S5 provides statistical specialist services mainly to the pharmaceutical industry, and in particular in the chemistry, manufacturing & controls (CMC) area. Services include planning of experiments, analysis and reporting of data, authoring and review of publications and regulatory documentation, and general statistical, strategic and development advice in particular for inhaled products.
S5 is a private company owned and operated since May 2010 by Dennis Sandell, Fil Lic in mathematical statistics from the University of Lund, Sweden. Dennis has worked in the pharmaceutical industry since 1991 and provided statistical support and guidance in the CMC area since 1995. The main part of his career Dennis has worked in development and registration of different types of inhalation products, including DPIs, MDIs, nasal sprays and nebulisers. He has deep technical understanding of these delivery systems, used formulations and regulatory expectations for documentation.
Dennis has worked for AstraZeneca in Sweden and the UK for the main part of his career. He has also worked for Amgen Inc., CA as head for the non-clinical statistics group, and for Siegfried Pharma Development GmbH in Munich, Germany as head for regulatory affairs and project management.
Dennis was the regulatory CMC statistics spokesperson for his employers, and has also represented these at conferences and in different international collaborations such as IPAC-RS, EPAG, PhRMA and PQRI. During 2004-5 he was member of the delivered dose uniformity sub-committee of the ACPS, and he is currently member of the USP Statistics Expert Committee. Dennis is also chairing the USP Expert Panel for Content Uniformity with Large Sample Sizes.
Dennis is a member of Statistics Without Borders (SWB), an apolitical organization under the auspices of the American Statistical Association, comprised entirely of volunteers, that provides pro bono statistical consulting and assistance to organizations and government agencies in support of these organizations’ not-for-profit efforts to deal with international health issues (broadly defined).
Since 2013 Dennis is adjunct professor at the Department of Pharmaceutics, University of Florida.
This S5 Flyer provides a summary of S5 Consulting’s experiences, services and contact information.