Shifting the Pediatrics Paradigm


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Product Description

The FDA’s push for pediatric studies since the late 1990s has nearly doubled the pediatrics market, which is expected to keep growing in the coming years. Nevertheless, children remain “therapeutic orphans,” and some experts believe that the pediatrics market may never be able to sustain itself without governmental incentives.
Regulations and incentives in recent years have forced a paradigm shift in the way pharmaceutical companies approach pediatric drug development. For almost a decade, federal regulations and incentives have helped to build an infrastructure for conducting clinical research in children. Since then, developers, investigators, and regulators have learned much about how to study a drug’s effect and the appropriate use of medication in children. Additionally, more than 100 labeling changes have been made to include these data…

Sound Bites from the Field
Alan Davies, M.D., MRCP
, European Medical Director, Kendle. For more information, visit
Cynthia R. Jackson, D.O., VP, Medical and Scientific Services Group, Quintiles Transnational. For more information, visit
Maxine Stoltz, Ph.D., VP, Early Development Services, PRA International. For more information, visit

Experts on this Topic
Albert J. Allen, M.D., Ph.D.
Medical Director, Strattera Product Team, Eli Lilly & Co., Indianapolis; Lilly is committed to developing a growing portfolio of best- in-class and first-in-class pharmaceutical products that help people live longer, healthier, and more active lives. For more information, visit
Cameron Durrant, M.D., MBA. Formerly, President and CEO, PediaMed — The Pediatrics Company, Florence, Ky.; PediaMed is a specialty pharmaceutical company focused on pediatric patients, parents, and the healthcare professionals that serve them. For more information, visit
Robert W. Keith. President and Chief Operating Officer, Verus Pharmaceuticals Inc., San Diego; Verus is building a portfolio of products for the unmet medical needs of children with an initial focus on the treatment of asthma, allergies, and related diseases. For more information, visit
Lance Lira. Industry Manager, Pharmaceuticals and Biotechnology Group, Frost & Sullivan, San Antonio; Frost & Sullivan is a global consulting company. For more information, visit
Lisa Mathis, M.D. Acting Director, Division of Pediatric Drug Development, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), Rockville, Md.; The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biologicals, devices, and products that emit radiation. For more information, visit
Christopher-Paul Milne, D.V.M., M.P.H., J.D., Assistant Director, Tufts Center for the Study of Drug Development (CSDD), Boston; Tufts CSDD, an independent research group affiliated with Tufts University, provides information for drug developers, regulators, and policy makers on improving the quality and efficiency of pharmaceutical development, research, and utilization. For more information, visit
Philip Walson, M.D. Professor, Pediatrics and Pharmacology University of Cincinnati, and Director, Clinical Pharmacology Division and Clinical Trials Office, Cincinnati Children’s Hospital Medical Center, Cincinnati; U of C is a public university founded in 1819. For more information, visit