Global law firm White & Case LLP has expanded its Global Life Sciences and Healthcare Group and Intellectual Property Practice with the addition of Bethany J. Hills as a partner in New York.
"Bethany's regulatory and compliance experience in the field of healthcare and life sciences is unmatched, and we are very pleased to welcome her as the Firm continues to prioritize strategically bolstering our US practices," said Peter Carney, Head of White & Case's Life Sciences and Healthcare Industry Group. "The US Food and Drug Administration (FDA) regulatory capabilities Bethany brings are a crucial component to maintaining a top global life sciences offering and will complement our life sciences-related practices worldwide."
Hills' practice focuses on the intersection of FDA and healthcare regulatory, advising life sciences and health tech industry clients on the full range of regulatory compliance issues, bringing together FDA regulatory, healthcare regulatory and life sciences compliance expertise. Her work covers the full scope of US regulations impacting such business activities, including US federal law regulatory regimes enforced by the FDA, Drug Enforcement Administration, Office of Inspector General and, more broadly, the US Department of Justice and Federal Trade Commission, including reimbursement issues, Clinical Laboratory Improvement Amendments oversight of diagnostic businesses, and US state-level licensing, pharmacy, distributor regulations and corporate practice of medicine.
In her practice, Hills manages complex issues for regulated companies, as well as agency engagement and product correction and recall strategies when issues are identified. She provides risk assessments, develops operational procedures and compliance programs, manages medical-legal-regulatory approval processes, structures commercial licensing and collaboration arrangements, and develops strong government agency engagement strategies for product and reimbursement submissions. Hills also helps her clients manage complex issues in product development, product launch and ongoing market compliance, and defends private and government enforcement actions. Hills was the vice chair of her prior firm's FDA regulatory practice, a position she's also held previously for other leading law firms.
"Bethany's broad life sciences regulatory practice and her deep experience in FDA regulatory and healthcare regulatory matters, and compliance across digital health issues, artificial intelligence and software solutions will provide significant support for our Intellectual Property Practice, as well as a number of practices across the Firm that touch the life sciences, pharmaceutical and healthcare industries including M&A, Private Equity, Capital Markets, White Collar and more," said Yar Chaikovsky, Head of White & Case's Intellectual Property Practice. "We are very pleased to welcome Bethany as we continue to focus on our US growth ambitions and build our reputation as a go-to Firm for major players in the life sciences and healthcare technology industries."
Hills is the 11th lateral partner to join White & Case's US offices this year and the fourth partner to join White & Case's growing Intellectual Property Practice in 2024.
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