Oncology Clinical Trials Office 2015 Annual Report

From the Directors’ Desks

The Oncology Clinical Trials Office (OCTO) of the University of Illinois Cancer Center had a very successful 2015. OCTO has enabled an increase of clinical trial enrollment, which is largely attributed to our institutional investigator-initiated trials, that now account for approximately 70% of all therapeutic enrollments. Additional operational highlights include continued development and improvement of standard operating procedures across the office, particularly for financial management, in which process improvements yielded a sustainable business model, and support for local (Rush and Stroger pediatric trials) and regional collaborations at affiliated sites (UI Champaign-Urbana, UIC Rockford, and Presence United Samaritans Medical Center—Danville, IL ). In addition, this last year has included the opening of our Outpatient Oncology Clinical Trials Suite (OCC 1E). OCTO actively participates in the strategic planning of the UI Health’s Clinical Decision Unit (CDU) that will also be used to accommodate patients in early therapeutic clinical trials. Throughout this report, we will demonstrate that the OCTO has facilitated significant growth of investigatordriven clinical research at UIC, while implementing and administering cost-effective processes to ensure that the research activities have scientific merit, protect safety, maintain scientific integrity, and are fiscally sound. The next phase of our service to our community includes providing a greater awareness of clinical trials by better bridging our patient navigation services and health screening events, which will result in greater access to all phases of clinical trials. Together with the Office of Community Engaged Research and Implementation Science (OCERIS), we will focus on expanding partnerships and highlighting key strengths of our institution. Our campus is home to some of the most innovative and renowned researchers in the country. We will leverage this strength to increase our local and national footprint in transdisciplinary collaborative research. Our recently funded P20 and U54 NCI grants will allow us to respond to our Chancellor’s charge to “enhance our student’s experience,” as well as engage students and junior faculty from around Chicago. We will develop a strategic plan to demonstrate how we can better serve our Cancer Center’s catchment area of over 400,000 community members through innovative research that is designed and conducted to address cancer inequities.

Robert Winn, MD Cancer Center Director Associate Vice President for Community-Based Practice

Arkadiusz Dudek, MD, PhD Medical Director Oncology Clinical Trials Office

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Overview of the Oncology Clinical Trials Office The Oncology Clinical Trials Office (OCTO) provides comprehensive service support to cancer researchers and clinical investigators. Encompassing the life cycle of cancer clinical trials beginning with their translation from basic research concepts through manuscript development, the OCTO insures validity and integrity of data that fulfill all NCI, federal, and University of Illinois regulatory requirements.

Clinical Trials Lead to a Cure. ASK ME HOW. UNIVERSITY OF ILLINOIS CANCER CENTER

OCTO fosters interactions between basic cancer scientists and clinicians and has become an integral part of the formation of multidisciplinary Cancer Working Groups (CWG) including: Breast Cancer, Lung Cancer, Head and Neck Cancer, Gastrointestinal Cancer, Prostate Cancer, and Hematopoietic Stem Cell Transplant Group. The OCTO has served as the bridging infrastructure to promote the development and execution of science that is driven and relevant to meet the needs of our community’s patient population, minority patients with cancer disparities that live within the University of Illinois at Chicago (UIC) and UI Health’s catchment area. Today, the OCTO has become a prominent common denominator between the clinical trials conducted by the medical oncology and hematology physicians and the members of the four Cancer Center Thematic Programs: Cancer Biology (CB), Cancer Targets and Therapeutics (CTT), Carcinogenesis and Chemoprevention (CCP), and Population Health, Behavior and Outcomes (PHBO). Once study concepts are identified and transformed into clinical trials, the OCTO assists Cancer Center basic scientists and clinical researchers through every step of the bench-to-bedside clinical trial life cycle, including the final report submission to clinicaltrials.gov and the publication of manuscripts to describe the conclusions of studies. The OCTO enables researchers of the UI Cancer Center to carry out highquality clinical and translational trials relevant for the UIC and UI Health patient population. The OCTO provides the following major functions:  Clinical Trial Operations,  Regulatory Affairs,  Quality Monitoring and Assurance,  Data and Clinical Material Management,  Facilitation of Collaborative Clinical Trial Enterprises, and  Clinical Trial Education. OCTO operations are in compliance with all federal, state and local regulations and is comprised of a staff of 18 FTE to manage a portfolio of over 80 clinical protocols (institutional investigator-initiated, industry, and NCI cooperative groups). 3

