Regulatory requirements are stringent across all phases of the drug life cycle. Brendan Doran touches on many of these phases with an emphasis on the process of bringing a drug to regulatory bodies for market approval.

Name: Brendan Doran

Position: Assistant Director of Operations, Regulatory Affairs, and Medical Writing at CTI Clinical Trial & Consulting

Connect with Brendan Doran on LinkedIn

Email: Brendan.Doran5@gmail.com

 

Interview Summary

 

Matt: [00:00:38] Matt Paterini here with The Nontraditional Pharmacist, part of The Pharmacy Podcast Network. We’ve been talking a lot about technology as an emerging area for pharmacists and rightfully so. There’s a lot of opportunity in the technology space. But another area of pharmacy that gets a lot of attention, and we’re going to highlight some of those key areas today is around regulatory affairs. It’s also a very fast growing area of pharmacy and one of the reasons is the large number of different careers available in the regulatory space. I saw a statistic recently from the U.S. Bureau of Labor Statistics that the regulatory market will actually grow at an average rate of 8 percent until 2026. So, an exciting area to be in and we’re lucky to be joined by Brendan Doran today, Assistant Director of Operations, Regulatory Affairs, and Medical Writing at CTI Clinical Trial & Consulting. So we’re going to learn about his work there and the regulatory space in general. So Brendan thank you so much for joining us today.

 

Brendan: [00:01:50] Sure thanks for having me, Matt.

 

Matt: [00:01:50] Pleasure to have you on. We like to start with the same question for all of our guests and that is, what was your path through pharmacy like? Give us a start to finish, and I know it’s an ongoing story but where you started, how you got into pharmacy, and your path to this point.

 

Brendan: [00:02:10] Sure. Yeah you know, it’s certainly very nontraditional. When I had graduated from from undergraduate, I went to Mercyhurst College in Erie, Pennsylvania. For me it was always going to be pharmacy or dentistry, and really before I made the six figure investment in tuition, I really wanted to make sure I was making the right choice. So instead of going right out of undergrad and into school, I took some time and worked as a pharmacy technician, shadowed dentists and oral surgeons and a few others. Along the way, just to stay on top of academics, I started taking a research certificate program at the University of Cincinnati. And through that, I was exposed to a number of different research companies in the Cincinnati area. One of them being CTI, who I work for now, and there was a number of guest speakers. So just learning about what a Contract Research Organization (CRO) is and what they do, and then just hearing the type of work they do I said, wow that sounds incredibly interesting. So I started working there as I was continuing to try to pick my path of which way to go and along the way, at CTI and throughout I had a chance to work with PharmD’s and pharmacists who may have worked in regulatory affairs or in clinical trial operations or pharmacists at academic centers that were investigational research pharmacists. So along with the traditional hospital/retail type settings, I mean to me what really sold me and got me going into pharmacy was just the portability of the degree. So for me it’s a no brainer. So actually it was about 10 years ago last week I believe, is when I had left and had started school. If I had to do it all over again, I’d do the same thing.

 

Matt: [00:04:09] That’s awesome. Myself personally, I actually consider dental school as well. But the word you mentioned “portability” resonated with me because yes, there are a lot of different avenues and that’s part of what we’re trying to do with The Nontraditional Pharmacist is highlight some of those new paths and unique paths that pharmacists can learn from and potentially embark on similar journeys. So CTI and regulatory affairs at a high level, what is regulatory affairs?

 

Brendan: [00:04:45] Regulatory affairs, and that’s a fantastic question, because you could look at it from a number of different ways. But I think from from our perspective, our regulatory affairs group, we take clients and it might be small biotech, which you might call two guys and a molecule, up to a large Pharma Companies. We help them get really from the concept phase of a trial, where they may be ready to to start an investigational new drug application (IND), helping them get to the point where they submit to 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 your new drug application, your biologic license application, or other marketing applications, what sort of messaging do you want to have on that label and how to develop along the way. It’s very nice seeing projects that we work on, that we may start at the very beginning with small type consulting type projects. We might help them strategize on endpoints for a clinical trial and then you see that. What’s really another neat part is being able to take that, help them submit their IND, pass that off to our clinical trial operations team, run the trials and then a few years later 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.

 

Matt: [00:06:23] A lot of different opportunity it sounds like, and boy you could spend a lot of time learning about all the different avenues just within regulatory affairs. You mentioned that you’re doing some work now around contract research organizations. Could you expand a little bit more on what CRO’s are.

