Biologics: a leadership journey

BOTH BIOLOGICS and biosimilars have revolutionised treatment options and transformed the care journey for millions of patients globally. In some cases, a painless injection is all that is needed to mitigate or manage life-altering illnesses. Today, there are over 3,000 biotech companies worldwide pushing the boundaries of what is possible in this revolution¹ and there has never been more opportunity for collaboration in the life science industry.

As we assess the unprecedented growth in the biotech sector together with the huge leaps in development of biologics and biosimilars, we can learn from the leaders who innovated, survived and thrived as this new industry took shape. So we ask, can collaborative partnership be a means of innovation? And what are the implications of increased accessibility to better healthcare fuelled by these new technologies?

Dawn of a new era in biologics

Insulin is one of the most well-known biologic products, created by bacteria using recombinant DNA methods pioneered by both Herbert Boyer and Stanley Cohen. These methods have become the cornerstone of biological advancement; prior to this, diabetics relied on injecting animal insulin, which is more challenging to produce in large quantities.

By 1976, both men had published ground-breaking research into recombinant DNA, ushering in a new dawn in biotech possibilities. Boyer would later go on to co-found Genentech, the first company to mass produce synthetic insulin via Eli Lilly using recombinant DNA methods.²

It is likely that none of the above would have happened without Boyer’s unusual propensity for openness, curiosity and willingness to engage in collaboration. Those who have studied him note the “fortunate happenstance” surrounding his activities and a closer look reveals this is a result of his consistent key behaviours.

Openness, curiosity and collaboration

These three key behaviours are resonating terms for life science leaders and organisations, yet it requires personal and organisational strategies, not resonance, to cultivate these attributes and break through innovation ceilings in pharma. Boyer’s consistent demonstration of these attributes led to some of the innovations in biologics we see today.

Openness is the ability to consider other possibilities, people and theories without their practical application in your work being obvious. This requires being comfortable with ambiguity and the unknown, while moving towards your goals. Curiosity is the desire to discover more for the sake of discovery itself. The transition to collaboration involves having gained enough information to formulate a strategic plan of action. Without openness and curiosity, the process could never begin.

These attributes may come naturally to some, but they can be cultivated by all. Cultivating openness and curiosity begins with attention and learning in order to truly listen and understand new ideas, making one’s personal agenda less obstructive to novel concepts. Research suggests that all too often when others are talking, the ‘listener’ is preparing to speak instead of listening.³ This tendency can worsen the further one climbs the corporate ladder. A curious leader who listens will subdue their own ego to create more space for a diversity of voices to be heard. Understanding the nuances of each voice in the room and asking the right questions (see Table 1)⁴ are essential here.

The present reality of online meetings may serve to facilitate the growth of these skills – it is easier to listen and harder to intentionally interrupt during video calls. Boyer was well known for his curiosity and would often ask searching questions.⁵ He also changed his environment constantly – when it comes to creative thinking, new environmental stimuli are shown to make a significant impact.⁶

A leadership advantage

Problems are not always solved through direct attention, but allowing the brain to adapt to new situations, people and environments can create the shifts required to progress. An upside of the current coronavirus pandemic is that managers and organisations with a penchant for encouraging presenteeism are being forced to treat their people in a more flexible manner. If those people are empowered to leave their desk, more problems could be solved as a result. This has been instituted in several organisations through a ‘flexible attention policy’ which normalises disengagement from ‘work environments’ for this very reason.

So why is such openness and curiosity towards people and ideas a leadership advantage? Mark Granovetter, an American sociologist, called this the ‘strength of weak ties’; the most revolutionary changes occur because of peripheral social contacts. Put simply, the more peripheral the contact the more likely they are to tell you something you do not know.⁷

Boyer’s openness, curiosity and thirst for collaboration led him to learn the technique of fluorescently staining DNA fragments, which would prove essential for his ground-breaking experiments. He was also able to source rare purified frog DNA from a freezer in Stanford, which was instrumental to demonstrating that his method could reliably clone complex animal genes in primitive bacterial cells. Boyer famously met Stanley Cohen, who was also researching recombinant DNA, at a conference and shortly after this meeting their partnership was formed. Such happenstance was a mark of Boyer’s success as a scientist and leader. For example, when young venture capitalist Bob Swanson asked Boyer for a meeting, his curiosity got the better of him and he agreed. This was the start of what became a controversial (for the time) collaboration between research and private capital. Boyer elucidated: “Bob explained venture capital to me. He had a desire to start a company of his own. He had read a lot about the [recombinant DNA] technology and thought it might be useful. I said ‘Sure, why not’.”

Openness to listen and curiosity to discover new information from outside of our functional silos and put collaboration into action is the foundation of enterprise leadership. For Boyer, this helped birth a new era in biotechnology and these attributes are just as necessary for leaders and teams today. What might be dismissed as a waste of time or irrelevant information could be the start of a fruitful internal or external collaborative partnership.

Indeed, in the 1950s, George Guy openly shared his discovery of the replicating cell line HeLa with collaborators. Since then, the HeLa cell line has been instrumental in many biomedical breakthroughs, including the development of a polio vaccine.

Boyer and other leaders demonstrated an ability to uniquely connect new information, ideas and concepts in novel and meaningful ways. Through a network of enterprises and concurrent research projects they uncovered new opportunities that others had overlooked. Recently, the industry has been accused of an innovation plateau, relying on acquisitions to prop up new advances.⁸ So how do leaders cultivate uninhibited openness as a trait when large organisations are already heavily matrixed and encouraging this within their own ecosystem takes intentional effort and focus?

