Articles
An interactive, intensive, one-day workshop designed to help you master the key skills required to manage and produce high-quality, submission-ready clinical study reports
An interactive, intensive, one-day workshop designed to help you master the key skills required to manage and produce high-quality, submission-ready clinical study reports.introductionThe production of clinical study reports is an essential component of any clinical development programme. One of the keys to a successful submission is the inclusion of documents that are well-written, clear and precise, that are therefore easy to read and understand and intuitive to navigate. "Mastering the essential skills: clinical study reports" is an interactive, intensive, one-day workshop designed to help you master the key skills req…
An interactive, intensive, one-day workshop designed to help you master the key skills required to manage and produce high-quality, submission-ready clinical study reports.introductionThe production of clinical study reports is an essential component of any clinical development programme. One of the keys to a successful submission is the inclusion of documents that are well-written, clear and precise, that are therefore easy to read and understand and intuitive to navigate. "Mastering the essential skills: clinical study reports" is an interactive, intensive, one-day workshop designed to help you master the key skills req…
SIRT increases progression free survival colorectal cancer patients with liver mets
Adding selective internal radiation therapy (SIRT) to first-line chemotherapy in patients with metastatic colorectal cancer (m CRC) spread only to the liver significantly increased median progression free survival compared to chemotherapy alone, finds the latest analysis of the SIRFLOX study presented at the ESMO 17th World Congress on Gastrointestinal Cancer, 1-4 July, Barcelona.While SIRT was granted CE Mark approval in the EU in 2002 for unresectable liver tumours and has been reviewed by NICE for treatment of primary and secondary liver cancers, there have never been large randomized controlled trials in combination with first-line standard-of-care chemotherapy. The SIRFLOX study, representing the larges…
Adding selective internal radiation therapy (SIRT) to first-line chemotherapy in patients with metastatic colorectal cancer (m CRC) spread only to the liver significantly increased median progression free survival compared to chemotherapy alone, finds the latest analysis of the SIRFLOX study presented at the ESMO 17th World Congress on Gastrointestinal Cancer, 1-4 July, Barcelona.While SIRT was granted CE Mark approval in the EU in 2002 for unresectable liver tumours and has been reviewed by NICE for treatment of primary and secondary liver cancers, there have never been large randomized controlled trials in combination with first-line standard-of-care chemotherapy. The SIRFLOX study, representing the larges…
New chemoablative approach for hepatocellular carcinoma and metastatic liver disease
One patient with hepatocellular carcinoma (HCC) and one with colorectal cancer (CRC) metastatic to the liver demonstrated non-existent liver cancer after a single injection of PV-10, reports a study presented at the ESMO 17th World Congress on Gastrointestinal Cancer, 1-4 July, Barcelona, Spain.Patients with HCC have a poor prognosis with median survivals of 10 to 11 months despite sorafenib use first line. Furthermore, liver metastases develop in nearly 20% of patients with stage II and 50% of patients with stage III colorectal cancer and represent the major cause death in this disease.PV-10, a 10% solution of rose bengal originally used an agent to stain necrotic tissue in the cornea, has already demonstr…
One patient with hepatocellular carcinoma (HCC) and one with colorectal cancer (CRC) metastatic to the liver demonstrated non-existent liver cancer after a single injection of PV-10, reports a study presented at the ESMO 17th World Congress on Gastrointestinal Cancer, 1-4 July, Barcelona, Spain.Patients with HCC have a poor prognosis with median survivals of 10 to 11 months despite sorafenib use first line. Furthermore, liver metastases develop in nearly 20% of patients with stage II and 50% of patients with stage III colorectal cancer and represent the major cause death in this disease.PV-10, a 10% solution of rose bengal originally used an agent to stain necrotic tissue in the cornea, has already demonstr…
09-Jul-2015
New dementia care guidance is published
Following the Prime Minister’s 2012 challenge to improve dementia care by 2015, PAS 1365 Code of practice for the recognition of dementia-friendly communities in England has been published by BSI, the UK’s National Standards Body. The guidance has been developed in conjunction with Alzheimer’s Society and the Department of Health. It has had collaborative input from organizations including Age UK, the Dementia Action Alliance (DAA) and Public Health England.There are an estimated 850,000 people living with dementia in the UK with numbers set to rise to over 1 million by 2021, and expected to soar further to over 1.7 million by 2050. Currently two thirds of people with dementia live in the community and 70 per cent of people in care homes have dementia…
Following the Prime Minister’s 2012 challenge to improve dementia care by 2015, PAS 1365 Code of practice for the recognition of dementia-friendly communities in England has been published by BSI, the UK’s National Standards Body. The guidance has been developed in conjunction with Alzheimer’s Society and the Department of Health. It has had collaborative input from organizations including Age UK, the Dementia Action Alliance (DAA) and Public Health England.There are an estimated 850,000 people living with dementia in the UK with numbers set to rise to over 1 million by 2021, and expected to soar further to over 1.7 million by 2050. Currently two thirds of people with dementia live in the community and 70 per cent of people in care homes have dementia…
Plasticell has developed a technology called CombiCult®, which, as a high-throughput platform that uses combinatorial cell culture technology to screen tens of thousands of protocols in one single experiment, overcomes a key industry challenge.
