Life Science Companies Caught in the Middle

Opposing forces are converging to complicate and delay the timely introduction of new life sciences products, costing manufacturers millions of dollars in lost revenue with every day that passes between the approval of a new drug or medical device and the availability of that new product to paying customers.

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	Kent St. Vrain

The pharmaceutical industry is under tremendous pressure to deliver safe, effective, and increasingly lower cost medical treatments and therapies. At the same time, pharmas are faced with equally daunting pressures from government regulators and public health safety organizations regarding complete, reliable, and fully documented packaging standards, consumer instructions, label warnings, and other safety controls.

Packaging and Labeling the Last Frontiers of Automation

Over the years, great progress has been made to automate, streamline, and "Six Sigma" the complicated and exacting development, testing, and manufacturing processes involved in the development of new life science products — with signi?cant time-to-market and cost-savings bene?ts. Little progress has been made, however, in applying these automated tracking and veri?cation capabilities to the ?nal stages of the commercialization process.

Marketing operations, in particular the packaging, labeling, and ?nal steps of new product development, line extensions, and changes, remain virtually untouched by the automation and computerized systems integration that pervade the rest of the life sciences industry. Yet, millions of dollars are lost at this critical stage in the form of delayed sales, inefficient operations, and costly rework.

Where It Hurts

The sources of the pain felt by pharmaceutical and medical device manufacturers in their quest to speed up the development and delivery of new products are many and varied. Among them are regulatory pressure points stemming from compliance with government regulations, such as the FDA's 21CFR-11 and current Good Manufacturing Practices (cGMPs); the continued reliance on paper-based and other inefficient processes for review, sign-off, and documented veri?cation, which acts as a primary bottleneck in the ?nal stages of new product commercialization; the logistical nightmare of chasing the various agents of change and approval from one office or manufacturing site to another; and finally, disparate data and disparate systems compounding the problem as manufacturers and their suppliers attempt to merge all means of data and images with a diverse combination of hardware and software systems.

The magnitude of the pain caused by these obstacles remains largely unaddressed by senior management at these organizations. The collective impact of the problems identi?ed here is so pervasive, and therefore hard to pin down, that the tremendous bene?ts of deploying a viable, new approach to the streamlining process are masked by the seeming complexity of the countless steps involved.

The Cost of Pain

The biggest impact of this protracted process is measured in the very real revenue dollars lost to the immediate competition, or simply never realized, as a result of the convoluted and overly complex review path for the last stages of commercialization. When added up, the days of lost sales throughout the entire process attributable to packaging and labeling alone can total in the tens or even hundreds of millions of dollars.

Another hard cost is the high cost of personnel, time, and other resources spent on ensuring the accuracy and quality of printed information on the label and inserts in both over-the-counter and prescription drug packaging. The paper-based review and approval cycle required for this "contract with the consumer" data is particularly slow, as this critical information often serves as the subject of any future liability claims in the event of an unperceived side effect or product recall. With increased importance comes increased scrutiny — and added cost.

In the often painstakingly slow manual process of the current environment, each insert and label must go through its own creation, review, modi?cation, and production process. Without a common path or track incorporating previously veri?ed and approved language, for example, few efficiencies of a shared, common process are available to cost-effectively assure accuracy.

The hard costs of having to rework the packaging and/or labeling of a new product at the last minute constitute yet another area of tremendous cost inefficiencies in the ?nal stages of commercialization. The regulatory headaches involved in having to attain approvals and veri?cation of any change once artwork has been plated and printing has begun is a costly and time-consuming setback.

The Prescription

Relief from the costly pain felt by the life sciences industry requires a comprehensive and uni?ed approach to marketing operations that radically streamlines the process, reduces error and rework, and lowers overall compliance costs.

Pharmaceutical companies should consider an integrated, comprehensive packaging and labeling system to meet current challenges. By changing the structure of the commercialization process itself from distributed to centralized, the documents, artwork, and data records stay in a single, secure location while the people involved in the creation, revision, proo?ng, and approval processes come to this central repository of information, not the other way around. Access to this rich repository is tightly controlled, and changes are monitored for proper review and approval — all managed by a single system running over a single, uni?ed platform.

This integrated, comprehensive packaging and labeling system:

• Incorporates every stage and sub-process of the project from start to delivery
• Accepts data, graphics, and text in all formats
• Provides a veri?able record and versioning control of every single step, action, and approval in the process from start to ?nish
• Utilizes a "Software as a Service" hosted approach that provides a relatively quick and cost-effective solution

Return on Investment

Pharmaceutical companies that streamline the packaging and labeling stages of product commercialization provide a readily identi?able and quanti?able return on investment:

• Performance improvement — improves time-to-market during the ?nal stages of the commercialization process
• Systems integration — grants greater operations performance and higher organizational efficiency
• Leveraged resources — frees up existing resources for additional projects
• Improved creativity — increases collaboration and therefore improves creativity through closer cooperation and multi-departmental coordination.

The improvements to this process will help organizations significantly shorten time-to-market, streamline regulatory and verification requirements, and deliver quantifiable returns on investment.

About the Author

Kent St. Vrain, a vice president for marketing and business development, is responsible for the partnering and marketing activities of Paxonix. He started his career in sales at Lanier Business Products and held a variety of sales, marketing, and sales management positions in both the dictating and word processing divisions. Subsequently, he spent 16 years with Digital Equipment Corporation in a variety of management positions in the Educational Services, Marketing Communications, Channels Management, Systems Integration, and Corporate Accounts organizations. Most recently, he served as vice president, corporate accounts. Mr. St. Vrain also served as vice president of sales and marketing for Polaroid Identification Systems and has been involved in start-up companies as well as having founded a sales consulting organization.

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