Sponsored Webcast: Optimizing Pediatric Oncology Drug Development: A Comprehensive Overview
Developing safe and effective oncology medications for children presents unique challenges due to ethical considerations and physiological differences across age groups. Traditional clinical trials often face limitations in sample size and recruitment of specific pediatric populations, hindering the efficient development of these critical drugs.
At this webcast, presenters will explore strategies to overcome these challenges and optimize pediatric oncology drug development.
Topics will include:
- Innovative approaches: Utilizing advanced methodologies and technologies to improve drug development efficiency.
- Regulatory considerations: Navigating the complex regulatory landscape for pediatric oncology drugs.
- Data-driven decision-making: Leveraging data and analytics to inform drug development decisions. By understanding and implementing strategic solutions to address challenges in these key areas, we can accelerate the development of essential oncology medications for children, improving patient outcomes and addressing unmet medical needs.
Registration Fees & Deadlines
Learning Objectives
- Understand the unique challenges associated with dose optimization of pediatric oncology drugs
- Explore the impact of the RACE Act and dose optimization guidance (Project Optimus) on pediatric oncology drug development.
- Discuss clinical pharmacology, PIP, and iPSP considerations specific to pediatric oncology drug development
- Learn how MIDD can support dose finding, justification, and extrapolation.
- Understand the role of real-world data in accelerating pediatric oncology drug development.
Who Should Attend?
Regulatory professionals, clinical pharmacists, researchers, and healthcare providers involved in pediatric oncology drug development. Individuals with a basic understanding of drug development and clinical pharmacology will benefit most from this webinar.
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Speakers
Ananth Kadambi
Real World Evidence and Modeling Solutions, Certara
Ananth Kadambi is Vice President of Real World Evidence & Modeling Solutions within Certara’s Evidence and Access group. He has more than 20 years of experience in pharmaceutical consulting across a variety of disciplines, including real-world evidence generation, complex statistical analyses of clinical and real-world databases, and other evidence generation activities required to support regulatory, payer and HTA submissions worldwide, e.g., health economic modeling, systematic literature reviews, and indirect treatment comparisons. Dr. Kadambi has led development of worldwide HTA submissions to the National Institute for Health and Care Excellence (NICE), the Canadian Agency for Drugs and Technologies in Health (CADTH), Gemeinsamer Bundesauschuss (G-BA), Haute Autorite de Sante, TLV, and the Academy of Managed Care Pharmacy (AMCP). Prior to joining Certara, Ananth was senior director at Evidera, senior vice president, PhysioPD ™at Rosa & Co., LLC, and vice rresident of R&D at Entelos. In these roles, he held wide ranging executive management and program leadership responsibilities. Ananth completed his PhD in biomedical engineering at the University of Virginia and is the co-author of over 50 publications.
Justin Hay
Senior Director, Certara
Justin Hay is a clinical pharmacologist with 25+ years of experience. He is a clinical pharmacology and regulatory expert at Certara and a core member of the Paediatric and Maternal Health Centre of Excellence and One Certara Oncology group. He previously worked as EMA & MHRA senior assessor and deputy manager MHRA, UK, senior clinical scientist at the Centre for Human Drug Research (CHDR), Leiden, the Netherlands. He earned his PhD in pharmacology from the University of Adelaide, Australia. He is the author of over 80 peer reviewed abstracts/manuscripts in the field of clinical pharmacology.
S.Y. Amy Cheung
Vice President - Europe/APAC regional Quantitative Science Lead, Certara
S.Y. Amy Cheung, PhD, is a Vice President at Certara, regional lead (EU and APAC) for Quantitative Science Services within Certara Drug Development Services, and Global Lead of the Pediatric and Maternal Health Center of Excellence. Dr. Cheung has more than 20 years of experience in modeling and simulation, as well as clinical pharmacology, with expertise in PBPK/PD mechanistic modeling, special populations (e.g., pediatrics, maternal, and geriatrics), extrapolation, model-based meta-analysis, vaccines, infections, HIV, complex biologics, and oncology across early to late-phase drug development.
Before joining Certara, she was a Senior Pharmacometrician and Scientific and Project Leader at the AZ Pediatric Working Group, which included 22+ cross-functional pediatric experts. During this time, she also served as the company representative on the IMI DDMoRe initiative and co-led work packages (e.g., PMX-workflow, cardiovascular training). Dr. Cheung has been a member of the EFPIA MID3 workgroup since the 2011 EMA M&S workshop, which resulted in several white papers. Currently, she is contributing her expertise to various professional societies, such as the IQ Consortium, EFPIA, EFGCP, ASCPT, and EU Horizon-funded projects. She has published over 50 papers on MIDD methodology/applications, reviews, and white papers in peer-reviewed journals.
Jacquelyn Binns
Principal Regulatory Writer, Synchrogenix, a Certara company
Exceptionally driven and dynamic research professional with over 20 years of combined experience in pharmaceutical drug development (from discovery through regulatory filing), clinical diagnostic care, and regulatory writing. Proven track record of effective collaboration and delivering timely results in cross-functional, matrix environments. Expertise spans therapeutic areas including neuroscience, CNS disorders, pulmonary and sleep medicine, and infectious diseases. Demonstrated ability to consistently provide project management, quality data analysis, and interpretation with meticulous attention to detail, while excelling in communication, conflict resolution, organization, time management, and interpersonal skills.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
