By Gwyneth K. Shaw
A new course in Berkeley Law’s groundbreaking LL.M. Certificate in AI Law and Regulation program is preparing students to handle the fast-moving and high-impact issues at the intersection of AI and biotechnology.
Taught by two experts from International Flavors & Fragrances Inc. (IFF), a global biotechnology company, AI in Biotechnology Law focuses on the legal, regulatory, and ethical challenges posed by AI-driven innovation in the life sciences.
Lecturer Amanda Casale, intellectual property counsel for IFF’s Grain Processing and Scent businesses, was trained as a neuroscientist and says she always found the connection between AI and biotechnology interesting. When she became a patent practitioner, the sector quickly became her favorite domain, and she’s spent the past decade helping clients develop strategies to bridge the tech and life sciences space.
“The application of AI to biotechnology is impacting the world and every person in it. Medicine, agriculture, industrial technologies — you name it — are all affected,” she says. “And in turn, the legal areas that touch these fields — contracts, privacy, ethics, intellectual property, regulatory, policy — will be impacted as well. We have a responsibility to prepare the LL.M. students in this program to think critically about these impacts, not only to support their clients, but to be thoughtful members of the legal profession.”
IFF Biosciences IP Team Lead Matthew Show, who’s teaching the class alongside Casale, says he was motivated to create the course both because the subject novelty made it an interesting challenge and because AI has become increasingly important in his own work.
“Over the last two years, I have seen the use of AI grow exponentially across the biosciences industry and in the practice of law itself,” he says. “The course is a chance to explore how these technologies are transforming innovation while giving students the tools to think critically about the legal and policy issues they create. While AI is transforming many sectors, its potential impact on biotechnology and healthcare may ultimately be among the most significant.
“Lawyers who understand both AI and the life sciences will be uniquely positioned to help navigate these challenges and shape policies that encourage innovation while protecting the public interest.”
Setting the pace
The LL.M. AI certificate program, which began in August 2024, is the first of its kind at an American law school and has attracted students from more than 40 countries, including lawyers working in the U.S. looking to broaden their expertise.
Built on the bedrock of the law school’s vaunted law and technology program, the certificate is open for applications from students interested in the LL.M. executive track program, which is completed over two summers or through remote study with one summer on campus.
AI in Biotechnology Law is one of two new courses offered this summer, along with Corporate Strategy in the Age of AI and Geopolitics. They’re building on the initial curriculum, which includes The Law and Governance of Artificial Intelligence, Global Regulation of AI, and Making AI Work for the People.
The chance to teach the course, which Casale thinks may be the first of its kind, provided an opportunity to share her experience as well as explore the topic’s breadth with students.
“Because there is so little case law and guidance in this space, we would have the chance to think creatively and critically in a way that is distinct from other law courses, and I wanted to give students that opportunity,” she says.
Show says he wants to drive home a simple message to students: AI isn’t coming to the legal industry, it’s already here.
“It is influencing everything from scientific research and medical practice to contracts, intellectual property, privacy, and trade secret protection. Lawyers who understand both the technology and the legal framework surrounding it will be much better positioned to help shape the future of innovation in the life sciences,” he says. “AI is not creating a completely separate area of law; rather, it is transforming virtually every area of biotechnology law that lawyers already practice.”
He and Casale have structured the course to highlight the breadth of AI’s influence, using case studies, analysis, and expert guest lecturers to explore the complexities of patenting AI-assisted inventions, regulatory compliance with data privacy laws, and the implications of algorithmic accountability in medical diagnostics and drug development. Students are also examining broader societal concerns, including algorithmic bias and the ethical boundaries of AI-enabled genetic engineering.
Italian LL.M. student Francesca Di Lazzaro, who works in her law firm’s IP and new technology department and has a Ph.D. in copyright, AI, and sustainability, says one of the best things about the course is the highly innovative structure.
“Rather than focusing solely on doctrine, the course brought together leading practitioners and experts working at the forefront of AI and biotechnology, giving us firsthand insight into the legal and practical challenges shaping the field,” she says. “Their contributions made it possible to appreciate how rapidly this area is evolving and how legal frameworks must continuously adapt to scientific and technological innovation. The combination of legal analysis, real-world case studies, guest experts, and the guidance of Professors Casale and Show made the course both intellectually stimulating and immediately relevant to practice.”
A unique opportunity
Di Lazzaro says she feels fortunate to be able to pursue the AI certificate, which combines regulation, intellectual property, privacy, licensing, risk management, technical foundations, and ethics to prepare students to understand AI not only as a legal subject, but as a transformative technology with profound societal implications.
“The experience brings both excitement and responsibility,” she says. “Whether we are lawyers, in-house counsel, policymakers, founders, or professionals advancing our careers, we have a shared responsibility to contribute thoughtfully to the development of AI governance.
“At a time when AI governance requires global cooperation and multidisciplinary thinking, Berkeley provides an exceptional environment in which to engage with these challenges and help shape the future and understanding of AI regulation.”
Both Casale and Show describe developing and teaching the course as challenging because of the lightning-fast pace of development in both the AI and the biotech sectors. Some materials they gathered in the springtime were outdated by the time the class began in late June. And unlike many traditional law school subjects, there’s not a well-developed body of precedent to draw from, so they framed the course as a guide to help students orient their legal lens rather than a set of hard facts and case law.
“In areas such as contracts, torts, or patent law, students can look to decades — sometimes centuries — of case law for guidance,” Show says. “With AI, many of the most important legal questions have not yet been answered by courts or legislatures.”
The feedback from students like Di Lazzaro has been overwhelmingly positive, Show and Casale say, with some students even wishing for an opportunity to get more in-depth than a 1-credit course allows. Students were engaged and energized by the topic, Casale says.
“Having such a diverse group of LL.M. students, coming from different practice areas, enriched the discussion,” she adds. “We learned from them.”
Casale hopes students leave the course believing that their opinions and thoughts matter.
“This area of law is rapidly changing, and the technology is going to affect every person on the planet. The students are uniquely positioned to shape how that happens,” she says. “I want the class to feel empowered to think, question, and learn. Although the topic is broad and complex, it is not unmanageable when broken into bite-sized pieces.
“My hope is that if they feel inspired by one of the many topics in this space, they will feel confident digging in and making their voices heard.”