Pharma R&D Today
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The Eternal Triangle of Quality, Speed, and Cost
Posted on August 7th, 2017 by Dr Andrew A. Parsons in Pharma R&D
A designer colleague once described to me the key issue involved in many of their creative design projects. It is finding the best balance between quality, speed, and cost. From a buyer perspective, we desire high quality, rapid delivery, and low cost. From a supplier perspective, the lower the cost, the more difficulty there will be in bringing resources to the project. Fewer people will stretch delivery times and the use of cheaper or lower-grade materials may impact quality. Finding the right answer to this eternal triangle can be the difference between success and failure for both supplier and customer.
This discussion was several years ago, but the simplicity of how issues can be captured with this eternal triangle have stayed with me. I find it a useful framework to agree on trade-offs, discover alignment and find potential ways forward.
The time element is a critical factor in innovation, but it can’t be the ultimate focus in the absence of information regarding quality and financial (cost/value) considerations. This is not just in terms of the cost of bringing products to the marketplace, but also in the perceived value. With rapid advances in science and technology, our ability to create innovation in healthcare with new products has enormous potential. To realize this opportunity, society needs to manage the eternal triangle of quality, speed and cost/value. Advancing new medicines quickly, efficiently and safely is a key component of future public health.
It is heartening that governments are standing up to the challenge by carefully looking at how innovation can be supported. An example is a collaborative approach taken to regenerative medicines in Japan. In 2014, new laws were introduced to facilitate innovation and maintain a focus on safety and quick access to the market through conditional approval. Two products have subsequently been approved (1) by 2017. Within Europe, a one-stop shop for bringing together the various groups involved in advanced therapies was announced in 2014 by the MHRA (2). As the UK moves away from the rest of Europe, managing the change in regulatory systems will be important for continued support of innovation.
In the US, following the Century Cures act in 2016, the FDA is also outlining plans to facilitate the delivery of new products to the public (2). The wide-ranging strategy plans to extend the use of in silico modeling, not only for understanding the pharmacodynamics and kinetics of individual molecules but also for developing natural history databases to aid clinical investigation of rare conditions. New guidance on regenerative medicine and advanced therapy is expected in September 2017 and a five-year timetable for issuing guidance regarding patient-focused endpoints.
It is really encouraging to see these initiatives operating in many governments across the globe. This is an area where everyone needs to get it right. I do believe the stakes are high for everyone, including patients, practitioners, regulators, innovators and commercial organizations bringing products to the market. The industry has developed considerably over the last 20-30 years. In the 1990s, biology was complex but the focus was on a relatively straightforward biological modulation from interacting with receptors, enzymes, and channels. The advent of biopharmaceuticals allowed the industry to target more complex protein interactions, and the science of today allows us to fundamentally alter the properties of cells and organs and how they function. I believe what is critical is that we need to focus on the “sweet spot” to maintain quality at an appropriate speed and cost/value. The quality aspects here are also in the widest sense of the meaning, from governance processes through execution of research and development programs and product manufacture.
This is never an easy undertaking and is an age-old problem for both straightforward creative design and highly complex innovation with medicines development. To do this effectively, we need to embrace appropriate risk management processes that allow all members of the innovation system a clear, consistent and objective assessment of the eternal triangle. The ongoing consultation process involved with the developing of the FDA guidance documents will be an opportunity for interested parties to engage and ensure we find the “sweet spot” or the “best balance” for the many involved.
- Toda, Y. (2017). Japan leading the way in regenerative medicine. Beyond Borders Biotechnology Report 2017, 76.
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All opinions shared in this post are the author’s own.
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Dr Andrew A. Parsons
Director of Reciprocal Minds Limited & Chairman of Pharmasum Therapeutics AS
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