Implementing agile in pharma

Updated: Nov 3


The pharma industry is heavily regulated and specialised, with slow timelines, strict processes and quality requirements, as well as rigid silos. Without a direct relationship with patients, the industry also struggles to understand customer insights and expectations beyond what clinical data reveals. These constraints might sound utterly incompatible with agile methods, frameworks and principles, nevertheless, agile in pharma is on the rise.


Not everything that works in other sectors, works well in a highly regulated sector such as healthcare. Agile methodology is all about leveraging experiences and failures to improve a process. It is a mindset, of doing more for less. At its heart, it enables you to deliver what the customer actually needs earlier, whilst reducing wasted time, effort and resources on the journey.


The four original agile values are:

  1. Individuals and interactions over processes and tools

  2. Working software over comprehensive documentation

  3. Customer collaboration over contract negotiation

  4. Responding to change over following a plan


The big question is, with its regulatory constraints and its unwieldy organisational structure, can pharma marketing be agile?



Over coming pharma specific challenges

The point behind agile is to learn from failures, and of course correct quickly, instead of spending a lot of time and energy trying to make the perfect decision for some event that may happen in the distant future. Using the bite sized decision making approach of agile allows an iterative process that can quickly course correct and be on target far more effectively. Agile, in the marketing context, means using data and analytics to continuously guide promising opportunities or solutions to problems in real time, deploying tests quickly, evaluating the results, and rapidly iterating.


There are several challenges facing the industry in its adoption of agile, but three stand out:

1) Overcoming the traditional mindset

2) Working around organisational structure

3) Coping with the slow pace of regulatory review


In order to effectively execute all of these factors, you have to reconstruct the way your marketing teams are built, to make them far more cross-functional and empower them to make choices without having to go through layer upon layer of sign-offs.


Overcoming the traditional mindset

The major challenges to achieving an agile mindset are breaking away from structured practices that have made marketers successful historically, creating a team that can rapidly collect, analyse, and develop actionable plans. As well as developing a diverse backlog of tactics that can be accessed and rapidly deployed in a short time frame when opportunities arise.

Someone with an agile mindset is willing to make an informed decision in a tight window rather than take weeks to reach that decision.


There also has to be a culture of learning from past mistakes and moving on. The point of agile is that everything won’t work out exactly as planned, and organisations need to develop a tolerance for that. The point behind agile is to learn from failures, and course correct quickly, instead of spending a lot of time and energy trying to make the perfect decision for some event that may happen in the distant future.


Working around organisational structures

The problem, is that internal pharma marketing teams aren’t built to be agile. There’s too much separation between the brand lead, the strategists, the functional leads, and the digital people. The structure of internal marketing teams need to be re-thought in a way that amplifies a cross-disciplinary style, but also assigns a lead, who has the authority to make autonomous decisions.


Coping with the slow pace of regulatory review

No matter how quickly everyone else can make decisions, if those decisions can’t get through legal quickly, the whole purpose of agile falls apart. Regulatory constraints can quickly put the full stop on agile, as its operations remain incredibly slow. As long as the legal department is required to review and approve every piece of material even when only the smallest strategic or tactical change is made, agile will not get the opportunity to live up to its potential.


All functions must attempt to have an agile mindset, or else none will be.


Pharma marketers will not be fully agile in any foreseeable future, the regulatory process is always going to make agile marketing in pharma a bit of a challenge. Despite these challenges, some pharma marketers are starting to think about moving to a more agile approach and are much more aware of the benefits.



When to utilise agile methods

Agile does not require an all-or-nothing approach. Some routines and tools will be valuable and applicable, others less so depending on your context and business needs.

While agile "purist's" often discouraged a "partial-agile" approach, the reality is that within the pharma sector a "purist" approach simply isn't a viable option. The best deployments of agile are often customised to the specific situation of a given company.

Focus on adapting agile principles that work to the realities of your environment.


If your project is something you have done many times, there is a clear process, the outcome is specifically defined and there is little ‘value added’ thinking on the journey, then it is perhaps best to continue with your existing effective approach.


If your project has unknowns, requires significant thinking and the exact inputs, outputs, outcomes and process may be understood at a high level but not at a detailed level, then testing out agile methods and a mindset might be very effective.


Neil Osmond Founder of Earthware developed a great scoring system to know when to use agile and when to continue with your existing approach.


Utilising the agile methods & mindset

Agile principles and scientific methodologies have many tenets in common: 

  • Start simple and build knowledge as you go

  • Do small experiments and learn from trial and error

  • Track metrics to know if you’re on the right track

  • Deliver at speed

  • Test, learn, then adapt new features or experiments to continuously learn and evolve the project

Simply put, being more agile means most teams and organisations will need to think like scientists. This requires experimenting frequently and often, learning and creating the best solutions based on real data, embracing failure, and providing teams with the autonomy and trust to make decisions on their own based on their expertise and proximity to the work. 


Preparation

Anticipate skepticism: Scientists are trained to trust only controlled experiments. To change any initial negative views on agile, you’ll need the right approach for spreading and executing on the concepts.


Emphases the why: Focus more on the “why” of the change to agile than you do on the “what” and “how” of incorporating the methodology. Consensus around goals should drive decisions on which organisational model and practices to apply.


