California Initiative to Advance Precision Medicine Advisory Council Working Groups
Learn more about the Data Integration and Equitable Consent Working Groups of the California Precision Medicine Advisory Council.
An early goal of the California Precision Medicine Advisory Council was to decide which areas of precision medicine that, if improved, would positively impact the widest range of Californians. In November 2020, two working groups were created to address the Council's top priorities: integrating new forms of data into electronic health records; and developing culturally appropriate consent processes for research.
The working groups meet bi-monthly, independent of full Council meetings, to advance projects within their respective subject areas. CIAPM staff works with each group to create workplans that are effective and well-suited to available resources.
There is enormous momentum in California, as well as across the nation, to uplift Social Determinants of Health (SDOHs) alongside biological determinants as critical data that can be stored in electronic health records (EHRs) to guide clinical decision-making and improve quality of care. Decades of evidence linking socioeconomic circumstances to health outcomes have guided the development of strategies to tailor prevention and responses to underlying conditions like food insecurity, housing instability, and poor access to health care that drive illness and disability. Rather than forever treating the symptoms of poor health, a system built upon principles of precision medicine finds and treats the root causes, physical or otherwise.
- Social Determinants of Health (SDOH)
- The conditions in which people are born, live, learn, work, play, and age that affect a wide range of health risks and outcomes, and are responsible for most health inequities, and the forces and systems that shape daily life, including economic policies and systems, development agendas, social norms, social policies, and political systems. (Data Integration Working Group definition, based on language from the Centers for Disease Control, World Health Organization, and The Gravity Project)
- Electronic Health Records (EHRs)
- An electronic health record is the digitized version of a patient's medical chart. It contains all the information a provider has collected for a patient, including diagnoses, test results, x-rays, procedures, and prescriptions. Digitization of health records make them searchable and easier to share among care teams. Researchers can also use EHRs to easily find potential study participants.
Real-world health data has never been easier to gather and share, but clinical trial participation is at a low point, especially among women and underrepresented minorities. To bridge this gap, it is important to view patients as partners not only in their own care, but also in medical research. A critical part of the study experience is informed consent. Many consenting protocols are often inconvenient and uninformative for patients. Many research studies do not effectively explain consent, and do not use entirely patient-centered consent terms.
The Equitable Consent working group will guide the development of culturally and linguistically appropriate consent protocols for research and clinical care, to ensure informed and empowered partnerships between patients, their care teams, and researchers.
- Informed Consent
- Informed consent occurs when communication between a patient and physician results in the patient's authorization or agreement to undergo a specific medical intervention (American Medical Association). In clinical research settings, informed consent also means that individuals should (1) be accurately informed of the purpose, methods, risks, benefits, and alternatives to the research, (2) understand this information and how it relates to their own clinical situation or interests, and (3) make a voluntary decision about whether to participate (National Institutes of Health).
Ysabel Duron is the Founder/CEO of the California based Latino Cancer Institute working to eliminate the Latino cancer burden nationwide by driving equitable access, research and policy.
Duron was an award-winning TV journalist for 43 years in the San Francisco Bay Area and elsewhere, but stepped away in 2013 to continue her role as a patient advocate and voice for the Latino community.
A cancer survivor, she serves both on the Institutional Review Board of the NIH All of Us Research Program, and most recently joined the Board of California Institute for Regenerative Medicine, a state taxpayer funded initiative to support stem cell research.
She was inducted into the National Association of Hispanic Journalists Hall of Fame in 2009, named one of the 25 most outstanding Hispanics in the Bay Area in 2005 and honored with the W.E.B. DuBois from the SJ Chapter of the NAACP in 2011, amongst other honors that reflect her community engagement.
Dr. Oliver Keown is a UK-trained physician, scientist and former policy advisor turned healthcare and medical technologies venture capital investor with Intuitive Ventures. Prior to joining Intuitive, he was a VC investor with GE Ventures, driving startup deal-flow in the Bay Area and beyond across HealthTech, life science and MedTech domains.
In past roles Oliver has advised and supported a range of US and international healthcare innovation projects across technology, policy, commercial, and academic fields. Early in his career he worked as a junior doctor in the UK National Healthcare Service across a variety of medical and surgical disciplines. He holds an MD and a Bachelor's degree in Pharmacology from the University of Edinburgh, Scotland.
Dr. Kenneth Kim received his MD from Harvard Medical School, completed a fellowship at the MIT Sloan School of Management, and received internal medicine and allergy/immunology training at UCLA. He has served on the clinical faculty both at UCLA and UC Irvine for over 15 years. He has been a medical monitor, consultant, and investigator on over 600 clinical trials, having published over 30 research articles and 50 abstracts in peer-reviewed journals. He is a nationally recognized expert in the areas of early stage clinical research, ethnobridging drug development strategy, influenza challenge, mold allergy, and latex allergy.
He has founded numerous health care services businesses, including a 200+ employee clinical research organization which he transitioned to private equity. He is currently the medical director of Ark Clinical Research and a strategic investor in a variety of startups, while also maintaining a private allergy and asthma practice in Southern California.
