The product development model in the biopharmaceutical industry needs to shift away from “two divergent paths based on clinical-medical and commercial information” and towards a single path yoking clinical and commercial resources to market access strategy, information and capabilities, argues a new white paper from Quintiles.

The white paper by John Doyle, Quintiles’ vice president and practice leader, Christian Gabel, senior director and Nicole Connelly, principal consultant in Quintiles’ Consulting group, offers a prescription for what the US-based biopharmaceutical services company calls the New Health landscape, one driven by “relentless pressure” for added value and innovation combined with enhanced safety, ethics and stewardship.

In this environment, the consultants say, companies must narrow the gap between the “clinical medical foundation” and a “fact-based understanding of the new constellation of stakeholders who control access to today’s markets – policy-makers, more empowered regulatory entities, payers and provider groups”.

They see “dramatic benefits” ahead for companies that “develop a differentiated understanding around the confluence of stakeholder needs early in the development phase and then continuously use this data throughout the [product] lifecycle”.

That understanding has to take into account the varying evidence requirements across the stakeholder spectrum, Doyle et al warn. While physicians are demanding more evidence of a new drug’s effectiveness, patients want more reassurance on product safety, payers are looking for demonstrable proof of a therapy’s value, and policymakers need confirmation of a product’s real-world risk-benefit in large populations.

From concept to application

More than ever now, the white paper points out, drug developers need to “understand the potential market realities, and incorporate commercial knowledge into the early stages of a product’s lifecycle”. In reality, though, applying the concept of clinical-commercial convergence “remains elusive”.

While a recent Quintiles study found that 77% of biopharmaceutical executives believed convergence between clinical development and commercial operations would have a positive effect on their business, “there are no clear processes or best-practice guidelines for biopharma companies to follow that address divergent stakeholder needs in an effective and efficient manner while providing the right data to the right stakeholder at the right time in the drug’s lifecycle”, Doyle et al write.

Moreover, they note, “the traditional silo structure of most large biopharmaceutical companies is not conducive to a convergent approach to development”.

The white paper proposes a ‘clinical-commercial product blueprint’ based on three pivotal actions:

- Building a new leadership and capability model to enable convergence. While
most major biopharmaceutical companies have commercial representation on their
product development teams, “the composition of the commercial sub-team is typically
only sufficient to provide insights into competitors, markets and patient disease states”,
the authors comment.

Rather, companies should be looking to “connect key commercial, evidence-generating
groups such as health economics, outcomes research and market access. This
integration will not only be effective for driving tactics such as a payer liaison strategy,
a cost-effectiveness strategy or a patient-reported outcomes strategy, but will also be
useful for establishing and embedding these steps as part of the drug development
process”.

These strategies, in turn, “must be aligned and focused on developing data through the
utilisation of the target product profile and clinical study plans, which will be critical to
addressing key stakeholders’ expectations”, Doyle et al add.

- Developing a differentiated perspective. This involves applying the relevant
capabilities of the product development team to understanding stakeholder needs and
decision-making as defined by type of stakeholder and market sector.

Moreover, the white paper says, the “underlying logic drivers” for determining,
evaluating and summarising the findings of this process must align with three key
parameters that drive stakeholder decisions: economic, social and political factors.

Translating this stakeholder analysis “from value perception into meaningful data-driven
outcomes” requires tactics such analysing real-world competitor experience when
addressing comparative effectiveness research requirements for certain drugs in certain
markets, or considering drug lifecycle stages and environmental changes/barriers that
could potentially limit market access.

- Defining a new converged clinical/commercial stage-gate process. To ensure
that synergies between cross-functional capability sets and analyses are realised to the
best advantage, “it is important to focus on integrating processes, data and tools”
throughout the progressive development stages, the consultants write.

A good starting point, they suggest, is to build a common project planning framework
that clearly defines responsibilities and time lines. This will facilitate critical cross-
functional development and management, while teams will benefit from leveraging a
common information platform, data-sharing environment and shared set of tools.

As the business approaches key integration ‘gates’, “processes for bringing
teams together for productive cross-functional discussions will be critical”, Doyle et al
stress. “In addition to ensuring that either face-to-face or virtual conversations are
productive, a robust team facilitation process will help to ensure that all cross-
functional view-points are brought to bear on the final decisions and outputs.”

Paradigm shift

If biopharmaceutical companies want to be better positioned to deliver on the promise of innovative, safe and effective medicines, they must “fundamentally change the manner in which their organisations are structured, and place more emphasis on early-phase convergence and collaboration among the clinical and commercial functions”, the authors conclude.

This “clinical development paradigm shift”, they argue, calls for “people, process and technology solutions to ensure sustainable change that will drive a product’s value post-launch”.