Roger Bottum suggested that among Axentis customers that are "doing particularly well, they have put in place the organizational
structure to support that."
Sabogal:
[One can] boil it down to a couple of key things.... [One of these is the ability to] derive operational excellence. It's
manufacturing on a global scale. It's supply chain on a global scale. So it doesn't matter if you're a biotech with one product,
we want to have the same solution for you as a medium-size company with a couple of products to one of these large pharmaceutical
companies with far-flung operations all over the place. What we're seeing in the market is they're all looking for the common
platform, because [the company's management has] got to grab everybody's attention because [they're] trying to drive revenue
for [the] company.... SAP's in the business of solving that problem. That's really what it boils down to: a common business
process with a business platform, with a lot of business applications. But what is the next step? What is the next thing that
we have to get to if we're going to multiply this by 100 products, by 200 products, by 1000 products? The amount of paperwork
and regulation we have to go through is astronomical. So that's the challenge.... And that is where I think [a] business platform
and common business processes get to be ... what we want to focus on.
Ran Flam agreed that the common goal of all three software manufacturers at the table was that they offer their customers
the means to "enable them to run their business in a systematic way."
Flam:
Whatever the process is, [we want to use the software to] handle different business processes, as well as action to be taken
[to assist employees to make decisions based on SOPs, to follow predefined enterprise business rules and guidelines.] I think
we all share this. [Sparta's QMS software, TrackWise, does not] hard-code any of those behaviors in the software itself but
rather enables the businesses themselves to [configure their database applications so that the software maps the desired business
practices and forces users to follow the same].
Compliance
The factor that distinguishes the pharmaceutical industry from just about any other is the degree to which it is regulated.
The US and foreign governments alike monitor drugs throughout their development and production life-cycle for safety, efficacy,
and purity of ingredients and the final product. Needless to say, compliance software is of supreme importance to pharmaceutical
manufacturers. Accordingly, we focused our discussion primarily there.
Sabogal raised the notion that the compliance issues faced by a company with only one product will only grow in complexity
when companies produce hundreds of products—as is likely once many targeted products replace the single blockbuster—in tens
of countries, each with their own set of regulations. The paperwork alone, he notes, is staggering.
Bottum followed up by noting that in addition to the number of products managed in-house that, "Big Pharmas are being more
aggressive about leveraging third parties for supporting services on clinical trials and sales and marketing."
Bottum:
The circle of the people that touch the development through the delivery of your product in any market is much more complex
even than is inside your four walls. And so [Axentis] is specifically focused on risk management and compliance .... The risk
a lot of times isn't the person that's sitting next to you in the cubicle—it's the person that's sitting a city away in a
totally different company and carries a different business card but for whatever reason is doing work for you on that day.
In particular, what we do is provide an overall consistent way to manage all the elements of governance, risk, and compliance.
Sabogal:
It's not uncommon for us to think about the problem in China being based in California.... You have to take compliance and
you really have to push it to a point where you institutionalize it. Everybody must comply with the regulations.
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