At the heart of the life sciences industry lies sensitive data—whether it's personal identifiable information (PII), genomic sequences, or proprietary research. Ensuring that this data is handled securely and remains compliant with regulatory frameworks isn’t just a matter of best practice—it’s essential for innovation and trust.
At the recent Charting a Path for Compliance in Life Sciences panel hosted by PTP, Aaron Jeskey, Principal Cloud Architect at PTP, shared expert insights on how early compliance strategies, secure cloud infrastructure, and well-structured security frameworks can mitigate risk and support biotech growth from startup to scale.
Why Compliance Starts at the Seed Stage
Jeskey emphasized that successful compliance journeys begin not during audits but at the very start of company formation. From day one, organizations should be thinking about IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification)—core pillars of FDA GxP frameworks.
- IQ: Ensures infrastructure is installed and documented correctly—especially critical for security controls like encryption and secure backups.
- OQ: Validates how the system operates in production, mapping out how instruments process data.
- PQ: Measures outcomes against documented processes—essential for audit readiness and demonstrating control.
Building Secure Foundations with AWS
Jeskey demonstrated how AWS services like GuardDuty, IAM, and AWS Config can play a central role in automating and maintaining security best practices across cloud infrastructure.
- Encryption of data at rest and in transit
- Access control through Identity and Access Management (IAM)
- Continuous compliance with AWS Config and CloudTrail
By building infrastructure as code and implementing scalable monitoring, biotech teams can reduce human error, minimize security drift, and strengthen resiliency.
Real-World Lessons: The High Cost of Delay
Jeskey shared a cautionary story about a diagnostics company that failed to prioritize compliance. A single sticky note with a password uncovered deeper issues: no encryption, shared credentials, and no chain of custody. The fallout included over $12 million in recovery costs, six months of disruption, and loss of trust.
Choosing the Right Path: Early Adoption vs. Refactoring
Jeskey outlined three common trajectories:
- Early adoption: The most scalable, cost-effective option. Build compliance from the start.
- Adoption during a new project: Practical for startups pivoting into regulated markets.
- Refactoring: The most expensive path—requiring rework, third-party audits, and major delays.
Compliance as Competitive Advantage
For biotech companies building diagnostics, therapies, and AI models, compliance isn’t a checkbox—it’s a differentiator. Jeskey urged startups to use compliance maturity to attract investors, accelerate partnerships, and build long-term market trust.