Precision medicine takes into account individual differences in patients' genes, environments, and lifestyles to guide treatment and prevention. That reliance on highly personal data, particularly genetic information, creates a legal environment that is fundamentally more complex than traditional drug development. This webinar is the second in a series exploring that environment, featuring Mina Frost, General Counsel for Sano Genetics. In this webinar, Mina focuses on market access, reimbursement, and intellectual property, providing a clear breakdown of how legal frameworks shape the delivery of precision treatments.
You can find the full webinar here; below is a brief summary for quick reference.
Mina Frost
Mina Frost is a global legal expert with over 20 years of experience specializing in healthcare law. Based in London, she is a US-qualified lawyer known for her approach to risk management, good governance, and ethical design thinking. Mina served as the first Global Privacy Officer at both GSK and Abbott Laboratories. Her expertise extends to digital risk, particularly as healthcare increasingly relies on digital-led drug discovery. As a special needs parent, her personal experiences inform her professional contributions across the healthcare and pharmaceutical sectors.
Unlike traditional therapies developed for broad populations, precision medicines target specific subgroups defined by genetic or biomarker criteria. This changes the economics of market access and the logic of reimbursement. Mina discusses how sponsors must navigate these landscapes across regions, highlighting the regulatory divergences between the United States and the EU. Each jurisdiction applies its own legal framework, and a tailored approach is required to secure access in each market.
A significant portion of the webinar focuses on data privacy and security. Precision medicine depends on detailed, individual-level patient data, including genetic information that is inherently identifiable and sensitive. This raises the legal stakes beyond what traditional clinical programs typically encounter. Compliance with regulations such as HIPAA in the US and GDPR in the EU is not optional, but the requirements differ in scope and enforcement. Mina emphasizes the importance of robust data protection measures and explains how sponsors must design privacy frameworks that account for the specific risks associated with genomic and biomarker data.
The discussion also covers the nuances of intellectual property in precision medicine. As research increasingly identifies specific genetic sequences and molecular signatures tied to disease subtypes, questions around patentability become more complex. Can a naturally occurring gene sequence be patented? What about a diagnostic method built on that sequence, or a therapy that targets it? Mina examines these challenges, including the impact of major legal precedents that have shaped current standards. She highlights the ongoing need for clearer legal frameworks to guide IP strategy as precision therapies continue to advance.
This webinar illustrates how legal challenges are not peripheral to precision medicine. They are embedded in every stage, from protocol design and data collection to market access and long-term patient engagement.
As precision medicine evolves, the coordination among legal experts, regulators, healthcare professionals, and patients becomes more important, not less. Sano operates within this landscape with a compliance-first approach, maintaining ISO 27001 certification and alignment with HIPAA and GDPR requirements. For sponsors navigating the intersection of genetic data, patient privacy, and regulatory complexity, understanding these legal dimensions is essential to designing programs that are both effective and sustainable.