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The Benefits of Digitizing Operations in the Biotech Industry
Episode

Matt Neal, Senior Director of Regulatory Affairs Operations at Atara Biotherapeutics

The Benefits of Digitizing Operations in the Biotech Industry

 

The Life Sciences Industry is ready to face communication, regulation, and innovation challenges.

 

In this episode, Matt Neal, Senior Director of Regulatory Affairs Operations at Atara Biotherapeutics, talks about his work introducing innovations to evolve the regulatory operations and submissions space. Matt improved knowledge management and information management at a company, by leading Atara’s transition towards a digital cloud-based database ecosystem that’s accessible and cross-functional. He explains why these changes can be challenging within the life sciences and why getting leaders to bring new data-centric technologies like AI and natural language processing is crucial for operations to be upgraded. Unfortunately, the industry finds itself behind others, and developing good ideas is still a very slow process, but Matt believes that communication with the patient community, bringing company information to an accessible platform, and standardizing the language in work environments can accelerate the innovation process in life sciences.

 

Tune in to learn how Matt Neal is getting rid of the waste in Life Sciences to improve the industry!

The Benefits of Digitizing Operations in the Biotech Industry

About Matt Neal:

Matt Neal joined Atara Biotherapeutics in 2019 as the Head of Regulatory Operations. Prior to that, Matt was the Head of Product Management for the InSight Suite of Regulatory Information Management Solutions at Parexel, Inc., and partnered with Microsoft. Before joining PAREXEL, Matt was a Director of Regulatory & Safety Operations at Amgen, Inc. (2003-2016) and was one of the pioneering members of the Regulatory Submissions Department for GlaxoSmithKline (1996-2003). Matt has been publishing and submitting electronic dossiers to the FDA since 1996 and submitted the very first fully electronic NDA for GSK in 1999.

 

LabOps_Matt Neal: Audio automatically transcribed by Sonix

LabOps_Matt Neal: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Kerri Anderson:
By building a platform to share challenges, thoughts from leaders, and network together, the LabOps Leadership podcast is elevating LabOps professionals as well as the industry as a whole.

Samantha Black:
With the intent of unlocking the power of LabOps, we deliver unique insights to execute the mission at hand, to standardize LabOps, and empower LabOps leaders.

Kerri Anderson:
I’m Kerri Anderson.

Samantha Black:
And I’m Samantha Black. Welcome to the LabOps Leadership Podcast.

Samantha Black:
Today we’re here with Matt Neal. He is Senior Director of Global Regulatory Affairs Operations at Atara Biotherapeutics. Thanks for joining us today, Matt. We’re really excited to have you.

Matt Neal:
My pleasure, thanks for having me.

Samantha Black:
Awesome, so can you just start us off and give us a little history? Tell us how you got to where you are today.

Matt Neal:
Sure, I started my career in the life sciences in the mid-nineties, actually, and when I started operations for regulatory, was really just making sure that things would print okay. For people that don’t remember, submissions to health authorities were truckloads of paper at the time, literally semi trucks, sometimes full of paper volumes, thousands and thousands of pages, and typically those documents were created in word processors at that point in time, but very difficult to make sure that they, that the links worked, there were no links, the references, the cross references worked or the tables of contents were accurate. So when I started in this business, I was creating word documents and writing macros and things that would actually make sure that the documents not only would print correctly but actually that all the references were correct, so that when we would create these giant volumes of paper, they would be accurate. It evolved into electronic submissions in the late nineties and I happened to just be in the right place at the right time and my group was at the forefront of doing that. At the time I was with GlaxoSmithKline, which was I think SmithKline Beecham at the time before a merger, and we were at the forefront working with the FDA and the team at Cedar and Sieber to develop a better way to do this with electronic submissions. So the first versions of that were kind of Adobe Acrobat PDF submissions, and then it evolved into the eCTD. And so I really just started in that realm building out submissions and went from the East Coast, I was recruited out to the West Coast, built electronic submissions teams for Amgen, and then I spent a couple of years, after a long time at Amgen, I spent a couple of years in software. I was working with a life sciences software company and we partnered with Microsoft to try to evolve this space, and most recently I came back into industry to work for Atara and it was my first foray into small biotech startup world. And it’s been really interesting and fun because A, it’s a small biotech startup, so it’s a whole different game, but also in the orphan drug area, which I had never been really a part of, and it’s really inspiring to be a part of orphan drug because for folks that don’t realize what orphan drug is, it’s a very small population of people have this disease in whatever realm that you’re working in, and to them they don’t care that only a small number of people have it, it’s their disease and their issue and they would like it to be taken care of and get as much attention as more prominent research areas, so that’s been really interesting. So that’s how I got here, but it’s always been in this space of operations and innovation in trying to evolve regulatory operations and submissions. And so I’ve been around for a while in this space, it’s very strange to have evolved into this career over a long period of time, but it is what it is.

