Combination of experts and software helps accelerate pediatric drug development and increase clinical trial success rates
PRINCETON, NJ – 2020 年 07 月 29 日 – Today, Certara®, the global leader in biosimulation, launches Certara Pediatrics, a new practice area to help biopharmaceutical companies apply model-informed drug development to their pediatric programs and better navigate the changing regulatory landscape. Certara Pediatrics brings together Certara’s broad range of expertise in pediatric drug development, regulatory services, and biosimulation software, including the Simcyp™ Pediatric PBPK Simulator, to increase the probability of achieving clinical trial endpoints and a pediatric indication.
“Pediatric drug development is complex, and the traditional drug development process can be problematic for ethical and logistical reasons. We are excited to offer a comprehensive program that harnesses our deep expertise in pediatric drug development, regulatory science, and biosimulation to advance safe and efficacious therapies designed for children,” said Patrick Smith, senior vice president of integrated drug development at Certara.
Certara has worked on over 100 pediatric study and investigation plans for medications seeking approval from the FDA and the European Medicines Agency (EMA) respectively. While approximately 25% to 40% of pediatric trials fail to establish safety or efficacy, biosimulation can increase the probability of clinical trial success by addressing the challenges posed by small and heterogeneous data, conducting studies with children, and sparse sampling. The U.S. Food and Drug Administration’s (FDA) draft guidance on pediatric study plans states that modeling and simulation can be used to optimize the design of planned pediatric studies and support dose selection, data analysis, and interpretation for planned pediatric studies.
To help accelerate the pediatric drug development process, Certara Pediatrics brings together leading pediatric experts, including former FDA and EMA Paediatric Working Party members, toxicologists, clinical pharmacologists, pediatric formulation experts, and an extensive network of pediatricians and clinical experts. This new practice will leverage:
- Biosimulation software, such as the Simcyp™ Pediatric PBPK Simulator, which models drug behavior in neonates, infants, and children, to inform first-time dosing decisions and design of pediatric clinical studies. This platform is used by the Simcyp™ Consortium’s 35 leading pharmaceutical members to conduct virtual trials or inform clinical trials for this fragile population.
- Quantitative methodologies including model-informed translational medicine, pharmacology, innovative clinical trial designs, physiologically-based pharmacokinetic modeling, quantitative systems pharmacology, pharmacometrics, epidemiology, and real-world evidence
- Regulatory science approaches, document authoring, and submission support to increase certainty in decision-making and expedite the regulatory review of pediatric submissions in the changing regulatory environment
The FDA’s Research to Accelerate Cures and Equity (RACE) for Children Act goes into effect on August 18 and requires sponsors to submit an initial pediatric study plan for any original, new drug application or biologics license application for an oncology product if the molecular target is relevant to pediatrics.
“While the RACE Act aims to promote pediatric cancer drug development, sponsors may have to evaluate multiple indications to address a range of pediatric populations for a single oncology drug. In addition, they may have to develop the first pediatric study before fully understanding the drug’s behavior in adults. Integrating biosimulation with innovative trial design and regulatory strategy can help to increase a pediatric program’s probability of success,” stated Lynne Georgopoulos, vice president of regulatory strategy at Certara.
To learn more, please join Certara’s webinar on “Fostering pediatric oncology drug development” on Thursday, July 30th.
# # #
 Pediatric Trial Design & Endpoint Considerations, Office of Clinical Pharmacology and Office of Translational Sciences, Center for Drug Evaluation and Research, Dionna Green, M.D. Accessed on 2020 年 07 月 26 日
 Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans, Center for Drug Evaluation and Research, March 2016