Healthcare - Articles
Amplifying the patient voice - the role of linguistic validation
Few would argue that the trend over the last decade or so to listen more to the patient voice has been a positive development. Life sciences firms have now recognised the importance of listening to target populations much earlier in the product planning, research and development lifecycle. This is reflected in the growing emphasis on strategies such as observational research, focus groups and social listening for trying to understand what patients need and want at a far earlier stage.As well as portraying the company as more patient-centric, this gives sponsors a chance to develop more of what the market wants and needs, and to hone their clinical trial activities. The more they understand about a condition and patients’ expe…
Few would argue that the trend over the last decade or so to listen more to the patient voice has been a positive development. Life sciences firms have now recognised the importance of listening to target populations much earlier in the product planning, research and development lifecycle. This is reflected in the growing emphasis on strategies such as observational research, focus groups and social listening for trying to understand what patients need and want at a far earlier stage.As well as portraying the company as more patient-centric, this gives sponsors a chance to develop more of what the market wants and needs, and to hone their clinical trial activities. The more they understand about a condition and patients’ expe…
Utilizing Technology to Benefit Diabetes Clinical Trials
With 100 million diagnosed with diabetes in the US alone and the condition predicted to be the seventh leading causing of death by 2035, affecting more than 592 million people worldwide, it’s not surprising that pharmaceutical companies are heavily investing in this area of research.1&2 This blog will look at the unique patient population in diabetes clinical trials and how the use of new technologies in these studies can support participants, as well as investigators, in order to improve outcomes.Patient Population Diabetes is a complex condition for patients to manage, and can involve a variety of demanding daily tasks, including taking regular measurements of blood glucose, monitoring the nutritional value of meals and trackin…
With 100 million diagnosed with diabetes in the US alone and the condition predicted to be the seventh leading causing of death by 2035, affecting more than 592 million people worldwide, it’s not surprising that pharmaceutical companies are heavily investing in this area of research.1&2 This blog will look at the unique patient population in diabetes clinical trials and how the use of new technologies in these studies can support participants, as well as investigators, in order to improve outcomes.Patient Population Diabetes is a complex condition for patients to manage, and can involve a variety of demanding daily tasks, including taking regular measurements of blood glucose, monitoring the nutritional value of meals and trackin…
Quality & Compliance Remedies for Pharmaceutical Companies
The global pharmaceutical market is expected to grow at an annual growth rate of 4.9 per cent, reaching $1.3 trillion by 2020.[1] This growth must be accompanied by closer scrutiny of quality and compliance measures within pharmaceutical companies. The minimum requirement for pharmaceutical companies is adherence to industry standards; for instance, in the US, Current Good Manufacturing Practice (cGMP) regulations are enforced by the Food and Drug Administration (FDA). Though many companies are implementing quality systems that go beyond these standards, others are failing to achieve compliance across business processes, a concerning situation in light of the industry’s growth and increasing cross-border activity. Robust quality…
The global pharmaceutical market is expected to grow at an annual growth rate of 4.9 per cent, reaching $1.3 trillion by 2020.[1] This growth must be accompanied by closer scrutiny of quality and compliance measures within pharmaceutical companies. The minimum requirement for pharmaceutical companies is adherence to industry standards; for instance, in the US, Current Good Manufacturing Practice (cGMP) regulations are enforced by the Food and Drug Administration (FDA). Though many companies are implementing quality systems that go beyond these standards, others are failing to achieve compliance across business processes, a concerning situation in light of the industry’s growth and increasing cross-border activity. Robust quality…
Three things life scientists need to know about GDPR
Sensitive personal data is sits right at the heart of the life sciences sector. It’s only right, therefore, that careful attention is paid to ensuring this information is handled with care and managed properly. The way in which those two criteria are met is changing. The European Union’s General Data Protection Regulation (GDPR) is refreshing the 20-year-old rules that currently govern the way data is collected, held and used. GDPR comes in on May 25, with businesses in every industry now facing a challenge to prepare themselves for the change. The rules are pretty clear when it comes to what is covered too. For the avoidance of doubt – and there has been a debate on this in some circles – genetic and biometric data is classed as ‘sensi…
