Insight at Biologics – Episode 7
In this episode of Insight at Biologics, industry expert Kerin Ablashi delves into institutional memory and knowledge management in the pharmaceutical industry. Discover exactly what institutional memory is, the role it plays in regulatory compliance, operations, and product development, as well as how you can develop knowledge management systems and continuity plans to support your organization, no matter what size.
James: Memory. We all have one, although, how well my particular one works is up for debate, but did you realize there was such a thing as institutional memory? There is, and we’ll talk about it with Kerin Ablashi. This is Insight at Biologics.
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So Kerin, if you would please tell everybody about yourself.
Kerin: Oh, sure James. So my name’s Kerin Ablashi. I am a technical writer consultant with Biologics Consulting. I’ve been with Biologics for over 17 years. I’m a technical writer. My focus is CMC. I don’t focus on other areas, so I don’t wanna talk about those cuz I don’t know anything about them. Prior to that I was with a small company, so I’ve seen some of the challenges of working in a very small company doing product development and knowing about getting everything documented.
And before that I was with what is now BioReliance and I was with them for almost 11 years. So I’ve seen sort of, a bigger company that already had systems in place. So I really do understand some of the challenges for smaller companies and also bigger companies. And then I’ve also seen this with our clients. We would interact with clients that are from pre IND, all the way to doing their BLAs and even after doing post licensure submissions.
So I’ve worked in and with companies at all stages of pharmaceutical product development. And anybody that needs to get more information about me is free to go to our website and check me out on biologics consulting’s web page.
James: So Kerin, what is institutional memory?
Kerin: Well, James, if you do an internet search, which, you can always trust everything on the internet –
– but if you do an internet search, you’ll see that the definition is the stored knowledge within an organization. So this is basically applicable to pretty much any organization. It could be, your company, it could be your church, it could be pretty much any organization or maybe even some people would consider their families to be an organization where you have institutional memory. It’s stored knowledge of what’s happened in the past, how you’ve done things, why you’ve done things.
Maybe, especially at holiday time, you have a lot of different family traditions. Why have you done those? It’s that kind of thing. But we’re gonna talk about it, obviously, not as it applies to your family or anything. We’re gonna talk about how it applies to pharmaceutical development, development of drugs –
Kerin: – and biologicals.
James: All right, so you say how it applies to what we do. Why is institutional memory important in what we do?
Kerin: Well, I would say a lot of it it’s because, well, what we do, we have to provide the FDA with a lot of data if you wanna get your product approved. Right?
Kerin: That’s just how it goes. The FDA or any other regulatory body, we need a lot of data. When you get a lot of data and if you’re doing product development, any kind of product development, I imagine, but I only know about this. You need to know what you did and why what worked, what didn’t work. When it did work, what were you using that made it work?
So all this stuff has to be written down. And so that is one challenge, which is getting people to write things down, which I worked with when I was back in my small company. That’s a topic for another day, is just getting people to write it down. So we need to know why things were done, how things were done.
So what we’ve been seeing, James, especially since Covid is, there’s been a lot of people changing jobs and moving from here to there, and a lot of people transitioning out. When you’re at a company, there’s always that one person or two people, or if it’s a big company more than that, who know everything and how everything’s been done.
But if those people leave and they go somewhere else or something happens to them, those people leave. You don’t know – why did you use this formulation? Why did you do it this way? Why did you pick this particular way of doing things? What was the starting material you used? You don’t know any of that.
You’re a new person. You come in and you have no idea what you’ve got. Some people have stuff stored in lab notebooks, other people have it stored on a database over here, people don’t know what they have. And what we’re seeing is because of this high turnover and, I have talked to colleagues that some other clients are actually having this issue because of the high turnover, we are seeing, submissions are becoming stalled or –
What I’m saying is basically, what we’re seeing is that because of the high turnover, people don’t know what data they have, and that’s actually hindering getting regulatory submissions put together. And in some cases this is actually delaying the regulatory submissions, and as we all know, and as my boss loves to say, time is money. So if you are delaying your regulatory submission, that actually can have a lot of negative impacts on your company.
