Pfizer is automating clinical trials through the use of Pega

Derek du Preez Profile picture for user ddpreez June 13, 2016
Kimberly Tableman, Director of Core Process and Technology at Pfizer, explains that the platform could introduce huge efficiency gains into he process.

Clinical trials and drug development is a lengthy and expensive business. Pharmaceutical companies can spend hundreds of millions of dollars developing just one drug for the market. And the process, as it stands, requires complicated engagement from a variety of stakeholders and isn’t currently organised in any efficient fashion.

However, that’s changing. A consortium of 19 pharmaceutical companies have come together to standardise on things that they don’t consider to be a competitive advantage, so as to further progress drug development and research. Pfizer is one of the first companies to take this on-board and is building a technology enablement platform around those standardised concepts.

That platform is being enabled by Pegasystems, which should allow the pharmaceutical group to streamline its processes, take out inefficiency and potentially introduce massive time and money savings into creating new drugs for the market.

I got the chance to sit down with KimberlyTableman, Director of Core Process and Technology at Pfizer, who explained that pharma groups had the opportunity to introduce quality management into their processes years ago, but have fallen behind in terms of what is possible. She said:

The concept is related to creating a quality management system within clinical trial execution. These concepts are not new. When I took over this specific quality area within Pfizer, I did a lot of research on total quality management, which I originally thought was from the 90s. But when I did research, an American scholar born in 1900 had a huge impact on how we do census counting here and then was asked to go to Japan to share those same concepts.

We know what the impact was of him sharing those concepts in Japan, which, in short oder, is that Japan took over in terms of a manufacturing perspective going into the 70s and 80s.

It’s not because there was a lack of knowledge here, it’s because no-one was listening. I asked the room yesterday during my presentation, how many people in attendance had a clinical QMS? Not a single person raised their hand. Zero.

A huge opportunity

Pfizer is at the start of a three to five year journey of implementing Pega and building in the 42 processes that relate to clinical trials into the system. Tableman explained that the thinking behind the new QMS system is that if you build consistency into those processes, you are much better able to identify quality issues at the point of them occurring. She said:

That’s the whole point of the manufacturing line, if you build consistency in, people know exactly when to hold the line. It’s no different for us, it’s exactly the same concept. We want people to know when to hold the line.

My belief is outside of reducing quality events in the context of clinical trial execution, the potential opportunity here is huge. Because you are really talking about true automation in many respects, that right now is still in every pharmaceutical company managed by email and Sharepoint slides.

But what does Tableman predict the impact to be? She says that the results of introducing the platform could have a drastic impact on the cost and speed to market of new drugs. She added:

I’m not sure that it will have an impact on the accuracy as it relates to drug development. I do predict that it is going to have a huge impact on operations. So as you know, in life sciences it takes seven to ten years to get a drug to market. It’s extraordinarily expensive, $700 million to £1 billion can be spent on one drug.

How much can we bring those numbers in? How much can we bring those timelines in? I don’t know. But I’m pretty clear that implementing consistency and efficiency in the process, where people are automatically prompted based on that whole concept of insights, action, next best action, evolution. I think you could significant efficiency gains.

Change management

Tableman also described the implementation as a “major change curve” and said that the platform will change the way that study teams have worked for “years and years and year”, which will require a shift from smart people typically having used their knowledge and know-how to get the job done, to relying on a system.

She said:

So you really are talking about a fundamental shift for the study team. And I think that’s where it really starts to get sensitive.

The biggest challenges, I would say, are change management and definitely because we are first [doing this]. It is incredibly hard. Incredibly hard. You would not believe the resistance and change management and the ‘why do we really care about this?’. To me it’s a no-brainer. If I were advising another company, I would say figure out early on how to win the hearts on minds, so you’re not fighting that uphill battle is useful.

Image credit - Images sources via Pfizer

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