Defining the Data Ecosystem for a Cancer Learning Health Systems

Amanda Borens, MS, is a health data science executive and former Chief Data Officer with a proven track record of building and directing international teams and organizational data strategies. With 25+ years of experience across public and private sectors, Amanda has a unique breadth of experience, having led technical teams in all phases of the FDA-regulated medical software development lifecycle for customers on three continents as well as in medical device development where her team achieved FDA clearance and CE Mark from EMA. Her teams and innovative data platform designs serve a wide range of clients across global health, pharmaceutical, academic, and healthcare sectors. As a cancer survivor, she weaves her personal experience into discussions of data collection and analysis strategies using real-world data to optimize patient and research outcomes.

Gregory H. Reaman, M.D. is the Scientific Director of the NCI's Childhood Cancer Data Initiative (CCDI) and Professor Emeritus of Pediatrics, George Washington University School of Medicine and Health Sciences, Washington, D.C. and Executive Director Emeritus of the Center for Cancer and Blood Disorders at the Children's National Medical Center, which he directed for more than 17 years. He was the Inaugural Chair of the Children's Oncology Group (COG), serving in this capacity from 2000 through 2010. Prior to this, he was the Vice Chair for Scientific Affairs and the Associate Chair for New Agent Studies of the Children's Cancer Group (CCG) for ten years and directed the CCG Phase I Consortium. He joined the FDA in 2011 as the Associate Director for Oncology Sciences in the Office of Hematology and Oncology Products in the Center for Drug Evaluation and Research and, in 2016 served as the Associate Director for Pediatric Oncology in the FDA's Oncology Center of Excellence until 2022 and joining NCI. Dr. Reaman has served on multiple editorial boards; he was an Associate Editor of Cancer and Leukemia and Lymphoma. He served on the Board of Directors of the American Cancer Society and chaired its Task Force on Children and Cancer and has served on the Board of Directors of the American Society of Clinical Oncology (ASCO) as well as the International Society of Pediatric Oncology (SIOP); he has served on numerous ASCO committees and ad hoc NCI review panels, and the steering committee of the AACR's Pediatric Cancer Working Group. His research interests are the biology and treatment of childhood acute leukemia and new drug development for pediatric cancers. He has authored over 375 peer-reviewed manuscripts, 25 book chapters and textbooks.

Umit Topaloglu PhD, FAMIA is a clinical research informaticist who has been focusing on creating a semantically interoperable clinical research solutions with ontologies, and other standards such as Fast Health Interoperability Resources (FHIR). His research involves semantic research data frameworks that includes standard based data collection, Natural Language Processing (NLP) and privacy preserving Federated Learning (FL). He also is interested in creating research informatics roadmaps, provide strategic planning that encompasses enterprise data warehousing, Data Governance, and participation to the data sharing networks and involved with AACR GENIE and the National COVID Cohort Collaborative (N3C). He currently serves as the Chief of the Clinical and Translational Informatics Branch at the National Cancer Institute where he oversees the biomedical informatics efforts for several NCI clinical research endeavors, including the NCI Precision Medicine Initiatives, the Clinical Trials Reporting Program, and the strategic roadmap development. He also leads NCI's Semantic Infrastructure (i.e. Enterprise Vocabulary Service [EVS] and cancer Data Standards Repository [caDSR]) and Real-World Data/Evidence (RWD/RWE) programs as well as several Artificial Intelligence (AI) efforts. Additionally, he provides data science expertise for these programs and collaborate closely with bioinformatics and data ecosystem initiatives. Previously, he was the Associate Director for the Center for Biomedical Informatics, CTSI Informatics Program, and the Wake Forest Baptist Comprehensive Cancer Center. He was also co- Director of the Bioinformatics Shared Resource for the Wake Forest University School of Medicine where he is currently an adjunct faculty.

