Biotechnology and AI IP Law and Regulation Lawyer of the Year law evolved, leading us to pivot towards trade secret and contract protections, especially for software as medical devices. Recognizing the importance of data provenance and the changing dynamics of collaborations between academia, health systems, and technology companies, we’ve encountered new litigation and concerns around health data, privacy, and consumer protection. Our approach includes developing strategies for a range of applications, recognizing that AI’s dynamic nature requires novel methods to protect innovation. We’ve adapted existing laws and leaned into regulatory processes, addressing challenges such as data provenance and the complexities of collaborative research. By teaching and contributing to discussions on AI in healthcare law, we stay at the forefront of navigating IP protection in this rapidly advancing field, reflecting our commitment to innovating within the IP realm for AI technologies. What are some of the biggest challenges you face when navigating the complex regulatory landscape for new biotechnological product applications? How do you innovate within these constraints to ensure client success? Many years ago, the issue was new, and different technologies and products required changes in the regulatory regime. However, the regulatory bodies are science driven and designed to develop and adapt. We have always engaged early and often with regulators and policy makers to facilitate the process. Without breaching confidentiality, could you share a case study or example where your firm successfully navigated a client “from concept to market”? Some of the most rewarding projects have been with technology that was created at a university or start-up. We have been involved with many biotechnologies over decades as they evolve from basic science to proof of concept through development and into commercialization. AI is much more diverse and now very fast-moving, so the timelines are much quicker. However, the common element, no matter how slowly or rapidly the IP and regulatory processes move, is thinking about the possibilities and risks presented on an ongoing basis and maintaining the dialog with our creators and makers. This work is hopeful and forward-thinking and continues to challenge and inspire me! Finally, how do you stay ahead of the regulatory changes affecting AI and biotechnology? We engage. We work throughout the innovation ecosystem. Working with many academic research institutions worldwide, start-ups, and growing companies, we understand the challenges of translating science into invention and/or proprietary applications and products. We screen technology for collaboration and investment opportunities. We also work in the merger and acquisition area, helping identify, evaluate, and validate opportunities. I teach in these areas and participate in task forces and panels. I love science and the law and am fortunate that my work involves the knowledge, skill, and passion that both require in collaboration with creators, visionaries, and changemakers. 80 www.lawyer-monthly.com Lawyer Monthly Women in Law Awards 2024 “I love science and the law and am fortunate that my work involves the knowledge, skill, and passion that both require in collaboration with creators, visionaries, and changemakers.”
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