Dr. Clara Lajonchere's background reflects a wide range of professional, clinical, and research activities across Central Nervous System disorders. She has spent her career on cross-cutting issues in psychiatric genetics and translational medicine. Through the Institute for Precision Health at UCLA, Dr. Lajonchere is working collaboratively with thought leaders across the state of California to advance precision medicine and improve outcomes for patients. Prior to UCLA, Dr. Lajonchere held faculty appointments at USC and Keck School of Medicine where she served as Director of the NIH Center for Genomic and Phenomic Studies in Autism and conducted research on models for dissemination of scientific information to underserved populations, including the Latino community. She also served as VP of Clinical Programs for Autism Speaks for over a decade where she oversaw a diverse portfolio of basic science and clinical programs. She currently consults for several tech start-ups in the autism space focused on AI, robotics, and targeted therapeutics.
Dr. Yvonne (Bonnie) A. Maldonado is Professor in the Departments of Pediatrics and Epidemiology and Population Health, Chief of the Division of Infectious Diseases, and Senior Associate Dean for Faculty Development and Diversity at Stanford University School of Medicine. Her research activities have included the epidemiology and prevention of viral infections such as rotavirus, measles, mumps, rubella, polio and pediatric HIV infection. Her research is conducted internationally in Zimbabwe and Mexico, as well as in the United States. She has written over 200 articles in peer-reviewed journals, and 50 book chapters on these topics. In 1989, Dr. Maldonado received the Epidemic Intelligence Service Alumni Award from the Centers for Disease Control and Prevention, and she was inducted into the Multicultural Alumni Hall of Fame at Stanford University in 2001 and the Stanford Medical Alumni RISE (Reach, Inspire, Serve and Engage) award in 2018. She is a Fellow of the American Academy of Pediatrics, a member of the Society for Pediatric Research, the Pediatric Infectious Disease Society and the American Public Health Association. Dr. Maldonado has devoted substantial effort to teaching and training activities at Stanford University as well as in the national and international setting. Throughout her career, she has invested heavily in her commitment to improving cultural and gender diversity at all levels.
Dr. Fatima Muñoz is the Director of the Department of Research and Health Promotion at San Ysidro Health (SYHealth), a high performing Federally Qualified Health Center (FQHC) providing care to over 105,000 patients throughout San Diego County. Fatima completed her medical training in Mexico and earned a Master's in Public Health from Universidad Autónoma de Baja California. She possesses over 15 years of clinical research experience working in health promotion programs and epidemiological research studies, specifically among underserved populations. Fatima’s expertise in public health issues spans both sides of the U.S.-Mexico border with emphasis in the elimination of health disparities. Her award winning research portfolio includes: chronic disease, HIV prevention and treatment, cervical and breast cancer, and the impact of bi-national access to care on health policy. Most recently, SYHealth was awarded the All of Us Research Program from the National Institute of Health. It is only one of six FQHCs west of the Mississippi that is part of this Program and Fatima is the Principal Investigator for SYHealth. In this capacity, she and her team have been contributing in the development and implementation of the program Spanish speaking participants.
As VP and Head of Diagnostics, Dr. Hakan Sakul leads Pfizer's company-wide Diagnostics efforts. Sakul worked in the biotech industry in human genetics and statistical genetics fields early in his career before moving to Parke-Davis Pharmaceuticals to direct human genetics, statistical genetics and pharmacogenetics programs. Following the merger of Parke-Davis with Pfizer, he has held positions of increasing responsibility, including Director/Site Head for Clinical Pharmacogenomics, Senior Director roles in Molecular Profiling and Translational Oncology, and most recently as Executive Director of Diagnostics. After receiving BS and MSc degrees from Ankara University in Turkey, and a PhD in Quantitative Genetics from the University of Minnesota as a Rotary Foundation Scholar, he conducted postdoctoral studies at the University of California, Davis. He is the author of over 30 refereed scientific articles as well as many other papers, abstracts, and book chapters. Sakul is keenly interested in diagnostics and related medical technologies to advance precision medicine for the improvement of individualized healthcare.
Dr. Mary Anne Schultz is an accomplished Senior Executive and Consultant with more than 40 years of success across the nursing service, nursing education, informatics, and clinical/business intel venues. Her broad areas of expertise include data analysis, program evaluation, and evidence-based practices customized to a system's health care client. Throughout her executive career, Mary Anne has held faculty and leadership positions within the California State University and University of California systems, and $chultz & Associates. Dr. Schultz is a Professor, Informaticist and former Chair for the Nursing Department at California State University, San Bernardino. She holds a PhD in Nursing Systems and Economics from UCLA, an MBA from Claremont Graduate University, and a certificate in Health Informatics from UC Davis.
Dr. Keith R. Yamamoto is Vice Chancellor for Science Policy and Strategy, and Director of Precision Medicine at UCSF. A UCSF researcher since 1973, he is a leader in determination of gene regulatory mechanisms. He has led or served on national committees focused on public and scientific policy, public understanding of science, science education, open science, and peer review. He chairs the Coalition for the Life Sciences and sits on the National Research Council Governing Board Executive Committee, the Board of Directors of Research!America, the Board of Directors of the Public Library of Science, the Governing Board of the California Institute for Regenerative Medicine, and the Advisory Board for Lawrence Berkeley National Laboratory. As Chair of the NAS Board on Life Sciences, he created the study committee that produced "Toward Precision Medicine," which enunciated the precision medicine concept, and he helped lead efforts in the White House, in Congress, in Sacramento and at UCSF to implement it. He was elected to the National Academy of Sciences, the National Academy of Medicine, the American Academy of Arts and Sciences, and is a fellow of the American Association for the Advancement of Science.
For more information about this content, please contact: