Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics
Ryan D. Rykhus,
Zachary V. Shepard,
Alix Young,
Hadley Frisby,
Kailee A. Calder,
Collin M. Coon,
Justin A. Falk,
Sydney R. McAndrews,
Aspen Turner,
Christina Chang,
Johanna Michelsohn,
Raegan Petch,
Sarah M. Dieker,
Benjamin H. Markworth,
Kevin Alamo-Perez,
Aaron J. Hosack,
Jacob M. Berg,
Christian Schmidt,
Joachim Storsberg,
Mark A. Brown
Affiliations
Ryan D. Rykhus
School of Biomedical Engineering, Colorado State University, Fort Collins, CO 80523, USA
Zachary V. Shepard
Department of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA
Alix Young
Department of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA
Hadley Frisby
Department of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA
Kailee A. Calder
Department of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA
Collin M. Coon
Department of Biology, Colorado State University, Fort Collins, CO 80523, USA
Justin A. Falk
Department of Mechanical Engineering, Colorado State University, Fort Collins, CO 80523, USA
Sydney R. McAndrews
Department of Biology, Colorado State University, Fort Collins, CO 80523, USA
Aspen Turner
Department of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA
Christina Chang
School of Biomedical Engineering, Colorado State University, Fort Collins, CO 80523, USA
Johanna Michelsohn
Department of Biology, Colorado State University, Fort Collins, CO 80523, USA
Raegan Petch
Department of Microbiology, Immunology, and Pathology, Colorado State University, Fort Collins, CO 80523, USA
Sarah M. Dieker
Walter Scott College of Engineering, Colorado State University, Fort Collins, CO 80523, USA
Benjamin H. Markworth
School of Biomedical Engineering, Colorado State University, Fort Collins, CO 80523, USA
Kevin Alamo-Perez
Department of Electrical and Computer Engineering, Colorado State University, Fort Collins, CO 80523, USA
Aaron J. Hosack
Department of Biology, Colorado State University, Fort Collins, CO 80523, USA
Jacob M. Berg
Department of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA
Christian Schmidt
Department of Biomaterials and Healthcare, Fraunhofer-Institute for Applied Polymer Research (IAP), Division of Life Science and Bioprocesses, 14476 Potsdam-Golm, Germany
Joachim Storsberg
Department of Biomaterials and Healthcare, Fraunhofer-Institute for Applied Polymer Research (IAP), Division of Life Science and Bioprocesses, 14476 Potsdam-Golm, Germany
Mark A. Brown
Department of Clinical Sciences, Colorado State University, Fort Collins, CO 80523, USA
Over the past two decades, the biopharmaceutical industry has seen unprecedented expansion and innovation in concert with significant technological advancements. While the industry has experienced marked growth, the regulatory system in the United States still operates at a capacity much lower than the influx of new drug and biologic candidates. As a result, it has become standard for months or even years of waiting for commercial approval by the U.S. Food and Drug Administration. These regulatory delays have generated a system that stifles growth and innovation due to the exorbitant costs associated with awaiting approval from the nation’s sole regulatory agency. The recent re-emergence of diseases that impact pediatric demographics represents one particularly acute reason for developing a regulatory system that facilitates a more efficient commercial review process. Herein, we present a range of initiatives that could represent early steps toward alleviating the delays in approving life-saving therapeutics.
