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Opentext brings intelligence to Pharma and biotech

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Whitepaper developed with Pharma Exec magazine on how EIM- Enterprise Information Management- can provide efficiency and kick start innovation by ensuring information flows correctly inside- and outside- the company

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Opentext brings intelligence to Pharma and biotech

  1. 1. SPONSORED BY Bringing Intelligence to Drug Discovery—The Importance of Contextual Information at All Levels An Executive Summary Bringing contextual information to multi-step, multi- department activities involved in commercialization of new therapeutic agents or devices. Overview The biopharmaceutical industry is on the cusp of deploying new comprehensive information services technologies that can inform key clinical and commercial decisions in ways traditional information systems cannot. Information management is becoming an essential part of the intelligent discovery and management processes that span departmental siloes to improve decision making and reduce costs across the organization. Nearly one-third of delays in deci- sion making can be traced back to a lack of data integration across departments. Forty percent of operational costs are lost in information sharing across departments. And, lack of historical context doubles the cost of early drug discovery. This article explores the potential for bringing contextual information to the multi-step, multi- department activities involved in bringing every new therapeutic agent or device to market. The tools to provide insight across multiple information sources already exist, but few firms have developed the expertise to apply those tools to bend innovation curves up and cost curves down. Achieving True Enterprise- Wide Intelligence The biopharmaceutical world is moving toward an all-digital information world. Impelled by regulatory, commercial, discovery and devel- opment demands, most firms have embraced the need to move away from physical data repositories to digital information resources that are available across the organization. The goal is not just to improve operational efficiencies, but also to improve insight across all information sources, departments and operations to bring intelligence to the entire organization. The key value is not the depth or the breadth of information that is available, but having the right information available to the right people at the right time to make better informed, more insightful decisions. Decision making is a perennial bottle- neck in any large organization. Biopharma executives estimate that 30% of the delay in decision making is due to the simple lack of data integration (see Figure 1). The right people do not have the right information at the right time. Organizations try to improve decision making by sharing information across departments. But without an overarching vision of what kind of data are available, data sharing is ad hoc, unpredictable and unsecured. Fully 40% of operational costs are lost due to a lack of simple cross-departmental information sharing. Christopher Wynder, PhD Content Services Product Marketing Manager OpenText
  2. 2. THE IMPORTANCE OF CONTEXTUAL INFORMATION AT ALL LEVELS Lack of historical context is another familiar barrier. Not having historical context impels researchers to repeat work that may have been done before, either in academic settings or elsewhere within the organiza- tion. Duplicating prior work and not recognizing earlier failures or successes doubles the cost of early drug discovery. The need to integrate data across departments and make information more widely avail- able is widely recognized. In fact, it is so widely recognized that no single department or executive owns the problem. The path forward is clearly analyzing across workgroups to chart the right course. But each workgroup is running harder and harder trying to keep up with continual updating of labeling and off- label use descriptions, security and governance of at-home medical devices, the growing use of artificial intelligence and robotics, consumer device data, ensuring compliant marketing, discovery and research, sourcing APIs and novel bioactives and other tasks. Digital disruption is projected to accelerate to the point that technology will change more in the next 15 years than in all of human history. Technology created the problem, but technology can help resolve it. An information management platform is the most effec- tive way to get ahead of change and reset the course of the organization by improving information access. The right platform address four key challenges: discovering information, managing information, market research and keeping data connected as key personnel or leave, file types and formats change and organizational goals and priorities evolve. It all comes down to balancing access and security of information and ensuring that every department is speaking the same language (see Figure 2). Departments and medical specialties are all tribes. Cardiology and nephrology each have their own jargon, as do regulatory and marketing. In order to share information in useful ways, each group must be able to speak with and work with other tribes within the organization. They need an internal Rosetta Stone to foster communication, understanding and decision making across the siloes. OpenText Confidential. ©2018 All Rights Reserved. 4 Intelligence requires insight across information sources 30% of delays in decision making is due to lack of data integration 40% of operational costs are lost in simple cross departmental information sharing Lack of historical context doubles the cost of early drug discovery Sources: KPMG, Accenture, Forbes, Lancet, NEJM, internal RD Figure 2: Innovation in drug discovery requires diverse information sources. Figure 1: Intelligence requires insight across information sources. Sources: KPMG, Accenture, Forbes, Lancet, NEJM, internal. OpenText Confidential. ©2018 All Rights Reserved. 7 Old files Innovation in drug discovery requires diverse information sources Post-release Discovery es iscovery Incompatible sources Lost knowledge Data connections Market research
  3. 3. BRINGING INTELLIGENCE TO DRUG DISCOVERY Different Sources, Same Language The original Rosetta Stone was a translation key, inscribed on stone, that linked Egyptian hieroglyphics with Greek and enabled modern scholars to read ancient Egyptian writings. Biopharma organizations face similar translation challenges. They must reconcile information from published sources such as PubMed or scientific journals with information gleaned from disease-specific patient interest groups, social media, images, audio and more. Information may appear as scrupulously formatted documents, visual or audio files, handwritten notes, transcripts, articles, informal notes, postmarketing data and more. The organization must identify which information sources are appropriate to include in decision making for different levels, times and purposes (see Figure 3). The first step is to separate the information from the format in which it appears. All documents and other information sources that come into the organization electronically, in hard copy or in some other format can be sorted and stored automatically in a centralized information repository. From there, it is a matter of applying access tools that allow anyone within the organization to access the central repository in