Drugs of the Future Start with Regulatory Affairs

Regulatory affairs is another frontier for pharmacists to explore, and pharmacists are just scratching the surface of the opportunities in this area. In this interview with pharmacist Brendan Doran of CTI Clinical Trial & Consulting, The Nontradtional Pharmacist touches on the many phases of the drug life cycle with an emphasis on the process of bringing a drug to regulatory bodies for market approval, and gives a look into some of the current and emerging roles available in regulatory affairs.

The full interview can be accessed in audio and video formats. These are the highlights:

What exactly is regulatory affairs?

Brendan: You could look at it from a number of different ways. From our perspective, whether it be a small biotech company or a large Pharma company, we help them get from the concept phase of a trial, where they may be ready to start an investigational new drug application (IND), and help them get to the point where they can submit to the FDA or the European Medicines Agency (or other regulatory bodies). In a way, we help them develop strategies to start thinking when they go for approval for a new drug application, biologic license application, or other marketing applications.

We may start at the very beginning with small type consulting type projects, helping them strategize on endpoints for a clinical trial. What’s really another neat part is being able help a company submit their IND, pass that off to our clinical trial operations team, run the trials and then a few years later for them to come back and we help them to develop those marketing applications. So there’s a lot of different areas where you can get into regulatory affairs, on the pre-marketing and post-marketing side.

Could you expand a little bit more on what CROs are?

Brendan: A CRO, or Contract Research Organization, is what CTI is (and there’s many others out there). So really, they’re another set of hands for a biotech company, a pharmaceutical company, or a device company. If you look at our company, we have many arms: A regulatory affairs group, a clinical trial operations group which includes project management (the ones that run the studies), a data team, a stats team, a medical affairs team, pharmacovigilance or safety teams, and on sort of the other end when you’re starting to think about the approval, we have a health outcomes and economics research group (sometimes called real world evidence). There are many different areas that clients may come to a CRO for. If it’s a smaller company, they use us as almost that extra FTE (full time employee). Or if they are larger Pharma companies they may come to us for their global reach, if they want to run trials in the US and Canada and EU and Japan, just to have that reach instead of having to hire full time employees in those locations.

Describe your role specifically with CTI.

Brendan: My current role is the Assistant Director of Operations. I oversee a group of regulatory scientists I guess you’d call them. We have another PharmD on our team, we also have Ph.D. level folks, Master’s levels who are typically scientists. In our group, they do a mix between regulatory affairs and medical writing. Some companies may have separate groups where the regulatory group does regulatory and we pass it off to the medical writing, but the way we look at it is as you’re developing a lot of these regulatory documents, you need to be able to write to them. So from an efficiency standpoint, for us it just makes sense to do both. I oversee the team that’s doing these projects, so on any given day we have I think somewhere around 60 to 70 active projects that are in certain stages of activity, so it’s a lot of juggling and then trying to resource.

Some may be a clinical trial that may last a couple of years, while other projects might last for two weeks to a month. That’s the one neat thing about it is, every day I’m always curious to see what comes in. I also have the opportunity to sit in a lot with our sales team and get on a lot of calls to try to bring business in, and to talk about our regulatory affairs capabilities with companies across the globe.

What advice would you give to people who are interesting in pursuing a path in regulatory affairs?

Brendan: Just like any other industry or role, it’s not just what you know but also who you know, such as the relationships you build along the way. Networking is one of the biggest things, especially in the CRO space.

The other piece is that I think it is difficult to get in without having any research experience. There’s plenty of certificate programs out there online or through many universities that offer research. There’s also Master’s degree, but that depends on how much you want to spend on that. But if you’re around a university area that has a research certificate program, I think doing it in person is good because of the guest lecturers that you may meet along the way and the connections you can make. And then the other option would be the various online certificate programs that they have.

The Nontraditional Pharmacist is a member of the Pharmacy Podcast Network.