Quality as Culture: Why Biotechs Can’t Afford to Get It Wrong

So welcome and thanks very much for spending some time with us today. And we are going to focus on a word today that we use every day in our work, and that's quality. And depending upon what industry you're in, quality can mean something completely different for all of us. So we're going to talk about quality and that in its association with data integrity and vendor oversight. And often these get labeled as operational details, but they're actually very strategic. They're levers that can shape your company's credibility, the legacy and ultimately the value. And as we all know, even with aspects of clinical trials that are outsourced, the sponsor is ultimately responsible and has full accountability for what happens in the clinical trials. And that's why strong quality and oversight management are key and critical in your processes.

So I'm really pleased to be joined today by Sandra Van Loden. Sandra and I have known each other for many years and she's been working in clinical global operations for about 15 years. She focuses on quality systems, inspection readiness, and she helps companies, specifically smaller biotechs, build something that's smart and scalable and processes that actually work for where they are.

What I really admire about working with Sandra and all the projects that we've worked on together is that she doesn't focus just on SOPs and systems. She sees the human side of quality and that doesn't happen very often. And when we work together, it's clear how much she values helping teams think and lead differently and especially when they're under pressure. So Sandra, welcome to Cut the Chat.

And maybe we'll start with the word quality. So what does it mean to you and why do you keep coming back and living in the space of quality?

Yeah, for me, quality, as you say in the interest of being quality is just a word and not just a word, it's a mindset. It's a mindset and that's why I'm so passionate about it. It's a mindset that I want to make sure that everybody lives every day, regardless of the function you're in in a team. What I really want to get done and where I really help especially small biotechs and startup is shaping them and helping shifting their mindset. Making sure that quality is not just on the head of the quality person and just the activity that quality as a function is focusing on, but quality is part of everybody's responsibilities.

And that's why I'm so passionate about quality because actually it's part of everybody's job.

Yeah. But it's tough to get them for, think it can be a challenge for companies to kind of live and breathe and have quality as culture within their organization. I think so often it comes in as like an afterthought, but it really is a strategy, isn't it? And how, maybe you can share some tips and tricks. So how do you start with building that into the culture of an organization?

Yeah, that's a good question. Where it all starts with Sabine, what I really try to teach companies when I come in is making sure that you can create an open atmosphere.

And why it's important, because often what you saw in the past, if that quality was something reactive, there was an inspection and then everything

Right, true.

had to do very rapidly. Everybody had to be on speed, speed up and making sure everything was okay. But that's not how we should handle it. It's important when you get started up to make sure that quality is embedded from the start.

And if you make sure that quality is embedded from the start, as you mentioned also in the intro, is a strategic advantage. And that's something that I really want to teach more and more to companies and also want to make it more visible. Because it's only when you create an open atmosphere from the start and making sure that you have constructive conversations with the entire team from the start saying, OK,

It's okay that you don't, that sometimes you do things not right first time, but then it's important that you talk about what can we do better? How can we do it in the next activity differently? Where do we need to focus on? And that's what I meant about creating that open atmosphere to avoid that you start pinpointing on people that are to just say, you that person did not do the right thing. It's really making sure that from the start,

that quality mindset is in there and that you... quality mindset is not about perfection. Quality mindset, it's really an intention, making

Mm-hmm.

sure that everybody is accountable for the different activities that they're doing.

Yeah, that's such an interesting point. And I have to reflect back because one of the services that we offer is a vendor selection process. And part of that vendor selection process, traditionally it's for CROs. And when we have what are traditionally called bid defense meetings, we call them partnership meetings because we feel that it's more that you're building a partnership moving forward. Quality usually has like this little piece.

of the agenda and often at the end and often gets pushed back because other topics are covered. But it's interesting what you say because it really should be not a section. It should be overarching. It should be the blanket around the organization. And I think that that's such an interesting way to look at it is not to do it, look at it as an individual service, but it's like it's in everything that you do.

Correct.

