Articles
26-Nov-2018
How technology at an operational level is the driving force behind innovative pharmaceutical businesses
The global pharmaceutical industry is often held up as an example of a sector that exists on the cutting edge of what is possible. But that doesn’t mean that it can avoid its own tech disruption.Digitalisation - the process of moving to digital business processes and away from legacy and paper-based ones - is changing the pharmaceutical industry just as it is changing many others. One seemingly simple, yet business-critical change will be in how companies collect, share and analyse data, with the result that digitalisation will have a radical effect on how products and processes are audited.When a consumer buys aspirin, paracetamol or any of the thousands of over-the-counter medic…
The global pharmaceutical industry is often held up as an example of a sector that exists on the cutting edge of what is possible. But that doesn’t mean that it can avoid its own tech disruption.Digitalisation - the process of moving to digital business processes and away from legacy and paper-based ones - is changing the pharmaceutical industry just as it is changing many others. One seemingly simple, yet business-critical change will be in how companies collect, share and analyse data, with the result that digitalisation will have a radical effect on how products and processes are audited.When a consumer buys aspirin, paracetamol or any of the thousands of over-the-counter medic…
Neo4j’s Emil Eifrem takes a look at how life science researchers can use graph databases to get granular insight from big data and make real advances in research
Neo4j’s Emil Eifrem takes a look at how life science researchers can use graph databases to get granular insight from big data and make real advances in researchBig data, defined as large complex data sets, has the potential to throw light onto every link in the life sciences value chain, which is why data mining has become so important to researchers – but having the right technology is key to its success.Traditional database tools, namely SQL and relational database technology, find the volume as well as the unstructured nature of these complex datasets extremely difficult to work with. Why? Because they model the world as a set…
Neo4j’s Emil Eifrem takes a look at how life science researchers can use graph databases to get granular insight from big data and make real advances in researchBig data, defined as large complex data sets, has the potential to throw light onto every link in the life sciences value chain, which is why data mining has become so important to researchers – but having the right technology is key to its success.Traditional database tools, namely SQL and relational database technology, find the volume as well as the unstructured nature of these complex datasets extremely difficult to work with. Why? Because they model the world as a set…
How Finance 4.0 can deliver cutting-edge technology to the pharmaceutical industry
The pharmaceutical industry is increasingly making use of modern digitalised technology to automate specific processes in drug development, testing and manufacturing, one UK based company predicts they will be able to commercialise printed tablets (using 3D printing) within the next 5 to 10 years.[1] New techniques such as personalised medicine, where the care and treatment of patients moves away from a ‘one size fits all’ approach and instead uses diagnostics, genomics and data analytics to identify the underlying cause of disease, have encouraged a wave of activity in the biotech sector, with several companies now offering a range of complex gene editing services.[2]Similarly, Artificial Intelligence (AI) i…
The pharmaceutical industry is increasingly making use of modern digitalised technology to automate specific processes in drug development, testing and manufacturing, one UK based company predicts they will be able to commercialise printed tablets (using 3D printing) within the next 5 to 10 years.[1] New techniques such as personalised medicine, where the care and treatment of patients moves away from a ‘one size fits all’ approach and instead uses diagnostics, genomics and data analytics to identify the underlying cause of disease, have encouraged a wave of activity in the biotech sector, with several companies now offering a range of complex gene editing services.[2]Similarly, Artificial Intelligence (AI) i…
Managing translations for submissions in regulatory affairs – what is best practice?
Managing translations for submissions in regulatory affairs – what is best practice? Few heads of regulatory affairs would dispute the complexity of compliance and regulation in the life sciences industry. Changing regulations puts greater pressure on regulatory professionals and makes the job of translating content for submissions ever more difficult, while the pressure to decrease time-to-market for life-saving new drug therapies grows all the time. Regulations change so frequently in countries all the time, that there is an almost constant re-evaluation as to what is needed to be included in dossiers and what parts of the dossier require translation. Given such challenges, whether handling translations…
Managing translations for submissions in regulatory affairs – what is best practice? Few heads of regulatory affairs would dispute the complexity of compliance and regulation in the life sciences industry. Changing regulations puts greater pressure on regulatory professionals and makes the job of translating content for submissions ever more difficult, while the pressure to decrease time-to-market for life-saving new drug therapies grows all the time. Regulations change so frequently in countries all the time, that there is an almost constant re-evaluation as to what is needed to be included in dossiers and what parts of the dossier require translation. Given such challenges, whether handling translations…
Maintaining the highest recruitment standards puts pharma companies at ease
With the pharmaceutical industry experiencing unprecedented talent shortages, the importance of finding a trusted partner to supply talent that can deliver to the highest professional standard has never been greater, which is why SEC has announced their delight at once again obtaining both bronze and silver Workforce Quality Accreditation from IAOCR.The accreditation – awarded to organisations that demonstrate a commitment to professionalism and competence in their own workforce – included a full analysis of SEC’s working practices and following the re-accreditation, Global Head of Workforce Strategy and Innovation Angela O’Connell, said “From the initiation of the Workforce Quality Accreditation, SEC Recruitment ha…
With the pharmaceutical industry experiencing unprecedented talent shortages, the importance of finding a trusted partner to supply talent that can deliver to the highest professional standard has never been greater, which is why SEC has announced their delight at once again obtaining both bronze and silver Workforce Quality Accreditation from IAOCR.The accreditation – awarded to organisations that demonstrate a commitment to professionalism and competence in their own workforce – included a full analysis of SEC’s working practices and following the re-accreditation, Global Head of Workforce Strategy and Innovation Angela O’Connell, said “From the initiation of the Workforce Quality Accreditation, SEC Recruitment ha…
More focus on SRG Clinical – this time in Europe!
