Cell and Gene therapies hold revolutionary potential for treating various diseases however operationalizing trials of such duration and complexity is a significant task. Their development demands meticulous planning and expertise across multiple disciplines.
- Regulatory submissions must adhere to evolving guidelines, focusing on compliance and communication
- During the startup phase, critical steps include establishing partnerships with academic institutions, hospitals, and stakeholders to ensure therapy accessibility
- Site selection is vital, requiring experienced teams and proper infrastructure
- Logistics play a pivotal role, encompassing the secure transportation and storage of biological materials
- Data management strategies must address the unique considerations of the substantial data volume associated with cell and gene therapies
- Patient engagement presents challenges, requiring long-term monitoring (5-15 years) after treatment
This webinar aims to comprehensively address these challenges, offering insights and strategies. By understanding and proactively managing logistics, startup procedures, data management, regulatory compliance, and patient engagement, participants can pave the way for successful Cell and Gene Therapy trials. The goal is to ensure these therapies become safe, effective, and accessible options for patients in need, ultimately transforming the landscape of medical treatments.
Desmond Cabrera, VP, Project Management, Americas, Allucent
As Vice President of Project Management, Desmond Cabrera is a seasoned professional with over 20 years of experience in leading cross-functional teams to deliver complex projects on time and within budget. He has a proven track record of success in managing large-scale projects across multiple therapeutic areas including oncology, cardiovascular, CNS and is the Global Ops lead for Allucent’s cell and gene therapy portfolio. With extensive knowledge of project management methodologies and tools, Desmond is able to drive efficiency and productivity throughout the project lifecycle. He is committed to delivering high-quality results that exceed stakeholder expectations and drive business growth.
Joyce Moore, Global Head, Patient Engagement, Allucent
Joyce Moore brings over 20 years of industry expertise spanning multiple disciplines and a diverse range of therapeutic areas. For the past 15 years, Joyce has focused on patient engagement, recruitment and retention; she is passionate about widening participation in clinical research and developing and deploying technology approaches to engage with both sites and patients, including decentralized approaches. In her current position as Global Head of Patient Engagement at Allucent, she is part of the clinical trial organizations leadership team. She is responsible for leading, managing and overseeing patient recruitment activities and Allucent’s decentralized trial offering known as patient direct trials.
Marita Kruskopf Osterberg, Senior Manager, Study Start-Up, Allucent
Over her 15+ years of experience within regulatory affairs and study start-up, Marita Kruskopf Osterberg has gained extensive knowledge on how to successfully navigate the complex and intricate clinical study start-up process. She has overseen the project start-up phase of several global trials across a variety of indications and phases and has overseen submissions in 30+ countries. Marita comes from a research background and has a PhD in Genetics. She is currently serving as Manager for a team of EU CTR specialists and led the coordination of the first EU CTR application done by Allucent in early 2022.
Francisca Samson, MSc, Director, Data Management, EMEA, Allucent
Francisca Samson is an experienced Director of Data Management with a proven track record in leading and overseeing complex data management and clinical research projects within pharma and CRO. With over 30 years of industry expertise and 20+ years within clinical data management, she has been involved in process optimization and team leadership. With her in-depth understanding of data processes, coupled with hands-on experience and an open mindset for new and creative approaches, she brings valuable insights into efficient data collection approaches that ultimately support analysis and reporting.
Who Should Attend?
This webinar will appeal to VPs, Directors, Managers and Department Heads working within:
- Research and development
- Project management
- Clinical operations
- Decentralized trials
- Clinical research
- Data management
- Patient recruitment and retention
- Medical affairs
- Regulatory affairs
- Clinical outsourcing/procurement
What You Will Learn
Attendees will get insights into:
- The critical importance of logistics in the field of cell and gene therapies and the specialized requirements in handling for safety and viability
- Gaining valuable knowledge of key considerations and processes involved in the start-up of cell and gene therapy studies, including site selection and staff training, ethics approvals, patient recruitment and sample management
- Discovering the challenges and importance of long-term patient follow-up in cell and gene therapy for optimal outcomes
- Understanding the unique data flow patterns to inform appropriate data management strategies that can be tailored to the characteristics of cell and gene therapy trials
- Hearing best practices in how to navigate the complex and evolving regulatory landscape for cell and gene therapies with a focus on EMA’s CTIS
Allucent has a depth of knowledge and a wealth of long-lasting experience with the design and execution of pediatric studies and clinical trials in rare diseases. Our A-Team of cross-functional experts come from regulatory, clinical operations, clinical pharmacology, and biostatistics backgrounds, creating a team with a purpose and a passion to facilitate pediatric development plans and clinical trials that help to overcome existing regulatory hurdles to expedite the development of pediatric medicines.