Oct 5, 2023
CEO/Founder Dessi McEntee, MS, DABT represented Mimicry Solutions at the PHUSE/FDA CSS in Silver Springs, MD on 18-20 September. The event brought together the PHUSE community and the FDA for a joint symposium geared toward progressing data science initiatives in the pharmaceutical industry.
All PHUSE working groups were in attendance, with the days consisting of strong conversation and networking between Sponsors, CROs, and FDA stakeholders. Mimicry is a part of the AI/ML in DHTs working group, but also attended several sessions for the Nonclinical Topics working group.
A big theme of the CSS was formats for data exchange and how underutilized ones can be leveraged for analysis while optimizing for global submission. One of the main takeaways for Mimicry was the lack of technology or platforms related to drug safety assessment, specifically in the nonclinical space. Much of the Nonclinical Topics discussions revolved around SEND and its pitfalls versus potentials. However, at the end of the day, it was clear SEND was built exclusively for data exchange and attempting to leverage it for analysis continues to prove troublesome. Even in the clinical space, there are two different standards for submission versus analysis: SDTM and ADaM, respectively.
Overall, the PHUSE/FDA CSS validated Mimicry's vision that a rejuvenating technology is long overdue in the nonclinical safety space and current tools are either outdated or underperforming. Importantly, it offered strong support for a platform such as ARTEMIS™, as the opportunity of having top stakeholders in the same room was seized to discuss the fit of ARTEMIS™ in the industry. Further, Mimicry was able to directly strategize with PointCross Life Sciences, a key partner in the development of ARTEMIS™, as well as Dragomir Draganov, MD, PhD of Roche, a key member of the Advisory Board.
Next year's PHUSE/FDA CSS is being held in June and Mimicry looks forward to the progress the industry makes as it is believed the next nine months will be a turning point for computational science technologies in pharmaceutical drug development. More importantly, in that time Mimicry plans to become an impactful source of a new, disruptive technology that will drive industry and regulatory decisions.
About Mimicry Solutions
Mimicry Solutions is disrupting the pharmaceutical industry with ARTEMIS™, a proprietary toxicology platform as the first ever alternative to animal testing for drug safety assessment at the industry level. ARTEMIS™ is being developed to outperform animals in the generation of toxicological readouts, providing more clinically translatable safety assessments of new drugs with a reduced ethical burden in animal research.
Learn more at www.mimicrysolutions.com.