Is Your Biobank Lean?

Jon Wetzel, founder of the Lean for Everyone blog, joins Andrea Charles from Pharma IQ  to discuss recent technological and commercial trends in the biobanking sector.

Pharma IQ: What technological and commercial trends have you seen in the biobanking sector recently?

J Wetzel: I think we’ve seen a slow shift from the big experiment to the smaller, discrete datasets that are more customised for the researcher out there; more…moving more towards prospective procurement. The researchers are looking more towards matched sets of tissue with bio fluids and zero patient follow-up, so I think that’s what we’re seeing from a trend into the biobanking sector; and biobanking, itself, I think we’re seeing more from the pharmaceutical companies and the biotech companies, they’re outsourcing their sample collection processes to smaller supplier companies. They don’t want the added cost of working with ten, 20, 30, 40 hospitals: they’d rather work with two or three main suppliers. And even their actual storage or banking of materials, they’re looking to actually send that up to third parties, much like Pacific Biosciences or BioStorage in Indiana.

Pharma IQ: Do you think there will be an uptake in Lean methodologies as companies face heightened pressures to cut costs and do more with less?

J Wetzel: I think it’s a requirement for survival. Many companies are struggling right now with their overburdened inventory of samples; it’s a lot of costs when you add up liquid nitrogen, electricity, alarm systems and routine maintenance. All of that totalled up has a huge burden that the company or the department has to bear and, as you add more samples each and every year, the cost just continues to grow. Sites are going to become more selective with what they process and how much processing is really necessary for QC, or to determine quality control, and I think that using Lean for all of these methods just has to become a part of their whole operational system.

Pharma IQ: How hard is it to implement Lean techniques within the operations of a company, and what are the typical bottlenecks to change?

J Wetzel: It’s funny, because you come across the exact same stumbling blocks as any other Lean implementation, whether it’s in a biobanking facility, a laboratory facility, or even in manufacturing. At first you might come up with reluctance to let the old paradigm or the old processing go, aversion to change, and sometimes the job survival instincts of the people currently employed kick in, you know, that little nervousness about does Lean mean we’re going to lose our jobs? So first it’s going ahead and making certain that you address all of those concerns right off the bat. As for the typical bottlenecks for the actual process, you’re looking at the standard. A lot of the laboratory side is batch processing issues. Scientists love robotics. They love technology. So usually a lot of that causes large portions of batch processing, long queues, even some black box processing, where you don’t actually know how the process occurs. It just occurs, but is not necessarily tracked. The last thing is you’re looking at silos of information sharing in the little fiefdoms in each one of the process centres of an entire system. So if you think about the way most academics… most of us in the academic range, went ahead for our training, there you have… the pecking order is BS degrees, MS degrees and PhDs, and unfortunately it sets up that same type of sharing model. The last but most difficult one I’ve come across is an inflexible quality management system that unfortunately has a lot of bureaucracy. For the laboratory worker to go ahead and make an improvement is fine and easy, but to actually get it implemented into the laboratory setting usually takes multiple sign-offs from several different levels of command. I’ve actually seen it in some cases where the CSO had to sign off on an SOP of a company that had about 300 people, which, to be honest, didn’t make much sense. So these are the types of typical bottlenecks to change that I see in most of the laboratories out there.

Pharma IQ:What do you see the as the future of biobanking from a Lean perspective?

J Wetzel:I see a move towards of course collecting, or doing prospective collecting, based on the customer requirements. From a Lean perspective, of course, you want to listen to your VOC or your Voice of the Customer, which of course is the researcher, the end-user in this case. So what you have to think about is right now the current biobanking is to collect large numbers of samples in a, quote, well-annotated bio repository, but the thing is that we don’t actually know what well-annotated or well-characterised really means, because we don’t know what the end researcher’s going to be using it for. If you think about a biobank, a biobank’s only value is actually given to it by its users, so a tissue sits in limbo until it’s actually utilised by the researcher itself, so it has to have the information that’s needed by the customer, and only then is the biobank of value. In some research you don’t know what the scientist really needs until they tell you, hence you really need the Voice of the Customer.

