title: The early career researcher's toolkit: translating tissue engineering, regenerative medicine and cell therapy products.
abstract: Although the importance of translation for the development of tissue engineering, regenerative medicine and cell-based therapies is widely recognized, the process of translation is less well understood. This is particularly the case among some early career researchers who may not appreciate the intricacies of translational research or make decisions early in development which later hinders effective translation. Based on our own research and experiences as early career researchers involved in tissue engineering and regenerative medicine translation, we discuss common pitfalls associated with translational research, providing practical solutions and important considerations which will aid process and product development. Suggestions range from effective project management, consideration of key manufacturing, clinical and regulatory matters and means of exploiting research for successful commercialization.
authors.affiliation: Centre for Biological Engineering, Wolfson School of Mechanical & Manufacturing Engineering, Loughborough University, Leicestershire, LE11 3TU, UK.|Aston Medical Research Institute, School of Life & Health Sciences, Aston University, Aston Triangle, Birmingham, B4 7ET, UK.
authors.forename: Qasim A
authors.initials: QA
authors.lastname: Rafiq
authors.affiliation: Bioengineering & Health Technologies Group, The School of Clinical Dentistry, University of Sheffield, S10 2TA, UK.
authors.forename: Ilida
authors.initials: I
authors.lastname: Ortega
authors.affiliation: Institute for Science & Technology in Medicine, Keele University, Staffordshire, ST5 5BG, UK.
authors.forename: Stuart I
authors.initials: SI
authors.lastname: Jenkins
authors.affiliation: Academic Ophthalmology, Division of Clincial Neuroscience, Queen's Medical Centre Campus, University of Nottingham, NG7 2UH, UK.
authors.forename: Samantha L
authors.initials: SL
authors.lastname: Wilson
authors.affiliation: Wolfson Centre for Stem Cells, Tissue Engineering & Modeling, University of Nottingham, Nottingham, NG7 2RD, UK.|David H Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, MA 02139, USA.
authors.forename: Asha K
authors.initials: AK
authors.lastname: Patel
authors.affiliation: Department of Biology, University of York, YO10 5DD, UK.
authors.forename: Amanda L
authors.initials: AL
authors.lastname: Barnes
authors.affiliation: Institute for Science & Technology in Medicine, Keele University, Staffordshire, ST5 5BG, UK.
authors.forename: Christopher F
authors.initials: CF
authors.lastname: Adams
authors.affiliation: Department of Materials, Imperial College London, Exhibition Road, London SW7 2AZ, UK.|Wolfson Centre for Stem Cells, Centre for Biological Sciences, School of Pharmacy, University of Nottingham, NG7 2RD, UK.
authors.forename: Derfogail
authors.initials: D
authors.lastname: Delcassian
authors.affiliation: Centre for Biological Engineering, Wolfson School of Mechanical & Manufacturing Engineering, Loughborough University, Leicestershire, LE11 3TU, UK.|PCT, a Caladrius company, 4 Pearl Court, Suite C, Allendale, NJ 07401, USA.
authors.forename: David
authors.initials: D
authors.lastname: Smith
mesh_terms: D002321:Career Choice; D064987:Cell- and Tissue-Based Therapy; D006801:Humans; D044968:Regenerative Medicine; D023822:Tissue Engineering; D057170:Translational Research, Biomedical
keywords: cell therapy; clinical and preclinical models; early career researcher; manufacture; regenerative medicine; stem cell; tissue engineering; translation; translational research