
Judgment in the Cloud: The future of risk and regulation with James Lord, Google Cloud
Eliza L. Andonova
Partner Global Regulatory
Eliza is a strategic partner in the development and implementation of commercialization models that expand access to innovative, life-sustaining, and life-improving therapies. She provides practical, risk-based guidance on the anti-kickback statute, false claims prohibitions, transparency obligations, and marketing regulations. Her practice also covers patient and product support programs, reimbursement services, charitable contributions, and a broad range of financial arrangements.
A trusted partner in times of challenge, Eliza conducts internal investigations, recommends corrective actions, and supports clients through self-disclosures and enforcement defense. She’s frequently called upon to assist manufacturers negotiate and implement Corporate Integrity Agreements with the U.S. Department of Health and Human Services’ Office of Inspector General.
Eliza also advises on the design and enhancement of compliance programs—from assessments and policy development to workforce training—helping companies remain agile in a constantly evolving enforcement landscape.
Earlier in her career, Eliza clerked for the Honorable James H. Michael, Jr. of the U.S. District Court for the Western District of Virginia.
Counseled drug manufacturers on patient support programs and agreements with purchasers, pharmacies, and distributors in preparation for the launch of new products.
Regularly advises manufacturers on their patient assistance programs and relationships with independent charitable foundations.
Negotiated and advised manufacturers and direct providers on the implementation of Corporate Integrity Agreements.
Advised manufacturers on design and implementation of product support programs, including sponsored testing programs.
Regularly works with clients to assess compliance programs, implement and update policies and training, and establish risk assessment programs.