NCI Sponsored Clinical Research The UI Cancer Center holds a main member institution status of the NRG Oncology, the Alliance for Clinical Trials in Oncology and the Children’s Oncology Group (COG) Research Bases. Over the past year our office underwent a routine audit from both the NRG and COG. Audits for these NCI-sponsored cooperative groups occur every three years, unless an unacceptable audit occurs. These audits include review of Regulatory Documentation, Drug Accountability and Storage, and Patient Case Review. Audit results range from “Acceptable” (no major and minimal minor protocol deviations) to “Acceptable, Needs Follow-up” (some major and some minor protocol deviations) to “Unacceptable” (multiple major protocol deviations). We are proud to report both audits were quite successful, allowing us to continue our research for another 3 years (the maximum time allowed between audits).

Big Ten Cancer Research Consortium

Teaming Up to Fight Cancer

The UI Cancer Center is a proud member of the Big Ten Cancer Research Consortium (BTCRC). The BTCRC arose from the fast-changing personalized medicine environment amid diminishing research opportunities for junior faculty and increasing demands to pre-screen large populations in order to identify small molecularly-enriched subsets. The Big 10 Cancer Centers (12 of them) create a uniquely powerful collaboration built on a robust history of research and an extensive research infrastructure. Leveraging geographic location and existing relationships among the cancer centers, collaboration flows from shared research visions and goals. The UI Cancer Center is leading the pack in submitting a variety of concepts for lung, breast, and GI cancers and Myeloid Malignancies to the BTCRC. In fact, UI Cancer Center opened the very first BTCRC trial (PD-1 antibody pembrolizumab with bevacizumab for the treatment of renal cell carcinoma) in March 2015 (PI: Dr. Arkadiusz Dudek). In addition, the BTCRC chose to highlight the UI Cancer Center as the “Featured Member” during January 2016. When asked how the BTCRC is unique from other research consortia, Dr. Dudek had this to say: “We are honored to be part of the BTCRC. As part of the consortia, we carry the University of Illinois name through highly responsive networking to all of the other institutions. We are introduced to and have a relationship with clinicians and researchers from this pipeline of outstanding schools, who share similar research goals. Not only do we support each other as scientists and as clinicians, but we support the research itself, and having this network provides for a framework and foundation to build ideas and test hypotheses. Finally, the BTCRC also provides for an opportunity for mentorship for junior faculty and trainees. It really fosters and celebrates an environment of learning which is the foremost intention of any academic institution.” 4

Phase 1 Clinical Research Program The UI Cancer Center and OCTO’s integral mission is to form bridges between bench research and clinical cancer care and to bring innovative and personalized care to our community. UI Health patients now have access to early phase clinical trials through our Phase 1 Unit. The Phase 1 Unit team works together with Laboratory Shared Resources and UICentre, and the Mass Spectrometry Laboratory in Urbana in the development of pharmacokinetic and pharmacodynamic assays, modeling and analysis. OCTO has connected investigators and shared resources such as: Biostatistics Shared Resource Design & Analysis Core, Biospecimen Shared Resource (Tissue Bank), and Laboratory Shared Resources (Flow Cytometry, Mass Spectrometry, Metabolomics and Proteomics, Genomics and DNA Services, Research Histology and Imaging). Below are the Phase 1 clinical trials that were started with UICC OCTO support and collaborations throughout the UI Cancer Center Research Programs: STM-01: Phase 1 Study of Aurora A Kinase Inhibitor Alisertib in Combination with Vascular Endothelial Growth Factor Inhibitor, Pazopanib in Patients with Solid Tumors. PI: Arkadiusz Dudek, MD, PhD. This Investigator-Initiated Trial evaluates the safety and pharmacokinetics of alisertib, in combination with pazopanib in patients with refractory malignancies. This study designed by Dr. Dudek (who is a sponsor for Investigational New Drug (IND) application) in collaboration with Drs. William Beck and John Nittis (CTT Program), receives partial financial support by Millennium: The Takeda Oncology Company. Drs. Dudek, Beck, and Nittis actively developed a concept of the inhibition of Aurora A kinase in cancer cells along with arresting formation of new blood vessels in the tumor microenvironment by interaction of pazopanib with vascular endothelial growth factor receptors in endothelial cells. The pharmacokinetic schedule was designed by Dr. James Fisher from Core 5 of UICentre, and analysis is being done by using Laboratory Shared Resources (Mass Spectrometry). In January 2016, the accrual goals were successfully met. STM-02: Phase 1 Study of IGF-Methotrexate Conjugate For Patients with Solid Tumors Expressing IGFR1. PI: Neeta Venepalli, MD, MBA. Fully financially supported by IGF Oncology, this study was designed in its entirety by Dr. Venepalli, via her skills learned at the 2013 ASCO/AACR Methods in Clinical Cancer Research Workshop under the mentorship of Dr. Dudek and other Workshop mentors. Dr. Venepalli devised an insulin-like growth factor 1 receptor (IGFR1) immunohistochemical test for tumor selection in collaboration with the Laboratory Shared Resource (Research Histology). A novel EffTox phase 1 clinical trial design was proposed by Dr. Hu Xie from the Biostatistics Shared Resource Design & Analysis Core, and it allows simultaneous safety and efficacy evaluation in this early clinical trial. Dr. Venepalli and her research team are close to determining the Maximally Tolerated Dose (MTD) of IGF-Methotrexate and based on disease response seen in one patient with Hodgkin Disease, we are in the early phase of developing a new Phase 2 trial, “Phase 2 Study of IGF Methotrexate Conjugate in the Treatment of Refractory Hodgkin Disease Expressing IGF-1R.” 5