Yeah, and I think this idea because obviously there are new regulations in place. We have ICHGCPR3 and oftentimes we hear and I imagine you have as well as that. Some biotech leaders say, well, we've outsourced it and that's really no longer a response that you can use or that they can use, is it?

Indeed, that's, and I actually think it's a good thing. That's one of the benefits now of that revised guideline on the, as you mentioned, the GCPR3, because it's really clearly stated, it's explicit mentioned that outsourcing does not absolve the sponsor of oversight or responsibility.

Mm.

And that's key because what you indeed saw in the past, it's

especially from a leadership perspective, sponsor said, okay, we authored everything to your CRO and they will do it and they do. But now it's clearly stated in regulation that the sponsor keeps, needs to keep the oversight and there, of course, it's important that the sponsor make sure that they can demonstrate that they have vendor oversight requirements fulfilled.

And besides that oversight specifically mentioned or the responsibility now of the sponsor is specifically mentioned in R3, besides that, also important is the risk-based quality management approach that this now

Yep.

also introduced in the R3, which actually requires the sponsor

to make sure that they have active systems for oversight so that they demonstrate that they do or they assess vendor competence, but that they also monitor their performance and that the

Right.

sponsor takes action when required.

Yeah, that's so true. And also this assessment piece, because again, it's so thought about, I'm working with this vendor or the CRO is taking care of it. I think important that you still need, you're as a sponsor still responsible for all of those sub vendors that maybe somebody else is contracting with. And I think that that's like a big realization that we're experiencing as well, that a lot of companies are like, yeah, I am responsible for all of them.

not just the main one that I have the main contract with.

Correct. Yes.

Yeah,

interesting. And what do you think? So you focus a lot. We work and we've had a lot of projects together in the past and focused on quality. But what are the misconceptions? Like when you start talking to some sometimes new biotechs that have just started up and are putting everything in place. So what are the misconceptions around quality?

One of the key misconceptions that I always or that I often encounter Sabine is that quality slows us down. It's a hassle.

Yeah.

But and we already elaborated on that. As you mentioned, quality needs to be seen as a blanket, as a strategy pillar across the organization. Because in reality, if quality is not taken into account from the early start, it just will

have additional costs for the company, but also potentially a lot of delays. Because

if you don't

Yeah, true.

have quality from the start, you can have issues with data integrity, data quality. And if that happens, it's just a throwback on everything within the company, not only on timelines, but on reputation. So it's really important to get that misconception.

really get out of the heads of leaders

Yeah.

within the startups and small companies. Sorry. I also...

Yeah. and okay, go ahead. No, I've got lots more questions to build on that, but I'll let you keep going.

Another important one that I often see Sabine is that they say quality is just documentation

Mm.

and that quality is reduced to just as a piece and forms.

Right.

But

it's also, okay, it's part, but it's not that that you need to focus on. just making sure you have that proactive approach, that you have that mindset. That is key because you can have as a piece in place, but if nobody knows them, if nobody's following them, yes, then it doesn't

Or if they're

really matter that you have these documentation and it doesn't help on the quality mindset and oversight.

Yeah, that is so true. Often you think quality equals SOPs and forms, that that's the formula to success. But it is so much more than that. And do you find it also a challenge to change that mindset or what are your experiences with that?

Yes,

that's certainly a challenge. why it is a challenge Sabine, of course, as you said, we are working with small companies, startups. So what you often see is that they are under pressure. They have limited resources. So that's why it's

that can be a challenge or sometimes a hurdle to really making sure that they understand that we need to embed quality from the start. And that's why I often try with stories that I already encounter in the years that I worked in quality to, I share a lot of stories from the past that I encountered just in the daily life that also can help them to understand

why it's important to take quality into account from the start and not just think, okay, we don't have time for this, we need to rush, we need to get these data, we need to show that the product or that the compound we're working with really delivers. And that's true, but you only can do that when you make sure that the data that you're gathering is from a good quality. So make sure that that quality is there from the start.

Yeah,

that's such a good point. And if we think about, because we also wanted to cover, it's the quality piece, but it's the oversight piece, which is so key, especially with the regulations that are in place. You mentioned you have some stories. Can you share one that's very practical, obviously without kind of sharing any confidential information?

