Since the recent signing of the FDA Safety and Innovation Act, that will expedite pediatric drug approval, more pharmaceutical companies are taking pediatric pharmacology and drug development into consideration. Before these companies can execute a pediatric clinical research strategy, they must conduct pharmacokinetic and pharmacodynamic studies to evaluate the differences between how children and adults react to and metabolize drugs, as well as address the efficacy and safety issues prior to a clinical trial.
Pre-clinical pharmacology plays a prominent role in creating translational research used in creating accurate pharmacokinetic profiles for pediatrics. In pre-clinical pharmacology, scientists test on immature animal models to determine toxicity and selectivity levels as well as create a model and simulation for human testing.
The marcus evans 3rd Pediatric Pharmacology Conference will provide delegates with a comprehensive view of the pediatric pharmacology industry, focusing on the effects that conducting pre-clinical and clinical research have on creating an accurate pharmacokinetic profile. By having this unique profile, the ability of modeling adult data to children will be more easily attained and can be utilized in pediatric drug development and formulation.
Barry Mangum, PharmD, F.C.P, Director, Clinical Pharmacology, at the Duke Clinical Research Unit, answered a series of questions provided by marcus evans. The responses below strictly reflect the views and beliefs of Barry Mangum, and not necessarily those of Duke Clinical Research Unit.
marcus evans: What are your suggestions for determining whether to use a neonatal animal during the pre-clinical stages to create accurate PK data?
Barry Mangum: The use of a neonatal animal during pre-clinical stages is not necessary, as long as there is some juvenile animal pharmacokinetic (PK) data. The modelers/pharmacometricians can make do with the modeling of the compound, provided they have adult pharmacodynamic (PD) and some pre-clinical, juvenile animal data to work from. The hold back would be that every drug is a little different depending on the size of the molecule and the metabolic degradation of the product.
marcus evans: Based on your experience, what is the biggest challenge that you have faced in regards to pediatric and neonatal clinical pharmacology? How did you overcome this?
BM: The biggest challenge that I have faced has been educating the regulatory agencies on what is needed in a study and what they will accept as an approvable indication. The regulatory bodies in Europe are not in lock step with the FDA in the United States. This makes for many unnecessary studies and the availability of study patients is low. There are too many failed trials in the pediatric population. Overcoming this will take time and education within the FDA and EMA. Pharmaceutical companies would be well advised to communicate with the "agencies" on an ongoing basis to serve the needs of them, as well as to educate the regulatory bodies.
marcus evans: How have you used modeling and simulation to treat pediatric and newborn patients as well as develop effective drugs?
BM: This process should be used in every submission. By the year 2020, all applications to the FDA will require modeling for the pediatric population. All modeling is not created equal; all drugs require careful scientific strategy in order to ask the right questions and obtain the right answer. What we are looking for is the correct dose and dosing intervals to make the compounds we develop safe and effective for children of all ages.
For more information regarding the 3rd Pediatric Pharmacology Conference, please contact Robin Yegelwel, Marketing & PR Coordinator, at (312) 540-3000 ext. 6383 or email@example.com
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