Phase 1 Clinical Research Program STM-03: Phase 1 Study of Procaspase Activator (PAC-1) in Patients With Refractory Malignancy. PI: Oana Danciu, MD This investigator-initiated trial was designed based on preclinical and clinical animal patients’ data collected by CTT program members Paul Hergenrother and Timothy Fan. PAC-1 is a small molecule that converts procaspase 3 to caspase 3, thereby inducing cancer cell death. PAC-1 is unique in that it penetrates the blood-brain barrier, and has been found to have efficacy in brain cancer models. This novel anticancer therapeutic agent has the potential to serve unmet needs of patients within our community with primary brain tumors and brain metastases. PAC-1 was discovered and developed at the University of Illinois in Champaign-Urbana, and uses resources for toxicology studies by Dr. Alex Lyubimov who leads the Toxicology Research Laboratory within the Department of Pharmacology at the UIC. Statistical Design was provided by Dr. Xie from the Biostatistics Shared Resource Design & Analysis Core. The study consists of two components: to determine the maximal tolerated dose (MTD) of single agent PAC-1 in solid tumor or hematologic malignancy (which is currently ongoing), and to determine the MTD of PAC-1 when combined with the front-line chemotherapeutic agent, temozolomide, in patients with primary brain tumors. OCTO assisted with preparation of the IND application to the FDA, and has total provision of infrastructure to perform this study. Over the past year, Johns Hopkins University was added as a collaborating performance site; OCTO monitors the site for quality assurance and compliance and the UI Cancer Center Data Safety Monitoring Board reviews the study for safety. This study receives full financial support from Vanquish Oncology, LLC.

STM-04: A Phase 1 Study of rSIFN-co for Subjects with Advanced Solid Tumors Where Interferons Are Known to Have Demonstrated Antitumor Activity. PI: Howard Ozer, MD, PhD The OCTO has forged international collaborations. One such example was Dr. Dudek, Medical Director of the OCTO, being invited to China by Sichuan Huiyang Life Science and Technology Corporation in 2014, to discuss the possibilities of initiating a Phase 1 trial with their compound, rSIFN-co. rSIFN-co, or artificial recombinant super-compound interferon, has a much higher level of activity than Infergen® and other Type I interferon drugs, and may be of benefit to patients with advanced solid tumors that have progressed on standard therapies. Dr. Ozer has designed an EffTox dose-escalation study to determine the optimal dose (OD) of rSIFN-co in patients with advanced solid tumors. The OD will be determined by evaluation of safety and disease response in each of three dose cohorts. Statistical design was provided by Dr. Xie from the Biostatistics Shared Resource Design & Analysis Core. The OCTO assisted with protocol development and preparation of the IND application to the FDA. The trial has been open for accrual since Fall 2015, and receives full financial support from Sichuan Huiyang Life Science and Technology Corporation.

