 3% Other 10% Endocrinology 3% Internal Medicine 10% Neurology 8% Pediatric Oncology 8% Pediatrics 9% Pulmonary

2014 StudiesTherapeutic Area %

2014 StudiesPopulation %

2014 StudiesProgram Funding %

Industry-Sponsored

Federally-Funded

59 35

6

Adult

Pediatric

84

16

13

10

10

8

8

9

3

3

36

IntramuralAwards


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Institute forResearch & Innovation

A not-for-profitcommunity organizationmulticare.org/research

multicare institute for research and innovation 2014 annual report

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