“My launch was based on an initial set of assumptions, but factors changed quickly, what should I do now?

Sound familiar? We hear this a lot.

One thing’s for sure, if your launch assumptions or timings change, don’t be tempted to follow your original plan – you will need to course-correct your project plan to achieve launch success.

In this post, we highlight the common ‘watch-outs’ for the internal, external and clinical factors that typically trigger changes to launch project plans on the journey to commercialisation. We also share our recommended ‘Launch Plan SOS’ strategies.

Internal Factor ‘Watch-outs’

There are many internal factors that can impact your launch planning process and trigger changes to your launch project plan:

  • Senior stakeholder input
  • Launch Readiness Reviews at T-18, T-12 or T-6 (Top tip – if you maintain a check-list for each review meeting you will keep on top of any potential ‘watch-outs’).
  • A launch sequence change
  • A change in launch lead with different ideas about how to implement launch

Launch Plan SOS Strategy – Internal Factors

If you document your launch project plan in an online, intuitive project management platform (such as Ignite), you can quickly and easily implement minor changes to your launch project plan and update the timelines accordingly. Ideally a Launch Excellence/ Implementation Project Manager will help you make these changes. They can also help you track your progress against your new updated launch project plan during your Operational launch project team meetings.

External Factor ‘Watch-Outs’

Monitoring any changes to your PESTLE (Political, Economic, Socio-cultural, Technological, Legal and Environmental) assumptions throughout your journey to launch is always a good idea, however in the current climate it’s especially important.

If your launch planning process started pre Covid-19, it is very likely that both your strategic and tactical launch plans will need a review and a refresh.  E.g. Are there likely to be any changes to the patient journey as a result?  Will your approach to stakeholder engagement have to change? What changes in format to your non-Branded and Branded materials will you need to make? 

It’s also possible that your clinical timeline may have changed due to delays caused by Covid-19 related restrictions to subjects and study centres. It’s more important than ever in the current climate that communication between Medical, Commercial and the full cross-functional launch team is high quality and frequent in order to keep abreast of the latest changes to the launch timeline as soon as possible.

Clinical Factor ‘Watch-outs’

The presentation of either a better than anticipated clinical profile, or a worse than expected dataset is a common source of significant change to launch plan content and project plan timelines. 

It’s essential to check in against your TPP and your assumptions about patient population, pricing, submission and marketing authorisation timelines, plus any anticipated additional evidence needs required after each significant dataset release.

When a better than anticipated clinical profile is established at an earlier phase, although this is great news – launch timelines can be expedited at short notice requiring the same number of tasks to be completed within the expedited launch timeline. It’s good practice to always plan for your shortest possible route to launch as it is much easier to extend a launch timeline rather than reduce it!  

Launch Plan SOS Strategy – External and Clinical factors

If external or clinical factors cause more significant changes to your launch project plan, it’s important to follow 3 key steps

  1. Share the impact to your launch plan with your whole cross-functional launch team as soon as possible.
  2. Escalate using the escalation pathway agreed during your project chartering process. Ideally as part of your chartering process you will have agreed the internal communication cascade for significant updates to your launch – such as positive opinion or marketing authorisation. This same cascade should be followed for any significant change to TPP or launch date.
  3. When you need advice and input from your whole cross-functional launch team the easiest way to do this and bring your launch plan back on track is to run a Launch Re-planning Workshop. During this process the launch plan timelines, milestones and activities are re-mapped based on your new set of assumptions and then your plan can be accurately tracked against its new timelines.

Curious to find out more?

If you like this article and would like to find out more – we would be delighted to help: launch@innovative-edge.com.

At IE, we inspire excellence in launch. We are passionate about supporting our pharmaceutical clients. We provide expertise in launch excellence counsel, capability development, project management and lead with the ‘best in class’ Launch Management Platform, Ignite™.

Author of this article

Jane Francis is an Associate Launch Implementation Partner at IE. Jane has 20 years experience of working on and around launches at Country, Regional and Global level at J&J and GSK.  Her client based background in Global Launch Excellence, coupled with several years providing launch counsel for a variety of clients in a strategic partner capacity has given her a great insight into launch best practice.