In this interview, Guy Bradshaw, Consulting Director at Comma Group, discusses the role data plays in the pharmaceutical sector with industry specialist Dene Baker. Dene runs a successful management consultancy practice and has spent over 25 years working with a variety of pharma companies, regulators, the NHS and CROs such as: AstraZeneca, GSK, Seqirus, Evidera, the UK Government’s MHRA together with two NHS Trusts where he’s developed a deep understanding into the intrinsic value of data.
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Interview: The role data plays in the pharmaceutical industry
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Issues such as supply chain management, sustainability, manufacturing and patient records are all data challenges
Guy: Let’s start off with supply chain vulnerabilities in the pharmaceutical sector - do you feel that the reason that some of these vulnerabilities persist is because of the risk averse nature of some pharmaceutical companies?
Dene: Yes, certainly. To get a product to market, pharmaceutical companies must dot a lot of I's and cross a lot of T's. That generates an awful lot of box-ticking and fact checking and making sure that they are keeping the regulators happy and it's a huge industry of its own. I think the pharmacovigilance people are very, very hot on making sure that they understand where all the data has come from, and that it's gone through quality control, and it's been checked.
We used to call it “four eye verification”, meaning two sets of people have looked at everything. And they certainly bring this risk aversion very much to the fore in bringing any product to market.
What do you think is a key challenge pharma companies have when trying to keep on top of that data exchange?
One of the things you will find is that so many different departments are looking at data, and they all have their own source. And one of the things that happens towards the end, as you get closer to the product release, is that somebody is checking an awful lot of sources of data to make sure that the facts are correct. As you will no doubt say, there should really be only one source of the truth.
From my experience, pharma companies are often trying to solve those problems with spreadsheets or with point solutions that aren't connected to the rest of the data landscape. Surely that can be a real challenge for an organisation who are just trying to make their supply chain more efficient?
Absolutely. And it really isn't about huge volumes of data. If we were talking about commodities trading, or equity trading, and even telecoms - the volumes of data that they talk about - there are millions of transactions a second. Pharma’s not about millions of transactions a second. It's about the quality of the data around those transactions.
And the disparate nature of the data sources within those organisations means it’s tough to get the integrity of that data established. When data isn't trusted, you have people spending more time questioning the veracity of that data than being able to execute any of the benefits that you were setting out to achieve.
Absolutely true.
As you quite rightly say, that data forms the basis of information and decisions that are then taken. Without that trust in the underlying data, those decisions can be flawed. They can be challenged. They can be misleading and send people off down the wrong path. So, I think that integrity at the start is absolutely vital.
When we're looking at good data management practice and how that can drive real benefits in the pharma world generally, but in the supply chain specifically, the fact that pharmaceutical industry is so heavily regulated needs to be factored in.
We've got pharmacovigilance regulations, we've got good manufacturing practice, good distribution practice, the IDMP data standard is coming up soon…so all these things need to be factored into the way data is managed.
Without a doubt.
As pharma companies move through the clinical trial phases, where they must prove that a product is safe. And that patient safety is what both sides – the pharmaceutical companies and the regulators – are looking to ensure. These ISO standards that are coming in is really just a case of really trying to formalise that product process.
Do you agree that regulation and standards such as IDMP shouldn't be viewed as ticking a box, but as improving the pharma industry and supply chain generally?
I do. But if you speak to a chemist, would they recognise those processes as a good data management practice? Or would they look at it from the point of view of saying, “I've got to follow these rules, it's a standard that's being introduced that we have to follow.” So, whilst I think you're right, I also think people are doing that role now but possibly not recognising it and standards and regulations help everyone understand their role.
Very true. It's part of the education process around data literacy we use when we're speaking to pharmaceutical companies; by getting them to see that whilst you may feel you’re doing something out of obligation, it's actually an opportunity to improve as a business.
Absolutely. And with the focus on research and development to generate new products, new molecules, and new ways to market…all of those things come from having a shared understanding. And, certainly, a shared data source where people are not having to chase around looking for information on a particular product. When they know that they can go to this trusted source, find that information, know it's correct, and then act upon it… I think technology has got a fantastic role to play in identifying further opportunities of exploiting that data.
What are your thoughts on sustainability in the world of pharma?
Well, all you need to do these days is to look at any of the annual reports from the pharma companies; sustainability is a board led initiative that is common across all of them.
I think, in a supply chain sense, it's not solely about transport - it goes much further than that.
