Session Abstract – PMWC 2022 Silicon Valley


Track Co-Chairs:
Aleksandar Rajkovic, UCSF
Kathryn G. Schubert, Society for Women's Health Research

Researchers have long been recognizing the uniqueness of women’s health and its substantial effect on clinical practice, acknowledging the increasing appreciation of the importance of multidisciplinary approaches to health and disease. In every organ system, there are diseases that are unique to women, more common in women than in men, or characterized by differences in disease course in women compared to men. This Track will focus on the following topics related to Women’s Health:

  • Intro to Women's Health
    - Aleksandar Rajkovic, UCSF
  • US Regulatory/Personalized Medicine and Women's Health
    Session Chair: Kathryn G. Schubert, SWHR
    - Kaveeta Vasisht, FDA
  • Reproductive Health
    - Hakan Cakmak, UCSF
    - Laura Jelliffe-Pawlowski, UCSF
  • Pregnancy (PANEL)
    Session Chair: Yoel Sadovsky, UPMC
    - Virginia D. Winn, Stanford
    - Ananth Karumanchi, Cedars-Sinai Medical Center
    - Mira Moufarrej, Stanford University
  • Carrier Screening: Perspective on the new ACMG Practice Resource
    - James D Goldberg, Women's Health Medical Affairs
  • Biological Sex Differences in Disease + Inclusion of Women in Clinical Research/Innovation
    - Rhonda Voskuhl, UCLA
  • Cardiovascular Health
    - Nisha Parikh, UCSF
    - Jennifer Ann Tremmel, Stanford
  • Bone Health/Osteoporosis & Menopause
    Session Chair: Risa Kagan, Sutter Health
    - Danit Ariel, Stanford
    - Massimiliano (Max) de Zambotti, SRI International
  • Showcase
    - Maneesh Jain, MirVie
    - Kevin P. Rosenblatt, NX Prenatal
    - Ripudaman Singh, ARCEDI Biotech
    - Michelle Perugini, Presagen
    - Claire Tomkins, Future Family

 Session Chair Profile

M.D., Ph.D., Chief Genomics Officer, UCSF Health

Biography
Dr. Aleksandar Rajkovic serves as the Medical Director and Chief of the Center for Genetic and Genomic Medicine (CGGM) that organizes, coordinates and oversees Clinical Genetics and Genomics Services across the UCSF Health System. He is also Stuart Lindsay Distinguished Professor in Experimental Pathology I, member of the American Society of Clinical Investigator, American Association of Physicians and National Academy of Medicine. His research interests lie in basic and translational medical sciences in reproductive and population genetics. His current work focuses on implementing precision medicine tools across UCSF and evaluate its clinical significance and validity.


 Session Chair Profile

President and CEO, Society for Women’s Health Research

Biography
Katie Schubert oversees SWHR’s mission to promote research on biological sex differences in disease and improve women’s health through science, policy and education. Prior to joining SWHR, she served as Chief Advocacy Officer at the Society for Maternal-Fetal Medicine (SMFM). Previously, Katie served in key staff roles for U.S. Representatives Nancy Johnson (R-CT) and Wayne Gilchrest (R-MD), and as a Senior Vice President at CRD Associates, where she advised her clients on government relations strategy targeted at Congress and federal agencies. Her areas of expertise include women’s health, public health, and value assessment and quality. She currently serves as Chair of the Board of the Maternal Mental Health Leadership Alliance and advisor to the John E. Lewy Fund for Children’s Health, and is a past president of Women in Government Relations (WGR). She lives in Virginia with her husband, three children, and dog George.


 Session Chair Profile

M.D., Associate Dean, Women’s Health Research and Reproductive Sciences, University of Pittsburgh

Biography
Dr. Sadovsky’s research focuses on feto-placental development and the molecular function of the trophoblast, which regulates maternal-fetal exchange, immunological defense, and hormone production. His work aims to advance our understanding of early human development and pregnancy health. Dr. Sadovsky received his MD from Hebrew University–Hadassah Medical School in Jerusalem, followed by OBGYN residency at Washington University in St. Louis, and maternal-fetal medicine fellowship and postdoctoral research training at the University of California, San Francisco. Dr. Sadovsky is the principal investigator of several NIH grants. His honors, awards and service include membership in the Councils for NICHD and the March of Dimes, Advisory Committee on Research on Women’s Health, the National Academy of Medicine, and the Association of American Physicians. He served as president of the Society for Reproductive Investigation, and was awarded the 2013 Cozzarelli Prize in Biomedical Science from the National Academy of Sciences.

