Welcome back to Cut The Chat Life Science Insider Podcast. Episode 5: Mastering the Art of Collaboration: Principal Investigator and Biotech Dynamics
Today’s episode is hosted by Seuss+ CEO and Co-Founder Sabine Hutchison, She’s joined by special guest Viviënne van de Walle
Cut the Chat – Life Science Insider promises to facilitate the conversations you’ve been dying to hear and tackle the real crux of our industry’s challenges while addressing the subjects of what we can do as life science leaders to be more successful in a shorter period of time, conversations that might actually help each other when we dare to open up.
So let’s get today’s episode started, let’s get to it, let’s cut the chat.
Sabine
So hello and welcome to episode number five of Cut the Chat. Today, our podcast is focused on principal investigators and biotech dynamics, mastering the art of collaboration. And I’m so pleased to welcome Vivian van der Waal.
She’s a highly respected principal investigator who studied medicine both at the University of Maastricht and the University of Oxford. She holds degrees in genetics as well as pediatric genetics. She’s always combined clinical research with patient care and has been a full-time principal investigator at independent research sites. And in 2006, she founded the independent research site PTNR, which she also owns. She’s a very creative entrepreneur.
which is reflected by her skills as a thought leader in consulting, educating, and managing at CROs, pharma, and nutritional companies. Vivian serves on educational and advisory boards including ECOA, vendors, and trade organizations like the ACRP, SCRS, Transcelerate, CISCRP, and the NVFG. She and her team were also the proud winners of the inaugural SPRIA,
EU awards at the SCRS. And because of her innovative mindset, she’s been nominated for numerous awards, including the Clinical Trial Europe Christine Pierre Lifetime Achievement Award, the Fifth Annual Congress on Advanced Clinical Trials and Research for Women in Science Awards, and she’s received the Christine K. Pierre Site Impact Award by the SCRS.
She began her research career as a participant in a clinical trial and during COVID-19 pandemic has participated in a vaccine trial for HCP and a virtual predictive COVID infection trial. As a result, Vivian has unique perspective of various sides of the table in clinical research and she’s eager to share her many years of experience. And as she stated to me, and she also talks to her sponsors
I love it when you pick my brain. Well, that’s exactly what we’re gonna do today. Pick Vivian’s brain. And I’m so pleased to have you on the podcast, Vivian, and looking forward to this conversation. Thank you for having me, it’s my pleasure. Yeah. So, in a previous conversation, we talked about communication, and that is truly the heart of a successful collaboration. I’m really curious to hear you elaborate
Vivienne van de Walle
Thank you for having me, it’s my pleasure.
Sabine
Well, we hear and we know communication is like the heart of successful collaboration everywhere. Everywhere you hear communication is key. But what would be interesting to understand from your perspective is how you see communication, how can it be improved, and how critical do you see that in creating and fostering relationships? And I think specifically with the focus of working with biotechs as a sponsor.
Vivienne van de Walle
Yes, communication is crucial everywhere in life. And when you’re working in clinical research, it’s even more so. Because you have to be transparent. You have to know each other’s expectations, manage those expectations. Timelines are crucial. And so having a fixed contact, single point of contact to go to, both from a side perspective as we have, and then also from the biotech company.
is making things more easier. Otherwise you’re just lost in the jungle perhaps of people where you have to go to, don’t know who’s responsible or who’s following up. So that’s how I work at my side, especially during the start of a trial. I’ll be the first point of contact to go to. The fortunate thing comparing Biotech with large pharma companies is that large pharma companies have a multitude of people where you have to deal with during the conduct but also during the startup.
Biotech is smaller and that’s why it’s far more easier sometimes to work with them because those communication lines are shorter, you know exactly who to go to. But it is all about, you know, keeping each other updated and raising the questions when something is not clear. So both know how to move forward and resolving those issues.
