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)