That’s why I see he prospective collecting is going to be the largest portion in the future of biobanking. Right now I’m actually currently working with a Lean start-up in the biobanking field, and they actually hope to do just that. Their CEO, recognises the inherent waste in most biobanks today, and he’s operating more on a CRO level than a biobank level. And we’re starting to see CROs starting to put their toes in the water, and I think it’s just a matter of time till they actually jump right in. The last part is I see on the future side of it, patients are going to be become a major part of the process. If you think about it, social media has ushered in a whole new era of openness and sharing, and I think while you have one side of the fence that is fighting for patient rights to privacy, ethics and technical compliance, the other side the patient is actually posting all their information on Facebook. So you have two different shifts. Right now, for example, you can have SNP analysis done on your own DNA for $199 at a company called 23andMe, and then turn around and share that information with other people. So I think I see biobanking moving towards prospective collection; I see it where the patient’s much more involved; and, even more importantly, I see it where the researcher itself you’re going to to get the exact details for that prospective collecting.

Pharma IQ:How are biobanks seeking to improve their data collection?

J Wetzel:I think the hospitals and the biobanks are integrating directly in the databases to eliminate any type of errors, prescription errors, when copying down data. If you think about it from the aspect of, let’s say, the European date format and a US date format, there’s a big different between month, day and year, compared to day, month and year, which is the European format, you know. If you’re having chemotherapy done on January 1st or January 12th, let’s say, it’s a big difference between that and December 1st. But if you transpose those errors it can make a huge difference in finding out how long the chemotherapy had been going on. So I think integrating directly with the hospital databases to obtain information is huge. Standardising, like I said, even with date format, but also nomenclature: how do you tag things, whether it’s nomen codes, or CEA bit-codes, or ICD-9 codes. You’re having minimum datasets to be expanded out. For example, back of the day it used to be just age, sex, and maybe a diagnosis. But you come in you have to weigh things. For example, you can come up with the danger of adding too many items to the dataset of a minimum dataset, and not really have what matters to the customer, which is why you have to be very in tune with your customer or with your researcher.

Pharma IQ: What recommendations do you have for companies that are trying to pursue a Lean strategy?

J Wetzel:Being a consultant, I, of course, would advise hiring an expert. But it’s true, I would say I’d highly recommend hiring an expert to come on in and give you a quick assessment. Many companies are penny smart but pound foolish when it comes to Lean, and they waste a lot of time doing extensive research, reading up books, and trying to do it from the do-it-yourself methodology. I think it’s very important that you at least have an outsider come on in for at least a week and do a quick evaluation. In essence, hire a really good sensei, get an assessment, and then move forward on your own if you want, but really get an assessment where you’re at. The other thing I would recommend is work both ends of your value stream. You not only need to be connected with your suppliers on the hospital side very, very closely, but you also have to be very well-connected with your customers. Not necessarily the buyer at a research facility, for example, let’s say the buyer at Pfizer, the person who goes out and gets the tissue acquisitions, but see if you can get further into the actual researcher themselves, so you can really understand their needs. And when you do that you can get buy-in from your supplier, and then move forward with that.

Pharma IQ: How do you think biobanking will develop and contribute to healthcare?

J Wetzel:I think the one everybody’s shooting for, which I think is a good one, is personalised medicine; biomarkers and new diagnostics is everybody’s ideal target. The most important part, like I mentioned earlier, was getting buy-in from the hospitals, and having them realise how important the bio samples are, and even what you’re talking about, getting buy-in from the patient themselves. Over the past, let’s say, eight to ten years, we’ve seen Lean healthcare emerge as a very dominant new implementation of Lean, and I think any biobank that’s actually utilising Lean methods will be welcome in these types of hospitals, because they’re adding value to the hospital system that also understands value; they’ll be more receptive to the idea of the biobanking side of it. And of course the biobanks as an industry, it will have to develop over time. I see over the next ten to 20 years the biobank industry itself will probably go through more consolidation. We’ve seen a lot of that already when Cytomyx bought Ardais Biorepository, and then OriGene turned around and purchased Cytomyx, so we’re seeing already some consolidation. But I think we’re seeing more of the CRO style, or prospective procurement style, coming onboard. I think the biobanking will continue to develop, where it’ll put being biobanking and being more of a biosupplier type of company with you have project managers working to go ahead and supply the needs of all the researchers.

IQPC
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