Kelly specialises in regulatory investigations and litigation, corporations and securities law, including corporate crime, intellectual property, and biotechnology and pharmaceutical law.
Drawing on her experience as a lawyer in enforcement at ASIC, Kelly offers significant expertise in regulatory and law enforcement investigations, administrative, civil penalty and criminal proceedings brought by Australia’s key regulators including ASIC, ACCC, AFP, AUSTRAC and the TGA. She has advised on numerous corporate investigations including in respect to anti-bribery and corruption, market manipulation, insider trading, misleading and deceptive conduct (including the promotion of therapeutic goods), director’s duties and criminal prosecutions.
Prior to joining Gadens, Kelly served as both Chief Legal Counsel and Head of Government Affairs and Policy for one of the world’s largest biopharmaceutical companies in Australia and New Zealand. As a result, Kelly offers extensive experience advising across the whole product life cycle, including clinical trial governance, intellectual property protection, licensing, registration, reimbursement, promotional disputes (including the Medicines Australia Code of Conduct), medical affairs, pharmacovigilance, product safety and recalls. Kelly’s deep understanding of government policy and health technology assessment enables her to provide strategic advice on submissions to the PBAC for reimbursement of medicines and vaccines. Kelly was a member of the Medicines Australia taskforce responsible for negotiating and implementing the 2018 Strategic Agreement, and associated legislative amendments, between the innovative medicines industry and the Federal Government.
Kelly’s broad skillset includes providing advice in relation to contentious and non-contentious intellectual property and technology matters including IP protection, litigation involving patent, design, copyright and trade mark infringement, as well as complex employment disputes including internal investigations, fraud, and adverse action proceedings.
Kelly is an also an experienced company director in the healthcare and creative arts industries. Kelly is also a member of the Human Research Ethics Committees of the Royal Children’s Hospital and Murdoch Children’s Research Institute.