Talk
Extracellular Vesicles and Placental-Maternal-Fetal Communication Systems
The discovery of regulated extracellular vesicle signals, such as exosomes, has added a new dimension to our understanding of placental-maternal-fetal transfer functions during human gestation. Tracking their cargo, trafficking, targets, and intracellular processing illuminates unique cell-and organ-level molecular communication systems that can directly inform maternal-fetal health during pregnancy.


 Session Chair Profile

M.D., FACOG, Gynecologist, Sutter Health

Biography
Dr. Kagan is a board certified obstetrician-gynecologist and has been practicing gynecology and teaching medical students and residents for over 35 year. She specializes in gynecology, specifically menopause related health conditions, quality of life, bone health, female sexuality, and female cancer survivorship. She was co-medical director and principal investigator for multiple clinical trials at the Foundation for Osteoporosis Research and Education (FORE) in Oakland, CA, and more recently has been doing menopause related clinical research with the Sutter Health Research Institute. She is a North American Menopause Society (NAMS) certified Menopause Practitioner (NCMP) and is certified by the International Society of Clinical Densitometry (CCD). She serves on many committees developing standards for women’s health in midlife and beyond. She is actively involved in several professional organizations including NAMS, and is a past Board Trustee, Scientific Program Chair and continues to serve on the NAMS Scientific Program Committee. She is an active committee member of the International Menopause Society (IMS) and International Society for the Study of Women’s Sexual Health (ISSWSH). Dr. Kagan is well known as a communicator and teacher and is often approached by media, public forums, and colleagues to lecture at national and international scientific meetings for her expertise in menopause and osteoporosis. She is currently on the Medical and Scientific Advisory Board of American Bone Health (ABH), an Advisor for Lisa Health and on the Provider Executive Group for Ms. Medicine.Dr. Kagan is a graduate of New York University and the Albany Medical College of Union University. She completed her internship-residency at the University of California San Francisco and has been on the clinical faculty since then.


 Speaker Profile

M.D., Ph.D., Associate Professor Obstetrics and Gynecology, Stanford University

Biography
Dr. Winn is a physician-scientist board certified in Maternal-Fetal Medicine with a PhD in Biochemistry. She is a leading expert in human placental development and preeclampsia pathogenesis. She leads an active NIH funded basic and translational research program. Dr. Winn’s research program focuses on both normal and abnormal human placental development and related obstetrical complications, particularly preeclampsia. Her laboratory also investigates the impact of pregnancy, and specifically placental factors, on the maternal immune and endothelial systems. Dr. Winn’s mission is to improve maternal and child health while training the next generation of perinatal researchers. 

Talk
Preeclampsia: Challenges of Personalized Medicine When There Are Two
The health of a pregnancy is determined by the maternal, placental and fetal units. Therefore, consideration of personalized medicine in pregnancy requires examination of the interplay of two genomes and the subsequent impact on biology. Preeclampsia, a leading cause of maternal and neonatal morbidity and mortality, will demonstrate the challenges in the field.


 Speaker Profile

M.D., Professor of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA

Biography
Dr. Karumanchi’s laboratory is focused on discovering pathogenic pathways and bringing therapies to patients in the areas of hypertensive disorders of pregnancy and chronic kidney diseases. Dr. Karumanchi’s research activities are vertically integrated, ranging from molecular and cell biological studies to animal models to first-in-class human clinical trials. Dr. Karumanchi has published over 300 papers (with several publications in NEJM, Circulation, Nature, Nature Medicine, JCI) and 25 book chapters. He has received prestigious awards from several societies including recognitions from American Heart Association (AHA) – Established Investigator Award (2008), the International Society for the Study of Hypertension in Pregnancy – Chesley Award (2010) – and Outstanding Investigator Award from the American Federation for Medical Research (2010). He was also elected as a member of the American Society for Clinical Investigation in 2007 and Association of American Physicians in 2015. His work in Preeclampsia has been highlighted in The New York Times, New Yorker, Boston Globe and LA Times. Dr. Karumanchi completed his medical degree from Kilpauk Medical College, India in 1992. He then completed his residency in Internal Medicine at the Henry Ford Hospital, Detroit (1996) and his post-doctoral training in Molecular Biology at the Beth Israel Deaconess Medical Center and Harvard Medical School, Boston (2000).

