Dear Colleague,

March is Women’s History Month so in this issue of our newsletter we profile some pioneering women in California whose collective work has made precision medicine possible. We also take a look at the history of research into women’s health and highlight some educational materials about sex and gender in biomedical research.  

We also include information about upcoming meetings for the Advisory Council working groups and the ACEs Expert Selection Committee, and make note that applications are now open for two graduate student interns! 

In health, 
The CIAPM Team 
Women and Research
California Women in Research
Clelia Duel Mosher, MD
Photo courtesy of Stanford University Archives.
A physician and advocate for women's health, Dr. Mosher's master's thesis at Stanford University proved that, contrary to popular belief at the time, women could and did breathe using their diaphragm just as men did, and that tight corsets were the reason that women primarily engaged their less-efficient chest muscles when breathing. After attending Johns Hopkins School of Medicine, Dr. Mosher returned to Stanford as an Assistant Professor and propelled early research about menstruation.
Florence Stroud, RN, MPH
Photo courtesy of the Stroud Family.
A leader in public health and a champion for the poor and patients of color, Ms. Stroud earned her MPH from UC Berkeley and was a Professor of Nursing at UCSF where she conducted research on racial disparities. She was the first African American to serve as the Director of Health for the City of Berkeley, and later became the Deputy Director for Community Health Services for San Francisco. Ms. Stroud provided seminal guidance on the prevention of prenatal HIV transmission and care for infants, children, and mothers with AIDS. She also co-founded the Bay Area Black Nurses Association, the Bay Area Consortium for Quality Health Care, and the CA Black Health Network. She was the first RN ever appointed to the CA Medical Board.
Flossie Wong-Staal, PhD
Photo courtesy of NCI Visuals Online.
A Chinese-American virologist, Dr. Wong-Staal was the first researcher to clone HIV. At 18 years old, she moved to the U.S. to pursue a BS and PhD at UCLA. At the National Cancer Institute, she conclusively linked human retroviruses with cancer, and during the AIDS epidemic, she added credence to the theory that AIDS was caused by HIV. In 1990, Dr. Wong-Staal moved to UCSD and later started the UCSD Center for AIDS Research, where she pioneered the use of ribozymes in gene therapy for HIV. In 2002, she left to pursue pharmaceutical research at a company she co-founded. Dr. Wong-Staal was named as the top woman scientist in the world of the 1980s by the Institute for Scientific Information.
A Short History of Research on Women’s Health*
The genesis of the modern debate about research on women’s health can be traced to one drug: Thalidomide. Starting in the 1950s, physicians in Europe and Australia prescribed Thalidomide to pregnant women as treatment for morning sickness. By 1961, physicians and scientists realized that Thalidomide caused severely malformed limbs and organs in babies born to mothers who took the drug while pregnant. 

The FDA responded by excluding "women of childbearing potential" from all phase 1 and 2 clinical trials. A decade passed before the public health community began to accept that limiting women’s participation in clinical trials was detrimental to women's health. By 1986, NIH-funded researchers were encouraged, but not required, to include women as study participants. A 1990 report, initiated by the Congressional Caucus for Women's Issues, found that the guidelines had not increased the number of women participating in research. The NIH then adopted a policy in which researchers had to provide clear rationale if women and minorities were excluded from their studies. That same year, the NIH established the Office of Research on Women’s Health (ORWH).  

In 1993, the NIH Revitalization Act codified the necessity for NIH researchers to include women and minorities in their studies, and that clinical trial data be analyzed for sex differences. 1993 was also the year that the FDA rescinded the ban on women of childbearing age in phase 1 and 2 clinical trials. The FDA established the Office for Women’s Health the following year.

In 2014, Ambien became the first drug to be prescribed at different dosages for women and men after studies showed that women metabolized the drug more slowly, leading to increased toxicity and side effects. Records indicate that the FDA was aware of the drastic difference in metabolization of Ambien as far back as 1992.

