News & Events
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January 8, 2021
Effective Data Sharing as a Conduit for Advancing Medical Product Development
Patient-level data sharing has the potential to significantly impact the lives of patients by optimizing and improving the medical product development process. In the product development setting, successful data sharing is defined as data sharing that is actionable and facilitates decision making during the development and review of medical products. This often occurs through the...... -
May 14, 2020
Serum Glutamate Dehydrogenase Activity Enables Early Detection of Liver Injury in Subjects with Underlying Muscle Impairments
King, Amy C. Porter, Jane Owens, et al. “Serum Glutamate Dehydrogenase Activity Enables Early Detection of Liver Injury in Subjects with Underlying Muscle Impairments.” PloS One 15, no. 5 (2020): e0229753. https://doi.org/10.1371/journal.pone.0229753.
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August 14, 2019
Conrado et al. 2019 Towards Regulatory Endorsement
Towards regulatory endorsement of drug development tools to promote the application of model-informed drug development in Duchenne muscular dystrophy.... -
October 26, 2017
226th ENMC International Workshop: Towards Validated and Qualified Biomarkers for Therapy Development for Duchenne Muscular Dystrophy
Aartsma-Rus A, Ferlini A, McNally EM, Spitali P, Sweeney HL, Aartsma-Rus AM, Szigyarto CAK, Bello L, Bronson A, Brown K, Buccella F, Chadwick J, Ferlini A, Frank D, Hoffman E, Larkindale J, McClorey G, McNally E, Munschauer R, Muntoni F, Owens J, Schara U, Spitali P, Straub V, Sweeney L, Tinsley J, Versnel J, Vroom E, Welch E. 226th ENMC International Workshop: Towards Validated and Qualified Biomarkers for Therapy Development for Duchenne Muscular Dystrophy. Neuromuscular Disorders. 2017 Oct.
- October 24, 2017