Talk
Targeted Therapies for Preeclampsia
Circulating anti-angiogenic proteins of placental origin are responsible for the maternal signs and symptoms of preeclampsia. We will present data for short interfering RNAs that selectively silence placental expression of anti-angiogenic proteins responsible for the human disease. Our results demonstrate a feasible path toward a new treatment paradigm for patients with preeclampsia.


 Speaker Profile

Ph.D. Candidate, Stanford

Biography
Mira Moufarrej developed 3 liquid biopsy tests that measure cell-free RNA (cfRNA) to predict how far along a pregnancy is and whether a mother is at risk of preeclampsia and preterm delivery long before traditional diagnostics. This work paves the way for affordable, simple, and reliable tests for preeclampsia and preterm delivery – risks that no other test can presently diagnose early enough to allow for meaningful clinical intervention. To enable such discoveries, she has also built a semi-automated pipeline to process samples, a notoriously tedious task, which to date, has extracted cfRNA from ~1100 samples in 9 days. For this work, Mira received the 2021 “Cure it!” Lemelson-MIT Student Prize. Her work has also been published in Science, and highlighted by the New York Times, CNN and Insider, among others. It was also recognized by Bill Gates as one of the top 10 innovations of 2019 in the MIT Technology Review.

Talk
Improving Prenatal Care through Liquid Biopsies


 Speaker Profile

M.D., Professor, University of California, Los Angeles; Director, UCLA Multiple Sclerosis Program; Jack H. Skirball Chair

Biography
Dr. Voskuhl is an internationally recognized expert in sex differences research, focusing on translation from bedside (clinical observations) to bench (research) to bedside (novel clinical trials). Voskuhl’s lab at UCLA investigates sex differences in neuroimmune mechanisms during health and disease. They demonstrated roles for sex hormones and sex chromosomes in the immune system and the central nervous system. Her lab showed X-dosage and parental imprinting effects on immunity, as well as neuroprotective effects of estrogen receptor ligands. Voskuhl translated findings in her lab to four clinical trials of novel hormone treatments. She received the Berlin Institute of Health Excellence Award for Sex and Gender Aspects in Health Research in 2018, the Kenneth Johnson Memorial Award by Americas Committee for Research and Treatment of MS in 2019, and UCLA’s Innovation Award in 2019. She is currently the President of the Organization for the Study of Sex Differences. Voskuhl received an MD from Vanderbilt University, residency at University of Texas Southwestern, and fellowship at the National Institutes of Health.

Talk
Advancing Sex Differences in Basic Research to Clinical Trials
Major progress has been made in sex differences research at the preclinical level, but these discoveries need translation to clinical trials to benefit both women and men. Beyond inclusion of both sexes with retrospective analyses, now is the time for trial designs prospectively powered to determine treatment efficacy in each sex.


 Speaker Profile

M.D., M.P.H., Associate Professor of Medicine, Division of Cardiology, UCSF; Deputy Editor, Cardiology, UpToDate, WoltersKluwer

Biography
Dr. Parikh is a noninvasive cardiologist with interests in prevention, echocardiography and women’s health. Her research program has focused on pregnancy effects on later cardiovascular diseases in women. She has applied novel epidemiologic techniques to answer important clinical questions in cardiology. She recently led the first American Heart Association statement to address adverse pregnancy outcomes and cardiovascular diseases. She is also now a Deputy Editor in cardiology at UpToDate, WoltersKluwer where she manages several topics including women’s cardiovascular diseases, atrial and ventricular arrythmias, and primary and secondary cardiovascular disease prevention.

Talk
Pregnancy as a Precision Medicine Tool in Women
This talk will explain why and how we can use information a woman’s pregnancy and reproductive health information to accurately predict later cardiovascular events, improve risk stratification, and tailor primordial and primary preventive therapy.


