By PJ Bogdan
Dan Jenkins is the head of regulatory and quality for Pairwise, a biotech company that uses breakthrough genome editing technologies to make fruits and vegetables more enticing and convenient than unhealthy packaged snacks.
Before they can create revolutionary new products, his company must navigate a wide range of complex regulations that could mean the difference between success and failure with bringing these new products to market.
Traditionally, Jenkins and other regulatory science experts spend months ― and sometimes even years ― training newly hired scientists in the complexities of regulation to help ensure the research behind their products support regulatory standards.
Now Jenkins ― and many others like him ― hope that NC State’s new Regulatory Science in Agriculture Certificate program will do much of that training for them.
This certificate program, developed by NC State’s Center of Excellence in Regulatory Science in Agriculture (CERSA) in concert with industry for undergraduate and graduate students, are the first two in the nation that prepare students and industry professionals for the complex world of agricultural regulation.
We connected with Jenkins for an industry veteran’s perspective on what makes this program so unique, why it gives a big hiring edge for job-seeking researchers, and which skills and education he wants to see in the workforce.
Why is there such a need for regulatory training in agriculture, and why is this certificate program so important for the industry’s biotech companies?
Regulatory science is very complex, especially for agriculture. It spans not just gene editing but also chemistry and all kinds of other areas. You have regulations from the FDA (Food and Drug Administration), USDA (U.S. Department of Agriculture), and EPA (Environmental Protection Agency). Then, as we talk about putting food into commerce, there are regulations in food safety, pesticide residues, labeling, the market, and where food is grown versus where it’s sold. Regulations are also different from state to state and country to country.
Traditionally, companies have had to onboard and train their new scientists in the regulations. Scientists need that practical understanding of how to apply regulations in product development so they can do the research and generate the data that helps launch new products. It takes a lot of time and energy to train each scientist. CERSA’s Regulatory Science in Agriculture Certificate program, and others like it, provide this kind of applied training for our industry so that new researchers can hit the ground running right after they’re hired.
The Regulatory Science in Agriculture Certificate is the first and only of its kind in the nation. Why is this program’s home at NC State?
It’s very uniquely positioned for NC State. You have a big pool of biotech companies in the Research Triangle Park area who have experts dealing with all kinds of regulation. Many of these experts are guest lecturers for the certificate program. They have direct conversations with students in the class about the current state of regulations ― and share examples and experiences to show how regulation works in the real world. These are things that cannot be taught in books. Also, NC State is just four hours away from (Washington) D.C. We’ve had experts from the federal agencies come down here to participate, so you get real-world perspectives from both sides.
Finally, you have CERSA itself. It’s housed under the N.C. PSI (Plant Sciences Initiative), which pulls faculty from a wide range of strengths and disciplines. Some are strong on the chem side; and others, like Jen Kuzma, are strong in areas like social considerations. There’s also a lot of experience around risk assessment and safety. It’s a well-rounded group for sure. So you have one of the leading agriculture programs in the country. And on top of all this, you have a large pool of students who want to build careers in the ag industry.
You might be able to have an organization like CERSA at another school. But do they have the student body that would funnel into that? Do they have the instructors? Do they have the companies in the area that can channel those needs? NC State is the perfect place for this. You can’t really do this anywhere else.
Why is it so important for students to learn from the real-world experiences of these regulatory experts?
In regulation, there’s a lot of “there’s how things are written, and then there’s how it really works.” There’s always a disharmony between regulations written 20 years ago and the state of technology today. You can have a Zoom meeting to talk about them. But the truth is, it isn’t always clear. A lot of times, you need an honest face-to-face discussion. They have protection goals to meet, and you have a community of professionals and scientists that want to do things right. That requires a lot of conversations, and they aren’t the same unless you’re there in person.
This same concept goes for training students in regulatory science. Through the CERSA certificate program, you get access to experts: those working for the major biotech players and the unique startups ― as well as the regulators themselves. You’re able to talk about the regulations, how they’re handled versus how they’re written.
What expertise are you looking for as you hire new scientists at Pairwise?
I’m looking for a strong familiarity with the actual regulations, plus a practical understanding of how to apply them in product development so they can generate the data, do the science, satisfy regulators and launch a product. Knowledge is good, but you also need to know the practical application, plus have a good understanding of risk assessments and principles. That would guide the experimentation and data collection well.
In your opinion, who should enroll in the Regulatory Science in Agriculture certificate program?
Students who are interested in regulatory science, agricultural product development and regulated technologies ― or ag technology issues and policy ― should consider pursuing this certificate. Gaining this knowledge should make a student or employee more competitive, because they will have a better understanding of what it takes to bring a product to market.
You are also a member of CERSA’s advisory board. Why did you decide to get involved with CERSA?
When the idea of a center for regulatory science in agriculture came up, one that could facilitate regulation while educating people and bringing in a talented and educated workforce, I was all in. The reason I love it: If you can address regulatory issues, you can bring products to life and solve problems that help people and society. For me, CERSA helps deliver on that. I’m excited and flattered to be a part of this program. It’s the first of its kind.
Original Source: N.C. Plant Sciences Initiative News