Pharmaco - Articles
30-Jun-2016
Compliance - more than just red tape
Using regulatory criteria to improve product quality
A growing customer demand for regulatory compliance combined with increased competition amongst manufacturers has made SCADA software a minimum requirement for the pharmaceutical industry. Here, Lee Sullivan, Regional Manager at COPA-DATA UK discusses why today, more than ever before, regulatory compliance is crucial for the pharmaceutical industry.FDA statistics are forcing the industry to identify and implement improvements to its manufacturing processes. In its latest reports, the FDA identified a significant increase in the number of drug shortages reported globally. With 65% of these drug shortage instances directly caused by issues in product quality, it’s clear that if more pharma manufa…
A growing customer demand for regulatory compliance combined with increased competition amongst manufacturers has made SCADA software a minimum requirement for the pharmaceutical industry. Here, Lee Sullivan, Regional Manager at COPA-DATA UK discusses why today, more than ever before, regulatory compliance is crucial for the pharmaceutical industry.FDA statistics are forcing the industry to identify and implement improvements to its manufacturing processes. In its latest reports, the FDA identified a significant increase in the number of drug shortages reported globally. With 65% of these drug shortage instances directly caused by issues in product quality, it’s clear that if more pharma manufa…
16-Jun-2016
Alexander Mann Solutions
The culture of the pharmaceutical sector reveres talent and experience above all else – and with good reason. However, at a time when cuts in government spending, patent cliffs, significant talent shortages, and shifts in business focus between therapeutic areas are all threatening the stability of the sector, how can organisations best manage their workforces to ensure future success and profitability?As a historically cash-rich industry, pharma has long had the freedom to hire at will, often from within, but bold new business models coupled with drives towards efficiency are rapidly changing talent needs. The traditional approach to managing skill shortages has been to draft in expertise with little consideration to cost. While this strategy has worked well in t…
The culture of the pharmaceutical sector reveres talent and experience above all else – and with good reason. However, at a time when cuts in government spending, patent cliffs, significant talent shortages, and shifts in business focus between therapeutic areas are all threatening the stability of the sector, how can organisations best manage their workforces to ensure future success and profitability?As a historically cash-rich industry, pharma has long had the freedom to hire at will, often from within, but bold new business models coupled with drives towards efficiency are rapidly changing talent needs. The traditional approach to managing skill shortages has been to draft in expertise with little consideration to cost. While this strategy has worked well in t…
On-tap analytics: the key to getting ahead in 2016
Whether it’s meeting new regulatory imperatives or the need to position products differently, there are a wealth of challenges facing life sciences companies - and the key to overcoming most of them is the intelligence locked inside everyday data, says Elvis Paćelat, VP Compliance Solutions at AMPLEXOR Life SciencesThe root of the problem seems to be that information capture, management and discovery projects in the industry have evolved according to specific individual requirements; they have not be aligned with a broader vision for business transformation. But the hope is that this will change in 2016, because of intensifying competitive pressures, the need for new business models, and the requirement to be much more transparent with cust…
Whether it’s meeting new regulatory imperatives or the need to position products differently, there are a wealth of challenges facing life sciences companies - and the key to overcoming most of them is the intelligence locked inside everyday data, says Elvis Paćelat, VP Compliance Solutions at AMPLEXOR Life SciencesThe root of the problem seems to be that information capture, management and discovery projects in the industry have evolved according to specific individual requirements; they have not be aligned with a broader vision for business transformation. But the hope is that this will change in 2016, because of intensifying competitive pressures, the need for new business models, and the requirement to be much more transparent with cust…
23-May-2016
As a recruiter it' up to you to weed out the bad candidates from the pile, so what strategies do you use? - Here are a few types of candidate who are best avoided...