Massively Parallel Combinatorial ScreeningWell-Known Technique Can Significantly Improve the Production of BiotherapeuticsDiana Hernandez, Ph.D.The challenges for the industrial production of medicinal products are substantial. For biologics in particular, the process defines the product. As with any process, a series of units of operation must be completed, controlled, and analyzed. For each unit of operation a number of steps exist and at each step a number of possible variables may be present that impact the critical quality attributes (CQA)…
Massively Parallel Combinatorial ScreeningWell-Known Technique Can Significantly Improve the Production of BiotherapeuticsDiana Hernandez, Ph.D.The challenges for the industrial production of medicinal products are substantial. For biologics in particular, the process defines the product. As with any process, a series of units of operation must be completed, controlled, and analyzed. For each unit of operation a number of steps exist and at each step a number of possible variables may be present that impact the critical quality attributes (CQA)…
Longer breaks between shifts promote nurses' recovery from work
Reducing short breaks between shifts helps nurses recover from work, according to a new study from Finland. The study analysed the effects of longer rest and recovery periods between shifts on heart rate variability, which is an indicator of recovery.Shift work can increase the risk of many diseases, for example cardiovascular diseases. The increased risk is partially caused by insufficient recovery from work, which interferes with the normal function of the autonomic nervous system regulating heart function and blood pressure, among other things. Nurses have too little time for rest and recovery especially in the backwards-rotating shift system, which allows less than 11 hours of rest between the night and the morning shift.Th…
Reducing short breaks between shifts helps nurses recover from work, according to a new study from Finland. The study analysed the effects of longer rest and recovery periods between shifts on heart rate variability, which is an indicator of recovery.Shift work can increase the risk of many diseases, for example cardiovascular diseases. The increased risk is partially caused by insufficient recovery from work, which interferes with the normal function of the autonomic nervous system regulating heart function and blood pressure, among other things. Nurses have too little time for rest and recovery especially in the backwards-rotating shift system, which allows less than 11 hours of rest between the night and the morning shift.Th…
11-May-2015
Why Pharma CIOs and CMOs need to get along
The pharmaceutical industry is currently going through a period of considerable upheaval. Indeed, as we’ve written recently, it could be suggested that the entire sector is in crisis and in need of fresh ideas. These challenges include the ever-nearing patent cliff and an overall lack of rendering many organisations unable to meet the demands of modern, global markets. One additional issue that hasn’t always initially sprung to mind is the lack of collaboration between Chief Marketing Officers (CMOs) and Chief Information Officers (CIOs); however a recent Accenture study found that solving this particular issue could directly benefit businesses in a number of ways. So with this in mind, what did the survey reveal and how can these two roles work to…
The pharmaceutical industry is currently going through a period of considerable upheaval. Indeed, as we’ve written recently, it could be suggested that the entire sector is in crisis and in need of fresh ideas. These challenges include the ever-nearing patent cliff and an overall lack of rendering many organisations unable to meet the demands of modern, global markets. One additional issue that hasn’t always initially sprung to mind is the lack of collaboration between Chief Marketing Officers (CMOs) and Chief Information Officers (CIOs); however a recent Accenture study found that solving this particular issue could directly benefit businesses in a number of ways. So with this in mind, what did the survey reveal and how can these two roles work to…
20-Apr-2015
The Arrival of the “Age of Abundance”
We are surrounded by millions of everythingWe are swamped with unlimited options, ideas, goods and services, intricate possibilities and simply drowning in overflow…never in the history of mankind have we had so much so easily and simultaneously available for so many in so many aspects across the farthest corners of the world. The arrival of the age of abundance is now a mainstream challenge for all creators and producers of ideas, goods and services. On one side we are witnessing the transformation from the ‘age of scarcity’ to the ‘age of abundance’ on the other we are in a massive global flood drowning the ordinary, mediocrity and old age execution.We are in the age of abundanceIt all started out with the “age of curiosity” where in the earlier darke…
We are surrounded by millions of everythingWe are swamped with unlimited options, ideas, goods and services, intricate possibilities and simply drowning in overflow…never in the history of mankind have we had so much so easily and simultaneously available for so many in so many aspects across the farthest corners of the world. The arrival of the age of abundance is now a mainstream challenge for all creators and producers of ideas, goods and services. On one side we are witnessing the transformation from the ‘age of scarcity’ to the ‘age of abundance’ on the other we are in a massive global flood drowning the ordinary, mediocrity and old age execution.We are in the age of abundanceIt all started out with the “age of curiosity” where in the earlier darke…
As the Affiliate Role Becomes More Sales Focused, Regulatory Functions Come into View
