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Generic pharmaceutical manufacturers should proceed with caution when developing generic versions of Avandia®, (Rosiglitazone maleate), according to experts at GenericsWeb...
Avandia® Patents Afford Protection Against Generic Competition , Sep 5, 2006 – Generic pharmaceutical manufacturers should proceed with caution when developing generic versions of Avandia®, (Rosiglitazone maleate), according to experts at GenericsWeb.  Analysis of their Pipeline Patent Intelligence reveals that the patent situation surrounding this product is very complex, and is likely to be problematic for lesser-informed generic developers, especially those developing for multiple markets. GlaxoSmithKline’s (GSK) oral medicine Avandia® is indicated to treat type 2 diabetes and belongs to the group of thiazol…

We would like to invite you to join us here at our offices in Maidenhead, Berkshire from 10.30 onwards to 14.30.
Saturday 9th September 2006, i3 are opening our doors from 10.30…………. We would like to invite you to join us here at our offices in Maidenhead, from 10.30 onwards to 14.30. You will have the chance to meet our experienced recruitment team for both internal i3 opportunities and opportunities with our Pharma Resourcing division. Please bring along your questions and an updated CV, should you be interested. We will also be holding a number of presentations during this time. We cover a number of areas…. Clinical Research Associates Data Management Project Managers Clinical Trials Administrators Finance Entry- level opportunities (partnership training course) Quality Assuran…

In an earlier field report, we looked at some of the issues surrounding manufacturing process instructions (MPIs) and manufacturing process records (MPRs). I want to look at the issue of recording data in MPRs in more detail, as the format of your MPR has a huge impact on its usability and therefore the error rate.
There are a number of different aspects to data recording and formatting. Each is considered separately below. Overall structure Structure is important for two reasons: it helps your users find their way around, and it can help to reduce the number of signatures required in the document.The structure of your MPR is necessarily related to the structure of your MPI; indeed, the two may be combined as one document. If your instructions are just that – a list of instructions with n…

Paul Hawkins, the General Secretary for the Health and Beauty Association, tells us his philosophy for career progression and how the H&BA’s new website will help them to progress. The website itself promotes HBA’s attempt to bring Health and Beauty companies together in debating and discussing how to develop and adapt the industry to meet changing customer and consumer needs. Paul hopes the move towards e-business will do just that.
Focus On: Paul Hawkins Paul Hawkins, the General Secretary for the Health and Beauty Association, tells us his philosophy for career progression and how the H&BA’s new website will help them to progress.  The website itself promotes HBA’s attempt to bring Health and Beauty companies together in debating and discussing how to develop and adapt the in…

You may not exactly be breaking into the gold vaults at Fort Knox, scaling the heights of MI5 à la James Bond or hacking into The Pentagon security system, but you want to enter the pharmaceutical industry, which can be nearly as difficult.
You may not exactly be breaking into the gold vaults at , scaling the heights of MI5 à la James Bond or hacking into The Pentagon security system, but you want to enter the pharmaceutical industry, which can be nearly as difficult.  However, the industry is currently undergoing rapid growth and development providing interest and opportunity for the feisty new graduate.  Despite this, available positions are limited and competition is fierce so you have to demonstrate that enthusiasm, drive and ability you know you have.  Read up and be k…

With overall healthcare spending set to continue rising, payers are implementing cost containment measures, increasing the importance of developing a robust and flexible pricing and reimbursement (P&R) strategy. In formulating and adapting a P&R strategy, it is vital for drug developers to understand how P&R fits into the US healthcare market, and to identify the different types of P&R controls.
In the , the two most important payers are the Center for Medicare and Medicaid Services (CMS) and private payers. Therefore, it is becoming increasingly important for drug developers to set up P&R policy tracking and to implement P&R strategy that is capable of rapidly responding to changes in the P&R environment. The introduction of Medicare Part D in January 2006 highlights the imp…

Candidate Profile: Paul Collins Current Job Title: Clinical Project Manager II Department: Clinical Commenced with ICON: July 1997
Candidate Profile: Paul Collins Current Job Title:  Clinical Project Manager II Department: Clinical Commenced with ICON: July 1997 Paul Collins is a Clinical Project Manager II at ICON and has worked for them since July 1997.  Paul explains the reasons for the longevity of his career at ICON and why he enjoys the working environment so much he has stayed there for nine years.  Paul answers our questions and describes his step by step journey to the top of the career ladder, recounting the support and development he received at every rung. 1. Can you summarise your career history with ICON? I started with ICON as a student during m…