James: It reminds me of a story that I heard, circling back just a little bit, to the family that you said we weren’t gonna talk about, about how everybody in a particular family would cut off one end of the ham before putting it into the roaster for Christmas dinner, and at one point the young children didn’t know why, so they asked the older people, who didn’t know why. So they asked the older people, and they eventually got back to great grandma who said, oh, I just used to cut off the end because my roasting pan was small. And you’re not going to know what you have or why you do, if you don’t document what you have and why you do it.
Kerin: And that’s exactly true, but even just documenting isn’t the whole thing. So we had a client way back who, it was a big company that bought a legacy product, so they bought this company and clearly whoever had worked on this had documented a lot. Because they had hundreds and hundreds of boxes of paperwork on this product and the company that bought it had to store this at Iron Mountain because there was so much data, and then they ended up having to hire an intern to go through the boxes and figure out what they had and what they didn’t.
Because yeah, people had done a great job documenting, but nobody knew what they had because they didn’t have a central warehouse for that information. So they didn’t know what they had and where it was. So they might have had everything they needed, but they couldn’t even show it because it was sitting in boxes.
James: So it’s more than just writing it down. It’s –
James: It’s making sure that the institution, beyond any of the individuals, comprehend what it is that they have.
Kerin: Comprehend it. Yes, and, in comprehending, know where it is, know what it is. So another company that we work with is a big company and they’ve got facilities all across different places around the world, and each place has its own database, or even within that, some of the product areas have, or functional groups have their own databases.
So you’ve got a formulations department that’s done beautiful, lovely work, but the product development people don’t know what they’ve done, because nobody can see what anybody else has done. So this is where it’s institutional memory, what’s been done, what knowledge do we have?
And trying to understand that and so, then when you go with small companies, I mean, the company, where I used to work, people would just jot things down in their lab notebooks. That’s great, but you’ve got a whole bunch of lab notebooks and nobody knows what’s in it.
Kerin: So unless there’s a central warehouse somehow for this information, you don’t really know what you have.
James: All right, so how do you make a good institutional memory structure in your company? How do you have it so that you just don’t have a bunch of random lab books, as you said?
Kerin: So there’s a variety of ways. And, in an ideal world, you’d have your company buy in, and from the beginning you’d get knowledge management.
There’s knowledge management software out there that you can get, and you’d have people who have their whole job is to, when somebody does the report and they’ve beautifully documented everything they’ve done, the report goes to somebody who will then go through and parse out the information they need to keep. Then they catalog the report in the correct places and everything.
And these people would have time to do this and they’d have management buy-in, and then you’d have all the functional groups happy to participate in this institutional memory activity or storage activity, right?
Kerin: But we don’t live in a perfect world. Nobody, everybody’s already ahead of, you’re already there. You’re already like, oh, great. Now I’ve got all these boxes of data, and what do I do with them? So I’ve got hundreds of boxes. What do I do with them? So that company hired an intern. Because their SMEs were too busy. And by the way, SMEs cost a lot of money, so they hired an intern. So that’s one way you can do it, is to get somebody to physically sort through the information.
And this is a painful way to do it and it doesn’t get done really fast, but it is one way to do it. But you start by making a database. You put everything into a database, you put everything in a place where, people can find it, but first you have to realize you have the problem. So that’s where Biologics can come in and help out.
You are gonna do your submission. We can come in and help you with a gap analysis and we can kind of see what you have and then we can help you figure out all those reports that you’ve got that are sitting around. What do you need? We do have people, like me, who work at a little bit lower rate than our SMEs.
It is extremely expensive and it will save you money to have the intern come in and do all that instead of having your SMEs do it or having highly paid senior consultants come in and sort through your boxes, that would be a poor use of money. So biologics can come in before you get started on your submission. We can look at your documents, not all your documents, but we can look at what you have for your submission.
We can kind of help you see what you’ve got, where things are, and we can help you. I mean, we could even have people come in before, we do send people to facilities that can help you set things up before you even get going. But most people are not in that place. Most people are, well, we’ve got all this information and now we’ve gotta kind of wrangle it and get it together, so we can help you and work with the different groups to put the information together in one central place. We can help you prepare a central database of sorts, listings that will help you to figure out what you do have and help you identify where you’re missing information.
