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There s Room for IT in GxP: LSIT s Howard Asher on Good Informatics Practices

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Howard Asher, Chairman of the Board, LSIT

Howard Asher, formerly group director of global life sciences at Sun Microsystems, founded the Life Sciences Information Technology Global Institute last May, when he was still with Sun. Now serving as chairman of the board of the nonprofit organization, Asher is an outspoken advocate of the need for good informatics practices for the pharmaceutical industry, which he describes as akin to the various flavors of GxP — good clinical practices, good laboratory practices, good manufacturing practices — on which the biopharmaceutical sector relies.

LSIT recently released the initial results of a survey it conducted of senior life and health science professionals. While LSIT is still analyzing the data, preliminary results indicate that nine out of 10 respondents "felt that consistent IT practices would accelerate the regulatory approval process," according to an LSIT statement. Furthermore, 76 percent of respondents said that GIP guidelines "would significantly improve business processes and regulatory compliance." More than 70 percent of respondents said they would be "likely" to adopt GIP guidelines in the areas of commercial software (74 percent), selecting standards and methods (74 percent), software implementation (73 percent), upgrading and replacing validated systems (72 percent), and auditing IT (72 percent).

BioInform spoke to Asher last week by phone to get a better idea of what GIP entails, and what's next for LSIT.

What are the goals of LSIT? What was the motivation behind the creation of the organization?

While I was with Sun, I spent a lot of time traveling the world and meeting with a number of life science companies, and it became pretty interesting that they are what would be called by the IT industry a late adopter of IT. And as a result of their late adoption, there's a lot for that industry as a whole to learn about best practice, if you will, of IT technologies.

It was further developed, in discussions with the FDA, as well as other regulators, that there was a lot of concern expressed about the methodology that the life science industry was using relative to IT adoption, and the question they had was, 'Who's right?' It was framed best by one of the people at FDA who basically said, 'Of the top 100 companies, they're doing the exact same thing 99 different ways.'

So that was really the driving force that caused me to, with Sun, found what is now called the LSIT Global Institute. Its sole purpose is to define IT technologies that are specific to the needs of the life sciences community that can be trusted. That's what's its sole focus is.

So in the development of that concept, there are all these good practices that are regulated — good manufacturing practices, good laboratory practices, and good clinical practices. The model that good clinical practices was developed under is the model that we're using. There's an organization called the International Harmonization Committee, and it's also referred to as the International Committee for Harmonization, so it's ICH. ICH years ago developed GCP. They're an independent, non-profit organization, like LSIT, that, because of the core competency of clinical studies, is not within the regulators' area of expertise. They drafted and developed a guidance on how to conduct regulated clinical studies — GCP. That was later adopted by FDA and virtually every other regulatory body in the 49 other nations that regulate this industry.

So when you look at that concept, GIP is essentially mirroring that concept and bringing trust to the IT utilized within the life science and healthcare community.

When I first heard about the launch of the LSIT Global Institute, I had the impression that this was a new initiative to standardize data, but it sounds like it's more about formalizing the IT procedures and methodologies that are used in drug discovery.

What we don't need is another standards body, and LSIT is not by any means intending nor chartered to be a standards body. The question becomes, 'How do you build GIP? How do you build this informatics practice guidance?' The way we do that is that it's a weaving process — what we do is we weave in all of the recognized appropriate international standards — from ISO, or IEEE, or CDISC — all of these standards bodies that are focused on this sector. So we weave these standards in with the IT best practices, which many times come from other sectors, like finance or telco or the government. And then we weave in the special needs of the health and life sciences community.

So it's those three bodies of information that we weave together to build good informatics practices … and hopefully, much like GCP was adopted, we hope that GIP becomes adopted by the regulatory agencies.

Have you identified some areas that might be the first target for a GIP?

Yes. We did the international survey. … The survey really overwhelmed us with the clarity it provided. Essentially, it takes our table of contents, which is on our website [http://www.lsit.org/initiatives/gip-toc.php], and it prioritizes it.

We're going to actually continue the work on the survey to make certain that not only is the high level described based on the survey results, but also a lot of the detail, in terms of where their points of pain really exist, and that's a white paper, essentially, that we're going to continue to develop because the data is pretty complicated.

The great big message was that we really need good practices in IT. The survey basically said, 'Yeah, GMP, GCP, GLP have helped us because they provide international harmony in the way we do things.' And then the question is, 'Would GIP help?,' and the answer is, 'Absolutely.' It was really important.

