PhM: What, in your opinion, are the key elements of an effective data/informatics infrastructure?
Ken Rapp, Accelrys: “For a data/informatics infrastructure to be effective, it must be flexible enough to meet the needs of a very dynamic customer environment. Customers should have the ability to use barcoding, connected computing or mobile technologies. Everything should be accessible whether on the premise or in the cloud, and it should have the ability to migrate from what is currently in place today to a new environment tomorrow. It’s also essential for customers to have the ability to work with their partners, and this partner ecosystem is constantly changing and evolving, so the infrastructure must also have the ability and flexibility to change too.
Another key component is standardization. In addition to the benefits mentioned above, standardization accommodates the flexibility use personnel. With personnel shifting from department to department frequently, the ability to provide them consistent tools regardless of their current setting is essential to ensuring data informatics solutions are effective.”
Forrest Rudnick, Datalynx-U.S.: “Key obstacles for achieving an effective data/informatics infrastructure facing pharmaceutical manufacturers today include an unstable economy, rising costs and fierce competition. Constant pressure from leadership to improve operational costs while embracing quality and long term output, cost reduction and quality/productivity improvement is always the fore front of executive meetings. With growing Global competitiveness undue pressure on cost, quality and customer demands, people cannot measure, monitor, and control performance for all personnel during the process time. It is important to track and leverage information technologies/systems and automation and satisfy management.
Measures can be taken to meet all the immediate needs through automation of monitoring inputs and outputs, trend analysis reports and by making simple processes repeatable. Review documentation each month to ensure adherence or improvement. Invoke an incentive program to catch problems early. This accomplishes two areas of concern, gets your employees involved with solution management and helps with reduced operating costs. Every company is good at putting together task forces to identify the cost problems, but no companies put together a task force to close the cost gaps identified.”
K.R. Karu, Sparta Systems Inc.: “The first step is to identify your core strategic systems for data, including ERP as the foundational system, and then Enterprise Quality Management Software (EQMS), LIMS, Document Management, CRM and any others that may be necessary to run your business. Then define which systems are responsible for which processes, and make sure systems can share data and hand off results to each other. Embrace technology advances: for example, using i-Pads during audit processes and mobile devices to report events as they are discovered.
Finally, collecting data is not enough. Identify how data is analyzed. Having an analytics tool to slice and dice the data for each individual business area allows for discovery of trends and better and quicker fact based decision making.”
PhM: What do you think are the consequences to the Pharma industry if it fails to effectively leverage information technologies to tackle industry challenges?
Forrest Rudnick, Datalynx-U.S.: “A key area of misunderstanding [stems from the fact that] many of today’s executives did not come up through the ranks of the blue collar environment so they do not grasp the far reaching effects and impact to all the processes and systems involved when demanding greater output or higher efficiency at a lower cost. The FDA Warning Letters and notification of violations repeatedly identifies the same issues regardless of what facility is inspected primarily due to humans not performing consistently as machines. Where a machine can run 24 x 7, be shut down for preventive maintenance or calibration and then be up and running again with consistent output, people cannot. Even on their best day, humans will always introduce errors into the process.
IT automation has the ability and capacity to out-perform a human in so many areas to make those FDA 483s become a thing of the past. Without the intervention of a mechanism that has repeatability with consistency, the FDA will continue to find the same problems over and over. Reducing time to market, lowering costs and providing a consistent product will remain a pipedream unless IT automation is introduced into the process. IT automation still requires human interaction, continual training, mentoring, and adapting to new technology. Without this progression, elements that have haunted the pharma industry will live on indefinitely.”
Ken Rapp, Accelrys: “I don’t think it possible for the pharma industry to fail here, and it is [our] mission to ensure that they don’t. There are already too many pharma companies on the path of effectively leveraging information technologies and succeeding for the entire industry to turn back. While some companies may not adopt these technologies, they will be the ones falling behind; not the industry. We’re at the tipping point with lab automation — the more companies that successfully implement the systems, the more others will need to follow suit.”
Lane Hirning, MasterControl: “As with submissions, safety reporting, and other regulatory responsibilities, the agencies will realize the efficiencies of electronic processes and begin to mandate those to the industry. This will force changes and catch a number of companies unprepared. That will cost them time and money as a result of delayed submissions, bringing in contractors or consultants to augment the workforce while the new systems are installed, tested, and validated. In the interim, companies will be falling short of what is expected by agencies since they will be adjusting timelines to match efficiencies gained by electronic processes while those firms remaining in the paper/manual world will not be able to keep up – requesting extensions, missing deadlines, and receiving warnings during audits.” (See White Paper: “Six Corporate Oversights of Quality and Compliance Issues in Pharmaceutical Environments:” bit.ly/12jUvLr.)
Trish Meek, Thermo Fisher Scientific: “To push the boundaries of innovation, companies across the life sciences spectrum must assiduously monitor performance and quality and be ready to capitalize on opportunities to transform and grow. The good news is that many established pharmaceutical companies have spent more than two decades methodically adding technology in preparation for these challenges. But all this investment could be for naught unless these companies take deliberate and strategic steps to align non-integrated, often disparate resources in ways that enable maximum agility for their businesses. And for a lab of any size, new technologies go well beyond instrument advancements alone; cloud and mobile computing, for example, are driving major changes that not only affect business velocity, but also lower entry barriers to increasing competition. In this way, technology is an equal-opportunity catalyst that puts even more pressure on CIOs to stay ahead.
The real risk to today’s pharmaceutical companies is that their competitors will discover how to more effectively leverage information technology. There is great focus in the industry on improving pipelines and optimizing manufacturing operations. Our customers are working with us to determine how to leverage their existing investments. Companies that aren’t thinking this way may fall behind in the market.”
K.R. Karu, Sparta Systems Inc.: “Companies that fail to leverage the information they can receive using technology are destined to have limited or declining growth. Being nimble and making decisions based on all of the facts can help assure a company will provide the market with safe and effective products that are trusted by doctors and patients, while creating manufacturing efficiencies that will allow faster time to market in a highly compliant manner.”
Published in the July 2013 edition of Pharmaceutical Manufacturing magazine