The Evasive Candidate You’ve more than likely come across this sort of candidate. Ask a straight-forward question, such as why they changed job/career path, and they’re unable to give you a straight answer. There might be valid reasons, but it might equally be because they’re hiding something, are unable to articulate or are uncomfortable being put on the spot. The Job Hopper This sort of candidate is easily spotted. Just look at their CV. Somebody who repeatedly changes job should be viewed with a degree of suspicion. It might be because they get bored easily; they are hard to work with; or they are so career driven that they…
The Evasive Candidate You’ve more than likely come across this sort of candidate. Ask a straight-forward question, such as why they changed job/career path, and they’re unable to give you a straight answer. There might be valid reasons, but it might equally be because they’re hiding something, are unable to articulate or are uncomfortable being put on the spot. The Job Hopper This sort of candidate is easily spotted. Just look at their CV. Somebody who repeatedly changes job should be viewed with a degree of suspicion. It might be because they get bored easily; they are hard to work with; or they are so career driven that they…
Tackling a credibility crisis: A watchout for Indian Pharmaceuticals
By Dev K. Ramchandani, Director & Head of India, Hitachi Consulting; and Vivek Chaturvedi, Vice President of EMEA, Hitachi Consulting The Indian pharmaceutical industry has been cited as a “flagship” sector by Prime Minister Modi’s government. It has one of the highest number of UDFDA, UKMHRA, WHO-GMP1 approved manufacturing facilities for medical ingredients and formulations outside of the US and Europe. These facilities are responsible for a quarter of all medicines consumed in the UK and they make nearly 40% of generic drugs and over-the-counter products sold in the US2 as well as many drugs and vaccines used by global aid agencies for health programmes. On paper, the industry is blossoming, so why in reality, is…
By Dev K. Ramchandani, Director & Head of India, Hitachi Consulting; and Vivek Chaturvedi, Vice President of EMEA, Hitachi Consulting The Indian pharmaceutical industry has been cited as a “flagship” sector by Prime Minister Modi’s government. It has one of the highest number of UDFDA, UKMHRA, WHO-GMP1 approved manufacturing facilities for medical ingredients and formulations outside of the US and Europe. These facilities are responsible for a quarter of all medicines consumed in the UK and they make nearly 40% of generic drugs and over-the-counter products sold in the US2 as well as many drugs and vaccines used by global aid agencies for health programmes. On paper, the industry is blossoming, so why in reality, is…
16-Mar-2016
The Science of Employee Engagement
A third of employees in the life science sector feel disengaged at work and a salary increase is not the solution. According to a recent survey carried out by leading international staffing agency – ProClinical – a third of staff working within the life sciences industry are disengaged in their jobs and at risk of leaving in the next 12 months. The survey of more than 1000 individuals employed in the life sciences industry, including pharmaceutical, medical device, biotechnology and contract research organisations in Europe, the USA and Asia Pacific, revealed that disengaged employees are twice as likely to leave and that it takes more than just a good salary to keep them motivated and loyal to their employers. The participants were asked a series of…
A third of employees in the life science sector feel disengaged at work and a salary increase is not the solution. According to a recent survey carried out by leading international staffing agency – ProClinical – a third of staff working within the life sciences industry are disengaged in their jobs and at risk of leaving in the next 12 months. The survey of more than 1000 individuals employed in the life sciences industry, including pharmaceutical, medical device, biotechnology and contract research organisations in Europe, the USA and Asia Pacific, revealed that disengaged employees are twice as likely to leave and that it takes more than just a good salary to keep them motivated and loyal to their employers. The participants were asked a series of…
Smarter steps to compliance: The future of regulatory compliance in the pharmaceutical industry
The pharmaceutical industry today operates in one of the world’s most heavily regulated environments. Over the past few years, the industry has experienced significant regulatory change and looking to the future, the strict nature of the industry doesn’t appear to be slacking. The repercussions of failing to comply with industry standards can be detrimental for pharmaceutical manufacturers. It’s no secret that the integrity and reputation of pharmaceutical brands is integral to their success. As a result, even the smallest failure can be irreversibly damaging. With industry standards surrounding crucial elements like product integrity, energy efficiency, health and safety and product testing, th…
The pharmaceutical industry today operates in one of the world’s most heavily regulated environments. Over the past few years, the industry has experienced significant regulatory change and looking to the future, the strict nature of the industry doesn’t appear to be slacking. The repercussions of failing to comply with industry standards can be detrimental for pharmaceutical manufacturers. It’s no secret that the integrity and reputation of pharmaceutical brands is integral to their success. As a result, even the smallest failure can be irreversibly damaging. With industry standards surrounding crucial elements like product integrity, energy efficiency, health and safety and product testing, th…
15-Jan-2016
Until life sciences companies are able to manage product lifecycle information holistically, their ability to seize new market opportunities will be limited, warns Mark Evenepoel, Group CEO at AMPLEXOR Life Sciences
Until life sciences companies are able to manage product lifecycle information holistically, their ability to seize new market opportunities will be limited, warns Mark Evenepoel, Group CEO at AMPLEXOR Life Sciences In 2016, the life sciences industry faces increasingly complex regulatory challenges and operational risks: the result of technology advances, clinician and patient expectations, and a globally-connected healthcare market. But unless organisations tackle the association product data management challenges holistically, they could be running up high levels of expense…
Until life sciences companies are able to manage product lifecycle information holistically, their ability to seize new market opportunities will be limited, warns Mark Evenepoel, Group CEO at AMPLEXOR Life Sciences In 2016, the life sciences industry faces increasingly complex regulatory challenges and operational risks: the result of technology advances, clinician and patient expectations, and a globally-connected healthcare market. But unless organisations tackle the association product data management challenges holistically, they could be running up high levels of expense…
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…
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…
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…
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…
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…