Sensitive personal data is sits right at the heart of the life sciences sector. It’s only right, therefore, that careful attention is paid to ensuring this information is handled with care and managed properly. The way in which those two criteria are met is changing. The European Union’s General Data Protection Regulation (GDPR) is refreshing the 20-year-old rules that currently govern the way data is collected, held and used. GDPR comes in on May 25, with businesses in every industry now facing a challenge to prepare themselves for the change. The rules are pretty clear when it comes to what is covered too. For the avoidance of doubt – and there has been a debate on this in some circles – genetic and biometric data is classed as ‘sensi…
Stop reinventing the wheel: why life sciences firms must be smarter about document production
A lack of structured authoring in life sciences has limited companies’ scope to infuse regulatory processes with efficiency. But there’s scope to change that now, says AMPLEXOR’s Romuald Braun. In engineering-based industries, used of structured authoring – routinely populating documents with approved information components - is second nature. By contrast, life sciences has muddled through with simple office-style content tools for generating routine operational and regulatory documents. This has meant that teams have had to start from scratch each time a new or updated document is needed – finding the right data all over again, and assembling it as required. As well as being laborious, this appro…
A lack of structured authoring in life sciences has limited companies’ scope to infuse regulatory processes with efficiency. But there’s scope to change that now, says AMPLEXOR’s Romuald Braun. In engineering-based industries, used of structured authoring – routinely populating documents with approved information components - is second nature. By contrast, life sciences has muddled through with simple office-style content tools for generating routine operational and regulatory documents. This has meant that teams have had to start from scratch each time a new or updated document is needed – finding the right data all over again, and assembling it as required. As well as being laborious, this appro…
Practitioner's guide to leveraging salesforce competitive intelligence in the pharmaceutical industry
Benchmarking refers to the comparison of the metrics, processes and practices of a particular business against the others in the industry. Proponents of benchmarking argue that, when performed judiciously, it is one of the best decision-making tools available. It brings an external perspective to the table, triggers sanity checks, eliminates internal biases, reveals blind spots and provides an opportunity to emulate or exceed. The pharma industry, is principally known for innovation, a fact reflected by the significant investment in its R&D function. In a reasonably sized pharma/biotech company with marketed products, sales and marketing typically constitute the largest expense as a p…
Benchmarking refers to the comparison of the metrics, processes and practices of a particular business against the others in the industry. Proponents of benchmarking argue that, when performed judiciously, it is one of the best decision-making tools available. It brings an external perspective to the table, triggers sanity checks, eliminates internal biases, reveals blind spots and provides an opportunity to emulate or exceed. The pharma industry, is principally known for innovation, a fact reflected by the significant investment in its R&D function. In a reasonably sized pharma/biotech company with marketed products, sales and marketing typically constitute the largest expense as a p…
The pressure of public scrutiny – Kinapse on whether the EMA’s demands for Plain Language Summaries for clinical studies, that are understandable by anyone, tip sponsors over the edge?
From 2019, to comply with requirements for greater transparency around clinical research, encapsulated in the EU Clinical Trials Regulation 536/2014 (Article 37), life sciences firms will have to prepare plain language summaries (PLSs) of their clinical studies that can be understood by lay readers as well as clinical experts. For trial sponsors, this is a significant undertaking. Challenges and concerns include: Clinical teams and medical writing specialists struggling to understand what to include/leave out and how to pitch the summaries so that patients’…
From 2019, to comply with requirements for greater transparency around clinical research, encapsulated in the EU Clinical Trials Regulation 536/2014 (Article 37), life sciences firms will have to prepare plain language summaries (PLSs) of their clinical studies that can be understood by lay readers as well as clinical experts. For trial sponsors, this is a significant undertaking. Challenges and concerns include: Clinical teams and medical writing specialists struggling to understand what to include/leave out and how to pitch the summaries so that patients’…
01-Mar-2018
The 32nd annual PM Society Awards, announced at the Grosvenor House on 2nd February saw a record number of Golds won by a single agency – VCCP Health. They scooped an amazing 10 Golds plus 3 Silvers and 3 Bronze awards. Other successful agencies were Havas Lynx with two Golds as well as five Silvers, and Lime taking two Golds. CDM London, H4B Manchester, Life, McCann Health, Solaris Health & Watchable and vivacity each took one Gold Award.
