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.