Recent reports generated by WHAM (Women’s Health Access Matters, a nonprofit organization focused on demonstrating the economic imperative of women’s health research) highlighted the discrepancies in investment in women’s health research which is, in general, severely underfunded. The example provided focused on lung cancer which interestingly…

• …is the number one cause of cancer death in women
• …kills 1.5x as many women as breast cancer
• …had a 2019 NIH budget which equates to nearly $1 per woman compared to $7 per man
• …did not mandate until 2016 to include female subjects in preclinical research (e.g., rodent disease models) by the NIH

The same discrepancy between relevance to health and funding also applies to Alzheimer’s disease which is more prevalent in women as summarized by another WHAM report. Besides these two examples (lung cancer, Alzheimer’s disease) other types of diseases are also more prevalent in women, including autoimmune diseases and osteoporosis. Additionally, it’s critical that researchers dedicate more focus to female-specific health issues, such as pregnancy disorders (e.g., preeclampsia, preterm birth), menopause, endometriosis and polycystic ovarian syndrome. These issues have an immense impact on the health of women globally, yet research on these conditions is limited.

Yoel Sadovsky (Magee Women’s Research Institute), co-chair of the PMWC January 26th Women’s Health Track: “Ample data indicate that the 9-months of pregnancy hugely influences health and disease risk across the 90+ years of our lifespan. Pregnancy disorders are associated with a higher incidence of maternal diseases and child disorders and neurobehavioral changes during infancy and beyond. Considering the nearly four million annual deliveries in the US, it is not surprising that gestational diseases may take a major toll on our healthcare system. These diseases and their effect on lifelong mother-child health are best interrogated via precision medicine approaches during pregnancy to help understand dynamic changes of integrated pathways that can lead to lifelong illnesses.”

If nothing changes, women’s health outcomes will continue to be suboptimal. It’s important to note that lawmakers can’t craft effective policies, nor can startups innovate in the women’s health space without reliable, research-supported data. Additional funding and resources are required to study the differences among disease states in men and women, allowing the healthcare sector to better account for the health of men and women separately and increase our understanding of the gender influence on outcomes, treatments, and prevention options.

For these reasons PMWC January 25-27, 2023 Silicon Valley (Program) has dedicated an entire track to this topic: The Women’s Health Track takes place on January 26 and is co-chaired by Yoel Sadovsky (Magee Women’s Research Institute, University of Pittsburgh, and UPMC).

Track highlights include:

• PMWC 2023 Award Ceremony – the Pioneer Honoree Award goes to Marcia Stefanick (Stanford University) for her extraordinary leadership in the Women’s Health Initiative (WHI) and her contributions to improving women’s health
• Chronic Diseases in Women – two talks by:
  o Marcia Stefanik (Stanford) focusing on “Chronic Disease Prevention”
  o Marina Sirota (UCSF) on “Endometriosis”
• Stem Cells, Preimplantation and Prenatal Genetics – talks by:
  o Akash Kumar (MyOme, Inc.) on “Polygenic Risk Score”
  o Teresa Sparks (UCSF) on “Prenatal Genetic Diagnosis”
  o Nathan Treff (Genomic Prediction) on “Reducing Polygenic Disease Risk Through Embryo Selection”
• Precision Health for Mothers and Babies – chaired by David Stevenson (Stanford University) giving an introduction “Towards Precision Health for Mothers and Babies” with other talks by:
  o Aleks Rajkovic, UCSF on “Genomics of Pregnancy Loss”
  o Ivana Maric (Stanford University) on “ML for Early Prediction”
  o Nima Aghaeepour (Stanford University) on “AI-Driven Prematurity Taxonomy”
• Precision Health for Mothers and Babies: Components of Pregnancy Health– chaired by Yoel Sadovsky (Magee Women’s Research Institute) giving an introduction “the placenta at the center of maternal-fetal health ” with other talks by:
  o Marina Sirota (UCSF) on “Leveraging Molecular and Clinical Data for Pregnancy Health”
  o Brice Gaudilliere (Stanford University on “Gestational Multi-omic Immune Profiling”
• Value of Early Risk Prediction, Screening & Digital Intervention in Pre-term birth Avoidance – chaired by Leslie Saltzman (Ovia Health) with Sydney Strickland (Labcorp)
• Reproductive Aging – a panel chaired by Aleksandar Rajkovic (UCSF) with Diana Laird (UCSF), Jennifer Garrison (Buck Institute), Nikolina Lauc (GlycanAge), and Christian Kramme (Gameto)
• Achieving Equity in Precision Medicine – a talk by Aida Habtezion (Pfizer)
• Sex Differences with talks by:
  o Noel Bairey Merz (Cedar Sinai) on “CV Disease”
  o Danit Ariel (Stanford) on “Transgender health and sex differences”
• PMWC Showcase by Amrie Grammer, AMPEL BioSolutions and on Jan 27 Michelle Perugini, Presagen; Mattias Ehrich, Juno DX

