Welcome to episode one of the Molecular Moments podcast! On this first episode, Dr. Chad Briscoe is joined by his guest, Ph.D scientist, Dr. Jim McNally, and they get down to business as the two explore the various nuances in the outstanding work of McNally, how his career in bioanalysis became personal in an unexpected way, and what type of gene therapy it would take to create the next Superman or Hulk!

They also discuss:

  • How bioanalysis has evolved within the gene therapy space and how it has the ability to treat patients who are suffering from cancer or diseases
  • Dr. McNally’s passion and curiosity for immunogenicity
  • Unraveling immunogenetic data for drug development Developing drugs for gene therapy and problem-solving as a program lead
  • Whether gene therapy realistically has the potential to create superheroes
  • How Dr. McNally’s mentors, like Dr. Boris Gorovitz, while at Pfizer, helped him grow to become a better scientist. And why he thinks it’s important for him to mentor other scientists
  • His son’s Crohn’s disease diagnosis and balancing being both a father and bioanalytical scientist while seeing first-hand the benefits of biotherapies
  • And Dr. McNally’s passion for…celery!

Did you enjoy this episode? Be sure to subscribe and rate Molecular Moments on Apple or anywhere else you get your podcasts!

Molecular Moments Episode 1: Dr. Jim McNally Talks Gene Therapy, Superheroes and Celery! transcript powered by Sonix—easily convert your audio to text with Sonix.

Molecular Moments Episode 1: Dr. Jim McNally Talks Gene Therapy, Superheroes and Celery! was automatically transcribed by Sonix with the latest audio-to-text algorithms. This transcript may contain errors. Sonix is the best audio automated transcription service in 2020. Our automated transcription algorithms works with many of the popular audio file formats.

Announcer:
Welcome to the Molecular Moments podcast, powered by Biogenetics, a global contract research organization specializing in large molecule bio analysis and supporting the development and release testing of biologics across multiple industries and disease states in today's Molecular Moments podcast. Our host, Dr. Chad Briscoe, is exploring some of the nuances and the outstanding work of guest Dr. Jim McNally, Ph.D. scientist, now our host, Dr. Chad Briscoe.

Dr.Chad Briscoe:
Well, I could be more excited to be hosting my first episode today. Molecular Moments is going to be an ongoing conversation with interesting people involved in all areas of drug development. We're going to be talking about interesting developments in the industry, our guest roles in the industry and the factors that have contributed to their success. We've been talking about science like scientists, you know, watering it down. And also mentoring is a passion of mine. I'm looking forward to exploring the roles of mentors and mentoring with all of my guests today, joined by my good friend, coworker and bio analytical superhero Jim McNally. Welcome, Jim.

Dr.Jim McNally:
Thanks, Chad. It's good to be here. Glad to be part of the first episode.

Dr.Chad Briscoe:
Jim, can you tell me a little bit about your role at BioAgilytix?

Dr.Jim McNally:
Sure. Well, for the two of us, we're co chief scientific officers. For me, I come from a background of biotech and pharma. So I bring a perspective of being the customer and what I'm looking for when I'm trying to design assays to be a counterpart to you brings the the industry s.r.o. perspective to it.

Dr.Chad Briscoe:
So you had a journey, you know, looking back from Mississippi through LSU and you ended up in Massachusetts.

Dr.Chad Briscoe:
So how does a Southern guy like you end up in Massachusetts in a in a fantastic career in drug development?

Dr.Jim McNally:
Well, I guess the the funny and probably real answer for a lot of people is it was the woman in my life. I met my wife in grad school. She was a Rhode Island native. We were both scientists. So we needed to find a place where we could both postdoc and find job opportunities. And Boston was a great area. It got us back closer to her family. And for me to be in a part of the country that I had never seen before.

Dr.Chad Briscoe:
It's interesting, Jim, actually, I could tell a similar story about how I in this part of the country.

Dr.Chad Briscoe:
So, yeah, it's it's also the woman in my life.

Dr.Chad Briscoe:
So you ultimately left the pharma research and joined a C.R.O., which is actually becoming a more common career path these days. So what made you decide to take that turn.

