Articles
2016: A critical year for compliance—and combative manoeuvres
As 2015 draws to a close—and with a number of important regulatory deadlines set to converge during the year ahead, data preparation efforts across the life sciences industry are reaching a peak. But what benefit do companies expect for their pains? wonders ProductLife Group’s Chief Operating Officer, John Farrell Data centralisation and harmonisation efforts are the preoccupations of regulatory teams across the life sciences industry because regulatory demands around product and process transparency have intensified. Activity reached a peak in 2015 as companies looked down the barrels of approaching deadlines, by which points a whole range of data must have been captured, managed, submitted, and updated in particular ways. Life…
As 2015 draws to a close—and with a number of important regulatory deadlines set to converge during the year ahead, data preparation efforts across the life sciences industry are reaching a peak. But what benefit do companies expect for their pains? wonders ProductLife Group’s Chief Operating Officer, John Farrell Data centralisation and harmonisation efforts are the preoccupations of regulatory teams across the life sciences industry because regulatory demands around product and process transparency have intensified. Activity reached a peak in 2015 as companies looked down the barrels of approaching deadlines, by which points a whole range of data must have been captured, managed, submitted, and updated in particular ways. Life…
As Biomedical companies from around the world take stock after attending the industry flagship MEDICA show in Duesseldorf, many will have sown the seeds of new partnerships, client relationships, and international research collaborations. For some, their company growth may be pointing to a rise in cross-border business and a need to consider an overseas presence – perhaps for the first time.
~~As Biomedical companies from around the world take stock after attending the industry flagship MEDICA show in Duesseldorf, many will have sown the seeds of new partnerships, client relationships, and international research collaborations. For some, their company growth may be pointing to a rise in cross-border business and a need to consider an overseas presence – perhaps for the first time. Connectin…
~~As Biomedical companies from around the world take stock after attending the industry flagship MEDICA show in Duesseldorf, many will have sown the seeds of new partnerships, client relationships, and international research collaborations. For some, their company growth may be pointing to a rise in cross-border business and a need to consider an overseas presence – perhaps for the first time. Connectin…
What can life sciences organisations learn from the investment banking sector?
With the most recent public debate on drug pricing, government healthcare budgets under scrutiny, ever more rigorous compliance and transparency demands, and problematic patent cliffs, is the life sciences sector heading for a modern day crisis? 2020 will see a surge in healthcare demand precipitated by an aging population with chronic care needs, income growth in emerging markets, and expansion in health insurance globally, with the industry having to shift to a more efficient management of costs as pressure from payers, reimbursement challenges and development costs increase. Most importantly there will also be a growing shortage of highly skilled and specialised talent in the industry. All of this is&nbs…
With the most recent public debate on drug pricing, government healthcare budgets under scrutiny, ever more rigorous compliance and transparency demands, and problematic patent cliffs, is the life sciences sector heading for a modern day crisis? 2020 will see a surge in healthcare demand precipitated by an aging population with chronic care needs, income growth in emerging markets, and expansion in health insurance globally, with the industry having to shift to a more efficient management of costs as pressure from payers, reimbursement challenges and development costs increase. Most importantly there will also be a growing shortage of highly skilled and specialised talent in the industry. All of this is&nbs…
26-Oct-2015
What Does a Biostatistician Do?
The Job of a Biostatistician
What is the Job of a Biostatistician? A Biostatistician must have a strong grasp of computing and mathematics and be capable of making logical decisions and deductions because their job is to combine math, statistics and science to provide relevant data monitoring for disease trends, preventive medicine, experimental treatments and many others. Biostatisticians must also be skilled interpreters because they must offer advice to clients or colleagues based on their data analysis. Job Responsibilities of a Biostatistician: Works with project team to decide on the appropriate study design and statistical methodology for routine designs Assists in the implementation of protocol methodology and statistical analysis plans Is re…
What is the Job of a Biostatistician? A Biostatistician must have a strong grasp of computing and mathematics and be capable of making logical decisions and deductions because their job is to combine math, statistics and science to provide relevant data monitoring for disease trends, preventive medicine, experimental treatments and many others. Biostatisticians must also be skilled interpreters because they must offer advice to clients or colleagues based on their data analysis. Job Responsibilities of a Biostatistician: Works with project team to decide on the appropriate study design and statistical methodology for routine designs Assists in the implementation of protocol methodology and statistical analysis plans Is re…
Mike Wood caught up with Austin recently following the renewal of Entrust’s recruitment contract with PharmiWeb.com. Entrust have been using PharmiWeb’s Job Posting and CV search since 2013.
