Kelly Gelinne, our Associate Director of Marketing, sat down with Brandon Burch, Ph.D., Nuventra’s Associate Director of Scientific Writing and Regulatory Affairs, to learn more about his career path into drug development consulting, advice for new scientists, insight into what often gets overlooked by Sponsors, and more. Listen to Kelly’s interview with Brandon above or read the transcript below.
Brandon has been with Nuventra for more than 6 years and currently oversees our regulatory affairs and medical writing department. Brandon has participated in numerous IND, NDA, and BLA submissions across a multitude of drug classes, routes of administration, and therapeutic areas. His experience includes overall regulatory strategy, client representation at FDA meetings, on-site assessments, and gap analyses for client development programs. He has also authored clinical, non-clinical, quality, and administrative modules of regulatory submissions, and has authored a diverse array of other regulatory, scientific, and technical documents.
Kelly: Most importantly, Brandon is a Tar Heel and he’s an excellent coworker. Welcome Brandon!
Brandon: Thanks, Kelly. Great to be here.
Kelly: Alright, let’s get to our first question…
How did you end up in the biotech/pharmaceutical industry?
Brandon: I guess my journey began when I started undergrad. Like a lot of folks, when I went in I wanted to go to medical school—at least I thought that’s what I wanted. But once I got into my classes and started digging in, I realized that it was the science I was most interested in, and so that’s how I positioned my career trajectory, and it was great and gave me the opportunity to do lots of really interesting things. I did marine biology, photosynthetic biochemistry, and RNA biology.
At some point during graduate school, I realized I still had an interest in human health and was really trying to do something that was directly translatable to helping people. So, I ended up doing a postdoc for about two and a half years in an HIV lab that was focused on cure research. While the research was very interesting and I really loved that the lab was working on making a direct impact on patient outcomes and their quality of life, I still felt that I wasn’t in the right place for me and that I was being drawn in another direction. So, I began thinking about what I wanted out of a career, and that kind of led me to think, “do I want to be at the bench or away from it?” I realized that I’d always liked to write and, you know, I’ve had broad interests, so I kind of looked for careers that would cobble those things together.
I ended up looking at a number of pharma and biotech companies during this time and ended up joining Nuventra as a Project Manager and Clinical Pharmacology Associate. From there, it was a good experience. I got a good amount of writing and regulatory experience and I’ve just kind of grown at the company and that sort of propelled me to where I am now.
Kelly: That’s Great. Thanks for sharing that journey.
What is your favorite project you’ve worked on at Nuventra so far and why?
Brandon: We have a project that’s still ongoing and it happens to be one of my first projects that I had here as a project manager, and we’ve been together so long that I feel like we’ve sort of grown together—kind of like a relationship over the years.
It’s a cellular therapy for treating brittle type 1 diabetes and this is a rare disease; it’s really quite severe and has some serious negative impacts on patient quality of life and health. The client is a wonderful group of academics and clinicians. They’re very knowledgeable and passionate about their work and that’s kind of infectious, and you can really see how they want to make a difference in the lives of these patients.
So, that’s one aspect that I really enjoyed about this, but not only are the people wonderful, but the work has been very diverse. We started out doing a gap analysis for them, looking at their program—nonclinical and clinical and manufacturing—and then from there, provided strategic advice, had the opportunity to have multiple interactions with the FDA, we’ve written their orphan drug application—and that was successful, it was a great experience. We’ve also prepared their BLA, which involved writing a lot of sections from scratch and really pulling everything together to make a complete submission, and we’re currently in post-submission support right now and we will be for the next several months while the FDA reviews.
And I guess the last thing I’ll mention about this project that I really enjoyed is that it just has been a great experience with my team and being able to bounce ideas off of them and work together through difficult challenges that we’ve been able to overcome along the way. Especially for the junior members, just watching them really blossom and grow in their knowledge and expertise—and I think that’s been one of the most rewarding aspects of this project, you know, with this project going on for as long as it has.
Kelly: Yeah, I know that project has been a lot of work for you, but it sounds like it’s been well worth it.
Brandon: Yes, it’s been great.
What advice would you give a new/junior scientist?
Brandon: So, like I did, a lot of our junior team members come into Nuventra and this is their first stop out of graduate school or postdoc. We’ve had a few that have had some experience in the industry, but not very much, so this is a really relevant question.
The advice I would give to someone who’s just getting started and coming into drug development for the first time is to understand that drug development is complex. There are lots of subdisciplines and specializations and it can be intimidating and challenging to try to figure out when you’re just starting. But really just take the time to learn as much as you can. There’s so much to learn, but try not to get overwhelmed. This certainly doesn’t mean you have to do it all on your own; there are classes you can take and outside reading, that sort of thing.
One of the great things about going into a new place like Nuventra is that there is so much collective experience out there. We have consultants who have been doing this for 15, 20, 30 or more years, and their experience is just so diverse and their backgrounds are diverse. Some come from big pharma or biotech, and we even have a few who have spent a decent number of years at the FDA. So, that’s just a great resource for learning.
So, my advice would be to just really try to soak up that knowledge to gain an understanding of drug development and really see what aspects of drug development speak to you. As far as junior members coming into Nuventra, I’ve seen people who have started out as project managers and they just wanted to stay there—they think it’s the greatest thing—they love timelines and budgets and day-to-day administration. Others, once they’ve gotten a taste of some of the project work, they’ve branched out into regulatory affairs and medical writing like I did, or they’ve gone into pharmacokinetics or programming, or something like that.