ways that promote informa- tion access while ensuring information security. For example, any item that mentions cardiology but does not include identifying data such as billing or patient identification could be available to everyone in the cardiology unit from management through basic research while items that include patient ID might be restricted to specific clinical trial personnel. Broadening access to information can transform the organi- zation by encouraging innovative thinking. The drug discovery pathway extends from new molecule to drug candidate to testing, approval, marketing and use. Biopharma traditionally builds information roadblocks between each stage to enhance information security. What those roadblocks really ensure is information gaps. Attempting to bridge those gaps produces 45% of all information breaches, according to data security surveys by Ponemon, Verizon and Calypitix. The most common scenario is someone trying to get the job done as expeditiously as possible. Passing key information to an internal colleague via an external means such as files on a flash drive may be efficient, but it is also a data breach. So too is deleting data an employee believes may have negative implications for the company. This has lead to the industry to lock down information in an attempt to limit data breaches. There are some examples that this may in fact be harming innovation and bring a different type of risk to companies that do not have the ability to control information access intelli- gently. For example, communication and access to information is a key reason why Pfizer had a failed cardiac drug, silde- nafil, that a few investigators noted had unusual sexual side effects. Those side effects were discussed informally inside and outside the company, which could potentially be a data breach, without the NDA agreements that clinical trial doctors typically sign to allow them to communicate with the company. The chatter eventually reached the development team, which realized this one failed agent might point the way to an entirely new class of drugs and Viagra was born. In today’s digital environment, it is paramount that organizations increase their chance of this type of innovation through better information security and access controls. “Information management can turn potential savings into real dollars by using artificial intelligence to proactively present information to different users based on their needs. ” Figure 3: Detach information from format to ensure findability. OpenText Confidential. ©2018 All Rights Reserved. 9 Standardize,classifyandroute Extractinformation,organize sourcefilesconnecttoexisting Detach information from format to ensure findability AUTOMATED SORTING FULL-PAGE IMAGE TEXT-BASED ANALYSIS PRECISION ANCHORS HAND- WRITING Content analysis Text-based analysis Source classification Handwriting Data extract Full text Index Competitive Operations Trials Public relations User-based search Workgroup- based predictive content surfacing Find
  4. 4. THE IMPORTANCE OF CONTEXTUAL INFORMATION AT ALL LEVELS While data breaches are a big deal, organizations have as a rule unnecessarily secured access to legitimate additional information sources that may provide key information and cost savings. PubMed searches and other sources suggest that about 75% of the preclinical work done in biopharma to establish a therapeutic index (i.e., the range between a thera- peutic dose and a fatal dose) for potential drug candidates is duplicated in academic and other settings. Because most biopharma firms lack an information management platform, they have no way to incorporate, verify and apply that kind of outside information. It costs about $600,000 to build each preclinical therapeutic index. The typical pharma is working on 15 candidates at any one time, a cost of about $9 million. Being able to incorporate outside research could save 75% of the effort, $7 million annually and hundreds of millions of dollars longer term by eliminating more candidates with narrow therapeutic indexes earlier in development. Information management can turn potential savings into real dollars by using artificial intelligence to proactively present information to different users based on their needs. About 80% of what any given user sees falls within the everyday scope of their job. The real payoff is in the other 20% that may be only tangentially relevant or possibly just interesting—like a failed cardiac drug that sometimes produced erections. Dusty Archives, Old Files Pfizer was lucky that sildenafil didn’t drift into the archive of failed and forgotten candidates that every developer accumu- lates. In an era when discovery costs are hitting $200 million and a launched drug costs another $500 million or more, the opportunity to find a new case for even a single failed agent is immense. Alzheimer’s disease, among others, is being associated with a growing number of drugs that were not originally con- sidered for the disease. Organizations that have intellectual property rights and easy access to lab notebooks, trial results and other data for older agents are ahead in the discovery game. There may be ways to retarget genes associated with specific diseases to different classes of drugs or vice versa. New, seemingly unrelated research may suggest new targets. These are all very real possibilities, but cannot happen in any organized and repeatable fashion unless researchers have unhampered access to archival material to help them better understand past success and failures. Most organizations scan or digitize, then archive informa- tion, which is promptly forgotten. What is needed are ways for today’s researchers to search and explore yesterday’s information in ways that are relevant to current projects. In addition to fully indexing and connecting old data, that means extracting data from formats that may not be compatible with current technologies. Most organizations have caches of archaic tape and floppy drives that may contain valuable data but cannot be read without access to equally archaic drives that may not be easily interfaced with current technology. A concerted effort to locate old files and extract the data can pay dividends far into the future (Figure 4). As the transition from paper to digital gathers momentum, information management is giving way to content manage- ment. The promise is contextual information, bringing the right information to the right person at the right time across every step and every department that is part of the development process from initial discovery to postmarketing surveillance. Every organization has a treasure trove of information in files, contracts, social media, online news, endpoint data, images, published and unpublished research and lab notebooks more. The tools already exist to provide new insight and new intelligence across these multiple information sources. As the pace of technological innovation builds, the organizations that develop or hire the expertise needed to apply these new tools will be in the best positions to bend their innovation curves up and their cost curves down. Figure 4: Protect your drug discovery pipeline through understanding past success and failures. OpenText Confidential. ©2018 All Rights Reserved. 15
  5. 5. Protect your drug discovery pipeline through understanding past success and failures Capture Digitize where needed Validate edge cases VisualizeProcess, Classify, Extract Manage Central Information Repository

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