Hook
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Some people are confused and they're asking me why would I want to go back to law school when I already have a solid career in clinical research. Specifically the function of regulatory affairs. And the honest truth is regulatory is a section of law. I've worked on clinical trials globally and every region has their regulations that are required for the drug development process, whether that's Latin America, Japan, Asia, Pacific, China, Europe, the US. The US clinical research and development landscape is governed by the FDA, generally follow ICH, which is an international guideline. But also follow specific federal regulations, specifically section 21. While my experiences are already very much so legitimized, getting a JD further legitimizes my experience and gives me the opportunity to gain more general knowledge. For example, intellectual property. People may not think or realize how that works with the life sciences industry, biotech and pharma. But a lot of companies are given exclusivity over their specific IP. IP landscape and regulatory are intertwined because you have to go about certain regulatory pathways in order to be given exclusivity over that treatment. For example, companies pursuing the development of orphan designations, which means in the United States, that affects less than 200,000 people. They are given exclusivity over that treatment and they have the opportunity to market that drug for a certain period of time. Mainly so they can recoup from investing in developing the drug. There's also pediatric exclusivity and then there's another exclusivity that companies can apply for to recoup additional years on their marketing ability because of how long it takes to get applications approved by the FDA. I've had the opportunity to have a general knowledge of what goes into the IP aspects of biotech and pharma, but I think going to law school again is just going to give me a more generalized outlook on how these things are approached. I mentioned this before in other videos, I'm starting to see a lot of roles in regulatory require a JD. So, I'm starting to see a lot more of my peers pursue a formal JD. Their biotech and pharmaceutical companies start to require people to have a JD to sit in higher positions such as SVP of regulatory or VP of regulatory or the chief regulatory officer. It doesn't really matter to me. I want to go back to school because I knew it would give me a broader outlook on what I can do with my current experience. I can do regulatory, I can do in-house counsel for a company, I can go work for a federal agency. Education combined with my experiences in drug development and possibly go work as an in-house counsel for a cosmetics company. I don't know. The world is my oyster.