The vision behind the transformation: The leadership team needs to establish a transformation vision and launch the shared understanding of why the transformation is needed. Ensuring employees at all levels understand how the new way of working is going to look like. Your vision must be communicated, shared, and reinforced. Staff development & training: The new ways of working will require new skills. You need to educate your people in your vision. Your people need to know what to do differently, want to behave in that way and have the skills to do so.

Measuring success: It is essential to set and monitor business KPIs that will play the role of your transformation compass. Using digital tools for a real-time overview of the metrics will provide data on your progress and will help you keep your transformation efforts on track.


Setting up the team

Agile teams are more streamlined, have cut out anything that isn’t useful to them, have clear goals in mind, and are able to fully recognise what is working for them and what isn’t. Along with the ability to quickly remedy anything that causes a roadblock in their process.


Build the right kind of team: You need to disrupt the traditional model that is hierarchical and organised by siloed teams. Agile projects have smaller, cross functional teams that include relevant subject experts and different levels of hierarchy. Creating a team that is fit for purpose starts with strategically identifying who must be on the team and defining clear responsibilities and goals. Ideally each team member should be experienced and multi-disciplinary, but in reality most new teams start off with team members with a mixture of experience and/or a single specialisation. To overcome this, a new team needs to be made up of cross-functional specialisations.


Faster decision making: Teams need to be empowered to make decisions within their defined scope, helping to remove bottlenecks, avoid miscommunication and improve flow of work. Some pharmaceutical organisations introduce daily progress discussions. Others transfer a big part of the decision making to the team meetings, to shorten approval chains and eliminate progress blockers.


Team size: A single team should be 7 to 8 members in size. If team size grows beyond 8, it should be split into two smaller teams. The reason for this is that too many team members will result in significant communication roadblocks.


Team structure: The project team includes the: Product Owner, Scrum Master, and Development team. These individuals share different tasks and responsibilities related to the delivery of the product.

  • Leader / Scrum Master - Owns the vision and makes the key decisions

  • Project Manager - Keeps the project on track

  • Customer Representative - Ensures the voice of the customer or user is heard. You need this person on the core team to ask the difficult questions such as ‘Has anyone actually spoken about this to a customer?

  • Knowledge Experts / Development team - Have detailed understanding of products, systems and processes.


Rhythms & rituals of an agile project

There are a number of different processes to Agile that a team can use to become more efficient, including Kanban, Lean Development, and Scrum, but the concept is all basically the same — get work done quickly with as little waste as possible.


Sprint Planning In the sprint planning meeting, your team will decide what will occur during the Sprint. Planning is encouraged to make sure everyone knows their role within the Sprint, and what tasks need to be accomplished.


At the meeting, the tasks at the top of the backlog (or ‘to do’ list) should be ratified, estimated, agreed and assigned with the whole team. There should also be a goal set for the sprint so that the team knows when it is completed, what success will look like and whether they can celebrate, or not, at the end of the sprint.


The Sprint The Sprint is the designated time where the team works on the tasks that will move the project forward. This can last a week, a month, or however long your team needs to get their work completed. Sprints should be long enough to see a significant progression that you can tangibly measure, but short enough to concentrate minds on achieving a goal.

Sprints are rarely less than a week and never longer than four weeks.


Daily Standup Meeting This is a meeting held each day (usually at the start of the day) during a Sprint to catch up with your team. This 15 minute meeting ensures everyone in the team knows exactly what is getting done and what needs improvement. Listing any problems or issues you may have is crucial, so that your team will know to help you out. And small problems should always be addressed so that they don’t turn into big problems.


Every team member answer three simple questions:

i) What did you accomplish since the last meeting?

ii) What are you working on until the next meeting?

iii) What is getting in your way or keeping you from doing your job?


Sprint Review This occurs near the end of the Sprint process when the work has been completed or is almost complete. It is often 30 minutes or less, with every core team member attending. In this meeting, each core team member gives an update, showing their work wherever possible. These should be quick with any detail comments, or questions, saved for afterwards. Each of the sprint tasks should be considered and whether they’ve been completed successfully. If they haven’t, they are moved back to the backlog or to do list.

Remember 95% done is still NOT complete.



Sprint Retrospective One of the principles of Agile is ‘Regularly, the team reflects on how to become more effective, and adjusts accordingly’. Retrospective is a time for the team to look back on the Sprint that just took place, and to go over what worked for them and what didn’t. What lessons have been learnt and will be applied to the next project.


To do this, keep it simple with everyone in the team answering two questions:

  1. What went well and we would repeat?

  2. What would we do differently in the future?

Consider the answers to these questions and write them where everyone can see them in order to change behaviours and practices for the better. Also, review previous retrospectives regularly to see if the team has followed through.


In summary

Implementing agile practices in pharmaceutical organisations comes with some challenges. Being a research intensive industry, staff tends to be highly specialised and used to sequential and rigid ways of working. Also, the overall company culture leans towards a focus on stability, pre-defined work and strong process orientation.


The approach to become agile should be focused on continuous, small incremental and evolutionary changes to the current process, without disrupting what is already successfully being done. Evolutionary not revolutionary changes to foster long-term flexibility and continuous improvements.



If you want to know more about the agile principles check out this article: https://www.hiya.marketing/post/agile-explained

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