Biography
Dr. Bove is a digital health innovator within the neurosciences at UCSF. Her NIH, DOD and NSF funded work focuses on delivering precision medicine tools to the point of care, where their efficacy can be tested.

Biography
Sheila D. Walcoff, J.D., is a strategic and regulatory advisor to pharma, diagnostic companies and investors engaged in companion diagnostics, and other diagnostic technologies. She is the CEO and Founder of Goldbug Strategies, which provides FDA regulatory consulting for companion diagnostics and other LDTs and IVDs, quality systems/FDA compliance, NGS platforms, and digital precision medicine tools. Ms. Walcoff’s 25+ years of experience includes Associate Commissioner at FDA, the senior science and public health official in the immediate office of the Secretary at HHS, a partner in a large international law firm, and majority counsel to a congressional committee.

Biography
Vivek Rudrapatna is a physician and a clinical data scientist. His research group works on developing new methods for analyzing electronic health records and other large datasets to uncover realworld evidence on treatment effects. Vivek is a practicing gastroenterologist and specializes in the treatment of patients with Inflammatory Bowel Disease (IBD). As a clinician, a researcher, and a patient, he is interested in the study of precision medicine as it pertains to this patient population. His group is working on the development of algorithms to predict which patients may be at greater risk for developing the condition and to optimize treatment selection for IBD patients. He hopes that this work may eventually lead to a future where we can prevent IBD altogether. Vivek received his AB from Harvard (2006), his MDPhD from Mount Sinai (2014), internal medicine residency at Baylor College of Medicine (2016), and gastroenterology fellowship at UCSF (2020).

Biography
Dr. Aaron Kamauu is an industry-leading advisor in the Real-World Data (RWD) space, specifically focusing on leveraging real-world healthcare data to support a variety of clinical research, informatics, clinical trials, and drug development activities, including pharmacoepidemiology, outcomes research, protocol design, site identification, data-driven patient recruitment, and the use of RWD to support evidence generation & submission to regulatory agencies (e.g., FDA). He has this experience across the spectrum of pharmaceutical/biotech, entrepreneurship, and large CRO businesses.In addition, Dr. Kamauu trained as a medical intern at Hurley Medical Center, where he treated patients in a variety of clinical settings, including Radiology, Emergency Medicine, Internal Medicine, Intensive Care and Cardiology. Dr. Kamauu is a member of leading medical societies where he has presented innovative research in clinical research informatics, public health informatics, and radiology/imaging informatics.

Biography
Dr. Dhruva uses health services research methods to understand and strengthen the evidence base for the safe and effective use of drugs and medical devices, with the goal of improving the quality of care and clinical outcomes for patients. His research has been funded by the NIH, Department of Veterans Affairs, FDA, and multiple non-profit foundations. Dr. Dhruva has more than 140 peer-reviewed publications, including in leading academic journals such as the New England Journal of Medicine, Journal of the American Medical Association (JAMA), JAMA Internal Medicine, BMJ, and Circulation. As a cardiologist, Dr. Dhruva cares for patients at the San Francisco Veterans Affairs Medical Center. Dr. Dhruva earned his MD degree and completed internal medicine residency at UCSF. He completed cardiology fellowship at UC Davis and earned an MHS at Yale University School of Medicine in the Robert Wood Johnson Foundation Clinical Scholars Program.

Talk
RWD generation for medical devices

Biography
Atul Butte is the Priscilla Chan and Mark Zuckerberg Distinguished Professor and Director of the Bakar Computational Health Sciences Institute at UCSF, and is also the Chief Data Scientist for the entire University of California Health System, the tenth largest by revenue in the United States, with 20 health professional schools, 6 academic health centers, and 10 hospitals. Dr. Butte is an inventor on 24 patents and has authored over 200 publications, with research repeatedly featured in the New York Times and Wall Street Journal. Dr. Butte was elected into the National Academy of Medicine in 2015, and was recognized by the Obama Administration as a White House Champion of Change in Open Science in 2013. Dr. Butte is also a co-founder of Personalis (IPO, 2019), providing medical genome sequencing services, Carmenta (acquired by Progenity, 2015), discovering diagnostics for pregnancy complications, and NuMedii, finding new uses for drugs using AI.

Biography
Rohit Vashisht research includes developing methods to manage and quality control large-scale electronic health record data, and generate real-world evidence in the light of causal inference and machine learning to help inform medical and regulatory decision-making in healthcare.

