Wettbewerbsvorteil in der Pharmaindustrie durch verbesserten Zugang zu Informationen und Sicherheit

WHITE PA P E R – I M P R O V E D I N F O R M AT I O N A CC E S S A N D S E C U R I T Y W H I T E PAPER 1/5 Improved information access and security The information dividend: competitive advantage in the pharmaceutical industry through improved information access and security The pharmaceutical industry is an information and data rich group with an absolute requirement for confidentiality and securi- ty. During the long and complicated process of drug development, data must be securely managed and stored. Furthermore it must also be available for later distribution and editing in a simple and efficient system. Without easy access to data, problems often arise in product out-licensing deals where the potential buyer wants to review specific confidential data that too often is hidden in dusty notebooks in the research laboratory. Complications may also occur in the middle of clinical trials when the FDA wants information on a protocol and the sponsoring company does not have an audit trail or other documentation showing when revisions occurred. Faced with these time-consuming and that they need a simple, web-based plement their critical information. They expensive breakdowns in information electronic document library -- a secure, firmly believe their employees were availability, it would seem obvious that easy-to-use repository to store and im- hired to get drugs to market, and not to the industry should be quick to embrace spend valuable time on labor intensive new digital technologies to manage its IT projects to manage information. They critical information. But the industry has want easy information access so when been very slow to adopt new methods specific confidential information is due to a lack of a simple, easy-to-use needed for a board member or the FDA system that combines efficiency and pro- or other stakeholders, it can be re- ductivity with critical security features trieved, shared with and reviewed by that assure confidentiality. Recently authorized individuals both inside and with the increasing electronic flow of outside the firewall. And, they want an information both inside and outside the intuitive interface with drag and drop firewall, it has become obvious that the functionality requiring little training. pharmaceutical industry has to re-ad- Furthermore, with flexible time, home dress its needs for efficient, secure offices and global travel, they want methods to manage, store and ex- their employees to be able to access the change its most important asset – information anywhere, anytime with ap- information. propriate user validation. Lastly, phar- maceutical executives want all of these To compete in today’s marketplace, features and benefits in a completely pharmaceutical executives are realizing secure system. W H I T E PA P E R – I M P R O V E D I N F O R M AT I O N A CC E S S A N D S E C U R I T Y 2/5 Many companies have implemented se- generated. For example, a pharmaceu- captured electronically so it can be re- cure, online, collaborative work spaces tical company may have licensed a drug trieved by people who have questions for safe filing, editing and distribution from a university that made the original about the technology. Additionally, it of highly confidential life sciences infor- observation and developed the original must also be securely shared with indi- mation within and between, organiza- intellectual property. All of the research viduals outside the firewalls such as law- tions. These web-based document repos- data and information supporting those yers and regulatory agencies. itories, also called virtual data rooms, patents resides in the academic institu- protect sensitive documents from unau- tion. When development begins in the Licensing thorized internal or external attacks, pharmaceutical company, the intellectu- Electronic communications have dramat- and document all activity in a tamper- al property path becomes more compli- ically changed the licensing landscape. proof audit trail. cated with new patent filings over many When a biopharmaceutical company de- years. The early research data at the uni- cides it is time to out-license a com- OPPORTUNITIES TO ATTAIN COMPETI- versity often is sitting in dusty note- pound, they do not want the deal to be TIVE ADVANTAGE THROUGH INFOR- books in the laboratories. But this infor- delayed by a lengthy process of pulling MATION EFFICIENCY mation is the basis for the future of the together information from a wide range project and unfortunately, as the years of places inside and outside the compa- Intellectual property pass this information can often be lost ny. To expedite the transaction, the Drug development is a long process in or misplaced. This information should be company needs to invest in an easy-to- which a significant amount of data is considered part of the project and be use, secure system for organizing RECENTLY WITH THE INCREASING ELECTRONIC FLOW OF INFORMA- TION BOTH INSIDE AND OUTSIDE THE FIREWALL, IT HAS BECOME OBVIOUS THAT THE PHARMACEU- TICAL INDUSTRY HAS TO READDRESS ITS NEEDS FOR EFFICIENT, SECURE METHODS TO MANAGE, STORE AND EXCHANGE ITS MOST IMPORTANT ASSET – INFORMATION. discovery and trial information and data If used correctly, these secure virtual da- very early in the compound’s develop- ta rooms can improve employee produc- ment that can ultimately be used to tivity and result in faster and more effi- manage, monitor, and optimize due dili- cient capitalization of assets, putting the gence and bidding processes. Systems company at distinct competitive advan- such as secure online workspaces or vir- tage in today’s marketplace. All docu- tual data rooms address all of the needs ments should be stored and used in a of licensing organizations for security, data room before initiating the out-li- traceability and ease of use. censing process in order to accelerate W H I T E PA P E R – I M P R O V E D I N F O R M AT I O N A CC E S S A N D S E C U R I T Y 3/5 TO COMPETE IN TODAY’S MAR- KETPLACE, PHARMACEUTICAL EXECUTIVES ARE REALIZING THAT THEY NEED A SIMPLE, WEB-BASED ELECTRONIC DOCUMENT LIBRARY -- A SECURE, EASY-TO-USE REPOSI- TORY TO STORE AND IMPLEMENT THEIR CRITICAL INFORMATION. due diligence and facilitate communica- maceutical company. There are thou- of thousands of dollars in lost opportu- tion between buyers and sellers. The sands of different documents covering nity. Use of a secure online work space seller can easily control access to docu- everything from discovery through clini- early in the drug development process ments, allowing them to be viewed se- cal trials to the pre-IND and final NDA can prevent these delays and save time curely with a complete audit trail. being managed and edited by numerous and money. All of the information can professionals both inside and outside be written and securely placed in this Regulatory Management the firewall. Serious delays can occur if central repository, easily assembled and A regulatory filing with the FDA or oth- all information and data is not well or- ultimately sent to the FDA. er international agency is one of the ganized, with serious repercussions most complicated, confidential and ex- when even a single day of delay can cost pensive projects undertaken by a phar- the pharmaceutical company hundreds Case study: Intellectual property A pharmaceutical company had licensed a drug candidate from an academic institution.