Business


As the University of Edinburgh noted in its


report Health Biotechnology to 203071, “…One innovation-related factor that made it possible to develop such niche markets on a profitable basis was the development of new approaches to the synthesis of complex biological and chemical molecules. Many potential products had been rejected from drug development pipelines in the past because they could not be synthesised at an affordable cost, even if they could be proven to be safe and effective. Synthetic genomics had an important impact in this area, as did the use of GM plants, animals and micro-organisms”. Broad application of DNA-encoded libraries72,


containing hundreds of billions of compounds73, effected a streamlined search for chemical matter and drug candidates, rapidly reducing the time and costs associated with discovery and preclinical development, while increasing transition probabil- ities to preclinical and clinical development. Furthermore, significant developments in bio-


pharmaceutical manufacturing occurred. The European Medical Agency (EMA) in its publica- tion EMA Regulatory Science to 2025 Strategic reflection, revealed it needed to encourage inter alia point-of-care-manufacturing74, and therefore might be required to facilitate a flexible approach to the application of GMP. The implementation of synthetic biology75 and AI-informed continuous flow drug manufacturing76,77 decreased the formidable capital investments that used to be nec- essary to build chemical laboratories and pharma- ceutical manufacturing plants. These were huge, multi-story facilities with more floor space than a dozen football fields and with a footprint that often included separate buildings for quality test- ing, utilities and a warehouse, all of which took many years and more than $1 billion dollars to build78. The next generation of biopharmaceutical facili-


ties developed beyond multiproduct to true multi- purpose capabilities. The multi-purpose facility could enable rapid scale-up of a process and be used for clinical testing, product launch, inventory building and long-term commercial supply. By 2020, drug manufacturing facilities could be creat- ed as small as a ship’s container; now in 2030 they can sit on a hospital laboratory bench.


Looking to the future It is clear there are a great many sociological, demographic and technological changes that life science, biopharma R&D and healthcare organisa- tions need to be preparing for. However, this is only part of the whole picture. In the second article


Drug Discovery World Fall 2019


Dr Steve Arlington has worked in the pharmaceu- tical and diagnostics industry for more than 40 years. He began as a research scientist in the field of immunology and developed and launched many products in this arena – he was part of the team that developed and launched Clearblue pregnancy tests. Steve is a retired partner from PwC and led the Pharmaceutical Team in Advisory Services and also previously led the IBM Life Sciences and Pharmaceutical Global Teams. In his career, Steve has grown two global consultancies into billion dollar businesses and launched a biotech company; he has also served on the advisory boards of major pharma and diagnostic companies, start-ups, ven- ture capitalists and health providers. Steve became president of The Pistoia Alliance in 2015.


John Wise specialises in precompetitive collabora- tion in the life science R&D information ecosys- tem. He is a consultant to the Pistoia Alliance, a not-for-profit organisation committed to lowering the barriers to innovation in life science R&D, and also serves as the programme co-ordinator for the PRISME Forum, a not-for-profit biopharma R&D IT/Informatics leadership group focused on the sharing of best practices. John has worked in life science R&D informatics in a variety of organisa- tions, including academia, the pharmaceutical industry and a cancer research charity, as well as in the technology supply side of the industry. John graduated in physiology before obtaining a post- graduate certificate in education.


49


in this series, we will cover the other challenges set to affect the industry in the next decade, including patient-centric innovations, a growing skills short- age and evolving regulations around the world. The full report is available on the Pistoia Alliance website.


DDW


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