The role of the affiliate has been under the microscope for many years, with discussion going back and forth about the relative merits of managing regulatory and pharmacovigilance functions at the affiliate office versus from the centre.Questions about the merits of having on-the-ground regulatory and pharmacovigilance personnel in each market have been raised, but little progress was made in answering those questions. It had been thought that harmonisation and standardisation of the submission process—first through the common technical document (CTD) and next through the electronic CTD—would simplify the affiliate’s role in handling dossiers. In fact the opposite was true. Then the expectation became that…
The role of the affiliate has been under the microscope for many years, with discussion going back and forth about the relative merits of managing regulatory and pharmacovigilance functions at the affiliate office versus from the centre.Questions about the merits of having on-the-ground regulatory and pharmacovigilance personnel in each market have been raised, but little progress was made in answering those questions. It had been thought that harmonisation and standardisation of the submission process—first through the common technical document (CTD) and next through the electronic CTD—would simplify the affiliate’s role in handling dossiers. In fact the opposite was true. Then the expectation became that…
02-Apr-2015
Pharma in crisis – what does it mean for talent?
As we’re all aware, the pharmaceutical industry has been going through something of a revolution in recent years. A number of issues, including the approaching patent cliff and a lack of innovation from major firms have meant that the current industry business model is unsuitable and unsustainable when it comes to meeting the demands of the global markets. Some reports have suggested that the arena is expanding and is set to double in size by 2020, however it’s likely these figures have been affected by firms diversifying their offering and moving into other sectors. What we do know is that the market is changing, but what does this mean for skills demands?We’ve now reached the end of the blockbuster drug era with around 110 major produ…
As we’re all aware, the pharmaceutical industry has been going through something of a revolution in recent years. A number of issues, including the approaching patent cliff and a lack of innovation from major firms have meant that the current industry business model is unsuitable and unsustainable when it comes to meeting the demands of the global markets. Some reports have suggested that the arena is expanding and is set to double in size by 2020, however it’s likely these figures have been affected by firms diversifying their offering and moving into other sectors. What we do know is that the market is changing, but what does this mean for skills demands?We’ve now reached the end of the blockbuster drug era with around 110 major produ…
BIOVISION: Fifty promising life sciences start-ups and projects selected for April 15 and 16
The selection committees have identified 25 companies seeking funding for the Investor Conference and 25 innovative projects for the Catalyzer session Lyon, France, March 26, 2015 – BIOVISION, the annual forum on future-oriented research in life sciences organized by the Fondation pour l'Université de Lyon, today announces the list of biotech and medtech companies and projects selected for the Investor Conference and Catalyzer pitching sessions. The third BIOVISION Catalyzer and Investor Conference sessions continue to engage project sponsors and start-up participation from France and around the world. Between 2013 and 2015, the two sessions respectively received 180 and 200 applications.&…
The selection committees have identified 25 companies seeking funding for the Investor Conference and 25 innovative projects for the Catalyzer session Lyon, France, March 26, 2015 – BIOVISION, the annual forum on future-oriented research in life sciences organized by the Fondation pour l'Université de Lyon, today announces the list of biotech and medtech companies and projects selected for the Investor Conference and Catalyzer pitching sessions. The third BIOVISION Catalyzer and Investor Conference sessions continue to engage project sponsors and start-up participation from France and around the world. Between 2013 and 2015, the two sessions respectively received 180 and 200 applications.&…
16-Dec-2014
Mega Collision of 15 Monster Trends in 2015
No matter what your position, location, size of your operation, the following 15 trends starts to collide and open up amazing and instant opportunities for you. And yet, if you are not fully prepared to recognize and adjust accordingly, they will bite you like a big great white shark in deep water…guaranteedDark Television:A series of new platforms will seriously disturb global traditional TV media. The supremacy of modern television is seriously challenged and being over taken by massive intelligent streaming. The constantly dumb-down often fake ‘breaking news’ blended with silly reality shows are now being replaced by highly categorized intelligent and customized contents with instant online streaming access from all over the world creating your…
No matter what your position, location, size of your operation, the following 15 trends starts to collide and open up amazing and instant opportunities for you. And yet, if you are not fully prepared to recognize and adjust accordingly, they will bite you like a big great white shark in deep water…guaranteedDark Television:A series of new platforms will seriously disturb global traditional TV media. The supremacy of modern television is seriously challenged and being over taken by massive intelligent streaming. The constantly dumb-down often fake ‘breaking news’ blended with silly reality shows are now being replaced by highly categorized intelligent and customized contents with instant online streaming access from all over the world creating your…
12-Dec-2014
How to write a pharmaceutical CV
