Charting a Path for Compliance in Life Sciences: Privacy, Cybersecurity, and Innovation

Life sciences organizations face complex challenges in ensuring compliance with evolving privacy and cybersecurity regulations. On February 25, 2025, PTP hosted a panel of industry experts in New York City. This insightful discussion provided crucial updates for biotech leaders navigating privacy laws, cybersecurity threats, and compliance using Amazon Web Services (AWS).

Click here for our YouTube video from this event

Key Insights from Industry Experts:

• Comprehensive National Privacy Law: Panelists explored the recent bipartisan push toward establishing a unified national data privacy framework, examining its potential impacts and current roadblocks in Congress.
• Global Compliance Complexities: The importance of understanding global data regulations was highlighted, emphasizing that compliance must consider international standards such as GDPR, HIPAA, and various regional laws.
• Cybersecurity in a Digital Age: Experts shared best practices on protecting sensitive biotech data, emphasizing the role of AI, quantum computing, and industry-driven security frameworks.
• Strategic Compliance from Day One: The panel emphasized that startups must prioritize compliance from inception to prevent costly future adjustments and potential liabilities.
• Funding and Policy Challenges: Discussions covered how changes in NIH funding and administrative policies are affecting research and development, and how companies can strategically adapt.

Featured Panelists Included:

• Aaron Jeskey (PTP): Provided detailed insights into key biotech compliance frameworks (HIPAA, GDPR, GxP), best practices for securing sensitive data including PII, genomic data, and intellectual property, and strategies for leveraging AWS services such as Amazon GuardDuty, IAM, and AWS Config. Aaron also discussed real-world examples of biotech firms overcoming security challenges using AWS and outlined practical steps for audit readiness and proactive risk management.

• Hector Rodriguez (AWS): Highlighted the role of automation, scalable data security practices, and leveraging AWS solutions to ensure comprehensive compliance and resilience.

• Han Chiu (Click Therapeutics): Delved into the intersection of technology and healthcare, explaining how Click Therapeutics develops FDA-regulated, AI-powered software treatments. He discussed the complexities of digital health compliance, cybersecurity, and data privacy, emphasizing the use of AWS cloud infrastructure for scalability and operational efficiency. Han also highlighted how Infrastructure as Code streamlines operations, enabling rapid development of digital therapeutics for conditions such as migraines and major depressive disorder.

• Jason Johnson & Linda Malek (Crowell & Moring LLP): Provided guidance on navigating complex regulatory landscapes, managing international data privacy challenges, and strategically mitigating compliance risks for biotech organizations.

• Stephen Holland (Crowell & Moring LLP): Offered insights into evolving federal privacy policies, upcoming regulatory changes, and their implications for compliance within the life sciences sector.

Actionable Takeaways:

• Prioritize compliance frameworks early to avoid future risks.
• Leverage existing security frameworks and industry collaborations to strengthen cybersecurity measures.
• Understand and prepare for global compliance to secure sensitive, cross-border data.
• Monitor policy and funding changes closely, adapting strategically to protect business continuity and innovation.

This event underscored the necessity of proactive, strategic compliance planning within the life sciences sector, ensuring data protection, regulatory readiness, and organizational resilience.

Connect and Learn More:

• Date: Tuesday, February 25, 2025
• Time: 5:00 PM – 8:00 PM EDT
• Location: 375 9th Ave, New York, NY

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