VCCP Health sweeps the board with a record 10 GoldsLEO and Teva are the top pharma companies recognisedThe 32nd annual PM Society Awards, announced at the Grosvenor House on 2nd February saw a record number of Golds won by a single agency – VCCP Health. They scooped an amazing 10 Golds plus 3 Silvers and 3 Bronze awards. Other successful agencies were H…
VCCP Health sweeps the board with a record 10 GoldsLEO and Teva are the top pharma companies recognisedThe 32nd annual PM Society Awards, announced at the Grosvenor House on 2nd February saw a record number of Golds won by a single agency – VCCP Health. They scooped an amazing 10 Golds plus 3 Silvers and 3 Bronze awards. Other successful agencies were H…
26-Feb-2018
The Current State of ICH E6 Revision 2
In November 2017, one of the EMA’s Inspectors, Sophia Mylona, reiterated the importance of Revision 2 (R2) to the attendees at the 5th Global QA conference in Edinburgh, Scotland. Her message surprised the crowd. Not because ICH E6 (R2) is something new. On the contrary, this revision was finalized in November 2016 and put into effect by the EMA back in June of 2017. The surprise revolved around the EMA’s expectations for ongoing trials. The EMA expects R2 standards to be applied to ongoing trials “to a reasonable and feasible extent, using common sense.” Thus, any Sponsor or CRO running a trial in Europe will need to be R2 compliant. For our Canadian clients, R2 adoption will be mandatory in April of 2018. We are predicting that the United States will…
In November 2017, one of the EMA’s Inspectors, Sophia Mylona, reiterated the importance of Revision 2 (R2) to the attendees at the 5th Global QA conference in Edinburgh, Scotland. Her message surprised the crowd. Not because ICH E6 (R2) is something new. On the contrary, this revision was finalized in November 2016 and put into effect by the EMA back in June of 2017. The surprise revolved around the EMA’s expectations for ongoing trials. The EMA expects R2 standards to be applied to ongoing trials “to a reasonable and feasible extent, using common sense.” Thus, any Sponsor or CRO running a trial in Europe will need to be R2 compliant. For our Canadian clients, R2 adoption will be mandatory in April of 2018. We are predicting that the United States will…
15-Jan-2018
Lifesaving labelling for hospital pharmacists
According to NHS National Statistics, the total number of items dispensed from Britain’s pharmacies rose from 752 million in 2006, to a colossal 1,104 million in 2016. With an ever-increasing number of prescriptions dispensed each year, Darren Pittock, Sales Representative at pharmaceutical packaging supplier, Valley Northern, explains the importance of listening to the packaging requests of those on the front line — the pharmacists. The NHS report states that the average number of prescription items per head of the population is 20 per year. This may seem like a modest figure, but it amounts to 2.7 million prescription medications every single day. For pharmacists, ensuring this immense number of prescriptions are dispensed accurately and…
According to NHS National Statistics, the total number of items dispensed from Britain’s pharmacies rose from 752 million in 2006, to a colossal 1,104 million in 2016. With an ever-increasing number of prescriptions dispensed each year, Darren Pittock, Sales Representative at pharmaceutical packaging supplier, Valley Northern, explains the importance of listening to the packaging requests of those on the front line — the pharmacists. The NHS report states that the average number of prescription items per head of the population is 20 per year. This may seem like a modest figure, but it amounts to 2.7 million prescription medications every single day. For pharmacists, ensuring this immense number of prescriptions are dispensed accurately and…
14-Dec-2017
2018 Editorial Calendar
January 2017 Looking back 2017 drug launches summary Dermatology Job Focus: Clinical Research Associate (CRA) February Big Pharma Respiratory Job Focus: Biostatistics March UK Clinical Research & Brexit Gastroenterology Job Focus: Medical Writing April Cardiovascular Stem Cells Job Focus: Medical Science Liaison (MSL) May Diabetes Digital Marketing in Pharma Job Focus: Sales / Business Development June Infectious diseases UK Biotech Job Focus: QA / QC July Vaccines Training Focus Job Focus: Regulatory Affairs August Inflammation Medical Devices Job Focus: Study manager …