Applying for jobs can often be a difficult and time-consuming process, particularly in the current climate in which jobs are scarce and the number of applicants high, despite the continuing economic recovery.The pharmaceutical sector is recovering from the recession, but it's important to ensure your application is as strong as possible to make sure employers take notice.Recruiters often have a huge number of CVs to get through and only a short amount of time available in which to view them. You should therefore ensure your CV achieves maximum impact - you need to prove you are the best person for the job.Apex Recruitment modifies the CVs it receives into an Apex standard format that can be easily used by employers. However, it is still important to ensure C…
Applying for jobs can often be a difficult and time-consuming process, particularly in the current climate in which jobs are scarce and the number of applicants high, despite the continuing economic recovery.The pharmaceutical sector is recovering from the recession, but it's important to ensure your application is as strong as possible to make sure employers take notice.Recruiters often have a huge number of CVs to get through and only a short amount of time available in which to view them. You should therefore ensure your CV achieves maximum impact - you need to prove you are the best person for the job.Apex Recruitment modifies the CVs it receives into an Apex standard format that can be easily used by employers. However, it is still important to ensure C…
11-Dec-2014
Things NOT to put on your CV for a Pharma Job
So you've got your CV up to date, and filled with lots of juicy relevant experience and qualifications. Now it's time to think about some things you DON'T want to include...ClichésRemove any obvious Clichés like team player, innovative, results orientated. These are so over used that they mean nothing. Leave them out.ReferencesYou don't need to say “references available on request”. It's not 1980 and you're not applying for your first job in a bank.Old or irrelevant experienceTake out anything that's not relevant, or more than 10 years old - it only serves to clutter up your CV. Use the space to provide more recent / relevant experience and achievements.ObjectivesYour objective is to get a job, so there’s no point in saying that - Employers are…
So you've got your CV up to date, and filled with lots of juicy relevant experience and qualifications. Now it's time to think about some things you DON'T want to include...ClichésRemove any obvious Clichés like team player, innovative, results orientated. These are so over used that they mean nothing. Leave them out.ReferencesYou don't need to say “references available on request”. It's not 1980 and you're not applying for your first job in a bank.Old or irrelevant experienceTake out anything that's not relevant, or more than 10 years old - it only serves to clutter up your CV. Use the space to provide more recent / relevant experience and achievements.ObjectivesYour objective is to get a job, so there’s no point in saying that - Employers are…
02-Dec-2014
Pharmaceutical interviews - preparation is key feature from Apex International
Job interviews can be a daunting experience at the best of times, so it's particularly important in the current climate to ensure you are well-prepared for this stage of recruitment.Preparing for a pharmaceutical interview is in many respects similar to applying for positions in other high-status professions. Punctuality, a confident manner and a professional appearance are essential parts of any successful job interview.It is also important that candidates spend an appropriate amount of time researching and familiarising themselves with both the company and the role for which they are being considered before the day of the interview.Recruitment for permanent pharmaceutical roles is often carried out in different…
Job interviews can be a daunting experience at the best of times, so it's particularly important in the current climate to ensure you are well-prepared for this stage of recruitment.Preparing for a pharmaceutical interview is in many respects similar to applying for positions in other high-status professions. Punctuality, a confident manner and a professional appearance are essential parts of any successful job interview.It is also important that candidates spend an appropriate amount of time researching and familiarising themselves with both the company and the role for which they are being considered before the day of the interview.Recruitment for permanent pharmaceutical roles is often carried out in different…
PV-10 and checkpoint inhibitor enhance melanoma regression
In mouse models of melanoma adding check point inhibitors to intralesional (IL) PV-10 improved tumour regression and stimulated immune response, reports a study presented at Society for Immunotherapy of Cancer (SITC) Annual Meeting, 6-9 November, National Harbor, Maryland, USA¹.An earlier phase 2 study showed injecting IL PV-10, into the lesions of 80 stage IIIB-IV melanoma patients refractory to a median of six prior interventions, delivered a best overall response rate of 51% and complete response rate of 26%. PV-10, a 10% solution of Rose Bengal taking its name from the dot that signals marriage on the foreheads of women in Bengal, was originally used in liver function studies and to detect eye disease. It has been developed by P…
In mouse models of melanoma adding check point inhibitors to intralesional (IL) PV-10 improved tumour regression and stimulated immune response, reports a study presented at Society for Immunotherapy of Cancer (SITC) Annual Meeting, 6-9 November, National Harbor, Maryland, USA¹.An earlier phase 2 study showed injecting IL PV-10, into the lesions of 80 stage IIIB-IV melanoma patients refractory to a median of six prior interventions, delivered a best overall response rate of 51% and complete response rate of 26%. PV-10, a 10% solution of Rose Bengal taking its name from the dot that signals marriage on the foreheads of women in Bengal, was originally used in liver function studies and to detect eye disease. It has been developed by P…
Patients with stage IIB-IV melanoma who had cutaneous and subcutaneous melanoma lesions injected with PV-10 showed marked differences in progression free survival according to number of lesions injected, reported the latest data from a phase 2 trial presented at the 2014 European Society for Medical Oncology (ESMO) Congress, held Madrid, Spain, 26 to 30 September.