Andy Sarfas is our mover and shaker of the week. He is the Global Internet Business Manager for Reckitt Benckiser.
Focus On: Andy Sarfas   Andy Sarfas is our mover and shaker of the week.  He is the Global Internet Business Manager for Reckitt Benckiser and is responsible for consumer portfolios ranging from household to healthcare, for example popular products Calgon and Clearasil.  Reckitt Benckiser’s values are summed up in four simple words: Achievement, commitment, entrepreneurship and teamwork, which Andy believes is reflected in their commitment to the development of online marketing.  Andy tells us how he enjoys the travel this role allows him to partake in, (but admits he is less thrilled with travelling to and from every day), and discusses the future of mar…

David Mitchell is the Commercial Director at McNeil Consumer Healthcare, a company that produces remedies for self-treatment available at pharmacies and supermarket stores.
Focus on: David Mitchell Every week we will be providing a light hearted focus on the movers and shakers in the Pharma industry.  We will be quizzing them about their thoughts on e-business and its future in the industry, whilst also divulging some trivia about their personal lives.  David Mitchell is the Commercial Director at McNeil Consumer Healthcare, a company that produces remedies for self-treatment available at pharmacies and supermarket stores, an area he feels will become ever more significant over the next few years. David answers our questions this week, giving us an insight into everything from hi…

Alex Bishop is the IT Business Manager at Pfizer, the largest supplier of medicines to the NHS.
Focus on: Alex Bishop Alex Bishop is the IT Business Manager at Pfizer, the largest supplier of medicines to the NHS.  Pfizer has an extensive range of prescription only medicines treating diseases such as infections, arthritis, depression, heart disorders, and certain types of cancer.  With the motto, “life is our life’s work”, Pfizer strive to lengthen and enrich people’s lives by providing them with better health. This week Alex talks to us about his love of the industry, his love of sport and his aspirations for love in his personal life.   1. Where and when did you start out in the industry? I started out in the Pharmaceutical Industry with Warner Lambert (remember…

Because of the ever-increasing costs of healthcare provision the world over, many governments are enacting legislation to promote generic prescription in order to keep costs down. With drugs worth $160 billion in sales coming off patent by 2015, it would seem a good time to be in the generics industry. However the generics market is not without challenges.
The rise in healthcare expenditure internationally has led to governments implementing a variety of cost-containment policies, with increased generic use being a fundamental part of these. In the , for example, the growing cost of healthcare provision is affecting the ability of companies to be competitive. Meanwhile in , it is predicted that if healthcare spending continues to grow at the current rate, the health system will be bankrupt…

Manufacturing Instructions and Records: Operators are expected to follow manufacturing instructions to produce a product that meets the required specification. Typically these instructions will be written by technical experts, the chemical engineers who were responsible for the technology transfer, the process validation and so on.
Manufacturing Instructions and Records Operators are expected to follow manufacturing instructions to produce a product that meets the required specification.  Typically these instructions will be written by technical experts, the chemical engineers who were responsible for the technology transfer, the process validation and so on.  They may be comprehensive and detailed, but that doesn’t make them good. Manufacturing process instructions (MPIs) are…

Networking: What is it and How do you do it?
What is networking?A definition is provided by the Oxford Dictionary: network n. & v. a group of people who exchange information, contacts, and experience for professional or social purposes. You might consider networking to make new friends, find a new job, develop your current career, explore new career options, obtain referrals or sales leads, or simply to broaden your professional horizons. Whatever the reason, it is important to focus on networking as an equal exchange of information, contacts or experiences.Networking helps you make connections in a personal context to build relationships of support, respect and to create mutual benefits. It is a skill set no serious professional can be without.Networking StepsEarly Bird – Much of th…

Every sponsor or CRO can expect their country’s regulatory agency to arrive on their premises periodically to conduct routine inspections. In the UK, for instance, the Medicines and Healthcare products Regulatory Agency (MHRA) conducts routine periodic inspections approximately every three years. Apart from these, the MHRA also conducts “for cause” and “follow up” inspections, and they also take part in the third-country inspection program. Because all inspections may be either announced or unan
By Triona Coll – Quality Assurance. i3 Research Every sponsor or CRO can expect their country’s regulatory agency to arrive on their premises periodically to conduct routine inspections. In the UK, for instance, the Medicines and Healthcare products Regulatory Agency (MHRA) conducts routine periodic…