Sabine
Absolutely. And I think one thing, you know, we, I mentioned to you earlier, we were recently in bio Europe this week and speaking to a lot of biotechs. Um, and, and then this issue is probably not just with biotechs as well as about patient recruitment. Um, you know, every site, I can imagine the pressure that the sites face and that you face as well, because everyone wants to be prioritized. You know, how can I get my patients in and how can I meet my timelines? And
I would really love to hear your perspective on this and how, you know, is there prioritization? What can help encourage the speedy recruitment of patients? I realize this is a whole, we could probably talk hours on this, but maybe we can summarize a bit for some of the companies on the struggle and this prioritization of patients.
Vivienne van de Walle
Yeah, I mean, there’s two ways, two things in this question. They asked a question on recruitment and, you know, what’s your sponsor of choice, basically, you know, what’s the best collaboration and where do you want to turn to? I’ll get to that later on. First about the recruitment. It’s not like I need my crystal ball to predict my recruitment, but sometimes you think it’s easy and it’s going slow and sometimes it’s going slow while you thought…
or it’s going fast while you thought it was going to be different. And it’s, you know, there’s so many variations in that whole recruitment that you try to take on board when you’re doing your feasibility and signing up for a trial, but then things change. Some diseases are influenced by the, how do you say that? The
the year, the, gosh, I can’t think about the English word. So the season, thank you. The season, the season, can we go back there? Or, yeah. So some, yeah, here we go. So some diseases are influenced by seasons, like certain skin diseases, for instance. So when you start recruitment early summer, you know it’s not gonna be a highly recruiting period.
Sabine
So the season, the time of the year? Yeah.
Sure, yeah, absolutely.
Vivienne van de Walle
But then when you move towards this time of year, you see an increase in patients coming like, yes, I do have my active disease right now, can I now participate? So you have to take those things into account. When you get a feasibility, quite often, it’s only a one pager. Then when you get through the protocol, only the exclusion criteria all of a sudden is five pages. And you never took that into account, but still they hold you to whatever prediction you made based on that one page.
Sabine
Mmm.
Vivienne van de Walle
abstract of the protocol. And there’s where communication is so crucial. Don’t assume that what I said during feasibility still stands when we’re starting the trial two years later. The world has changed, a standard of care might have changed, the season has changed. And then that means that my target might have to be adapted to that. The other thing is some sponsors think that I can just, I don’t know, find them.
you know, growing on trees, my patients, but there’s an active, it’s an active job to find patients. What we do is making a pathway where these patients are actually popping up. To give you an example, we were asked to step in as a rescue site for an alopecia trial. And this is with a product for like beginning alopecia and alopecia is like when you’re losing your hair.
And they were going to these academic centers and dermatology clinics. And they said, but those are the severe ones. And you were looking for the mild ones. And they said, what if I would do the trial and I would go to my local hairdressers and saying, if anybody’s coming in and they’re just talking about I’m thinning. And then and literally we had that, you know, we had that we reached a target in no time, but it was just literally thinking out of the box like.
Sabine
Right.
Vivienne van de Walle
where are these patients popping up and where can I create awareness for them that there’s a trial happening that they could participate in. And again, that is about communication because I do need a budget to do this outreach to create awareness. And it’s not only putting out an advertisement, but it’s also chasing and calling back. So it’s very labor consuming work and having
Sabine
Right. Vivian, that’s a good point if I could just interrupt there for a second, because I think that that’s true. We forget, I think potentially, you know, when you’re far away from the sites, you can forget about how labor-intensive things are. And if you want a creative site, again, that needs to be taken into consideration to also ensure that also costs are covered for those kinds of activities as well.
Vivienne van de Walle
The other part.
Yes, yeah, yeah. The other part of your question is like, how can you be like the sponsor choice or the zero choice or, you know, where do you like to work with? And it’s all about collaboration and being felt respected, that they understand like we just talked about that they do understand that some things do take a lot of time and labor, and it’s implemented in the budget.
What happened to me earlier this year was a sponsor and CRO writing me an email. And I had to read it two, three times. I stepped out of my office and I said to one of my nurses, I think you have to resuscitate me. And she said, why is it? I just had an email in my 25 year career. I never had that happen to me. And what happened was this sponsor wrote this email to me saying like, we do understand we signed the contract at the end of 2021. And
world has changed. You know, we’re in the pandemic, there’s a huge inflation. That contract is just not representing of the cost that you’re making today. And we were in the start of the trial. So here’s actually a new budget. They increased the budget of all the trials that I was running with them by 20%, which is a huge impact. Yeah. And I was talking to another side that was conducting
Sabine
Wow.