Biography
Courtney has worked at UCSF as a senior project and program manager for 14 years, where she strategically develops, plans and implements precision medicine projects and programs. Courtney works closely with Keith Yamamoto to manage UCSF’s presence at the Precision Medicine World Conference, from strategic development, track and session planning, speaker preparation, logistics, communications and our physical presence. She has a background is biological sciences, neuroscience and pediatrics. Courtney is also a rare disease patient and advocate.

Biography
Dan is a serial entrepreneur, having founded and built companies with products influencing millions of patients. He is board-certified in 4 specialties, including surgery, critical care, palliative care, and clinical informatics.Dan helped define policy through the Obama Campaign Health Advisory Committee and invited Congressional testimony on 21st Century Cures. His work in data-driven healthcare and artificial intelligence has been featured by the Wall Street Journal and Forbes and has been presented at FDA, NIH, NSF, DARPA, and NASA.

Biography
Ben Rubin advances precision medicine across UCSF and with external partners by developing new strategic directions, long- and short-range plans, and innovative initiatives. He directs the Precision Medicine Platform Committee, which establishes precision medicine as a central overarching institutional vision at UCSF. Prior to this position, Ben led business development efforts for UCSF’s Bakar Computational Health Sciences Institute (BCSHI), where he helped establish the Center for Real World Evidence, and served as a Science Officer for the California Initiative to Advance Precision Medicine (CIAPM), where he oversaw the selection, execution, and evaluation of demonstration projects and provided strategy and support to CIAPM and its partners. Before joining CIAPM, Ben served in the California State Senate Health Committee as a Science & Technology Policy Fellow and drew on his neuroscience research background to leverage the science of resilience, toxic stress, and childhood trauma to support multi-sector public policy efforts.

Biography
Dr. Ashley Brenton is the Vice President of Real World Evidence and Genomics for Optum Life Sciences. In this role, she is responsible for leading data strategy, product development, business development and operations for genomics. Ashley bridges the gap between clinical genomics and product development to leverage the wealth of Optum data into commercial datasets and stategic alliances to drive precision medicine initiatives. Prior to joining Optum, Dr. Brenton was the Chief Science Officer at Mycroft Bioanalytics, where she led corporate valuation and sales strategy of the intellectual property portfolio, including the worlds largest Clinicogenomic biobank in chronic pain. Previously, Dr. Brenton developed and commercialized a number of precision medicine tests and algorithms while building Clinicogenomic datasets. Ashley is an accomplished athlete, completing the Ironman twice and a number of ultramarathons, and competing in CrossFit competitions. She lives in Washington state with her husband and two daughters.

Biography
Dr. Abasi Ene-Obong is the Founder of 54gene. He is a seasoned business leader with extensive experience in the US, UK and Nigerian healthcare industries. Among other notable mentions, Dr. Ene-Obong has been recognised as one of Africa’s young innovators, one of Fortune’s 40 under 40 most influential people in healthcare and is a Bloomberg Catalyst in recognition of his contributions towards accelerating solutions to global health problems. 54gene is a health technology company equalizing precision medicine for Africans and the global population through innovative scientific research, advanced molecular diagnostics and clinical studies. The company is working to ensure that Africa, a genetically diverse population, is adequately represented in drug discovery and other clinical research.

Biography
Scott Morris leads the Health Sciences business at Change Healthcare, now part of Optum Insight following the recent completion of the company merger with Change. Scott oversees the Clinical Trials Access Network solution, a patient matching and provider referral solution designed to improve patient access to appropriate clinical trials. He is an experienced executive who has successfully introduced innovations and scaled new offerings in data, analytics, technology, and services that support life sciences and the broader health care industry. Before joining Change Healthcare, Scott held leadership positions at Oracle Health Sciences and IQVIA. He earned his Bachelor of Science from Clemson University and completed an Executive Leadership Program at the Kenan-Flagler Business School at the University of North Carolina at Chapel Hill.

Biography
Dr. Hebert-DeRouen’s ongoing research efforts are focused on cancer prevention and control and address inequities in cancer outcomes due to multi-level determinants, especially structural and social determinants of health. She has expertise pooling and harmonizing complex multi-level data from disparate sources, including contextual-level data and data from electronic health records, and designing analyses that use multi-level data to study cancer inequities. She also has experience conducting mixed-methods, community-engaged participatory research studies to address how neighborhoods impact cancer risk.