So, again, just learn as much as you can, and that starts when you’re researching companies before you actually take that plunge into industry, but also once you get into that first position, trying to learn as much as you can. Find out what interests you because when you’re passionate about something, when you’re really interested and engaged, you’re much more likely to excel in whatever it is that you’re trying to do.
And I guess the last piece of advice that I would give is this, and this is something that early career professionals should really internalize, is to focus not only on the professional aspect of your life, but also to remember that it’s important to make time for yourself and your friends and your family and hobbies outside of work, because having that work-life balance is just so important and it’s going to make you much more effective at your job.
Can you tell us about something you’ve seen that is often overlooked by Sponsors?
Brandon: I think one of the biggest things, and it varies from Sponsor to Sponsor, is really just taking that long-term view of drug development. You’ve probably heard, “beginning with the end in mind,” and I think that that’s a really important concept.
It’s not just thinking about the next 3 months or the next year, but what it’s really going to take to get your program from wherever you are in development, whether that’s concept or preclinical or wherever it is, to IND to NDA and on from there. That could be from planning out your clinical program before you dose your first patient to making sure you plan for and prepare for your interactions with regulatory authorities like the FDA and just making sure you really do those well. Or, it can be something as simple as seeking expert advice, especially if they’re disciplines where you and your team might not be quite as strong—this is going to save you a lot of headaches down the road and it will make things a lot easier. These are sort of the fundamentals of drug development, but I think they go underappreciated in many cases.
As an example, (this affects companies of all sizes, especially smaller companies): What do you want your marketed product to look like? How is it going to compare to the competition? Have you put together a target product profile that’s really going to guide your development and that can be built on through clinical development all the way to your marketing application? Do you have a clinical development plan? Do you have a regulatory strategy that takes into account all of the nuances of your particular program?
And then, going back to something I mentioned before, just asking for help. One of the biggest things with drug development (especially when you look at all the regulations and especially when you’re working with a unique product), is sometimes not knowing what you don’t know. So, often it’s a good idea to have somebody else take an expert view of your program, really give you those honest insights that you need—where you stand and where you need to go—to give you some idea of whether there are ways to add efficiency to your program or incorporate innovative strategies. Maybe adding modeling and simulation or something else that you might not have thought of that will make your program more efficient and your marketing application more impactful. Again, sort of seeing that big picture and taking that long-term view, beginning with the end in mind, I think is something that is very important that can go overlooked by some Sponsors.
What do you enjoy about life as a consultant?
Brandon: There are lots of things that I enjoy about being a consultant and I mentioned this a little bit before, but one is the diversity of the work that you see and all the opportunities for professional development. So, for example, in my position I might be working on a Phase 1 clinical study report for a small molecule for treating something like a neurological disorder, while at the same time I’m also working on a briefing document for a COVID-19 therapy, then also overseeing preparation of a marketing application for a cellular product.
I’ve had the privilege of working on a lot of different indications and drug types while I’ve been at Nuventra. It’s just been super interesting and a great way to stay fresh and focused and really build my knowledge about drug development. One thing I like about it as well is that you don’t get pigeonholed, so to speak, like you might get at other companies with one program, one product, one development pathway. To be clear, there’s certainly something to be said for taking long-term deep dives that you might get elsewhere, but even with consulting, you have these longer-term projects like I mentioned before, the one that’s been going on for about 6 years so far, that fulfills that aspect for me—that deep dive. But, I also have the opportunity to jump in on shorter-term tasks and that helps keep things interesting.
I’ll also add that there’s just a lot of exciting work going on that you might not even realize if you weren’t a consultant seeing these things coming in. You know, getting to work with a lot of these companies, big to small, especially the smaller ones who are really reliant on your expertise and experience to guide them through what are sometimes really challenging issues, and in innovative products a lot of times, and they’re just not as familiar with drug development and those sorts of things—that’s something that I really enjoy.
And finally, I’ll give a plug here to my colleagues at Nuventra. Not to sound too much like an advertisement, but they’re just a tremendous group of people, very talented and genuinely great folks. I feel so fortunate to work with them, and that’s with my team and across teams and disciplines. I think that’s something that as a consultant you can get that maybe you don’t get just everywhere, so I think that’s also one of the key perks.
Kelly: I would have to agree with you there, Brandon.
Kelly: Alright, let’s throw in a bonus question to get to know you a little bit on a personal level. What do you do in your free time these days?
Brandon: It seems like that, you know, we’re sticking at home a lot more, but I like to write poetry. I’ve been writing poetry since I was in the seventh grade; a lot of diverse topics: nature, love, and everything in between. I’ve also begun writing some early sketches for a novel, so I’m kind of excited about that and interested to see where it goes. I don’t know if anything will ever come of it, but at least I’m getting some enjoyment out of it and helps me spend some of my time here while we’re in quarantine.
Kelly: Well, I’m happy to test read a chapter for you.
Brandon: Alright, that sounds great. I might have to take you up on that.
Kelly: Well, thank you so much for chatting today, Brandon.
Brandon: Thanks guys, it’s been great.
Kelly: If you have any questions for Brandon or for any of our other consultants, please don’t hesitate to contact us.