Vivienne van de Walle
similar trials and he says the nurses are on strike in my country if they have to increase their wages as they want you know where they were negotiating during the strike he said I know I’m not even have on a break even with my current contracts anymore I’m losing money and I told him what happened and he said why doesn’t every sponsor in zero take their responsibility why do we have to beg for it because they do it.
and understanding what we’re doing at the site and they see the news that the wages has to be increased, why don’t they automatically come to us and say like we don’t understand that, we don’t want you to lose money over it. Because next time when this sponsor come back or the CRO come back and I have another CRO coming to me with a protocol that’s more or less the same, guess who I’ll choose?
Sabine
Yeah, it’s true. Because it’s a partner, isn’t it? I think that going back to what we were talking about, collaboration and communication, it’s that partnership. So obviously it’s a financial benefit, which helps you, maybe not even to make lots more profit, but to be able to do those extra things as well. But you feel like you feel in a relationship with those types of organizations then.
Vivienne van de Walle
It is a partnership. Yeah. Literally a collaboration. You’re on the same level. Yeah.
Sabine
Yeah. Yeah, so true. And so that’s interesting. So do you because obviously some with some sponsors, you work directly. I’m not sure how many with how many biotechs you work directly or is it via CROs. And, you know, I think one of the things that sometimes the biotechs are a bit smaller, they’re very dependent on their on the partner CROs.
Do you also encourage them then to talk to you directly? Can they have that line of communication with you or does it always have to come via the CRO?
Vivienne van de Walle
Yes, we love when we have a direct contact with the sponsor, the BioTech company. Actually, we like to be involved at an early stage when they do the protocol development to give our practical input. And I hear more and more sites saying like, if only we would be sitting at the drawing table, we could have prevented multiple amendments from happening or recruitment being easier, or it would be a far better fit to the patient population than…
we have right now. So it’s not to subside the CRO, but being there and making a protocol that is actually conductable. And this is not to say that CROs and these sponsors don’t have a good idea about it, but they often don’t have to full scope of the impact of the site, especially when you’re also adding decentralized elements in it.
having those conversations and having that input and sorry to say but don’t go to the KOL because he’s the scientific person but you need to have the practical person there like the coordinator or the hands-on investigator to help you guide you through the protocols saying this is feasible or this is not feasible and also from a perspective of getting high quality data sometimes I see
with so many things that we have to do to a patient that it’s literally exhausting for a patient. And then you have to do like a pulmonary test and you know it’s not going to be representable because people are literally exhausted. These are severe CUPD patients. They have to do a multitude of things. And then after three hours you still think they’re able to do a good test. And from a theoretical perspective you think like, yes, but we need to have that data.
but then we can help you guide like how can we implement it into a protocol where it is feasible to do and you get good quality data.
Sabine
That is just such a good point. It’s interesting. I had one of the first, actually the first podcast, Alan Morgan and I were talking about also KPIs and, but more focused also on the time spent on the protocol early on. And you just totally confirmed that again, it’s the time we spend looking at that, looking at exclusion criteria, looking at the flow of the patient visits, looking at all of that can have such an impact. And I think you mentioned earlier,
the point of not having to make a protocol amendment. You know, doing all of this in advance can just make it so much easier as you move forward. And sometimes I think there’s this speed, we have to get it done, but that extra time and conversations with the sites can actually have such a huge impact. It’s such a true point. And do you see that happening? Do you experience that at all, these early conversations sometimes or?
Vivienne van de Walle
It is happening more and more and I give you a very recent example where we were conducting a phase 2 trial and a lot of things went wrong and I knew the project manager for many years even from his previous job and I eventually picked up the phone saying like some of these things could have been prevented if you would have talked to a site, not specifically to me but if you’ve talked to a site.
And he appreciated the fact that I literally picked up the phone and raised my concerns. About three months later, he called me back. He said, I’m now in a new position within this company and we’re rolling out a large phase three program with that same product. I want you at that drawing table. Would you be interested to work with us for a whole year? There’s going to be patient representatives in that working group and there’s going to be another physician from the US also in that working group.
