Agile ways of working for a Pharmaceutical Study 

Southeast Asia’s pharma and healthcare sector is expanding and changing quickly. Significant progress has been made in the areas of research and development capabilities, healthcare infrastructure, and regulatory frameworks in recent years to facilitate the expansion of this business.

Malaysia, in particular, is gaining recognition as a preferred destination for medical treatment and conducting more clinical studies and research each year due to its well-established healthcare infrastructure, diverse patient population, efficient approval processes by regulatory authorities (such as the National Pharmaceutical Regulatory Agency), and strong ethical guidelines.

Clinical research programs often face evolving requirements and changing circumstances, such as protocol amendments or unexpected challenges, such as regulatory hurdles and complexities, stakeholder involvement, and shifting priorities. Agile practices allow teams to respond quickly to these changes by adjusting priorities, reallocating resources, and incorporating new information, requirements, and data.

The ask

A well-established global biopharmaceutical leader with in-house experts, experience, and tools to implement such a challenging program approached us for our services due to requiring support in navigating the complex nature of the program.

Their main request was to set up a structure for smooth cross-functional collaboration among the different expert teams to ensure there would be no time wasted in double work, unnecessary delays, or handovers.

To set their team up for success, Ekipa provided a 2-day Agile fundamentals training course and kicked off the cross-functional collaboration with a 3-day big room planning. We introduced a series of Agile practices, including Agile planning and visualisation, establishing a team-of-teams to support and lead the cross-functional program work, and a lightweight iterative framework to ensure feedback loops and a chance to inspect and adapt to maximise the chances of achieving the challenging program outcomes.

The Challenges

Complexity of a launch event

Large-scale product launch events are typically rather complex endeavours within the pharmaceutical sector. There is a lot to plan, consider, follow up, mitigate, and comply with. Moreover, the pharmaceutical market in Malaysia and the broader APAC region is very competitive and highly volatile. 

Government initiatives and regulatory requirements

To facilitate greater collaboration across APAC and reduce market fragmentation in the industry, there are a number of regulatory harmonisation initiatives happening in Malaysia. On top of that, the Malaysian government is actively promoting biotechnology and biopharmaceuticals as a key economic sector through incentives and policies to attract investment, partnerships, and clinical trials from global biopharmaceutical companies. This is a bonus obviously, but also a challenge, when it comes to complying with new and changing policies and regulatory requirements.

Managing internal and external stakeholders

All this means is that a considerable amount of coordination is required among stakeholders– both internal and external. The process of setting up a large-scale vaccine launch event, in combination with establishing a registry-based study, therefore requires deep knowledge, advanced expertise, and excellent communication skills. With tight deadlines, and a large group of subject matter experts involved, the risk of siloed work and internal miscommunication was a constant worry that our client wanted to tackle.

Risk of siloed work

In a high-risk-prone and regulated environment like Pharma, many inbuilt checks and balances and a wealth of SOPs and signoffs exist. Many companies in this industry are posed on having full control by building a watertight system of detailed planning, and skillful experts working on certain parts before handing over to the next team. For complex initiatives, this siloed work raises the risk of not seeing the whole picture, and optimising locally instead of systemically. 

By adopting Agile practices and ways of working within and across teams, our client was able to allow cross-functional collaboration, planning flexibility, and program-wide transparency. How useful is it, after all, to stick to a long-term plan, if the market is evolving, policies are changing and the pharma industry is moving more rapidly than anticipated?

Our Solution: Enabling transparency and cross-functional collaboration through Agile

There is one main answer to this challenge, and that’s ‘Transparency’.

By listing, visualising, and planning out the foreseeable work, the program team was able to draft a month-by-month backlog during the multiple-day ‘Big room planning” sessions. We had prepared an aligned agenda with a range of topics that would kick start the Agile way of working and enable smooth team collaboration all the way to the the vaccine launch, and beyond. As facilitators, we made sure there was enough time and room for meaningful discussion, timely breakouts, and loads of fun. The group consisted of more than 30 people from all layers and relevant areas in the organisation, it was what could be described as ‘a perfect storm’. These sessions not only involved planning and brainstorming,  but also making team agreements, crafting a vision and purpose, creating a narrative, and literally connecting the dots—  everybody joined in to discuss and connect the inter-team dependencies with a thin, colourful thread. 

This visualisation enabled the team to clearly communicate the roadmap in the months thereafter, as well as the blockers, changes and delays that evidently emerged along the way. 

This co-created planning board was only just the beginning. By promoting regular communication through stand-up meetings, sprint planning sessions, and sprint review sessions, the team ensured that progress was clearly communicated to stakeholders and that risks and impediments were spotted and discussed in a timely approach.

Sprint retrospectives allowed the team to connect in new ways by taking a break from delivery to playfully interact, inspect the work process, and consider feedback gathered during the review. 

The program has now been successfully launched, and the team is keen to keep growing. The next retrospective will help define how the team intends to evolve the goals and possibly the process. 

As a group of agile coaches and consultants, Ekipa is honoured to support leaders and accelerate teams who work at the cutting edge.

Testimonials

“We were looking for an Agile coach to guide and improve our way of working through the introduction of Agile principles and practices. Ekipa supported this program and the team by introducing different Agile frameworks, followed by big room planning and sustained the Agile mindset within the team via coaching and helped discover ways to unblock impediments. The pilot team became more effective and minimised setbacks by practising iteration and transparency. The team’s roles and responsibilities are clear and yet blurred (shared) with the team moving towards achieving common goals.”

–  A cross-functional team member and program expert

“I just joined this company while they were in the final stages of launching a new product. Ekipa was brought in to allow for better coordination among the teams, and they introduced  Agile ways of working and practices along the way. Ekipa has delivered outstanding Agile training, facilitating and conducting well-organised and informative sessions. Their expertise and clear communication made the complex concepts easy to understand. Michaela Broeckx has been the coach/facilitator since we started implementing Agile ways of working and practices in the program. She has been accommodating and brilliant at conducting our Sprint meetings. Her enthusiasm and mastery kept us engaged and motivated. Highly recommended for anyone seeking top-notch Agile training and facilitation.” 

–  A cross-functional team member and program manager