Chapters
00:00 Navigating Nontraditional Pharmacy Roles
02:54 Transitioning from Regulatory Affairs to Clinical Operations
05:45 Understanding Clinical Operations and Its Importance
08:54 The Role of Pharmacists in Clinical Trials
12:07 Career Pathways for Pharmacists in Clinical Operations
14:59 Networking and Mentorship in Nontraditional Pharmacy
17:53 Future Aspirations in the Pharmaceutical Industry
Transcript
Matt Paterini (00:02): Matt Paterini here with The Nontraditional Pharmacist and pleased to be joined by Dr. Brendan Doran for the second time on The Nontraditional Pharmacist. I think it’ll be interesting to hear, Brendan, today on your, obviously your nontraditional role within pharmacy, but also for some background on your transition story from where you were previously, and by my count, it was about a little over six years ago that we spoke last. Industries changed a lot, I’m sure your work has changed a lot. So we appreciate you joining up for the second time on The Nontraditional Pharmacist
Brendan Doran (00:44): Yeah, Matt, thanks for having me and to you and the rest of the group at The Nontraditional Pharmacist, I think the work that you all do just to bring exposure to nontraditional roles is great, especially given the times, and you’re spot on. I was kind of thinking about the last time we connected. I think my daughter was just barely one. Now she’s seven going into second grade. And then I think USP 797 was finally updated and that was a long time coming. Then 800 adopted. The last time we spoke, biosimilars were this new thing and everyone was trying to figure out what was going to happen regulatory-wise and a lot of other changes since then. So, good talking to you.
Matt Paterini (01:21): No, we appreciate the time. And remember, COVID was in there too, right? So, we would have spoken in 2019. It’s 2025. Spanned a pandemic in there as well. So, from the healthcare perspective, a lot has changed from point A to point B.
Brendan Doran (01:25): Yeah.
Matt Paterini (01:42): Well, let’s start with a little bit of background. If we catch up, folks that have listened to the previous interview and listening today, maybe for the first time, maybe give us a background of what your role was as Associate Director of Operations, Regulatory and Scientific Affairs prior in that work, what that involved, and then how you made the transition into your role today as head of clinical operations.
Brendan Doran (02:10): Yeah, so CTI, clinical trials, so they were a contract research organization (CRO), so that’s where I was before. And I’ll talk a little bit more as we go on about contract research organizations. They’re great spots for PharmDs who are looking to maybe transition into industry to get a foot in the door. So really those CROs are kind of an extra set of hands for biotech and pharma companies. Rather than hiring out a full staff, a biotech company may utilize a CRO to run many or all facets of a clinical trial for them or help with medical writing or statistics. And so, my role when I was at CTI, I was in more regulatory affairs. So that group was really focusing on helping clients develop their regulatory strategy as they think about bringing a drug into development, what does that look like? What are the regulatory constructs that the FDA puts out in front of you to get there? And then how do you develop documents to basically get approval from the FDA to study your drug in humans? There’s a lot of other aspects that go along with it, but at a high level that’s roughly what that was. And CTI has grown quite a bit when I was there. I think it was a little bit over thousand employees. And where I am now is a company called CinRx Pharma, which is a biotech company with a pretty interesting model and I’ll detail that. But I went from over a thousand-person company to I believe I was employee number 11 when I started here. So much smaller, much leaner and definitely more startup mentality. It’s been an interesting six years here and for sure at CinRx
Matt Paterini (04:04): What’s been the harder part of that transition? The nature of the work or the type of organization in terms of size and culture and structure?