And I said, yes, you know, for me, it was a no brainer saying, like, I want to be there and help to make this a very good protocol. This was like into our second or third meeting, this US physician said on that call, I think I found my twin sister in the Netherlands. And I started to laugh and said, what do you mean? She said, you know what, everything that went wrong at your side was going wrong at my side. Every solution that you bring up or I bring up, will you agree with?
Meaning that if it’s not working at one place, it’s probably not gonna work at other sites either. But not all sites pick up the phone or are the challenges. They’re too scared, they’re scared of losing the business or the PI is not involved, it’s the coordinator struggling and there’s no direct communication with the sponsor. And as I said, some people say like, yeah, we have to have these PIs more involved. I said, have the ones that are literally conducting the clinical trial.
Sabine
Yeah, true.
Vivienne van de Walle
Sometimes it’s the coordinator. She’s struggling with the e-diary. She’s struggling with having that patient doing all these things and explaining. And there are a lot like, I’m a hands-on investigator and there are a lot of hands-on investigators as well. And you can have those on those drawing tables. But to have that conversation and literally what this sponsor said during that whole process, we don’t know what we don’t know.
We realized there’s a lot of things we didn’t know and thank you for bringing it out to our attention during these discussions, making it into a good FaceTree program.
Sabine
Yeah, that makes total sense. We’ve had recently, we had one of our biotech clients actually set up most weekly calls in the beginning and then they’ve tapered them and looked at them differently and they’ve been with the sites and it’s been more on the medical side, which I think of course is very valuable. But to your point, it’s also a good thing to get the coordinators in because they’re the ones that are talking to the patients every day. They’re the ones that are entering the data. So let’s, I think it’s important not to forget to.
It’s not always the investigator that needs to be involved, but also to talk to the staff that is working with the patients on site to set those touch points as well. So really good point. And you just mentioned the patient, and that is of course the most important thing. We hear about patient-centric, everyone is, that’s like the words that are used, but.
How can actually the biotechs really think about and create protocols that are patient-centric? Is it to the point what you’ve said to talk more with you or do you have any other ideas or creative ideas on how we truly make the studies very patient-centric?
Vivienne van de Walle
First of all, when you’re developing something, make sure that that’s something that these patients need. One of my biggest lessons I’ve ever learned was from a mother from a child with this Duchenne’s disease. Duchenne’s disease is a muscular disease with boys. They’re thriving in the first couple of months, years of the life, and then the muscles are deteriorating and they end up in a wheelchair and eventually they possibly, because as this little boy taught me…
my heart is a muscle too, you know? You know, that just put it all together. Yes, and what she taught me, she said, she interviewed these boys, like what is so important to you? Because everybody was focusing on the fact that these boys were in a wheelchair. So they assumed, they assumed that they wanted to walk and they were looking at something that would keep them walking for a longer time. Then when they did the interviews with these boys
Sabine
It does.
Vivienne van de Walle
in their, you know, early 10s and teenagers, they knew they were in a wheelchair. They couldn’t care less about the fact, but they wanted to have their motor skills in their hands because then they could move their wheelchair, they could be on their laptop, they can do computer games. That was their freedom. Their big motor skills, like their legs weren’t working. Whatever.
But please make sure that our hands are the ones that we can rely on for the rest of our lives because that makes us independent. So every drug company or any biotech company that was focusing on, but these boys have to work, we’re missing the whole clue of what they had to develop. So even I made mistakes assuming that certain people would not want to have injections because
injections they prefer to have pills. Then when I was asked for an obesity trial and they had to give themselves injections every day and go like I don’t think these people are willing to do that until I called some of the patients I had in my database said yes would you be considering participating in the clinical trial taking a drug you have to inject every day and go like if I lose weight whatever if I have to do it three times a day but if I lose weight in a you know in a healthy way I’ll do it.
So what would work for one patient group might not work for another patient group. The same thing goes for side effects. The same drug in diabetics patients, you know, the GLP-1, which is a very hot topic currently, we did some trials with them already eight years ago. So the side effect of being nauseated and literally throwing up for diabetics patients was unacceptable. When we’re doing this, giving this drug.