Dr.Jim McNally:
For starters and actually inside of pharma companies kind of run a small S.R.O. In the time that I was at Pfizer, five years of building a little group under Boris Gurvitz team. And we really served that entire portfolio and ran assay development and validation for the Pfizer portfolio.

Dr.Chad Briscoe:
So, Jim, you ultimately left a great 20 plus year career and pharma research and development to join a C.R.O. BioAgilytix. So what drove you to to take that career turn?

Dr.Jim McNally:
A couple of things. I think for me, I had gone from relatively large companies into progressively smaller companies. So I was working on fewer and fewer projects. And after having the experience of working on such a large portfolio, getting an opportunity to work on different drug types, different disease types was really important to me. And I was very familiar with the biogenetics team, having worked with them in the past as a sponsor and wanted to be part of that team.

Dr.Chad Briscoe:
So I want to step back again to your academic career. So you're an immunologist.

Dr.Chad Briscoe:
We sometimes joke. I'm a chemist. So. So what led you down that path? Why did you pick immunology? It's certainly a fascinating subject space.

Dr.Jim McNally:
You know, when I was an undergraduate, I took an immunology course as part of my biological sciences requirement. Core courses aced. Every test really enjoyed the professor. I was fascinated by the complexity of the topic, and it was so new and such a young space that there was so much to work in. And it was an amazing opportunity to learn.

Dr.Chad Briscoe:
So I took one immunology course in graduate school in the 90s. And, you know, I know the field has changed a lot, but can you give me some perspective on where immunology has come in the 25 years or so that since you first took up the profession?

Dr.Jim McNally:
Yeah, I think when I first started it felt very straightforward, even though it was fairly complex. Even at that point. Our. Understanding of the different cell types of molecules that were involved was interesting, was complex, but has become even more complex because some of the tools that we've developed for measuring it so we can really fine tune our understanding of individual cell populations, the proteins they're producing and how much of a relationship they have with the antigens and infections that they encounter. It's such an up and down balanced part of our body that you never fully understand all the pieces that are going on, which means you're always learning something new.

Dr.Chad Briscoe:
So I'm a trained analytical chemist, so moving into a field like bio analysis seems like a natural right, using instruments, measurement and things like that. It's going from an immunologist to a bio analyst who is spending their time measuring, measuring the quantities and things related immunology. How did that transition happen for you?

Dr.Jim McNally:
I think it was accidental in some respects. My first job in industry after I left academics was in a small company of about 30 or 40 people. I was the immunologist in the building and responsible for developing assays, for everything from discovery to lot release to bio analysis, for clinical testing.

Dr.Jim McNally:
If you put that hand in hand with the sheer explosion of Biotherapeutics and the need to understand immunology around that, it became an interesting on ramp into industry and then moving into a career of trying to understand what happens when we put these crazy proteins into people and how our bodies and immune systems respond to them.

Dr.Chad Briscoe:
Jim, you have five or six talks coming up in the next month or so that we had talked about. It's it's quite a lineup. I'm really excited about the talk at Farmstay 360. You're hosting a roundtable.

Dr.Chad Briscoe:
You told me there's a lot of material to talk about, particularly in your current area of emphasis, which is which is gene therapy. Maybe highlight a little bit of what you're going to talk about in your apps talk and some of the other areas that are of general interest. Yeah, sure.

Dr.Jim McNally:
So gene therapy in and of itself is a pretty exciting field. But the bio analysis for gene therapy, I think is new and exciting to people. There are a lot of areas there where we're developing assays that haven't been used previously for bio analysis. And there are a lot of regulations. And I think that this is an amazing opportunity to help craft the regulations around what those assays look like and what they what they should be capable of delivering from a data set. I feel like when I entered the field of bio analysis, so many of the rules had already been set in place for pharmacokinetic assays and immunogenicity assays. But here in the gene therapy space, we've got a chance to be at the front and set those rules in a way that's meaningful and biologically relevant to both the patient population and the people that are trying to analyze the data on clinical trials.