The other thing that the survey was telling us is that here are the professionals, the IT professionals within the community, saying they need somebody to lead this effort. They talk about leadership, and then they also talk about how they want somebody knowledgeable to lead in this effort. So the two things are critically important because it's apparent when you travel around to these companies that a lot of the so-called best practices in other sectors don't apply here, or they need something different — Part 11, for example. So they need a means not just to manage documents and data, but to demonstrate via proof that it was done by an individual authorized to do so, if it's regulated, and that nobody's fiddled with it or changed it without documenting that change.

So it's a critical factor that we really get into the issues like HIPAA, and what is that all about, and what is Part 11's intention — not so much the regulatory wording, but what's the intent? The regulatory intent of Part 11 is the FDA's way of expressing that [they] need to trust that you haven't fiddled with these electronic records — that they are in fact true and reflective of exactly what happened.

It seems that people on the IT side within pharma are still unsure on the details about how to provide that information to the FDA.

They are, and here comes the problem: FDA has issued guidance on Part 11 [several] different times. So if you ask yourself, 'Why did they issue it and withdraw it, issue it and withdraw it?,' the reason is that IT is not the core competency of FDA either — nor should it be.

So if the world were perfect, what we would have is that the IT industry itself would actually come to learn what the needs are for this particular sector. Where we saw that happen in a way that we can all relate to was in the banking industry. When the IT industry came close to the banking industry and looked at the enormous complication in doing simple transactions and keeping all the numbers straight, and keeping everybody's account correct, and they learned all the nuances of it, and they also learned that it would be cool if it were a global system that internationally harmonized banking, what was developed from that is what today is called the ATM.

So it's a demonstration that once the IT industry comes to an intimate understanding of an industrial sector's needs, it can solve the problems, period. They have all the capability to do that and it is their number-one core competency. And that's who we need at the table. We really need the IT industry to step up. It's something that is critically important in order for this to succeed.

The current membership of LSIT appears to be made up mostly of people on the user side — the biotech and pharmaceutical companies, academic groups — and not so much the IT vendors or the regulatory agencies.

That is true. LSIT is a young organization, and we are now recruiting a number of new members, which will hopefully soon be announced. Some of those will include major IT companies. The reason for that is when you look back at the founding of this, the IT industry basically said, 'What problem do you have? We have a lot of products, here's a catalog — buy something.' They didn't perceive any problem. So the industry first had to organize itself and basically said, 'Yes there is a problem.'

The fact of the matter is that when you get involved in biotech and genomics and all this omics stuff, it's very complicated. And the IT industry kind of stands back and says, 'Well, it's data and we have things that can manage data.' But yet what they don't understand is that these are crown jewels, and these data come with a lot of computational requirements that are unique, and there are people within the IT industry that are knowledgeable, yet if you sit down with Bill Gates and Scott McNealy and Larry Ellison and all the celebrities out there — they don't get it; they don't have a clue. And it's time that the industry really takes an interest in this sector because there are some really important things. One is that this industry is doing something that no other industry has ever done to IT, ever, and that is that it's growing data at a rate that's never been seen before.

So from an IT perspective, why pay attention to this industry? Because it's going to spend a lot of money managing these crown jewel data. It's a complicated message, but it's unique and important.

So besides refining the survey results and getting that whitepaper together, what else do you have on the short-term horizon?

The major effort is now rolling up the sleeves and putting the ink on paper. So LSIT, for example, is developing a relationship with a group called GAMP [Good Automated Manufacturing Practices]. They've been around for 10 years, and what they've done is developed a very detailed book of guidance … for all the automated manufacturing systems. So LSIT is organizing a relationship with them, because we at LSIT do not want under any circumstances to reinvent the wheel. What we want to do is for those who have invented a good wheel, we want to essentially adopt it to the automotive build, if you will, of GIP. So IEEE is a partner of LSIT, as is hopefully soon to be GAMP. We will also develop a similar relationship and we've begun the effort with CDISC, and eventually HL7.

So we're going to roll up our sleeves and start building the GIP. We're going to take the table of contents that's posted on the LSIT website and prioritize it based on the survey guidance that we received. And we're going to make sure that we're aligned with organizations like ISO, IEEE, GAMP, CDISC, HL7, etcetera. That's our near-term go-to-work.

Do you have a goal for when you expect to have some initial GIP guidance available?

LSIT will publish these to the open public, and we're hoping to start publishing them in 18 months to 24 months at the latest. They have to obviously be well socialized before we publish them, which includes input from regulators as well as the life science and healthcare community, as well as the IT industry itself. So that's heavy lifting.

That's a lot of interested parties.

No kidding. It's like herding cats with firecrackers. It's very tough.

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