Sabine
Yep
Vivienne van de Walle
to the obese patients, they go like, great, because I won’t eat and I’ll lose weight. I’m happy because I’m not even tempted to eat more. Even the side effect, which was actually counterproductive for one patient group, was actually in favor for the other patient group. I couldn’t have thought about it until I talked to these patients. Patient centricity, what is it what they really need? What is it that they want to have resolved? What are they afraid of?
Sabine
Yeah, right.
Vivienne van de Walle
But how much do they want to bear? How much are they willing to take and go for it? And the only one that can tell you that is a patient, not their physician, because we assume based on what we see, but every patient is different. But have them, yeah, listen to them, ask them.
Sabine
Yeah, yeah. Back to the communication piece, right? Making sure that we’re listening and talking to them. Yeah, so true. Those are some interesting stories. And again, these assumptions that we make, they’re dangerous. You know, one, you mentioned DCT earlier, and also just this whole concept of technology. It’s everywhere. You know, it’s AI. It is, it’s here to stay. And it’s just going to be this.
Sabine
become more and more evident also in the clinical trials that you run. But I can imagine as a site, um, that can be overwhelming. I think, okay, I’m making an assumption now, but I think it can be overwhelming, um, because there must be so many systems that you have to manage. Um, when you, when you’re working with, in clinical trials, depending upon the ECOA pro, you know, all of these bits, data entry. Um, so how do you deal with that? And
And if you could paint a perfect world with working with technology, what are some important things for you to make it accessible and easy to harness and utilize at your site?
Vivienne van de Walle
Yeah, we can talk hours on this topic. First of all, it’s not an aim in itself to go for technology. It’s a tool to help you conduct a clinical trial and make it easier for patients. That’s my belief. And I see more important people, even the new or the new, the more recent EU guidelines not talking about decentralized trials, but decentralized elements in clinical trials, which is a very different perspective.
Sabine
Yeah.
Vivienne van de Walle
There’s a clinical trial and you can have decentralized elements in it. We have used technology for many years. We had e-diaries and wearables for many years. Right now, it just, and even COVID, you know, it was kind of like a pressure cooker where we wanted to do more things remotely. And there is a multitude of systems we have to work with. The data, it varies anywhere between 8 to 12 systems per trial that we have to deal with and knowing that an average
I don’t know, but some sites run between 10 and 20 trials. And of course, there’s an overlap. Some systems come back. But even if you’re working with the same service provider, the way you set up the devices might be different for each and every trial, despite the fact that they’re the same devices. I don’t know why, but that’s what’s happening. So we have this little joke at my site that we get into a very bad escape room every morning, and we hope we get out at the end of the day trying to find a lock and key.
Sabine
Oh no!
Vivienne van de Walle
trying to find a login details and getting the links to activate and go to the next step and coming back and things not working or do work or help desk not working. Yes, it is a challenge and it can be very time consuming. We’re not technology people, but we’re pretty savvy. But I have nurses that say like, I hate it. So we changed the way we work is in the…
old days, a coordinator had to do a trial from A to Z. She had to do everything. And I’m not the only scientist that has changed that around saying like, you know, if you don’t like to work with all these technology things and setting up devices, that’s fine. I have somebody else on my team who loves it. So she’s responsible for every trial for the technology. You’re good at a laboratory, you’re responsible for everything that has to do with a laboratory. And so
Sabine
That makes sense, yep.
Vivienne van de Walle
Yeah, and there’s always a backup and everybody sort of has to know a bit about everything. But there’s one person that is, you know, my point to go to. And I want to know every system. I want to try every system. I want to have access to every system because I think that is important.
Vivienne van de Walle
But it is challenging. It is challenging because a lot of these systems don’t communicate. Meaning that we have to do this redundant task of re-entering things over and over and over again. I was asked this question by one of the service provider early this week. What system or technology do you use for this redundant work? And I just looked at her and said, my fingers and my brain.
there’s no technology that helps me doing the redundant task going from one sister to the other one. And they’re laughing like, Oh, yeah, that makes sense. That makes sense. But what I’m really, you know, I compare it to my iPhone, I Google on Safari, that I need to go to a hairdresser or something. And then Safari will give me the closest one and then I can call them up to make an appointment or I can go to another app that makes, you know, the appointment.
