With drug sales continuing to decline, pharmaceutical companies are pinching their pennies and closely picking and choosing
what areas they should invest in. Unfortunately, infrastructure technology is one of the more expensive areas, and also one
of the first to be scaled back. From manufacturing mainframes to desktop computers, almost every aspect of IT is being evaluated.
And if an existing solution is working, chances are that a non–mission critical update will be skipped, or a new installation
will be put on the back burner. Pharm Exec reached out to some of the biggest players in IT to find out what advice they're giving to life sciences firms that are more
interested in investing in dollars and cents than ones and zeroes.
IN THE CLOUDS
Director of US Life Sciences, Microsoft, Health Solutions Group
Pharmaceutical companies should consider an elastic service in which customers pay for computational services when they need
it. By moving services into the digital cloud, companies can move not only their storage capabilities, but also compute programs
to the Web at a variable cost. Then not only can they get away from the fixed cost of managing their own data centers, they
can also leverage their partner company's internal resources. Those people can write applications for the cloud rather than
have the pharma install them and maintain them internally. The best part is that you can pay for those applications when
you use them rather than depreciate the fixed cost over a period of time.
Companies must look for really well-articulated service agreements that can provide assurance that what they put in the cloud
is secure. I think that's a problem for everybody getting into the cloud space. That is a paradigm that we have to establish.
Increasingly, life sciences organizations are becoming global performance networks, so it's not just about research and manufacturing
or development that's being done within the organization. Increasingly, these organizations are being spread out across entire
continents and the globe. So when I think of applications, I think of managing all the consumables that go into R&D, managing
the global integration of a company with the proper approved vendors, and manufacturing inventory-item lists that these vendors
are providing product to. Those are all things that could be in the cloud. Establishing any information market in the cloud
and having it be accessible by vendors and the organizations that make up the pharmaceutical company is a good use for this
type of service.
We are working with our customers to establish guidance and procedure to get a cloud that can pass an FDA-validated environment.
So expect to see more applications hosted in the cloud in the near future.
Vice President of Pharmaceuticals, AspenTech
Drug firms have committed to moving to a paperless environment for processes such as batch record management. The problem
is that companies insist on keeping paper backup records that require an army of people to manage, process, and move it around
in parallel with the electronic data. Going paperless is a binary thing—either you are paperless or you are not.
In the last 15 months, we have seen a greater push to truly paperless environments. That means that companies validate what
they have in order to eliminate redundant paper-backup personnel. It becomes a productivity and cost of compliance enhancement
by having a more disciplined approach to the assets they already have.
I've seen poorly considered investments in software and technology that proposed to solve a problem without having done the
proper re-engineering or organizational change management. They throw a technology band aid on something and end up with a
solution that is not used at all used or only partially used. That typically happens outside or above plants. Because of the
regulatory nature of that environment, I think there has been a "if it ain't broke, don't fix it" mentality within manufacturing.
So sticking to a paper-based process has been perfectly acceptable. There's a risk of supply disruption when you have to implement
any kind of change in a validated environment. That becomes an impediment to a new technology.
But I think that's changing right now. In the current economic climate, it is important to look at manufacturing and operations
to save money. The spend on technology in operations has become a C-level priority.
On the supply chain side, I've seen planning and scheduling leveraged to increase capacity in manufacturing, particularly
in the biologics area where the complexity of the scheduling environment tends to be extraordinary compared to traditional
small molecule companies. Capacity is really expensive in biologics; the idea is to improve your scheduling to create capacity.
We've seen companies erroneously move to commissioning more capacities when through better utilization of their planning tools,
they could use the same capacity that they have. That doesn't go on forever, but it certainly can bridge a major capitol gap.