The Roadmap towards Product Launch Excellence

Partnering clinical & commercial teams under their common goal of achieving better health outcomes for patients is crucial.

With stricter payer requirements, pharma companies need to figure out how to become excellent at launching their products in a way that proves value to payers, physicians, and patients. According to Steve DeVrieze, VP, Head of Emerging Biopharma and Technologies, U.S. Commercial, Quintiles, this is possible by partnering clinical and commercial teams under their common goal of achieving better health outcomes for patients. However, to clearly define this partnership and see its effect through, companies need to build a roadmap where commercial planning and product launch assessment starts as early as possible.

DeVrieze, whose firm has assisted the successful launch of more than 220 products globally in the last decade (in 20 countries since 2009), recommends a roadmap that starts at least 36 months prior to product launch. Furthermore, this roadmap must be informed by an analysis of the end points that command value once the drug gets to commercialization - the physicians who prescribe the drug, payers who reimburse for it, and patients who use it.

The performances of functions are commonly measured against separate and distinct metrics, but metrics need to tie clinical and commercial together.

A comprehensive and integrated product launch roadmap includes specific plans for each function – regulatory, medical affairs, distribution, payer engagement, marketing and promotions, sales, patient impact – along with the major milestones for each function in relation to making an accelerated and efficient product launch. Mapping out product launch milestones requires tremendous amounts of data, and early market access research and value insights from stakeholders should inform clinical teams prior to Phase II and Phase III trials.

DeVrieze suggests scheduling the implementation of the distribution plan 12 months prior to launch, the medical affairs plan nine months prior (to engage with key opinion leaders), the payer engagement plan six months prior, and the sales plan three months prior. The roadmap, therefore, formalizes what each function is accountable for while also letting them know what they can expect from other functions.

For the roadmap to be effective, the following three factors need to be present:

1. Leadership – To pull the company together as it meets the payer landscape challenge head on, senior management should be the driving force of effective product launches. “Leadership needs to ensure the integration between clinical and commercial teams,” says DeVrieze, adding that silos are detrimental to any product launch. Leadership is crucial in conducting integrative launch plan reviews to ensure that everyone stays on track. DeVrieze suggests making monthly reviews when the launch is 24 months out, weekly reviews at 12 months out, and even daily reviews when it is just a few months out.

2. Internal processes – The internal processes of a company facilitate partnerships between clinical and commercial teams. “Comprehensive launch plans with milestones and accountabilities developed early on and tracked throughout can significantly improve integration of commercial and clinical teams, leading to a more effective product launch,” explains DeVrieze. Transparency is extremely important so that all teams maintain their collaboration with each other and the interdependencies between functions stay clear. Heads of each function must meet each roadmap milestone to ensure interdependent success of the launch and to maintain trust between functions and with stakeholders.

3. Cross-functional incentives – “The performances of functions are commonly measured against separate and distinct metrics, but metrics need to tie clinical and commercial together,” says DeVrieze. The scorecard by which each function is evaluated needs to encourage integration between functions. “Their incentives need to be mutually aligned to drive collaboration for long-term success,” he adds. Indeed, clinical and commercial teams can be integrated together smoothly if their focus is on prioritizing patient value. For instance, clinical teams can work from an R&D process to facilitate health outcomes for patients, while commercial can maximize patient health outcomes once the product is in the market.

A roadmap that identifies the commercial and value end points, as well as visualizes how to get the product to market more efficiently, provides a picture of how much collaboration, accountability, and timeliness is expected from each function. It also exposes how the decisions of one function can affect the others, and how all functions are ultimately united under the main goal of putting the patient first. As DeVrieze emphasizes, “In driving more effective product launches, we ultimately drive stronger health outcomes for patients" – a topic Quintiles will be discussing in more detail at the eyeforpharma Philadelphia 2016 conference.

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