Don’t miss the Women’s Health Track at PMWC 2023 Silicon Valley IN TWO WEEKS and hear from leaders about how we can help drive positive change in this critical area of human health.
Register Now for PMWC 2023 Silicon Valley January 25-27

Sincerely,

Tal Behar
President & Co-founder, PMWC
PMWC 2023 Silicon Valley – January 25-27, 2023

“Achieving precision medicine depends on federal resources to de-risk bold development, prototype impactful technologies, advance manufacturing, and put public good and public health on solid economic ground.”

“Science the Endless Frontier”, the 1945 report prepared for President Roosevelt by Vannevar Bush, established the U.S. science policy framework that stands to this day: the federal government shall provide funds for basic research and to train the next generation of scientists, while industry, propelled by the profit motive, would develop applications derived from the newly discovered knowledge – marketable technologies, diagnostics, therapeutics and cures that improve the length and quality of people’s lives.

Today, even more than in 1945, at least three obstacles impede industry-driven innovations that create applications of scientific discoveries: (i) risk of failure to successfully translate and apply new knowledge; (ii) insufficient near-term market; (iii) public good outweighed by uncertain long-term profit. The consequences of these obstacles are daunting. Two examples among many: microbial pathogens are approaching resistance to all existing antibiotics, yet industry is not developing new antimicrobials; the median time between a basic science discovery and its eventual development into an impactful FDA-approved drug is 32 years.

Achievement of the precision medicine continuum that bridges basic, clinical and population research, and enables transformative technologies that extend and improve lives, depends on overcoming the obstacles inherent in the Vannevar Bush doctrine. How might the federal government contribute funds, facilities and intellectual resources to de-risk bold developments and applications, to prototype impactful technologies that appear “impossible”, to advance environmentally-sound manufacturing and distribution at scale, to put public good and public health on solid economic ground?

I’m excited to chair the session “How New Public-Private Collaboratives Can Catalyze Transformative Health Breakthroughs” at PMWC 2023 Silicon Valley, January 25-27 (Program) which will explore these questions and examine novel approaches by which government can catalyze action by teams drawn from academia, industry and government, to carry innovation far enough forward that profitable business concepts can emerge that address challenges and deliver for the public good.

Joining me in this session will be Douglas Friedman, CEO of BioMADE (Bioindustrial Manufacturing and Design Ecosystem), a Department of Defense-sponsored agency, which seeks to develop bioindustrial technologies, such as serological testing and countermeasures, that reduce barriers to follow-on technology development, scale up and commercialization; Jay Keasling, CEO of JBEI (Joint BioEnergy Institute), a Department of Energy Bioenergy Research Center), Senior Scientist, Lawrence Berkeley National Laboratory, Professor of Biomolecular Engineering, UC Berkeley, and founder of Amyris Biotechnologies, which developed a synthetic biology approach to production of a malaria therapy; and Renee Wegrzyn, Director of ARPA-H (Advanced Research Projects Agency for Health), a Department of Health and Human Services agency, which seeks to develop capabilities to prevent, detect, and treat some of the most intractable diseases.

“PMWC is the perfect forum for cross-sector consideration of the imperative for federally-supported joint ventures that transform biological discoveries into technologies that extend and improve people’s lives.”

Please join me in this important conversation at PMWC 2023 SV, January 25.