Dr.Chad Briscoe:
Can you talk about in the gene therapy space? It's not easy, right? You're literally editing genes and hoping to see those genes proliferate throughout the body. Talk about some of the challenges and pitfalls in gene therapy.

Dr.Jim McNally:
Well, I think delivery is a big thing. As you mentioned, there are a lot of systemic diseases where trying to deliver a particular gene or in a case where you're editing genes, hitting all the different cell types, all the different tissues that are involved is a big challenge. When you put that hand in hand with the ability to dose people multiple times with gene therapy and get it to these different tissues, you get a very complex relationship between that first delivery, how the patient's immune system responds to it, and then your ability to go back in and perhaps hit other tissues in the body or reduce to get to certain levels as opposed to just, you know, I'll take another pill tomorrow and keep doing it until I reach the right drug levels systemically with other more small molecule oriented drugs.

Dr.Chad Briscoe:
So typically we see gene therapy treatments most prevalent in oncology and rare diseases.

Dr.Chad Briscoe:
Can you explain for the audience why that is?

Dr.Jim McNally:
I think in rare disease, one of the key elements is that you're typically trying to replace a missing or protein that's simply not functioning the way it's supposed to and delivering a functioning protein back to that patient, to gene therapies per. Suited for that, instead of giving them a drug over and over, you deliver gene therapy, it expresses that protein the proper way and hopefully in the proper tissue and it's a one and done type of treatment that for the foreseeable future, that patient is going to have a functional protein that they've been missing and restore whatever missing function that they've they've lost.

Dr.Chad Briscoe:
And what's it going to take to get gene therapy into other therapeutic areas, whether it's CNS or immunology or in other spaces? I think that's a more complex challenge.

Dr.Jim McNally:
Right, right. Yeah, I think so. I think, for starters, just more experience in the gene therapy space, understanding that they're safe to use, that they're functional, that they actually achieve the stated goal. And then I think you'll see more movement towards areas in the CNS where maybe the delivery's a little more tricky, but the risk reward benefit is far higher in those situations that you can restore a lost function and a tissue that's very hard to reach through other therapeutic methods.

Dr.Chad Briscoe:
So, Jim, I know comic books and superhero movies and things like that are a passion. Here is it's a shared passion. Right. And one of the things we've joked about a little bit is, you know, talking about gene therapy. So gene therapy be used to create superheroes.

Dr.Jim McNally:
You know, I hope not one, because they're far more entertaining on the page and on the movie screen than I think they would be in real life. Kind of hard to imagine people with that level of ability and the amount of restraint that they would need in real life to to use it properly, you know, use their powers for good instead of evil. Right. Ideally, that's what we're doing in the in the Biotherapeutics space is all for the patients. It's all to help people that are suffering from horrible diseases. But I don't know if someone with that type of power level could be trusted in the real world.

Dr.Chad Briscoe:
So, Jim, over the past year that we have come to know you, certainly gene therapy is where a lot of your emphasis letter time has been. But I get the impression that immunogenicity may be more generally.

Dr.Chad Briscoe:
Of course, it's still an important part of the gene therapy treatments, but the study of immunogenicity in general is is a passion of yours. Can you talk a little bit about that? Am I right in that?

Dr.Jim McNally:
Yeah, definitely. And I think that's one of the hawks that have, you know, have really kept me interested in the area of bio analysis. I think there's a lot of data that's generated in the immunogenicity space. But honestly, we don't always know what it means and how it relates to the efficacy of the drugs, which means there's a lot to learn. And for someone like myself, that's what I'm here for. Aside from just trying to do good. It's also this curiosity around is this even meaningful? You know, are we measuring something that has some effect and how does it help us design the next round of drugs as part of the second, third, fourth generation of all of these things we're doing?

Dr.Chad Briscoe:
So that's that's great. I continue to learn from you every day when we have conversations about this stuff. And I really appreciate it. So we talked about you've over 20 years in drug development, a number of pharmaceutical companies.

Dr.Chad Briscoe:
One of the disadvantages, if you will, of my career in a cross that I don't really see these drugs to market. Right. I work on a part of the program. But could you highlight for me maybe a highlight of that pharmaceutical career, maybe a specific drug that you worked on that now is out on the market that's helping helping people, treating, treating patients?