Brendan Doran (04:15): I don’t know if it’s really been that hard, it’s actually been exciting. The model, the way CinRx is set up, CinRx is a holding company and all our employees kind of work at this holding company. And what we do is we find drugs. We have somebody whose job it is to essentially hunt for new drugs. And we bring them in, and we start subsidiary companies. And really those subsidiary companies are the drugs and the patents that go along with the drugs. And from an efficiency standpoint, we all work across these different subsidiaries. So, every day it’s a little bit different. We have two companies that are focused in the GI space. We have another that’s focused in metabolism and obesity. We have an oncology company. And so, every day it’s a little bit of working across all these different companies. If anything, the toughest part has been how do you balance having all these moving parts and where do you prioritize? But it’s a great group of people we work with. There’s some really talented folks we work with, and it’s been very exciting.
Matt Paterini (05:28): Have you noticed a difference in working in the smaller group versus a larger company in terms of your kind of day-to-day responsibilities? I would imagine in a larger organization, you’re more singular focused versus the smaller, you span multiple things. Is that the case?
Brendan Doran (05:45): Yeah, Matt, exactly. So I always joke that I have a day job, and this is true for all of us here. I think we’re somewhere around 25 employees now. We all have a day job, and mine is clinical operations, and I’ll detail kind of what that means. But at the same time, being a small group, there’s a lot to get done, and everybody wears multiple hats. So on any given day, I may be covering some aspects of clinical operations, but then there may be going back to some regulatory affairs activities. We may be going out trying to do a fundraise from venture capital groups and we’re on the phone trying to raise money. So there’s a lot of different things that everybody, and this is true from our CEO on down, that we all do a little bit of everything.
Matt Paterini (06:34): Yeah, I think that’s typical of a smaller organization, regardless of the industry and the business. I think just the nature of the size of the organization. That’s typically what you see. So focusing on, let’s just focus on the primary job then, because I would say the same thing. Working in a small organization, you wear a lot of hats. But for those that aren’t familiar with clinical operations, what exactly is that and where does a pharmacist kind of fit in?
Brendan Doran (07:05): Yeah, so clinical operations and really I could lump my role in a little bit of a mix between clinical development and clinical operations. And I’ll explain a little bit about what the differences are between the two and then how they kind of come together. But if you think about clinical development, it’s a little bit of a broader stroke. And really, it’s the process by which new drugs or biologics or devices are tested in humans, really to see if they’re safe and effective. Those are the two things to get a drug or device approved. They need to be safe. They need to be effective. And so, if you think about that approval pathway and for drugs or biologics, you need to run your clinical trials before you get there. There’s a whole litany of usually animal tests and kind of non-clinical testing that need to be done to demonstrate to the FDA that it’s safe to dose in humans. And we have a team of folks that do that. But once it gets past there, then the clinical development, clinical operations group is kind of when these human trials of the drug or device in humans start. And so, you’re thinking about, I mentioned a regulatory construct. What do these clinical trials look from a design standpoint? What are the endpoints that you need to achieve in order to demonstrate efficacy? For example, we have a drug we’re developing in gastroparesis, which is a delayed gastric emptying condition, and there’s certain thresholds that the FDA sets forth that we need to use this specific endpoint, and ideally we should demonstrate a reduction of X percent or an absolute number from baseline. Then you take all those and you design the clinical trial around that. And then the operations piece, that’s really the logistics, it’s called the logistic engine that runs these trials. It’s a lot of taking these protocols and then going out and making sure we can find sites. And those are sites, sometimes those are hospitals, sometimes they’re physician’s offices, there’s for-profit, clinical research sites out there. And it may be all US focused, or it may be globally focused. And we work with contract research organizations to do a lot of that on our behalf, but really, we do a lot of overseeing them. And ultimately, it’s to ensure we get the data because the data are ultimately what turns into your FDA approved label and demonstrates what you need. But we have a group that’s always concerned about regulatory, making sure you’re following all the rules and the regulations. And then paramount, obviously, is patient safety. These are investigational drugs. Many times, they’ve never been tested in humans before. And you need to make sure that safety is kept in top of mind.
Matt Paterini (10:10): So I think I already know the answer to this, but for that work that you just described, what has better prepared you for this role in that work now? Your prior role at CTI or your pharmacy education training prior to that?
