全新的硕士学位 —— 监管科学与数字创新

美国著名的加州大学旧金山分校（UCSF）药学院，首创监管科学与数字创新（Regulatory Science and Digital Innovation, RSDI）理学硕士学位，本月开始招生，明年7月开学。详情请见附在本文后面的药学院官方介绍（中文译本 + 英文原文）。在此只想简述些我的感想。

20年前，北京大学创立国际药物工程管理（International Pharmaceutical Engineering Management, IPEM）硕士项目，开始招生，第二年开学。作为IPEM的创始主任，我能体会RSDI创始主任赵亮教授此刻的兴奋，为他感到高兴，也为药业感到高兴。

试想，如果20年前你成为了IPEM的首届学生，认真学习了由美国FDA负责GMP的Nick Buhay讲授的《药监法规与产品和工艺的结合》，FDA仿制药办公室研究主任余煊强博士的《仿制药审评》，Hospira叶玲博士和Pfizer叶潮博士的《仿制药开发》，Lilly郑玉群博士的《小分子产品开发》，Amgen周新华博士和Bayer汪德潜博士的《大分子产品工艺开发》，Merck杨立虎博士的《新药研发》、孙勇奎博士的《小分子工艺开发》、王建博士的《晶型开发》，FDA何如意医学博士的《新药临床审评》等课程，及FDA负责GMP和GCP的合规办公室副主任Joseph Famulare和新药质量办公室主任Moheb Nasr博士的《质量源于设计》讲座，FDA临床审评泰斗Robert Temple医学博士，临床审评一部副主任、植物药审评组长Shaw Chen医学博士，统计学会主席李宁博士、李自立博士等的《临床药物审评和生物统计》讲座，会对你的行业视野、知识结构、思考方法等有多大的影响，这且不说与同级学生们的互相学习和建立友谊。

IPEM面向国内，RSDI面向全球，只会有更丰富的师资和学生来源。UCSF具有全球领先的药学院和医学院。UCSF和Stanford大学每年1月份联合举办的《监管科学创新峰会》，FDA总是派局长和各产品中心主任参加，是不折不扣的峰会。峰会设在每年JP Morgan医疗健康大会的前一天，两会址只有10分钟车程，所以总有投资人参加。Stanford离UCSF只有40分钟车程，著名加州大学Berkeley分校，也只有20分钟车程。UCSF-Stanford-Berkeley，三位一体，构成了全球生命科学研究和交流的主要基地之一。著名药企Genentech和Gilead，车距UCSF分别为10分钟和20分钟。全球AI巨头OpenAI与UCSF更是邻居，Anthropic步行也才40分钟。据悉，赵亮教授未来将有不尽的算力。由于距开学日期尚远，具体课程内容和授课老师尚在准备之中。当然，创办是一回事，办好是另一回事。但难以想象，在监管科学和数字创新领域，创办RSDI硕士项目哪里还有比UCSF更理想的学校。这也是3年前赵亮博士决定来UCSF任教的原因之一。

今天是教师节，作为退休教师，我享受着来自学生们的节日祝贺和鲜花，并为有机会见证RSDI的创办而感到幸运。

全新硕士项目旨在塑造监管科学的未来

Katherine Tam, 加州大学旧金山分校药学院 对外传播主任，2026年8月31日

加州大学旧金山分校药学院推出监管科学与数字创新（Regulatory Science and Digital Innovation, RSDI）理学硕士学位（https://pharm.ucsf.edu/msrsdi），旨在培养能够领导有效的监管、研究和开发解决方案的专业人士，使有前景的新药和健康技术能够安全地惠及患者。

该项目是全国首创，正值该领域发展的关键时刻。人工智能、数字医疗、数据科学和技术的进步正在迅速改变新疗法和医疗器械的研发方式。

“监管领域的发展速度与它所监管的科学技术一样迅猛，”项目主任、教授赵亮博士表示，“我们需要能够预见未来趋势、并有效应对的专业人士。新项目将使他们具备在产业界、医疗保健和政府等领域开发创新解决方案的技能。”

新的硕士课程依托于药学院在监管科学和药物开发方面的长期专业知识，包括自 2014 年以来领导 UCSF-斯坦福监管科学与创新卓越中心，以及该学院两年前启动的人工智能和计算药物开发与发现理学硕士课程。

有两种课程路径可供选择

新的 RSDI 计划于 9 月 1 日开始接受申请，首批学员计划于 2027 年 7 月开始学习。

项目提供两条发展路径，分别针对当前职业阶段和未来发展方向。高管路径面向医疗保健、产业界或政策领域的中高级专业人士和领导者；基础路径则面向希望进入或转型至监管科学、生物技术或数字医疗领域的职业生涯初期人士。