James: So we can provide both the ounces of prevention, if you’re lucky enough to realize you need this in the first place, or the pound of cure afterward.
Kerin: Yeah, and unfortunately most of us end up in the pound of cure because most companies when they get started are so keen to get going that, they don’t have the money to put this in place. But if you do have it in place and, and the sooner you start with this, the better, because if you do have it in place, say that you do have turnover, people leave.
You get somebody new in, they can look in a central place and they’ve got this information, oh, that’s what we did. Oh, that’s why we came up with that formulation. Oh, because we based it on this and here’s the report that explains what we did, what we tried, and what didn’t work. And it also helps you when you troubleshoot something went wrong.
Oh, okay. We see that when we did this this other time, this one thing caused something else not to work. And it really does help with a lot of things down the road. So yeah, the sooner you can implement this, do it yourself or call somebody like us, we can come in and help you, the better off you can be and get your submissions in more quickly.
James: Awesome. So now, this is great for a small to medium size company where the decision maker can go in and start to set things up. But what if you’re in one of these super ultra ginormous companies, like one I was at at one point in my career and you’re lucky to get them to allow you to change the color of the paper around your desk. What can you do for someone in a larger company with institutional memory needs?
Kerin: Well, that’s a good question cuz that goes back into the company buy-in because you do have to have some, somebody believing that there’s gotta be some reason for this memory to be captured in a single place. Frequently, that is because you need to get this mission done, you’re gonna do your BLA, because now you’re talking about a huge Mondo company that needs to, they wanna do their BLA. We can come in and work with you and work with the different groups. We can go into the different sites if it’s needed, now post Covid, everything’s done virtually.
We can do a lot of work with you and, I’ve worked on BLAs virtually where we were working with different groups who did not know, we were pulling the reports and going through and helping them identify what information they needed, and that was all being pulled together, working with, the – it’s a bigger company, they did actually have some staff to help, house the information and put them more, put things into a more global central place so that people could find it.
So we can work with you with the systems you have, because we realize that you’re not gonna be able to just take everything you have and redo it and start all over. So we kind of have to work with what you have so we can work with you to work within your systems, but more, we can also help you to talk amongst yourselves because sometimes the groups don’t talk and just sometimes just having a dialogue helps and, and by having to have these meetings, having us in there helps to facilitate intercompany discussions, if that makes sense.
James: Yes. Yes it does. So let me ask you, because this has been fascinating to me, but sometimes people have a little, little trouble boiling things down. What would be the too long didn’t listen version of what we just talked about?
Kerin: Sure. Okay, so the too long didn’t listen, is, you gotta know what you have. You have to know what you have, why you did it, so, it means it’s all gotta be written down. But we knew that anyway cuz we all believe in our GMPs and everything, so we know we gotta write it down. But we really need to have a centralized sharing of knowledge, be it in a database, using knowledge management system, but it needs to be a corporate culture of trying to understand what went before and appreciate it.
And, coming back to the family analogy, there’s a reason why things were done a certain way. We don’t always know what it was. Sometimes it’s silly, like cutting off the end of the roast just because of the pan, and now everybody else does it, but sometimes there is a reason like cutting off the end of the roast because it didn’t fit otherwise, you know there’s a reason for it.
Knowing what you have is really important and will save you time and money down the road. If the experiments are there and documented and you know about it, you don’t have to repeat them. So it’s gonna save you time, money, headaches, help your submissions get in faster, help your people focus on what’s really important to moving your product forward instead of repeating what’s already been done.
James: Thank you to Kerin Ablashi for joining us. Now, if you’d like more information, you can email Kerin or any of us at firstname.lastname@example.org. That’s Insight, @ Biologics Consulting, all one word, .com. Also, we’d love it if you’d like, subscribe to, and rate and review our show.
The executive producer of Insight at Biologics is Chris Kraihansel. This episode was produced and edited by James C. Taylor. The technical supervisor is Jeff Weiss. The Insight at Biologics theme is by Tom Rory Parsons. I’m James C. Taylor. Thank you for joining us and please come back for more insight at biologics.
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