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Life sciences companies look to Jim for innovative legal strategies that minimize risk and move their businesses forward. As a seasoned health care executive and lawyer, he is well-versed in complex regulatory and commercial issues related to drug development, life cycle management, compliance matters, internal investigations, and transactions.
Jim's extensive pharmaceutical and health care industry expertise includes mergers and acquisitions, licensing, litigation, intellectual property, securities, and corporate governance, as well as regulatory issues. Known for his deep knowledge of Food and Drug Administration (FDA) regulatory matters, Jim is a trusted advisor to clients on the development and commercialization of pharmaceutical products, medical devices, and food products. He also has a deep understanding of the emerging field of biosimilars.
Prior to joining Lowenstein Sandler, Jim was of counsel at Hyman, Phelps & McNamara in Washington, D.C. Previously, he was General Counsel and Head of Government Affairs and Quality at Novo Nordisk, one of the most successful global health care companies. During his tenure, Jim oversaw all legal issues, helped establish the company as the market leader in diabetes, and played a key role in the success of several other therapies. Additionally, Jim served as Corporate Counsel at Pfizer, where he advised management on various matters, including the company's compliance with manufacturing, clinical, and laboratory processes. At the start of his career, Jim was an associate in the FDA law group at Sutherland, Asbill & Brennan, and worked at the FDA as a regulatory counsel in the office of the Associate Commissioner for Health Affairs.
A frequent writer and speaker, Jim is sought after for his perspective on the regulatory, legal, and policy challenges shaping the global health care industry. He has spoken at various industry conferences, congressional briefings, and FDA public hearings.