Samantha Black:
That’s very admirable work. I think that a lot of people would probably thank you for working on the digitization of that whole entire process because what a nightmare, beforehand. Well, I’m sure it’s hard, difficult work going, working with the government agencies, but definitely very important work and especially now like working in orphan drugs. I just want to give you an opportunity to maybe talk a little bit more about what Atara is actually doing and what they’re working on. And I totally agree, it’s very important work, and really proud that us as a country are able to invest in this and really see some of these products through because it is really important.

Matt Neal:
Yeah, the interesting thing at Atara, we did a few things obviously there I would be out of my depth to talk about the science, but we just recently got approval for the first ever of its kind, this allogeneic T-cell therapy. So we got approval in Europe for this and it’s first of its kind, never been done before. The basic concept is around being able to create T cells from donor cells rather than from the individual, that’s, the T cells are for. So it’s radical innovation to be able to do that. You can imagine the implications of being able to key donor cells so you can have a Be the Match event or like any anybody who donates plasma, you have this sort of universal donor idea and you can now use it for targeted patients. So it’s really incredible, and there’s a lot of stuff in the pipeline behind the scenes for future indications around that, but pretty amazing stuff. And at that front, not only is, I think, Atara very innovative, obviously in their science, but something that really attracted me to coming to Atara was they made this decision to go cloud only with all of their systems, Microsoft Cloud and Veeva is the Life Sciences Document Management Information Management platform. And so that’s a pretty big bold move for a pharma or a biotech company to do where they don’t have any in-house systems, basically, they don’t have any servers, they’re not monitoring these, they went with vendors. And as I mentioned, I was working in the software world for a long time and I was basically competing against Veeva. So to join a company that had gone all in on Veeva, I was like, All right, well, I know a lot about it, Let’s make it work. One thing I did learn is that in the software world, especially in the life sciences software world, having the financial ability to innovate on a product is key, and Veeva certainly has the finances to be able to continue to innovate, continue to add features, and function to their product. So it was like this, I know they’re going to keep developing and we can push the boundaries and because we have a small portfolio of products at Atara, it’s a small data set to use in the software space because we don’t have a gigantic migration project to switch softwares or whatever, because the software packages life sciences companies are behemoths. I mean, if you have a lot of products, you have a lot of data stored in these systems, whether it’s documents or metadata about the products, in order to switch software is like a multi-year project, usually, you’re like, okay, we’re going to migrate this data, we’re going to operate with both software at the same time for a period of time, and then we’ll do the switchover. I didn’t have that problem, I could immediately say, okay, we’re going all in on this product, we can move quickly. And so that was really interesting to go full cloud only I didn’t have to do a cloud migration and then to know I was with the leader in the space that had the finances to continue to evolve their product. I knew that even if it was immature in some ways they would get there and that we could utilize the idea that we had a small portfolio, a small team, and that’s key, also is like I had buy-in at a very high level at my organization to do this, which is usually a sticking point for a lot of people. Maybe it’s only one department that wants the software and they have to argue with the rest of the teams or try and get budget from somewhere else to be able to innovate. Really think that we’re in a special and unique spot to have management buy-in, to have already chosen these cloud vendors, and to allow us to push the boundaries of that product and say, We’re going all in. For example, when I joined in the 19, there were very few customers using the, this publishing tool and I was like, It’ll work for us, we only have one product, so we’ll figure it out and we’ll learn together. And as a result, we are at the tip of the spear and we are using everything they have. It’s actually changed the whole landscape for how quickly we can move in the submission space. So you take essentially all of the work off of critical path, you know what that means. So basically in operations, when you’re doing submissions get dropped all of the documents usually at the last minute and your deadline doesn’t change. So we’re able to work all throughout the process, and the last day or two really is just cleaning up and finishing up rather than being the first to get your information at that time. So it’s been really useful to be able to innovate with them and see this change, to pull the development of submissions off critical path and making our organization, which is very lean and we don’t have a ton of people. That’s the other thing is in bigger companies you always have a bunch of people doing things as opposed to, now there’s only three of us where we’re going to do it, so it’s been pretty interesting.

