S5 E50.8 – Wrapping Up 2023 – An Interview With Biotech Entrepreneur Rachel Zayas

S5 E50.8 - Wrapping Up 2023 - An Interview With Biotech Entrepreneur Rachel Zayas
Surfing the MASH Tsunami continues its 2023 wrap-up conversations with biotech entrepreneur Rachel Zayas, Founder and CEO of AGED Diagnostics, along with co-hosts Louise Campbell and Roger Green.

The conversation focuses on AGED’s progress in 2023, what Rachel has learned about fundraising and creating winning pitches, and what she anticipates for her company and the entire MASLD community in 2024.

The discussion begins with Rachel, like most other participants in this series, highlighting the FDA decision on resmetirom, anticipated by March 14, 2024, as a breakthrough event for the MASLD community. She expects this will lead to a breaking down of traditional silos between medical fields, fostering a more integrated approach to healthcare. She already sees greater participation from other metabolic specialties in hepatology-related discussions and conferences.

Roger, intrigued by her comment, inquires about the specific forums facilitating this interdisciplinary engagement. Rachel responds that she sees small numbers of such specialists today but believes this foreshadows a growing trend.

The conversation then pivots to potential challenges facing the hepatology field in 2023. Roger asks Rachel whether she has seen any impact from the FDA’s non-approvable letter for obeticholic acid on her segment of the investor community. Rachel states that the early-stage investors she courts assume high risk in their investments and, if anything, seem more likely to commit based on what the community is learning from burgeoning amounts of high-quality academic and commercial research.

Louise joins the discussion by highlighting the evolving landscape of healthcare investment. She emphasizes the significance of improved tracking mechanisms, noninvasive techniques, and adaptive FDA approaches. Louise advocates for a more inclusive approach in hepatology, suggesting increased participation in broader medical conferences to bolster interdisciplinary collaboration.

Turning to AGED Diagnostics, Rachel shares her team’s advancements in research and development, particularly their work on a multi-site pre-clinical trial focusing on liver disease biomarkers. She outlines her team’s objectives and expectations for the upcoming year, highlighting significant progress in their research endeavors.
The conversation also touches on Rachel’s experiences with early-stage investors in the life science space. She notes their growing interest in hepatology, especially in noninvasive diagnostic tools for liver fibrosis and MASH. This shift in investor attention streamlines her pitching process, allowing her to focus more on developing AGED’s technologies and solutions her team offers.

Looking ahead to 2024, Rachel anticipates the hoped-for resmetirom approval as pivotal. She also predicts an increased demand for noninvasive tools to monitor MASH progression and regression, foreseeing a rise in supply and demand for such tools once a therapeutic solution is available. She estimates that between 2025 and 2027, more tools in this area will emerge,

In closing, Roger asks about potential storm clouds and bright spots Rachel sees. She notes that payer approvals might constitute a logjam. Roger suggests that diagnostics that tell us which patients benefit from therapy will provide the best defense against such a logjam. In contrast, Louise suggests that the lack of education among allied health professionals might become another obstacle in implementing new treatments and diagnostics. She emphasizes the need for adequate frontline delivery systems to support the introduction of new medical solutions.