Paul Radensky > McDermott Will & Emery LLP > Washington DC, United States > Lawyer Profile

McDermott Will & Emery LLP
THE MCDERMOTT BUILDING, 500 NORTH CAPITOL STREET, NW
WASHINGTON, DC 20001-1531
United States
Paul Radensky photo

Work Department

Healthcare

Position

Partner Paul Radensky, MD, advises manufacturers at every stage of product development, including the design and monitoring of clinical trials, positioning and applying for Food and Drug Administration (FDA) approval, maintaining regulatory compliance, and obtaining coverage, coding and payment for new technologies by Medicare, Medicaid and other third-party payors. He serves as a principal of McDermott+Consulting LLC.

Paul also advises clinical laboratories on Clinical Laboratory Improvement Amendments (CLIA) and state licensure compliance as well as evolving policies on FDA regulation of laboratory-developed tests. He is a recognized authority on the full range of legal, regulatory and reimbursement issues pertaining to pharmaceutical, biotechnology, medical device, and clinical laboratory development and marketing.

For further details of Paul’ biography, please view McDermott website:
https://www.mwe.com/people/radensky-paul-w/

Career

Paul’s background as a clinical researcher and medical practitioner informs his practical and scientific understanding of product manufacturers and clinical laboratories. He is board certified in internal medicine.

Lawyer Rankings

United States > Industry focus > Healthcare: life sciences

McDermott Will & Emery LLP‘s life sciences practice stands out for its strong patent litigation offering. In addition, the firm handles commercial litigation, corporate and M&A transactions and regulatory matters. Kristian Werling and Stephen Bernstein jointly lead the team from its Chicago and Boston offices. Also recommended are Silicon Valley-based IP litigator William GaedeSarah Hogan in Boston, who advises on the structuring and negotiating IP licenses, strategic collaborations and other complex commercial transactions; Washington DC-based FDA-regulatory expert Vernessa Pollard; and Paul Radensky, who specializes in regulatory matters. The team was recently strengthened by the hire of senior advisor Scott Bernstein, who joined from Kite Pharma, and focuses on IP and licensing mandates.