The biopharmaceutical industry is in continual change Increased competition and diversity in business models creates a leadership challenge of sustaining growth and performance To address this challenge we outline a focus on Human Centred Organisations with Leaders creating meaningful and engaged work environments to maximise performance sustainably
To maximise performance, it is time to put the human in the centre of the complex, multicultural and dispersed ecosystem of biopharma innovation.
The pharmaceutical industry has changed dramatically over the past 10 years. Despite a range of merger and acquisitions within large companies, the industry has grown in the number of companies selling products within the market. Comparing 2003 to 2015, the global industry has grown 41per cent in terms of revenue, 53 per cent in terms of R&D spend with a 100 per cent increase in clinical projects. Organisationally, the dispersed nature of the sector supports increased number of deals resulting in merger and acquisitions or IPO. The industry is therefore becoming increasingly fragmented and competitive in terms of revenue and organisational autonomy.
Against this backdrop of increased fragmentation, it is apparent that successful projects and products remain elusive. The cost of development and easy access to medicines is a persistent issue that regulatory agencies and industry professionals are increasingly aware. There is an inherent tension within the system between the high levels of failure, the costs involved in development and commercialisation and the needs of public and private healthcare providers.
Big Pharma has consequently adapted its strategy with wider global networks of research and development across hubs and a focus on the emerging markets. The dispersed and global nature of the business has resulted in reductions within the knowledge base of discrete organisations and a drive to collaborate and gain expertise and know how from collaborators. A recent academic review highlighted key areas of collaboration including sharing and learning at organisational and team levels, and access to infrastructure and management expertise with appropriate governance control points of projects. These macro level changes in the pharma sector are evidence of some dramatic changes in operational business models. The days of large fully integrated pharmaceutical companies with depth and breadth of R&D projects and finances appear long gone. No doubt the model will continue to develop further over the next 10 years.
At a more specific or micro level of leaders and managers within individual companies, these macro level changes create some difficult challenges. Some key issues include how to create impact in decision making when you may work virtually or remotely? How to ensure effective and efficient communications across cultural boundaries and how to create engaged and productive teams and collaborations?
There are no simple answers to these questions. We often focus on how to better use technologies and information. However, there are other approaches commonly used to ensure the most productive interface between people and what they do. In this article, we aim to raise awareness of human factor approaches and outline some pull and push approaches to ensure people can operate at their best, especially in the fast paced, multicultural, and global biopharma industry of today.
Human factors encompass a professional science often known as ergonomics. It relates to the understanding of interactions among humans and other elements of a system. Human factors research has been applied across high-hazard sectors to develop safe practices that not only anticipate, but also mitigate, human error. Within the U.K. NHS, the importance of human factors has been highlighted and identified as an avenue for collaboration between disciplines providing key benefits in the utilisation of people, their needs and containing costs.
In 2016, some guiding principles were developed by the International Standards Organisation (ISO) for developing human centred organisations. Part of the rationale for developing this standard was the recognition that human well-being is an important measure to complement the traditional measures of output. The standard, ISO 27500, is not an operational standard but highlights the principles, values, and beliefs that make organisations human centred. The standard draws on a wealth of ergonomic and human factor design principles that are known to be successful across a range of organisational structures from large to small private or public organisations. Seven principles were identified that characterise a human-centred organisation that encompass individual perspectives, usability of products and systems, and social responsibility that includes being trustworthy. Through efforts based on a systems approach encompassing human factors these principles are known to make significant contributions to overall productivity.
We suggest at least two of these principles have high relevance to the complex, multidimensional, and fast-paced world of the biopharmaceutical sector that operates across multiple organisational and cultural boundaries. Attention to the principles of ensuring individual differences is an organisational strength and valuing employees to create a meaningful work environment will have positive impact in a multicultural environment.
It is important to remember that people deliver on organisational objectives and utilise their skills and capabilities to adapt to a variety of situations. Not surprisingly, therefore, there is evidence that indicators of worker wellbeing are linked to performance. Meaningful work supports not only our wellbeing but also our engagement and absorption into the work that we do. These are essential ingredients for releasing the creativity of research and development scientists to bring new products into the market. Innovation in both developing new products and processes requires individuals who are engaged and confident within their roles. Innovation is hampered by stress and distraction, particularly by the distraction of leadership when it is inconsistent, irresponsible, excluding, silent, and by the distraction of conflict or lack of connection and understanding between individuals. It is supported by tuning into the bigger picture the benefits to those who use our products; in other words, each seeing the value of their contribution and how their work makes a difference. Within the healthcare industry, our ultimate endgame is to improve human health through whatever aspect our work may involve. However, it is perhaps too simplistic to assume these links drive a meaningful work place. For front-line medical Staff there is a risk of compassion fatigue and burnout often related to workplace stress.
A human-centred approach would suggest that the balance needs to be struck between financial rewards and the meaning the work brings to the individual in terms of their own sense of being and what matters most to them. Creating the right blend of performance measures that are linked to the ultimate patient value will provide transparency in decision making.
