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Labs in Transition: The Digital Face of Laboratory Science: The problems facing modern laboratories in informatics are significant, with the regular implementation of new software and hardware labs can quickly find themselves overwhelmed. Our columnist Joe Liscouski guides you through the planning required for an implementation. read more
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Lab Automation: What we need to accomplish in 2013: If we accomplish one thing in 2013 it has to be a change in mindset, from “lab automation/computing is about products” to “lab automation/computing is about systems design”. read more
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Elements of Laboratory Technology Management: If lab automation is going to advance to the level of a discipline, which it needs to if we are going to take advantage of the capabilities available, it needs structure. read more
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Why the view from 30,000 feet is important: Given the rapid development of products and technologies for lab work, we need to spend a lot more time above the details of implementation, doing lab work, planning for technology use and the impact of changing corporate priorities read more
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Adapting to the Disruption in the Pharma Industry: Leadership Challenges & Building Culture for Continuous Change View All Posts
Adapting to Disruptive Change in the Pharmaceutical Industry: The Pharmaceutical Industry continues to change at what feels like an exponential pace. What used to be a stable industry now faces almost continual re-shaping as the life cycle of R&D and commercialisation adapts to new players and shapers. New Pharma IQ columnist, Andrew Parsons explains. read more
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REVIEW: 8th Annual Smartlabs Exchange: Columnist Sheraz Gul shares highlights of the recent 8th Annual Smartlabs Exchange. The main themes included the future of lab informatics, implementing solutions to improve efficiency, data integration and smart knowledge sharing, enabling a more efficient lab. read more
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The role of IT initiatives by the European "Innovative Medicines Initiative" in supporting drug discovery: We are currently witnessing an expansion in the disciplines encompassing drug discovery outside the pharmaceutical industry. This is most notable with a significant number of Universities worldwide now hosting infrastructures such as compound libraries and automated screening systems. read more
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Review: 11th Annual ELNs and Advanced Laboratory Solutions Conference: Sheraz Gul reviews the recent 11th Annual ELNs & Advanced Laboratory Solutions Conference, which recently took place in Milan read more
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Implementing an Electronic Laboratory Notebook (ELN) in pre-clinical drug discovery?: The pre-clinical phase of drug discovery involves many years of research being conducted by multi-disciplinary teams. These teams will read more
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Raising the bar: 5 Areas for Improvement within the Pharmaceutical Outsourcing (CDMO model): Within the last few years the Pharmaceutical industry has taken a change in direction. Outsourcing (CDMO - external manufacturing model) has become a normal course of business. read more
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A Guide to Ensure FDA Audits & Inspections are Successful: How can FDA Audits & Inspections for FDF (Finished Dosage Form) manufacturers be successful? Know the process and requirements. read more
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Compounding Pharmacies or Manufacturers?: Columnist Tye Spillum reflects on the recent FDA initiative to identify & inspect several of the top compounding pharmacies manufacturing sterile products, which began earlier this year. read more
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CDMO Quality Agreements: Reviewing the purpose of the Quality Agreement and looking at what degree the customer will be integrated into the manufacturing process from a Quality perspective. Communication, roles, responsibilities, requirements, expectations, level of control, and the decision making process are a few of the key areas. read more
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The Art of Measuring the ROI of ELNs - Keep it Real: Typical corporate business cases are created to demonstrate strategic alignment, define scope, identify risks, target resource requirements, obtain funds, and show the financial and operational benefits after the project has gone live, i.e. ROI. It’s this last set of measures that often remain elusive for ELNs, but are critical for project justification. read more
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Sustain Your ELN – Before You Start Your ELN: Change management can be found as a bullet under “critical success factors” in many Electronic Lab Notebook project charters. Touted as crucial in determining the success of an ELN, many agree in principle that change management is needed, but don’t know how to go about making it effective, tangible, and measurable. read more
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Peace in our Time? R&D and the IT Department: One of the consequences of the increasing convergence of science and technology is the nature of the relationship between R&D and IT. As scientists increasingly depend on information technology as an integral component of laboratory work, they become increasingly dependent on the IT infrastructure and IT resources. read more
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Management Buy-in and User Acceptance in an ELN Project: But the management commitment is also required throughout the implementation phases. Getting the balance right between hands-off and hands-on is critical; too much hands-off, and the project team and users get concerned whether management cares; too much hands-on and it can feel like interference and a lack of trust. read more
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Where Do the Ideas Come From?: When it comes to purchasing and implementing laboratory systems’ software, return on investment is inevitably one of the key drivers. The up-front requirements to justify the expenditure are usually aligned to process improvement and productivity often driven by a functional need to work with dispersed teams, across different sites, regions and time zones. But there’s usually a secondary, softer requirement aligned to return on investment, but more difficult to quantify, that alludes to an improvement in knowledge management within the organisation by making laboratory information explicit, accessible and reusable. read more
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What Every CRO Should Know When Becoming Fully Electronic: As the global CRO community studies how to most efficiently move to fully electronic business processes, there are numerous issues that must be addressed to assure secure global collaboration. These include identity trust, data integrity, regulatory compliance, and time and cost savings. read more
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Six Questions to Ask Before Investing in a Digital Identity or Digital Signature Solution: When evaluating any digital identity or digital signature solution, ask these questions. The answers will help determine if you’re about to get full value for this important decision read more
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Nobody Knows You’re a Dog: A few years ago, The New Yorker magazine published a cartoon of two dogs sitting in front of a computer monitor. One was explaining to the other: “On the Internet, nobody knows you’re a dog.” Given the regulated nature of the global biopharmaceutical industry, the explosion in global collaboration, and our reliance on the Internet, it is absolutely essential that we know and trust the identity of people on the other side of the screen. read more
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Your Sample ID’s are Too Complex – Stop the Insanity: Most of us started in a lab with one or two other techs labeling our tubes with a fine tip Sharpie marker and using an internal code that made it understandable to our small group of people. “MTO -15” meant Maybe This One sample 15 while testing a new compound or “12654A2-1” meant sample 12654, A = Tumor, 2 = DNA, and 1 = 1st isolation. read more
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OpEx for 2013 – Crystal Ball Predictions: To look forward we need to first look back. From 2008-2012 we saw big pharma collide creating larger companies. Genentech-Roche, Novartis-Alcon, Pfizer-Wyeth and GlaxoSmithKline-Human Genome Sciences just to name a few. During this same time frame the economies of the world have seen crashes and upheavals causing some of these same companies to “trim” their workforces. What does all this mean for 2013? read more
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Doctor Who – Change Agent with a TARDIS: What lean business knowledge can we learn from a fictitious doctor that travels through space and time in a shiny police box? Let’s discuss. read more
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Chunk it or Choke on it!: We’ve finished the future state map on how to fix the entire system but it’s going to take us at least a year, involve a ton of man hours and cost a lot of money. It also involves every department and it’s going to triple our daily work load until we get all the bugs worked out.” Have you heard this before? Did the idea flash and then fizzle? Next time….Chunk it! read more
Events of Interest
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Compound Management & Integrity Online 2011
November 14, 2011
Register Now -
Regenerative Medicine and Barriers to Commercialisation Online Summit 2011
October 25, 2011
Register Now -
Electronic Laboratory Notebooks Online
December 2, 2011
Register Now -
Drive Successful Commercial Product Launches through Effective Key Packaging
February 7, 2013
Register Now
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