Martin Hanus

Multi-talented professional with 15+ years of demonstrated commitment to problem solving, driving projects to completion, and stretching beyond core responsibilities. A highly effective communicator and SME responsible for method development, validation, transfer, regulatory submissions, pre and post approval questions/commitments.

• Led analytical contributions for the sevelamer carbonate CMC team.
• Successfully organized, completed, and documented the full release and stability testing of an in-process material, finished formulation, and placebo formulation of two drug products coordinating two fellow chemists and three outside testing facilities ensuring the use of cGMP's and cGLP's from IND through NDA and MAA approval and postapproval activities.
• Designed, proposed, executed, prepared for submission and addressed post submission questions a comprehensive in vitro equivalency experiment that successfully persuaded FDA and EMEA eliminating the need to conduct in vivo clinical equivalency trials.
• Volunteered as the analytical representative to our site HSE committee for more than 20 years contributing to the development and evolution of the chemical hygiene plan.
• Established effective communication between the committee and the analytical team to facilitate the implementation of the site safety standards in a manner that balanced the commitment to ensuring a safe work environment with the efficient performance of regular operations.
• SME expert for the successful defense of a formulation patent in both Canada and China ensuring the continued market exclusivity of a 300 million dollar per year drug product.

• "A phosphate binding assay for sevelamer hydrochloride by ion chromatography", Mazzeo JR, Peters RM, Hanus MR, Chen X, Norton KA, Journal of Pharmaceutical and Biomedical Analysis, 1999, pp911-915
• "Bile acid salt binding with colesevelam HCl is not affected by suspension in common beverages.", Hanus, M, Zhorov, E, J Pharm Sci., 2006, 95, 12, 2751-9
• "Novel dosage forms and regimens for sevelamer-based phosphate binders", Duggal A, Hanus M, Zhorov E, Dagher R, Plone MA, Goldberg J, Burke SK, J Ren Nutr., 2006, 16, 3, 248-52
• "Assessment of phosphate binding by sevelamer carbonate powder for oral suspension mixed in foods", Hanus M, Zhorov E, Brommage D, Plone M, Holmes-Farley SR., Nephrol Nurs J., 2012, 39, 3, 239-43, 255, 22866363

• Master of Science in Biotechnology
• Genzyme Management Fundamentals Program
• Effectively Using the USP NF
• LC/MS Fundamentals and Applications

• Vice President Award, 05/18/07, For the design and execution of pivotal equivalence studies to support the sevelamer carbonate and Renagel NDAs
• Vice President Award, 12/16/05, In recognition of superior technical development of new analytical methodology for sevelamer carbonate and in the successful effort to gain approval from worldwide regulatory agencies