Cell and gene therapies (CGT) are rapidly transforming treatment options for cancer, autoimmune and rare diseases, but they also present significant challenges for post-marketing pharmacovigilance due to their potential for delayed-onset toxicities, such as immune reactions and secondary malignancies. Long-term safety and effectiveness remain uncertain, often requiring follow-up periods of 15 years or more, which can be difficult to maintain.
Additionally, CGTs are typically approved based on small, highly selective clinical trial patient populations, which limit the safety data available and their applicability in broader, real-world settings due to the potential for rare and long-latency adverse events. These issues are exacerbated by the scarcity 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, all of which demand 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 CGTs and explore advanced strategies for monitoring emerging safety risks in CGTs, including the vital role of long-term follow-up through post-authorization safety studies (PASS) and spontaneous reporting. Topics to be explored will 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. The featured speakers will also share best practices for stakeholder engagement, tailored educational materials and effective safety communication to promote appropriate use of the therapy.
Register for this webinar to learn how to build a forward-looking pharmacovigilance strategy that ensures CGT safety in the post-approval setting.
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 track record of accomplishment in establishing and maintaining profitable, compliant pharmacovigilance systems and leading operational teams. He is driven by the ability to develop and lead motivated and effective teams, while supporting companies in developing and executing their pharmacovigilance strategies. Ian holds a Bachelor’s degree in Pharmacology and a PhD in Haematopathology from the University of Southampton.
Message Presenter
Desmond Cabrera, Vice President, Global Head, Cell and Gene Therapy, Allucent
Desmond Cabrera is a seasoned global operations leader with extensive experience in the biotechnology and pharmaceutical industries. 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.
Message Presenter
Oksana Fabri, MD, PhD, Sr. Medical Director, Global Head, Hematology/Oncology, Allucent
Oksana Fabri has over 16 years of experience in hematology, oncology and stem cell transplantation and 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.
Message Presenter
Georgia Kolangi, MSc, Associate Director, Pharmacovigilance, Allucent
Georgia Kolangi is a health sciences professional with over 15 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 of Allucent’s local pharmacovigilance (PV) network. She also serves as EU QPPV for the organization.
Message PresenterWho 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 and Data Science
What You Will Learn
Attendees will:
- Gain clinical insight into the long-term safety monitoring of CAR-T and other CGT, with a focus on managing immune-related toxicities, interpreting real-world safety signals and adapting follow-up strategies to diverse patient populations
- Learn how to design and operationalize effective long-term safety monitoring strategies for CGT, including the use of PASS studies and patient registries
- Explore techniques for early identification of emerging safety risks, even in small post-marketing populations, using real-world data and expert clinical insight
- Understand the role of tailored risk minimization tools and clear safety communication in addressing complex CGT safety profiles — from DHPCs to patient education
- Review key regulatory expectations from EMA, FDA and MHRA — and how to stay inspection-ready in a field where science evolves faster than guidance
Xtalks Partner
Allucent
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including clinical trial operations, regulatory strategy, clinical pharmacology, pharmacovigilance, and biostatistical programming consulting. With more than 30 years of experience in over 70 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients.
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