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Phase 1 Clinical Research Program BMT-02: A Phase 1 Trial of Total Marrow Irradiation in Addition to High Dose Melphalan Conditioning Prior to Autologous Transplant for Multiple Myeloma following Initial Induction Therapy. BMT-03: A Phase 1 Trial of Total Marrow Irradiation in Addition to High Dose Melphalan Conditioning Prior to Autologous Transplant for Patients with Relapsed or Refractory Multiple Myeloma. PI: Pritesh Patel, MD Drs. Patel and Damiano Rondelli have developed a novel autologous transplant induction regimen for the treatment of multiple myeloma. This regimen spares patients from toxicities associated with standard therapy and yet could provide similar activity in eradicating myeloma cells. Both studies’ goals are to define the degree of toxicities from this new regimen utilizing lower doses of total marrow irradiation. Both studies were developed as a result of robust preclinical data resulting from previous studies at UIC. The study investigators consulted the OCTO on the study design and the OCTO has provided the research infrastructure and safety monitoring for both studies.

AML-02: Study of the Activity and Safety of the Addition of Omacetaxine to the Standard of Care Induction Therapy Regimen of Cytarabine and Idarubicin in Newly Diagnosed AML Patients. PI: John Quigley, MD Dr. Quigley has designed a dose-finding study to determine the activity and safety of omacetaxine mepesuccinate in combination with standard induction chemotherapy in newly diagnosed AML patients. Based on the findings from earlier trials, he has hypothesized that combining the semisynthetic version of homoharringtonine, omacetaxine mepesuccinate with the standard AML induction regimen of “7+3”, will result in a significant increase in the complete remission rate among newly diagnosed patients with AML. The OCTO assisted Dr. Quigley in submitting this Phase 1 study to the FDA as part of a successful IND application. Teva Pharmaceutical Industries, Ltd. is supplying omacetaxine mepesuccinate and partial financial support to Dr. Quigley for the conduct of this ongoing study. 7

OCTO Patient Accrual Report The NCI Cancer Centers Program is one of the anchors of the nation’s cancer research effort. There are currently 69 NCI-Designated Cancer Centers, located in 35 states and the District of Columbia, that form the backbone of NCI’s programs for studying and controlling cancer. As the UI Cancer Center strives to achieve this designation by 2017, OCTO has increased its efforts to ensure that clinical trials are offered to all cancer patients who present to UI Health for their care. This has included increased attendance at weekly, disease specific, multi-disciplinary tumor boards, and spearheading meetings with individual disease working groups, to discuss current and pending accruals, as well as new potential studies that would best suit the needs of our patients. As a result, OCTO clinical trials accrual has steadily increased over the past calendar year, making 2015 the highest accruing year in recent UI Cancer Center history.

The minimum annual clinical trial required accrual to achieve NCI-designation for cancer centers is 10% of analytic cases presented. For UI Health, this means that we need at least 100 accruals to therapeutic clinical trials. In 2015, we exceeded this minimum requirement, by enrolling 129 patients in therapeutic clinical trials (~12% of analytic cases enrolled), positioning us for greater success of achieving NCI designation. Therapeutic Clinical Trial Accrual (Calendar Year 2015)

Non -Therapeutic Clinical Trial Accrual (Calendar Year 2015)

Pediatric and Adult/Young Adult Oncology Trials

14

Pediatric and Adult/Young Adult Oncology Trials

75

Adult Oncology Trials

115

Adult Oncology Trials

192

TOTAL (therapeutic) These accruals were to a variety of different sponsor types. The majority of the therapeutic trial accruals (70%) were to those Studies developed by UIC researchers, specifically designed to meet the special needs of our patient population served by UI Health.

129

TOTAL (non-therapeutic)

Therapeutic Clinical Trial Accrual by Sponsor Type (C alendar Year 2015)

1%

Phase I Accruals (UICdeveloped) 9%

BTCRC Accruals (UICdeveloped)

21% 57%

This clearly demonstrates our commitment to the Bench-to-Community Model of our Cancer Center.

267

12%

NCI Cooperative/Consortium Accruals Industry Accruals

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OCTO Patient Accrual Report

UI Health underwent its tri-annual Commission on Cancer survey on April 15, 2015. Standard 1.9 mandates that accredited academic institutions need to maintain at least a 6% accrual rate based on the institutional analytic case load. Further, to receive a commendation for this standard, the accrual rate should be at least 8%. As our accrual at the time of the survey was over 8%, we met the requirements to receive a commendation in this category—an honor that in previous surveys had not been achieved. 300

267 250 200

179

137

136

150

Therapeutic Accruals

129 111

Non-Therapeutic Accruals

100 57 50

33

0 2012

2013

2014

2015

Overall Accrual by Race

Overall Accrual by Ethnicity

Self-reported by Patients

Self-reported by Patients

3%

  

28%

41%

27%

Asian

Black or African American

Unknown or >1 Race

9

White

Hispanic—15% Non-Hispanic—45% Unknown—36%

Our minority enrollment exceeds national benchmarks, making UI Cancer Center one of the highest minority accruing institutions among all academic cancer centers.

