Despite remarkable progress in medical science, women's healthcare continues to face critical gaps—nowhere more evident than in drug innovation. This talk will explore the current state of drug approvals for women’s health, highlight substantial unmet medical needs, and discuss how funding dynamics shape innovation. It will highlight current trends in drug discovery and map out future directions for advancing innovation in women’s health.

Despite growing recognition of the unmet medical needs in women’s health, drug development continues to be hindered by critical gaps, including limited understanding of disease mechanisms, absence of early diagnostic tools, and insufficient clinical trial stratification. This talk will explore how pre-competitive academic–industry partnerships can unlock innovation by addressing these challenges upstream. Using endometriosis as  an opportunity, Dr. Fretzen will highlight collaborative approaches to biomarker discovery, patient stratification, and translational strategies that can accelerate progress not only in endometriosis but across a spectrum of women-predominant conditions.

Women face distinct biological, hormonal, and social factors that influence cancer risk, progression, and treatment response—yet these differences remain underrepresented in oncology research and drug development. This session will examine the unique cancer needs of women and persistent gaps in therapeutic innovation for cancers that disproportionately or uniquely affect women. Experts will highlight emerging tools, sex-specific insights, and collaborative strategies aimed at closing these gaps and advancing equitable, personalized cancer care for women.

Proliferating cell nuclear antigen (PCNA) plays an essential role in regulating DNA synthesis and repair and is indispensable to cancer cell growth and survival. It represents an attractive molecular target to develop broad-spectrum anti-cancer agents. By targeting a cancer specific domain of PCNA, we identified a novel compound, AOH1996, which selectively kills cancer cells but causes no significant toxicity to a broad range of non-malignant cells. AOH1996 is in clinical trials. Our research suggests AOH1996 may significantly improve women’s cancer therapeutic approaches.

Breast cancer affects one in eight women during their lifetime, making it the most frequently occurring cancer among women. Globally, the World Health Organization estimated that breast cancer caused approximately 670,000 deaths worldwide in 2022. About 70% of all breast cancers express estrogen receptor alpha (ERa), making it a key target for breast cancer treatment. Giredestrant, a full ERa antagonist and degrader, has undergone multiple Phase III clinical trials for patients at various stages of breast cancer. The discovery and development of giredestrant will be shared to inspire further groundbreaking research aimed at helping patients in need.

Life-threatening pregnancy disorders such as preeclampsia remain understudied, limiting therapeutic options for mothers and infants. This talk introduces a chemoproteomic drug de-orphanization framework using activity-based protein profiling to identify actionable targets of approved drugs. Importantly, disease-relevant stress pathways defined in (pre)eclampsia converge with vulnerabilities in glioblastoma, enabling rational discovery of lead molecules and therapeutic strategies for otherwise intractable brain cancers with immediate translational relevance to oncology, neurology, and maternal medicine.

Adjuva Bio is developing next-generation cell therapies to treat endometriosis by targeting the fibrotic and inflammatory microenvironment that drives the disease. Our in vivo cell therapy platform is designed for precision targeting and localized immunomodulation to reduce inflammation. This presentation will highlight our therapeutic strategy, early preclinical data, and the broader potential of cell-based platforms to address major unmet needs in women’s health.

Endometriosis (EM) affects over 10% of reproductive-aged women and adolescents and causes lesions, infertility, and severe pain, with pain reduction remaining the main treatment goal. A major driver of the intense, pulsating menstrual pain in EM is excessive uterine and gastrointestinal contractions—mechanistically similar to labor. Patients experience abnormally strong and prolonged menstrual contractions, producing dysmenorrhea two to three times more severe than non-menstrual pelvic pain and affecting most patients. Targeting these hypercontractions may address a root cause of EM pain. This talk proposes a paradigm shift away from largely unsuccessful anti-inflammatory strategies toward therapies that modulate uterine hypercontractility, treating dysmenorrhea.

The FDA's Botanical Drug Guidance offers drug developers a regulatory pathway to approval for plant-based medicines. Plants are sophisticated chemical manufacturing environments and hold therapeutic promise for a multitude of conditions. Altin Biosciences is pursuing a novel botanical therapeutic for the non-hormonal treatment of uterine fibroids. Learn about the regulatory pathway for botanicals, myths, challenges and opportunities.

There is a significant gap when it comes to understanding the underlying causes affecting women's health and funding for R&D, and there are tools and data that we can leverage to help us begin to close the gap and pave a path towards addressing diseases that result in a significant societal and economic burden. I will describe the work we did in collaboration with Gynae Solutions, the Buck Institute for Research on Aging, and the Chinese University of Hong Kong to identify novel targets implicated in immune pathways, as well as a drug being repurposed to address endometriosis.

Iambic is advancing a pipeline of next-generation oncology therapeutics through its AI-driven drug discovery platform, with a strong focus on women’s healthcare, particularly ovarian and breast cancer. This presentation highlights a HER2 inhibitor in a Phase 1/1b clinical trial, demonstrating exceptional selectivity, broad mutant coverage, and robust brain penetrance. Programs are powered by Iambic’s ML models, including PropANE, Enchant, NeuralPLexer, integrated with high-throughput synthesis and screening to accelerate end-to-end discovery.

Women are not just small men, and their health solutions shouldn’t be scaled-down versions of male-centered models. Daré’s novel drug-delivery technologies are designed specifically for women and address the often-overlooked areas such as sexual and reproductive health that demand more targeted, thoughtful approaches to care.

Luteinizing Hormone/ Choriogonadotropin Receptor (LHCGR) is a critical regulator of fertility in women and men. It is necessary for follicle development and normal spermatogenesis, and loss of LHCGR activity leads to infertility. The injectable LHCGR agonist, hCG, is the current standard of care for females undergoing controlled ovarian stimulation and/or males with secondary hypogonadism. Using our machine learning platform, we identified potent, drug-like small-molecule LHCGR agonists with comparable efficacy to hCG in murine in vivo models.

Persistent disparity in female drug pharmacokinetics and dosing leads to a "one-size-fits-all" approach, often based on male-centric data. This oversight causes suboptimal efficacy or increased adverse drug reactions in women. Examining historical clinical studies and drug approvals where female-specific data were inadequately considered is crucial for understanding these failures and informing appropriate drug-development and prescribing practices.

Personalized predictive models are transforming the landscape of women’s health. By leveraging data-driven insights and AI-powered tools, researchers and clinicians can identify unique health patterns, accelerate biomedical discoveries, and tailor interventions to individual needs. We'll discuss how these models are being applied to close gaps in diagnosis and improve clinical trial representation. We'll highlight considerations, challenges, and translational opportunities that come with deploying predictive models in real-world settings.