Amy Baker

Amy Baker is a Partner in PLG’s Life Sciences, Litigation, and Privacy & Cybersecurity practice groups. Amy focuses her practice on advising clients in the life sciences industry.  She 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.

Amy also advises life sciences clients on the wide range of legal issues which may impact them, including growth strategies, funding, 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. Amy represents life sciences companies in litigation where required.

Representative Experience

Life Sciences:

• Advise life science companies on growth strategies and regulatory path to market strategies
• Perform due diligence in connection with mergers, acquisitions, and financing of life science companies
• Provide advice and counsel to life science, healthcare, and health tech companies concerning regulatory compliance with FDA and FTC regulations, HIPAA, Stark, Anti-Kickback, and privacy laws, defend companies in FDA and FTC investigations
• Negotiate and draft transactional healthcare documents including master service agreements, collaboration agreements, licensing agreements, clinical trial agreements, and other contracts
• 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.
• 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.