Organisations make work meaningful by:
• Identifying the meaning
• Expressing the meaning
• Living by the meaning (all efforts aligned to it)
• Repeating it often
Human factors also indicate that people work best when they are valued and feel included in the workplace. This has an important aspect in the biopharmaceutical world of the 21st Century. With so many enterprises working across wide cultural and organisational boundaries, the industry is one of collaboration and partnerships. To get the best from these collaborative networks, the individuals need to feel valued, that they have a voice and are invited to use it, and that they contribute to meaningful goals. Failure to satisfy these basic human factors creates a risk that the performance of the teams becomes transactional, adhering to the status quo and focussed on intermediate goals.
Figure1 outlines the influence of engagement and disengagement of leaders and their staff on their own and their team’s performance. Supportive leaders develop human centred and holistic approaches that significantly modify team behaviours.
The difficult aspect of working with people across the multidimensional matrices involved in biopharmaceutical innovation include how to measure the engagement of individuals, and how their experience of work relates to how they feel. A variety of methods are present to measure work engagement, and are all self-reported measures. Engagement is an experiential state, an experience that is very personal to the individual involved and covers many aspects of thoughts, feelings and autonomy. Individuals are engaged when they experience their work as being part of something with colleagues they trust. The converse of engagement relates to high levels of work place stress and an absence of absorption in work. Dis-engagement can limit performance of leaders and impact their teams.
Leaders need to be trusted and engender trust between their colleagues. Much research has been undertaken in this area but some early work provides some simple rules that openness /congruity in actions of leaders, having shared values and understanding the limits of decision making with feedback provide a guide that appears relevant to the complex multi-organisational and cultural biopharma ecosystem.
A recommended Human-Centred principle is to see individual differences as an organisational strength. There are no ‘standard persons’. An ergonomic approach takes into consideration the whole, allowing multiple viewpoints and create environments that support a range of body types and social networks. This is perhaps even more important in the multi-cultural and global nature of business today.
Many industries have embraced ergonomic approaches to ensure critical performance. This is especially so in the case of high hazard industries such as the nuclear and aviation industries. Within these areas, a focus on safety is also a key property of the sector. Perhaps it is time to learn from professional ergonomists / human factor professionals in creating systems that enable performance across the complexity of the biopharma industry? As the industry continues to fragment and disperse, the tacit knowledge that resides in the experience of skilled professionals is likely to be lost.
Drug discovery is a socio-technical enterprise that crosses the boundaries of hard experimental data and a huge range of uncertainties regarding prediction of ultimate clinical safety and efficacy and value. This system has some similarities with other high technology industries that span the divide between hard empirical observations and the human perspective. A recent development in engineering systems to allow appropriate control of safety aspects in these socio-technical enterprises has been proposed. Approaches such as these may well provide the appropriate risk management infrastructure—the pull—to ensure appropriate performance.
In this context, we suggest push approaches are based on building individual skills and an infrastructure to create feedback and learning. Challenges of mental health issues related to work place stress are becoming apparent in many cultures. Whereas a engaged workplace facilitates performance, prolonged periods of stress can have significant negative effects. Salutogeneis is a concept developed by Aaron Antonovsky that focuses on an individual’s ability and resources to promote health rather than on treatment or managing risks. This approach is widely used in public health and seems appropriate in the workplace setting.
The key elements of a salutogenic approach are the ability to develop and utilise general resources of wellbeing and maintain a problem solving orientation through a sense of coherence and meaning. Developing general resources across a multicultural workforce requires a focus on the individual. Building on psychosocial approaches provides an individual framework to work cohesively within the community. Several areas of individual skill modelling are appropriate within the salutogenic approach to build engagement and include the five factors of wellbeing, building mindfulness skills and being in flow are part of being actively and attentive. A recent model also highlights individual skills to enable presence with self and others as a leader.
Push programmes to enable engagement across multicultural boundaries should focus on the following areas to maximise value to the individual and organisation
• Mindfulness/paying attention
• Managing emotions
• Building self-awareness of values, beliefs, and meaning
• Solution focus
A focus on how people interact with their work is an established scientific discipline that has been widely used in other safety-critical industries. The international standards organisation has developed a series of principles to support orientation of work activities at a board level to ensure that companies develop appropriate working practices to maximise their performance.
We suggest that in the fast paced, multicultural, and dispersed biopharma industry today these principles are critical to the success of the socio-technical endeavour of Pharmaceutical R&D. All these principles are important and we suggest an initial starting point would be to focus on the level of employee engagement across the system to ensure adherence to principles relating to diversity and meaning in the workplace.
The opportunities presented in the biopharmaceutical business sector can provide significant value to everyone involved — from investors to customers. Adopting a push and pull approach to what is done is essential to maximise performance. A human-Centred experiential learning process to develop leaders, managers, and employees is also an essential prerequisite for success. Paying attention to the ‘human’ will enable solutions to be developed for the essential leadership challenges mentioned above.