Topic: Clinical Trials and Regulatory Milestones for Global Life Sciences Licensing
Clinical development and regulatory milestones for pharmaceuticals, biologics, medical devices and laboratory tests are often orchestrated on a global basis. This presentation will cover the essential clinical milestones and U.S. and EU regulatory milestones that can form the basis for license milestones, and then discuss licensing strategies for dealing with data read out in disparate jurisdictions intended to satisfy those different milestones.
John Wilkinson is a partner in Cooley's Life Sciences practice and is resident in the London office. John's practice focuses primarily on the life sciences sector advising pharmaceutical, biotechnology and medical technology companies on a wide range of IP, regulatory, anti-trust and transactional matters. Amongst other things, John's practice has involved a number of highly complex alliances and joint ventures, co-promotional and co-marketing arrangements, distribution and supply agreements, together with the operational, IP, anti-trust and regulatory issues relating to such transactions.
John is recognised as a leading practitioner in the transactional life sciences field by Chambers, the Legal 500 and PLC Global Counsel and is highly recommended by IAM's guide to the World's Leading Patent & Technology Licensing Lawyers. John has been recognised by Who's Who Legal as one of the world's five most highly regarded individuals for transactional life sciences matters in both 2014 and 2015. He has also been recognised by The Times as a Lawyer of the Week for his involvement in Bavarian Nordic's Ebola vaccine transaction with Janssen.
Before qualifying as a lawyer, John obtained a degree in Chemistry from Imperial College of Science Technology and Medicine and spent five years in the chemical and pharmaceutical industry working in drug development and other areas. John's practice involves advising pharmaceutical and biotechnology companies in the U.S., Canada, UK, Denmark, Hungary, Switzerland, Portugal, Sweden and Norway. Prior to joining Cooley, John was a partner at Reed Smith and previously at Bird & Bird. Prior to that, he was Legal Counsel at Cancer Research Technology Limited.
Natasha Leskovsek is an FDA regulatory partner in Cooley’s Washington, DC office. Natasha advises biopharmaceutical and medical device companies and their investors on strategic pathways to commercialization and pre- and postmarket compliance with FDA requirements. Prior to practicing law, Natasha worked as a clinical research nurse at NIH and in project management for a CRO. She received her J.D. from Georgetown University Law Center and BSN and MBA degrees from the University of Maryland. Natasha is a member of the Food and Drug Law Institute and the American Health Lawyers Association.