October 2008
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INDUSTRY INSIGHT Of particular interest was the keynote presentation by Steven S. Little who wrote The Milkshake Moment: Overcoming Stupid Systems, Pointless Policies and Muddled Management to Realize Real Growth. Little illustrated how internal business processes can stymie innovation, because no one will step outside of routines to truly deliver what the customer needs. He encouraged us to balance internal and external focus to understand how to better deliver to customers. He reminded us that the marketplace should be defining “better” – not our internal teams. Little thinks that even in a tough economy, individuals can plant seeds of growth – especially by finding ways to save money. Both Little and IBM partner Romas Pencyla cited the importance of talented workers as key for growth. According to IBM’s 2008 Global CEO Study among life sciences executives, employee retention and training are expected to become even more paramount to companies’ success over the next three years. Aegis’ commitment to customers’ training continues to grow, evidenced by our recent conference and training courses announced in this newsletter. Many thanks to those who joined us and helped continue to make this an annual success. We learned a tremendous amount from you that will benefit ongoing efforts of both product development and customer service. We look forward to seeing all of you at next year’s event.
Customer Success Stories: Users from Biogen Idec, Eli Lilly and Merck Serono shared valuable lessons learned through their Discoverant implementation process and daily use. One implementation began in process development and is moving to manufacturing, and another has scaled globally. A company with two domestic sites using Aegis’ solution says its “manufacturing science community is addicted to Discoverant, generating 600 charts each week.” Future Discoverant: Aegis led a discussion about potential features for Discoverant 4.0, which will help to bring the Discoverant architecture to next stage to support new user and IS requirements. Themes under consideration relate to system needs, user/admin needs and connectivity. Beyond version 4.0, Aegis envisions adding features and functionality to support the broader use of data for “observational analysis” throughout the enterprise. Measuring ROI: A panel discussion with Abbott, Bristol-Myers Squibb and Eli Lilly examined how to make the business case for Discoverant. Companies provided examples of what worked in their organizations to demonstrate the need for the software and its potential return on investment. Participants agreed that a visionary decision maker helped to champion the adoption of Discoverant. In all cases, company leaders and/or site level directors were looking for solutions to access data. In one case, a strategic decision to be a pharmaceutical company vs. a “software” company led to purchasing Aegis’ COTS package. Estimations of reduced APR preparation time and saved batches were consistently cited across companies to demonstrate efficiency as a key benefit. On the process development side, shortening time to market and the CMC preparation process were key metrics. One company cited a deviation holding up a process that threatened to shut down the inventory and supply chain. A Discoverant power user was able to solve the problem in a matter of hours. Each company has its own methods of attempting to quantify the time investigations take. One company estimated a 90 percent reduction in time required to gather data for one APR. Hands-on Training: Discoverant users advanced their knowledge of product stability analysis, visual process signatures, transition analysis, acceptance reporting using alerts, creating annual product reviews and other reports, and setting up hierarchies – connecting to multiple data sources. User and Administrator Resources:
If you are interested in learning more, please contact info@aegiscorp.com. Online Customer Resource Center Goes Live At its customer event, Aegis launched its new online Customer Resource Center (CRC) and Self Service, a new Support feature that allows the designated Support contacts for an organization to enter and monitor Support cases directly. The CRC gives customers with qualifying agreements their own private web portal with links to resources, such as the customer’s account team, forms to submit feedback and requests, a collaboration tool to post internal discussions, and a link to Aegis’ Community of Practice external discussion group. Content resources – including articles, best practices, presentations, product demonstrations and technical briefs – can be easily accessed in a central repository. "We expect the Customer Resource Center to help customers and our support organization share a deeper level of content much more efficiently,” said Aegis’ Geri Studebaker. “Working across global time zones, it will be most helpful to have information at customers’ fingertips.” Customers can contact their account executives to activate their customized portals.
Analysis Group Manager
InVision
PRIMR
Statistics Course Designed for Life Sciences Manufacturers This instructor-led course contains lectures and hands-on exercises covering:
The course is designed for upstream and downstream manufacturing team members, QA/QC team members and mid- to senior-level managers. An advanced course will be offered for experienced statistics users who want to start using methods, such as multifactor ANOVA and multivariate statistics, on a routine basis. For more information and registration, visit: http://www.aegiscorp.com/products/training.html. For information on pricing or to schedule a course, please contact info@aegiscorp.com.
Collaborating with a CMO (Sponsor’s Perspective)
Inc. magazine recently listed Aegis at number 3,310 on its annual ranking of the 5,000 fastest-growing private companies in the country. The 2008 Inc. 5,000 list measures revenue growth from 2004 through 2007. To qualify, companies must be U.S. based, privately held and have had at least $200,000 in revenue in 2004, and $2 million in 2007. See the complete list of companies at www.inc5000.com.
Aegis’ President and CEO Bob Di Scipio shared the impact Discoverant has made on life sciences manufacturers’ businesses at the Venture Capital in the Rockies (VCIR) Fall conference in September in Sun Valley, Idaho. Showcasing the most promising emerging growth companies from the Rocky Mountain region, the conference assembled hundreds of investors, CEOs, entrepreneurs and service professionals to network and learn first hand about the venture funding and entrepreneurial opportunities that are flourishing throughout the region.
How do you account for multi-step processes, where steps are run separately with different batch/run IDs? Discoverant Hierarchies can be modeled to support multi-step processes, where batches may be split or combined between process steps. Using a “Step Hierarchy,” users can select the parameter set identifier for the step in the process relevant to their analysis. Data can be retrieved from that step or any other step in process, and it will be organized by the parameter set identifier from the selected process step. Discoverant Step Hierarchies can be used to map linear processes, allowing for pooling and splitting, and views can be developed to skip over optional steps. Branches in the process must be integrated within the main process flow. In a Step Hierarchy, the Step View linking batches of the current process step to the subsequent step is configured by:
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