Dr.Jim McNally:
Yeah, I think a couple of examples where in the gene therapy space I saw, you know, and I filed for a particular program that was pretty exciting and moving forward into hemophilia, something that I was very proud of getting an opportunity to work on one, because it was my first experience as a program lead to really looking at the entire drug development process. I was given the opportunity to lead that program. It was my first time. I luckily had a great team around me and a lot of people that I learned from, but take particular pride in that program. And then I think other experiences earlier in my career where there were really complex problems that needed to be solved, that were holding a program back from moving forward, I think a lot of times by analytical scientists find themselves in a space where they're trying to solve something before it crashes a program, those types of investigations and. Problem solving, that's the fun stuff to me, it doesn't feel like it when you're in the middle of it, but when you can say I answered the questions at the end and either kept or sometimes killed a program as a result of it. That's that's the value that I think I bring to it. And what I really enjoy a lot about what I do.

Dr.Chad Briscoe:
Yeah, I think that's ultimately what drives a lot of us to science or pulls a lot of us into science is asking questions, asking unknown questions, and then and then seeking out the answers to those questions. So appreciate your insights. And that's a Jim, you're a leader in a lot of industry discussion groups. We talked about immunogenicity. That's something where you play a big role in leading some discussion groups, the apes and other organizations.

Dr.Chad Briscoe:
Can you talk about some of your involvement in that and why that's so important for you to take your valuable time to to that effort? Sure.

Dr.Jim McNally:
I think one of the big parts of it for me, and this comes back to what I said about bio analysis for gene therapy, we have this opportunity to help set the guidelines in a meaningful way that have biological relevance to to what it is that we do and the data that we generate. And I think being part of these industry groups, you get a chance to influence that and say this is what we're seeing. This is adding value to a program, this effort that we put into validating and asay adds value to a program. But maybe in this other category, it's not to sharing those experiences with my colleagues in the industry is a big part of it.

Dr.Chad Briscoe:
I think in another aspect of that is the globalization of regulations has become an important part of drug development. So what's been your involvement in some of that globalization efforts and how is that going to impact pharmaceutical development in the future?

Dr.Jim McNally:
Well, I've been part of an icy group previously working with regulators around the globe, trying to set guidelines around gene therapy by distribution studies and ongoing effort that's continuing now. I think in a lot of cases, as we move towards rare disease and need to call patient populations around the globe simply to find enough of them for clinical trials, there's such an impact in the different regions that getting everyone on board with the same plan, eliminating we work additional studies and getting these clinical designs and non-clinical designs as focused as possible really benefits all of us in industry and ultimately the patient population. The faster we can get to trial with this work, the sooner we learn whether it's benefiting the patients.

Dr.Chad Briscoe:
So, Jim, mentoring is a big part of my passion. I feel like you share that same passion is something that I want to talk about in each of these podcast episodes. And so I'd like you to talk a little bit about some of your mentors early in your career.

Dr.Chad Briscoe:
And maybe even now being somebody is a little bit further along in your career and also your passion for mentoring in general.

Dr.Jim McNally:
Sure. I'm a huge believer in mentoring. I am acutely aware of the fact that if it weren't for people early in my career, I wouldn't be where I am.

Dr.Jim McNally:
And then part of my job is to help return the favor and develop people so that they can move into the next level of their career to. I think there are some very sort of self-serving parts of had if I develop people on my team, it frees me up to grow and do the additional things that I want to do. It builds trust with your team, that you have expectations for them, that you're going to help them reach those goals and then you're going to cut them loose and let them do what they need to do so that they can grow and learn on their own. Also, I've mentioned a couple of times already my experience at Pfizer, the five years that I spent learning from from Boris corvids were just an amazing opportunity. I I almost think of it like it was my second postdoc in both circumstances. I had mentors that were teaching me not just how to get the job done, but how to think and how, as you mentioned, you know, the job our job is to ask questions. I think a lot of what they did was help me figure out what are the right questions to ask. And there's a thousand things that you can ask most days about the things that we do. But how can you drill down to the important questions so that you can stay focused and move forward to the next series of questions to advance a program? Incredibly important. And I simply want to share that with other people. I mean, I feel like I've got. To where I am because of my mentors and it's simply my responsibility to to return that to to the next generation.

