Celeste, a registered nurse with both in-house and private practice experience, advises biologic and pharmaceutical manufacturers on FDA and health care regulatory, compliance, and enforcement matters across product life cycle. Celeste has particular experience in advising clients on FDA regulatory issues related to drug development strategy, planning, and conduct of Phase 1–4 clinical trials, marketing strategy, product approval, and post-marketing compliance.
On the development side, Celeste has helped clients to establish and manage large multicenter trials from start to data lock, including site selection, subject enrollment, contracting, payments to health care practitioners, and compensation to subjects. She has assisted in addressing and resolving non-compliance issues and providing support to manufacturer’s medical affairs teams to ensure compliance with applicable regulations and trade association standards. Matters have included coordination with local EU counsel to address country-specific clinical trial contracting and regulatory requirements.
As products proceed to approval, Celeste helps clients launch newly approved products or already marketed products with expanded indications. She has extensive experience in FDA oversight of advertising and promotion to inform marketing strategy, and she participates on legal and medical review committees for advertising and promotional review of materials to ensure ongoing compliance with FDA and health care laws and regulations. As needed, Celeste coordinates with Reed Smith EU attorneys to provide country-specific support and counsel to manage a multinational trial.
Celeste also has significant experience with manufacturing and product quality matters. She has assisted clients with product recalls, corrections and market withdrawals, labeling review and revisions, and ongoing safety surveillance activities, including managing and addressing FDA enforcement actions and internal compliance investigations. Given the global footprint of many of her clients, Celeste often works on cross-border matters with colleagues in Europe and Asia to support clients with multinational or global operations. Working hand in hand with her corporate colleagues and supporting her clients’ organizational growth and changes, Celeste performs due diligence, risk assessment, and risk mitigation for her clients’ merges and acquisitions, divestitures, and commercial collaboration activities.
Given Celeste’s science and nursing background, combined with her ability to understand complicated medical product development projects implicating various federal and state laws, Celeste excels in her ability to advise clients on some of their more important matters.