Dr Mark Ballard, the Medical Director of Respiratory and Dermatology Therapeutic Areas at the Novartis Pharmaceuticals Corporation answers our questions about their eczema cream Elidel.
Dr Mark Ballard, the Medical Director of Respiratory and Dermatology Therapeutic Areas at the Novartis Pharmaceuticals Corporation answers our questions about their eczema cream Elidel.1. Can you very briefly summarise the results of the recent study on the effect of Elidel on eczema sufferers?  How reliable are these findings?It was a global study mainly conducted in Europe, Italy and Switzerland. It was a standard controlled study approved by the regulators. The study ran over a six-week period, consisting of a randomized double-blind phase followed by a six-week open-label phase.  It main…

Doctors taking part in a survey on Alzheimer’s Disease (AD) management have called for clear and consistent guidelines on diagnosis and treatment of the condition to be drawn up as a matter of urgency. The survey was sponsored by Eisai Europe Ltd and Pfizer Inc, who market the cholinesterase inhibitor Aricept (donepezil), and was presented during the International Conference on Alzheimer’s Disease and Related Disorders.
Call for guidelines on when to stop or continue drug treatment for Alzheimer’s Disease Doctors taking part in a survey on Alzheimer’s Disease (AD) management have called for clear and consistent guidelines on diagnosis and treatment of the condition to be drawn up as a matter of urgency.  The survey was sponsored by Eisai Europe Ltd and Pfizer Inc, who market the c…

The Treasury is aware of a growing trend, which has recently moved into the pharmaceutical sector, for staff to be provided to clients through “umbrella” or “composite” companies. These companies promise a golden scenario of reduced costs to their clients and greater take-home pay to the individuals who work through them.
Sheltering under an Umbrella? Hidden in the detailed materials published by the Treasury at the time of this year’s Budget was the following (paragraph references are to the Budget Red Book) “5.85 Since the Pre-Budget Report, further evidence has emerged that employment income is being disguised as dividends in order to take advantage of the small companies’ tax rate, often encouraged by promoters of mass-marketed managed service company schemes. There is also evidenc…

Atrial fibrillation (AF) is the most common form of arrhythmia, or irregular heartbeat, with an estimated nine million sufferers worldwide. Although safe, effective treatment for AF is critical, historically there has been little R&D investment and little innovation in the AF market. However, this may be about to change, with the AF market expected to triple by 2015.
Arrhythmia is defined as an irregular heart rhythm, or an abnormality in the timing or pattern of the heartbeat, causing the heart to beat too rapidly, too slowly, or irregularly. Due to the complex nature of the condition, comprehensive epidemiology data on the prevalence of arrhythmia as a whole is difficult to come by. However, accurate data does exist for AF, the most common form of arrhythmia; it suggests a prevalence of c…

Cognitive behaviour therapy (CBT) combines two very effective kinds of psychotherapy delivered face to face by medical therapists
New Tools for Mental Health Professionals: Computerised Cognitive Behavioural Therapy (CCBT) in Primary Care Cognitive behaviour therapy (CBT) combines two very effective kinds of psychotherapy delivered face to face by medical therapists: Behaviour therapy helps weaken the connections between troublesome situations and habitual reactions such as fear, depression or rage.  Cognitive therapy teaches how certain thinking patterns may be causing the symptoms, by giving a distorted picture of what’s going on, crating anxiety, depression or anger without rational explanation.  CBT is a very powerful tool for stopping symptoms and getting life back on track.…

In the last report we analysed part of an SOP control system for inefficiencies and opportunities for error, by mapping the system and asking ‘what if?’ at each stage. But, as we mentioned previously, documentation systems (or, indeed, any type of control system) rarely operate in isolation. So let’s look at some of the inputs and outputs there might be on a typical site, using the same process as before.
System Analysis (2) – System Interaction In the last report we analysed part of an SOP control system for inefficiencies and opportunities for error, by mapping the system and asking ‘what if?’ at each stage.  But, as we mentioned previously, documentation systems (or, indeed, any type of control system) rarely operate in isolation.  So let’s look at some of the inputs and out…