Dr.Chad Briscoe:
Oh, it's great. I think probably people that aren't in the scientific field don't understand the value of the mentor in the relationship. A lot of times I see it like professional sports, right, where both we're both passionate NFL football fans. And I think of somebody like Bill Belichick. And you look across the NFL football landscape and it seems like half the coaches at some point or another Bill Belichick, and they imagine somebody like Boris Gurvitz on the scientific side, you might say something similar. He's mentored so, so many people in the industry. That's pretty cool, right?

Dr.Jim McNally:
Yeah, it's it's funny you mention it. There are a lot of similarities there between Belichick and Gore.

Dr.Jim McNally:
Ovid's, I can't say that I've ever drawn that connection before, but, you know, amazingly direct, wickedly funny when they're maybe not on camera or off on the sideline and a pretty powerful coaching tree that's come out of it. Right. I mean, the number of people that are part of the team that we had at Pfizer that have moved on to their second and third job since then and have taken on leadership roles, it's amazing. So, yeah, it's it's a pretty strange parallel.

Dr.Jim McNally:
I hope he understands the humor of that. If he gets a chance to listen to this. Have you ever seen Boris wear a hoodie? I have. No, I know I have especially not the not the sleeveless off version of it, that's for sure. I pay money for it, though, that's for sure.

Dr.Chad Briscoe:
So, Jim, another topic you and I talk about a lot is families. We mentioned sports.

Dr.Chad Briscoe:
I think those passions that you have at home play into your passion as a scientist. Do you want to take a minute and, you know, share a little bit about how those pieces might be connected in your life?

Dr.Jim McNally:
Yeah, you know, I mean, obviously, the element of being married to another scientist, we were literally grad students in the lab next to each other. I was a T cell immunologist. She was a B cell immunologist. So we spent a lot of time talking about things.

Dr.Jim McNally:
When we work around the house, we use scientific terms. You know, we're not putting away leftovers. We're allocating the leftovers, things along those lines.

Dr.Jim McNally:
You know, for me, I have had a very fortunate sort of personal life getting to this point, healthy family. But about four or five years ago, my son was diagnosed with Crohn's disease. It was my first experience, one with an immediate family member suffering from something, the first person in my family that ever received Biotherapeutics as part of their treatment. I went from being a bio analytical scientist, which was kind of hard to turn off.

Dr.Jim McNally:
But the father of a patient and listening to doctors talking about his anti drug antibody levels against his Remicade to make sure that they weren't getting too high and neutralizing the effect of the drug that he was receiving every eight weeks, seeing the benefit of a Biotherapeutics and watching my son put weight back on, move back into a more normal life and being an active athlete and then making that trip into an infusion center every eight weeks and watching them hook him up and do all the things that they do. I will say that typically a couple of days after each one of those trips to the Children's Hospital in Boston, they publish on the patient portal the data that's been collected from his samples. And I look at it is one part father and one part bio analytical scientist looking to see how his numbers are and everything that's being maintained. They're a completely different perspective about what I do now and how important the quality of the data that we generate is to real people's lives out there.

Dr.Chad Briscoe:
Yeah, well, Jim, thanks for sharing that personal bit and I appreciate it. And it really does bring it home for us. So I'm going to transition to some a little bit later now.

Dr.Jim McNally:
Well, you know, it is light. It hasn't always been. Yeah, and it wasn't in the early days, but now it is a success story. And it is something that I look at and say, you know, thank goodness that I get an opportunity to be part of this industry and do something like that for someone else. And I'm thankful for the people that did it for me before we got here. You know, it's a it is part of why I'm acutely aware of every scientist that I help and train as part of all of this. They're going to be doing something like this for someone else.