Mike Wood caught up with Austin recently following the renewal of Entrust’s recruitment contract with PharmiWeb.com. Entrust have been using PharmiWeb’s Job Posting and CV search since 2013. MW: Austin, let’s start with Entrust, perhaps you could give me a quick overview? AC: Sure, Entrust People are a professional, dynamic and progressive resourcing consultancy specialising in the Life Science and Technology sectors. We have a dedicated team for each, and the Life Science team consists of specialists originally from the clinical research sector; so they “get the sector” and empathise and engage wel…
Mike Wood caught up with Austin recently following the renewal of Entrust’s recruitment contract with PharmiWeb.com. Entrust have been using PharmiWeb’s Job Posting and CV search since 2013. MW: Austin, let’s start with Entrust, perhaps you could give me a quick overview? AC: Sure, Entrust People are a professional, dynamic and progressive resourcing consultancy specialising in the Life Science and Technology sectors. We have a dedicated team for each, and the Life Science team consists of specialists originally from the clinical research sector; so they “get the sector” and empathise and engage wel…
22-Nov-2022
Study Start Up (SSU) Specialists act as subject matter experts on all SSU-related activities, overseeing and leading SSU activities in collaboration with other Clinical Research professionals. They are also involved in SSU process improvement, including patient recruitment strategies.
What are the Main Job Responsibilities of a Study Start-Up Specialist? Study Start-Up (SSU) Specialists act as subject matter experts on all SSU-related activities, overseeing and leading SSU activities in collaboration with other Clinical Research professionals. They are also involved in SSU process improvement, including patient recruitment strategies. The main responsibilities of an SSU Specialist may include: Reviewing and negotiating investigator contracts/budgets Tracking the status of contracts and con…
What are the Main Job Responsibilities of a Study Start-Up Specialist? Study Start-Up (SSU) Specialists act as subject matter experts on all SSU-related activities, overseeing and leading SSU activities in collaboration with other Clinical Research professionals. They are also involved in SSU process improvement, including patient recruitment strategies. The main responsibilities of an SSU Specialist may include: Reviewing and negotiating investigator contracts/budgets Tracking the status of contracts and con…
Modern Technology in Medicine: How it's changing the future of treatment
Technology is expanding on an ever-changing and regular basis. It has helped to achieve multiple breakthroughs in science and medicine, providing our society with new means of treatment that often lead to potential cures for various illnesses and diseases etc. Technology helps us to gather essential information, research and treatments that have changed and will continue to change the future of medical treatment. Improved Patient Care Technology does not just refer to the digital aspects of the term. It also refers to the practical and physical advances in modern technology such as the various medical supplies available on Brosch Direct. IT has also had a great advantage with regards to patient care as hospital staff…
Technology is expanding on an ever-changing and regular basis. It has helped to achieve multiple breakthroughs in science and medicine, providing our society with new means of treatment that often lead to potential cures for various illnesses and diseases etc. Technology helps us to gather essential information, research and treatments that have changed and will continue to change the future of medical treatment. Improved Patient Care Technology does not just refer to the digital aspects of the term. It also refers to the practical and physical advances in modern technology such as the various medical supplies available on Brosch Direct. IT has also had a great advantage with regards to patient care as hospital staff…
How can smaller pharmaceutical firms secure game-changing talent?