Yeah, So I have been involved in, it was at that stage, a phase two trial that sponsor was running. I came in later. So they were already working with the CRO managing the data and the trial. And actually they did not have a formal...

vendor oversight. And they were at the stage that they had to get additional fundings to make sure that the company could move forward. And some due diligence was done to make sure to understand if it made sense to have that additional funding. So some QA consultants came in to have a look. And then of course they found that there was no oversight documentation. There were no...

There were protocol deviations, but they were not followed up. Also the TMF, so the trial master file, there were some serious gaps. And so that meant that at that moment in time, of course, there were lot of questions on the truth of the data, the quality of the data. And that during that due diligence process, there was a lot of questions. There were a lot of questions and

It was flagged as a risk, actually caused delays. It caused delays and the investors then also asked to make sure that there was a QA remediation plan in place and

you

that afterwards, again, an audit was conducted to understand if with that remediation plan, the critical

Mm-hmm.

issues that were flagged were solved.

Yep. Yeah, so true. And you're right. You mentioned earlier that had the work been done earlier, the costs would have been less. And if you think about the costs to get up to the standard where you need to be, plus all of the time lost moving forward, that's substantial. we know, yeah, investors and companies, it's so key to watch your runway and to watch your cash flow. And sometimes I think that we forget about this early work.

how crucial that is and it helps in the long run. It helps with inspections, for instance, that we've seen that and that when an inspection does come, if you've taken all of those steps and things have been working well, then the inspection is so much smoother. There's less time to prep to get ready. It just makes everything so much smoother and easier because you're not having individuals focus on so much energy on getting ready because you've taken all these beautiful steps along the way.

and

you are not in the reactive mode then. You are really in that

Yeah, true.

proactive mode and it's totally different because also there if you are in that reactive mode a lot of pressure, a lot of additional stress but also you don't have that open, you don't create an open atmosphere at that moment because everybody just is focused on making sure that all these reactive things are done and then you also start the pinpointing again and you don't have that safe environment.

Yeah, that's true. It doesn't lend to more accuracy. It can actually lend to more mistakes and more stresses on the team, which is definitely not needed because especially if an inspection is coming, you're already nervous. And I also wanted to ask you about this because we talked a bit about ICH GCP R3 and there's this emphasis on system-wide approaches to quality and design and this term quality by design.

Could you share more with us about that?

Yes, certainly. And it's also, I find it very nice that it's really also embedded now in the guidelines because it's making sure that actually we can now use also the guidelines to promote the proactive approach because what it's meant that in quality by design, how you want to do it is making sure that

you actually embed everything, the trial design,

Mm-hmm.

the execution, monitoring process from the early start on. So in a proactive way. And that you don't, as we already mentioned in the previous question, that we, by setting this up from the start, by designing it such a way, you are immediately in that proactive mode and not in the reactive sets. And I believe that that is...

Now that's in the guidelines, it's also for us as quality experts, good that we have that because then we can use that also as a driver to make companies aware why they need to be in that proactive mode, knowing that it is promoted through the R3 now, that culture that is shifting towards quality by design.

Okay, so the idea is really to get away from like tick, tick, tick checklists and this idea of embedding. it actually sounds nice, doesn't it? Quality by design.

Yep. Yep.

It gives a totally different feeling, think too, potentially for the organizations and the way it's designed and thought about. And what about teaching that mindset? how do you teach this quality by...

by design mindset, maybe not even teaching, maybe teaching is the wrong word, but help companies integrate that mindset.

Yeah,

that's for me Sabina, that's something that starts with the leadership. Because

Mm.

if you have a leadership that has that quality mindset from the start, it also helps to make sure that that quality by design mindset is embedded through the organization.

And that's also very key. And also there, I have an example. I worked in the past also in a startup where the chief business officer, he also had a lot of experience and he had some bad experience in the past, which helped him to realize why quality is important from the start. And working with

him having that quality mindset and he really understood why that quality mindset from the start and quality by design was so important. He was at that moment my partner in crime to make sure we could

Mmm.

convince the other C-level leaders to understand why it's crucial to have it from the start and that by having

That's, yeah, it's really important as a quality professional, felt that example really made me realize if you already have a partner in crime from the start in leadership, that is really...