 Speaker Profile

M.D., Clinical Assistant Professor, Stanford University School of Medicine; Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism

Biography
As an adult endocrinologist, Dr. Ariel has a special interest in gender hormone related care. She is a Certified Menopause Practitioner through the North American Menopause Society, and is a member of the NAMS Educational Committee. Her clinical care focuses on the management of perimenopause and menopause, using a combination of evidence based medicine with a personalized approach. She is also a member of Stanford's LGBTQ+ Health Program providing gender affirming care for the transgender population. Dr. Ariel graduated cum laude from UC Berkeley and then from UC Davis School of Medicine. She completed a residency in Internal Medicine at Stanford School of Medicine, and a fellowship and post-doctorate in Endocrinology and Metabolism at Stanford while also completing a Masters in Clinical Research and Epidemiology before joining the faculty at Stanford. Currently, she serves as the Founding Director of the Stanford School of Medicine Student Guidance Program working closely with medical students in the development of clinical skills. She also holds the role of Faculty Well-Being Director for the Department of Medicine and Division of Endocrinology, and is a Distinguished Member of the Stanford Teaching and Mentoring Academy.


 Speaker Profile

Ph.D., Chief Executive Officer & Co-Founder, MirVie

Biography
Maneesh leads Mirvie’s efforts to develop the first early detection RNA test with the potential to detect pregnancy complications months before they occur. The platform is powered by state-of-the-art machine learning and liquid biopsy technology to analyze tens of thousands of molecular messages from the mother, baby, and placenta – all from a simple blood sample. As a proven life-science entrepreneur, Maneesh served in founding and executive roles at transformational biotech startups addressing large unmet needs for over two decades. He helped pioneer the first platforms to create more accessible next generation sequencing (Ion Torrent) and medical ultrasound imaging (Butterfly Network), as well as the first liquid biopsy plasma test for the early detection of cancer (Cirina and Grail). Maneesh also serves as an independent board member for Mission Bio and Mammoth Bioscience, holds degrees from Caltech and Stanford, and is an author on over 20 publications and several patents.

Talk
Pioneering The Future of Pregnancy Health with RNA
1 in 5 pregnancies experience a complication, yet there is no reliable way to detect them. Mirvie’s RNA technology promises to help identify individuals at risk early enough in pregnancy with the potential to allow preventative treatments and reduce the lifetime health consequences for mother or child they often cause.


 Speaker Profile

M.D., Ph.D., Chief Medical and Scientific Officer, NX Prenatal

Biography
Dr. Rosenblatt leads the clinical assay development efforts for NX Prenatal, leveraging more than 29 years of clinical and biomedical research and development experience in multiple settings, including academia, biotech, startups, and clinical practice. Prior to joining NX Prenatal, he was Chief Scientific Officer, Chief Medical Officer, and Clinical Laboratory Director at CompanionDx's CLIA/CAP certified reference lab. Among other appointments, he has served as Director of the Center for Clinical Proteomics at the Brown Foundation Institute of Molecular Medicine, as well as the Director of the UT Health Science Center at Houston's Center for Clinical and Translational Sciences Proteomics Core. Dr. Rosenblatt also serves as Associate Professor in the Division of Oncology, Department of Internal Medicine at UT Health and the McGovern Medical School and Associate Adjunct Professor in the School of Health Professions at the MD Anderson Cancer Center. Earlier in his career, Dr. Rosenblatt was co-founder and Laboratory Director of Risk Assessment Laboratories, which partnered with Perkin-Elmer to develop adverse pregnancy outcome biomarkers.


Women's Health Showcase:
NX Prenatal

NX Prenatal utilizes proprietary exosome-based liquid biopsy techniques to create breakthroughs in maternal-fetal diagnostics. Our NeXosome® Platform has yielded Preterm Birth and Preeclampsia biomarker panels at week 10-12 of pregnancy in asymptomatic women to support personalized care pathways.

Exosomes: Decoding Maternal-Fetal Cross Talk
Maternal-fetal cross-talk is mediated by exosomes, which actively support a number of physiological systems, including regulating the immune protection of the fetus. NX Prenatal has demonstrated that the profiling of exosomal-bound proteins circulating in pregnant women provides early markers predicting preterm birth and preeclampsia, and also provides new insight into the molecular pathways associated with such outcomes.

