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Connections Vol. 6 No. 1 Spring 2016 Inside this issue New Board of Directors members...................................2 Meeting news............................3 – Spring ACCRU Scientific Program Overview – ACCRU to exhibit at ASCO Membership news.....................3 – Top accruing members – ACCRU welcomes new members – How to submit study concepts to ACCRU – Membership profile: National University Cancer Institute, Singapore Trial highlights...........................6 – ACCRU trial for lung cancer approaching accrual goal – New trial evaluates the utility of topical cryotherapy – New trial examines treatment for metastatic colorectal cancer Operations updates..................11 – New business management system – Personnel update – Membership survey – ACCRU Research Coordinating Center staff Message from the chair New COO and board members This past December, we said farewell to Aimee Tillman, who has served Axel Grothey, M.D. as ACCRU’s chief operations officer since 2011. She previously served in this role for the Mayo Clinic Cancer Research Consortium, ACCRU’s predecessor, starting in 2005. Aimee was instrumental in establishing ACCRU as a successful clinical trials network with national and international reach. Aimee Tillman Please join me in thanking Aimee for her outstanding service and wishing her the best of luck in her new position as director of Eye Services for Mayo Clinic Health System in La Crosse, Wisconsin. We welcome Elizabeth (Beth) Kiefer as our new chief operations officer for ACCRU. Beth has been with the Mayo Clinic Cancer Center since 2010, serving as the operations manager for the Systems Management Office Beth Kiefer with a strong presence for the Alliance and Alliance Foundation. She brings to ACCRU a wealth of experience in systems and process improvement, and great insights into the needs of clinical trial networks. For the past five years, Beth has partnered with ACCRU to provide electronic case report forms and information technology support. Please join me in welcoming Beth to her new role with ACCRU. We also welcome two new members of our Board of Directors – Minetta Liu, M.D., and Tanios Bekaii-Saab, M.D. Their expertise will prove invaluable as we expand our scientific efforts (see article on page 2). Supporting our members Our goal is to provide our members with outstanding support for their clinical continued on next page Academic and community investigators partner to develop new cancer therapies continued from previous page research participation. We are excited about a new web-based application called ACCRU Business Management System (ABMS) that we implemented in February to enhance our clinical trial administration capabilities. The new system automates many of our operations, allowing us to gather information about each membership and identifying disease areas where there is a demand for clinical trials (see article on page 11). University Cancer Institute, Singapore, a group which focuses research on cancers endemic to its region (see article on page 4). We value our members’ input and encourage each membership to complete our upcoming membership survey. It will help us identify additional information and services that will assist you in your clinical research efforts with ACCRU (see article on page 5). We thank you for your continued support and hope to see you at the upcoming ACCRU Scientific Program Overview on May 14 in Chicago and at our American Society of Clinical Oncology booth in Chicago from June 4 to 7 (see article on page 2 for more information on these meetings). New members and upcoming trials Axel Grothey, M.D. ACCRU chair ACCRU offers investigators a unique opportunity to bring clinical research ideas forward that may otherwise not be possible. In this issue, we highlight three trials that are exploring new treatment or symptom control options (see trial highlights beginning on page 6). We continue to welcome new members to our growing network, including National New Board of Directors members We welcome two new Mayo Clinic representatives to the ACCRU Board of Directors. They are Minetta C. Liu, M.D., an oncologist at Mayo Clinic’s campus in Rochester, Minn., and Tanios Bekaii-Saab, M.D., an oncologist who will join Mayo Clinic’s campus in Arizona on May 23. Dr. Liu specializes in breast cancer, and Dr. Bekaii-Saab, currently section chief for Gastrointestinal (GI) Oncology and associate professor of Internal Medicine and Pharmacy at The Ohio State University, also serves as co-chair of the ACCRU GI Disease Committee. We also wish to thank two retiring board members – Edith A. Perez, M.D., an oncologist at Mayo Clinic’s campus in Jacksonville, Fla., and Charles Erlichman, M.D., an oncologist at Mayo Clinic’s campus in Rochester, Minn. – for their commitment and outstanding service to ACCRU. 