 

Brendan: [00:06:39] Sure yeah. So a CRO, or Contract Research Organization, which 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, so we have a regulatory affairs group, we have our clinical trial operations group which includes project management (the ones that run the studies), we have 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’s many different areas where clients may come to a CRO for. And you know again, if it’s a smaller company they use us as almost that extra FTE (full time employee) or many FTE’s. 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.

 

Matt: [00:07:57] Okay, so what about your role specifically within CTI? Maybe give some background on day to day responsibilities, but also what you’re doing in the larger organization.

 

Brendan: [00:08:10] So I’ve been in this role for about a year. Prior to that, I split time with sort of a hybrid role. So I oversaw a research unit, I oversaw our investigational drug pharmacy for phase I through IV studies, and then also did some clinical trial study management. A lot of good experience there, and we can certainly talk about opportunities where PharmD’s may be involved there. My current role is the assistant director of operations. So I oversee a group of regulatory scientists and 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. So 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 unlike a clinical trial that may last a couple of years, some of these projects we work on might last for two weeks to a month or some may be a little longer term, six months to a year or so. 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. The other night we were just on a call with an Australian company who is looking to come to the US. It’s neat to be exposed to folks from all over the globe.

 

Matt: [00:10:18] Well that’s phenomenal, 60 active projects at one time. Let’s talk about project management skills coming into play a little bit.

 

Brendan: [00:10:26] Absolutely yeah. Luckily we also have some project managers in the groups, so they are assigned to sort of keep everybody going, kind of the sheepherders I guess you can say, to keep the budgets in check and everybody on time and keep the clients happy.

 

Matt: [00:10:43] Yeah you’d almost have to. We talk about technology as an emerging area in pharmacy a lot. How has technology impacted your role or your business, or how do you see it impacting it in the future?

 

Brendan: [00:11:00] Yeah and again this is another exciting area, I think we could talk for an hour or so about this. From the pharmacy standpoint, and I’m sure if anybody listening to this that’s ever done investigational pharmacy has probably used an IWRS (Interactive Web Response System), or sometimes called IVRS, so an interactive web response system for randomizations. In my old role, I had a chance to work with our information technology group on sort of being the business owner of those systems and helping to develop the randomization process, the drug shipment process. So seeing the technology, and even the user interfaces on these systems continually improve, I think in my career I’ve used gosh I’d say at least 50, and over the years I think they’ve gotten a lot better. I mean it’d be great to see, I think I’ve heard rumors that there is sort of a phone-based app that’s coming along that would make life a lot easier, especially for late night or urgent randomization when it’s not exactly easy to get to your computer. So that’s one area. And in the other area, I think just in general, the technology, maybe it’s the science and the technology. Our company particularly works in a lot of immunology and a lot of cell and gene therapy. So just seeing the advances in science and the technology, whether it’s in the delivery systems, the way these these products are manufactured or made. To me, that’s one of the most exciting things about working in the CRO world. So you’re not going to have one or two or five products in your portfolio that you know and you work with every day. I mean every day when you come into work, even our medical directors, and we have some pretty world renowned medical directors, and they’re excited just by some of the science and technology that we get to see along the way.

 

Matt: [00:13:00] Yeah, that keeps it interesting. It’s always nice to see new stuff, learn new things, you’re never bored. Where is the regulatory space today?

 

Brendan: [00:13:12] I think it’s an exciting time to be regulatory. For those that might have been paying attention to Scott Gottlieb and what he’s doing at FDA, I think he’s really trying to pull out a lot of stops to help try to get some of those critical access products to market, or those that might be on shortage to try to get them back on the market. A couple different areas we see that in. Rrecently, Scott Gottlieb just had a little op-ed in The New England Journal about now for gene therapy there’s a couple different steps each company needs to go through. That’s through FDA, but there’s also the NIH Recombinant DNA Advisory Committee, so they are looking at trying to streamline that process and maybe make it a little less of a duplication and make it easier on everybody. The other area that I think we’ve all as pharmacists been watching for quite a while, and I think the FDA is really trying, is in the biosimilars space. Just sort of waiting to see what’s going to happen with those and market share. So it sounds like FDA is really pushing to try to get those going. So I think it is an exciting time to be in and regulatory.

 

Matt: [00:14:27] Is your team in particular hiring or looking for pharmacists?