The manufacturing plants use huge amounts of power for all of their microscopes, chemical analysis, the computers that are running…they are far more power hungry than, say, a bank that's running an office in in the city. All of those things added together are certainly higher up on the agenda of each and every board.
And not a simple problem to solve when you think about the complexity of all those different moving parts in the supply chain. Of course, one of the key aspects is carbon footprint. I saw a study by Maersk recently on pharma logistics that stated the difference between transportation by ship versus air is 3g per tonne versus circa 600g per tonne respectively. When you look at a stat like that, it’s important for sustainability targets that you ship by sea whenever possible. But of course, to do that, you've got to be really on top of your data and demand forecasting - correct?
You also have to look at the longevity of the product. Can it survive the time on board a ship, and the environment that it has to be kept in? We've all heard recently about the COVID-19 vaccines where they were talking about it needing to be refrigerated at -70° to keep its formulation intact. If you’re shipping around the world, you have to have a supply chain that can cope with the containers that handle those products and are able to maintain a constant temperature, a constant humidity and all of the things that go along with that.
From a data perspective, there is an awful lot of data elements to be able to track there.
It's all about the characteristics, the attributes and all the different facts about the product. And then as that product becomes part of a larger products as well. So, absolutely, having tight control and visibility through the supply chain is critical.
You have a depth of data, rather than a broad width of data. So, the critical information isn’t going to apply to hundreds of thousands of records, it's detail about one particular product. So for example with vaccines, can they move those with products of the same nature – say milk – in the same container? So again, it's not volumes of data. It's just being very, very specific and accurate with the data being used.
I know they’re looking at displaying information like CO2 or air miles per packet into the food industry - can you see that being introduced into pharma too?
Yes, and I think that's going to be driven by the consumer, or patients. Consumers now have a huge interest in recyclable packaging and how products are manufactured. That consumer awareness means the boards of pharma companies are very, very keen on showing that they are looking to play their part.
So far we've talked about getting the basics right – what are your thoughts on innovation in pharma?
I think the ability to innovate comes back to the integrity of the data source. One of the things that I believe is on the horizon for a lot of pharma companies is blockchain. Particularly the trusted handoff of data – if you can use blockchain and artificial intelligence to record the transaction of data from one entity to another, you know that you can rely on that data.
What are your thoughts on 'fast data' and reducing the lead time between demand at the front end from patients to manufacturers and the whole chain in between?
Just look at the pandemic and how quickly they were able to move through the phases of clinical trials to get that information out there.
A lot of the learning and the knowledge doesn't stop once the product is released. They have to maintain data sources that say, “have we had any adverse reactions to this particular product?” and that goes on throughout its entire life cycle. The volume of information that's held within those data sources is so valuable if it can stop being ‘data’ and start to be used as information and knowledge for other people within the process.
There’s a certain level of maturity that you need to get to in the way your data is managed. If you do it too early and it's not trusted then applying innovative solutions such as blockchain technology means it'll be secure and it'll be auditable, but it'll still be the wrong data at heart.
And we’ve all got horror stories of what happens when people make decisions based on that wrong data and the amounts of money that can be just thrown away and wasted, particularly around IT projects that haven't necessarily been given the best start in life. By looking at some of the data to begin with, and sitting down and working out what was necessary, would save an awful lot of money.
Finally, what are some of the other areas where you see data management being important in pharma?
The amount of information that exists about people’s health. Those records are highly confidential, and consumers patients don't want companies to know too much about them. However, pharmaceutical companies need vast, vast volumes of data about people to develop new products. That means they must keep a strong focus on the anonymity of some of that data so that they can't identify individual people. That applies from clinical trials all the way through to a product where they have ADR's (adverse drug reactions). Those things are vital. That integrity, again, is where the pharmaceutical companies see themselves being very much risk averse.
Yes, quite – there’s still a balance that we want those big data sets to be able to get insights, but they have to be delivered incredibly securely, and in a way that maintains confidentiality.
Also, confidentially in data plays a role for the pharmaceutical companies themselves. They have huge investment made in research and development and want to protect that information and that knowledge so that it's not flowing out the door to a competitor. And again, I think some of the areas that technology can assist in is to ensure who has access to this.
Join us to hear from Guy and Dene live at 11am BST on Tuesday 20th July for a discussion on how data is revolutionising the pharmaceutical industry.
We'll take a deeper dive into how data is adding huge value in key areas such as:
- Supply chain
- Sustainability
- Manufacturing
- Patient records