The Organizational Capabilities and Financial Health of OCTO Over the years, the OCTO has facilitated significant growth of investigator-driven clinical research at the UI Cancer Center, while implementing and administering cost-effective processes to ensure that the research activities have scientific merit, ensure patient safety, maintain scientific integrity, and are fiscally sound. Today, OCTO’s operational highlights include:    

Development and improvement of standard operating procedures Improvement in financial management, which will better enable us to achieve financial stability and sustainability. Growth in partnerships to establish transdisciplinary collaboration and coordination Development of PK assays (UI Centre) and a cancer genomics core.

Because of these accomplishments by OCTO, UI Health has also received increased awareness among a number of industry sponsors. This has increased our funding capacity, allowing OCTO to get closer to its goal to become more self-sustaining. In addition, OCTO has been able to negotiate higher rates with industry sponsors, making it possible to provide better reimbursement rates for patient services to a variety of clinical departments, including Radiology, Cardiology, Pharmacy, and Pathology/ Laboratory. In addition, the home divisions of physicians who serve as Principal Investigators receive reimbursement for time and effort

Departments & Divisions that Benefit from Clinical Trial Reimbursements:      

Hematology/Oncology Radiology Cardiology Pharmacy Pathology/Laboratory Nuclear Medicine

Many of our sponsors have sought out partnerships with the UI Cancer Center to test novel cancer therapeutics in phase 1 trials at our UIC Phase 1 Unit. This sets us apart from other Chicago Health Systems that currently do not have Phase 1 Programs. These Health Systems see the same demographics of patients as UI Health. By having a Phase 1 Program for these patients, we are further exemplifying our commitment to our “Bench to Community” model.

Number of Industry-Funded Studies with Patients Accrued in 2015 Average Reimbursement for Patient Services (per patient) Average Reimbursement for MD Time and Effort (per study) Average Number of Patient Accrued to EACH Industry Funded Study Open to Accrual in 2015

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15 $17,021.00 $17,186.00 2.6

The Organizational Capabilities and Financial Health of OCTO OCTO’s “Per Patient Cost” reimbursement exceeds the national remuneration average on common clinical trial a s s e s s ments.

In addition, OCTO’s robust clinical trials program has been able to generate revenue for UI Health beyond charges related to research.

Beyond Research Charges Standard of Care Revenue from Research Patients (as part of the research)

7% 24%

Standard of Care Revenue from Research Patients (not part of the research)

69%

Research-Only Related Charges

OCTO’s Benefit Equation for UI Health Increased Recognition + Increased referrals for cancer services + Increased referrals for other services = Financial Gain for the Entire Health System

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OCTO Noticed for Trial & Advancement OCTO also celebrated a number of other achievements over the past year. Our clinical trials program was highlighted in the US Airways Magazine, a publication made available to readers on all US Airways and partnered airline flights, giving our institution and clinical trials program national and international exposure. The article spoke of our robust clinical trials program, our innovative Phase 1 trial treatments and our collaboration of 250 researchers across all four campuses (Chicago, Peoria, Champaign-Urbana, and Rockford).

Educational Goals of OCTO In 2015, the OCTO developed an informal oncology clinical research training program for medical students, residents, fellows, and hematology and oncology junior faculty. This program successfully formed teams of researchers and trainees that ask significant clinical questions and design clinical trials to answer unmet needs in therapy for our patient populations. This resulted in several peer-reviewed publications and abstracts presented in national meetings. The OCTO’s goal is to train a cadre of clinician-researchers that will collaborate with members of the UI Cancer Center research programs. Several research concepts are now in progress in collaboration with Cancer Biology, Cancer Target and Therapeutics, Carcinogenesis and Chemoprevention, and Population, Health, Behavior and Outcomes Programs. The OCTO will support the expansion of existing tumor biorepositories by assisting in the development of research protocols. It recognizes the importance of such biorepositories in a multitude of research endeavors, including the UI Cancer Center’s research mission of developing novel agents and treatment modalities in our laboratories and bringing them to our community members for the treatment of their cancers. During the past year, the OCTO helped with the development and implementation of a lung cancer screening program and it remains actively involved in fostering research collaborations that are addressing the needs of the communities served by UI Health. Over the next year, the OCTO will assist cancer care programs in introducing modern cancer screening programs to these communities, which historically have had low rates of participation. In addition, research initiatives posed for the upcoming year will help us to establish more effective

