Abstract
Advanced therapies, including cell and gene therapies (CGT), T cell engagers, mRNA-based products, and other novel platforms are transforming the treatment landscape across a wide range of diseases. These modalities while offering promising therapeutic potential, introduce complex safety challenges due to their immune-mediated mechanisms of action and novel manufacturing processes. These include cytokine release syndrome (CRS), neurotoxicity or and other severe inflammatory responses as well as delayed-onset toxicities including secondary malignancies. As such, proactive safety monitoring from Phase 1 through post-marketing is critical to ensure patient safety, accelerate development, and meet evolving regulatory expectations.
Compounding these challenges, advanced therapies are often approved based on small, highly selective clinical trial patient populations, limiting the availability of safety data and its relevance in broader, real-world settings due to the potential for rare and long-latency adverse events. These challenges are compounded by the limited availability of patients with rare diseases, further hindering data collection and signal detection. As a result, regulators mandate enhanced pharmacovigilance efforts, including long-term patient registries, post-authorization safety studies, and the use of real-world evidence, requiring a strategic approach to monitoring patient safety throughout the post-approval period.
This dynamic webinar brings together experts in medical affairs, pharmacovigilance, and project management to dissect the evolving safety landscape of advanced therapies and explore advanced strategies for monitoring emerging safety risks, including the vital role of long-term follow-up through PASS studies and spontaneous reporting. Topics include proactive signal detection approaches, including the use of real-world data, artificial intelligence (AI), and machine learning, as well as the importance of robust traceability systems. Panelists will also share best practices for stakeholder engagement, tailored educational materials, and effective safety communication to promote appropriate use of these therapies.
Join us to learn how to build a forward-looking pharmacovigilance strategy that ensures the ongoing safe and effective use of these transformative therapies in the post-approval setting.
What you will learn:
- Clinical insight into the long-term safety monitoring of advanced therapies with case examples of CAR-T and other cell and gene therapies, with a focus on managing immune-related toxicities, interpreting real-world safety signals, and adapting follow-up strategies to diverse patient populations.
- How to design and operationalize effective long-term safety monitoring strategies for advanced therapies, including the use of PASS studies and patient registries.
- Techniques for early identification of emerging safety risks, even in small post-marketing populations, using real-world data and expert clinical insight.
- The role of tailored risk minimization tools and clear safety communication in addressing complex advanced therapy safety profiles — from DHPCs to patient education.
- Key regulatory expectations from EMA, FDA, and MHRA — and how to stay inspection-ready in a field where science evolves faster than guidance
Who should Attend?
This webinar will appeal to professionals from Biotech/Pharma companies involved in:
- Pharmacovigilance professionals, QPPV office
- Regulatory Affairs
- CMOs & Medical Affairs
- Quality Assurance
- Clinical Operations & Clinical Research
- Project Management
- Epidemiology, Biostatistics & Data Science
Speakers
Ian Kovacs, PhD, Global Head of Pharmacovigilance, Allucent
Ian Kovacs has more than 20 years of professional experience in all areas of pharmacovigilance (including EU QPPV) and medical information, gained within both pharmaceutical companies and CROs. In his current position as Global Head of Pharmacovigilance at Allucent, he is responsible for providing strategic leadership and oversight of global pharmacovigilance services provided by Allucent.
Ian is a highly motivated, business leader with a proven record of accomplishment in establishing and maintaining profitable and compliant pharmacovigilance systems and leading operational teams. He is driven by the ability to develop and lead motivated and effective teams whilst supporting companies to develop and execute their pharmacovigilance strategies. Ian holds a Bachelor’s degree in pharmacology and a PhD in Haematopathology from the University of Southampton.
Georgia Kolangi, MSc, Associate Director, Pharmacovigilance, Allucent
Georgia Kolangi is a health sciences professional with over 16 years of experience in pharmacovigilance. Throughout her career, she has developed extensive expertise across all areas of pharmacovigilance and medical information, both from an operational and strategic leadership perspective.
Before joining Allucent, Georgia held several senior roles within contract research organizations (CROs), most recently serving as EU/UK QPPV for a large global CRO. In her current role as Associate Director at Allucent, she is responsible for overseeing post-marketing safety activities, including the development and maintenance of Allucent’s local pharmacovigilance (PV) network. She also serves as EU QPPV for the organization.
Desmond Cabrera, Vice President, Global Head, Cell and Gene Therapy, Allucent
Desmond Cabrera is a seasoned global operations leader with extensive experience in biotechnology and pharmaceuticals. He specializes in cell and gene therapy and has led clinical trials across multiple therapeutic areas. As VP, Head of Global Operations for a mid-sized global CRO, Desmond oversees global project management teams, financial planning, and milestone delivery. His expertise in multinational team leadership, process optimization, and strategic partnerships consistently drives operational excellence and customer satisfaction. Desmond’s track record in advancing clinical development and executing high-stakes negotiations has been instrumental in achieving corporate goals and ensuring long-term success.
Oksana Fabri, MD, PhD, Sr. Medical Director, Global Head, Hematology/Oncology.
Oksana Fabri with over 16 years of experience in hematology, oncology, and stem cell transplantation, she is a recognized expert in the development of advanced cell therapies. She brings deep clinical and strategic insight into CAR T-cell therapy, with a particular focus on overcoming treatment limitations and accelerating innovation. Dr. Fabri’s extensive understanding of current treatment modalities, cutting-edge therapies, and evolving regulatory landscapes further strengthens her ability to guide development strategies. Her leadership spans early phase trial design through execution, where she provides high-level medical oversight and ensures scientific rigor, regulatory alignment, and patient-centered outcomes.
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