2 ACCRU Connections | Spring 2016 Minetta C. Liu, M.D. Tanios Bekaii-Saab, M.D. Edith A. Perez, M.D. Charles Erlichman, M.D. Meeting news Spring ACCRU Scientific Program Overview Join us for the spring ACCRU Scientific Program Overview meeting on Saturday, May 14, at the Loews Chicago O’Hare Hotel in Rosemont, Ill. Please note this meeting is not included on the Alliance for Clinical Trials in Oncology agenda. No registration is required and all Alliance members are welcome to attend. We look forward to seeing you there. ACCRU to exhibit at American Society of Clinical Oncology (ASCO) 2016 Visit ACCRU (booth #2039) at the American Society of Clinical Oncology (ASCO) meeting from Saturday, June 4, to Monday, June 7, 2016, 9 a.m. to 5 p.m., at McCormick Place in Chicago. Membership news Top accruing member sites We would like to recognize and thank the following ACCRU memberships, which are the top sites for patient accrual to date for 2016: Academic memberships • Mayo Clinic, Rochester, Minn. • Duke University Medical Center, Durham, N.C. • The Ohio State University Wexner Medical Center, Columbus Community memberships • Illinois CancerCare, Peoria • New Hampshire Oncology-Hematology, PA, Hooksett • Rapid City Regional Hospital, S.D. Meet ACCRU investigators and staff, and learn about current ACCRU trials, how to bring a study forward in ACCRU and our network’s capabilities. ACCRU welcomes new members For more information on the ASCO meeting, visit http://am.asco.org/. • AnMed Health Cancer Center, Anderson, S.C. The ACCRU leadership would like to extend a warm welcome to our newest members: • Allegheny Singer Research Institute, Pittsburgh, Pa. • Waverly Hematology Oncology, Cary, N.C. • Vassar Brothers Medical Center, Poughkeepsie, N. Y. • Maine Center for Cancer Medicine and Blood Disorders, Scarborough 3 ACCRU Connections | Spring 2016 How to submit study concepts to ACCRU We encourage all members to bring study concepts forward for consideration by ACCRU. Here are answers to your frequently asked questions about the study concept submission process. Who can submit concepts? Any ACCRU investigator can bring a protocol, concept, or letter of intent (LOI) forward for consideration. What types of trials does ACCRU conduct? ACCRU accepts concepts for investigator-written or industry-sponsored clinical trials. We offer a broad range of clinical trials for many types of cancer and conduct phase II, phase III and biosimilar trials as well as expanded access programs. What information needs to be submitted? Provide information on: • The protocol, concept or LOI • Mechanism for funding the trial What support does ACCRU offer? • Concept/protocol review by key opinion leaders • All clinical trial administrative services, including protocol development, regulatory document and data management and operations and statistical support • Biospecimen repository and correlative laboratory services Who do I contact to submit a study concept? Contact the ACCRU Research Coordinating Center by email at [email protected] or by phone at 507-538-7448. Membership profile National University Cancer Institute, Singapore joins ACCRU We are excited to welcome National University Cancer Institute, Singapore (NCIS) as a new member of ACCRU. NCIS is a national specialist center under the National University Health System (NUHS). It is the only public cancer center in Singapore treating both pediatric and adult cancers in one facility. Cancer is the most common cause of death in Singapore, with colorectal cancer being the most common cancer. The goal of NCIS is to provide comprehensive, personalized care – from cancer awareness and prevention to diagnosis and treatment – through multidisciplinary tumor groups for every patient, complemented by long-term supportive care. Cheng Ean Chee, M.D. 4 ACCRU Connections | Spring 2016 Rachel Lim continued on next page continued from previous page Cheng Ean Chee, M.D., assistant professor at the Yong Loo Lin School of Medicine, Singapore, and a gastrointestinal oncologist at NCIS, is the principal investigator for ACCRU. She is also part of the Developmental Therapeutics group at NCIS. After completing her Hematology-Oncology fellowship at Mayo Clinic, she joined the Hematology and Oncology Division at Case Western Reserve University in Cleveland, Ohio, before moving to Singapore in 2014. Rachel Lim at NCIS is the primary clinical research associate for ACCRU. “Along with our involvement in more regional and global clinical trials, our membership with ACCRU will raise our visibility and enable us to become a global center for cancer treatment and research,” says Dr. Chee. “We will also gain recognition by the international academic community and industry. We hope to contribute investigator-initiated studies to ACCRU, especially in cancers endemic to our region, such as stomach, liver, lung and nasopharyngeal