Meanwhile, a lack of curiosity can mean wasted opportunities. For example, life science is well known for its relatively closed (albeit large) network of professionals who move between organisations. Prior to acclimatising new staff to your company culture, are you ever curious about what they appreciated from their previous organisation? Also important is to contemplate ways to encourage curious conversations within your team. Are they stuck because of their functional viewpoint? Or try a thought experiment – if your team could ‘rip up the rule book’ on their current ways of working, what could be possible?

In our view, it is also important to consider how to implement a personal strategy around collaboration. Consider where the opportunities are for you to collude with another function lead or perspective. When was the last time you swapped seats with a patient, regulator or R&D professional? From an organisational perspective, consider which activities, policies and cultural norms impede collaboration. What are you unconsciously doing that gets in the way of collaboration? How could you find out?

The race for biologics dominance has led to an organisational proclivity to restructure and grow through mergers and acquisitions. This demands agile leadership and high-trust diverse teams knowing how to respond to rapid changes in their environment. One approach has been spearheaded by 3M, a company known for its consistent innovation. Their policies to encourage innovative leadership involve rotating staff to completely different departments every few years.⁹ These policies are often resisted, but they ensure that ideas and leaders are able to break out of their silos and evolve. This is a function of enterprise leadership; rotating new and longer serving hires through functions is suggested to improve retention of talent and increase collaboration and shared goals.

We are currently in the midst of pandemic-induced accelerated digital transformation, increased accessibility for disruptive start-ups in the industry and the growth of the biosimilar market. Considering this, it is essential these behaviours are embraced for leaders and organisations to navigate these changes.

Biosimilars and the future

Since the European Medicines Agency (EMA) issued regulatory guidelines for biosimilar development and assessment in 2005, Europe has led the way globally in the market. Meanwhile the US, rather belatedly, approved the regulation of biosimilars with the introduction of the Affordable Care Act in 2010.¹⁰

Biosimilars are expected to deliver huge cost savings to healthcare systems and increase access to treatment in the coming years as expensive biologic drugs lose patent protection. To be approved, these medicines must be shown not to have any clinically meaningful differences from the biologic originator in terms of quality, safety and efficacy.¹¹

The emergence of biologics, new technology, a global talent pool and the rapid reduction of cost in outsourcing production means the life science landscape is becoming more accessible. Will pharmaceutical companies eventually begin to reflect those whose artificial intelligence (AI) and machine learning technologies they are embracing? Vivek Ramaswamy, CEO of Roiviant Sciences, predicts the move towards a decentralised group of companies, more akin to Alphabet, that can establish new biotechs from scratch to maintain an entrepreneurial edge while taking advantage of economies of scale. If so, should it be a priority to invest in leaders and their teams so they can thrive in these environments?

Organisations need to consider how they can deliver unique partnerships that facilitate uninhibited openness and collaboration, prioritising collaboration as a unique selling point (USP). The merger and acquisition spree that is dominating the industry will eventually run out of fervour. Therefore, developing a framework for global and fast-moving collaboration and diversity of thought will become a priority. Daniel Ghinn, CEO of Pharma Data Insight company Creation.co, said: “Today’s biopharmaceutical companies have more information at their fingertips about the unmet needs of patients and healthcare professionals than ever before. The ability to remain agile and form effective partnerships could be the distinguishing factor that defines the industry’s future leaders.” This means investing in leaders who are self-aware, agile and with clear goals in sight. Businesses will also need to look again at their support functions like IT, HR and finance to ensure they are aligned to help leaders deliver in their unique country or disease context. The Biomarkers Consortium is a good example of this – the public-private partnership has pulled together a diversity of stakeholders to enable improvements in drug development, clinical care and regulatory decision-making.

The future shape of the industry is still forming and it is under seismic pressure from outside forces, unforeseen events and the threat of misplaced regulation and deregulation. Despite this, complex collaborative partnerships, internally and externally, are possible but rely on the right framework and, more importantly, leaders with the skills and determination to make such partnerships succeed.

References

1. EY. EY Biotechnology Report 2017: Beyond borders – Staying the course [Internet]. Slideshare.net. 2020 [cited 13 October 2020]. Available from: https://www.slideshare.net…
2. Hughes S. Genentech: The Beginnings of Biotech. Chicago: The University of Chicago Press; 2011. pp 75-105
3. Cracking the Code of Sustained Collaboration [Internet]. Harvard Business Review. 2020 [cited 6 October 2020]. Available from: https://hbr.org/2019/11/cracking-the-code-ofsustained-collaboration
4. What Cross-Silo Leadership Looks Like [Internet]. Harvard Business Review. 2020 [cited 6 October 2020]. Available from: https://hbr.org/2019/05/crosssilo-leadership
5. Hughes S. Genentech: The Beginnings of Biotech. Chicago: The University of Chicago Press; 2011. pp12
6. Lehrer J. Imagine. Edinburgh: Canongate Books; 2012. pp 25-27
7. Granovetter M. The Strength of Weak Ties. American Journal of Sociology. 1973;78(6):1360-1380.
8. Emma Walmsley, GSK’s CEO, in a conversation with Sarah Neville [Internet]. 2020 [cited 6 October 2020]. Available from: https://www.youtube.com/watch?v=fkPrLUOU2xQ
9. Harford T. Messy: How to Be Creative and Resilient in a Tidy-Minded World (2nd Ed.). London: Abacus; 2018. p26
10. [Internet]. 2020 [cited 13 October 2020]. Available from: https://inspirabiotech.com/2018…
11. England N. NHS England » Biosimilar medicines [Internet]. England.nhs.uk. 2020 [cited 6 October 2020]. Available from: https://www.england.nhs.uk/medicines-2/biosimilar-medicines/