Miki Yamamoto, PhD, is the vice president and head of regulatory affairs at Arrivent Biopharma. Yamamoto is joining the QB3-Berkeley Professionals in Residence (PIR) program on February 9th 2023. UC Berkeley and LBL trainees may register for Yamamoto’s events here. Yamamoto spoke with graduate student Anneliese Gest about her journey in regulatory affairs.
Anneliese Gest: Could you please share an overview of your career path?
Miki Yamamoto: Sure. As an undergraduate, I studied genetics and cell biology at Washington State University, and at the time I thought the only next step was to attend graduate school! I went to UC Berkeley, and I got my PhD in the plant and microbial biology program working with Barbara Baker on virus-host interactions in plants. I knew I wasn’t going to do academic research at the end of my program, but I didn’t know what next, so I did a postdoc at Lawrence Berkeley National Lab, studying cell-signaling, but in red blood cell differentiation and breast cancer systems.
While I was doing my postdoc, I also took night classes in the clinical trial design and management certificate program at San Francisco State University. That certification opened up some career possibilities outside of academic research, and I started talking to people about how I could apply my skillset in a position that might serve as a jumping off point for a career outside of academic research. I considered positions in clinical operations in biotech and pharma, as well as research positions in industry, and I took a position at Genentech in strategic regulatory affairs. That position worked out well, and I’ve been happy with the path on which it’s taken me.
That role at Genentech launched my regulatory affairs career, specifically in targeted cancer drug development. I was at Genentech for about five years, where they trained me, and I worked on a number of drugs. Some of these are FDA-approved now, which is rewarding to see. There I met smart and awesome people, including my mentors. In fact, I followed one of my mentors to a small pharma company in San Diego, Aragon Pharmaceuticals, where I worked on a cancer drug that is now approved and is marketed by Janssen. At that point I realized I liked the small company experience, where instead of getting deep knowledge in one specific job, it’s much more of that startup mentality of “let’s figure it out.” It’s an environment where there are many opportunities to learn and grow. I then followed my mentor to two other small pharma companies developing cancer drugs—all of which have since been acquired.
More recently, I was at a subsidiary of Bridgebio Pharma, which focuses on genetically driven rare diseases, including some cancers. In that position, I was head of regulatory affairs and led a team to submit a new drug application for a cancer drug that then received an FDA approval. Currently, I’m the head of regulatory affairs at ArriVent Biopharma, a small pharma startup, developing a drug for non-small cell lung cancer targeting the EGFR pathway.
AG: Can you describe for those who may be unfamiliar what regulatory affairs is, and what your work in this position looks like?
MY: I had no idea this existed when I was a graduate student, either. Regulatory affairs has a number of aspects to it. One of the main parts of my job is interacting with health authorities, including the FDA, and leading our clinical and manufacturing teams through interaction with the health authorities. We prepare detailed briefing documents and meet with these agencies to get alignment on our path to ensure that when we bring our clinical trial data to these agencies for marketing application and approval, that we have all the data that’s needed to assess that the drug is efficacious and safe, and that we’ve addressed the regulatory requirements.
Another aspect of regularity affairs includes helping to design and conduct the clinical trials that are the bases of assessing if the drug is effective and safe. The last aspect of the role is overseeing the deliverables that go to these agencies. Every time a new study is initiated, detailed information must be sent to every health authority in each country where the study is conducted, as well as all the local research review boards. The position involves elements of project management; I use my critical thinking skills, review data, and guide the team in presenting it to these health authorities.
AG: How did you decide to pursue a path in regulatory affairs?
MY: I have friends who are motivated by research and answering scientific questions, but for me, it was stressful to publish and secure grants, and those elements of science didn’t appeal to me long-term. I do, however, enjoy thinking about the science, and I like interacting with folks who have a scientific mindset. Regulatory affairs offers a different angle for me to apply my skillsets. It’s data-driven field, without creating the data. At the same time, a lot of my job involves communication: managing stakeholders, technical writing, and facilitating discussions to drive toward decision-making. That is something I missed in research and enjoy in my job now. I also enjoy the feeling of being on high-functioning, fast-moving teams, where the end product is something none of us could have accomplished on our own. The collaborative part of my work is exciting.
AG: Which experiences and skills from your scientific training have prepared you for your career?
MY: There are skills I developed that at the time I didn’t necessarily know would be useful, but the more I look back, the more I appreciate them. I was the only graduate student in my PI’s lab for many years; it was all postdocs except for me. Lab meetings often involved rapid-fire questions, which is a great environment for learning to do good science. That prepared me for the fast-paced environment and rigorous problem solving I’ve been doing since leaving academia. Every time I move to my next position, I consider a couple of essential elements. First, the company’s work has to be good science, driven by the data. Second, I want to be around smart people at work; I never want to be the smartest person in the room. Also, the value of critical thinking and problem solving has been crucial for me. For example, when an experiment didn’t work and figuring out what went wrong—that thought process has been helpful throughout my career, especially at startups where there’s not a lot of process; there’s a lot you just have to figure it out.
AG: What’s it like to work at a small company that gets acquired, and then move to the next company quickly thereafter?
MY: It sounds tenuous when you say “Oh, I’ve changed jobs every three to five years,” but in this field it’s fairly common. I think about it more like projects: when you’re in research, and a project doesn’t work out, or even if it does, you get to a point where it’s time to move on to the next thing. In some ways you’re starting over with each company or research project, but often you’re taking everything you’ve learned from your last project and applying it. I’ve been lucky – for me moving on has been largely a happy event, where we’ve done a tremendous amount of work to develop a drug, and now a larger company is going to commercialize it. It’s exciting to hand it off and see the project go on and patients gain access to these drugs.
AG: Is there anything else you’d like to share?
MY: One of my interests outside of my day job is supporting women; at my last company I was on the steering committee for Women at Bridge, with the goal of putting effort into creating a more equitable working environment for women. I co-led the rollout of a pilot mentorship program for women mentees that has now been handed off to HR and rolled out on a broader level. We also wanted to support girls in STEM, and another effort I led sought out nonprofits that support girls in STEM and connected employees were interested in volunteering to these organizations. Connecting and supporting women has been a rewarding element of my career. There’s been a lot of progress for gender equity, and women in the professional space, but there’s still a lot of work to be done.
Miki Yamamoto is VP and head of regulatory affairs at Arrivent Biopharma and has previously worked in regulatory affairs at companies including Genentech, Aragon Pharmaceuticals, and Bridge Bio, where she’s helped bring several drugs to market, mostly targeting cancer. She received her PhD in Plant and Microbial Biology at UC Berkeley in 2005.
Anneliese Gest is a recent PhD graduate in chemistry on the chemical biology track in Evan Miller’s lab, where her research focused on developing methods for measuring voltage in living cells using fluorescence lifetime imaging microscopy and voltage-sensing dyes. She is passionate about teaching science and science communication and has participated in QB3-Berkeley’s Science Writing for the Public workshop and has served as an editor for the Berkeley Science Review Blog for the last five years.