Stephen Tindal Email & Phone Number

Stephen holds a corporate R&D role consulting on development of small molecules in late discovery, and when manufacturing or clinical outcomes don't meet expectation at any phase.Stephen specializes in data analysis, critical thinking and "triage".Triage is the selection of the right molecule, the right salt / polymorphic form and the right formulation to progress to GLP tox, Phase 1 and beyond using Catalent’s award winning Optiform® Solution Suite toolkit, especially designed for small companies.Stephen also advises on broader aspects of drug delivery: Getting good data out of animal studies and applying PBPK modelling to determine druggability. Selecting the right formulation technology to mitigate API development issues or liabilities like solubility, first pass loss, short circulating half life, window of absorption. Selecting the right formulation technology to support evaluation of the clinical hypothesis and mechanism of action. Selecting the right dosage form based changing needs during various clinical phases.Stephen holds a bachelors degree in Chemistry and Analytical Science from Loughborough University, UK. He has worked at Catalent for 32 years (17 prior years in the UK, 16 years in the USA and now back in the UK from 2019 ), holding leadership positions in Formulation Development, Process Development and both Clinical and Commercial Operations at FDA & EMA regulated facilities.Stephen has been responsible for the development validation and commercial support for products with bulk product sales well over $100M over a broad range of VMS, OTC, Rx and Gx products.Stephen served as an expert panel member on USP committees for Dissolution Testing of Liquid Filled Capsules and Use of Enzymes in Dissolution Testing of Gelatin Capsules from 2010-2015.Stephen is part of Catalent’s Science and Technology Team and is based in Swindon, UK where he leads the technical support in Europe. This S&T team are available for customer consultation.* Optiform® Solution Suite toolkit is an integrated offering designed to efficiently and rapidly help solve complex oral bioavailability challenges for early stage small molecules using a unique set of bioavailability enhancing technologies.

Listed skills include Formulation, Gmp, Fda, R&D, and 29 others.

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  Loughborough University

  Chemistry And Analytical Science