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Investing in Our Future Clinical research is a major driver of innovation and central to the UI Cancer Center and UI Health for maintaining and further developing high standards of patient care. Expanding OCTO presents a major strategic opportunity for University of Illinois at Chicago (UIC), to strengthen its position in health-related degree programs, to boost graduate employment outcomes, and build research capabilities and success. This will also be a positive asset to UI Health and to patients locally, nationally and internationally. The conduct of clinical research requires detailed preparation and care. As OCTO continues to grow, we must continually uphold the ethical and safety responsibilities to our patients. Our goal is to develop more robust disease-specific teams within OCTO, to enhance our capabilities to serve patients through clinical trials. This will include heading each disease-specific team with a dedicated project manager, to ensure that the advancement of all studies is smooth and swift. In addition, as an increase in more complex trials includes an increased need of biomarker analysis, OCTO will look to build its own biospecimen processing and sample shipping laboratory, complete with supply and storage. Lastly, we will continue to assist physicians and all other clinicians with easy access to clinical trials, by stationing OCTO’s Clinical Research Coordinators within the Outpatient Oncology Clinic.

The Oncology Clinical Trials Office of the UI Cancer Center realizes the importance of fostering the introduction and growth of new graduates in clinical research. As such, we are working to structure our team with varying levels of experience, as well as opportunities for advancement. In addition, there are great opportunities for strengthened partnerships with the UIC School of Public Health (e.g., program in Clinical and Translational Research), College of Medicine (e.g., programs in cell biology, cellular and molecular pharmacology), and the College of Engineering (e.g., bioengineering and bioinformatics), to name a few. Through these partnerships, research internships can be developed in order to ensure a better educational investment in our institution and health care system.

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At the UI Cancer Center, We strive to help people get better.

...but we also strive to become better doctors, better researchers, better collaborators, and better caretakers. We work tirelessly to advocate for the health of our patients, and in the process, we become the best healthcare providers we can be.

BETTER. PEOPLE.

BETTER. HEALTH.

BETTER. CAREGIVERS.

The UI Cancer Center is thankful to the UIC Office of the Chancellor, Office of the Vice Chancellor of Academic Affairs, Office of Vice President of Health Affairs and the UIC Colleges of Medicine and Pharmacy for institutional funding support and resources. Resources and support from the UIC leadership positions the UI Cancer Center to continue to serve as a major part of the UIC commitment to excellence in research, teaching and community engagement.

Michael Amiridis, PhD UIC Chancellor

Eric Gislason, PhD UIC Vice Chancellor of Academic Affairs, Provost

Jerry Bauman, PharmD Dimitri Azar, MD, MBA Dean Dean UIC College of Pharmacy UIC College of Medicine

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A Special Thanks and Dedication

We’d like to thank our patients for the strength and courage they have shown throughout the cancer journey. While those who choose to participate in clinical trials know that they might not personally benefit from their participation, they carry faith and hope that their participation may help future patients with their fight against a sometimes unrelenting disease. They are the true warriors and heroes, who remind us everyday that quitting is not an option.

Acknowledgements This report would not have been possible without our dedicated UI Cancer Center Clinical Trials Office staff members. Their tireless efforts have helped our program grow and become increasingly successful, resulting in greater treatment options for our patients. Research Development, Regulatory Compliance, & Research Finance

Clinical Trials Management & Research Assurance

Denisha Brown, Regulatory Compliance Jennifer Collier, Regulatory Compliance Tiffany Drinkwater, Regulatory Compliance Amy Graf, Regulatory Compliance Saima Saraf, Regulatory Assistant

Alberto Cabrales, Clinical Research Coordinator Elizabeth Jeanes, Clinical Research Coordinator Meredith Russell, Clinical Research Coordinator, Jerilyn Galley, Clinical Data Manager Almae Uy, Clinical Data Manager

Monica Winiarski, OnCore Coordinator James Zacny, Protocol & Grant Specialist

Johnathan Davidson, Lead Pediatrics CRA/Supervisor Michael Buraglio, Pediatrics Regulatory Coordinator Nitin Sane, Pediatrics Clinical Research Associate Ashish Thakkar, Pediatrics Clinical Research Associate

Jenny Dawson-Tibbits, Pre-Award Specialist FranciaMaria Goluch, Post-Award Specialist

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