Kerri Anderson:
Yeah, that’s incredible to hear and see a company that the leadership supports that because I think a lot of times, especially in smaller companies, you are stuck in the Stone Age and doing things not digital, not in the cloud. So that’s great to hear that you’re doing that.

Matt Neal:
Yeah, it’s been really fun. The key is that management push to be like, we need to innovate. We’re not getting more people, we’re not getting more money, and this is just how it’s going to be. So you have to do more with less and you’re able to do that if you’re using the right tools, I think.

Kerri Anderson:
Yeah, taking a step back, just, I’m thinking about some of our listeners here, and a lot of times we do in operations and regulatory, you are doing that switch over from paper to digital, whether it be an inventory system, a LIM system, or using Veeva. Do you have any advice to offer listeners as they’re making that switch over to being digital?

Matt Neal:
I think regardless of the format and where you’re switching to or from, it’s really important to understand what you’re actually, what you’re, what you actually have. The metadata and the information about what you have is really important to capture. A lot of times we would go on these searches for people that were storing Excel files, right? So they have their own little personal Excel database and it has all this information in it, and they don’t go to the system because it doesn’t have all the bells and whistles that their Excel file does because it’s so easy to add a column of data or whatever. And with these new modern cloud systems, you can actually move them quickly and change them quickly and say, okay, why are you using Excel instead of the database? Because the Excel file is just for you, nobody else can see it unless you email it to them. It’s not real-time, you can’t report off of it effectively in real-time. So we would go and we were like Excel hunters, we would go find people that were storing this information and say, okay, you need to put this in the database. We’ll fix the database so it has the information you need so that you can get rid of that Excel file, because when you put it into the database, now it becomes part of the ecosystem. Now it becomes something that you can report with. Now it becomes something that you can share with other people in the organization more readily. And so the key, though, is knowing what that metadata is and what you’re actually trying to store in the system and using it effectively. I think there’s also an element of thinking long-term about that data, not just what you need right now, but also what’s this going to look like when it fits in with the rest of the data that I’m marrying it to or trying to report on? Because metadata is easy. You can add a whole bunch, you can add all kinds of things to tell your story, but if you don’t have that information about your documents and your content, it gets really difficult. So I think the key is understanding why people mark information the way they do. So what do they need to know about it so that you can build the container first in your database? Except for the data entry part, which you can’t get around, somebody has to put it somewhere. You’re not going to be missing anything if we move it over into this system rather than storing it in pockets. So I think people need to understand what the metadata is and then also look cross-functionally and figure out, are we storing the exact same thing as these other ten groups and are we all calling it the same thing? So if you have product name, for example, maybe one group calls it product, another calls it name, another calls it product name, it’s all the same thing, so you need to unify and say, okay, this is going to be called this. Can we all agree? You know that this is, it’s ok. And so that’s another thing where the small company piece comes into play because you can gather the four or five people that need to answer that question and they can say, Yep, we’re all okay with, we’re all going to keep it the same. It’s just going to be called product everywhere. Okay, cool, we’re in. So that becomes really part of it is that kind of gathering hearts and minds to understand the reason for this is universal across-the-board information storage. It really comes down to like knowledge management and information management at a broad scale, at your company’s level, not in your silo of your department, and I think that’s where it becomes really key because each department is managing their own thing a lot of times, and there’s never that an opportunity to bring it up a level and bring it all together, and I think that’s where operations across the board, kind of is the end result of a lot of those cross-functional things. So you might see the problems and be like, man, if they just called this product, we wouldn’t have to redo this report or we wouldn’t have to manually change all this stuff. Can we all just agree this is called whatever it is? I think it’s that cross-functional piece is let people know if you’re going to embark on this kind of project, you’re probably going to have to bring in people who you’ve never talked to before who are probably doing something similar, but not completely, exactly the same as you, and you have to figure out where you have overlap and try to save everybody the headache and the time. I think there’s a lot of upfront work, but it’s usually worth it that build the container that you want and then get everybody together so that they can move forward in the same, all pointing in the same direction towards having that information together.

