Acquisition of experience in industrial project management and commercial product development supporting non-invasive stem cell separation technology

A BBSRC funded collaborative research at Heriot-Watt and Edinburgh Universities has resulted in the development of novel engineering technology to separate human stem cells from specialised cells that originate from them. Unlike currently practiced approaches, the new technique does not rely on surface attachment of probes that may alter cell behaviour. The probe-free separation technology has applications in the isolation and processing of stem cells for industrial drug discovery and cell manufacturing for clinical application. To develop these applications further it is necessary to (1) secure funding from sources supporting non-academic development of a commercial product, and (2) identify and engage industrial and clinical end users. Academic institutions are not generally effectively positioned or best experienced in acquisition of this type of funding or to commercially engage with others.
The purpose of this award therefore is to interchange Dr Marieke Hoeve, a senior academic researcher with a background in immunology, cell biology & stem cell research, and experience in academic project management, from the laboratory of Dr. Paul De Sousa at Edinburgh University, first to Heriot-Watt University to learn the underpinning engineering technology of the engineering scientists and acquire experience in academic technology transfer office practice. This is followed by a placement at a stem cell contract manufacturing organisation, Roslin Cells Ltd, whose remit is to facilitate industrial and clinical translation of stem cell research. Lastly Dr Hoeve will return to the applicant's lab to apply the multi-disciplinary experience gained. In this placement Dr Hoeve will aim to:
1. Gain experience in the acquisition of funding for non-academic commercial product development for Roslin Cells.
2. Acquire industrial project management experience by contributing to management of existing Roslin Cells projects.
3. Prepare a market analysis of the demand and competition for the cell separation technology.
4. Secure funding for the application of the probe-free cell separation technology for inducing pluripotent stem cells from adult cells that resemble embryonic stem cells, for purposes of modelling diseases in a 3-way collaboration between Roslin Cells, the University of Edinburgh and Heriot-Watt.
5. Secure funding for application of the probe-free cell separation technology in other industrial and clinical applications in a collaboration between the aforementioned and other academic and commercial end users.

The primary objective of this interchange is to professionally develop an academically qualified research associate and project manager, Dr. Marieke Hoeve, so that she acquires the multi-disciplinary and industrial knowledge, experience and network contact exposure to facilitate the commercial development and end user uptake of a minimally invasive probe-free cell separation device for human stem cells developed in collaborative BBSRC funded research with academic partners at Heriot-Watt (HW) University. This will be achieved through a series of placements at HW, Roslin Cells (a not-for-profit company whose remit is to facilitate the translation of stem cell research to industrial and therapeutic applications) and University of Edinburgh, the first and last placements under the supervision of the developers of the technology platform. Dr Hoeve's goals will be to:
1. Understand the engineering basis of the technology which has been developed. (HW)
2. Understand University technology transfer commercial licensing practice in the context of engineering science. (HW)
3. Acquire experience in acquisition of non-academic translational/commercial product development. (RC)
4. Acquire industrial project management experience interfacing with academic, clinical and industrial partners/customers. (RC)
5. Perform a market analysis of commercial demand and competition for the non-invasive cell separation technology. (RC/UoE/HW)
6. Prepare funding applications with the applicant and partners for development of the probe-free cell separation technology for purposes of deriving induced pluripotent stem cell lines. (UoE/HW/RC)
7. Secure funding for development of probe-free cell separation technology for other applications. (UoE/HW/RC)
Dr Hoeve's achievement of these goals will be tracked against defined metrics consisting of preparation of line management or peer reviewed reports, publications and grant submissions.

Stem cell manufacturing for industrial and clinical purposes requires technology for cell processing which does not damage or alter cells unpredictably or permanently. A particular challenge concerns methods to purify or segregate mixed cell populations whether from embryonic or adult tissues, during culture, or prior to transplantation in the case of clinical use to improve efficacy of processing and safety, respectively. Current methods require coupling probes to cell surfaces. This may be limited by the availability of probes, the potential for probes to alter cell properties in unknown ways, and the necessity for minimum quantities of cells in excess of what is available. This includes isolation of rare stem cells or cells which appear transiently amongst a population of diverse cells such as in the course of pluripotency induction. The probe-free technology developed in collaborative research between Heriot-Watt and Edinburgh Universities provides a novel platform whose further development and validation for these applications would yield a commercial product that could impact on the efficiency and cost-effectiveness of stem cell manufacturing, helping to bring down the costs of cell processing. This would promote public access to the outputs of industrial research and development. This could also help to purify cell populations prior to transplantation in order to improve the safety of new regenerative medical therapies.