It’s ‘go time’ for the pharmaceutical industry

Now more than ever, the strategic use of information technology (IT) combined with operational excellence — integrated, streamlined and harmonized processes in an electronic work environment – becomes critical to a pharmaceutical company’s success as well as the way to get the industry to an entirely new business model.

As companies rethink these models, many are adopting unconventional approaches to leveraging IT. Take, for example, the case of one of the world’s 20 leading international pharmaceutical companies focused on prescription drugs and therapies for humans and animals. In the company’s continuous effort to shorten development and regulatory cycles, the company is using the International Conference on Harmonization guidance for the electronic Common Technical Document (eCTD) to rethink its enterprise-wide processes and guide its strategic decision making in the future.

The company wants to leverage technology solutions to save money and get new drugs to market faster. With speed and efficiency as its primary goals, the company conducted an internal business analysis and evaluated the leading eCTD solution providers on the market. They then made an unprecedented decision: rather than buy or build the software, the company would rent the technology it needs to submit new drug applications electronically and in compliance with the eCTD.

From a business standpoint, the model adopted – called “software as a service”(SaaS) – makes perfect sense. The company’s core competency is not in supporting large systems. And when the company figured the cost of implementing and maintaining another internally supported system, it discovered it would be more cost effective to rent the necessary software and associated services as needed.

By implementing this innovative approach, the company is transforming the way IT supports the company and, in turn, has provided direct and measurable value to the company’s core business of developing drugs.

This case provides an example of some of the more inventive approaches today’s CIOs and functional executives need to consider. Management now has the opportunity to elevate the IT function from a discrete web of functional systems and networks to the center stage of a transforming business model. Technology will not only identify the form the new model will take but it places CIO’s squarely in the unique position to move the new model into its execution.

The journey to successful implementation of a new business model will be easier for CIOs that will plan for – and act – on the following trends.

1. Enterprise solutions: the sum is greater than the parts: Successful pharmaceutical companies need to operate without boundaries – between functions, divisions, operations, and across the greater life sciences value chain. Today’s CIO’s should not only strive to integrate business processes and systems but should implement solutions that finally realize the common vision of the greater heath care network.
2. Rent what you need: Another way for CIOs to achieve an enterprise view of their business and share data and processes with other applications and third parties is through a new digital business architecture called SaaS. SaaS allows software applications to be deployed as a hosted service and accessed over the Internet. The service provider deploys and maintains the application.
3. Outsourcing takes on a whole new meaning: Many analysts report that pharmaceutical companies are planning to increase their reliance on business process and IT outsourcing. While companies have relied on outsourcing for decades, the use has been tactical and sporadic. The pharmaceutical company of the future will outsource much of its core business, including clinical trials, drug discovery, and even regulatory approvals.
4. Beyond data management – turning data into drugs: CIOs must drive the organization’s ability to translate data into actionable insights, thus accelerating the discovery of new therapies or enabling better connections between clinical trials and adverse event reporting, for example.
5. Speeding Drugs to Market: With the trend toward regulatory agencies requiring detailed information on all facets of a drug’s development lifecycle, and requiring that information to be submitted in new XML-based formats, CIOs must have a planned approach toward managing the transition to electronic regulatory submissions. The approach to the eCTD provides an opportunity to simplify the regulatory submissions process and reduce time to market to simplify the regulatory submissions process and reduce time to market.
   

Mr. Gil Kampfner
Managing Director
Image Solutions Europe GmbH
Frankfurter Strasse 63-69,
65760 Eschborn
Germany
Phone: +49 (0) 6196 77 625 0
Email: infoeurope@imagesolutions.com