pharma launch project plans

In this post, we highlight the common watch-outs for the internal, external and, clinical factors that trigger changes to pharma launch project plans on the journey to commercialisation.

We also share our recommended ‘Launch plan SOS’ strategies.

“I based my launch project plan on an initial set of assumptions, but factors changed quickly; what should I do now? “

Sound familiar? We hear this a lot.

If your launch assumptions or timings change, don’t be tempted to follow your original plan. Instead, the best advice is to course-correct your project plan to achieve launch success. Here’s how…

Pharma launch project plans – internal factor watch-outs

Many internal factors 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 checklist for each review meeting, you will keep on top of any potential watch-outs.
  • A launch sequence change.
  • A new launch lead who has a different approach.

SOS strategy – internal factors

Document your launch project plan in an online, intuitive launch management platform. From here, you can quickly and easily implement minor changes to your plan and update the timelines accordingly. Ideally, a Launch Excellence Partner will help you make these changes. In addition, during your operational launch project team meetings, they can also help you track your progress against your new updated plan.

External factor watch-outs

Monitor any changes to your PESTLE (Political, Economic, Socio-cultural, Technological, Legal, and Environmental) assumptions throughout your journey to launching. In the current climate, this is especially important.

If you started your launch planning process pre-pandemic, your strategic and tactical launch plans will likely 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 format changes will you need to make to your non-branded and branded materials? 

Your clinical timeline may have changed due to delays caused by Covid-19 restrictions to subjects and study centres. Therefore, it’s more important than ever in the current climate that communication between Medical, Commercial, and the entire cross-functional launch team is high quality and frequent to keep abreast of the latest changes to the launch timeline.

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 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 that are required after each significant dataset release.

Whilst it is excellent news if you receive a better than anticipated clinical profile at an earlier phase. You will still have the same number of tasks to complete but within a shorter timeline. Therefore, it is good practice to always plan for your fastest possible route to launch, as it is much easier to extend a launch timeline than reduce it!

Launch project plans 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 three key steps

  1. Share the impact on 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 decided on the internal communication cascade for significant updates to your launches — such as positive opinion or marketing authorisation. Then, follow this same cascade for any substantial 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, you will re-map the launch plan timelines, milestones, and activities based on your new set of assumptions. You can then accurately track your plan against its new timelines.

Curious to find out more?

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

At IE, we inspire launch excellence. We are experts in pharma launch planning, launch excellence technology, and launch project management.