James C. Shehan Senior Counsel

New York
T 646.414.6897 | F 973.597.2400



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.

Publications

Reviewing Changes Made by the 21st Century Cures Act to Drug and Device Development
Westlaw Journal Pharmaceutical, April 2017
James Shehan, Tara D'Orsi, Donna Hanrahan
Sparking Discussion and Adding Fuel to the Fire: FDA Discussion Paper on Laboratory Developed Tests (LDTs)
Life Sciences Client Alert, February 21, 2017
James Shehan, Alan Wovsaniker, Donna Hanrahan
FDA Breaks Medical Product Communications Silence
Law360, January 27, 2017
James Shehan, Tara D'Orsi, Donna Hanrahan
View More...

Press Mentions

Jim Shehan comments in Reuters on Trump Administration proposals for FDA deregulation. , Reuters , February 15, 2017
Jim Shehan comments in Law360 on the deluge of bold policy statements made by the FDA during the final days of the Obama administration. , Law360 , January 20, 2017
In Bloomberg Law, Jim Shehan comments on the importance of maintaining contacts for GCs returning to law firms. , Bloomberg Law , September 19, 2016

Related Areas

Corporate
Life Sciences

Education


Georgetown University Law Center ( J.D. , 1985 )
Columbia College, Columbia University ( B.A. , 1982 ) , Biology, French Concentration

Bar Admissions


New York
District of Columbia

Affiliations


  • Healthcare Institute of New Jersey (2005-2012, vice-chair 2012)
    • Trustee
  • Healthcare Leadership Council (2006-2012)
    • Board Member
  • American Friends of the Statens Museum for Kunst (Denmark’s National Gallery) (former Chairman)
    • Board Member
  • National Association of Manufacturers (2009-2012)
    • Board Member
  • PhRMA Law Section Executive Committee
    • Company Representative
  • BIO General Counsel Committee
    • Company Representative