Although children constitute 27% of the world’s population, at least 50% of all drug products may still lack pediatric labelling. Drugs without appropriate clinical research in pediatric patients significantly increase the risk of unexpected adverse events.
However, with the evolution of pediatric legislation, the pharmaceutical industry has demonstrated a growing commitment to pediatric studies, and renewed interest in therapeutics for rare diseases has increased the demand for timely, high-quality and cost‐effective clinical trials in children.
Despite significant progress in pediatric clinical research, childhood cancer remains a leading cause of death among children. Continued research is crucial for developing new treatments that can improve survival rates and outcomes. Pediatric cancer clinical trials encounter many challenges, especially within today’s clinical drug development landscape. These include the need for targeted therapies for children, regulatory delays and design constraints, and gaps in representation and equity within current clinical trial research. Conversely, the infrastructure of cooperative groups conducting clinical trials is excellent in the US and Europe. However, offering studies in other parts of the world where the incidence of pediatric malignancies is even higher and fewer treatments are available remains a major obstacle.
This webinar addresses these key challenges in advanced therapies, including gene and cellular therapies, while offering different and innovative approaches that can be put into practice so that future clinical trials can avoid enrollment challenges and delays in study timelines. Ultimately, this results in the best chance for clinical trial success and better outcomes for patients.
Register for this webinar to learn how novel strategies are transforming pediatric clinical trials in oncology and hematology.
Speakers
Charity Schuller, PharmD, MS, RAC, Executive Director, Regulatory Affairs, Head of Regulatory Intelligence and Delivery, Thermo Fisher Scientific
Charity-Anne Metz Schulle is the Executive Director of Regulatory Affairs and Head of Regulatory Intelligence & Delivery at PPD, with over 27 years of experience in pharmaceutical regulatory affairs. In her current role, she oversees Regulatory Intelligence Policy and Advocacy, Regulatory Publishing Solutions and Regulatory Country Solutions for Canada, China, Japan and the US. Dr. Schuller has extensive experience in regulatory project management, consultation and compliance, as well as pediatric product development and risk management programs.
Before joining PPD, she was a Regulatory Affairs Project Manager at Trimeris Inc., focusing on HIV research. Before that, she worked at Bertek Pharmaceuticals Inc. and Mylan Pharmaceuticals Inc., where she handled IND and NDA submissions, SOP development and clinical-related reviews. Dr. Schuller has also served as a Course Director and Guest Lecturer at Campbell University’s School of Pharmacy and has published articles in various professional journals. She received her US Regulatory Affairs Certification in 2002.
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Mariana Burin, MD, Medical Director, Clinical Research, Thermo Fisher Scientific
Mariana Burin is a Hematologist specializing in bone marrow transplant. She completed her training at Hospital de Clinicas in Porto Alegre, Brazil, a recognized center for genetic diseases, which provided her with extensive experience in rare diseases. Mariana also holds a Fellowship in Laboratory Medicine and has 12 years of experience in hemato-oncology. For the past four years, Mariana has been involved in clinical research at PPD, the clinical research business of Thermo Fisher Scientific, including pediatric trials in gene therapy, hemato-oncology and rare disease.
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Marcie Weil, MD, Medical Director, Clinical Research, Thermo Fisher Scientific
Marcie Weil initially trained at Johns Hopkins University as a Pediatric Oncologist. After years of conducting clinical trials at a practice affiliated with the Children’s Oncology Group, which was later acquired by the National Children’s Medical Center, Dr. Weil pursued a second fellowship in Early Cancer Drug Development at the National Cancer Institute. There, she conducted adult oncology clinical trials and also worked at the Investigational Drug Branch of the Clinical Trial Evaluation Program (CTEP). Dr. Weil has been at PPD, the clinical research business of Thermo Fisher Scientific, for 13 years, focusing on both cellular therapy trials and pediatric studies. She is active in the Pediatric Hematology-Oncology subdivision of the Pediatric Center of Excellence. She facilitates the monthly medical cell therapy meetings in which the medical monitors and safety physicians share their experiences on cell therapy trials and discuss cell therapy news. She also contributes to the cross-functional Adoptive Cell Therapy NOW (ACT Now) monthly meetings and contributes to the ACT Academy Training.
Dr. Weil strives to bring effective therapies to children with cancer and blood disorders.
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Sheree Gilmore, Project Lead, Clinical Research, Thermo Fisher Scientific
Ms. Gilmore is a dedicated, patient-centered, clinical research professional whose career spans more than two decades. Since 2022, Ms. Gilmore has served as a Project Lead for adult and pediatric Phase I-IV Oncology/Hematology/Cell/Gene Therapy projects at CRG. Before joining CRG, she led clinical research and stem cell donor operations for adult and pediatric populations at an academic medical center, overseeing investigator-initiated, cooperative group and sponsored Phase II-IV trials. As such, Ms. Gilmore became a subject matter expert in clinical data and clinical data capture systems, leading multi-disciplinary teams in clinical database implementation projects. She enjoys problem-solving and developing operational efficiencies to deliver quality medical solutions to patients in need.
Ms. Gilmore holds a BA in Biology from the University of North Carolina, Charlotte and an MS in Organizational Leadership from the College of Saint Mary, Omaha, NE.
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Sush Sankpal, MD, Medical Director, Clinical Research, Thermo Fisher Scientific
Dr. Sush Sankpal is a Hemato-Oncologist with over 25 years of clinical and research experience in both pediatric and adult hemato-oncology. She currently serves as the Medical Director at CRG, a role she has held for the past four years.
Prior to this, Dr. Sankpal led pediatric hemato-oncology clinical trials and advanced cell and gene therapy studies at PPD, the clinical research business of Thermo Fisher Scientific, focusing on a wide range of indications. Her extensive expertise is rooted in a distinguished career at leading UK institutions, where she contributed significantly to both patient care and translational research.
Dr. Sankpal brings a unique blend of clinical insight and scientific rigor, making her a trusted leader in the development of innovative therapies in hematology and oncology.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Biotech and biopharma companies interested in pediatric oncology studies
- Healthcare Providers and Clinicians involved in the management of clinical research trials for pediatric oncology patients
- Clinical Research Investigators and Site Directors
- Patient advocacy groups
- Researchers involved with clinical operations of pediatric oncology studies
What You Will Learn
Attendees will gain insights into:
- The evolving field of pediatric cancer treatment
- Key challenges and complexities of pediatric oncology clinical trials
- Regulatory considerations needed to manage these trials
- Patient recruitment and site feasibility strategies
- How patient-centric trial design and caregiver support approaches can increase patient recruitment strategies
- How novel therapeutic approaches can improve clinical outcomes for pediatric oncology patients
Xtalks Partner
The PPD clinical research business of Thermo Fisher Scientific Inc.
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, they 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, they apply cutting edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies.
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