Sincerely,

Keith Yamamoto
Vice Chancellor for Science Policy and Strategy, UCSF; Director, UCSF Precision Medicine; Professor, Cellular & Molecular Pharmacology, UCSF

Real-world evidence (RWE)-based approaches will increasingly influence clinical decision-making as real-world data (RWD) analysis methods advance, along with expanding acquisition, aggregation, and harmonization of RWD from traditional and novel sources. Growth of real-world datasets will elevate statistical power and generalizability, and ultimately is expected to enhance disease prevention and management across clinical domains and populations. However, this progress will require that the precision medicine community ensures that RWD are unbiased and drawn from diverse populations. Indeed, realizing the promise of precision medicine will depend upon empowering RWD to identify and address health disparities.

RWE – the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD – has already been included in various approval procedures of regulatory authorities, yet RWE research is still in a transition process. Since several gaps in this field are still being explored, more guidance and definitions are necessary to increase the implementation of RWE applications.

The field of RWE applications is diverse, and its impact is expected to include speeding up approval processes for therapies and vaccine research and development as has been shown during the COVID-19 pandemic. In this context, RWD is being collected to monitor vaccine uptake, safety, and efficacy, particularly among vulnerable populations. On the clinical side, artificial intelligence (AI) driven by RWD has been beneficial for clinical risk screening.

“To expedite RWE applications the community should make raw data and code to analyze RWD accessible, develop, and disseminate advance methods to collect and apply RWD, and participate in government programs, such as the FDA’s Advancing Real-World Evidence Program, and take measures to avoid, detect, and address bias (e.g., by using the Algorithmic Bias Playbook).”
Dr. Ben Rubin, Associate Director, Precision Medicine, UCSF & PMWC Jan. 25-27, 2023 Real World Evidence Track co-chair (Program)

Considering these facts and the importance of RWE and RWD in becoming instrumental for drug discovery and health care decision making, we have designed a full one-day track (Track 2 Day 2) focusing on Real World Evidence during PMWC 2023 SV, which is co-chaired by Courtney McFall and Ben Rubin (both at UCSF, Precision Medicine, Office of the Vice Chancellor of Science Policy & Strategy). The focus will be on important critical aspects of developing RWE applications, integrating RWE and RWD to support drug development, clinical studies using RWD (real-world data), and methodologies and challenges in the construction and application of real-world databases.

Come join us today at the Real-World Evidence / Data Track at PMWC 2023 Silicon Valley, January 25-27. Highlights of the track include:

• Clinical Studies Using RWD – a panel chaired by Aaron Kamauu (Navidence) with Liora Schultz (Stanford University), Sanket Dhurva (UCSF), Scott Morris (Optum Life Sciences), Motiur Rahman (FDA), and Atul Butte (UCSF)
• Beyond the EHR: Acquisition of RWD Types to Enable Precision Medicine – a panel chaired by Riley Bove (UCSF) with Anna Berry (Sypase), Ashley Brenton (Optum Life Sciences), and Vasu Chandrasekaran (Ontada)
• Data Linkage, Harmonization, and Quality – a panel chaired by Vivek Rudrapatna (UCSF), Rohit Vashisht (UCSF), Adam Asare (QLHC), Dan Riskin (Verantos), Wanmei Ou (Ontada), and Mindy DeRouen (UCSF).
• Using RWE to Uncover and Address Health Disparities – a panel chaired by Chris Boone (AbbVie), Robert Hiatt (UCSF), Abasi Ene-Obong (54gene), Nuray Yurt (Novartis Oncology), Alice Popejoy (UC Davis Health), and Vic Spain (Genentech)
• FDA RWE/D Draft and Final Guidances – a talk by Motiur Rahman (FDA)
• Fireside Chat – with Vivek Rudrapatna (UCSF), and Hilary Marston (FDA)
• From Real-World Data to Regulatory-Grade Real-World Evidence – a panel chaired by Sheila Walcoff (Goldbug Strategies) with Elaine Katrivanos (Tempus), Kathy Hibbs (23andMe), and Mike Ryan (McDermott Will & Emery)

We look forward to your participation in this most relevant and timely, not-to-be-missed scientific conference where we address the critical topic of RWE/RWE and strive to identify solutions enabling improvements to benefit our healthcare system. Register today to save.

Sincerely,
Tal Behar

President & Co-founder, PMWC
PMWC 2023 Silicon Valley – January 25-27, 2023