Katherine Leibowitz has been supporting the clinical trials enterprise for 25 years. She co-founded Leibowitz Law in 2013, after spending 17 years at a top global law firm. Her boutique life sciences regulatory and technology transactional law firm is laser-focused on clinical trials and technology commercialization. The firm serves sponsors/manufacturers, technology service providers, research institutions, and CROs.

Katherine handles the full clinical trial operations contracting process, from CTAs and budgets to HIPAA authorizations, informed consent forms, EDC vendor agreements, CRO MSAs, DMCs, and more. In today’s fast-evolving world of AI, electronic databases, decentralized trials, cyber risk, secondary research, and biobanking, she excels at modernizing contract templates and negotiations to align with the shifting landscape and move deals forward efficiently.

A frequent speaker and author, Katherine enjoys combining the multiple regulatory, legal, and industry norms to provide integrated, practical guidance to the life sciences community.