Abstract
Medical-product development has become increasingly challenging and resource-intensive. In 2004, the Food and Drug Administration (FDA) described critical challenges facing medical-product development by establishing the critical path initiative [1]. Priorities identified included the need for improved modeling and simulation tools, further emphasized in FDA’s 2011 Strategic Plan for Regulatory Science [Appendix]. In an effort to support and advance model-informed medical-product development (MIMPD), the Critical Path Institute (C-Path) [www.c-path.org], FDA, and International Society of Pharmacometrics [www.go-isop.org] co-sponsored a workshop in Washington, D.C. on September 26, 2013, to examine integrated approaches to developing and applying model- MIMPD. The workshop brought together an international group of scientists from industry, academia, FDA, and the European Medicines Agency to discuss MIMPD strategies and their applications. A commentary on the proceedings of that workshop is presented here.
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Appendix
Appendix
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A1.
FDA’s plan to advance regulatory science: http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM268225.pdf.
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A2.
Further information on the workshop (including slide presentations): http://c-path.org/modeling-and-simulation-for-medical-product-development-and-evaluation-workshop/.
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A3.
FDA-approved irbesartan-hydrochlorothiazide combination label (see Figs. 1a, b, 2a, 2b): http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020758s064lbl.pdf.
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A4.
Coalition against major diseases: http://c-path.org/programs/camd/.
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A5.
Regulatory decision from FDA on the CAMD AD CTS tool: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm180485.htm.
Regulatory decision from EMA on the CAMD AD CTS tool: http://www.google.com/url?sa=t&rct=j&q=&esrc=s&frm=1&source=web&cd=1&ved=0CCoQFjAA&url=http%3A%2F%2Fwww.ema.europa.eu%2Fema%2Fpages%2Fincludes%2Fdocument%2Fopen_document.jsp%3FwebContentId%3DWC500146179&ei=zB7LUvG3GMrA2QXkrIHICw&usg=AFQjCNGDBQWSJJX5DjqHc-CFZaArfDeReg&sig2=G9ZUieb3VLs-I8lvTI279g.
AlzForum feature on the regulatory decisions for the CAMD AD CTS tool: http://www.alzforum.org/news/research-news/ad-trial-simulation-tool-receives-regulators-blessings.
Wall Street Journal features on the use of simulations to improve drug development: http://online.wsj.com/news/articles/SB10001424052702303914304579192033377938714. http://online.wsj.com/news/articles/SB10001424052702304361604579290572010514840.
Further audiovisual materials on modeling and simulation (for clinicians and non-modelers): http://c-path.org/category/videos/.
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A6.
Public Meeting—FDA/NIH/NSF Workshop on Computer Models and Validation for Medical Devices, June 11–12, 2013: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm346375.htm.
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Metamodl: http://www.metamodl.com/index.php?/page/metamodl.html.
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Romero, K., Sinha, V., Allerheiligen, S. et al. Modeling and simulation for medical product development and evaluation: highlights from the FDA-C-Path-ISOP 2013 workshop. J Pharmacokinet Pharmacodyn 41, 545–552 (2014). https://doi.org/10.1007/s10928-014-9390-0
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DOI: https://doi.org/10.1007/s10928-014-9390-0