More focus on SRG Clinical – this time in Europe!Since 1990, SRG’s Clinical division has been committed to providing outstanding temporary, contract and permanent resourcing services to its clients and career opportunities in all areas of clinical research and drug development across the UK and Europe. Following the exciting progress of SRG’s Clinical team over the last year, we have now taken the next step in pursuing our growth plans by appointing Julian Stec to fly the SRG flag in Poland and beyond. This appointment will expand our Clinical Business Development function and solidify our presence in Europe.Based in Warsaw and focusing on expanding our presence with existing and new clients, Julian comes with the great advantage of expert…
More focus on SRG Clinical – this time in Europe!Since 1990, SRG’s Clinical division has been committed to providing outstanding temporary, contract and permanent resourcing services to its clients and career opportunities in all areas of clinical research and drug development across the UK and Europe. Following the exciting progress of SRG’s Clinical team over the last year, we have now taken the next step in pursuing our growth plans by appointing Julian Stec to fly the SRG flag in Poland and beyond. This appointment will expand our Clinical Business Development function and solidify our presence in Europe.Based in Warsaw and focusing on expanding our presence with existing and new clients, Julian comes with the great advantage of expert…
04-Oct-2018
Clinical Research – Quo Vadis?
Clinical Research – Quo Vadis?In recent times we began observing a significant acceleration of technology development which aims at improving the quality and speed of clinical trials as well as lowering the costs of it.It would seem that moving from simple paper digitalization to IoE (Internet of Everything) and Big Data will reduce the demand for qualified on-site CRA workforce. But will it? And would it completely wipe out the needs? There are ones who prophesies this is inevitable, but personally, I doubt that. Why, you may ask? GCP regulation is very clear about it - ICH GCP 5.18.1 (a) states: “The purpose of clinical trial monitoring is to verify that the rights and well-being of human subjects are protected.” Although today's CRA skillset is far…
Clinical Research – Quo Vadis?In recent times we began observing a significant acceleration of technology development which aims at improving the quality and speed of clinical trials as well as lowering the costs of it.It would seem that moving from simple paper digitalization to IoE (Internet of Everything) and Big Data will reduce the demand for qualified on-site CRA workforce. But will it? And would it completely wipe out the needs? There are ones who prophesies this is inevitable, but personally, I doubt that. Why, you may ask? GCP regulation is very clear about it - ICH GCP 5.18.1 (a) states: “The purpose of clinical trial monitoring is to verify that the rights and well-being of human subjects are protected.” Although today's CRA skillset is far…
28-Sep-2018
What’s a strategic partnership between friends?
A few weeks ago, my colleague Marianna in London shared her thoughts on strategic partnerships and since this service offering is one of the areas I focus on, I wanted to add a few thoughts of my own. What do you first think of when hearing of a strategic partnership? A picture of a bunch of CXOs shaking hands and smiling? Bosses sending emails to the staff guiding them through the principles of a new corporate programme or introducing the company’s latest leaders? Another weekly call with half a dozen consultants? Pretty often that’s exactly what we get. What do you first think of when getting into a new close friendship? It might be something like: It’s amazing how much we have in common; I have never been listened to that…
A few weeks ago, my colleague Marianna in London shared her thoughts on strategic partnerships and since this service offering is one of the areas I focus on, I wanted to add a few thoughts of my own. What do you first think of when hearing of a strategic partnership? A picture of a bunch of CXOs shaking hands and smiling? Bosses sending emails to the staff guiding them through the principles of a new corporate programme or introducing the company’s latest leaders? Another weekly call with half a dozen consultants? Pretty often that’s exactly what we get. What do you first think of when getting into a new close friendship? It might be something like: It’s amazing how much we have in common; I have never been listened to that…
28-Sep-2018
Don’t work hard, work smart!