Samantha Black:
So you’ve talked a lot about innovation. And so normally when we’re talking about LabOps, I think this is a really good conversation because they’re upstream … very early, and so you’re kind of the downstream aspect of this operations piece, right? And so what does innovation mean in regulatory affairs and regulatory affairs operations? What does that mean when you say innovate? Is that data maturity? Is that, you know, what does that look like for you?

Matt Neal:
So it’s funny, right? Because I don’t think the odd thing is that most of the things I’m talking about are not absolutely revolutionary innovations. They’re innovations for life sciences companies, but they’re not really innovative necessarily. The tools exist today to, have very mature reporting, very mature database analytics. But for pharma companies generally, it’s behind, oddly. I talked about bringing the eCTD forward in the late nineties, early 2000s, they’re still doing the eCTD. It’s not like they’ve moved past it, it took 15 years to become a standard and even still it’s still just electronic paper. So innovation loosely, in parentheses, in quotes, using the technology as you would like it to be used. I think the innovation might happen where we start to implement things like AI and natural language processing into some of these things. So a human doesn’t have to type things, right? If the data comes in, it just goes to the database correctly because the machine, the AI, or whatever knows that it’s there. So the innovation is going to be very stepwise to using things that kind of already exist, but don’t necessarily aren’t the most amazing thing in the world, but they are innovations for life sciences. And I did a lot of work with knowledge management and I got to go to these sort of cross-industry organizations and you would see, for example, NASA’s space industry, aerospace, and oil and gas actually are way ahead in knowledge management and using this data, and you wouldn’t think that would be the case because life sciences has this responsibility and all this innovation, but from a data storage and manipulation standpoint, they’re still rock-and-paper, that’s the standard. So innovation to me would be move everybody into a more data-centric mode, and it’s starting to happen, but it happens very slowly. So things like, there’s a thing called a IDMP, which is this data standard for storing information about your product as it relates to patient safety and drug manufacturing. That thing’s been talked about for a decade, it’s still not the standard, and it’s a simple data set of everything you would probably want to know about your product. And it’s, Man, if we can’t get you guys to see that this is important to do, it’s going to be a long road. Essentially, what the health authority needs to approve a product is still paper-based. It’s electronic paper, but now they take the data sets now and they can mess with the data sets and look at the data sets in anyway they want. But yeah, I mean, there’s a lot of room for moving this forward. The science is incredibly innovative, but the capturing of it and the storing of it, and the reviewing of it is not. It’s controversial to say, I don’t understand why there’s still multiple health authorities reviewing these things like they’re human drugs, yet geographical organizations decide whether or not their geography can take the product, it’s weird. The idea that we innovate is, like I said, it’s in air quotes there, that it’s innovative, but there’s a lot of cool things, there’s a lot of AI products out there now that are doing things. For example, you could, I was just talking to medical writers about this, like you could give the results of a study to Chat GPT and say, write the clinical summary of efficacy and you’d have a pretty good first draft coming out of that, and that’s bananas, that’s innovative, right? But it’s also scary for a lot of people to think that that’s the case.

Kerri Anderson:
Yeah, absolutely. It’s wild to see the technology that’s emerging today and how quickly it’s emerging. So I think sometimes the bigger problem is a little bit more of the soft skills, which is getting leadership buy-in to bring in these new technologies and then motivating employees to actually use them. Do you have any advice to offer for that?

Matt Neal:
Yeah, I think you’re right. A lot of the innovation can come from a top-down understanding of what’s what they want to have, and also understanding that underneath those requests you can have hundreds of people buzzing around trying to answer your question, or you could just use a system to do it. And I always think that where people’s thoughts around what they do on a day-to-day basis needs to be a not a zero-sum thought process, right? So it’s not like I have this information, I’m going to hold it because this is what makes me important, and I want to share it. Instead, kind of make yourself replaceable, make yourself obsolete in a way, because there’s other things you could be doing that are more interesting than typing information into a database, right? So you have knowledge, you have, there’s a mindset shift that needs to happen with folks in moving towards this as the job itself is changing. We talked about the early days of submissions, you needed somebody who could mine, like man a DocuTech printer, and make sure that the pages lined up and had the holes punched in them, that was a job. We don’t need that job anymore, but it doesn’t mean that person doesn’t know things that could contribute, right? I think the roles change, which makes people nervous and understanding that your job is to build the story of the product for your company in whatever way that is necessary, apply your own special skills to it. But I think there’s definitely a shift, there’s a shift happening in this whole landscape around digitization of the information. You have less and less opportunity for adminis… that can be taken care of by either AI or systems and things like that. So it’s an interesting spot.

