Strategic Intent Meets Regulatory Reality
May 2, 2025
Welcome to the inaugural edition of RISK NAVIGATOR: Life Sciences, a platform dedicated to exploring the regulatory, legal, and strategic developments shaping the global Life Sciences industry. As founder and CEO of Koios Global in Switzerland and Co-Chair of the Life Sciences Working Group at Ethics & Compliance Switzerland (ECS), I support organizations navigating complex legal, regulatory, and compliance challenges.
Whether you're in Legal, Compliance, ESG, or executive leadership, you're aware that today's challenges demand more than best practices. They require foresight, resilience, and informed action. In this series, I will examine evolving regulations, government mandates, compliance expectations, and policy shifts that influence how companies operate, innovate, and grow across borders in these complex times.
Aligning Growth with Governance: Insights from the C-Suite Survey
To launch this series, I’m highlighting a recently published survey by a global consulting firm, dealing with the CEO perspectives and strategies for 2025, a pivotal report that reflects the strategic mindset of today’s Life Sciences leadership and signals the direction of the industry. The survey offers insights from over 1,700 C-suite executives across more than 35 countries regarding their priorities and challenges in 2025.
Chief priorities noted:
International Expansion – targeting high-growth markets such as the U.S., China, and India, which offer both commercial opportunity and scientific collaboration.
New Products and Services – particularly in oncology, rare diseases, and digital therapeutics, where unmet medical needs drive investment
Technology Transformation and AI – aimed at streamlining operations, enhancing regulatory responsiveness, and improving data-driven decision-making
ESG and Sustainability – increasingly treated as a core business imperative, with supply chain integrity, emissions, biodiversity, and equitable access central to strategy
The Survey captured strategic intent. The Q1 2025 earnings release from leading pharma companies largely validated the CEO sentiment indicating strong pipelines, resilient revenues, and continued investment in innovation. How will this sector adapt and sustain its momentum going forward given the current global complexities, including geopolitical tensions, shifting trade dynamics, and new tariff regimes?
Geopolitical Impacts
As these pressures evolve through Q2 and Q3, leadership must now balance intent with agility and control, ensuring that growth strategies remain viable, not only on paper, but under pressure. This is where forward-looking compliance structures, scenario-based risk planning, and forensic-level due diligence become essential enablers of execution.
Success now depends not only on vision, but on the ability to manage risk, align with evolving regulations, and ensure transparency across every part of the business. In practice, this means moving from generic risk frameworks to targeted, intelligence-led execution.
Based on our forensic casework and industry engagements, several actions consistently distinguish resilient strategies from reactive ones.
Components of Sustainable Execution
Expand M&A Due Diligence to Include Forensic Due Diligence - M&A in life sciences holds strategic value, yet due diligence often focuses narrowly on financials and IP. Post-close issues are rarely technical, rather they stem from compliance failures, supply chain gaps, and corruption risks. Forensic red flags must be surfaced early. If these areas are excluded, you're not buying an asset, you’re buying blind spots.
Stress-Test Governance in High-Risk Markets with Local Insight- Expanding into high-risk regions without local regulatory insight is a frequent and costly misstep. Weak rule of law, and opaque procurement systems elevate exposure to bribery and corruption, especially when third-party intermediaries are involved. Enhanced due diligence must include local intelligence (HUMINT), not just online research (OSINT), to detect risks often invisible from a distance.
Extend Supply Chain Visibility - Managing third-party and supplier risk extends well beyond onboarding, yet many organizations stop at tier-1 visibility. Overlooking sub-tier risks such as conflict minerals, labor violations, and customs exposure can lead to significant liabilities. Mitigate risk by segmenting suppliers, leveraging technology and local intelligence, and ensuring contracts include audit rights and notification obligations. Shortcuts in this process often lead to far greater costs later.
AI and Big Data Deployment Readiness - AI and Big Data are transforming life sciences, from predictive pharmacovigilance to early trial detection and real-time monitoring via devices in us, on us, and around us. The data enabling this insight is often drawn from electronic health records and connected tech bringing risks related to privacy, compliance with patient consent, integrity, and cybersecurity. Success requires a clear business case, an effective data platform, and strong alignment across Clinical, R&D, and Compliance.
ESG Risk Management in Geopolitical Uncertainty - Nearly 60% of companies report on ESG, yet shifting timelines, regulatory delays, and U.S. political pushback have left many unsure how to proceed. As data demands are high, costs significant, and global rules still evolving inaction seems to be a viable choice for many. Taking measured steps to establish strong governance, verify claims, centralizing auditable data, verifying sustainability claims with documented controls, and applying enhanced due diligence in high-risk markets would be more prudent. Pay now or pay later.
New Product & Service Categories - Innovation brings scrutiny. Gene therapies, combination products, and AI-assisted diagnostics are stretching existing frameworks. Pre-market planning must anticipate regulator expectations, evidence thresholds, and cross-border approval complexity, not react to them.
These are not check-the-box activities. They are core components of sustainable execution, particularly in a climate where regulatory expectations and public scrutiny are escalating in parallel. The Survey affirms that growth and risk are no longer separate conversations. Success in 2025 will be defined not just by innovation, but by the ability to implement it in legally and ethically sound ways across jurisdictions, technologies, and stakeholder expectations.
If these insights resonate, feel free to reach out to discuss how we can support your initiatives vflowers@koiosglobal.com
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