 Speaker Profile

Ph.D., Chief Technology Officer, ARCEDI Biotech

Biography
One of the co-inventors of ARCEDI's cell-based noninvasive prenatal technology using fetal cells isolated from pregnant women's blood for prenatal testing.

Talk
Circulating Fetal Cells for High-resolution Noninvasive Prenatal Testing


 Speaker Profile

M.D., Associate Professor of Medicine (Cardiovascular), Stanford University

Biography
Dr. Jennifer Tremmel is an Interventional Cardiologist and the Endowed Medical Director of Women’s Heart Health at Stanford. She conducts research on sex differences in cardiovascular disease. Much of her work has focused on patients with angina in the absence of obstructive CAD, both in the stable and acute setting. She also was an early adopter of the transradial approach and is a national expert on the topic. More recently, she started the CTO program at Stanford and has contributed to the field by demonstrating that the radial approach and same-day discharge are readily achievable in complex PCI.


 Speaker Profile

Ph.D., PHARMD, CEO, Presagen

Biography
Dr. Michelle Perugini is an academic and health tech entrepreneur with extensive experience in healthcare and advanced AI technologies. Michelle is also a dedicated advisor to many start-ups, a member of numerous Government Committees, and an avid supporter of the AI and women’s health sectors globally. She has a PhD in Medicine and was a post-doctoral research fellow in Oncology for a decade. She has founded 2 global AI tech companies, the first of which was acquired by EY in 2015. Michelle is currently Co-Founder and CEO of Presagen, an AI healthcare company building The Social Network for Healthcare, with a focus in women’s health. Presagen’s first product Life Whisperer uses AI for embryo selection to improve pregnancy outcomes in IVF, and is being sold in IVF clinics globally.

Talk
Presagen: The Social Network for Healthcare
AI often lacks scalability as it is based on biased data that lacks diversity. Presagen's Social Network model enables global collaboration and data sharing by clinics and patients, creating AI healthcare products that are globally scalable, accessible and affordable for all.


 Speaker Profile

Ph.D., Chief Scientific Officer, Lisa Health; Principal Scientist, SRI International

Biography
Neuroscientist, expert in women’s health, sleep, psychophysiology, neuroscience, and wearable technology. I am strongly devoted to the mission of advancing science, discovering and developing novel approaches and technologies to improve people’s health and well-being.

Talk
Wearable Technology and AI to Address Key Menopause Symptomatology
This session introduces novel advancements in detecting, tracking, and delivering relief for hot flashes and related sleep impact, within the concept of precision medicine.


 Speaker Profile

M.D., Associate Professor, UCSF

Biography
Dr. Hakan Cakmak is a reproductive endocrinologist and fertility specialist who cares for patients seeking treatment for fertility issues or recurrent pregnancy loss, and those interested in assisted reproductive techniques (such as intrauterine insemination and in-vitro fertilization) or fertility preservation (such as egg or embryo freezing). In research, Dr. Cakmak develops better strategies for treating infertility, particularly by improving ovarian stimulation protocols and embryo selection techniques. He also investigates the molecular causes of implantation failures and miscarriages.

Talk
End of Infertility is Insight
Infertility may be caused by wide range of factors affecting ovarian development, maturation of oocytes, and fertilization competence, as well as the potential of a fertilized egg for preimplantation development, implantation, and fetal growth. Genetic abnormalities leading to infertility comprise large chromosome abnormalities, and DNA sequence variations in the genes that control these biological processes. Understanding and potentially screening these genetic abnormalities may pave the pathway for more successful infertility treatments in the future.


 Speaker Profile

Ph.D., Professor, Epidemiology & Biostatistics, UCSF

Biography
Dr. Laura Jelliffe-Pawlowski is a Professor in the UCSF School of Medicine and is the Director of Precision Health and Discovery with the UCSF California Preterm Birth Initiative (pretermbirthca.ucsf.edu). She serves as the Primary Investigator for the HOPE COVID-19 study which examines the impact of COVID-19 and pandemic-related hardship on adverse pregnancy and infant outcomes (HOPE.UCSF.edu/covid_19). She is leader and founder of the HOPE Consortium (HOPE.UCSF.edu) which includes investigators from across the US and world whose work focuses on uncovering causes of adverse pregnancy and infant outcomes and identifying in-roads for interventions. She has served as a state, national, and international adviser on committees and task forces focused on the early detection and prevention of preterm birth and developmental disabilities and holds patents for blood tests and algorithms predicting preterm birth.