Liz Turi, M.Eng, CPHIMS is the Branch Chief for the Care Coordination Branch at the Assistant Secretary for Technology Policy (ASTP), Office of Standards, Certification, and Analysis (OSCA), Standards Division. She is the program management lead for USCDI+, and the project lead for USCDI+ Cancer. She has an IT career of 26 years, roughly half of that dedicated to Healthcare IT, with roles from software architecture and engineering to implementation and consulting. She has special interests in health equity, SDOH, public health, and interoperability. She is a CPHIMS, holds a BS in Anthropology from Ball State University, and a MEng in Healthcare Systems Engineering from Lehigh University.

May Terry M.Sc., BSEE, BSN, RN has an extensive background in engineering, nursing, and health informatics, May Terry has over 13 years of experience in healthcare data standards and interoperability with the last 9 years in the field of cancer informatics. She is one of the original authors of the minimum Common Oncology Data Elements (mCODE) Fast Healthcare Interoperability Resources (FHIR) implementation guide9. She also supports the CodeX FHIR accelerator GenomeX use case currently in development. Ms. Terry serves as a co-chair in the HL7 Clinical Genomics Working Group, and supports the CodeX FHIR accelerator as an information modeling architect and terminologist. She also led the FHIR-to-OMOP Oncology sub-group sponsored by the HL7/OHDSI initiative, whose goal is to allow clinicians as well as researchers to pull data from multiple sources and compile it in the same structure without degradation of the information.

Su Chen, MD, is a Clinical Science Principal at MITRE. She is an intrepid emergency medicine physician, computer scientist, and clinical informaticist with systems leadership experience in healthcare information systems optimization. Su currently co-chairs the CodeX HL7® FHIR® Accelerator, a not-for-profit member community advancing open clinical specialty data exchange standards in cancer, genomics, cardiovascular health, and beyond. She serves on the Executive Committee and the Technical Review Group for mCODE® (minimal Common Oncology Data Elements), an open standard for cancer data exchange. Prior to MITRE, Su has had roles in varied health settings, serving as Chief Information Medical Officer and Urgent Care Medical Director for a Federally Qualified Health Clinic (FQHC) and Director of Clinician IT in a nationwide health network.

After receiving her PhD, Golozar joined the faculty at the JHU Department of Epidemiology, where she focused on cancer and diabetes epidemiology, the application of epidemiologic and statistical methods for robust synthesis of evidence from epidemiologic data, and applying evidence-based findings to strengthen public heath infrastructure and policies. In 2017, she moved into industry roles at Bayer AG, AstraZeneca, and Regeneron, where she led lifecycle management and real-world evidence generation activities in oncology, women’s health, and other therapeutic areas. As a professor of the practice, Golozar brings a comprehensive knowledge of healthcare systems to Northeastern. She also has the skills in research methodology and statistics required for addressing safety and effectiveness outcomes and risk assessment, and for generating high quality real-world evidence (RWE) from real-world data. She has played leading roles in large-scale private-public partnerships, including the Innovative Medicines Initiative (IMI) Big Data for Better Outcomes project and the IMI PIONEER Prostate Cancer Study-a-thon. Since 2018, Golozar has led the OHDSI Oncology Working Group, endeavoring to extend the OMOP common data model to support oncology use cases and advance oncology real-world evidence research. In 2021, Golozar received an OHDSI Titan Award for Clinical Application. In addition to her role at Northeastern, Golozar is an adjunct faculty member at the JHU School of Public Health and vice president of data science at Odysseus Data Services, a leading RWE technology vendor.

