DAY ONE - Wednesday July 24, 2024
8:00 am Check In & Morning Coffee
8:50 am Chair’s Opening Remarks
Fast-Tracking Phase Development across Women’s Health from Bench to Bedside
9:00 am Panel Discussion: Spotlighting Women’s Health in 2024: What are the Greatest Bottlenecks & Priorities for Industry to Tackle?
Synopsis
- Collaborating as a community to outline the greatest hurdles to overcome this year to advance diagnostic and therapeutic tools to the clinic faster
- Cross-referencing the priorities for women’s health innovations for biotechnology companies, pharmaceutical companies, academics and clinicians
- Brainstorming strategies to create a more cohesive women’s health community to allow for more synergy in the projects that are executed
9:45 am Mapping the Pre-Clinical to Clinical Pathway for Women’s Health Diagnostic & Therapeutic Tools to Drive Clinical Advancements
Synopsis
- Outlining the current pre-clinical tools in use to convey proof of concept effectively with the limited availability of effective models
- Aligning industry around the most optimal way to collect data which creates a thorough foundation for IND submission
- Implementing a proactive, early-stage approach to develop the most comprehensive assays to showcase the safety and functionality of the product
10:15 am Showcasing Effective Clinical Trial Advancements in Women’s Health to Apply Cross-Learning Potential Between Indications
Synopsis
- Driving efficacy scales that are now established within the field of endometriosis and female sexual dysfunction that allow for the consistent assessment of new therapies within high unmet needs categories
- Establishing strategies of recruitment of diverse women in clinical contraceptive studies (demographics and BMI) to generate data that is generalizable to real-world use
- Relaying the important differences in current vs historic contraceptive study design
10:45 am Roundtable Discussion: Sharing the Latest Regulatory Guidelines for Women’s Health Products to Ensure an Efficient Journey to Approval
Synopsis
- Reflecting on the clinical advancements across women’s health and the successful regulatory interactions
- Rationalizing the current guidelines in place to create food for thought in relation to preclinical data collection fit for submission
- Debating the current pitfalls regulators are recording across IND submissions to present a clear pathway to regulatory approva
11:15 am Morning Refreshments & Speed Networking
Synopsis
A dedicated hour to chat women’s health over a coffee, put a face to a name and exchange business cards in a controlled networking set up designed to ensure you have the chance to meet everyone in the room, multiplying your women’s health network by the minute!
Honing the Current Understanding of Bacterial Vaginosis to Translate into Diagnostic & Therapeutic Advancements
12:15 pm Distinguishing the Classification of Vaginal Dysbiosis to Form a Model of Optimal Microbiota Within the Vagina
Synopsis
- Collating the key contributing microbes which lead to a dysbiotic vaginal microbiome
- Articulating bacterial vaginosis as an indication along a spectrum, with varying strains and variations of the disease
- Diving deep into the differing characteristics of vaginal microbes, with greater clarity around the severity of varying microbe population sizes
12:45 pm Exploring Efficient Diagnostic Tools as a Viable Alternative to Accurately Diagnose Bacterial Vaginosis
Synopsis
- Prioritizing non-invasive and efficient vaginal microbiome testing providing reliability in results from a single swab
- Creating a clear journey for the patient from point of diagnosis to acknowledging the clear next steps necessary to restore vaginal microbiome health
- Providing guidance around the causal factors of bacterial vaginosis to assist education across women
1:15 pm Lunch & Networking
2:15 pm Leveraging Vaginal Microbiome Research to Develop Therapeutic Tools to Re-establish a Healthy Microbiota
Synopsis
- Implementing rigorous cutting edge science to address the current gaps in vaginal microbiome knowledge to provide the foundations for therapeutic interventions
- Driving groundbreaking microbial immunotherapies to reset and modulate the vaginal microbiome to address local immune dysregulation
- Collating extensive data from vaginal microbiome samples to further understand the mechanisms behind a wide array of indications affecting the female reproductive system
Translating Extensive Vaginal Microbiome Research to Combat Increased Infertility & Pre-Term Birth
2:45 pm Vaginal Ring for Hormone Therapy, Prevention of Preterm Labor & Luteal Phase Support During ART
Synopsis
- Focusing on use of a novel segmented intravaginal ring (IVR) to deliver estradiol and progesterone over 28 days for treatment of vasomotor symptoms associated with the menopause
- Exploring the segmented IVR to reduce the incidence of preterm labor by delivery of vaginal progesterone
- Understanding the use of the segmented IVR for its use in the luteal phase support during ART including combinations with injectable progesterone
3:15 pm Afternoon Coffee & Networking
3:45 pm Focusing Research into the Hormonal Impact on Fertility to Indicate the Most Efficient Treatment Methods Available
Synopsis
- Overviewing the mechanisms of action that surround common causes of infertility across a wide variety of female demographics
- Implementing non-invasive diagnostics tools to promote efficiency and accuracy when diagnosing infertility
- Collating diagnostic data to translate into clear therapeutic interventions to improve pregnancy outcomes
4:15 pm Progressing Research into Increased Pre-Term Birth to Grasp Causal Factors and Interventions Available Across Women’s Health
Synopsis
- Evaluating the new opportunities for assessment of risk of preterm birth through comprehensive vaginal microbiome data
- Researching the association between proinflammatory cytokines in the vaginal fluid and risk of preterm birth
- Analyzing the recorded levels of varying bacteria sampled from the vagina and subsequent risk of preterm birth