As we’re all well aware, the pharmaceutical sector is going through something of a challenging time. Innovation is down and a combination of growing financial pressures and technological advancements are forcing firms into reviewing their long-term strategies. While this period of transition has disrupted the sector, it’s also opened up a range of opportunities for more agile firms to make their mark. However, in order to seize this, they need to be able to recruit talented professionals ahead of their larger and generally more powerful rivals. On the face of it these bigger organisations can offer considerably more to the average pharmaceutical professional, so how can firms secure talent ahead of the major players? An eff…
As we’re all well aware, the pharmaceutical sector is going through something of a challenging time. Innovation is down and a combination of growing financial pressures and technological advancements are forcing firms into reviewing their long-term strategies. While this period of transition has disrupted the sector, it’s also opened up a range of opportunities for more agile firms to make their mark. However, in order to seize this, they need to be able to recruit talented professionals ahead of their larger and generally more powerful rivals. On the face of it these bigger organisations can offer considerably more to the average pharmaceutical professional, so how can firms secure talent ahead of the major players? An eff…
Business Development Training Course
Business Development Training Course PharmiWeb is pleased to announce that we are offering places on our new recruiter training course to be held at our Bracknell offices This is on a first-come-first-served basis, so if you’re interested...Contact Kelly Tipper to request info about the courses or reserve a spot PharmiWeb Promotional Business Development Training …
Business Development Training Course PharmiWeb is pleased to announce that we are offering places on our new recruiter training course to be held at our Bracknell offices This is on a first-come-first-served basis, so if you’re interested...Contact Kelly Tipper to request info about the courses or reserve a spot PharmiWeb Promotional Business Development Training …
01-Sep-2015
PharmiWeb.com Training Courses with Vincent Lody
Recruiter/Resourer Training CoursePharmiWeb is pleased to announce that we are offering places on our new recruiter training course to be held at our Bracknell offices This is on a first-come-first-served basis, so if you’re interested...Contact Kelly Tipper to request info about the courses or reserve a spotPharmiWeb Promotional Recruiter/Resourcer TrainingSuitable for any recruiter/resourcer in the industry with hints and tips on key elements of recruitment as well as information on how to be more successful.Course content Big Pharma RecruitmentIssues and StrategyRecruitment IssuesWhat’s stopping you achieving your targetsUK RecruitmentMarket overviewRecruitmentBeing a recruitment consultantUSP’sWhy youClient business…
Recruiter/Resourer Training CoursePharmiWeb is pleased to announce that we are offering places on our new recruiter training course to be held at our Bracknell offices This is on a first-come-first-served basis, so if you’re interested...Contact Kelly Tipper to request info about the courses or reserve a spotPharmiWeb Promotional Recruiter/Resourcer TrainingSuitable for any recruiter/resourcer in the industry with hints and tips on key elements of recruitment as well as information on how to be more successful.Course content Big Pharma RecruitmentIssues and StrategyRecruitment IssuesWhat’s stopping you achieving your targetsUK RecruitmentMarket overviewRecruitmentBeing a recruitment consultantUSP’sWhy youClient business…
28-Aug-2015
Phases of Clinical Trials
A clinical trial is a research study involving patients that can be used as a way of measuring effectiveness and safety as well as comparing different treatments or the level of side effects between different drugs. Clinical trials are also used to test new methods of screening, diagnostic tests etc. For a drug to enter everyday use it must first pass a series of clinical trials and then obtain approval from the appropriate regulatory agencies (EMA for European Union and FDA for USA).Clinical trials involving new drugs are commonly classified into three main phases (1, 2 and 3) but there is also a preclinical phase and a fourth phase. The phases of clinical drug research are the steps in which scientists do experiments in an attempt to find enough evidenc…
A clinical trial is a research study involving patients that can be used as a way of measuring effectiveness and safety as well as comparing different treatments or the level of side effects between different drugs. Clinical trials are also used to test new methods of screening, diagnostic tests etc. For a drug to enter everyday use it must first pass a series of clinical trials and then obtain approval from the appropriate regulatory agencies (EMA for European Union and FDA for USA).Clinical trials involving new drugs are commonly classified into three main phases (1, 2 and 3) but there is also a preclinical phase and a fourth phase. The phases of clinical drug research are the steps in which scientists do experiments in an attempt to find enough evidenc…
27-Aug-2015
Is M&A set to replace R&D in Pharma?
