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Developing a Skill Base for the Future: With a narrow focus in industry on antibody related products, we may find ourselves in danger of developing a workforce with too specific a skillbase. Tony Hitchcock makes the case for industry working closer with education bodies to make a career in industry more appealing to students read more
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GSK Lead the Way with Staff Training for Disposables Implementation: "With regards to the design of single use systems it is apparent that the best people to assess how the systems should be designed and the process ergonomics are the operational staff themselves"- Columnist Tony Hitchcock explains the GSK approach, presented at the recent Disposables Solutions for Biomanufacturing Conference. read more
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Off the shelf bio-processing: There is a risk of missing great opportunities in Disposable Solutions for Biomanufacturing if developments are simply restricted to those solutions which offer short term commercial attractions to the industry. read more
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Disposable Systems - Where Next?: Single-use systems are increasingly becoming the norm for all but very large scale processes. In his column this month, Tony Hitchcock, Head of Manufacturing Technologies at Cobra Biomanufacturing asks where will technology go in the future or is it just a case of driving down costs and increasing standardisation? read more
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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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Making it Happen: Change Management Issues in Artwork Improvement Programmes: Andrew Love employs his experience in change management issues that can happen in an artwork improvement programmes. Taking a person-centric approach to these management difficulties, the important issues in improvement programmes are raised and essentials for how organisations can chart their way through these stormy seas is outlined. read more
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Packaging & Labelling: The Technology Side: Technology is a necessary and useful part of any packaging, labelling and artwork capability, it is practically impossible to operate an artwork capability today without some elements of technoloy, columnist, Andrew Love explains. read more
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Packaging and Labelling: Organisation and Governance: Andrew Love looks at how roles are structured to support the packaging and labelling process and the governance that needs to be put in place to lead this. read more
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Packaging and Labelling: Artwork core, interfacing and supporting processes: Creating correct artwork is an activity that requires many groups to act together in an orchestrated way to deliver a successful result, on time. The way of ensuring that these people act together in a co-ordinated way is to define a set of processes that everyone adheres too. read more
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The Search for New and Innovative Excipients – Possible Applications of Semi Fluorinated Alkanes: Identifying delivery routes to optimise bioavailability is a core topic in delivering safer, more effective drugs to market. In his latest column, René discuses the chemically curious compounds, semi-fluorinated alkanes and their uses as excipients read more
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Buccal Delivery: Simple Physical Chemical Considerations: Efficient treatments options that are acceptable for both the patients and the physicians are the corner stones in drug development within the pharmaceutical industry. In his new column, 'Drug Delivery', René Holm, Head of Pre-formulation at Lundbeck looks at how Buccal delivery has been explored intensively during the last decade to overcome the disadvantages of oral drug delivery. read more
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Copy More! Copy Better!: In his latest column, Jonas explains the pharma industry should re-examine its aversion to copying and how this aversion can restrict innovation. He then makes the case that 'follow-on' drugs are good for companies and patients. read more
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Not even wrong - The Failure of Drug Likeness Rules: Jonas Boström, of AstraZeneca explains how the idea of drug-likeness rules has been controversial ever since Lipinski introduced his rule of five for predicting oral bioavailability 15 years ago. Read more read more
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New EU Regulations: One of the most important developments to come out of the new EU Pharmacovigilance regulations is the requirement for the preparation of Risk Management Plans (RMP) for all new submissions including generic submissions, Regulatory Expert and Columnist, Deepa Arora explains. read more
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Pharmacovigilance: 5 Predictions for 2013: Wondering what 2013 might look like for Pharmacovigilance, here are some predictions that can help you with better planning… read more
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Safety Data Exchange Agreements: As more pharma organizations’ collaborate, sharing their expertise, it is important that all parties are in agreement of their role and that a degree of compliance exists. Deepa Arora explains these agreements, which are better known as Safety Data Exchange Agreements. read more
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Indian Regulatory Authority Releases Draft Guidelines for Ethics Committees: The Indian Regulatory Authority, the Drugs Controller General for India (DCGI) , has released draft guidance for Ethics Committees to determine the amount of financial compensation to be paid by the sponsor in cases of injury or death in clinical trials. 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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Why so many FDA Recalls?: Looking at the FDA website for the recalls over the last few years is shocking & disappointing. Columnist Tye Spillum reflects on the consequences this has on the Pharma market and proposes solutions to prevent so many. read more
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Global Supply Chain Risk Management Strategies: Managing Risks & Threats in Global Logistics View All Posts
Logistics: Who is Responsible for Compensation when Deliveries Fail?: Insurance is critical for the safe delivery of your products. Mark Edwards, Global Freight Manager at Actavis, shares tips on pitfalls to avoid and speaks of his own experience which shows why it must be a priority for any organisation. read more
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Ten Rules of Good Manufacturing Practice: A basic introduction to GMP which explains the key points and how these can be effectively communicated to staff. 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
| 24 column results |
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Events of Interest
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Compound Management & Integrity Online 2011
November 14, 2011
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Regenerative Medicine and Barriers to Commercialisation Online Summit 2011
October 25, 2011
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Electronic Laboratory Notebooks Online
December 2, 2011
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Drive Successful Commercial Product Launches through Effective Key Packaging
February 7, 2013
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