21 May 2024
By Stuart Schofield & Pete Harpum
Keeping up with these changes will be the next big challenge for any forward-looking biopharma organisation.
Driven by AI and other digital innovations, the way that development projects are managed is about to encounter paradigmatic change. Shepherding of the product development process will become more agile, depend ever more on really effective transversal collaboration, and be significantly digitally enabled. To succeed and thrive, leaders and managers responsible for discovering, developing, and launching new products must broaden their perspectives.
Drug discovery scientists, drug development clinicians, medical affairs, manufacturing experts, and commercial, marketing and launch teams are all managed in very different ways. Managing new product development projects through the various stages of their respective development lifecycles means effectively integrating all these diverse and distinctive functional groups contributing to a product development project. This is always challenging and will only become more so. Individuals within the functional teams are experts in their own specialist areas, and each possesses knowledge and experience that cannot be easily codified or quantified. Managerial attempts to control and micromanage have no chance of succeeding.
Governance, scientific, and safety committees oversee the product development process, often with overlapping roles and responsibilities. This provides a strong oversight capability but also complicates the navigation of the governance structures. Suboptimal preparation for governance presentations, mixed with the challenges of meeting the information needs of different committees, means that it is often not easy to ascertain where the final decision rests on project progress. Accessing the members of the committees for guidance and to test thinking ahead of formal meetings is recommended yet difficult to achieve. Senior leaders and decision-makers are perpetually busy, and building high-quality relationships with these leaders can be challenging.
The way forward for leaders and managers overseeing biopharma product development projects is to cut through this complexity. This means effectively reaching across the functional silos that are inevitable in biotech and pharmaceutical organisations. Building truly integrated teams. This is made possible with an agile and highly cooperative outlook. IBM agree with us! Their Institute for Business Value (IBV) suggests that to optimise R&D investments and create more sustainable value, pharmaceutical companies must focus on improving internal collaboration across traditional boundaries within the organisation.
New approaches to leading and managing product development need to emerge within the biopharma sector. In this new world, project coordination tasks will be carried out by AI, and project managers will need to leverage its benefits. More importantly, this shift towards digitalisation will leave space for managers to build their skills in other areas, not least:
Ironically, in this digital and AI landscape, ‘Trust’ and ‘Empathy engagement’—the ability to forge relationships—will become paramount.
As drug, device, analytics, and digital health development shifts into a new gear and those tasked with managing these innovation-driven development projects are further challenged to work in a more collaborative approach, the question becomes: ‘Are We Ready?’
One thing we know…the future will come (very) fast.
We just need to keep up!
[1] Grand View Research: Pharmaceutical Manufacturing Market Size, Share & Trends Analysis Report By Route of Administration, By Molecule Type, By Drug Development Type, By Sales Channel, By Age Group, By Formulation, By Region, And Segment Forecasts, 2023 – 2030
[2] Internal collaboration is the key to improved innovation’, by Jeffrey Jung and Andy Wang
[3] Schuhmacher, A. et. Al, The present and future of project management in pharmaceutical R&D, Drug Discovery Today, Volume 26, Number 1 January 2021. https://doi.org/10.1016/j.drudis.2020.07.020
