Mechanical, Electrical and Manufacturing Engineering

Staff

Professor Nick Medcalf FREng, FIChemE, CChem, CEng, MRSC, PhD

Photo of Professor Nick Medcalf

Professor of Regenerative Medicine Manufacture

Director of the EPSRC Centre for Innovative Manufacturing in Regenerative Medicine

Background

  • Educated from within industry: PhD: ‘A New Business Model for Cell-Based Therapeutics’, National University of Ireland, Galway, 2011; Master’s Degree in Bioprocessing, with Distinction, University College London, 2002; Graduate Membership of the Royal Society of Chemistry, University of Hertfordshire, 1982;
  • Director of the EPSRC Centre for Innovative Manufacturing in Regenerative Medicinefrom 2014
  • From 1990-2013: Smith & Nephew Research Centre, York:
    • 2012-2013: Manager: Quality and Translational Science;
    • 2010 – 2012 Principal Scientist: Bioprocessing;
    • 2003 – 2010 Bioprocessing Manager: Biologics (including responsibility for operational management of the GMP-grade research cleanroom);
    • 2001 – 2003 Technology Manager: Tissue and Cell Engineering, including collaborations with Universities of Birmingham, Wales (Cardiff), Cambridge, UCL;
    • 2000 – 2001 Principal Scientist: Tissue Engineering;
    • 1993 – 2000 Principal Scientist: Process Research;
    • 1990 – 1993 Senior Development Chemist;
  • 1988-1990: Chemist, Resolution Chemicals Ltd, Stevenage;
  • 1980-1988: Chemist, Smith & Nephew Research Ltd, Gilston Park, Harlow;
    • Head of Synthetic Chemistry 1986 - 1988
  • 1977-1980: Analytical Research Technician, Glaxo Group Research, Ware, Herts
    • Analysis of products and intermediates and analytical method development, working primarily on the Zantac process and on salbutamol-based products

Research Interests and Activities

  • ‘Regulatory science’ i.e. industry-facing, challenge-led research aimed at providing the confidence in process design necessary to satisfy regulatory constraints for advanced therapeutic products, such as cell- and tissue-based products
  • Commercialisation of regenerative medicine;
  • Manufacturing technology for cell- and tissue-based therapies;
  • Translational research;
  • Systematisation of process design in regenerative medicine through new definitions of unit operations;
  • Application of tools for business process re-engineering to discover more cost-effective ways of delivering advanced therapeutic products to market;
  • Application of quality management systems (ISO9001, GLP, GMP) to provide industry-ready technology advances
  • External Activities
    • HITF: Reporter for Smith & Nephew Research to the Health Industries Task Force Special Interest Group 2006
    • DTI: Delegate: Department of Trade and Industry GlobalWatch Mission on Advanced Cell Therapies (to California). Scope: process validation. Chair, public dissemination event, Edinburgh, 2006.
    • BIG-T Contributor to response to Bioscience Innovation and Growth Team reporting on regenerative medicine.
  • Learned society engagement
    • Fellow of the Royal Academy of Engineering, 2011, active in the Enterprise Hub to promote entrepreneurism in the UK
  • Professional affiliations
    • Member of the Research Quality Association, 2012
    • Fellow of the Institution of Chemical Engineers, 2000
    • Chartered Chemical Engineer, 2000
    • Chartered Chemist, 1986
    • Graduate Member of the Royal Society of Chemistry, 1982
  • Advisory Roles (past)
    • BBSRC
    • Bioprocess Research Industry Club
    • Georgia Tech (Educational Partners Programme)
    • Smith Institute
    • University of Sheffield (Chemical Engineering)
    • University of Leeds (Chemical Engineering)
    • UCL (Department of Biochemical Engineering)
    • Wellcome Trust
  • Collaborative Research
    • Management of academic collaboration with the Tissue Engineering Research Centre (TERC), Japan
    • Industry Project leader for Project ‘CARA’ (Cellular Arthoplasty for Regeneration in Arthritis) at NUI Galway

Patents

  • Thomson B M, Ali S A M, Medcalf N, Maltman J, Winter S D, Cell culture products, 5 April 2000, EP0989866, family of 4 patents covering 83 countries
  • Medcalf N, Peel C, Grant I W, Orthopaedic splinting material, 11 February 1998, GB2315687, two families of 3 patents each covering 2 countries
  • Ansell C W G, Medcalf N, Williams P W, Surgeons’ gloves, 3 November 1988, WO 1988/008311, family of 10 patents covering 15 countries
Invited and Keynote Presentations:
  • Medcalf N, “Dermagraft® and TransCyte® – pioneering products in tissue engineering”, UCL Stem cell and regenerative medicine module (MBI course for Masters Degree students), February 2008
  • Medcalf N, “Bioprocess design – current drivers, future successes” Symposium “Cell-based strategies in cartilage repair” REMEDI, National University of Ireland, Galway, 26 July 2007
  • Medcalf N, “Bringing regenerative medicine to market – lessons from dermal repair products”, 4th Spring School in Stem Cell Biology, Oslo 15 May 2007
  • Medcalf N, “Validation of cell-based therapeutic processes”, Annual bioProcessUK Conference, Edinburgh, 29-30 November 2006
  • Medcalf N, “Innovative supply networks - the case of tissue engineering” University of Bath School of Management, 19 October 2004
  • Medcalf N, “Overview of tissue engineering in UK”, International Symposium on Bio-integrated Materials & Tissue Engineering, Tokyo University, 7 March 2002
  • Medcalf N, “Chemical engineers as tissue engineers - the challenge of small, complex, bioproducts”, American Institute of Chemical Engineers Conference: “Refocusing Chemical Engineering”, Barga, Italy, 27 May-1 June 2001

Awards

  • Winner of the Hanson Medal of the Institution of Chemical Engineers, 1999
  • Project Leader for the re-design of production processes for advanced dressing OpSite IV3000®, which received the Queen’s Award for Technological Achievement in 1996

Key Publications

  • Medcalf N and Pietrowski R, “Regulation in the biosciences”, Chapter 9 in Adams D and Sparrow J (eds.) “Life Skills for Life Scientists: Enterprise and Innovation in the Biosciences”, pp 201-222, Scion, 2007, ISBN 978-1-904842-36-1
  • Neves, André A, Medcalf N, Brindle K M, “Influence of stirring-induced mixing on cell proliferation and extracellular matrix deposition in meniscal cartilage constructs based on polyethylene terephthalate scaffolds”, Biomaterials, 2005, 26, 4828-4836
  • Neves, André A, Medcalf N, Brindle K, “Functional Assessment of Tissue-Engineered Meniscal Cartilage by Magnetic Resonance Imaging and Spectroscopy”, Tissue Engineering, 2003, 9, 51-62
  • Neves AA, Medcalf N, Brindle K, “Tissue engineering of meniscal cartilage using perfusion culture”, Annals of the New York Academy of Sciences, 2002, 961, 352-5
  • Medcalf N, “Body Works: Tissue as a manufactured product: a new role for the chemical engineer”, The Chemical Engineer, 22 July 1999 (685) 6-8 (Winner of the Hanson Medal of the Institution of Chemical Engineers)