cancers.” Focus on cancers endemic to Asia The Hematology-Oncology Research Group (HORG) is the research arm of NCIS. Comprised of committed hematologists and oncologists, the HORG team strives to provide the best treatment options and care for patients through continuous research of cancers endemic to Asia. HORG is part of the Cancer Therapeutics Research Group (CTRG), an Asia-Pacific medical oncology cooperative cancer research group that includes member institutions from Singapore, Australia, Hong Kong, Korea and Taiwan. Through its membership in CTRG, NCIS has participated in the Mayo Clinic Phase 2 Consortium, which provides access to novel compounds offered through the National Cancer Institute – Cancer Therapy Evaluation Program for proof-of-concept studies. NCIS also participates in the Breast International Group in Belgium. NCIS works closely with scientists from the Cancer Science Institute (CSI) of Singapore, a national research center of excellence, and the National University of Singapore (NUS). CSI Singapore conducts basic and translational cancer studies through their Cancer Stem Cell and Biology and Experimental Therapeutics research programs. Areas of focus lie particularly in gastric, liver, lung and leukemia cancers, which are prevalent in Asian populations, along with a breast cancer working group examining Asian phenotypes. There is a full spectrum of basic and clinical translational facilities with a multitude of stateof-the-art core support technologies. For translational research in clinical imaging, NCIS collaborates with the Clinical Imaging Research Center at NUS, the first center in Southeast Asia to use the latest imaging technologies such as MRI/PET scanners. Developmental Therapeutics Unit Given the lack of Asian patients recruited to phase I trials, which are generally conducted in western countries, NCIS recognized the need to establish a phase I unit that would specifically address the question of identifying optimal drug doses in Asian patients. In the area of pharmacogenetics, HORG is one of several global teams studying inter-ethnic variability in anti-cancer drugs. The establishment of NCIS Developmental Therapeutics Unit has already helped attract interest from drug companies seeking academic partners who have the appropriate infrastructure to support early phase clinical trials in Asia. These research efforts have enabled NCIS to provide its patients access to cutting-edge therapies. 5 ACCRU Connections | Spring 2016 Trial profiles ACCRU trial for lung cancer approaching accrual goal ACCRU trial RC1126 is a randomized phase II trial investigating erlotinib with and without bevacizumab in patients with stage IV non-small cell lung cancer (NSCLC) with an activating mutation of the epidermal growth factor receptor (EGFR). Thomas Stinchcombe, M.D., at the University of North Carolina, is the principal investigator for the study. Currently, 74 of the planned 86 patients have been enrolled. “Single agent erlotinib is currently approved for treatment of patients with EGFR mutant NSCLC,” says Dr. Stinchcombe. “The Thomas Stinchcombe, M.D. hope is that the combination of erlotinib and bevacizumab will improve outcomes for patients with stage IV NSCLC.” Background Patients with an EGFR mutation, defined as an exon 19 mutation and exon 21 L858R point mutation, receive an EGFR tyrosine kinase inhibitor, which results in a high response and long progression-free survival. However, patients inevitably develop progressive disease, generally within 10 to 12 months of starting therapy. Bevacizumab is a monoclonal antibody that targets the vascular endothelial growth factor and inhibits the growth of new blood vessels, which are critical for cancer growth and metastases. Bevacizumab is approved for use in advanced NSCLC in combination with carboplatin and paclitaxel chemotherapy. A previous trial compared erlotinib to erlotinib and bevacizumab in patients who had progressive disease after chemotherapy. In this trial, a subset of 30 patients had an EGFR mutation, and patients who received erlotinib and bevacizumab compared to erlotinib alone had a longer progression-free survival. In Japan, a trial of similar design to RC1126 investigated the combination of erlotinib and bevacizumab compared to erlotinib alone specifically in patients with an EGFR mutation. This trial revealed that patients assigned to the combination had a statistically significant longer progression-free survival with acceptable toxicity. Study objectives The primary objective of this study is to compare the progression-free survival of erlotinib with bevacizumab compared to erlotinib alone. The secondary objectives are to assess the objective response rate, overall survival and safety of each treatment arm, and to explore if type of mutation (exon 19 versus exon 21 L858R) is associated with benefit. The correlative science studies will investigate the molecular mechanisms of resistance. 