Samantha Black:
Yeah, I think it’s, you’re at an interesting place because you have your own internal company to deal with and all the data that comes through your own company, but then you also are having to lead this conversation with external partners as well, agency, who move extremely slow like … like, Why haven’t we gotten more tools involved? It’s not because of companies, right? It’s because of agencies and not 100%, but largely they’re the ones who are moving so slow. And so you’ve got a dual job of managing everything internally and then leading that path externally to influence where you can because we know we can do it, do these really cool things. It’s, I can imagine that’s frustrating to have to work with that.

Matt Neal:
It’s a little of both, right, because the agency is on the hook to have requirements. And the weird thing that generally industry doesn’t push, they wait. They wait till it’s required instead of proactively innovating, right? So the eCTD and the electronic submissions was, grew out of trying to figure out, is there a better way to do this? And agencies and industry came together to make that decision and say, okay, we don’t want to give gigantic piles of paper that just are going to sit in a warehouse for, in perpetuity, we want to make this more of a digital experience. So it was an advancement that required both of them coming together with a mutual goal, right? It doesn’t always happen that way. And right now it seems like there isn’t a super strong push from either direction right now to take it to the next level. Although there are things in the works, there’s a project called a Cumulus, which is trying to build out this idea of a shared cloud space where health authorities and we will share information in more real-time. There’s standards that are trying to get in place, I mentioned IDMP, which is one that’s been out there for a while, but you also have regional differences. You have EMA, for example, pushing in one direction where FDA kind of is pushing in another direction. Japan did their own thing and went all in on eCTD 4.0 which was not the best idea. So it’s weird, but I don’t see right now like a huge push necessarily, and it’s almost, I don’t know, one of the things that would be interesting is if the patient community knew how inefficient it was to get this done and what was involved in the review process for these products, maybe that would start this upswell of moving forward. There have been a lot of communications around it. I know the FDA has a new mandate around digital transformation, so we may see a new upswing coming together in that data-based submissions, data standards are starting to come online, but like I said, it’s slow. It’s a very slow process, you measure it in years and you can say we’ll make it, we’ll accept it in two years, it’ll be mandatory in five and it’s already obsolete by the time you kind of make it acceptable. But it’s, I don’t know, I don’t know why, I don’t know why it’s so slow when good ideas happen, but it definitely is slow in our industry.

Samantha Black:
Yeah, like so in my background, we call it like the cost of compliance and that’s just like the phrase that we always say, and it’s just, it’s the high cost that you have to pay and it’s just a slow-moving body that’s there. And at least in our customers that we talk to, like it’s you move around it, you don’t like, it seems like I’m very intrigued by the work that you’re doing because you seem to go directly towards it, whereas I feel like a lot of people move around it in order to like not rock the boat and understandably, because do you want to put risk your product not getting approved because you’re trying to innovate or be a pioneer in data. So that’s a kind of a conundrum that we’re up against, I think, advance in what we could do and what we know we probably should do, or we’ve already invested a billion dollars to develop this drug, so we’re not going to risk it. It’s, how do you pick? I don’t know. That’s not the question.