Biography
Dr. Anna Berry works in partnership with Syapse’s functional leaders to support product and service development, serves as a subject matter expert to Syapse’s customers, participates in joint-authored research and publications, and advances Syapse’s thought leadership efforts in the area of real-world evidence. Prior to her recent move to Syapse, she served for 6 years as the Deputy Director for Molecular Pathology and Genomics, and as the Scientific Director for the Personalized Medicine Program at the Swedish Cancer Institute in Seattle, and concurrently served as Director of Genomics Programs at CellNetix Pathology and Laboratories. Dr. Berry has focused professionally on genomics education and personalized medicine. In these roles, she has given numerous presentations, nationally and internationally, and has served on multiple task forces and committees for several professional organizations and coalitions, spanning Pathology and Oncology focused efforts.

Biography
Saurabh Gombar is the Chief Medical Officer and co-founder of Atropos Health as well as adjunct faculty at the Stanford School of Medicine. Atropos Health provides the worlds first clinical informatics consult allowing physicians to create on demand RWE to inform clinical care.

Biography
Dr. Chandrasekaran has over 15 years of pharmaceutical industry experience at the intersection of data science, RWD and drug discovery/development. He joined Ontada in 2021 and has responsibility for the development, delivery and growth of data products and data science offerings to biopharma clients seeking to leverage real-world data across the discovery, development and commercialization lifecycle. Prior to joining Ontada, he spent 5 years at Merck & Co. where he led a data science team responsible for data science capabilities and strategy. Before Merck, Dr. Chandrasekaran held positions of increasing responsibilities at UMass Medical School, Cubist and Novartis. Dr. Chandrasekaran obtained his Ph.D. in structural bioinformatics from the University of Georgia and completed postdoctoral fellowships at UNC-Chapel Hill and MIT prior to joining the pharmaceutical industry. He has published in several peer-reviewed journals and presented at scientific meetings, including the American Medical Informatics Association (AMIA) and Observational Health Data Sciences and Informatics (OHSDI).

Biography
Wanmei Ou is currently a Vice President of Product at Ontada. She is responsible for product roadmap, data science, and data informatics to ensure high quality of data and reproducible methods are delivered to real-world evidence research study and provider-facing clinical decision support applications. Since graduating with a PhD in Computer Science, Wanmei has led multiple enterprise digital initiatives transforming the use of data to enable precision medicine. In her most recent position as a White House Presidential Innovation Fellow. Wanmei led the Veterans Affairs’ data analysis platform and SMART-on-FHIR clinical decision platform. Wanmei was a Director of Outcomes Research and Data Science at Merck, she focused on the generation of real-world evidence through both observational studies and innovation pilots. Prior to Merck, Wanmei was a product strategist at Oracle Healthcare Life Sciences. During this time, she also served on the Health Information Technology Standards Committee at the ONC.

Biography
Dr. Yurt is the Head of Global AI Solutions for Novartis Oncology . As a business strategist and data science expert, she led several teams in the areas of data science, business analysis, information management and market research within Novartis and other small biotechs.Dr Yurt is a board member of Pharmaceutical Management Science Association since 2013 where she works on bringing new business analysts and data scientists with industry experts.She is also the President of the board for Peace Islands Institute where she partners with interfaith organizations to improve local peace within the NJ community. Dr. Yurt has Ph.D in economics. She studied the effects of social ability on life time earnings at University of Arizona and tought several courses in this subject. Dr.Yurt received several scholarships including George W. Coleman Scholarship at University of Arizona and National Academy of Sciences and Technology of Turkey (TUBITAK) Fellowship award.

Biography
Motiur Rahman is an Epidemiologist at Real-World Evidence (RWE) Analytics in the Office of Medical Policy, CDER, FDA. His responsibilities include developing guidance, improving internal Agency processes, stakeholder engagement, collaborating on Agency-funded demonstration projects, and providing consultancy on RWE study submissions. He joined FDA in April 2022 after working as an epidemiologist in industry settings.

Biography
Motiur Rahman is an Epidemiologist at Real-World Evidence (RWE) Analytics in the Office of Medical Policy, CDER, FDA. His responsibilities include developing guidance, improving internal Agency processes, stakeholder engagement, collaborating on Agency-funded demonstration projects, and providing consultancy on RWE study submissions. He joined FDA in April 2022 after working as an epidemiologist in industry settings.

