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Pilot Project Program

Photo by Robert A. Lisak

WHRY’s Pilot Project Program has been recognized as a national model for launching new research on the health of women and uncovering sex and gender differences that affect health outcomes.

Our “seed” grants generate the data required to obtain larger external grants that focus on disorders of high morbidity and mortality in women, and conditions with meaningful clinical differences between and among women and men.

Active Pilot Projects

Understanding Effects of CBD on Brain Function

Sarah D. Lichenstein, PhD

Assistant Professor of Psychiatry

Dr. Sarah Lichenstein (center) is leading a study examining the sex differences in the effects of CBD on brain function.

Though not regulated by the Food and Drug Administration, cannabidiol (CBD) is increasingly used within the U.S., and the primary consumers are women. Dr. Sarah Lichenstein is leading a study targeting sex differences to determine how CBD may affect behavior and the brain in women and how that differs from the effect men experience.

The majority of research on the neurological effects of CBD in healthy adults derives from a single small study conducted entirely on men and little research has been done on optimal dosing guidelines. Understanding how the brains of women and men respond to CBD is critical to create dosing guidelines, maximize safety and efficacy in an unregulated market, and determine therapeutic potential.

Dr. Lichenstein is particularly focusing on CBD’s potential to treat anxiety disorders, the most common reason cited by CBD users for their interest in these products and a condition that is twice as prevalent among women than men. Learn more.

Improving Diagnostic Precision in Women with Chest Pain

Samit Shah, MD

Assistant Professor of Medicine (Cardiology)

Dr. Samit Shah tests for small vessel spasm in a patient experiencing chest pain who did not present an artery blockage.

The most common cause of a heart attack is blockage in a cardiac artery. Dr. Samit Shah is developing a new diagnostic approach for detecting reduced blood flow to the heart when a cardiac artery is not blocked. His study focuses on detection of microvascular disease as the cause of reduced blood flow to the heart. This condition, which occurs when small blood vessels constrict or spasm, affects more women than men.

Dr. Shah is studying 100 women over two years at Yale New Haven Hospital and comparing the outcomes for patients who receive the standard of care with those who undergo an additional method of screening for microvascular disease when an arterial blockage is not found. Using this method, 80 percent of women have been given the correct diagnosis and treatment plan. Dr. Shah also is tracking the health outcomes and quality of life of these patients to determine the long-term value of this new testing as a clinical standard. Read more.

Understanding the Intersection Between Pain and Opioids

Sarah Yip, PhD

Associate Professor of Psychiatry

Dr. Sarah Yip is using connectome-based predictive modeling to try and identify individuals who may be more likely to relapse into opioid addiction.

Dr. Sarah Yip is using a new technique known as connectome-based predictive modeling that relies on data and machine learning to try to predict the likelihood of relapse for those recovering from substance use disorder. Dr. Yip is determining how pathways in the brain respond to the sensation of pain and pain relief from opioids and how these connections differ between men and women. This study is one of the first to use a brain map of connections to investigate the neurobiology of pain and analgesia while investigating sex differences at the same time.

This study is designed to determine gender-specific treatments for substance misuse and with predictive modeling identify those who may be more likely to relapse into addiction so that these individuals can be provided prevention resources. Learn more.

Alternative Pain Management for Opioid Dependent Women after Cesarean Section

Audrey Merriam, MD

Assistant Professor of Obstetrics, Gynecology & Reproductive Sciences

Dr. Audrey Merriam (left) is studying for the first time if an existing steroidal medication can reduce pain, and thus the need for opioids, in women having a cesarean section.

Pregnant patients with opioid use disorder (OUD) may be prescribed drugs such as methadone or buprenorphine to optimize health outcomes before and after they give birth. However, even with these therapies women with OUD face an increased relapse risk in the postpartum period.

Dr. Audrey Merriam is determining for the first time if an existing steroidal medication can reduce pain, and thus the need for opioids in women with OUD, after a cesarean section. If proven effective, this intervention to target postoperative pain in this high-risk group would reduce opioid exposure after delivery for this population and lower the risk of relapse. It would also provide an option for all women to help reduce introduction of opioid therapies, which is the primary pathway to subsequent use and misuse of opioids. Learn more about this study.

Predicting Memory Change in Healthy Aging Women

Carolyn Fredericks, MD

Assistant Professor, Neurology

Dr. Carolyn Fredericks (right) is leading a study to understand the role genetic risk factors play in the progression of Alzheimer's Disease.

Neurologist Dr. Carolyn Fredericks is working to understand the role genetic risk factors play in the disease progression of Alzheimer’s Disease (AD) – a condition that disproportionately affects women.