两个路径的课程都侧重于现代监管科学，包括人工智能、医疗器械软件、数字医疗和全球监管框架。课程设置将严谨的理论学习与实际应用相结合，旨在帮助学生应对不断变化的监管挑战。

“在我从事医疗技术工作的 30 年里，阻碍优秀技术惠及患者的最大瓶颈很少是科学或工程；而是应对监管并将创新转化为监管机构、医院和医疗保健提供者都能理解和信任的东西的能力，”直觉外科公司（Intuitive Surgical ）监管事务高级副总裁兼 RSDI 项目执行委员会成员Ian Purdy 说。

他补充道：“这是一种难得的技能，而这正是RSDI项目旨在培养的。我真心为这个项目感到兴奋，因为它不仅将监管专业知识视为合规职能，更将其视为一种独立的领导力学科。”

课程作业与实际应用相结合

学生将在四到五个学期内完成硕士学位，具体时间取决于所选路径。该项目将高级课程与应用学习相结合，高管路径的学生需撰写硕士论文，而基础路径的学生则需完成毕业设计项目。

该项目由学校的生物工程与治疗科学系管理，并由一个执行委员会指导，该委员会成员包括来自Genentech和Accumulus Technologies等主要生物技术和技术公司的领导人。

“未来的领导者需要将科学、技术和监管融会贯通，负责任地运用创新来加速开发和提供安全有效的疗法，造福患者，” Accumulus Technologies首席执行官兼RSDI项目执行委员会成员Francisco Nogueira表示。“凭借世界一流的科学专长、创业生态系统以及对公共卫生的承诺，加州大学旧金山分校在培养引领这一变革的毕业生方面拥有得天独厚的优势。”

New Master’s Program Aims to Shape Future of Regulatory Science

Katherine Tam, August 31, 2026

The UCSF School of Pharmacy is launching a new Master of Science degree in Regulatory Science and Digital Innovation (RSDI)（https://pharm.ucsf.edu/msrsdi）to prepare professionals to lead effective regulatory, research and development solutions that allow promising new medications and health technologies to reach patients safely.

The program, the first of its kind in the nation, arrives at a pivotal moment for the field. Advances in artificial intelligence, digital health, data science, and technology are rapidly changing how new therapies and medical devices are developed.

“The regulatory field is changing as quickly as the science and technology it oversees,” said Liang Zhao, PhD, program director and professor. “We need professionals who can anticipate what’s coming and respond effectively. This new program will equip them with the skills to develop innovative solutions across industry, health care, and government.”

The new master’s program builds on the School of Pharmacy’s longstanding expertise in regulatory science and drug development, including leading the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation since 2014 and the school’s Master of Science program in AI and Computational Drug Development and Discovery that launched two years ago.

Two program tracks to choose from 

Applications for the new RSDI program open Sept. 1, with the inaugural cohort slated to begin July 2027.

The program offers two tracks tailored to a student’s current career stage and where they want to advance. An executive track is designed for mid- to senior-level professionals and leaders working in health care, industry or policy, while a foundational track is geared toward early-career professionals seeking to enter or pivot into regulatory science, biotech, or digital health. 

Across both tracks, the curriculum focuses on modern regulatory science, including artificial intelligence, Software as a Medical Device, digital health, and global regulatory frameworks. The coursework combines rigorous coursework with real-world application, preparing students to address evolving regulatory challenges.

“In my 30 years working in medical technology, the biggest bottleneck to great technology reaching patients has rarely been the science or engineering; it's been the ability to navigate regulation and translate innovation into something a regulator, a hospital, and a health care provider can all understand and trust,” said Ian Purdy, senior vice president of regulatory affairs at Intuitive Surgical and a member of the RSDI program’s executive committee.

“It's a rare skill set, and it's what UCSF's RSDI program is built to develop,” he added. “I'm genuinely excited about a program that treats regulatory expertise not just as a compliance function, but as a leadership discipline in its own right.”

Coursework with real-world application

Students will complete the master’s degree in four to five quarters depending on the track. The program combines advanced coursework with applied learning through either a master’s thesis for those in the executive track or a capstone project for foundational track students.

The program is administered by the school’s Department of Bioengineering and Therapeutic Sciences, and guided by an executive committee that includes leaders from major biotech and technology companies such as Genentech and Accumulus Technologies.

“Tomorrow’s leaders will need to bridge science, technology, and regulation, applying innovation responsibly to accelerate the development and delivery of safe, effective therapies to patients,” said Francisco Nogueira, CEO of Accumulus Technologies and a member of the RSDI program executive committee. “With its world-class scientific expertise, entrepreneurial ecosystem, and commitment to public health, UCSF is uniquely positioned to prepare graduates to lead this transformation.”

Katherine Tam is the Communications Director for the UCSF School of Pharmacy at the University of California, San Francisco.