6 ACCRU Connections | Spring 2016 New trial evaluates the utility of topical cryotherapy In December 2015, ACCRU opened a randomized, controlled clinical trial evaluating the effectiveness of topical cryotherapy to decrease chemotherapy-induced peripheral neuropathy and paclitaxel-induced acute pain syndrome. The pilot clinical trial is expected to enroll 46 patients. Charles L. Loprinzi, M.D., an oncologist at Mayo Clinic’s campus in Rochester, Minn., and vice chair of ACCRU, is the study chair. ”There is a considerable amount of anecdotal information and a couple of reports that support the use of topical cryotherapy Charles L. Loprinzi, M.D. to decrease paclitaxel-induced neuropathy,” says Dr. Loprinzi. “Nonetheless, prospective controlled data is necessary to better understand the efficacy and tolerability of this approach.” Background Paclitaxel, one of the more widely used chemotherapy agents in the treatment of cancer, can cause peripheral numbness, tingling and pain, usually starting in the hands and feet. These symptoms begin in the first weeks of therapy and become more prominent over time with continued drug use. After paclitaxel is discontinued, symptoms tend to improve over time. These symptoms are related to nerve pathology and are called chemotherapy-induced peripheral neuropathy, which is also caused by other neurotoxic chemotherapy agents. For a majority of patients, paclitaxel also causes a syndrome of subacute aches and pains that had been commonly referred to as arthralgias and myalgias. In studies to further identify the cause and nature of these symptoms, patients commonly described the discomfort as “aching” or “deep pain” that was “radiating,” “stabbing,” or “shooting.” The pain was usually generalized and located in the back, hips, shoulders, thighs, legs and feet and, at times, radiated down the legs, arms or back. Researchers concluded that the subacute paclitaxel-induced pain appeared to be related to a pathologic process in nerve tissue, such as sensitization of nociceptors or nociceptive fibers, as opposed to being from a musculoskeletal injury. Because both of these paclitaxel toxicity syndromes appear to be related to nerve pathology, researchers have studied agents that treat neuropathic pain as a method for preventing and treating these problems. A recent review article, Supportive cryotherapy: a review from head to toe, details the history of cryotherapy as a part of the management of patients with cancer (Kadakia et al., 2014). Cryotherapy was initially reported to be helpful for decreasing Adriamycininduced alopecia, with initial studies dating back to the 1970s. There has been a recent resurgence of this approach with newer methods of providing scalp cryotherapy. In addition, oral cryotherapy was first reported to be helpful for preventing 5-fluorouracil-induced mucositis in 1991 in a manuscript published by the 7 ACCRU Connections | Spring 2016 continued from previous page North Central Cancer Treatment Group. It is now recommended for clinical use by the Multinational Association of Supportive Care in Cancer mucositis guidelines following multiple confirmatory trials. Cryotherapy has also been reported to be beneficial for decreasing 5-fluorouracil-induced ocular toxicity, and it has been shown to decrease chemotherapy-induced onycholysis (Matsumoto 2009). Some past studies may explain how cryotherapy decreases peripheral neuropathy. Study results demonstrate that patients receiving paclitaxel lose epithelial nerve fibers (Ko et al., 2014, Boyette-Davis et al., 2013, and Bennett et al., 2011). This may occur because of a local reaction from chemotherapy getting to the distal epithelial nerve fibers. Cryotherapy should cause vasoconstriction and decrease the amount of paclitaxel getting to the distal epithelial nerve fibers, thus resulting in decreased neuropathy. A potential concern regarding the use of cryotherapy is that paclitaxel has a reported half-life of about five hours (Gianni et al., 1995). Given this, it would seem that decreasing blood flow during the time of chemotherapy administration would not have much effect. However, docetaxel has a terminal half-life of 13.5 hours (Extra et al., 1993), yet cryotherapy has repeatedly been shown to decrease nail toxicity (Kadakia et al., 2014). Additionally, Adriamycin has a reported half-life of 30 hours (Benjamin et al., 1977), yet scalp cryotherapy can decrease alopecia when only given for a couple of hours (Kadakia et al., 2014). In all three of these situations, it may be that the cryotherapy decreases blood flow to target tissues when there are peak drug concentrations in the plasma, and this decreases the toxicity. The above data support further evaluation of cryotherapy as a means to prevent paclitaxel-associated neuropathy. Pilot