Eric Perakslis, PhD, is the Chief Scientific and Data Officer of Pluto Health and the Senior Vice President and Chief Technology Officer, IMIDomics. Prior to this, he was the Chief Science and Digital Officer at the Duke Clinical Research Institute. He was previously a Rubenstein Fellow at Duke University, where his work focused on collaborative efforts in data science that spanned medicine, policy, engineering, computer science, information technology, and security. Immediately prior to his arrival at Duke, Eric served as Chief Scientific Advisor at Datavant, Lecturer in the Department of Biomedical Informatics at Harvard Medical School, and Strategic Innovation Advisor to Médecins Sans Frontières. Eric was Senior Vice President and Head of the Takeda R&D Data Science Institute, where he built an integrated institute of more than 165 multi-disciplinary data scientists serving all aspects of biopharmaceutical R&D and digital health. Prior to Takeda, Eric was the Executive Director of the Center for Biomedical Informatics and the Countway Library of Medicine, an Instructor in Pediatrics at Harvard Medical School, and a faculty member of the Children's Hospital Informatics Program at Boston Children' Hospital. During his time at HMS, Eric focused on the approval of the Department of Biomedical Informatics as a full academic department, the development of the NIH Undiagnosed Diseases Network, industry collaborations, leading the technology efforts for multiple Ebola response programs, and building active research programs in medical product development, regulatory science, and cybersecurity. Prior to HMS, Eric served as Chief Information Officer and Chief Scientist (Informatics) at the U.S. Food and Drug Administration. In this role, Eric authored the first IT Strategic Plan for FDA and was responsible for modernizing and enhancing the IT capabilities as well as in silico scientific capabilities at FDA. Prior to his time at FDA, Eric was Senior Vice President of R&D Information Technology at Johnson & Johnson Pharmaceuticals R&D and member of the Corporate Office of Science and Technology. While at J&J, Eric created and open-sourced the tranSMART clinical data system, which is now being freely used by hundreds of healthcare organizations. During his 13 years at J&J, Eric also held the posts of VP R&D Informatics, VP and Chief Information Officer, Director of Research Information Technology, and Director of Drug Discovery Research. Prior to working at J&J, Eric was the Group leader of Scientific Computing at ArQule Inc. Eric has served on the editorial board of Cancer Today magazine and as the Associate Editor for Novel Communications for the Journal of Therapeutic Innovation and Regulatory Science. Eric has also served on Science and Technology Advisory Committees and in leadership roles for the American Society of Clinical Oncology, NuMedii, Precision for Medicine, the Survivor Advisory Board at the Cancer Institute of New Jersey, the Kidney Cancer Association, OneMind4Research, and the Scientist - Survivor program of the American Association for Cancer Research. Internationally, Eric has served as the Chief Information Officer of the King Hussein Institute for Biotechnology and Cancer in Amman, Jordan. Eric has a PhD in chemical and biochemical engineering from Drexel University. He also holds BSChE and MS degrees in chemical engineering.

Jeremy L. Warner MD, MS, FAMIA, FASCO is a Professor of Medicine and Professor of Biostatistics at Brown University, the Associate Director of Data Science at the Legorreta Cancer Center at Brown University, and an attending physician at the Lifespan Cancer Institute. He is board certified in Medical Oncology, Hematology, and Clinical Informatics. Dr. Warner's clinical focus is malignant hematology and he is the Editor-in-Chief of JCO Clinical Cancer Informatics. His primary research goal is to make sense of the structured and unstructured data present in electronic health records (EHRs) and clinical knowledge bases, and he has published over 140 manuscripts in these areas. He is the Chief Technology Officer of HemOnc.org, where he oversees the development and maintenance of HemOnc, an ontology focused on capturing all relevant knowledge pertinent to chemotherapy drugs and regimens. In March 2020 he co-founded the COVID-19 and Cancer Consortium (CCC19) and is the Director of its Research Coordinating Center. In June 2022, he transitioned from Vanderbilt University to Brown and is the founding Director of the Center for Clinical Cancer Informatics and Data Science (CCIDS).