Vivienne van de Walle
I go to my navigation system, it will get me there. I can put it in my contacts. And what nobody realizes, these apps are from different companies, but they all are integrated. And I said, why isn’t this happening in clinical trials? Why are we so stuck in silos? Why aren’t we sharing these API codes that these systems are communicating? So once I enter, and whoever’s gonna be the one that has integrated all these things, that I just log in.
and I go to my ICRS, I go to my EDC, and then I do have my drug accountability form and I do have my e-diary, and it’s all there in one place, that’s gonna be the winner. That’s someone that we want to work with. System immigration, yes, single login. And I know, and sponsors and service providers know that they have to move to that, you know, to that space, they have to, because it is not helping sites.
Sabine
All right, so systems integration is key.
Vivienne van de Walle
It’s taking time away from our patients.
Sabine
Yeah, that’s so true. And times are tight and actually having them wait and that’s actually goes back to the point about being patient centric that we also want to make it easy for everyone to participate in the trial. Yeah, really good information. Yeah, thank you so much. And as you said, I think on each of these questions we probably could have spent lots more time but we wanted to try to keep it 35 minutes and keep it short and tight and compact.
Vivienne van de Walle
Yes.
Vivienne van de Walle
compact
Sabine
and easy for individuals to listen to. So thank you so much. I mean, I think these insights are so valuable and our goal is that we want to share information out. So people listen and maybe take some of the ideas that you’ve shared today, integrate it and make some changes to make this whole process yeah, better for us all because it’s yeah, obviously clinical research is.
Yeah, is what we all need. We need new medications. We need this all to work and we need to have positive collaborations and partnerships. So that’s what we’re all striving for.
Vivienne van de Walle
Yeah, we need to develop new options, treatment options, continuously. So, yeah, clinical research is fundamental.
Sabine
It is fundamental. And it’s incredible that you’ve had the, that you, what can I, this is a bit off, off of some of the topics, but I’m really curious to hear what made you want to set up your own site.
Vivienne van de Walle
Well, I was working at an independent site and I wanted to set it up in a way that I could be as patient centric as I wanted to be. I have time with my patients, that’s why I also stepped away from regular healthcare because it’s the insurance companies that actually tell me how many minutes for patients I have.
and just explaining things to patients is sometimes already enough for them to, I’m not saying cure it, but at least get an insight and be helped. Even data is out there that even the group that is on placebo and clinical trials actually benefit from participating in clinical trials.
Vivienne van de Walle
And there have been numerous of larger network sites that have been knocking on my door, like, do you want to join? But the closeness of my team, the way we collaborate, and the way that patients are responding to the way that we are, I said, I can never ever have that when I’m with a larger network. Not the ones that, you know, and being able to do this and speak out and talk to
being constructive and trying to find the solutions. Having that freedom, all of these things made me want to do the job that I do and share my experience and move forward. As Christine Pierre, the founder of the SDR, said, there’s no witching and whining, just coming down with solutions. And she implanted that into my head. She was a close friend of mine. And fortunately, there are so many companies like you.
Sabine
Right.
Vivienne van de Walle
that are willing to listen and share it and move forward and making it a sustainable environment to work in, but be there for patients. And have clinical trials as a treatment option.
Sabine
Well, fantastic. And I think it’s wonderful that you actually speak out because I know that you’re very active that way. And that’s what’s gonna help make change as well. Because if we just sit and keep all of this information internal and don’t share it external and let others hear the ideas, then we won’t see change. So thank you so much for everything that you’re doing also in this space. It’s very valuable. It’s valuable for the patients and for the companies that are developing new medications for the patients. Thanks so much.
I understand you’re going to Portugal this weekend for a conference. So I hope you enjoy that safe travels and I hope you get to actually enjoy some warm weather as well.
Vivienne van de Walle
Yes, I will. But it’s always good to see people like-minded and share experience and move forward. Yeah.