January 2017 Looking back 2017 drug launches summary Dermatology Job Focus: Clinical Research Associate (CRA) February Big Pharma Respiratory Job Focus: Biostatistics March UK Clinical Research & Brexit Gastroenterology Job Focus: Medical Writing April Cardiovascular Stem Cells Job Focus: Medical Science Liaison (MSL) May Diabetes Digital Marketing in Pharma Job Focus: Sales / Business Development June Infectious diseases UK Biotech Job Focus: QA / QC July Vaccines Training Focus Job Focus: Regulatory Affairs August Inflammation Medical Devices Job Focus: Study manager …
Are you current and up to date with your training?
ICH-GCP Training including E6R2 addendum ICH-GCP states that it is the sponsors’ discretion as to how often you should be taking GCP training, several guidelines suggest every two years. However, in recent audit findings the Regulatory Authorities have found significant compliance issues in clinical trials due to insufficient training. If you haven’t taken GCP training since the E6R2 update was implemented in June 2017, then you will have to familiarise yourself with the new changes to meet GCP requirements. Good news is you don’t have to fully re sit GCP you can just complete training on the update with proof that you have done so, along with your up to date GCP certificate. Depending on how long ago you took your GCP training it may w…
ICH-GCP Training including E6R2 addendum ICH-GCP states that it is the sponsors’ discretion as to how often you should be taking GCP training, several guidelines suggest every two years. However, in recent audit findings the Regulatory Authorities have found significant compliance issues in clinical trials due to insufficient training. If you haven’t taken GCP training since the E6R2 update was implemented in June 2017, then you will have to familiarise yourself with the new changes to meet GCP requirements. Good news is you don’t have to fully re sit GCP you can just complete training on the update with proof that you have done so, along with your up to date GCP certificate. Depending on how long ago you took your GCP training it may w…
Part One of a four part series
In a new blog series, Kimty Bui-Van of ProductLife Group considers how increasing regulatory harmony between regions is improving the prospects for companies looking to grow their global opportunityAs global opportunities expand and barriers to market entry diminish in the form of increasingly consistent submissions requirements, we can expect to see more pharmaceutical organisations expand their international reach in and beyond 2018.There are few geographic markets more strategically attractive than the European region of Benelux.Market scopeThe Benelux region (Belgium, the Netherlands, and Luxembourg) is an important European market for life sciences, not least because Brussels is home to the administrative HQ of the European Union. At the heart of Benelux,…
In a new blog series, Kimty Bui-Van of ProductLife Group considers how increasing regulatory harmony between regions is improving the prospects for companies looking to grow their global opportunityAs global opportunities expand and barriers to market entry diminish in the form of increasingly consistent submissions requirements, we can expect to see more pharmaceutical organisations expand their international reach in and beyond 2018.There are few geographic markets more strategically attractive than the European region of Benelux.Market scopeThe Benelux region (Belgium, the Netherlands, and Luxembourg) is an important European market for life sciences, not least because Brussels is home to the administrative HQ of the European Union. At the heart of Benelux,…
Part two of a four part series
In a new blog series, Kimty Bui-Van of ProductLife Group considers how increasing regulatory harmony between regions is improving the prospects for companies looking to grow their global opportunity Evaluating the Baltic region Since joining the European Union, Lithuania, Latvia, and Estonia have adopted relevant European Union legislation; and companies preparing local submissions must have authorisation from the local authority (each country has its own) or from the European Medicines Agency (EMA) depending on the type of registration. The respective national authorities cooperate readily, and they liaise closely with EMA, the European Directorate for the Quality of Medicines & HealthCare, and other international organisations. In Latvia, the State Ag…
