Pediatric Pharmacology USA
This will be a two day meeting for clinical pharmacologists and pharmacometricians, PK/PD scientists and pediatricians to discuss using tools such as modelling and simulations, biomarkers and PK & PD studies to overcome the scientific challenges in the development of new pediatric medicines.
It is well known that recent regulatory changes in the USA and Europe have made it mandatory to further development of medicines for children. Many previous discussions have taken place on the impact these regulatory changes have had or the difficult topics of locating willing pediatric populations and informed consent.
However NextLevel Pharma’s focused and interactive event will look to concentrate on the importance and place of pharmacokinetic and pharmacodynamic studies to answer the questions of how children metabolize drugs differently. It will explore the best use of modeling and simulations, what extrapolation is possible from existing data, how to assess optimal drug dosage levels, measure the drugs interactions on child physiology with minimal samples and subjects to optimise the design of studies for pediatric treatments.
Experienced industry pharmacologists and pediatricians will join us to discuss recent developments and assess how to better understand optimum drug formulation and dosage, as well as measure the efficacy and understand the drugs interactions.
Why attend:
- Hear fresh perspectives from experienced pharmaceutical companies who have designed successful pk/pd pediatric studies.
- Learn what place pk/pd studies have in the development of pediatric drugs and how they can be used more effectively to determine dosages, measure efficacy and demonstrate value to the pediatric world.
- Hear case study presentations from industry leaders on how to adapt methods used from adult to children.
- Discover what approaches are best to predict dosage, utilize existing (adult) data, and understand the interactions between drug and child.
Who will benefit:
Pharmaceutical & Biotechnology Organisations:
Vice- Presidents, Directors, Managers; Pediatrics, Pre-Clinical and Clinical Pharmacologists, Modeling and Simulation Specialists,
CROs & Solution Providers:
CEOs, Business Development Directors, Product Managers, Marketing Managers
Academics:
Pediatricians, pharmacologists and scientists involved in the development of new pediatric medicines
About the Venue

Washington, DC, as well as being the nation's capital, also has an unparalleled business environment and a rich cultural background. It is the seat of national & federal authorities, including the FDA, and this is combined with it's well established transportation network allowing easy access from international locations. All of these factors combine to provide an excellent opportunity for US and global pharmaceutical companies and related organisations to meet at this ideal venue.

Your Prestigious Speaker Panel:
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Industry
Associate Director Experimental Medicine/Oncology, Merck Research Laboratory, USA
President, CEO POP-PHARM USA
Senior Director Head Early Development Group Oncology Clinical Pharmacology Pfizer, USA
Senior Expert Modeler, Modeling & Simulation Novartis, USA
Clinical Pharmacology & Discovery Medicine GlaxoSmithKline, UK, and Leiden/Amsterdam Center for Drug Research, The Netherlands
Academia
Director Pediatric Pharmacology research Unit (TBC) Cincinnati Children's Hospital Medical Center, USA
PhD Candidate University of Manchester, UK
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Professor, Anesthesia & Pediatrics Lucile Packard Children's Hospital at Stanford, USA
Board Member of the The Foundation for the NIH (TBC) Head of Children's Mercy Hospital Center for Personalized Medicine, USA
Regulators
Director Pharmacometrics Division, FDA, USA (TBC)
Center for Biologics Evaluation & Research FDA, USA
MSc, Pediatrician, Deputy Head Section Clinical Trials Paul Ehrlich Institute, Germany
Experienced Solution Providers
COO Vitalea Science, USA
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