Dr.Chad Briscoe:
That's that's fantastic, Jim, so so, Jim, what's your favorite comic book? We reference passion earlier comic book and why?

Dr.Jim McNally:
Yeah, so so at the most basic level, I'm a DC guy, not a Marvel guy. From the comic book standpoint, obviously the is far and away. The whole Marvel universe is just something you can't turn away from. It's it's been an amazing thing. You know, as a kid, I grew up reading about this stuff and to actually see it come to life on the screen, I honestly I'm just amazed.

Dr.Jim McNally:
I never thought these things would happen. I'm a huge fan, both from a science fiction standpoint and from a comic standpoint around time travel. So anything that's involved there, that's always a hook for me. I don't know whether it's just because I want to change things that I've done in my life or be able to go back and rethink and edit things that I love. But that's a fascination for me, too. But, you know, I'm a Superman, Batman, Wonder Woman guy. It's the it's the basics for me.

Dr.Chad Briscoe:
That's that's fantastic, Jim. And I think you knew that this last topic was going to come up at some point. But it's well-known to those of us that have been maybe hundred and fifty or two. Zoome calls that you have a passion for Sellery. So I got to know the seller is there. You're showing me the Sellery. So what is it about the salary, Jim?

Dr.Jim McNally:
So one of the great things, right, about our new sort of remote environment is that I am constantly on calls. I do not really get a chance to leave the basement office. Once you get up and get on a call, it just doesn't stop and you just go back to back to back. So the opportunity to sit down and eat is complicated. I also tend to just munch throughout the day anyway. So just having something at the ready that I can take a quick bite of and not immediately grab, you know, a Snickers bar or something is an advantage. And I've actually liked celery since I was a kid. I don't know why. I don't know when it was the first time. But, you know, it's one of my favorite snacks. At some point I'll probably tire of it. It'll become carrots or become, you know, snap peas or being I go through these phases with vegetables, but, you know, it's I don't know.

Dr.Chad Briscoe:
Snap peas are good.

Dr.Jim McNally:
It it is kind of funny, though, because it has become this sort of signature thing other than the the I spy game that's played with my shelves and boxes that are behind me on both sume calls, everyone trying to figure out what's back there. I guess there are worse things to be known for eating too much celery.

Dr.Chad Briscoe:
Jim, that's a funny place to leave it. But but I think we're going to leave it there. I really appreciate the conversation. Like I say, over six or eight months we've worked together to become a good friend and a fantastic colleague.

Dr.Chad Briscoe:
And I couldn't thank you enough for being the first guest on the first episode of Molecular Moments. We'll have you back sometime down the road as we as we see things evolve in the industry. And we've got new and interesting things to discuss. Thanks so much.

Dr.Jim McNally:
Oh, thanks. I really enjoyed it. You're also a great colleague. This has been a great nine months, far of us working together. I'm excited to be part of this and really excited to hear who the next guest is that you bring on. So looking forward to the next molecular moment.

Announcer:
Thank you for listening to the premiere edition of Molecular Moments powered by biogenetics. Subscribe to not miss an addition. In the next episode, Dr Chad Briscoe will be speaking with award winning scientist Chen Zemo.

Automatically convert your audio files to text with Sonix. Sonix is the best online, automated transcription service.

Sonix uses cutting-edge artificial intelligence to convert your mp4 files to text.

Create and share better audio content with Sonix. Automated transcription is much more accurate if you upload high quality audio. Here's how to capture high quality audio. Better audio means a higher transcript accuracy rate. Quickly and accurately convert your audio to text with Sonix. Transcribing by hand is no longer necessary; put away those headphones. Journalists worldwide transcribe their interviews and short audio segments with Sonix.

Sonix takes transcription to a whole new level. Powerful integrations with the most popular software allows Sonix to easily fit within your workflow. Save time and money with automated transcription. Convert your audio to subtitles and fine tune the timing with out advanced subtitle editor.

Sonix uses cutting-edge artificial intelligence to convert your mp4 files to text.

Sonix is the best online audio transcription software in 2020—it's fast, easy, and affordable.

If you are looking for a great way to convert your audio to text, try Sonix today.

Share This