With most pharmaceutical companies counted as customers, and electronic submissions to the FDA requiring documents to be in PDF format, Adobe is no stranger to the life sciences.
But the company has been reinforcing its ties to the industry with a concerted life science effort that has a dedicated staff of industry experts.
“The vertical focus on the life sciences is new, but [Adobe’s] work in the area is not new,” says Melonie Warfel, director of Adobe Life Sciences.
The life science effort at Adobe is an umbrella program that covers pharmaceutical, biotech, and medical device companies. Part of the effort is ensuring that documents meet FDA submission and other regulatory requirements. Within the pharmaceutical industry, the program targets a wide range of application areas, including R&D, clinical development, regulatory affairs, manufacturing, and marketing and sales.
Warfel notes that many of the business trends and business priorities that the Life Sciences group deals with are not new. “Our customers say they need to maintain their competitive advantage, comply with regulatory requirements, and protect their intellectual property,” says Warfel.
What is new is the amount of information that is being collected in life science organizations today. Adobe sees its strength in helping companies gather, present, and safely share this information.
Part of the life science effort is tied to a transformation within Adobe. The company has quietly morphed from a desktop software company to a server software company. The fruits of this change can be seen in its Adobe Intelligent Platform architecture, which is made up of the universal client, intelligent documents, and Adobe document services.
Most people are familiar with the universal client aspect of Adobe’s architecture. This is basically the client software – the Acrobat Reader and Web browser plug-in – that allows workers, partners, and others to access and work with documents. With the client software, people can share documents within and outside a company and documents can be accessed using virtually any platform ranging from a PC to a PDA (personal digital assistant) to a cell phone.
And while the universal client is essential in any company, it is the other parts of the Intelligent Platform architecture that have great potential and application in the life sciences.
Specifically, Adobe’s intelligent documents combine Adobe PDF and XML technology. This enables a digital document to keep the look and feel of a paper document while allowing life science companies to embed business functions within the document. For instance, intelligent documents can include error checking while data is being entered, data validation, and routing of information such as parts of a document or an entire document.
Architecturally above the intelligent documents is what is known as the Adobe Document Services. Among the features supported within the Document Services offerings are things like document generation, document control and security, collaboration, and process management.
For example, when it comes to document control and security Adobe offers the Adobe LiveCycle Policy Server for managing and monitoring electronic forms, and Adobe LiveCycle Document Security, which offers encryption and digital signature features for safeguarding the content of an electronic document. The LiveCycle line of enterprise products also includes a handful of document-generation and process-management offerings.
Part of the Life Sciences group’s strategy is to work with partners such as Accenture, EMC/Documentum, IBM, Open Text, Oracle Clinical, and others. Members of the Adobe Life Sciences group also take active roles in many of the industry standards development efforts.
Are you using more electronic forms to collect data? What technologies and formats are important to you? PDF? XML? eCTD? Who are you turning to for help in these areas? Drop me a note at Salvatore_Salamone@bio-itworld.com and share your thoughts on this topic.