Starting in 2016, the NIH required researchers to report on sex as a biological variable.

The last five years have seen continued evolution in the way researchers consider the role of sex and gender in research and treatment. Increased data collection and reporting about sex, race, and ethnicity is helping to identify and rectify sex-based differences, leading to more precise interventions.

*Adapted from this timeline at Society for Women's Health Research

Resources on Sex and Gender in Health 
CA Precision Medicine Advisory Council
The Data Integration working group meets Tuesday, March 30 at 1:00 p.m.

The Equitable Consent working group will meet on Thursday, April 22 at 2:00 p.m. An agenda will be posted soon. Register to attend now.
Programmatic Updates
Upcoming Events
Precision Medicine Leaders Summit
This event is part of the Precision Medicine Leaders Summit Virtual Series 2021. The yearlong series will include events about telehealth, rare diseases, oncology, pathology, AI, and community health.

April 13 Precision Health

April 28
The COVID-19 pandemic has thrown into relief the longstanding racial inequities in the U.S. healthcare system. One major problem: making sure that the studies that test medical treatments reflect the populations of people who will receive them.
External Opportunities
Administrative Supplements for Research Focused on Maternal Health, Structural Racism and Discrimination, and COVID-19
Opportunity for investigators with relevant active NIH-supported grants to address scientific priorities for improving maternal health outcomes in the context of the ongoing COVID-19 pandemic for pregnant persons and up to one year postpartum.
Earliest submission date April 14.

Neurological and Neurocognitive Sequelae from SARS-CoV-2 Infection and COVID-19 in Aging and Age-Related Neurodegeneration 
This NOSI is to inform applicants to the National Institute on Aging (NIA) in basic and clinical mechanistic research on neurological and neurocognitive sequelae originating from COVID-19 in aging and age-related neurodegeneration.
Visit the Notice page for more details.

National Initiative to Address COVID-19 Health Disparities Among Populations at High-Risk and Underserved
This grant will provide funding to address COVID-19-related health disparities by expanding capacity and services to prevent and control COVID-19 infection or transmission.
Applications due May 3.

Exploratory Grant Award to Promote Workforce Diversity in Basic Cancer Research
This is a continuation of an NCI program to enhance workforce diversity by recruiting and supporting eligible New Investigators and Early Stage Investigators from diverse backgrounds, including from groups that have been shown to be nationally underrepresented.
Earliest submission date May 15. 

High-Priority Behavioral and Social Research Networks in Alzheimer’s Disease Related Dementias 
This Funding Opportunity Announcement (FOA) supports new research, research infrastructure, and new researchers via networks for behavioral and social research on Alzheimer's disease and related dementias.
Letter of intent due May 23. 

High-Priority Behavioral and Social Research Networks
This FOA supports new research and infrastructure for life course research on aging; attract new researchers in aging; focus on health disparities into aging research; and address ongoing needs for harmonization and biomarker collection in large population panel studies.
Letter of intent due May 23. 

Early-Stage Development of Data Science Technologies for Infectious and Immune-mediated Diseases
This FOA is to solicit applications for the development of enabling data science technologies to improve the acquisition, management, analysis, visualization, and dissemination of data and knowledge for immune-mediated and infectious diseases.
Earliest submission date June 2. 

Enhancement or Sustainment of Data Science Tools for Infectious and Immune-Mediated Diseases
This FOA is to solicit applications for the enhancement and/or sustainment of high-value data science research software to improve the acquisition, management, analysis, visualization, and dissemination of data and knowledge across the immune-mediated, and infectious-disease research continuum.
Earliest submission date June 2. 

Exploratory Data Science Methods and Algorithm Development in Infectious and Immune-mediated Diseases 
This FOA is to support exploratory research focused on developing innovative methods and algorithms in biomedical computing, informatics, and data science addressing priority needs across the infectious or immune-mediated disease research continuum.
Earliest submission date June 2.