The rationale for PV-10, a 10% solution of Rose Bengal developed first as a dye, is that the agent has a local chemo ablative effect where it enters lysosomes causing local necrosis, and then in some patients a systemic effect believed to be immunologically mediated. Previous studies have demonstrated increased CD8+, CD4+, CD3+ and NKT in peripheral blood within seven days of injection.In the open label phase 2 study 80 patients w…
The rationale for PV-10, a 10% solution of Rose Bengal developed first as a dye, is that the agent has a local chemo ablative effect where it enters lysosomes causing local necrosis, and then in some patients a systemic effect believed to be immunologically mediated. Previous studies have demonstrated increased CD8+, CD4+, CD3+ and NKT in peripheral blood within seven days of injection.In the open label phase 2 study 80 patients w…
09-Dec-2014
PharmiWeb.com is pleased to offer on-line training courses in partnership with ePharma Global.
These online courses are designed by a team of experts with PhD's from leading Universities in the UK and clinical research experience from the world’s leading Pharmaceutical and Biotechnology industries.We are able to provide you with access to bespoke on-line training courses that will provide your students with the skills that are needed to enter and understand the Pharmaceutical and Biotechnology Industries. We are also able to meet individual training needs. Clinical Project Manager (CPM) Clinical Trial Administrator (CTA) Clinical Research Associate (CRA) Good Clinical Practice (GCP) Responding to an Audit Report (QA/QC)An Introduction: Preparation for a site audit Pharmacovigilance Associat…
These online courses are designed by a team of experts with PhD's from leading Universities in the UK and clinical research experience from the world’s leading Pharmaceutical and Biotechnology industries.We are able to provide you with access to bespoke on-line training courses that will provide your students with the skills that are needed to enter and understand the Pharmaceutical and Biotechnology Industries. We are also able to meet individual training needs. Clinical Project Manager (CPM) Clinical Trial Administrator (CTA) Clinical Research Associate (CRA) Good Clinical Practice (GCP) Responding to an Audit Report (QA/QC)An Introduction: Preparation for a site audit Pharmacovigilance Associat…
02-Oct-2014
PharmiRecruiter Feature
I know it’s pretty competitive out there for recruiters, but there is one underhand practice that some unethical recruiters use that should be stamped out.That is, the use of “fishing” or fake job applications; this underhand technique is the ploy of applying for jobs but pretending to be a candidate with a great CV, with the aim of trying to find out which employers are currently recruiting.So applying for multiple jobs under a fake name like “Mark Cook”, “Thomas Brown” or “Alan Stewart” etc. clearly wastes recruiter’s time and undermines the work they’ve legitimately put in finding the client in the first place. Secondly it’s lazy – why not do some real prospecting rather than relying on someone else doing the real work?From PharmiWeb’s point of view, it’s somethin…
I know it’s pretty competitive out there for recruiters, but there is one underhand practice that some unethical recruiters use that should be stamped out.That is, the use of “fishing” or fake job applications; this underhand technique is the ploy of applying for jobs but pretending to be a candidate with a great CV, with the aim of trying to find out which employers are currently recruiting.So applying for multiple jobs under a fake name like “Mark Cook”, “Thomas Brown” or “Alan Stewart” etc. clearly wastes recruiter’s time and undermines the work they’ve legitimately put in finding the client in the first place. Secondly it’s lazy – why not do some real prospecting rather than relying on someone else doing the real work?From PharmiWeb’s point of view, it’s somethin…