Biography
With over 15 years’ experience in academia and industry developing clinical and research information systems. Joint appointment with Quantum Leap Healthcare Collaborative and UCSF Breast Care Center in overseeing efforts for process re-engineering and quality improvement of clinical care and research. Technology and data management portfolio includes: I-SPY COVID and I-SPY 2 TRIALs, the OneSource/eSource platform collaboration with the FDA, the Clinical Trials Matching platform and the Athena Breast Health Network platform.

Biography
Dr. Yamamoto is a leader in science and public policy. He has made an indelible impact by simultaneously advocating for Precision Medicine across the .edu, .gov, .com and .org sectors. As Chair of the National Academies Board on Life Sciences, he appointed and served on the study committee that produced “Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease”, the report that enunciated the precision medicine concept. He helped to stimulate President Obama’s interest, which led to the Precision Medicine Initiative, as well as Gov. Jerry Brown’s launch of the California Initiative to Advance Precision Medicine. He also promoted a precision medicine approach to Vice President Biden’s Cancer Moonshot, provoked broader participation by the corporate and nonprofit sectors, and directs UCSF Precision Medicine, an institution-wide imperative. In addition, Dr. Yamamoto has led or served on numerous federal or national committees focused on public and science policy, public understanding and support of biological research, research funding and peer review, and science education and the biomedical workforce; he chairs the Coalition for the Life Sciences, and sits on the National Academy of Medicine Council and Executive Committee, and the National Academy of Sciences Division of Earth and Life Studies Advisory Committee. He is a member of the Advisory Board for Lawrence Berkeley National Laboratory and the Board of Directors and Executive Committee of Research!America. At UCSF, Dr. Yamamoto is vice chancellor for science policy and strategy and professor of cellular and molecular pharmacology. He is a leading researcher, investigating transcriptional regulation by nuclear receptors, which mediate the actions of essential hormones and cellular signals; he uses mechanistic and systems approaches to pursue these problems in pure molecules, cells and whole organisms. He is an elected member of the National Academy of Sciences, the National Academy of Medicine, the American Academy of Arts and Sciences, and the American Academy of Microbiology, and a fellow of the American Association for the Advancement of Science.

Biography
Robert A. Hiatt, M.D., Ph.D., is Professor and former Chair of the Department of Epidemiology and Biostatistics at UCSF, and the Associate Director for Population Sciences at the UCSF Helen Diller Family Comprehensive Cancer Center. His research interests include cancer epidemiology, especially breast cancer, cancer prevention and screening, health services and outcomes research, the social determinants of cancer, and environmental exposures in early life development related to cancer. He was the first Deputy Director of the Division of Cancer Control and Population Sciences at the National Cancer Institute and a past president of the American College of Epidemiology and the American Society for Preventive Oncology. He is Principal Investigator of the NIH All of Us Precision Medicine Initiative at UCSF. He received his medical degree from the University of Michigan and his doctorate in epidemiology from the University of California, Berkeley.

Biography
I am a pediatric oncologist actively pursuing immunotherapy research with a focus on translating cellular therapies. In the laboratory, I engaged in CAR T cell engineering and studies of T cell subset optimization for adoptive transfer. I lead early phase clinical trials studying alternatives to CD19-monospecific targeting, including bispecific CAR and CD22 CAR development, and am a co-investigator studying GD2-specific CAR T cell therapy for fatal brainstem tumors. In efforts to expand our knowledge of ‘real world’ performance of CAR T cell therapy, I founded and chair the Pediatric Real-world CAR Consortium (PRWCC), a consortium with 38 participating core institutions and a mission to foster collaboration and create a forum for multi-institutional data and sample sharing. This is a growing collaborative network that is poised towards advancing outcomes following immunotherapy for pediatric cancers.

Biography
At Genentech, Dr. Spain’s role includes identifying and evaluating new or evolving data sources from routine clinical practice that can inform strategic decisions in Genentech’s development programs. Vic is an epidemiologist and veterinarian by training, having obtained his PhD in Epidemiology from Cornell University, NY, and Doctor of Veterinary Medicine degree from UC Davis. He has spent 15 years in the pharmaceutical industry, working at GSK and Merck in Health Economics and Outcomes Research. Prior to his work in the pharmaceutical industry, Vic was the Bioterrorism Epidemiologist for the Philadelphia Department of Public Health and an animal-welfare researcher at the American Society for the Prevention of Cruelty to Animals. When he is not working, Vic is often playing cello with The Oleta Trio or backpacking in the Sierra Nevada Mountains with his husband and their son.

