Working in animal health, you can do almost anything!"Aki
What's your current role at Merial, and what does the position involve?
I joined Merial in January 2012, starting in Regulatory Affairs Biologicals for NPD—New Project Development. In 2015 I moved from Regulatory Affairs to the Clinical group. My title now is Team Manager of Clinical R&D. I’m in charge of all clinical studies in Japan,
which can be divided into vaccines and pharmaceutical products. My team is also in charge of all necessary information and data for registration of all products, in addition to generating clinical data for both the new and existing Merial products.
And you're generating clinical data for product registrations just in Japan, or other countries as well?
Japanese regulatory authorities (called JMAFF) require local field clinical study data for vaccines—because of epidemiological differences between Japan and other countries such as the U.S./EU—so we need to conduct local field trials for Japan registration of vaccines. But we're also contributing supporting data for global registrations.
Can you explain more how that works?
Do you know VICH? OK, so the "V" is for "veterinary," and ICH is the international harmonization program for human medicines. So VICH is an initiative for harmonizing the regulatory requirements for registering veterinary products across the U.S., EU, and Japan.
So basically, this means that data generated in the U.S., EU, and Japan can be shared and used for product registrations all across those regions. So our country is helping contribute to Merial product registrations far beyond Japan. This is a very exciting part of my role!
Our country is helping contribute to Merial product registrations far beyond Japan. This is a very exciting part of my role!"Aki
What brought you to where you are today—what was the course of your career path?
In 2001 I went to the U.S. to work at a small biotech company for tissue engineering products for orthopedic application. Working at a startup, I had to do a lot of different things: cell cultures in the laboratory, implanting the cartilage product, and even mimicking a pathologist to analyze the data. And because I developed a new implantation technique, I also trained orthopedic surgeons in that. And then after that for about four years I was a stem cell scientist at MIT.
So what brought you back to Japan?
After spending 10 years in the U.S. in both industry and academia, I was thinking: stay, or go back to Japan? Then I got an opportunity from Japan to work in stem cell research, as an assistant professor. The project was collaborating with Professor Shinya Yamanaka, who won the Nobel Prize in Physiology and Medicine in 2012. So you know, nobody turns down an opportunity like that!
I did that about two years, but I thought, "You know, I'm a veterinarian, I need more experience in surgery and treatment." So then I went to work in a small animal clinical for one year.
And how did you land at Merial?
While I was working at the U.S. biotech company, I realized I was missing regulatory affairs knowledge. This knowledge and experience is really important for that final part of taking a product to launch. So when I learned of a Merial Regulatory Affairs (RA) role, I jumped on the opportunity. I spent two years in RA and then I got the opportunity for my current Clinical role.
I think Merial really has a respect for science and technology, at all levels throughout the company"Aki
What's a typical workday like for you now?
Usually, I’m working in the office. When we start clinical trials, we have to be a monitor, which means going to visit the veterinary clinics or farms to make sure they're doing well. And even in the office, we're always communicating with our on-site investigators.
Plus, we're communicating with regulatory authorities because we have to make sure our study design is appropriate for regulatory requirements.
How long does a clinical trial generally run?
Oh, it varies widely depending on the product. And even if a trial site is set to run, let’s say three months—that's really just in the real field for three months. But before that, of course, we have to make a protocol and analyze data and make a report—so overall it may take more than a year. And some products like a cancer vaccine may require a very long follow-up—because just like human cancer medicine, it measures survival time or remission time.
What do you find most rewarding about your current role?
That we are getting to contribute data to International Regulatory Affairs and helping advance global product approvals! Especially with the growing Asian markets, Japan plays an important role in a global company.
What would you say to other scientists who are considering joining Merial?
Well, I'm a veterinarian—if I work in human pharmaceuticals, then usually toxicology and safety are the main career options for veterinarians. But working in animal health, you can do almost anything! Regulatory affairs, clinical science, even industrial operations or management or executive positions—you can do many different roles.
And I think Merial really has a respect for science and technology, at all levels throughout the company.
Finally, since we're talking animal health: If you were an animal, what kind of animal would you be?
Oh, definitely a bird, because I wish to fly, and want to see many things! But I don’t want to eat worms—I want to eat meat or fish, so I’d be an eagle or a hawk.