Ino de Bruijn, MSc is the Manager of Bioinformatics Software Engineering and Data Visualization Team Lead at Memorial Sloan Kettering Cancer Center. As a developer in Dr. Schultz's lab, Ino leads the development of knowledge systems, including the renowned open-source cBioPortal for Cancer Genomics, which enables the visualization, analysis, and download of large-scale cancer genomics datasets. His technical expertise spans React, MobX, Spring Boot, MySQL, Continuous Integration, Docker, Kubernetes, and AWS. In his earlier role, Ino spent two years developing an analysis pipeline in Dr. Reis-Filho's breast cancer research lab, focusing on mutation calling, copy number analysis, and estimating ploidy, purity, and clonality. This work utilized cluster computing and programming languages such as Python, Bash, and R.

From 2011 to 2014, Ino worked as a Bioinformatician at SciLifeLab in Stockholm, Sweden, where he developed analysis pipelines for environmental genomics research. He also provided bioinformatics consulting to research groups across Sweden, specializing in DNA short-read analysis.

Xuelu (Jeff) Liu is the Director of Data Management & Strategy at the Division of Population Sciences, Dana-Farber Cancer Institute (DFCI). Jeff has 15+ years of experience in biomedical informatics, with a particular focus on supporting cancer research and precision oncology. He collaborates extensively with research faculty and staff to develop research data strategies to address data challenges across diverse cancer research programs, establishes the best practices for data lineage and data lifecycle management, and promotes data harmonization and sharing across disease centers at DFCI and cancer research community. Currently, Jeff spearheads multiple projects aiming at creating an integrated cancer research data ecosystem. These endeavors facilitate streamlined access not only to institutional resources but also to community programs like the NIH All of Us, Cancer Research Data Commons (CRDC), SEER, and UK Biobank. Before joining DFCI, Jeff held various technical, management and leadership positions, contributing expertise to diverse biomedical research projects across federal agencies, industry, and academic settings. Jeff is a strong advocate for open science, GA4GH, and OHDSI/OMOP.

Yuri Quintana, Ph.D. is Chief, Division of Clinical Informatics, Division of Clinical Informatics, Beth Israel Deaconess Medical Center; Assistant Professor, Harvard Medical School, Harvard University, and Senior Scientist at Homewood Research Center. He is a global leader in developing and evaluating digital health systems. He is Chief of the Division of Clinical Informatics at Beth Israel Lahey Health and Assistant Professor of Medicine at Harvard Medical School, Harvard University. He leads the DCI Network (https://www.dcinetwork.org), which brings together national-level leaders to work on complex health problems requiring collaborations between institutions, government, and the private sector. His research is focused on learning networks and clinical care collaboration platforms that empower patients, families, and health professionals. He is developing InfoSAGE, a mobile app (https://infosagehealth.org) for medication and symptom management. He created Alicanto Cloud (https://www.alicantocloud.com), an online platform for learning and collaboration used by health professionals at Harvard-affiliated hospitals such as Beth Israel Deaconess Medical Cancer to disseminate best health care practices and virtual consultations. Alicanto is used at the Massachusetts Institute of Technology's JWEL Center for sharing best practices in education. Alicanto has won numerous international awards. As a Senior Scientist at Homewood Research Institute in Canada, he has developed new methods to evaluate digital mental health systems using evidence-based approaches. Previously, at St. Jude Children's Research Hospital, he envisioned, implemented, and managed global eHealth solutions for children with cancer that have improved the lives of countless children and made a significant contribution to global clinical informatics. His developed platforms have been used as a reference model for collaborative platforms developed by international agencies such as UICC, WHO, and IAEA. Previously, he was a faculty member at the University of Western Ontario, where he served as director of the New Media Research Lab, developing innovations in interactive media and online education. Quintana was also a principal investigator in the Canadian HealNet Research Network, focusing on consumer health informatics. He has held high-tech positions at IBM Canada Limited and Watcom. He has been the chair of international conferences. He serves on the editorial board of several journals, including the International Journal of Medical Informatics and the Journal for Cancer Education. He has held high-tech positions at IBM. Quintana obtained his engineering degrees from the University of Waterloo in Electrical and Computer Engineering and Systems Design Engineering.