Cell therapy represents a groundbreaking frontier in medical treatment, presenting unprecedented potential for addressing a diverse array of medical conditions where traditional therapies have fallen short. However, the successful execution of cell therapy clinical trials demands meticulous attention to detail from clinical sites to safeguard patient welfare, uphold regulatory standards and achieve trial objectives.
In this webinar, the expert speakers will delve into the critical components of site readiness, encompassing specialized infrastructure and training essential for the proper management of cell therapy products. Additionally, they will explore pivotal aspects of patient selection criteria, safety protocols and emerging trends in non-oncology clinical trial research, illuminating key considerations for navigating this dynamic landscape.
Register for this webinar today to learn key considerations of cell therapy trials, from clinical site readiness to ensuring patient safety, all while meeting trial goals.
Speakers
John Hamlet, Executive Director, Neuroscience, PPD clinical research business of Thermo Fisher Scientific
John Hamlet is an Executive Director of Neuroscience within the PPD clinical research business and serves as neuroinflammatory, movement and pain disorders lead for project delivery. As a member of the leadership team for neuroscience operations, he oversees and supports all projects within these indications and is responsible for the overall delivery, profitability and growth of that book of business.
John provides direct supervision, support and mentoring to project team leadership regarding project management, budgeting, staffing and therapeutic training. He enhances commercial and operational excellence by ensuring project/milestone delivery, improving data integrity and proactively managing risk. John excels at driving employee engagement to achieve a talent and culture advantage and is passionate about data integrity and the mitigation of placebo response in clinical trials.
Message Presenter
Nora Carroll, PhD, MPH, Senior Director, Project Delivery, PPD clinical research business of Thermo Fisher Scientific
Nora M Carroll has over 20 years of experience in Clinical Research, both in academic and industry settings. Based in Ireland, she is a Senior Director of Project Management. She is the subject matter expert on clinical trials in lupus and lupus nephritis, and is responsible for developing and supporting strategies for effective trial implementation. She has a special interest in ensuring that trials are available to underserved communities.
Message Presenter
Marcie Weil, MD, Medical Director, PPD clinical research business of Thermo Fisher Scientific
Dr. Marcie K Weil is committed to expanding the application of cell therapies to additional indications where they can offer significant benefits. She initially trained at Johns Hopkins University as a Pediatric Oncologist. After many years conducting clinical trials at National Children’s Medical Center, Dr. Weil did a second fellowship in Early Cancer Drug Development at the National Cancer Institute where she conducted adult oncology trials and also worked at the Investigational Drug Branch of the Clinical Trial Evaluation Program (CTEP).
Dr. Weil has contributed her expertise to the PPD clinical research business for 12 years, initially focusing on cellular therapy trials in oncology and subsequently expanding into other therapeutic areas. More recently, she has also been instrumental in pediatric hematology and oncology studies. Dr. Weil and other medical monitors work across functions to ensure patient safety and the integrity of the study.
Message Presenter
Jennifer Pietrowski, Senior Director, Project Management, PPD clinical research business of Thermo Fisher Scientific
Jennifer Pietrowski is a seasoned clinical research professional who specializes in the development of cell therapies. With over 25 years of experience, she has overseen the progress and performance of clinical trials. Additionally, she has extensive experience managing global project management teams, global operations teams and program governance. Her expertise includes managing complex Phase I/II global trials in cell therapy and immunotherapy across North America, Europe and APAC.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Biotech and biopharma companies involved in site and patient recruitment for clinical research
- Healthcare providers and Clinicians involved in the management of clinical research patients for cell therapy trials, autoimmune and neuroscience disorders
- Clinical Research Investigators and Site Directors
- Patient advocacy and study consortia groups
What You Will Learn
Attendees will learn about:
- The essential infrastructure requirements necessary for clinical sites to effectively manage cell therapy products in non-oncology clinical trials
- Key considerations in patient selection criteria for non-oncology cell therapy trials, including factors influencing eligibility
- Best practices and safety protocols for ensuring patient safety throughout the duration of non-oncology cell therapy clinical trials, including proactive adverse event monitoring and management strategies
- People and processes to operationalize non-oncology clinical trial research involving cell therapy, enabling patients to stay informed and adapt their approaches accordingly
Xtalks Partner
PPD clinical research business
The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, enables customers to accelerate innovation and increase drug development productivity. Utilizing patient-centered strategies and data analytics, their capabilities cover multiple therapeutic areas and include early development, all phases of clinical development, peri- and post-approval, novel approaches to patient recruitment and investigator sites, and comprehensive laboratory services. Recognized as a global industry leader in accelerating promising medicines from early development through regulatory approval and market access, we serve pharma, biotech, medical device and government organizations with custom-tailored solutions, including full-service partnerships and functional service partnerships. As a strategic partner in clinical development and analytical services, we apply cutting edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies.
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