Mm-hmm, right.

working with you to have that mindset from the start, it's a huge advantage and it helps you

Yeah.

a lot to get into that quality by design mindset. You really need to have a buddy, someone in the leadership who understands why it's key to make that happen,

Yeah.

to make that mindset shift happening.

Right, yeah, and to embed it really across the organization, I think that that's just

Yeah.

such an important piece as well. And I think sometimes we hear quality and people roll their eyes, like, oh yeah, here we go with the quality topic again. And that's such a shame, isn't it? Because it doesn't have to be. think also because of this quality by design kind of mindset and how we work around things, we've taken it away from this kind of siloed.

Yep.

entity within an organization that's, you know, off in the corner somewhere. And again, like blanketed it more around the organization. That is so key that when the leadership team talks about quality, they talk about it in a way that's almost respectful. That's not like, you know, well, we'll deal with the quality later, or it's not as relevant, but they give it the weight that it deserves and needs.

Yeah.

Yeah. Yeah. Really interesting. And,

There's

also obviously a balance. We work with companies, we've had a lot of projects together too where there's limited resources. What do companies do with that? mean, we've teamed up together to work on processes. And I think from my perspective, what I really value is when we work together is that we look for ways, somebody thinks about that if we come in and do a quality audit.

that we're gonna come in and say, you have to do these 100 SOPs and forms and all this needs to be created. And that's actually, I think also a shift of mindset with biotechs that really this idea of fit for purpose is so crucial

Yep.

when you move forward with them.

That's correct.

Yeah. And I think that's a good point that you bring up Sabine because fit for purpose is actually making your, if you think about the QMS that you set up a fit for purpose QMS, you make it scalable. you

Mm.

just, when you just start up as a company, you don't need to have hundreds of...

QMS documents, you just need to make sure, as you said, that it's fit for purpose. And therefore it's important that when you start up as a company, also can understand, you just understand what are the essentials that we need

Mm-hmm.

to have. Certainly as we talked about.

about the oversight and how it's now embedded in the R3. There are a couple of things that you know are essential that you need to have in the early phases when you kick off with your company. And there it's important with a fit for purpose mindset that you just also understand from a QMS perspective, okay, we first going to focus on a couple of essential documents, having a couple of essential processes in place. And then later on,

we can add on depending on where we're with our company.

Yeah. And I think looking at this and going back to this, the idea of also the oversight and making decisions and incorporating this fit for purpose and this quality by design, how can companies actually make smarter decisions around the vendors that they work with? And then having that quality lens on as part of that process.

Mm-hmm.

Yeah.

Important one key I always say Sabine is that for me when you're starting with actually with the selection process already it's key

Mm-hmm.

that quality is included from the start. It doesn't need to be complicated in the selection process just make sure when you have your proposals sent out to different CROs make sure you include five to ten quality questions.

already based on the input of these to these five to 10 quality question, you can already assess a lot about the culture, but also what they have in place from a quality perspective. And that's important to make sure that quality is an equal.

element

in your decision process when you select the CRO next to other like finance or whatever, but that you also take quality part and that you make it an equal pillar in that selection process. First of all, that's

Yep.

key. Then when you go through the vendor qualification questions, it's important that you not just focus on the services that the CRO will provide to you,

but also on their systems. What is their audit history? How do they handle data integrity, GDPR activities? How do they manage protocol deviations? So there are a couple of very practical and simple questions that you standard can ask and that already give you as a company a lot of additional value.

and that can also help in your selection process.

Yeah, that's so true and it's interesting because years ago we were already thinking especially about the systems pieces when we brought in Lauren Alani and started developing this clinical systems analysis piece because it is so crucial. And now everyone's eyes are so much more focused because we've seen, know, there's news out there about companies that are gone because of these data integrity issues and that they didn't check things properly.

