In our latest Minds Behind VICT3R , we’re catching up with Karolina Kopańska from CAATevents. Karolina co-Leads VICT3R WP8, dedicated to the retrospective and prospective testing supporting the qualification of the Virtual Control Group (VCG) concept. She also coordinates the VICT3R Regulatory Interaction Task Force (RITF), which drives VICT3R’s engagement with policymakers and regulators worldwide.
1. Can you tell us a bit about yourself and your role in VICT3R?
Last year, I completed my PhD in Computational Toxicology at Univ Pompeu Fabra, where I contributed to developing risk assessment frameworks that connect in vitro NAMs, integrate novel computational systems, and reason with uncertainty. I’m currently postdoc at Johns Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing (CAAT) and its non-profit spin off, CAATevents. I’m also member of the EUROTOX Early Career Forum, Toastmaster and dancer in my free time.
In VICT3R, I collaborate with our pharma partners and CROs to support the planning, execution, and reporting of retrospective and prospective studies that include VCGs for qualification purposes. I also lead the Regulatory Interaction Task Force, which connects the consortium with regulatory and governmental agencies worldwide, translating the qualification results into scientific opinions and harmonised guidance documents.2. As a young researcher working in VICT3R at the interface of science and regulation, what have you found most rewarding – and most challenging?
Without any doubt, the most rewarding is the “exclusive” knowledge that cannot be taught through university courses or found in papers. Every conversation with my VICT3R colleagues feels like a private lesson in preclinical development, while each regulatory interaction allows me to get advanced insights into policy and legislative frameworks.
Time is always a challenge! All VICT3R partners are highly committed to the goals of the project, which is fantastic. But everyone has limited resources and competing priorities… and since our procedures are stepwise and rely on close collaboration within and between different organisations, some tasks can take longer than we would ideally like.3. From your experience, how could the critical dialogue between scientists, regulators, and stakeholders in shaping the acceptance of new approaches be improved?
What I have observed over the years (not only in VICT3R) is that scientists, including myself, tend to overcomplicate and overexplain things to make them as correct as possible. This contrasts with the pragmatic, rule-based style in which regulators communicate their requirements.
To improve this dialogue, as any other, mutual understanding is highly desirable. One way to support this understanding would be to make explanations of regulatory processes directly accessible, since they are often difficult to interpret. At the same time, scientists could benefit from being more pragmatic and adapting the documentation of their systems in ways that aligns with specififc regulatory requirements.4. Looking ahead, what outcomes or milestones do you hope VICT3R will achieve in the coming year to help advance the regulatory readiness of VCGs?
Since the beginning of the project, we have invested major efforts into the qualification of VCGs in dose-range finding studies with the EMA Scientific Advice Working Party (SAWP). This work is progressing very well and I hope that it will result in a formal scientific opinion based on a non-clinical process. If successful, an even greater milestone would be for this opinion to be shared across the Atlantic with the FDA colleagues.
Together with our advisory board, we are also preparing a Project Proposal Form to submit to the OECD Working Party on Hazard Assessment (WPHA). If granted, we will initiate the development of an OECD Guidance Document for the implementation of VCGs in preclinical studies. Although this project may take long, I believe that starting it next year would bring us significantly closer to the regulatory readiness of VCGs.
