Mark Varley: RegMedNet Rising Star Award finalist
We are pleased to announce that our judges have shortlisted three outstanding finalists for the RegMedNet Rising Star Award. Mark Varley is a multi-discipline engineer with expertise in mechanical, electrical, software and first principles, who is passionate about creating and launching new innovative technologies to advance cell and gene therapy manufacturing.
Read more about Mark’s career and contribution to the field.
Describe the main highlights of your regenerative medicine work
Since joining Ori Biotech (London, UK) in 2021 I have led the systems and electro-mechanical development of the Ori cell manufacturing platform that has the potential to revolutionize cell therapy manufacturing. This proprietary full-stack manufacturing platform closes, standardizes and digitizes cell and gene therapy (CGT) manufacturing to enable new treatments to be brought to market at scale. Although not launched yet, this technology has already been demonstrated with both public and private partners to generate a step-change in performance to existing solutions. This will enable significantly increased patient access to these life-changing therapies and ensure that those who need access can get the existing cures. Being responsible for the delivery and performance of these prototype systems has ensured that Ori Biotech can demonstrate the potential of the platform to support full commercialization.
Previous to that, I was the technical lead for the development and launch of the Sartorius (Göttingen, Germany) Ambr 15 Generation 2. The second generation introduced improved technical performance and new features, including the perfusion mimic that enables the product that has revolutionized the bioprocessing industry to expand capability for cell therapy development and enable automated multi-parallel optimization of process parameters.
How has your work impacted your laboratory, the regenerative medicine field and beyond?
The development of Ori Biotech’s platform has enabled proof-of-principle of the underlying concept and enabled the scientific optimization of CGT processes on the new platform. This has enabled rapid development of the cell biology and production processes to demonstrate the platform’s performance and allowed tech transfer of partner processes to verify performance at rates unheard of in the industry.
This ultimately will lead to the delivery of the Ori biotech platform to the industry over the coming years and will deliver a step-change in scalability to allow new and existing CGT products to get through clinical trials quicker, at lower cost and then scale much more effectively. Ultimately, this is benefiting the patient population, which can have improved clinical outcomes through expanded access to CGT products. The full impact has therefore not yet been felt, but the work I am doing will deliver these benefits.
Describe the most difficult challenge you have encountered in your scientific career and how you overcame it
All of the products that I have developed are extremely complicated multi-disciplinary developments involving large numbers of stakeholders. Coordinating all these different disciplines and stakeholders to ensure that products are successfully developed, can achieve the performance required and can be launched and be commercially successful is the most significant challenge.
Delivering on this requires zoning in on what is actually needed to launch and staying laser-focused on what needs to be delivered. Working hard to maintain communication channels and ensure that all voices are heard but that decisions are made and the development moves forward is critical to delivery. This is done in parallel to significant technical challenges that need to be overcome and balancing these different demands and protecting time and team members from these distractions to enable laser focus on what is important.
Specific examples include bringing the first Ori prototype back on track when distractions and future thinking were delaying delivery. This was achieved by stripping anything extraneous away and educating the organization on what successful product development looks like and why focusing on the minimum valuable product is essential.
Can you describe how you try to give back to the community/support a cause you feel passionate about? (i.e., describe your role in regenerative medicine focus groups, inter-disciplinary groups, internal workshops)
Within Ori Biotech I regularly deliver coaching and mentoring for both junior engineers and senior engineers moving into the industry. This mentoring encompasses technical and soft skills to enable the delivery of highly complicated multidisciplinary developments. In particular, I have a passion for personal effectiveness and how to maximize potential and I work with the people I coach to enable them to get the most out of themselves. This is something I have done in various guises for the past 10 years, including supporting the apprenticeship program at Sartorius and before that tutoring at the University of Cambridge on engineering principles as I developed my first bioreactor systems for bone regeneration.
Additionally, I have run company-wide presentations on the principles of product development and how you successfully go from invention through to delivering innovation. This has brought together people who had backgrounds from academia, industry scientists and commercial sales and marketing to understand how the product development process is essential to deliver a vision successfully to the market. This training and understanding have grown and resulted in Ori Biotech becoming ISO-13485 certified for product development to enable us to deliver the game-changing manufacturing platform to the market.
The decision is in your hands, so choose wisely! Have a browse of all the candidates, and make sure to cast your vote today.