Matt Neal:
Yeah, I’ve needed to really have like strong conversations with people in the organization, and it’s not until you really shine a light on the fact that, I’m not asking you for anything you don’t know the answer to. You just like to answer it differently. You have an Excel sheet over here that you like to fill in. You like to email this other stuff to these people, and if you bring it to them very vividly and say, okay, and I did this when we, because believe it or not, early days of electronic submissions, there were not, there were people didn’t believe that was a good thing either. So I took I took a clinical study report, printed the printed version of it, which fit on like a pushcart, right? So it was like 15 or 20 volumes of 300-page binders, right? The whole thing. I rolled in a clinical study report and into a conference room with all these VPs who I had to get agreement to spend money on building eCTD, and so I rolled the started report in. At the time, not everybody had laptops, so I’m extremely old, but I bring, I brought in a laptop and a couple of them and I gave them to people around the room and I said, okay, we’re going to run a simulation. I’m going to be the FDA calling you to ask a question about a patient, and you’re going to find that information so that we can talk about it while we’re on the phone. I said, here’s your study report. You know, it’s right there on the cart. You can, we’re going to pretend that you have it in your office and you don’t have to go to the archive and get it. I already did that for you. It’s here in the office and I had my laptop and I said, okay, phone call, what’s the patient number? And of course, I have PDF version of that study report on my desktop and I do a find for the patient number and I say, okay, I’m staring at the narrative, You guys ready? Not even a person that got up from their table to go get the volume to figure out where it was. I’m like, That’s why we need to do electronic submissions. Because when the FDA is on the phone, you want to be looking at exactly what they’re looking at the same time and know that it’s the right thing and it’s important, it’s important for the patients. And so the same type of thing is happening now, or it’s like you can have people have an excuse like, I like to email it or I like to put it in this Excel sheet and it’s okay, but in four years when you’re not at this company anymore and the FDA asked us a question about this, how are we going to find it? Are we going to dig through your emails and your old C drive hopefully that you saved? No, it belongs to the company and it needs to be in a findable space. So it’s that idea of thinking long term that folks need to understand, is like we are on the hook to understand this product, products take 10 to 15 years to get through development and get to a health authority, and that’s longer than most people’s careers at any one organization. So it’s like this breadcrumb trail that we’re all responsible to fill in along the way, and if we have a container, that’s great. It should stay in that container its whole life and be available historically for that whole time. So sometimes you have to show people the example and illustrate like, okay, we’re being inspected, can you find X, Y, and Z? I don’t know. I’m like, See, too late. And actually, the inspectors are getting more savvy as well. So the inspectors know that these systems exist. So if you take too long to find things, they’re like, shouldn’t this be in your database? Shouldn’t this be in your trial master file? What do you mean you can’t find X, Y, and Z? So it’s interesting and I think it just takes people the experience of going through those things and realizing they’re not that good at remembering where they put everything, then you should let systems do it. That helps people do that.

Kerri Anderson:
Yeah, absolutely. That right there is the push that everyone needs to hear to go digital. I think that it’s valuable and we need it.

Samantha Black:
Yeah, and I think that starts with LabOps and goes all the way through an organization and goes the entire spectrum to the regulatory agencies. So I think this is a great example of how, you know, everybody talking the same language and getting on the same page could really help make that happen a lot faster.

Matt Neal:
In the lab is one of those things that’s happening five, eight years before regulatory even gets wind of it, right? So instead of going back and having to dig through a paper archive and scan lab notebooks, I know you love your notebook, but you’re going to need to put this information in here so we can get to it at all times. The digital lab notebook makes a lot of sense because it has to be stored for a long time over a period of time, be available. And you can also start to spot signals too, because you can have AIs looking at candidates from the lab and saying, Hey, did you guys realize, you know what you’ve got over here? This is how some of the most innovative products have been found is from early-stage experimentation and they flag and say, it doesn’t work for this, but it’ll work for that data marker that we weren’t even trying to hit, right? It’s almost let the machines do their work from even the earliest days in the lab, and that’s something that companies are always trying to figure out. Is this product worth our investment? Should we carry it forward? Having that digitally and having that in a space that’s innovative is pretty remarkable. And a lot of, the one excuse I hear all the time is not all these candidates go forward, so we don’t want to do the big expensive system stuff early on because it might not be anything. It’s like that’s a bad excuse to not capture all this information because maybe you don’t want to develop it, but maybe somebody else would, so, in the orphan drug space, right? So wouldn’t you rather hand over a nice digital package that is ready to go to the next stage rather than having to dig through all of that paper and all of that kind of stuff? So there’s benefit across the board as being marketable, as being transferable. There’s a lot of benefit in storing all of that kind of stuff. It’s almost, I think about it all the time, like when I was a kid, I think there’s maybe, I don’t know, six photos of me when I was a kid because there’s, you had to get your film developed, you had to have a camera, you had to get your film developed, and most of the pictures are terrible because you couldn’t see whether it was in focus or not anyway, as opposed to kids growing up today whose basically every day of their life is digitized and on video, and it’s, I wouldn’t mind seeing it, it might be interesting. There might be stuff I wish I didn’t have on video, but the idea is why not have it at least to choose from to see how things developed as opposed to a couple of little snapshots here and there?

