For the 2nd year running Kubo will be at the PSI Annual Conference next month!

Kubo are proud for the 2nd year running will be exhibiting at the 2015 PSI conference between the 10th and 13th of May at The Millennium Gloucester Hotel in London. 

This year the PSI Annual conference theme will be "Relevant Applications in a Changing Environment", with a focus on case studies and collaboration.  This will the 38th consecutive annual event which is regarded as the principal annual event for statisticians in the pharmaceutical and healthcare industry in Europe. 

The conference is held over a 3 day period and made up of plenary sessions, parallel sessions (including breakout sessions and sessions for career young statisticians), poster sessions and the annual general meeting. Sessions include data transparency, meta-analysis, estimands, risk-based monitoring, data visualization and many more with speakers from industry, academia and regulatory agencies.

There will 60 speakers over the 3 days a pub quiz and a barn dance! I'm not sure if Kubo will be donning our cowboy boots just yet, but im sure that the event will have a lot to offer and will be a great success!

If you will be attending the event next month make sure you stop by our stand and say hello!

690,000 people are employed by the pharmaceutical industry in Europe!

New figures have been released showing the impact that the pharmaceutical industry makes within Europe. 

 Methods are evolving and there are many promising prospects on the horizon for research and development. Many cancers are being controlled and even cured and figures show that European Citizens are living up to 30 years longer than they did a year ago. Its not just the improved impact on our health that the pharmaceutical industry is responsible for. It is also one of Europe's top performing sectors.

Including drug sales the overall pharmaceutical revenue has reached almost one trillion U.S. dollars across the globe, at present with Europe contributing $260-$280 billion to that figure. Research and Development invested an estimated € 30,630 million in Europe and directly employs 690,000 people and a further 3 to 4 times more in indirect employment in Europe alone. The sales of drug-device combination sales are set to increase by 7.1% worldwide to an estimated $31 billion by 2019!

By the time a medical product reaches the market it has undergone a lengthy and costly process. Estimates show that it takes 12-13 years for a product to reach the market at an estimated cost of  €1,172 million. With only 1 or 2 of every 10,000 substances synthesised in laboratories passing all development stages, it is clear to see why there is such a major investment from R & D. 


Figures on behalf of the European Federation of Pharmaceutical Industries and Associations. http://www.efpia.eu/

NEWS! Pharma spending to rise 30% by 2018!

IMS Institute for Healthcare Informatics have released last week, that annual spending will hit an all time high this year when absolute growth will be about $70 billion, up from $44 billion in 2013 and $26 billion in 2012!

This fast growth will be driven primarily by increased specialty drug innovation, greater access to medicines and reduced impact of patent expires, says the study. 

It is forecasted that spending will rise 30% by 2018 to an estimated $1.3 trillion!
The US which leads the market will remain strong, but the five major European markets France, Germany, Spain, UK and Italy along with Japan, are expected to be at the forefront of the worlds growth. China, which is already the world’s second largest pharmaceutical market, will reach spending levels of $155-$185 billion in 2018, the report adds.

Remarkably almost 200 new drugs are expected to be launched in the next five years. Over 2,000 products are currently in late-stage development, a quarter of which are oncology drugs. However, the IMS Institute notes that the availability of new medicines to patients worldwide varies significantly by country and disease area, on average, fewer than half the medicines launched during the previous five years are now available across the major developed markets.

To read more about this study visit www.theimsinstute.org

The Challenges of Pharmacovigilance: Database and Reporting Solutions

In recent years, regulatory agencies - including the EMA/European Union and the FDA - have taken steps to improve patient safety in clinical trials. The EU estimates that approximately 200,000 patients die each year from Adverse Drug Reactions. Companies are often faced with the challenge of finding solutions that can improve quality and analysis of safety data while managing the increase in data and the need to satisfy regulatory requirements.

In Europe, the latest pharmacovigilance regulations, known as Good Pharmacovigilance Practice (GVP), went into effect in 2012 in order to better analyze and understand data from clinical studies, especially post-market studies, to identify risks to patients. More recently, the EMA has released guidelines for complying with ICH E2B (R3) which regulates electronic transmission of individual case safety reports.

 

Safety Database

 

Companies conducting pharmacovigilance activities will need a safety database that can optimize safety reporting. Many pharmaceutical and biotech companies may opt for Oracle AERS or Argus, while some store safety data in SAS. Oracle AERS is a comprehensive solution for product safety monitoring and compliance. The graphical user interface allows users to visualize the case elements and understand the holistic case picture. Oracle Argus, on the other hand, is a fully integrated platform of end-to-end pharmacovigilance solutions to ensure regulatory compliance from clinical development to post-market surveillance. 

 

Combining statistical analysis, programming and IT support under a commonly used platform like SAS is an ideal solution for automating data collection and analysis from multiple sources. This approach is even appropriate for smaller companies, because automation can be done without a complex or expensive Business Intelligence platform.

 

Customized Reporting Solutions

 

1. Automating signal detection in SAS is one ideal solution for customized reporting. In order to automate the process, a system needs to be in place to pull and analyze data from the safety database. The key aspect is the data integration between safety database, regulatory databases, and patient data from external database resources. The identification of signal criteria and the implementation of standardized programs automates the signal detection process and produces structured data which speeds up the task of finalizing Eudravigilance submissions.

 

2. Integrating an Oracle database with Business Intelligence produces real time data and results. With the support of our technology partner, we can integrate Oracle 9i database with Oracle Business Intelligence Standard One edition to create interactive dashboards for readily accessible data and results.

 

Welcome to the Kubo Recruitment Blog!

Welcome to Kubo Job Knowledge - The Recruitment Blog! 

Kubo Recruitment focuses on sourcing talent for the Life Sciences sector. With headquarters in Milton Keynes, United Kingdom, we operate internationally and recruit professionals in clinical research including data managers, statisticians, statistical programmers, Monitors, CRAs, Medical Writers, IT professionals and more. This blog highlights trends and news from the recruitment and life sciences industries and provides job seekers with tips on new job openings and how to make yourself an ideal candidate.

Our blog will occasionally feature Community updates, including news on the Milton Keynes Storm Under 16 ice hockey team for which Kubo is a proud sponsor.

Stay tuned for regular blog posts as Kubo continues to expand in the recruitment sector. Next month, Kubo is exhibiting at the DIA 49th Annual Meeting in Boston, Massachusetts. 

Happy Reading!