Public Meeting on Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics

Greetings NMusers, The Food and Drug Administration (FDA) in Collaboration with The University of Maryland Center of Excellence in Regulatory Science and Innovation (CERSI) Will Host a Public Meeting on Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics on June 1st, 2016 The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (CERSI), is holding a public workshop on June 1st, 2016 titled Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics. The objective of the workshop is to discuss quantitative and qualitative approaches for verifying assumptions pertaining to disease and therapeutic response similarity between adults and children. The workshop will also provide a forum for discussion on the use of modeling and simulation for systematic assessment of extrapolation assumptions. The purpose of this public workshop is to provide an opportunity for relevant stakeholders, including clinicians, academia, industry and FDA to discuss systematic assessment of data needed to support extrapolation of efficacy in pediatric product development. Specifically, the workshop will include: * Presentations on approaches for assessing disease and therapeutic response similarity between adults and pediatrics * Discussion of alternative approaches to the assessment of extrapolation assumptions in pediatric product development, including the use of clinical trial simulation and Bayesian approaches. * Examples in partial onset seizures, inflammatory bowel diseases, and polyarticular juvenile idiopathic arthritis will be presented and discussed. Date: Wednesday, June 1st, 2016, 8:00 a.m. - 5:00 p.m. Location: FDA White Oak Campus, Building 31, the Great Room (Rm. 1503A) Interested individuals can attend the meeting in person or via Web cast. Seating will be limited, so early registration is recommended. For more information, please visit: http://www.pharmacy.umaryland.edu/centers/cersievents/pedsextrapolation/ For further information contact: Lily Mulugeta (email: yeruk.mulugeta_at_fda.hhs.gov<mailto:yeruk.mulugeta_at_fda.hhs.gov>) Best Regards Nitin ************************************************************ Nitin Mehrotra, M.Pharm., Ph.D. Pharmacometrics Team Leader Hematology, Medical Imaging, Metabolic & Endocrinology and Gastroenterology & Inborn Error Products Division of Pharmacometrics, Office of Clinical Pharmacology, OTS, CDER, FDA 10903 New Hampshire Ave, Bldg 51, Rm 3199 Silver Spring, MD-20993 E-mail: Nitin.Mehrotra_at_fda.hhs.gov<mailto:Nitin.Mehrotra_at_fda.hhs.gov> Phone: 301-796-0976 Cell: 301-802-5329 ************************************************************ The contents of this message are mine personally and do not necessarily reflect any position of the Government or the Food and Drug Administration. This message, including attachments, is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized use, disclosure, or distribution is prohibited. If you are not the intended recipient, please contact the sender and destroy all copies of the original message