| T Nicholas Mitchell |
There is a primary research and development model that for decades, we as professionals in life sciences, pharmaceuticals, and biotechnology companies typically pursue, namely the nominal advancement model of innovation.
The nominal advancement model is well known; it takes an existing technology and measures the parameters that afford the product’s benefits. Then it considers incremental advancements or improvements to some or all of these parameters, and projects the measured increase to the product benefits. The associated costs for these improvements are formalised, and the feasibility of accomplishing the advancement is predicted to determine the level of risk associated with the potential decision to go ahead with the advancement. Upon a successful debate within management, the development proceeds. Throughout the lifecycle of the nominal advancement model, there can be ‘breakthrough innovation steps’ which allow the product to take a major leap ahead, but in a study over time, a relatively linear curve is still realised for the advancements.
Take, for example, the development of a new processor for standard desktop PC. The graph on Moore’s Law (Figure 1) illustrates how PC technology has advanced over the last 40 years. Moore’s Law clearly indicates the nominal advancement model in action (http://www.planetfuture.info/eng/e_index.htm).
The associated performance improvement curves relate to the speed of the device, the amount of memory/storage the device contains, and the relative amount of space (foot print) required for the device. All of these parameters are marginally improved (or improved 1x, 2x, etc.) in each successive generation. The proportionally expanding customer base for the products appreciates the advancements and typically accepts a similar incremental increase in the price based on the new value.
A primary example of this type of innovation for Phenomenex and the HPLC column industry has been the progression of the spherical silica base material to smaller and smaller particle sizes over the last four decades. Starting in the 1970’s and early 1980’s with particle sizes of 15-20 micron, over the 40 years that the products have been available the charted migration to ‘sub-2 micron’ particles has moved the performance of the commercially available tools to increasing levels of performance, similar to that of the improvements of the microprocessors within the computer industry across the same timeline.
This migration to smaller particle sizes has led to the increase in efficiency (N, or theoretical plates per meter), the major parameter measured by column manufacturing companies and our customers, to indicate the level of performance the column is achieving (Figure 2). A higher efficiency value means many benefits for the chromatographer, the primary two being higher sensitivity (detecting lower quantities more accurately) and faster run times, increasing laboratory throughput and decreasing turnaround times for analysis.
Accordingly, the user base has also expanded from being a technology used primarily by analytical chemists to finding its way throughout a variety of laboratories in the pharma development process, including formulations, process chemistry, and drug metabolism and clinical trials segments (often outsourced today to separate companies providing these services) as well as the supporting CRO companies in the closely aligned space.
Disruptive innovation
As liquid chromatography proceeds through its fifth decade of commercial existence, let us consider a newer model, disruptive innovation, to more rapidly advance our progress and change our present paradigm. According to Harvard Professor Clayton Christensen, ‘Disruptive innovation’ transforms a product that was historically so expensive and complicated that only a few people with a lot of money and/or a lot of skill had access to the technology; a disruptive innovation makes it more affordable and accessible, that a much larger population have access to it (Clayton Christensen; http://www.claytonchristensen.com/key-concepts/).
Disruptive innovation is typically reserved for larger market sectors, such as the IT or telecommunications. But, one globally recognised disruptive innovator comes from right here in India, namely Tata’s Nano automobile. (Figure 3: Taken from: http://mashable.com/2011/10/09/7-disruptive-innovations/)
The major barrier to this model in our industry is the sharing of knowledge across the supplier-customer-regulatory interfaces. While the pharma and biotech pharma companies must keep their research efforts confidential to protect their position in the most competitive of markets, openness to collaboration with your life science partners like Phenomenex can afford an entire new rate of innovation. Additionally, the subsequent acceptance of these new innovations by the regulatory agencies that govern our testing environments will require a collaborative presentation of the developments to assure these groups there has been absolutely no compromise to the quality of the results delivered by these new testing methods.
Today there are two major platforms within the analytical chromatography arena that are not being utilised in many cases to even 25 per cent of the capacity for which they were originally designed – namely Ultra High Performance Liquid Chromatography (UHPLC) and Supercritical Fluid Chromatography (SFC). Why? Perhaps it’s because we are trapped within the mental constructs of the nominal innovation model? Perhaps it’s because at the intersection between the science and the business of the science some of the most effective communicators are not taking the time to consider the advantages of a disruptive model and subsequently developing better game plans for educating the masses on both sides of the equation? Whatever the reason, now is the time to move beyond these barriers and begin making more substantial progress with the tools the most innovative life science companies are providing to the market.
One of the technologies that Phenomenex has introduced to be used within these two instrument platforms is our Kinetex Core-shell Technology. Using sol-gel processing techniques that incorporate nano-structuring technology, a durable, homogeneous porous shell is grown on a solid silica core to create a core-shell particle. This particle morphology results in less band broadening compared to fully porous particles and thus delivers extremely high efficiencies (http://www.phenomenex.com/Kinetex/CoreShellTechnology). At present, neither of these two platforms, nor these incredibly advanced consumable technologies that are incorporated into them may be considered disruptive innovation as defined by Christensen.
Disruptive innovation challenge in pharma/life sciences in India
- The time is now to realise a disruptive innovation within our industry. In order to achieve this innovation, three things have to happen:
Common goals and incentives must unite us
- Lowering the cost of global healthcare
- Lowering the cost of R&D as a percentage of pharma expenditure
- Offering awards and recognition to those organisations that significantly advance the initiatives of the challenge
Scientists must have better platforms to communicate
- Develop forums where these collaborations can be regularly pursued and tracked
- Develop on-line technologies to facilitate more interactions and exchanges
Government agencies need to offer their support and commitment
- Approval processes incorporating these new technologies need to be passed through the regulatory hurdles with little or no delay, perhaps even expedited when possible to show the global governments’ commitment to these initiatives.
Metrics for success
The emerging testing markets here in India and in some of the impoverished nations surrounding us will be the measurement for success. When food testing and environmental testing laboratories that cannot currently afford our state-of-the-art technologies for their testing requirements are capable of outfitting their laboratories with our products, then we will realise as a scientific community that we can count this accomplishment as one of our successes.
Phenomenex India is doing our part to assure these strategies for success. At present, we are working more closely with our customers than we ever have before, sharing information about the research and development of our product technologies and interfacing with our customers technically in a number of different ways:
Phenomenex seminars are being conducted in India by US-based research and development scientists for a number of our product technologies that are based on the core-shell technology. We are regularly presenting detailed specifications about the development of the products, and we are encouraging our clients to further intensify their use of these technologies in their laboratories.
Phenomenex deminars are being conducted within the laboratories of some of our closest clients, to challenge the limits of conventional thinking by working side by side and pushing these clients to move out of their comfort zone of standard method development parameters and enter a new age of lightning fast analyses.
Phenologix is full-service analytical support laboratory within Phenomenex that specialises in method development and optimisation. Here, we bring your most aggressive challenges back to our laboratory and develop methods to specifications agreed upon in advance, and with our commitment to be as efficient and reproducible as possible.
Phenomenex India Management is working closely with Confederation of Indian Industry (CII) and the Life Sciences Panel of Andhra Pradesh, as well as Indian Analytical Instruments Association (IAIA) on a number of initiatives that we hope will begin educating the young workforce just now coming into the laboratories of Indian pharma and biotechnology companies to empower them to promote these changes to the research and development processes established within the industry today.