You only get one shot at launch, and mistakes can be costly…and PERMANENT.  So, get it right!

One can easily argue that launch is probably the most important point in a product’s life.  Especially in biopharma, where the first few months in the market can easily impact, if not dictate, the future path of the drug’s success.  But, launching into this highly regulated space is tough—to say the least.  About two thirds of all drug launches fail to meet expectations, and almost 80% of those continue to lag behind expectations after year two!

How well your launch is planned and executed will create the path for your brand’s success potential.

Just as a good business plan is so important in starting any business, a well-built launch plan is critical to a drug’s launch.  The launch plan incorporates strategic and operational thinking from key stakeholders across the organization, ensuring that all elements to a drug’s success at launch are considered.  And, this launch plan becomes the team’s guiding light for the ~12-18 months prior to launch.  Therefore, it is important to get it right.

But, launch planning is a delicate, complicated, and time-staking process.  It requires a good understanding of what needs to be done in order to launch successfully, and unfortunately not many launch teams are stacked with deep (or sometimes any) biopharma launch experience.  And, it requires input from many different teams and people, often, as mentioned earlier, from across the entire organization.

With so many different teams involved, a well thought-out launch plan can easily amount to hundreds of deliverables, each with their own sets of steps and actions required.  With so many moving parts, managing and preparing for a drug launch can be a daunting task for any person and team.

A well-built launch plan will capture all of the critical actions and steps needed for success across all teams.  A well-built plan will highlight the key interdependencies between action items, which identify all downstream activities that may be impacted by a particular deliverable.  A well-built launch plan will call out key milestones and deadlines to help teams ensure launch deliverables stay on track, and avoid delays that could have downstream or cross-stream impact.

So, how do you come up with a well-built launch plan?  Below are a few tips that can help you build yours.

Give Yourself Lots of Time

Launch planning is a complex and intricate process, and can be time consuming just to setup, let alone execute!  We have seen that the most successful launch plans are those that start as early as 12-18 months or more before launch!  When working with a compressed timeline, many non-essential, but still valuable deliverables are omitted in order to meet the tight timelines.  However, when adequate time is available, teams can execute on many more deliverables to help shape and prepare the market for launch, creating demand for the product so that you hit the ground running come launch day!  Planning ahead requires timelines and resources to be flexible, but, an early look at potentially busy times of the launch can allow teams to move deliverables to help smooth out the effort required across the duration of the launch plan.  Early planning also allows for recruitment and selection of contractor resources well in advance, saving costs associated with expedited delivery from external 3rd party consultants. .

 

Identify your Launch Subteams and Stakeholders

The development and execution of a launch plan is a collaborative effort across multiple stakeholders and subteams.  Identifying who those stakeholders are, and what functional subteams should be included, can help ensure all appropriate parties are engaged early on.  This can result in a better laid out plan, incorporating expertise from stakeholders in each functional area, and providing a sense of ownership within each subteam, as they execute against a plan they co-developed.

Functional subteams often span across almost the entire organization, including:

  • Scientific and Clinical Development
  • Regulatory Affairs
  • Medical Affairs
  • Manufacturing and Supply Chain
  • Marketing and Market Research/Analysis
  • Sales
  • Finance
  • Legal
  • HR
  • IT

Within each subteam, a lead should be appointed to manage the plan for their respective subteam.  The lead also acts as the key liaison and representative in launch related meetings, and is responsible for communicating updates and issues with the launch team.

 

Develop a Cross-Functional Plan and Identify Interdependencies

Each defined functional subteam should commence development of their individual launch plans.  Each team should be responsible for creating their own functional launch plan, using available resources including previous plans and experienced team members, ensuring that the plan is comprehensive and complete for the brand(s) and indication(s) involved.

Once initial plans are drafted, they should be brought together to form a cross-functional “master” launch plan.  As plans are reviewed and incorporated into the master plan, interdependencies across functional teams should be identified and captured, providing visibility to downstream deliverables that may be impacted by changes or delays in the plan.  Deliverables requiring cross-functional collaboration should also be identified at this time.

 

Identify your Critical Path

Understanding the critical path of your launch plan is critical to the launch plan’s success.  Inevitably the launch plan will change.  Timelines, budgets, staff, resources are all subject to change midway through the launch plan.  As these changes arise, it will be important to adjust the plan to ensure minimal impact on key milestones like regulatory submission (amongst others).  As the launch plan adjusts, knowing the critical path will allow you to reprioritize deliverables and allocate resources in order to minimize the risk of key milestones being delayed.  Knowing which deliverables can be reprioritized, where budgets can be reduced, where staff can be reallocated from, is all an important part of successful launch planning and execution.

 

Team Meetings

Scheduling regularly recurring meetings is essential to ensuring appropriate stakeholders are apprised of the latest launch status, and risks, delays, and other issues are identified and communicated promptly.  Different teams can meet at different schedules, RxL recommends the following:

  • Weekly Functional Subteam Meetings: Frequent meetings within each subteam to convey a detailed status for appropriate deliverables and activities, and discuss potential risks as they arise, and appropriate mitigation strategies.
  • Weekly Launch Team Meetings: Frequent meetings with the Launch owner and each functional subteam lead to provide a cross-functional overview of the launch plan, and discuss risks and issues that may result in a cross-functional impact.
  • Quarterly Cross-Functional Meetings: Larger, cross-functional team meetings with all team members involved in the launch can help keep drive engagement and keep focus on any near to mid-term milestones approaching. These meetings can also be used to communicate changes in strategies or tactical execution.  These larger meetings may also promote cross-functional dialogue, especially in areas where collaboration or interdependencies exist.

 

The Right Tools can make a Big Difference

Though there are several project planning tools available on the market that may be helpful (we absolutely recommend using SOMETHING), there are tools available, like our very own LAUNCHxL, which are designed specifically for launching products in the BioPharma industry!  These tools have been designed with the specific challenges of launching a BioPharma product in mind, and are catered specifically for your type of project.

For example, our purpose-built tool LAUNCHxL allows you to develop a cross-functional launch plan, complete with deliverables, activities, timelines, status, budgets, and responsibilities, while also providing the ability to generate reports to highlight key aspects of the launch status that are easy to export and incorporate into management and executive presentations.

Furthermore, LAUNCHxL comes fully populated with all the launch deliverables needed to launch a project, pegged to your launch date, so that you can leverage our experience when creating your launch plan!

 

Experience Matters

How do we know that these are some of the most valuable tips to keep in mind when planning a product launch?  Because we have extensive launch planning experience!  Our team at RxL Partners has worked in the industry for over 15 years, and help launch over 30 products in the US!

So when you think about launching your next product, keep this list in mind.  And remember, it’s always best to have experience on your side!  Let RxL be your launch partner, so you can leverage our experience and build a winning launch plan!