Articles

Learning the microbead lesson
A UK-wide prohibition on the use of plastic microbeads came into effect in 2018, but what fundamental lessons can we learn from this high profile case? Dr Rachael Benstead, senior aquatic ecotoxicologist at translational science and research organisation, Fera Science Ltd. explains all.   Figures from The Department for the Environment, Food and Rural Affairs (DEFRA) suggest that an estimated 680 tonnes of microbeads are used in cosmetic products every year. These tiny pieces of plastic, used for exfoliation in rinse-off products such as toothpastes, face scrubs and shower gels, inevitably end up contaminating the environment.   With particle sizes varying from 10 micrometers up to 1 millimetre, microbeads are the same size as much of the…

Preclinical IPOs: Is the window starting to close?
A record-breaking year is on the cards, as biotechnology companies continue the trend of pre-clinical initial public offerings (IPOs). As of July, six young firms had raised almost $800million through their IPOs, despite none having permission from regulators to start clinical trials in humans.[1] These companies are now generating significant returns. For example, the most recent preclinical IPO by Gritstone Oncology Inc was initially valued at $100 million, and as of 12 December 2018 has a market value of $731 million.1 Pre-clinical valuations Traditionally, there are two good times for biotech companies to go public: right after proof or concept in humans or upon the publication of promising, pivotal data.  But these pre-cl…

~ Unpacking the potential of smart packaging ~ One of the biggest challenges for manufacturers of consumable goods is how to extend product shelf life while ensuring safety. Over the past hundred years, the food and beverage industry has invested billions of pounds in researching suitable packaging, but what can the pharmaceutical industry learn from this?
Here, Dale Pittock, sales director of pharmacy consumables provider Valley Northern, explores the latest developments in the smart packaging market. Imagine if a packet of antibiotics could tell a patient whether it had been opened and which pill had been taken and at what time. Then, imagine if things could be taken a step further and the medication could alert patients when it was time to take the next one, then feed this informat…

~ Pharmacy and healthcare supplier releases advisory whitepaper ~
Leading pharmacy and healthcare consumables supplier, Valley Northern, has released its latest whitepaper, exploring the increasing issue of patient non-adherence. The whitepaper, which can be downloaded directly from the Valley Northern website, looks at why non-adherence is an issue and how those across the healthcare industry can help to tackle it. Download the whitepaper here: Valley Northern Downloads.Across the United Kingdom, one billion items are prescribed and dispensed by pharmacists every year. However, one in five patients surveyed as part of a recent industry report admitted to not taking their medication as prescribed. The issue of patient non-adherence is a big issue, particularly when patients try to take thei…

3rd World Congress On Applied Microbiology Microbiology Conference | Microbiology Conferences Brussels, Belgium May 15-16, 2019
Applied Microbiology Conference 2019 which is going to be held on May 15-16, 2019, at Brussels, Belgium by Meeting International . 3rd World Congress On  Applied Microbiology based on the theme Emerging Trends And Innovations In Microbial Research. 3rd World Congress On Applied Microbiology is delighted to invite all the participants globally to attend the conference which will be held in Brussels, Belgium during May 15-16, 2019. It will bring together world-class highly reputed microbiologist, Professor, Scientist, Researchers, Doctors, Academicians, Business professionals, Government Officials, and young scientist to discuss strategies for Microbial diseas…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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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…

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…

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…

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…