Biography
Hilary Marston, M.D., M.P.H., Chief Medical Officer, FDA, serves as the primary clinical advisor to the Commissioner and oversees the Office of Clinical Policy and Programs. She leads cross-cutting initiatives that support the FDA’s centers in making effective, safe, and innovative medical products available for patients. Dr. Marston previously served as the Senior Advisor for Global COVID-19 Response on the White House COVID-19 Response Team. Other prior roles include Director for Medical Biopreparedness and Response at the U.S. National Security Council and Medical Officer and Policy Advisor for Pandemic Preparedness at the National Institute of Allergy and Infectious Diseases, National Institutes of Health. Dr. Marston also served in positions with McKinsey & Company and the Bill & Melinda Gates Foundation.Dr. Marston trained in Internal Medicine and Global Health Equity at Brigham & Women's Hospital. She completed her M.P.H. at the Harvard T.H. Chan School of Public Health.

Biography
Elaine Katrivanos is Vice President, Regulatory Affairs at Tempus Labs, Inc. and, in this role, is responsible for leading the Regulatory Affairs department. Prior to joining Tempus, Elaine was a global regulatory lead in pharmaceutical drug development at AstraZeneca. Before that, Elaine worked at CDRH/FDA for 12 years and served in a variety of key roles including premarket and post-market device review, policy development, and management. Elaine earned a degree in biomedical engineering from the University of Pittsburgh.

Biography
Kathy Hibbs is a leading voice in consumer health and the intersection of biotechnology and consumer products. She is an accomplished health care technology executive and active board member. With over two decades of expertise in health care and genomics, Kathy leads on key corporate and product objectives in highly regulated – and innovative – environments, across a wide array of complex, cutting edge business and product issues, regulatory strategy and industry-critical technology and data uses.

Biography
Michael W. Ryan advises clinical laboratories, device manufacturers (including IVD manufacturers), and investors on the legal, regulatory and reimbursement issues that arise during the development and commercialization of diagnostic testing services and devices. He guides clients by evaluating and implementing strategies to optimize coverage (including evidence generation), coding, and payment for novel technologies. Michael also helps innovative companies identify and navigate applicable FDA regulatory requirements for new technologies, particularly in vitro diagnostics and digital health products. In particular, he regularly advises clients on the FDA’s evolving requirements for laboratory developed tests (LDTs) and digital health products.

Biography
Farid Vij is President & GM of Invitaes Patient Network & Data division where he leads strategy, product and operations for the business. His core focus is building a two-sided platform that connects patients, providers and researchers through patient-consented data to help patients find better care options and advance research through real world evidence generation. Prior to Invitae, Farid was co-founder and COO at Ciitizen, a company focused on providing patients with access to their complete medical records. At Ciitizen, he drove the companys operations and go-to-market strategy, before leading its acquisition by Invitae in September 2021. Before Ciitizen, Farid held various commercial and operational roles at ZL Technologies, a big data company focused on harnessing unstructured information to drive critical privacy decisions for large organizations. Farid holds a BS in Economics from the Wharton School at the University of Pennsylvania. He enjoys angel investments in mission-focused companies and supporting education-focused non-profit organizations.

Biography
Terry Myerson is a founder and CEO of Truveta, the world’s first health data and analytics solution to study patient care and outcomes. Truveta was formed and governed by more than 25 US health systems with a shared vision of saving lives with data. Truveta’s members provide 16% of patient care in the United States in more than 20,000 clinics and 700 hospitals. De-identified data from this care is provided to Truveta daily. Truveta offers the most complete, timely, and highest quality data on U.S. health empowering researchers to discover insights on yesterday’s care, today. A leader for teams responsible for some of the world’s most popular technology platforms, Terry enjoyed a 21-year career at Microsoft leading development of Windows, Surface, Xbox, and the early days of Office 365. An entrepreneur at heart, prior to Microsoft Terry cofounded Intersé, one of the earliest internet companies, which Microsoft acquired in 1997.