Facilitating change to process hypervelocity conditions
The speed of drug development is often informally characterized as velocity, wherein there is a passage of new drugs through a stage-gate process. Increasing the velocity of the pipeline flow is often achieved by including innovative tools, either decisionable biomarkers, or using modeling and simulations. The term hypervelocity is usually referenced in space research, and signifies super high velocity. The author introduces a new use of the term hypervelocity to describe the pressing patient need in pandemics, which require a heightened sense of speed and resource mobilization in the backdrop of significant uncertainty, to deliver therapeutics in the face of pandemics.
Issues that may have contributed to poor conversion rates is the lack of agility in the organization and tolerance towards risks. A risk-averse culture may reflect the presence of greater bureaucracy stifling innovation. The inherently large failure rates for NME development (one in 10 compounds reach the market as a drug [4]) coupled with the slow innovation nature of the NME business [1] predisposes an innovation enterprise to stage its investments carefully. Such a predisposition contributes to an organizational lethargy, which in the context of the short window of opportunity that exists for opportunistic investments may create an unsustainable barrier to value maximization.
Hansen and Birkinshaw [3] indicated conversion-poor companies will benefit from multichannel funding and safe havens. Let us further examine these aspects.
In a pipeline-centric model (as we call prioritized-investments model), there is a single pipeline and single funding and resource pool. For example, a firm may opt for a particular therapeutic area focus for such investments. When a change situation occurs (e.g., a repurposed product for a new indication) the new situation now competes with the prioritized investments for resources and funding. Invariably, the new drug candidate for that therapeutic area gets a higher priority and the repurposing of the molecule may receive a lower priority. While the former provides an anticipated benefit more than 10 years in the future, the latter provides a more imminent benefit in enhancing patient value.
In a patient-centric model (as we define hypervelocity model), there may be multiple pipelines and multiple resourcing models created with more directed investment funding pool established to support emerging diseases or pandemics. The funding of such ideas is at a noticeable fraction of that required for the NME, and can be stage-gated to weed out the low probability ideas and select ones with high probability of technical and commercial successes for full development.
The hypervelocity enabling apparatus should be nimble, leveraging the power of “skunkworks” [5], with little managerial oversight to avoid hindering its mission. This creates a safe haven for emerging realizable opportunities which may fall by the wayside in the firm’s current organizational structure [3].
The cultural environment within the patient-centric apparatus will be entrepreneurial in nature. Individuals, teams, and managers will be expected to exercise entrepreneurial alertness and attitudes towards risk taking [6,7]. Like Hamel [8] proclaims, entrepreneurs create new wealth while stewards conserve. Over time, the conserving attitudes paralyze the organization’s ability to remain vigilant to new business opportunities. There may be hybrid models where there may be a primary pipeline apparatus that plays a conserving role, while a second pipeline apparatus be opportunistic, tolerant to risk-taking, and be entrepreneurial. Creating an overall organizational balance between these two forces will also develop agility in thinking while creating a buffer between long range and short-range goals.
Such an organizational mindset change will be more aligned with a“play-to-win” strategy [9], where winning is improving quality of life for patients. It will be incumbent upon firms to establish patient-centric innovation as a priority for the company, and directly take ownership for innovation productivity. This will send strong signals aligning innovation priorities as a key link to company business strategy to the rest of the organization on enhancing product and patient value. Table 1 summarizes the critical determinants of successful innovation performance.