In a new blog series, Kimty Bui-Van of ProductLife Group considers how increasing regulatory harmony between regions is improving the prospects for companies looking to grow their global opportunity Evaluating the Baltic region Since joining the European Union, Lithuania, Latvia, and Estonia have adopted relevant European Union legislation; and companies preparing local submissions must have authorisation from the local authority (each country has its own) or from the European Medicines Agency (EMA) depending on the type of registration. The respective national authorities cooperate readily, and they liaise closely with EMA, the European Directorate for the Quality of Medicines & HealthCare, and other international organisations. In Latvia, the State Ag…
Part four of a four part series
In the final part of this blog series, Kimty Bui-Van of ProductLife Group considers how increasing regulatory harmony between regions is improving the prospects for companies looking to grow their global opportunity in the uppermost reaches of North America Canada in close-upAs a member of the International Council for Harmonisation, Canada takes a regulatory approach familiar to most global companies. The approach is similar to Europe’s, although Health Canada has implemented certain country-specific regulations.Canada requires that a physical entity (directly owned or otherwise) be in the country for a drug establishment licence. Companies that have experience with the European eCTD or even US submission requirements should find preparing an eCTD for Canada…
In the final part of this blog series, Kimty Bui-Van of ProductLife Group considers how increasing regulatory harmony between regions is improving the prospects for companies looking to grow their global opportunity in the uppermost reaches of North America Canada in close-upAs a member of the International Council for Harmonisation, Canada takes a regulatory approach familiar to most global companies. The approach is similar to Europe’s, although Health Canada has implemented certain country-specific regulations.Canada requires that a physical entity (directly owned or otherwise) be in the country for a drug establishment licence. Companies that have experience with the European eCTD or even US submission requirements should find preparing an eCTD for Canada…
The key objective when posting a job advert, is to maximise the application rates from suitable candidates. So take a minute to review this checklist.
Firstly, when creating a job advert, please, please, PLEASE, don't simply cut and paste the job description. It's plain lazy, and can often put off candidates with a dry list of what they will be doing and the skills they need. Job Title Is the Job Title obvious? Make sure you're not using any job titles that are specific to your organisation. Have you included variations of the Job Title where relevant? (eg "Clinical Research Associate / CRA") Don't include any superlatives (eg "excellent opportunity") - these just make it harder to read the job title, and actually don't add anything. Don't include the location unless it's s…
Firstly, when creating a job advert, please, please, PLEASE, don't simply cut and paste the job description. It's plain lazy, and can often put off candidates with a dry list of what they will be doing and the skills they need. Job Title Is the Job Title obvious? Make sure you're not using any job titles that are specific to your organisation. Have you included variations of the Job Title where relevant? (eg "Clinical Research Associate / CRA") Don't include any superlatives (eg "excellent opportunity") - these just make it harder to read the job title, and actually don't add anything. Don't include the location unless it's s…
These days, we all have to be careful about discrimination in recruitment. It’s also worth remembering that you might be breaking the law if any discrimination happens during their recruitment process, even if you use a recruitment agency.