Samantha Black:
Oh, I can, yeah, I could talk about this stuff all day long. It’s a lot of, I think, where we could go, and I think that it’s like one of those topics that the possibilities are endless. And so you get caught up in the excitement of, Oh, like I can see where it’s going, and then you have to ground yourself, be like, okay, but we’re here today. You kind of have to meet somewhere in the middle, and again, I think it’s a really important work and I think probably going into this conversation I was like, oh, regulatory. I probably had a different idea of what we’re going to talk about than what you actually talked about, and so it’s I think it’s super exciting. And I think for operations folks, I think it’s a really great place for, even if you don’t go into regulatory affairs, I can see a lot of opportunities to collaborate and to help an organization, biotech company, be better in a lot of different ways. So I’m really grateful that you shared your perspective because I think it’s super interesting. Awesome, so, Kerri, unless you have anything else, I’m going to close this out with a question that I’m sure people are going to ask. How can they talk to you again? How can they find you? How can they learn more about what you’re doing or collaborate with you?

Matt Neal:
Yeah, I think the best thing to do is find me on LinkedIn, that’s the easiest place to do that, and yeah, I post a lot of information out there. I’ve been doing a lot of work writing industry white papers and blogs across the board about this stuff. As I told you guys, I’ve been around a long time. I’m at the point where I’m like, I’m just going to say this stuff because what do I have to lose at this point is, I know it’s inefficient, I know we can be better, and my, a lot of my colleagues and I get together and like, we’re tired of saying this over and over again, we’re going to actually say it out into the world and hopefully, it will shift. Hopefully, we will see these things start to evolve faster because, at the end of the day, it’s the patients’ time that’s really valuable here. In so many of these spaces, a day or two can really make a difference. And so knowing when you look at the operations of a giant company from a zoomed-out perspective, you could save time, days, weeks, months, whatever the case may be, in your contribution to the science that’s creating these products, and those days, weeks, and months mean a lot to patients, whether it’s who, wouldn’t survive otherwise without a treatment or wants to have a better life during their time on treatment. It’s incredible what can be done, and so those days, weeks, and months really matter. So my goal with my career is to try to get rid of all the waste, if I can, so that at least we know we’re doing it as good as possible with the technology available to give that time back to patients and to their families. So that’s really what I’m trying to do.

Kerri Anderson:
Thank you, that is incredibly inspiring to hear, and we need people like you that are making the push for that.

Matt Neal:
My pleasure, it’s been great chatting.

Samantha Black:
Awesome, thanks, Matt. We appreciate it and best of luck, and we’ll definitely follow your journey.

Matt Neal:
Thank you.

Kerri Anderson:
Thank you for tuning in to this episode of the LabOps Leadership Podcast. We hope you enjoyed today’s guest.

Samantha Black:
For show notes, resources, and more information about LabOps Unite, please visit us at LabOps.Community/Podcast. This show is powered by Elemental Machines.

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Things You’ll Learn:

  • An orphan drug is a medication used for a disease that only very few people have. These deserve as much attention in research as other medications.
  • Atara Biotherapeutics recently got approval for the first-ever allogeneic T-cell therapy that can create T cells from donor cells rather than from the individual the T cells are for.
  • Life Sciences standards for data storage and manipulation standpoint are far behind other industries.
  • The IDMP (Identification of Medical Products) is a data standard for storing information about medical products as it relates to patient safety and drug manufacturing.
  • A Regulatory Affairs Operations department has to deal with health authorities and share information with them about the operations behind medical products.
  • Medical products take from 10 to 15 years to get through development to a health authority’s approval.
  • A digital lab notebook allows data stored inside a company’s database with easy access for a long time.

Resources:

  • Connect with and follow Matt Neal on LinkedIn.
  • Follow the Atara Biotherapeutics on LinkedIn.
  • Explore the Atara Biotherapeutics Website!
  • Connect with and follow co-host Kerri Anderson on LinkedIn.
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