study data are needed prior to conducting a larger phase III, more definitive trial. The data from the ACCRU trial will provide an estimate of the amount of potential benefit from this approach. Study objectives Trial objectives include: • To estimate whether topical cryotherapy can alleviate chemotherapy-induced peripheral neuropathy • To estimate whether topical cryotherapy can alleviate paclitaxel-induced peripheral neuropathy • To examine the possible relative toxicities related to topical cryotherapy in this study situation For further information For further information on ACCRU trial RU221511I, contact Michelle (Shelly) Hewlett, research protocol specialist at the ACCRU Research Coordinating Center, at [email protected]. 8 ACCRU Connections | Spring 2016 New trial examines treatment for metastatic colorectal cancer In second quarter 2016, ACCRU will activate an open label, randomized phase II study of nintedanib alone or in combination with capecitabine for patients with refractory metastatic colorectal cancer. Clinical trial BI1199.251 is sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. Arvind Dasari, M.B.B.S., assistant professor, Gastrointestinal Medical Oncology at Arvind Dasari, M.B.B.S. Axel Grothey, M.D. The University of Texas MD Anderson Cancer Center, in Houston is principal investigator for the trial. Axel Grothey, M.D., an oncologist at Mayo Clinic in Rochester, Minn., and ACCRU chair, is the principal investigator for the trial. The trial is expected to enroll 100 patients. “The results of this trial, if favorable, will lead the way to further development and integration of nintedanib in the therapy for metastatic colon cancer,” says Dr. Dasari. “Given the excellent tolerance of nintedanib, we are hoping these efforts will eventually lead to improved survival of our patients with minimal impact on their quality of life.” “This trial will investigate the activity of an exciting novel agent, nintedanib, in combination with capecitabine in patients with pretreated advanced colorectal cancers,” adds Dr. Grothey. “If active, this combination regimen could be integrated into earlier lines of therapy for this malignancy in future studies.” Background Colorectal cancer has a high incidence, with approximately 1.4 million new cases per year worldwide and approximately 132,000 new cases per year in the U.S. In addition, it is the second leading cause of cancer-related deaths in western countries. Most of the newly diagnosed patients initially undergo surgery and receive adjuvant systemic treatment. However, 25 to 35 percent of patients eventually develop metastatic disease in addition to the 15 to 25 percent of patients presenting with metastatic disease at the time of diagnosis. Patients with metastatic colorectal cancer have a large unmet medical need. Treatment options for these patients are restricted due to the efficacy and toxicity of available treatments. While there are reported clinical advances in the treatment of metastatic colorectal cancer by using a combination of chemotherapy and targeted therapies, there is additional need for more effective and tolerable agents for these patients. In metastatic colorectal cancer, as well as in other types of cancer, the combination of chemotherapy and anti-angiogenic therapies has been shown to provide bene¬ t. In addition, preclinical and observational studies indicate that vascular endothelial growth factor (VEGF) inhibition, when sustained by administering bevacizumab, is bene¬ficial in some patients with solid tumors. Also preclinical data suggest that continued VEGF inhibition leads to achieving and maintaining tumor regression. 9 ACCRU Connections | Spring 2016 continued from previous page Studies have also shown that the combination of 5FU/capecitabine chemotherapy and bevacizumab as an anti-angiogenic complement each other. For patients with metastatic colorectal cancer, continuation of VEGF inhibition after first disease progression was associated with significant prolonged overall survival. Nintedanib use, instead of bevacizumab, in combination with a fluoropyrimidine, may be associated with less frequent hospital visits since it is an oral therapy and does not require intravenous administration. Van Cutsem et al. reported on a 128-patient randomized phase I-II trial that evaluated nintedanib plus mFOLFOX6 versus bevacizumab plus mFOLFOX6 in ¬ first-line treatment and mFOLFOX6 showed efficacy as first-line therapy in patients with metastatic colorectal cancer and offered a manageable safety pro¬ le. Investigators concluded that further studies in this population are warranted. Clinical trial BI1199.251 will investigate the ef¬ficacy and safety of nintedanib alone or in combination with capecitabine for patients with refractory metastatic colorectal cancer after failure of at least two lines of standard treatment. The outcome of this study should be informative for future trials to investigate this dual oral combination therapy in the maintenance setting after primary chemotherapy induction. Study objectives Trial objectives include: • The primary objective is to assess progression-free survival in patients with refractory metastatic colorectal cancer, treated with nintedanib alone or in combination with capecitabine. • The secondary objectives are to assess overall survival, objective response, disease control and safety for both treatment arms. For further information For further information on clinical trial BI1199.251, contact Danielle Davis, research protocol specialist at the ACCRU Research Coordinating Center, at [email protected]. 