Accelerate preclinical development, improve clinical study design, and advance regulatory clarity in the development of women’s health drugs and devices and inclusion of women in research.
What You Can Expect:
- Stay ahead of evolving FDA and global regulatory trends shaping drug and device development for women’s health, including safety, efficacy, and approval pathways.
- Discover groundbreaking therapies and technologies progressing through clinical trials poised to transform care.
- Learn how to optimize clinical trial frameworks to better represent women, improve safety profiling, and accelerate market access and commercialization of solutions.
Agenda Highlights
1
Regulatory Landscape Surrounding Women’s Health Drugs & Devices
Understanding FDA approval pathways for women's health drugs and devices.
Addressing regulatory gaps and challenges in clinical trial design and data collection.
Strategies for working with regulators to accelerate innovation and ensure patient safety.
2
Safety Profiles & Women’s Reproductive Drug Development
How can pre-trial screening effectively predict side effects and symptoms associated with reproductive therapeutics.
What are the appropriate safety profiles to apply for endometriosis, PCOS, and fibroids?
3
Advancing Clinical Trial Design for Women’s Drugs & Devices
Sharing the role of technology and partnerships in the design & recruitment of studies.
Highlighting adaptive trial designs, decentralized models, and inclusive recruitment strategies.
Exploring how smarter trial design accelerates approval, reduces risk, and improves real-world outcomes.
4
Menopause Data Advancements in Clinical Practice & Research
Discuss strategies for trial design that account for hormonal fluctuations, comorbidities, and age-related variables unique to the menopausal transition.
Highlight regulatory, industry, and advocacy efforts that are pushing for menopause-specific representation in therapeutic areas beyond just women’s health.
Sharing advancements to educate clinical trial patients about menopause.
5
A Novel Oncolytic Peptide for Triple Negative Breast Cancer Therapy
Explore the mechanism of action and preclinical efficacy of a first-in-class oncolytic peptide targeting triple negative breast cancer (TNBC).
Understand how peptide-based approaches offer new hope for aggressive and treatment-refractory subtypes of breast cancer.
Learn about the breast cancer therapeutic roadmap and landscape.
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