Dr. Fredericks’ study focuses on a genetic variant, referred to as the APOE4 allele, which is the greatest known risk factor for AD. She seeks to understand whether healthy aging women who carry this gene have a change in brain connectivity – the way in which the brain communicates internally – that signals memory decline and subsequent AD. Her investigation aims to uncover this information that is essential to understanding the underlying causes of AD and eventual treatment.

Read more.

Sex Differences in Neuroendocrine Cancers

Pamela Kunz, MD

Associate Professor of Internal Medicine (Medical Oncology)

Dr. Pamela Kunz is studying sex differences in the side effects experienced by patients with a rare form of gastrointestinal cancer.

Dr. Pamela Kunz is conducting one of the first studies to examine sex differences in side effects when treating patients for neuroendocrine neoplasms (NENs), a rare form of cancer often found in the gastrointestinal tract. Sex differences have been found in where cancers start and in survival rates yet understanding the side effects of treatment is limited. This research focuses on analyzing clinical trial data to determine the extent of sex differences in NEN chemotherapy and radiation treatment side effects that contribute to poor quality of life, worse outcomes, and increased costs of care.

Additionally, Dr. Kunz is examining gene variations associated with these cancers that may predict how a patient will respond to a treatment. This effort is designed to tailor therapy to specific persons, and thus reduce side effects, and improve therapy outcomes and the lives of patients who are on long-term treatments. Learn more.

Developing Diagnostics for Early Detection of Ovarian Cancer

Stacy Malaker, PhD

Assistant Professor of Chemistry

A WHRY grant is funding research to identify a biomarker that can detect ovarian cancer at an early stage.

Ovarian cancer outcomes drastically improve the earlier the cancer is diagnosed. Dr. Stacy Malaker is pursuing a novel approach to identify “biomarkers” that can effectively detect ovarian cancer at an early stage.

The focal point of her research is on the sugar molecules or “glycans” that coat the outside of all cells and the process in which these sugars combine with the amino acids in a protein to create a glycoprotein. Glycoproteins are essential in maintaining the immune system and errors in this process can allow a cancer cell to evade immunity defenses. Dr. Malaker is examining a glycoprotein known as Mucin 16. When cancer invades a cell, the Mucin 16 on that cell is shed into the bloodstream and becomes the one of the only known ovarian cancer biomarkers called CA125.

Dr. Malaker’s goal is to determine how and why the glycan patterns change on shed CA125 to develop a method to detect cancer earlier. Read More.

Using Nanoparticles to Treat Infection and Improve Pregnancy Outcomes

David Stitelman, MD

Associate Professor of Pediatric Surgery and Obstetrics, Gynecology, and Reproductive Sciences

Dr. David Stitelman is studying the use of nanoparticles to deliver antibiotics to the amniotic space and reduce premature births due to intra-amniotic infection.

One of the leading causes of premature delivery during pregnancy is intra-amniotic infection (IAI). This occurs when bacteria infect the placenta, the amniotic fluid, and the membranes that line the uterus and maintain the structure of the amniotic sac. Once IAI has been diagnosed, delivery must occur quickly, which puts infants at risk of both short and long-term health challenges. While the pregnant woman can be given antibiotics to treat the infection, one of the biggest challenges has been getting the medication past a protective biofilm and to the area surrounding the fetus.

Dr. David Stitelman and his team are studying the use of biodegradable synthetic particles called nanoparticles, which are about the size of the head of a pin. These nanoparticles can pass through the biofilm and deliver the antibiotics directly to the amniotic fluid, membranes, and placenta.

If the research team is successful at tailoring a nanoparticle to deliver the correct dose of antibiotics to treat the infection, they will be well positioned to continue trials on the path to a new treatment for IAI and improving the health of women and children. Learn More.

Investigating Sex and Gender Based Disparities in Diagnosis and Outcomes of Thoracic Aortic Disease

Roland Assi, MD

Assistant Professor of Cardiac Surgery

A WHRY pilot project study is investigating the biological and social determinants of why women with thoracic aortic disease face poorer health outcomes than do men.

Thoracic aortic disease occurs when the walls of the aorta, the main chest artery that carries blood from the heart to the rest of the body, begin to weaken and cause the artery to widen. If the artery becomes too wide, it can rupture or tear resulting in a life-threatening aortic aneurysm. The widening process of the aorta is slow and can often be managed with diet, lifestyle changes, and routine surveillance if it is detected. However, understanding who is at risk is difficult because signs and symptoms of the disease can be difficult to diagnose until there is a rupture.

Dr. Roland Assi is investigating both biological and social determinants of why women with this disease face poorer health outcomes than do men. His research will include determining how the symptoms of the disease appear in women compared to men, how women-specific conditions like pregnancy, menopause, and hormone therapy affect the disease, and whether women receive treatment plans in a less timely manner than men. Read More.