Student Profile

Contact Email:   m.mccall@lboro.ac.uk

Undergraduate Degree: BSc Physics with Medical Physics (Queens University Belfast)

PhD Summary

This research quantifies and attempts to reduce the cost, time and risk associated with developing and delivering cell therapy products.  A mixed methodology approach has been adopted including; case studies, novel simulation models, analytical models and lab based technology development.

Results from the simulation model quantify the time, risk and cost associated with the clinical development of cell therapy products.   An application of this model comparing alternative regulatory approaches indicates that the current favoured strategy of targeting an orphan indication gives little benefit for certain clinical indication because of reduced clinical trial recruitment rate.

Results from the analytical cost models quantify the financial and temporal cost of build, validating and operating multiple sites of manufacture for cell therapies.  The model takes account of initial ‘start-up’ validation costs for each facility and the ingoing burden of comparability demonstration. High impact areas are the interdependence of product shelf life (and distribution potential) and the number of manufacturing sites needed to satisfy a global market. 

As part of this research a novel cell expansion technology has been designed, developed and tested, which enables cost effective production of clinically relevant anchorage dependent human cells.  Furthermore, a cell culture system has been constructed around this technology and is the subject of a patent application.

Publications, Presentations and Awards

Publications

• Chris Mason, Mark J. McCall, Emily J. Culme-Seymour, Shalini Suthasan, Simon Edwards-Parton, Gregory A. Bonfiglio, and Brock C. Reeve. Industry Report. The Global Cell Therapy Industry Continues to Rise during the Second and Third Quarters of 2012 CELL STEM CELL Volume 11, Issue 6, 7 December 2012, Pages 735–739
• Mark J McCall, Robert J Thomas, David J Williams. Developing Cell Therapies: Enabling cost prediction by value systems modelling to manage developmental risk. Journal of Commercial Biotechnology. Volume 19, Issue 2, April 2013.
• Mark J McCall, David J Williams. What are the alternative manufacturing and supply models available to RM companies and how do the finances stack up?” Developing Regenerative Medicine: Navigating the Uncertainties. VALUE TSB Project Final Report. March 2012

Oral Presentations

• Cell therapy distributed manufacturing – managing costs and risks. Consortium for Medical Device Technologies Regenerative Medicine Workshop,  Auckland, April 2013
• Manufacturing cell therapy new product introduction - managing costs and risks. 1st Annual EPSRC Manufacturing the Future Conference, MtF September 2012
• Cell Therapy New Product Development Modelling Cost, Time and Risk to Market. ECI Cell Therapy Manufacturing Conference, San Diego, January 2012
• The regenerative medicine value system; navigating the uncertainties. CDT annual cross cadre conference, Nottingham, April 2012
• Regenerative medicine: Value and cost systems analysis VALUE Open Workshop – 24th February 2012

Awards

• Enterprise Fellowship In Regenerative Medicine - £198,000
• Loughborough University Enterprise Office Project 692 - Efficient (next generation) Manufacturing Platform for Adherent Cell Culture - £17,000
• EPSRC Small equipment grants - £9,700

Additional roles/experience and responsibilities

• Founding member, UK and European representative to the International Society for Cell Therapy (ISCT) reimbursement sub-committee
• Experience of GMP compliant clean room automated processes gained during the operational qualification of the Cell Therapy Manufacturing Facility at the CBE.
• Lecturing and tutoring junior CDT students on health economics and business plan finances. 
• University subwarden for Robert Bakewell Hall where he is jointly responsible for the safety and pastoral care of 400 undergraduate students.
• Conceived and organized the “Engage” one day industry meeting – bringing together CDT PhD students and industry representatives from the field of Regenerative Medicine.
• Organizing committee member of the 1st Annual EPSRC UK Manufacturing the Future Conference (September 2012).  Responsible for all audio/visual management of the two day event.
• MM was involved in the 2011 Biotechnology Young Entrepreneur Scheme (Biotechnology YES), where he assumed the role of Chief Executive Officer/Chief Financial Officer of a fictional biotechnology company.  The team reached the national finals of the competition.

 Future/Career Plans

I have recently secured an 18-month Enterprise Fellowship funded by the EPSRC Impact Acceleration Account at Loughborough University. The fellowship will commercialise product IP and know-how developed during my PhD.

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