Pharmaco - Articles

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…

A well-run documentation system will support your business processes and improvements, not hold them back. How do you ensure that this is the case?
System Analysis (1) – Document Creation A well-run documentation system will support your business processes and improvements, not hold them back.  How do you ensure that this is the case? Let’s look first at what is required of a good documentation control system: 1.       Documents must be version-controlled, with traceability on all changes.  You have to be able to demonstrate which version you were using on a particular date, and, essentially, ensure that everyone is using the correct version. 2.       Review and approval cycles need to be well-managed.  This is a h…

PowderMed has submitted an application to UK regulators seeking to conduct human trials of its avian influenza vaccine. Developing an effective vaccine against the next influenza pandemic is a challenging task, but one many companies are taking on. However, until a virus able to cause a pandemic emerges, no one knows for certain which product will be most effective.
PowderMed: flying ahead in avian flu PowderMed has submitted an application to regulators seeking to conduct human trials of its avian influenza vaccine. Developing an effective vaccine against the next influenza pandemic is a challenging task, but one many companies are taking on. However, until a virus able to cause a pandemic emerges, no one knows for certain which product will be most effective. PowderMed has applied to…

Treatment of chronic kidney disease (CKD) is focussing increasingly on prevention of cardiovascular complications with the aim of reducing the cardiovascular mortality and morbidity to which many patients currently succumb.
Role of Arenesp and cinacalcet in protecting hearts of renal patients Treatment of chronic kidney disease (CKD) is focussing increasingly on prevention of cardiovascular complications with the aim of reducing the cardiovascular mortality and morbidity to which many patients currently succumb. Recognition of the fact that it is heart disease rather than renal failure that kills most CKD patients, and that the risks start early in the disease process, was reinforced a couple of years ago when an analysis of the Kaiser Permanente Renal Registry of 1.1 million patients was…

Hints and Tips: Survive in the Work Place Part Two
It’s good to talkPeople like it when you take time to call. A five minute phone call can do the work of several emails because you can hear someone’s tone of voice and gauge reaction.Plan to talkJust because the phone is an informal medium you can still plan an agenda of the points you need to cover and decide what information you need from the other person.Be politeIf your mobile rings during a land-line call, forward it to voicemail. Taking the call is equivalent to looking over someone’s shoulder while they are talking with you.Record itWhen you’ve had an important call, commit to paper what’s been said and agreed.Writing a one page overviewAn executive summary is all most people want or have time to read to make an informed decision o…

'Drug In Focus' is written by Leighton Howard, a patent information expert with extensive generics experience. He has worked within the professional patent information industry and major generic pharmaceutical firms and now provides consultancy services to the generics industry and government organisations via his company XIP Pty Ltd. He is also the founder of GenericsWeb and remains instrumental in maintaining the high quality and accuracy of data contained in Pipeline Patent Intelligence.
As a provider of comprehensive patent intelligence to generic pharmaceutical companies in over 25 countries, GenericsWeb frequently fields questions about how we identify and select relevant patents for inclusion in our Pipeline Patent Intelligence. This article is not intended to explain exactly how we…

A new class of drug for tophaceous gout, the first to be developed in 40 years, is generating hope for patients currently unable to tolerate or respond to standard therapies.
A new class of drug for tophaceous gout, the first to be developed in 40 years, is generating hope for patients currently unable to tolerate or respond to standard therapies. Puricase (PEG-Uricase), currently in phase III trials is being developed by Savient Pharmaceuticals Inc. a small company based in . Puricase is a polyethylene-glycolated recombinant version of the porcine enzyme, uricase.  All mammals except humans and primates produce the uricase enzyme which breaks down uric acid leaving very low levels in the circulation with no untoward effects. Uricase converts uric acid to the more water-soluble metabo…

The UK is the only country in Europe where patients with metastatic colorectal cancer (mCRC) do not have routine access to Erbitux (cetuximab) a drug with potential to extend survival and even cure some people, it was revealed recently.
The is the only country in where patients with metastatic colorectal cancer (mCRC) do not have routine access to Erbitux (cetuximab) a drug with potential to extend survival and even cure some people, it was revealed recently. Erbitux approved for treatment of mCRC in countries all over the world, thanks to a British-led study, is able to arrest growth and spread of aggressive tumours and causes cancer cell death. It is approved for use when irinotecan-based chemotherapy has failed.  However, trials of Erbitux used early in mCRC alongside several chem…

Baraclude (entecavir), a new oral drug developed by Bristol-Myers Squibb, recently approved by the European Commission for treatment of chronic hepatitis B viral (HBV) infections, is expected to become available in a few months in some countries of the EU, the Middle East and Africa.
Baraclude (entecavir), a new oral drug developed by Bristol-Myers Squibb, recently approved by the European Commission for treatment of chronic hepatitis B viral (HBV) infections, is expected to become available in a few months in some countries of the EU, the Middle East and . It will provide a much-needed new antiviral therapy in the face of widespread resistance to existing therapies, according to liver specialists who discussed the drug during the 12th International Symposium on Viral Hepatitis and Liver Di…

The FDA has approved Tibotec and Johnson & Johnson's HIV drug Prezista, enabling it to join Boehringer Ingelheim's recently launched Aptivus as one of just two second-generation protease inhibitors currently available. However, competition will be fierce as both drugs target similar patients in a crowded market where small differences in marketing approaches could impact hugely on sales.
The FDA has granted accelerated approval for Tibotec and Johnson & Johnson's anti-HIV protease inhibitor Prezista (darunavir, previously known as TMC114) co-administered with ritonavir for use in combination therapy in treatment-experienced patients who have failed other antiretroviral therapies.  Prezista belongs to a class of antiretrovirals known as protease inhibitors, or PIs. It is the secon…

ROCHE is set to file for a new indication for its oral, targeted cancer drug Xeloda® following impressive new data presented at the American Society of Clinical Oncology conference (ASCO).
ROCHE is set to file for a new indication for its oral, targeted cancer drug Xeloda® following impressive new data presented at the American Society of Clinical Oncology conference (ASCO). Jonathan Dickinson, Life Cycle Leader - Xeloda®, told Pharmiweb: “Roche plans to file in the next few months for a gastric cancer indication for Xeloda in Europe. The label will be for advanced gastric cancer, because that is what the data at this stage supports. Data in the future may support an indication for gastric cancer in the adjuvant setting.” Mr Dickinson predicted that, if granted, a new indication for Xelod…

Pharmaceutical companies are renowned for exhaustive pages of regulatory reports and documentation procedures. An enormous amount of effort goes into creating and maintaining these documentations, usually by people for whom it is only a small part of their job. Another problem is that complexity exists in such documents and may be due to an excess of information or to inappropriate structure. Again, historically there may have been a drive to put every little detail into the procedures, in t
Lean DocumentationDocumentation is the backbone of the pharmaceutical industry – the taken-for-granted support for GLP, GCP, GMP and many other regulations.  We have to document what we do, how we do it, the expected result, the actual result, what went wrong, what we did about what went wrong,…