Talk
Precision Metrics and Pregnancy Health: Insights from Pandemic
The COVID-19 pandemic has changed the way many us think about pregnancy and precision health. Critical is the consideration of how metrics can do a better job at identifying those at the highest risk -- especially low-income and Black and Brown pregnant people. Lessons learned and new metrics will be shared.


 Speaker Profile

M.D., Pharm.D, Associate Commissioner For Women's Health - Office Of Women's Health, FDA

Biography
Dr. Kaveeta Vasisht is the Associate Commissioner for Women’s Health at the U.S. Food and Drug Administration (FDA). She is responsible for directing the Office of Women's Health at the FDA. Under her leadership, the Office works to advance the health of women through scientific programs, policy development, research, education and outreach. Prior to joining the Office of Women’s Health, Dr. Vasisht served as the Deputy Director for the Division of Clinical Trial Quality in the Office of Medical Policy in the Center for Drug Evaluation and Research. She has led multi-stakeholder international collaborations and policy development that are critical to the Agency’s approach to improving clinical trial quality and methodologies. She has worked to promote the inclusion of diverse populations in clinical trials. Dr. Vasisht began her career at the FDA in the Division of Metabolism and Endocrine Products, Office of New Drugs, where she served as the clinical expert on multidisciplinary teams in the review and evaluation of scientific data to make regulatory decisions regarding risk-benefit assessments on the safety and effectiveness of therapeutics to treat endocrine conditions for the U.S. population. Dr. Vasisht is board certified in both internal medicine and adult endocrinology and holds a Doctor of Pharmacy degree. She completed her internal medicine training as well as her fellowship training in adult endocrinology, diabetes and metabolism at the University of Chicago Hospitals, where she also served as a clinical instructor of medicine. She has completed a hospital pharmacy practice residency. Dr. Vasisht continues to practice endocrinology in a volunteer clinic. She obtained her medical degree from the University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School. Dr. Vasisht combines her clinical experience and academic training with her diverse regulatory background to further advance FDA’s mission to protect, promote and advance the health of women.


 Speaker Profile

Ph.D., CEO/Founder, Future Family

Biography
Claire founded Future Family to address the growing demand for fertility services in the U.S. and globally. Prior to Future Family, Claire served as Director of Product and Partner Marketing at SolarCity (now TSLA), the largest consumer finance business in the solar industry. Claire has been recognized as a National Science Foundation Fellow and a Kauffman Fellow, and for her work at Future Family as Hustle 2X’s Woman of The Year Top-50 finalist, Inc Magazine’s list of Top 100 Female Founders, Fortune’s Most Powerful Women Next Gen, and one of San Francisco Business Time’s 40 Under 40. Claire holds a PhD in Management Science and Engineering from Stanford University and a B.A. from the University of Arizona. Claire is passionate about women's health and fertility based on her personal experience building her family with IVF.


Digital Health Showcase:
Future Family

The company’s mission is to make fertility care accessible and affordable to all. Future Family combines advances in fintech, fertility, and concierge care to empower women and couples throughout their fertility journey.

Removing the Biggest Barrier to Fertility Treatment: Accessibility
With the average cost of IVF over $20,000, cost is the greatest barrier to IVF keeping more than half the people who want it from moving forward. We cannot discuss fertility options in the U.S. without including financing in the conversation.

 Speaker Profile

M.D., Consultant, JDG Consulting

Biography
Dr. Goldberg is board certified in obstetrics and gynecology, maternal-fetal medicine, and medical genetics, and is a founding fellow of the American College of Medical Genetics. He was previously the chief medical officer at Counsyl and Myriad Women’s Health. He has also served as president of the Perinatal Quality Foundation and on the board of the Society for Maternal Fetal Medicine. Dr. Goldberg has published extensively in the area of prenatal diagnosis and screening and has served on committees that establish national obstetrical care policy.