Amy Baker

Amy Baker is a Partner in Rimon’s Orlando office. Ms. Baker focuses her practice on advising clients in the life sciences industry.  Ms. Baker provides regulatory consulting services to life sciences clients, advising them at all stages of their life cycle, from formation through to clinical trials and commercialization. She advises life sciences clients on the wide range of legal issues which may impact them, including growth strategies, emerging technologies, regulatory compliance with the FDCA, as well as FDA, FTC and HIPAA regulations, labeling and advertising compliance, intellectual property and brand protection issues, and privacy, data breach, and cybersecurity concerns.  She also works with life sciences clients to facilitate funding for early stage life science and technology companies. Ms. Baker represents life sciences companies in litigation where required.

Ms. Baker is active in life sciences industry associations and serves as co-chairman of Central BioFlorida, is a board member of the Central Florida Chapter of the  Risk and Insurance Management Society (RIMS), and is Chair of the Copyright Special Litigation Group for the Defense Research Institute (DRI).

SELECTED EXPERIENCE

Life Sciences:

• Advising life sciences companies on regulatory schemes for FDA-regulated products.
• Reviewing labeling, packaging and advertising to ensure regulatory compliance with the FDA, FTC and USDA for medical devices, drugs, supplements, cosmetics, and food and beverages.
• Advising on FDA compliance including establishing and enforcing industry standard manufacturing practices, post-market surveillance and pharmacoviligence.
• Reviewing clinical trial contracts.
• Consulting on clinical trial ethics matters.
• Representing companies in FDA enforcement actions and advising them in relation to FDA submissions.

Litigation:

• Acting as lead counsel in intellectual property litigation between FDA regulated companies and other companies.
• Acting as lead counsel in false advertising/unfair business practices lawsuits.
• Acting as lead counsel for product liability lawsuits involving drugs, medical devices and food products.

Privacy and Cybersecurity

• Acting as counsel to Fortune 500 SaaS companies in various types of pre-litigation and litigation disputes.
• Providing emergency data breach response action plans in relation to cyber attacks.

PUBLICATIONS

• Interview, “Unlocking the Potential of ChatGPT in Healthcare from a Legal Perspective,” ChatGPT in Healthcare Live LinkedIn Chat, February 2023
• Interview, “Classifying Aging as a Disease Could Speed FDA Drug Approvals,” Broadcast Retirement Network, January 2023
• Author, “Classifying Aging as a Disease Could Speed FDA Drug Approvals,” The Hill, December 2022