Brendan Doran (10:28): It’s a little bit of both, Matt. I think the PharmD, the last time we spoke, I think I mentioned the portability was really what brought me into being a pharmacist. I was kind of thinking about dentistry, but realizing the portability and really kind of the translatable nature of what the training as a PharmD brings in and even my hospital experience when I was working in the hospital, but really, I find myself on an almost daily basis relying on some of my training as a pharmacist. And in the same token, the experience I gained on the regulatory side. I think really helped because now as I am in kind of more clinical operations, clinical development, that regulatory piece is incredibly important in everything we do as we design these trials. That’s one of the biggest pieces. But from a PharmD side of things, just to give you an example, the other day we’re working on using a commercially available drug as part of one of our trials. And we’re trying to get on the line with a pharmacy and they’re working on getting a license in a certain state, so understanding pharmacy law, my MPJE definitely came in handy. And even just 10 minutes ago before we got on the call, I was looking up a drug. Sometimes we exclude medications from our protocol, various CYP enzymes and kind of going through a package insert to see, should we exclude this drug or not? So there’s still definitely a lot of PharmD in there.
Matt Paterini (12:07): It is additive, right? Everything that you’ve experienced to this point kind of leads to the role that you’re in and serves the work that you’re doing now in some form or fashion. So if you’re looking at students or pharmacists that are interested, well, I guess let’s talk about this work specifically, interested in clinical operations, what are some realistic starting points for them to explore?
Brendan Doran (12:19): Yeah, some of it may depend on where somebody may be in their career. If I think of somebody who is maybe in school or maybe fresh out of school or maybe willing to do it. If you really wanted to get a leg up, I think there’s a number of fellowships out there. I will definitely miss a few, but some that come to mind, I know University of Southern California, University of North Carolina-Chapel Hill, Rutgers. I’m sure you can go online and check these out. These are usually one-to-two-year programs where you get a pretty deep dive and a lot of experience in a lot of different areas. So that’s something I always recommend that students or maybe newer grads check out. The other piece, I mentioned the CROs. There’s some CROs that specifically target PharmDsand even kind of PhD level folks and realizing, one of the challenges with research is, there’s a whole new set of language and acronyms. It would be like Matt, you or I without pharmacy training, walking into a pharmacy and somebody’s rattling off QD or BID and you’re going “what?” So research has its own set of language and it’s figuring out, how do you learn that? And these larger companies and CROs, they usually have some pretty robust training groups that they realize you understand the science, but they’re going to teach you about the ins and the outs of research. So I definitely think looking for those types of roles with CROs. And the other thing I would say that helps is there’s certificate programs many universities offer. And there’s master’s programs, for example, I have an academic appointment at University of Cincinnati and they have a master’s of drug development program, which is fantastic. And I know there’s a number of others across the country that have those programs. So obviously there’s some tuition costs there, but something to consider. And I think one of the lowest hanging pieces that I always recommend, clinical trials are largely governed by what’s called, it’s the ICHGCP – International Conference of Harmonization, Good Clinical Practice. There are certificate programs out there online that you could probably do for free or probably pretty low cost. But that to me, if I saw that on somebody’s CV who’s kind of entry level, that signals, hey, you at least maybe now have a foundational knowledge of trial regulations and kind of the ins and the outs. And that may be enough to say, great, let’s talk to this person.
Matt Paterini (15:21): I think that’s an important point for any kind of specialty work. The farther you get into a subject matter, so much of it is the language that’s unique to that area of practice or that type of business. So just being able to hold a conversation that’s knowing either the acronyms or the context of some of that subject matter is important. Because you can learn subject matter within the role. And I think that’s the case for most roles. But to have that foundational knowledge to be primed for that learning is important. And you said, additive before from prior roles and even back to the pharmacy training. So that can probably be, you talk about the portability, right? That type of concept to any type of role that you’re pursuing. So when you’re looking at or mentoring students or other pharmacists, what’s your go-to advice for pharmacists pursuing non-traditional paths in pharmacy?