The key areas to avoid in your job adverts are: Age discrimination Disability discrimination Gender discrimination Race or religion discrimination Firstly and most obviously, you must not include anything in your job advert that directly says you’ll discriminate against anyone. For example, you’re not allowed to state you can’t or won’t employ workers with a disability, of a certain age, gender etc. Be careful using phrases like ‘highly experienced’ or ‘recent graduate’ unless these are actual requirements of the job. Otherwise you may…
The key areas to avoid in your job adverts are: Age discrimination Disability discrimination Gender discrimination Race or religion discrimination Firstly and most obviously, you must not include anything in your job advert that directly says you’ll discriminate against anyone. For example, you’re not allowed to state you can’t or won’t employ workers with a disability, of a certain age, gender etc. Be careful using phrases like ‘highly experienced’ or ‘recent graduate’ unless these are actual requirements of the job. Otherwise you may…
20-Oct-2017
How to get the most out of your PharmiWeb.com banner
If you are using banners, these few tips can be used to help you get the most out of your Banner Advertising on PharmiWeb.com or anywhere else for that matter. Just increasing your Click Through Rate (CTR) by a few percent might make a huge difference to the success of your campaign. Pose Questions Try questions like “Did you know…” “Have you seen…” – the visitor who subconsciously reads the question will be enticed to take action. Some research shows that this can raise click through significantly. Bright Colours Bright colours can attract the eye, particularly where you’re competing with other banners and distractions. If you’re not constrained by branding, try Blue, Green or Yellow. White and Black are less effective. Make it Clea…
If you are using banners, these few tips can be used to help you get the most out of your Banner Advertising on PharmiWeb.com or anywhere else for that matter. Just increasing your Click Through Rate (CTR) by a few percent might make a huge difference to the success of your campaign. Pose Questions Try questions like “Did you know…” “Have you seen…” – the visitor who subconsciously reads the question will be enticed to take action. Some research shows that this can raise click through significantly. Bright Colours Bright colours can attract the eye, particularly where you’re competing with other banners and distractions. If you’re not constrained by branding, try Blue, Green or Yellow. White and Black are less effective. Make it Clea…
AI: The next frontier of innovation in life sciences
ProductLife Group’s Marco Anelli looks at the potential of artificial intelligence to change the way life sciences organisations operate. From discovery and development and throughout the entire product life cycle, artificial intelligence (AI) has already shaken up the life sciences industry by way of innovations such as AI-enabled drugs expected to be brought to market in the near future. But AI has the potential to go beyond that. Given the plethora of data all across the life sciences value chain, the ability to gather, manage, and effectively use intelligence from that data has posed a challenge. AI offers the chance to exploit the data in both structured and unstructured forms. Data that previously was hard to access or too difficu…
ProductLife Group’s Marco Anelli looks at the potential of artificial intelligence to change the way life sciences organisations operate. From discovery and development and throughout the entire product life cycle, artificial intelligence (AI) has already shaken up the life sciences industry by way of innovations such as AI-enabled drugs expected to be brought to market in the near future. But AI has the potential to go beyond that. Given the plethora of data all across the life sciences value chain, the ability to gather, manage, and effectively use intelligence from that data has posed a challenge. AI offers the chance to exploit the data in both structured and unstructured forms. Data that previously was hard to access or too difficu…
Master data management and addressing the forthcoming ISO IDMP standards
AMPLEXOR’s Sonia Monahan looks at what is involved in practice and how can life sciences firms ensure the investment pays off ISO IDMP compliance is more than just another regulatory hurdle for life sciences firms to straddle. It also promotes the kind of structure and discipline needed if organisations want to break new ground and take their businesses forward. It all begins with data though, and with assumptions about its quality, completeness, and reliability as an accurate record of operations.As EMA’s IDMP requirements near finalisation, the scale of the standards’ impact on managing regulatory data becomes more apparent. The transition from the current xEVMPD submission requirement to the more extensive and round…
AMPLEXOR’s Sonia Monahan looks at what is involved in practice and how can life sciences firms ensure the investment pays off ISO IDMP compliance is more than just another regulatory hurdle for life sciences firms to straddle. It also promotes the kind of structure and discipline needed if organisations want to break new ground and take their businesses forward. It all begins with data though, and with assumptions about its quality, completeness, and reliability as an accurate record of operations.As EMA’s IDMP requirements near finalisation, the scale of the standards’ impact on managing regulatory data becomes more apparent. The transition from the current xEVMPD submission requirement to the more extensive and round…
