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Gain a deeper understanding of the product launch process

Use best practices to create a cohesive strategy for a successful product launch, whether it is for a small molecule, biologic, vaccine or device
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Based on the experience of over 150 launches around the world, this article draws on the lessons learned to delve into the specific approaches necessary to deliver best practice at each of the three stages of the development and launch of a product:

1.  Early development: discovery through to the end of phase II

2.  Late development: phase III through to 'commit to file'

3.  Launch window: 'commit to file' through to launch


Early development

Understand the market
In the early development stage, the first step is to gain a robust understanding of the market landscape. The brand team needs to identify how patients are currently being treated, the unmet needs in the therapeutic category, the competitive landscape and the payer environment. 

Using secondary research, marketers can develop a disease dossier. The same secondary research, combined with primary market research, can be used in the development of a treatment-flow model, which highlights the interactions between patients and healthcare providers.  A competitive assessment, including both current and future products, can provide new product planners with specific insights into likely competitors' strengths and weaknesses. Finally, a high-level understanding of the payer environment can help inform the likely value proposition requirements for the asset moving forward.

Create a winning label
It is necessary to create a winning label in early development that can be used to guide subsequent development and commercial efforts. A strong understanding of the market, preclinical and early clinical findings and insights from key opinion leaders can provide guidance into whether the product has the ability to address any of the unmet needs that have been identified. The strategic role of the commercial function at this period in the product's life cycle is to ensure the development team creates a strategy and supporting trials that adequately differentiate the product from its competitors.

Forecast the opportunity
The third step in early development is to forecast accurately the opportunity and set management expectations of both revenue and the required spend pre- and post-launch.  The forecasted revenue, as well as development costs, are two critical inputs that must be factored into the organisation's decision about whether to move beyond proof of concept and into pivotal – and costly – phase III trials.

Late development
Deepen market understanding
In the late development stage, brand teams should create a comprehensive global commercial plan. The first step in this process is to deepen the organisation's understanding of the market situation. In addition to incorporating anything that has taken place from a macro-event perspective, such as changes in government policy or major competitive events, the organisation also needs to deepen its understanding of the existing information by either refreshing previously conducted work or, alternatively, conducting more rigorous quantitative work to validate and quantify assumptions that were previously sufficient.

Develop a commercial strategy
The next major component of the global commercial plan is the commercial strategy. This needs to include the following: a differentiation platform, product positioning, a message platform and critical success factors/strategic imperatives.

Create a launch plan

Owing to the intense demands of this stage, individuals who are involved often find themselves extremely busy doing important work without having a complete understanding of their priorities, what the critical interdependencies are and which deliverables other launch team members are completing.

To manage this important phase of a brand's life cycle and set the stage for a successful launch, the launch team must develop a strong launch plan that will:

  • Identify the functional areas (subteams) involved in launch
  • Determine the key deliverables to be completed by each subteam
  • Define the deliverables to ensure transparency across subteams
  • Assign realistic start and stop dates for each deliverable
  • Outline the specific activities that must be conducted to complete the deliverable
  • Identify critical interdependencies within and across subteams
  • Assign individual accountability.

If co-ordinated effectively and within the parameters defined in the commercial strategy, effective completion of the launch deliverables will generate market excitement for the coming launch – for example, market education – and ensure the product is correctly positioned, effectively pre-empting the competition.

Structure the organisation

The next step is to understand how to structure the organisation and identify the team members that will be required; marketing, sales, medical affairs, manufacturing, trade, distribution, regulatory and reimbursement. It will be necessary to get the appropriate hires in place in the appropriate regions and get their perspective and involvement as the transition from global to regional planning takes place.

Launch window
Ensure seamless management
Once the decision has been made to file and potentially launch the product, all of the launch-related activities shift into high gear. Launch project management becomes a critical function at this time, as it is necessary to monitor and track progress of the launch plans. This is done through a well-defined process to update and manage them and report on a regular basis.

Prepare for regulatory interactions

At this stage, the team also needs to prepare for regulatory interactions and make sure there is a compelling and well considered label negotiation strategy in place. To minimise surprises and facilitate adherence to timelines, brand managers should proactively maintain open lines of communication with regulatory officials.

Pre-submission interactions with regulatory authorities can assist in adequate preparation for the application process and can help evade oversights that cause delays. Risk management processes should also be developed early in the application procedure.

Establish a pricing and reimbursement strategy

Although the vast majority of the work related to the access and reimbursement strategy should have been done well in advance, at this stage, it is essential to have the most appropriate pricing strategy at the global level. This must ensure adequate reimbursement and access in each of the local markets targeted for launch with the appropriate launch sequence that minimises the risk of reference pricing.

A well-developed value dossier with the appropriate health/economic models and guidance on contracting and negotiation for the local markets are essential to implement the pricing and market access strategy successfully.

Maintain internal communication and training

Another key element at this stage is an adequate level of internal communication. This will ensure that all functions and regions responsible for the product launch are well aware of all of the most recent developments with respect to the market and the product status, as well as the launch strategy. This goes hand in hand with training of all internal personnel, including the field salesforces and the commercial and medical teams in the various local markets.

Conclusion
A successful pharmaceutical product launch requires a complete strategy that unfolds over the course of the development and initial launch of the brand. By following the best practices described here, brand teams can benefit from the lessons learned through long experience.


Darius-NaigamwallaAshwin-Dandekar
The Authors

Darius Naigamwalla (left) is managing director, North America, Campbell Alliance, and Dr Ashwin Dandekar is global practice area leader, Campbell Alliance

13th January 2012

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