As has been previously reported, the pharmaceutical industry looks set to benefit from a strong 2015 thanks to an increase in the price of drugs and an increase in the number of sales. However, more recent reports have also emerged detailing how the internal structure of pharmaceutical companies are also set to change dramatically, alongside the dramatic increase in M&A activity in the sector.According to the VCCircle website, M&A activity in the pharmaceutical sector in the US surpassed $59.3 billion by March of this year, and overall global pharma deals announced from January to August of 2015 reached $284 billion. Mega-mergers across the globe are also taking place, with Shire hoping to acquire Baxalta, Mylan hoping to acquire Perrigo but faci…
As has been previously reported, the pharmaceutical industry looks set to benefit from a strong 2015 thanks to an increase in the price of drugs and an increase in the number of sales. However, more recent reports have also emerged detailing how the internal structure of pharmaceutical companies are also set to change dramatically, alongside the dramatic increase in M&A activity in the sector.According to the VCCircle website, M&A activity in the pharmaceutical sector in the US surpassed $59.3 billion by March of this year, and overall global pharma deals announced from January to August of 2015 reached $284 billion. Mega-mergers across the globe are also taking place, with Shire hoping to acquire Baxalta, Mylan hoping to acquire Perrigo but faci…
Healthcare apps and wearable tech have a long future in the treatment of patients, according to a panel of Primary Care Physicians (PCPs)[i] interviewed as part of a newly launched Ipsos Healthcare study.
“Digital Doctor” is the first study of its kind looking specifically at the attitudes of PCPs to new healthcare technologies. The annual study of PCPs, across the UK, France and Germany, will track trends in this emerging field, look to understand the level of engagement in new healthcare technologies, and identify concerns or barriers to adoption.Cautious optimismThe results show PCPs are wary of new health technologies, but 25% see a role for healthcare apps in the treatment of patients with certain conditions. As many as 72% have already used or recommended at least one form of digital…
“Digital Doctor” is the first study of its kind looking specifically at the attitudes of PCPs to new healthcare technologies. The annual study of PCPs, across the UK, France and Germany, will track trends in this emerging field, look to understand the level of engagement in new healthcare technologies, and identify concerns or barriers to adoption.Cautious optimismThe results show PCPs are wary of new health technologies, but 25% see a role for healthcare apps in the treatment of patients with certain conditions. As many as 72% have already used or recommended at least one form of digital…
Risk Management Opportunity in Health and Social Care
Individual businesses differ in their level of accountability or, to use a term from the safety management profession, maturity. In an immature industry, we rely on the behaviour, maturity and professionalism of the individual manager. Yet, as the industry grows, it becomes more complex and ever more difficult (impossible) for managers to maintain situational awareness and know what the hell is going on. This is the moment when the industry is ripe for a step change in management control. It cries out for great systems in order to cope, move forward and thrive at the next level.Sadly, the trajectory for change often involves undesirable events that, with hindsight, might have been avoided (such as financial failures, safety failure…
Individual businesses differ in their level of accountability or, to use a term from the safety management profession, maturity. In an immature industry, we rely on the behaviour, maturity and professionalism of the individual manager. Yet, as the industry grows, it becomes more complex and ever more difficult (impossible) for managers to maintain situational awareness and know what the hell is going on. This is the moment when the industry is ripe for a step change in management control. It cries out for great systems in order to cope, move forward and thrive at the next level.Sadly, the trajectory for change often involves undesirable events that, with hindsight, might have been avoided (such as financial failures, safety failure…
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…
