Session Abstract – PMWC 2023 Silicon Valley

Track 2 - January 26 9.00 A.M.-4.30 P.M.


Track Chair: - Courtney McFall, UCSF
- Ben Rubin, UCSF

Patient-centric data – Real-World Evidence (RWE) and Real-World Data (RWD) - is becoming instrumental in the drug development process and for health care decisions in general. This data is not only informative for the process from discovery to new indications, clinical trial design, and drug development, it also can be of value to monitor post-marketing drug safety and for decision support in clinical practice. As the data becomes a decision driver, science companies and medical organizations are increasingly focused on leveraging RWD and RWE to not only better understand the patient populations using their drugs and the respective outcomes, but also to accelerate clinical decision support. This session will focus on the various aspects of integrating RWE and RWD to support drug development and clinical decision support.

Sessions:

  • Clinical Studies Using RWD (PANEL)
    Chair: Aaron Kamauu, Navidence
    - Liora Schultz, Stanford
    - Sanket Dhurva, UCSF
    - Eze Abosi, Optum Life Sciences
    - Motiur Rahman, FDA
    - Atul Butte, UCSF
  • Beyond the EHR: Acquisition of RWD Types to Enable Precision Medicine (PANEL)
    Chair: Riley Bove, UCSF
    - Anna Berry, Sypase
    - Ashley Brenton, Optum
    - Vasu Chandrasekaran, Ontada
  • Data Linkage, Harmonization, and Quality (PANEL)
    Chair: Vivek Rudrapatna, UCSF
    - Rohit Vashisht, UCSF
    - Adam Asare, QLHC
    - Dan Riskin, Verantos
    - Wanmei Ou, Ontada
    - Mindy DeRouen, UCSF
    - Saurabh Gombar, Atropos Health
  • Using RWE to Uncover and Address Health Disparities (PANEL)
    Chair: Chris Boone, AbbVie
    - Robert Hiatt, UCSF
    - Abasi Ene-Obong, 54gene
    - Nuray Yurt, Novartis Oncology
    - Alice Popejoy, UC Davis Health
    - Vic Spain, Genentech
  • FDA RWD/RWE Draft and Final Guidances
    - Motiur Rahman, FDA
  • Fireside Chat:
    - Vivek Rudrapatna, UCSF
    - Keith Yamamoto, UCSF
    - Hilary Marston, FDA
  • From Real-World Data to Regulatory-Grade Real-World Evidence
    Chair: Sheila Walcoff, Goldbug Strategies
    - Elaine Katrivanos, Tempus

 Session Chair Profile

Scientific Project Manager, UCSF

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.


 Session Chair Profile

UCSF

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.


 Speaker Profile

M.D., Assistant Professor of Medicine, UCSF

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


 Speaker Profile

M.D., Ph.D., Ph.D., Institute Director and Distinguished Professor, UCSF

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.


 Speaker Profile

Ph.D., Associate Director, Precision Medicine, UCSF

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.


 Speaker Profile

Ph.D., VP RWE & Genomics, Optum

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.


 Speaker Profile

Ph.D., Founder, 54Gene

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.


 Speaker Profile

Master's, Vice President, New Products, Optum Life Sciences

Biography
Eze K. Abosi currently serves as a Vice President of New Product for Optum. In this role, he supports the commercialization of Clinical Trial Optimization, Clinicogenomics, and NLP based solutions from Optum Life Sciences. In addition, Eze leads innovative partnerships on behalf of the Optum Growth Office. Eze has accumulated 16 years of experience supporting the life sciences with data, analytics, and consulting services, in various roles of increasing responsibility throughout his career. He earned a Bachelor’s of Science from Union College (NY) and obtained his Masters in General Management from Harvard University.


 Speaker Profile

Ph.D., MPH, Research Scientist, UCSF

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.


 Speaker Profile

M.D., SVP Biomarker Data and Lab Medicine, Syapse

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.


 Speaker Profile

M.D., Ph.D., Chief Medical Officer, Atropos Health

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.


 Speaker Profile

Vice President, Real-World Data & Analytics, Ontada

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).


 Speaker Profile

Vice President, Product Life Sciences & Analytics Data Platform, Ontada

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.


 Speaker Profile

Ph.D., Global ahead of AI Solutions , Novartis Oncology

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.


 Speaker Profile

Ph.D., Senior Epidemiologist, Real World Evidence Analytics, FDA

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.


 Speaker Profile

Ph.D., Senior Epidemiologist, Real World Evidence Analytics, FDA

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.


 Speaker Profile

Ph.D., Chief Data Officer, QLHC

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.


 Speaker Profile

J.D., CEO & Founder, Goldbug Strategies

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.


 Speaker Profile

Ph.D., Vice Chancellor for Science Policy and Strategy, UCSF; Director, UCSF Precision Medicine; Professor, Cellular & Molecular Pharmacology, UCSF

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.


 Speaker Profile

M.D., Ph.D., Professor, UCSF

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.


 Speaker Profile

M.D., Pediatric Oncologist, Stanford University

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.


 Speaker Profile

Ph.D., DVM, Global Real World Data Lead, Hematology and Respiratory, Genentech, Inc.

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.


 Speaker Profile

M.D., Ph.D., Assistant Professor, UCSF

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).


 Speaker Profile

M.D., M.P.H., Chief Medical Officer, FDA

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 & Womens Hospital. She completed her M.P.H. at the Harvard T.H. Chan School of Public Health.


 Speaker Profile

Vice President of Regulatory Affairs, Tempus

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.