Guest Column | December 9, 2024

Leading Through Biotech's Perfect Storm: Lessons From The Front Lines

By Erik van den Berg, CEO, Memo Therapeutics AG

Erik van den Berg_Memo Therapeutics
Erik van den Berg

The biotech industry has always operated at the intersection of science and business where innovation is plentiful but there is also risk and uncertainty. However, the past few years have stress-tested our adaptability like never before — from the pre-COVID funding surge through pandemic disruption to today's capital-constrained environment — and now there are reasons for optimism as we look ahead to 2025. These experiences have reinforced crucial lessons about leading biotechnology organizations through perpetual change and constantly evolving environments.

The Pendulum Of Capital Access

The pre-COVID and early COVID era saw unprecedented capital availability, enabling many biotechs to pursue multiple programs simultaneously. While this accelerated innovation — demonstrated most dramatically by COVID-19 vaccine development — it also created unsustainable burn rates for many companies. When capital markets contracted, numerous well-funded startups struggled to adapt quickly enough to the new reality.

The key lesson? Even in times of plenty, prioritize capital efficiency and maintain strategic focus. The most successful organizations during this period balanced ambitious development with strategic partnerships to extend their cash runway. This approach proved crucial when market conditions shifted, allowing companies to adjust cash burn while maintaining critical programs.

Strategic Pipeline Management

In today's environment, pipeline prioritization has become more critical than ever. Leading biotechs have implemented rigorous approaches to determine which programs are selected and advanced. Rather than pursuing multiple parallel programs, successful companies focus intensively on their most promising candidates while maintaining selective investment in discovery platforms.

This focused approach enables organizations to maximize the probability of success for lead programs while maintaining sufficient resources for high-quality execution. By addressing key regulatory and commercial questions early, companies can preserve capital for critical development milestones while retaining the flexibility to accelerate when opportunities arise.

Building Resilient Organizations

The pandemic forced a wholesale reinvention of how we operate. Remote collaboration, once deemed impractical for biotech, proved not only viable but advantageous. We learned that strong corporate culture and clear accountability matter more than physical proximity. This insight has transformed how innovative companies build teams — recruiting the best talent regardless of location, united by shared values reflected in an explicit culture rather than shared office space.

However, this distributed model demands different leadership approaches. Success in this new paradigm requires clearly articulated company values that emphasize collaboration and accountability. Regular face-to-face gatherings remain essential for building relationships, while the focus has shifted from activity monitoring to deliverables and outcomes. Strong communication frameworks that work across time zones have become non-negotiable.

Thriving Amid Market Complexity

Today's biotech landscape is more complex than ever. Beyond traditional small molecules and antibodies, we're seeing an explosion of new modalities and therapeutic approaches. This innovation surge, while exciting, creates new challenges for leaders.

The temptation to chase every promising technology must be challenged with a risk assessment and development and commercial reality check. Experience shows that solving novel problems often requires simplification rather than additional complexity. Adding multiple new technologies to address a single challenge typically reduces chances of success.

Success in this environment demands starting with the end in mind and carefully considering what evidence regulators, investors, prescribers, patients, payers, and potential partners will need. Implementing stage-gate models enables conscious go/no-go decisions, while early understanding of potential partners' diverse priorities shapes development strategy. Throughout all of this, maintaining awareness of competitive developments while staying focused on the core mission remains paramount.

Clinical Development In A Changed World

The pandemic has permanently altered how we conduct clinical trials. Remote monitoring, decentralized trial designs, adaptive trial design, and patient engagement have become standard practice. These changes demand new approaches to trial planning and execution.

Success in modern clinical development combines the traditional fundamentals of patient population and endpoint selection, with new adaptive approaches enabling changes to be made during the trial based on preliminary data. These include elements from patient criteria and indication selection to dose optimization and combination treatment strategies. Even endpoints can be adaptively selected based on emerging data. This comprehensive approach to adaptivity, combined with protocol flexibility and robust remote monitoring capabilities, enables trials to evolve based on real-world evidence.

Organizations must implement robust data collection systems that integrate risk monitoring, oversight, and control across diverse settings. Throughout all of this, maintaining strong patient engagement has become essential.

Embracing Uncertainty

The concept of complexity theory — the study of how order emerges from chaos — offers powerful insights for biotech leadership. Just as flocking birds create beautiful patterns as they fly in the sky can be described by simple rules, biotech organizations can thrive amid uncertainty by establishing clear principles while remaining adaptable to change.

This approach means accepting that not everything can be controlled while focusing oversight on major risks and allowing flexibility in execution. Organizations must create systems and cultures that can adapt to unexpected challenges, making decisions with incomplete information while maintaining quality standards.

The key is understanding that chaos doesn't equal randomness. In complex systems operating in a chaotic world, patterns emerge from the interaction of simple rules and principles. For biotech organizations, this means establishing clear corporate culture, purpose, and decision-making frameworks while allowing teams the autonomy (and accountability!) to adapt to changing circumstances. When teams understand the core principles guiding their work — whether in research, clinical development, or business operations — they can respond more effectively to unexpected challenges.

Consider the development of breakthrough therapies: while the end goal remains constant, the path to success often involves unexpected turns. Rather than trying to control every variable, successful organizations focus on creating environments where innovation can flourish within established guardrails. This means setting clear criteria for program advancement while remaining open to unexpected discoveries that could lead to breakthrough insights.

The complexity theory approach also applies to organizational development. Rather than implementing rigid hierarchies and processes, leading biotechs create adaptive systems that can evolve with changing circumstances. This involves cross-functional teams that can rapidly reconfigure based on project needs, or decision-making processes that balance speed with rigor.

Looking Forward

Success in biotech leadership increasingly requires combining scientific expertise with business acumen and change management capabilities. The most successful biotech leaders share several key characteristics. They maintain comfort with ambiguity and rapid change while balancing scientific rigor with business pragmatism. Strong communication skills across diverse stakeholder groups prove essential, as does decisive action in uncertain conditions. Above all, they demonstrate the capacity to build and motivate high-performance teams.

As we face continued market uncertainty, supply chain challenges, and accelerating innovation, the ability to embrace and navigate chaos becomes ever more critical. Leaders must build organizations that are both focused and adaptable, maintaining unwavering commitment to quality while remaining agile enough to seize unexpected opportunities.

The biotech industry's fundamental mission — developing breakthrough therapies for patients — remains unchanged. However, our path to achieving this goal requires new leadership approaches that acknowledge and harness the inherent chaos in innovation. Those who can master this balance will be best positioned to deliver the next generation of therapeutic breakthroughs.

About The Author:

Erik van den Berg is the CEO of Memo Therapeutics AG, bringing over 25 years of industry experience and a proven track record in leadership and company growth. He is the former CEO of AM-Pharma and holds chairmanships in Step Pharma and TargED Therapeutics. He has orchestrated over 20 transactions and partnerships, notably a $600 million alliance with Pfizer, a $290 million partnership with Kyowa Kirin, and has secured over $500 million in equity and debt financings for biotech firms from seed to IPO. Erik holds an MSc in Chemistry from the University of Utrecht and an MBA from Manchester Business School.

To learn more about Erik van den Berg and Memo Therapeutics, check out this episode of the Business of Biotech.