Dear ,

For any organization in the regenerative medicine field, the hardest part isn’t always the research, but rather the challenge of successfully navigating the regulatory pathway to human trials. This demands meticulous planning, quality assurance, and a deep understanding of international compliance standards, which is precisely why Beatrix Szebeni-Varga, Foregen’s Clinical Project Manager, is an indispensable member of the team.

Beatrix is tasked with preparing Foregen for this demanding transition. She brings an extensive background from key roles at companies like Gedeon Richter, Argenx, and AstraZeneca, managing global clinical trials across all phases (Phase I through Phase III). Her professional focus is on quality assurance, which led her to pursue and complete a Clinical Site Auditor Certification and an Auditor Course at the European Centre for Clinical Research Training in Brussels. This expertise in GCP (Good Clinical Practice) Quality Assurance means she is equipped to ensure every aspect of Foregen’s research is compliant and prepared for regulatory scrutiny.

Beatrix is currently applying this high-level strategy directly to our preclinical work in Slovakia. She is working closely with Dr. Žiaran and Ján Kováč to ensure the data on biomechanical properties produced by our current project is not just scientifically sound, but is stored and reported in a format that is optimal for when we apply to the regulatory authorities for approval to conduct human trials. Furthermore, she assists Dr. Žiaran’s team in making critical day-to-day decisions, using her regulatory knowledge to guide choices about sample numbers, equipment use, and the precise configuration of testing approaches to ensure minimal complexity later on.

By laying this rigorous foundation, Beatrix is effectively removing risk from the future clinical pathway for Foregen. Beyond her operational duties, she has also been instrumental in building new strategic partnerships, such as the one we have with Dr. Žiaran, and in applying for new grant opportunities. Her dedication ensures that the passion of our scientists translates into a compliant, achievable plan for our mission.

We hope this glimpse into the dedication and high-level strategy that Beatrix brings to Foregen inspires you. It is the direct support from our donors and supporters that allows us to hire critical staff like Beatrix and the experts in the lab, like Ján, who are capable of guiding our research through the complex scientific and regulatory hurdles. Your support is greatly appreciated in ensuring our research can progress expediently toward our ultimate goal.

Sincerely,

Foregen Staff