 

Brendan: [00:14:33] We are hiring right now. Actually yes we have a director level position open right now. So the typical candidate that we would have, a good example is somebody on our team is a pretty senior level person. He’s a PharmD by training. So it’s funny, the pharmacists you meet in regulatory affairs or even medical writing, a lot of times they kind of fall into it accidentally. He has probably about 20 years of experience and he started out in a hospital setting. Moved into a pharmacology clinic, doing some research and then went into industry and he’s been in industry ever since. So he’s gained a lot of experience on the trial side, and even the post marketing sort of medical science liaison side, and now he’s on the regulatory side. So you know certainly opportunities for pharmacists out there. I think the role we’re looking for right now is somebody that does have experience, but one thing that you know, since I’ve been back with CTI for about four years, and the the pace that we’re growing right now is really encouraging. I would imagine within the next six months to a year, or somewhere around there we’re probably looking for additional staff.

 

Matt: [00:15:55] That’s fantastic. What advice would you give to people who are interested in pursuing a path either with CTI, or not even necessarily CTI in particular, but regulatory affairs?

 

Brendan: [00:16:05] So I think just like you know with almost any industry or role, I mean it is what you know, but it’s also who you know. So along the way, the relationships that you’ve built, I mean I think networking is one of the biggest things, especially in the CRO space. I’m always amazed by as we get on a lot of these calls with many clients, with smaller biotechs, smaller pharma companies, as some are acquired or dissolve, you know how many people sort of bounce around as we stay in contact. We understand where they are, and every so often they end up working for us. So I think that’s one aspect. The other piece is you, know it is difficult I think without having any research experience to really get in there. So I think there’s plenty of certificate programs out there online or through many universities that are offered in research. There’s also Master’s, just maybe depends on how much you want to spend on that. But I think you know 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.

 

Matt: [00:17:28] We talk about that so often with The Nontraditional Pharmacist, and part of the reason we are trying to facilitate a platform of networking is because it’s so important. We know to get new positions, new careers, change a career path, whatever it may be, that the contacts and relationships that you build are so important to do that.

 

Brendan: [00:17:50] Absolutely. Many of the jobs I’ve gotten are from the contacts that I’ve made along the way, so I see that as one of the biggest things. I couldn’t agree more.

 

Matt: [00:18:03] Absolutely. We even talk about go as far as to say, you can’t obtain a job with a job application or submitting a resume. You have to build a relationship or make some key and critical contacts in that organization if you truly want to have a position there.

 

Brendan: [00:18:20] Sure.

 

Matt: [00:18:22] Where do you see the future of pharmacy. big picture in general?

 

Brendan: [00:18:28] So I oversee our PharmD intern program and I have this conversation about once a month with our interns. I think I see it, you know with the type of therapies we work on, which are the cell and gene type therapies or the biologics in general, and we do do some small molecule type work. The one thing I wish it was more time on is probably molecular biology and the physiology. You know subjects before pharmacy school, even after because I think it’s getting pretty complicated to understanding what these cell and gene therapies do, and what the difference between when a lentiviral vector is versus an adeno-associated vector and you know in what these do. I mean these are things that I’m still trying to wrap my head around. So I think it’s becoming a field where we’re really going to be need to be on your P’s and Q’s, as far as the science goes, so you can talk to the patients about that. I think it’s going to be interesting to see what’s happening with companies like Amazon and others, and what that does to the retail space. I have plenty of classmates and really good friends that are in retail space and maybe over a beer every now and again we talk about that and just what it looks like. So it’s going to be interesting to see. But I think in general it’s still a really good field to go into. And I think the opportunities that are growing in the nontraditional space are really out there. One thing I haven’t mentioned is we have PharmD’s that are in business development that do sales. I mentioned the health outcomes researchers, safety, or others. So certainly there’s opportunities out there are beyond just being in the hospital setting or the retail setting.

 

Matt: [00:20:31] Well thanks so much for the great insight, Brendan. A fantastic overview on regulatory affairs, the field of pharmacy in general. I know we could spend a lot more time on probably each one of these topics, quite honestly, but you know if this whole regulatory thing doesn’t work out for you, maybe we start a sitcom or something called Two Guys and a Molecule, that sounds pretty good to me.

 

Brendan: [00:20:54] It’ll be the follow up to The Big Bang Theory.

 

Matt: [00:20:58] Exactly. Well, be sure to connect with Brendan on LinkedIn. We will share his contact information below this post, and feel free to reach out to us at The Nontraditional Pharmacist any time for any further questions. We look forward to seeing you next time. Matt Paterini with The Nontraditional Pharmacist, part of The Pharmacy Podcast Network. Thanks again Brendan, we really appreciate it.

 

Brendan: [00:21:19] Thanks a lot Matt.