In recent years there has been loads of talk about strategic partnerships. And whilst some organisations feel hesitant to partner with clients too closely for fear of putting all their eggs into the same basket, it can actually be quite beneficial if done smartly. I would like to go even further – strategic partnerships can become an independent service offering to our clients! With the evolution of talent acquisition over the last 10-15 years, gone are the days when we worked directly with the hiring manager who could make all their hiring decisions alone, sign T&Cs and take our candidate through the entire recruitment process in 2 days…. We now all work through centralised, metrics-monitored, cost conscious, report producing MSPs, RPOs and VMS soluti…
In recent years there has been loads of talk about strategic partnerships. And whilst some organisations feel hesitant to partner with clients too closely for fear of putting all their eggs into the same basket, it can actually be quite beneficial if done smartly. I would like to go even further – strategic partnerships can become an independent service offering to our clients! With the evolution of talent acquisition over the last 10-15 years, gone are the days when we worked directly with the hiring manager who could make all their hiring decisions alone, sign T&Cs and take our candidate through the entire recruitment process in 2 days…. We now all work through centralised, metrics-monitored, cost conscious, report producing MSPs, RPOs and VMS soluti…
28-Sep-2018
Securing the best talent for your team this year
With the new year firmly in, so are our business plans – along with all the targets, aims and challenges that come with them! One of the frustrations we all face – hiring companies and recruiters alike – is getting the top talent for our teams. So what are the challenges and how do we overcome them to position ourselves for success? First things first – and it is a cliché because it works – analysis always helps! To help you understand how your organisation can attract top talent fast, here are the questions you need to ask yourself: What does your recruitment process look like? Is it speedy, sleek, professional? Or does it lack all these components? Does it reflect the values and aspirations of the organisation and are all these attra…
With the new year firmly in, so are our business plans – along with all the targets, aims and challenges that come with them! One of the frustrations we all face – hiring companies and recruiters alike – is getting the top talent for our teams. So what are the challenges and how do we overcome them to position ourselves for success? First things first – and it is a cliché because it works – analysis always helps! To help you understand how your organisation can attract top talent fast, here are the questions you need to ask yourself: What does your recruitment process look like? Is it speedy, sleek, professional? Or does it lack all these components? Does it reflect the values and aspirations of the organisation and are all these attra…
27-Sep-2018
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 qualit…
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 qualit…
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 ‘s…
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 ‘s…
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 appr…
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 appr…
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…
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…
24-May-2018
As regulatory workloads soar, the first step to better resource management is better measurement, says Adrian Leibert, life science and pharma programme manager for regulatory outsourcing at Kinapse
Since it’s hard to manage what you can’t measure, the best way to keep pace with regulatory resourcing is to unambiguously understand what’s involved in complex workloads, says Kinapse’s Adrian Leibert As budgets have come under pressure and more Regulatory work has been outsourced, firms have faced a growing need to monitor, manage and report on resource consumption and value for money. The default approach has been to do this according to the raw number of documents processed – so if one year 1,000 documents were authored, and the next year the number was 900, there was an expect…
Since it’s hard to manage what you can’t measure, the best way to keep pace with regulatory resourcing is to unambiguously understand what’s involved in complex workloads, says Kinapse’s Adrian Leibert As budgets have come under pressure and more Regulatory work has been outsourced, firms have faced a growing need to monitor, manage and report on resource consumption and value for money. The default approach has been to do this according to the raw number of documents processed – so if one year 1,000 documents were authored, and the next year the number was 900, there was an expect…
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 pati…
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 pati…
15-Mar-2018
We all know that LinkedIn is a great resource for recruiters, but how can you take advantage of it without an expensive recruiting account? Here's a few ideas:
Use Your LinkedIn Headline By using your LinkedIn Headline as a “quick advert”, anyone who looks at your profile will see what you’re after. For example “Looking for experienced Regulatory Affairs professionals in London” Post an Image of Your Hot Job You can use an online tool like PicMonkey or Stencil to create an image of your Hot Job (or a generic version) . Keep it simple and clean and come up with a template you can use repeatedly by changing the job title. Then post your image so that it appears on your timeline. Do Some “People” Searches Now that you have the job in your headline and timeline, do some sim…
Use Your LinkedIn Headline By using your LinkedIn Headline as a “quick advert”, anyone who looks at your profile will see what you’re after. For example “Looking for experienced Regulatory Affairs professionals in London” Post an Image of Your Hot Job You can use an online tool like PicMonkey or Stencil to create an image of your Hot Job (or a generic version) . Keep it simple and clean and come up with a template you can use repeatedly by changing the job title. Then post your image so that it appears on your timeline. Do Some “People” Searches Now that you have the job in your headline and timeline, do some sim…