Brendan Doran (16:25): The thing I come back to all the time, and I love working with students or folks that are kind of trying to make that transition. I love connecting people, trying to hear their story and figure out, great, you got to talk to this person. And I think it really comes to networking. Not to sound cliche because you hear it all the time, but I always say it’s networking, but understand what networking is and also what it isn’t. Networking is a two-way street. You have to add value to whatever relationship you’re building somehow, some way. So find how to do that and then it becomes who you know, but also who you keep in touch with along the way because if you just talk to somebody once and then you disappear for a while, months or a year later they’re not going to remember you the next time you come back. I recommend keeping a tracker of who you make connections with and maybe even reminders that in three or four months, let me follow up with Matt and see where things stand. Another thing I talk about is try to find a mentor or even develop your own personal board of directors. There’s a lot of different decisions you can make and obviously you have to factor in what’s best for yourself, what’s best for your family, and having a good group of friends and mentors is incredibly valuable. And then I think taking time to research who you are yourself. Think about these personality tests that a lot of people take, or there’s something called the Ikigai and understand number one, why do you want to go? Why do you want to switch industries? And what are you good at? What does the world need? What do you love to do? And then what can you get paid for? And does that fit the mindset or are you just going to industry because it sounds good? So really understand why are you doing it. Lastly, I think the other piece is you think about now with, especially with the dawn of AI. And when you’re applying, all these companies are using applicant tracking systems and they may, if you don’t have the right keywords within your resume or your LinkedIn profile, they may throw you out before you can get your foot in the door. Really try to look at the roles that are out there, job descriptions and look for keywords that repeat across these and maybe try to optimize your resume or your LinkedIn profile to include some of these key words. I think that’s some advice that I think has helped a few people along the way.
Matt Paterini (19:08): I think it’s a combination of all those and I think the two that are overlooked are the first two that you mentioned: the personal network and the definition of what you want your personal and professional life to look. If you start with that and then back your way into potential roles and align the people that you communicate with, that’s now a three-pronged approach that can serve you well as you move through your career. Not that it’s going to happen all the time and that you need to necessarily lean or rely on that, but you keep those relationships there and you never know when the conversation might be worthwhile to either make a change or help someone else make a change. And I think it’s overlooked sometimes, and it’s tough too because real life gets in the way and people have families and hobbies and other things that are going on. But all good advice and I guess last question for you then Brendan. What’s next for you in the career and where do you see kind of your career progression headed?
Brendan Doran (20:14): CinRx is incredibly exciting company just in the fact that part of our model is we look to develop drugs, bring them to a certain point, and then maybe look to sell those or partner with a larger company and then keep starting new companies along the way. So we continue to do that. It’d be interesting to see where everything goes with CinRx, the sky is the limit. And it’s fun to show up every day and get to work with fantastic people, get exposed to a lot of incredible science just as we look at potential new drugs that are either coming out of large pharma or academia and seeing what’s on the horizon. And then thinking about maybe someday one of these companies will need a CEO and maybe step in there and do that. But the important part is that I always try to keep in mind, and really all of us here, a lot of us have a background in healthcare, and I think it’s kind of thinking out, how do we get these drugs approved for the patients out there that really needs them? And hopefully one day one of these drugs will make it, and we’ll see it out there and make a difference for everybody.
Matt Paterini (21:41): Well, thanks a lot for the time, Brendan. Appreciate your continued support of The Nontraditional Pharmacist. Thanks for joining for a second time. Six plus years later, we hugely appreciate it and your contribution and your perspective on the field of pharmacy and nontraditional pharmacy. Hugely valuable to us as a group and I know our listeners and followers. We appreciate all the help and support. We’ll link this interview to the prior one to see the progression, which I think will be fun. And look forward to staying in touch. Thanks again for joining.
Brendan Doran (22:13): Thanks for having me, Matt.