10 ACCRU Connections | Spring 2016 Operations updates New business management system offers streamlined processes for members In February 2016, ACCRU implemented a new web-based application called ACCRU Business Management System (ABMS) to enhance our clinical trial administration capabilities. Over the course of the year, members will be using the application for several administrative tasks. The new system features a Site Profile section that enables us to gather information about each membership, including staff, patient population and facility capabilities. In addition, members will now use the system to complete online feasibility forms. These automated forms enable ACCRU to more efficiently access feasibility data for each membership and identify potential sites for ACCRU studies. Members can contact the ACCRU Research Coordinating Center by email at ACCRU@mayo. edu or by phone at 507-538-7448 with questions about the new system or suggestions for expanded capabilities. The ABMS user manual is also posted under the Clinical Research Associate tab on the ACCRU members’ website at www.accru.org. Personnel Update Jennifer Quam Program Coordinator Jennifer Quam In December 2015, we said farewell to Jennifer Quam, program coordinator for ACCRU. Jennifer has been an integral part of ACCRU and Mayo Clinic Cancer Research Consortium (MCCRC), ACCRU’s predecessor, for the past nine years. We thank Jennifer for her outstanding service and commitment and wish her the best in her new role as associate project manager in Mayo Clinic Validation Support Services. Megan Jordahl Finance Analyst Megan Jordahl, who has served as a regulatory affairs specialist for the past year, has transitioned to a new role with ACCRU as a finance analyst. Megan’s responsibilities will include addressing finance questions for members and sponsors and processing site payments for clinical trial participation. Megan Jordahl Membership survey Our members’ input and participation are critical to our research efforts. To ensure that we are providing you with the best service, we ask that you complete a survey that will be sent via email during second quarter 2016. The survey will help us identify how we can serve you better. We look forward to your feedback. 11 ACCRU Connections | Spring 2016 ACCRU Research Coordinating Center staff Bandel, Lorelei Research Protocol Specialist [email protected] Ronken, Christine (Chris) Administrative Assistant [email protected] Cheslock, Jolene Administrative Assistant [email protected] Rossman, Susan (Sue) Data Manager [email protected] Davis, Danielle Research Protocol Specialist [email protected] Sagdalen, Desirae Coordinator of Research Operations [email protected] Elsing, Alicia Research Protocol Specialist [email protected] Shevlin, Tracee Research Protocol Specialist [email protected] Harding, Kathleen (Kathy) Administrative Assistant [email protected] Sleeper, Cindy Finance Analyst [email protected] Hewlett, Michelle (Shelly) Research Protocol Specialist [email protected] Sunnock, Leslie Regulatory Affairs Specialist [email protected] Jordahl, Megan Finance Analyst [email protected] Van Esch, Debra (Debbie) Administrative Assistant, Supervisor [email protected] Kiefer, Elizabeth (Beth) Chief Operations Officer [email protected] Zabel, Cristina Quality Assurance Specialist [email protected] 12 ACCRU Connections | Spring 2016 Contact ACCRU ACCRU Research Coordinating Center 200 First Street SW Rochester, Minnesota 55905 Phone: 507-538-7448 Fax: 507-538-0906 Website: accru.org ACCRU YouTube Channel By email: •ACCRU Operations Office: [email protected] • Finance Office: [email protected] • Membership Roster Office: [email protected] • Regulatory Affairs Office: [email protected] ACCRU Connections Editorial Staff Medical Editor Editorial Board Contributors Axel Grothey, M.D. Oncologist – Mayo Clinic ACCRU Chair Michelle Hewlett Research Protocol Specialist Alicia Elsing Research Protocol Specialist Managing Editor Beth Kiefer Chief Operations Officer Sharon Rosen Public Affairs Desirae Sagdalen Coordinator of Research Operations Debbie Van Esch Administrative Assistant, Supervisor MC5724-01rev0316