Again, to your point, do it early, spend, think about your spending wisely and spend smart in order to make sure that you don't have those situations later. Yeah, I think that's so true. And I can imagine, you it's a challenge. There's so much to think about and especially, you know, with the new regulations and what's going on and with limited resources, it's, you know, it's a challenge. But there are companies and people out there that can help.

with these processes for sure.

Yeah, interesting. So how has it changed? How has, the new regulations have come out, and maybe to maybe take the focus on oversight, what have you seen that shifted also in the mindsets or in the questions that are coming from some of these biotechs?

Yes, so you see now, it's been that, so it's still early because

Hmm.

they became effective only a couple of days ago. So you see that it's still a process, but what

Mm-hmm.

you see is that the biotechs are now more and more, they understand more and more that even if they delegate activities, that they remain accountable. So they really better understand now.

why

also from a quality perspective we also always said that the vendor oversight piece is so important. So what I see is that that part in terms of setting up a vendor oversight, how you document things, is less questioned because they understand that as a sponsor you remain accountable and that's

important because that means that you don't you need to spend less energy or discussions on that topic which mean that you also can can have more energy because what I still feel subpoena quality by design is still something where there are a lot of questions about about the small companies and by the color in doing that or does it really mean and so

What I see is that the accountability on the oversight, that's quite clear and they understand. So they understand also what needs to happen, but how they need to make sure that that quality by design shift is embedded plus that quality culture, because that quality culture

Mm-hmm.

also is now really into the guidelines. That is still something.

that needs to have some attention and discussion with small companies and startups and where I feel I still need to do some educational.

Yeah, yeah, definitely. I think the quality by design, we could probably just have a session. There should be some webinars just around, what does that mean? Yeah, and how do you implement it and how do you implement in a way that fits again to the size of the organization that you are and what you need? So it's not just size, of course.

Yeah

It's like where you are in your developmental process and yeah.

Lots to do, lots of support. I I think that that's the beautiful thing with this is that there are a lot of organizations that that can help. And if you were to give one tip or one thing that you could suggest that cuts the noise around this to biotech leaders, that could be very actionable for them. What would you say or what would you suggest?

One clear actionable message coming from the updated guidelines is for companies, if you can't explain how you're overseeing your vendors, you're not ready for any approval or inspection. So that's really key.

Yeah.

First thing, second thing, what I just want to also give away is the mindset shift. Make sure that...

From the start, with your company you work on that mindset shift meaning make sure that you accept as a sponsor that you can outsource the execution of activities but you can't outsource your accountability. And last but not least, quality is not a technical detail. Quality is a strategic enabler of your approvals.

partnership but also of the value of your company.

Yeah, that is so true. Really the value of the company. And you're right. Think about due diligence. Think about all of those aspects that are key for the financial side of the organization. And if the quality, that's like you're the base of the house, isn't it?

Yes.

And to have more organizations think about it as the base of the house. I think that they do. They're like, of course, we have quality at the top of our list.

It's really good to do a reflection and do a little gap analysis yourself, is it? If you say, if you feel confident in saying that, maybe reflect, get someone in, get, you know, we can help with that to do some reflection, ask some questions and really determine if quality is at top of your list. You may want it to be, but I'm sure that there's some gaps in areas that can be improved. Nice.

Yeah. Well, thank you. Those are really good. You can actually ask for one and you gave me three Sandra things or you didn't give them even give them to me. You gave them to the listeners. So I'm sure that everyone's going to be very appreciative of that. And and thanks. I love working with you, Sandra. It's it's it's always so refreshing to work with somebody in this space because there there are definitely biases when we think about quality. And what I love is the practical approach, looking really at the human side.

and seeing what companies need and not wanting to come in and say, you need all of this when you don't. So I think that that's so important for organizations when they're looking for support in this space, to find somebody that really is gonna take the time to listen and to look and to understand

Yeah. And thank you Sabine for having me here during the podcast. It was a pleasure and I really liked our conversation and I hope I could sparkle some of the listeners to really make sure that quality is now on top of their mind.