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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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A Revolutionary Paradigm Shift in Big Pharma's Organisational Development: A paradigm is the conceptual framework upon which we build our world; it is built upon past experiences; if we are not willing to make shifts in our paradigms, we will remain stagnate in our growth; a paradigm shift is a change from one way of thinking to another; it is something that does not happen like self generation it is driven by change. read more
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Taxing “Globesity” To Save Our Children: Will “Fat taxes” affect consumption, and eventually obesity? The impact of imposing taxes on the consumption of certain foods depends on the responsiveness of consumers to price changes, i.e. price elasticity. It is difficult to predict how consumers will react to price changes caused by taxation. read more
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Big Pharma Cannot Afford to be Lost in Translation: Since more and more clinical research and drug manufacturing are being done in multiple countries and in multiple languages, quality language services can help bring a drug to market faster, and can help streamline the clinical trial process. Translation may be required at many stages, including clinical research, regulatory submission and review, production and marketing. read more
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Personalized Medicine –A Game with More Than One Nash Equilibrium: PM is no longer about the pharma industry alone – the players/stakeholders go far beyond the pharmaceutical and biotechnology industries, presenting a new challenge in assembling diverse technologies and partners working together. Success in this space will require new approaches, new relationships, and new ways of thinking. read more
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Whose Lab Kung Fu is Best?: In the movies no single person ever had the best Kung-Fu right from the start of the film. There were strikes on both sides and you saw that they quickly learned the strengths and weaknesses about themselves and their opponent. read more
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Being An Instrument of Change: Ask your colleague, “How can I make it easier for you when transferring over these products?” By doing this you are making the job easier for you and for them. How? read more
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Top 5 things You Need to Know about Inventory: Inventory is one of the primary wastes in lean thinking and is also the hardest for people to change their mindset about. I’ve compiled my list of the top 5 items you need to know in order to understand the downfall of having Inventory laying around. read more
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Today’s Countermeasure is Tomorrow’s Standard: Areas of rapid growth and change cycle their “standard” processes quickly. Those that do manufacturing are much slower at developing countermeasures because of the checks and balances that need to be taken into consideration during implementation. read more
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Implementing QbD Initiatives: But what is Quality? How do you measure Quality? Is Quality related to a product, a process or a system or all above? The Quality Transformation is a culture of commitment to continual improvement read more
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Value-Based Pricing in 2012 – Is it Still Worth the Trouble?: As the old aphorism goes, a New Year means a new beginning. It also provides an opportunity for all of us to make New Year resolutions – promises we make to one or more lasting personal goals, projects, or the reforming of a habit. In the world of health policy, this has added meaning. The Government continues to face opposition to its NHS reforms. 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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Biopharma Suppliers’ Budgets Increase: Bellwether for Better Times: Biopharmaceutical companies have weathered a rough recession, layoffs, and budget trimmings. These cutbacks have affected their vendors as well. In BioPlan Associates’ 8th Annual Report and Survey of Biopharmaceutical Manufacturing, we surveyed 352 biotherapeutic manufacturers, and 180 of their vendors, in 32 countries. The substantial budget cuts at vendors that started in 2008 have begun to turn around. We measured 10 budget areas for vendors to this industry. Sales budgets, the only area that did not take a downturn, continued to increase, this year, by an average of 5% globally. read more
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Single Use Device Adoption Impacted by Slow Standards Setting: Leachables and extractables category, (which also leads the 2011 list of Factors Restricting Use of Disposables) are a key concern. Worries over “leachables and extractables” have increased for both groups over the past 4 years. read more
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Higher Tech Outsourcing Repositions CMOs: While many biomanufacturers continue to view outsourcing as part of their cost reduction approach, more are considering how they can incorporate outsourcing of the technical more complex upstream and downstream operations as part of their business strategy. If biopharma companies hold to these plans, the outsourcing arena may change considerably over the next few years. read more
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Single Use Bioreactors Lead in New Use and Market Penetration: Single use technologies are strong change agents in biopharma manufacturing. Disposable devices emerge once again as a top new technology of interest among the 352 surveyed biomanufacturers in BioPlan Associates, Inc.’s 2011 8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production. 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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The Future Potential of Human Limb Regeneration: Salamanders and newts can regenerate missing legs, tails and eyes in just weeks! Why can’t mammals possess the same super powers of regeneration as these smaller animals? read more
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Solving the Challenges of Stem Cell Tissues: Although there are many political and scientific hurdles that need to be overcome, the future of regenerative medicine is strongly racing forward. read more
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Patent Drafting and Claim Construction: To determine whether the patentee has right to exclude for a particular claimed invention, it is essential to know what is claimed and this process is called determining the scope of the invention or claims construction. read more
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Pharmacoepidemiology and Pharmacovigilance: As an important arm for pharmacovigilance, recently many voices are raised to consider using clinical trials in the post-marketing surveillance phase and not only depending on non-clinical or experimental methods to study drug safety issues after marketing the drug. read more
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Medication Errors - A Shared Responsibility: We can not separate pharmacovigilance from medication errors, pharmacovigilance had always been concerned with minimizing the risks of adverse drug reactions and medication errors. Pharmacovigilance contributes to the detection and prevention of medication errors, collaboration of all parties will improve the quality of data collected, and enhancing patient safety. A shared responsibility, in detecting Medication Errors depends on the collaboration of the patient, the pharmaceutical companies, the pharmacovigilance centers, and poison control centers. read more
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Global Drug Safety and Risk Management: The role of pharmaceutical companies is to decide how to manage the results of an AE signal. Some drug companies develop and prepare the safety programs that are implemented from the moment drugs when enter their product portfolio. Also collecting and analysing data in an advance way is an important tool in drug safety and risk management program. In this concern, whatever the approach selected, each program needs to be reasonably relevant to the nature of the risk. When a signal of a potential side effect is detected it should be documented with its response. read more
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Patients Safety and Clinical Trials: Emerging new safety data may result in an action plan by the pharmaceutical company producing a drug to review its data retrieved during the clinical trail phases and especially in Phase II conducted to demonstrate and assess the product’s safety. read more
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Events of Interest
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Global Pharmaceutical Distribution 2012
Venue to be Confirmed, Amsterdam, The Netherlands
September 18- 19, 2012 -
Cool Chain Logistics 2013
Congress Center Basel, Basel, Switzerland
January 28- 30, 2013 -
Information Governance & eDiscovery for Pharma, Biotech and Medical Devices
London, UK
June 26- 28, 2012 -
Cold Chain Global Forum 2012
Chicago, IL
September 24- 28, 2012
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