Understanding drug effects in children

Pediatric drug development continues to be a vexing challenge, yet pediatric research is increasingly being mandated by regulators and patients alike. Traditional development methods can be problematic for ethical and logistical reasons. Children are a heterogeneous population, especially neonates and infants, as organ maturation affects drug exposure and response.

Major regulatory agencies strongly encourage the use of modeling and simulation (M&S) for pediatric drug development. In fact, US FDA guidance states that M&S, using all of the information available, should be an integral part of all pediatric development programs. M&S uses quantitative mathematical models that leverage all available and relevant sources of existing knowledge to inform pharmacokinetics, pharmacodynamics, efficacy, and safety of a drug. The usefulness of M&S in pediatric drug development includes clinical trial simulation, dose selection, choice and optimization of clinical trial design, endpoint selection, and extrapolation.

With experience working on over 100 pediatric drug development programs, Certara has built deep expertise in pediatric drug development that is unparalleled, leveraging our industry-leading Simcyp™ Pediatric PBPK Simulator and our team of pediatric experts spanning modeling and simulation, regulatory science, and market access,   From start to finish, we can support your entire pediatric drug development plan or supplement the areas where you need additional help, including developing pediatric investigational plans (PIPs) and pediatric study plans (PSPs) and using pharmacometrics, PBPK, and real world evidence to expedite and increase probability of your success.

Unique capabilities in pediatric drug development

Recognizing the great importance of serving pediatrics balanced against the inherent hurdles, Certara Pediatrics offers comprehensive pediatric drug development services focused on:
• Strategic planning of pediatric development plans
• Clinical pharmacology strategy and stewardship of complex pediatric programs
• Pediatric clinical trial study design
• Real world evidence
• Juvenile toxicology
• Innovative modeling and simulation, characterizing PK, PD, disease progression, safety and efficacy
• Regulatory strategy and writing from IND through submissions and post-marketing
• Interactions with health authorities
• Pediatric formulations

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Get the dose right and reduce risk

Certara scientists and experts meet the needs of the regulators, enhance feasibility of the studies, and increase safety for pediatrics.

Certara’s quantitative methods leverage sparse data and prior information from pre-clinical studies, adult trials, literature data, and pediatric studies of related indications or drug actions. We build that knowledge into models of patient physiology, drug actions and trial characteristics, which enable us to develop and iterate clinical trial design and explore alternative dosing scenarios, in silico patient responses, drug-drug interactions, and whole trial outcomes

Our consultants also use the Simcyp™ Pediatric PBPK Simulator, the industry’s most sophisticated physiologically-based pharmacokinetic (PBPK) technology for modeling drug performance and assessing drug-drug interactions in neonates, infants, and children. The Simcyp Pediatric PBPK Simulator, routinely used by the Simcyp Consortium’s 35 leading pharmaceutical companies, contains extensive libraries on demographics, developmental physiology, and the ontogeny of drug elimination pathways. It is used by all of the industry’s leading pharma companies.

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Regulatory writing, publishing and submission support for your PIP and PSP

Our regulatory science expertise in pediatrics spans more than 15 therapeutic areas, including oncology, infectious diseases, and cardiovascular disorders. Core competencies include consulting, writing, preparing and managing documents, including pediatric investigational plans (PIPs) and pediatric study plans (PSPs) through global regulatory processes, and authoring scientific and commercial documents.

Oftentimes, Certara will support the PIP/PSP development plan by creating a population PK (popPK) model using adult data scaled to pediatrics. That model will integrate a range of maturation and disease factors with allometric scaling to set the best dose for the first pediatric trial cohort.

Furthermore, our GlobalSubmit™ clinical trial operations technology facilitates the eCTD submittal process, providing scalability and consistency for sponsors.

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Lynne Georgopoulos, RN, MSHS, RAC Vice President, Regulatory Strategy

Lynne has over 30 years of biopharmaceutical and CRO experience providing strategic, clinical development and regulatory advice at all stages of product development. She has spent the last several years promoting innovative methods to accelerate pediatric drug development as VP of Regulatory Affairs and Pediatric Strategic Development at Synteract, and Sr. VP Regulatory Affairs and Clinical Development at KinderPharm.  She has lead numerous successful regulatory filings and agency interactions (e.g., Pre-IND, INDs, NDA/BLAs, EMA scientific advice, EOP2, and Pre-NDA).

Patrick Smith, PharmD Senior Vice President, Integrated Drug Development, Strategy

With over 20 years of global drug development experience, Patrick works across all phases of development with particular expertise in infectious diseases, oncology, and inflammation as well as novel early development program design and applying modeling and simulation to solve critical development problems. Patrick has over 125 peer reviewed publications, in journals including NEJM and Lancet.

Roman Casciano General Manager and SVP Market Access, HEOR and Real-world Evidence

As an applied health economist and market access strategist, Roman has personally led hundreds of engagements in the international market access and HEOR context related to product value demonstration and has deep experience in the management of multidisciplinary teams of scientific and strategic consultants.