investment in cell therapies

Promising scale and market success for cell therapies after large financial injection

In a report released this week, by BCC Research, it was forecasted that the global market for stem cells (including cell therapies) is to reach US $10.6 billion in 2018. However with currently no medicines, based on stem cells, having yet received marketing authorisation from the EMA*, or the FDA*, how are we going to get there? In 2013, the stem cell …

Clinical Trials Briefing - Marie Manley Ebook

Download Ebook: Navigating the Perils of the Clinical Trials Regulation

On 16th April 2014 the new EU Clinical Trials Regulation was adopted. This new regulation, which comes into force in 2016, replaces a convoluted Clinical Trials Directive and aims to streamline clinical trial applications across the EU, making cross border trials easier. Marie Manley is Head of the Regulatory team at Bristows and has an in depth understanding of the new …

Download Ebook: Mylan on EU Clinical Trials Regulation

On 16th April 2014 the new EU Clinical Trials Regulation was adopted. This new regulation, which comes into force in 2016, replaces a convoluted Clinical Trials Directive and aims to streamline clinical trial applications across the EU, making cross border trials easier. Manfred Kurz, Senior Global Regulatory Affairs Manager at Mylan has an in depth knowledge of how clinical trials are conducted …

Clinical Trial Management System Market, Trends and Forecasts

A new report has stated that the global Clinical Trial Management System (CTMS) market “is expected to grow at a CAGR (compound annual growth rate) of 14% from 2014 to 2019, to reach an estimated value of USD 1,848.5 million in 2019”, compared with USD 844.0 million in 2013. CTMS is a software system which manages clinical trials in clinical …

Clinical Trials Briefing - Top Ten Key Issues

Download Ebook: Top Ten Key Issues Regarding EU Clinical Trials Regulation

The EU Clinical Trials regulation was adopted on 16th April 2014 and comes into force in 2016. It replaces a convoluted Clinical Trials Directive and aims to streamline clinical trial applications across the EU. Although it is a positive move forward, it brings with it, its own issues, from protecting commercially sensitive information to setting up a new ‘one stop’ …

Delay for Clinical Trial Data Publication Policy Adoption

The EU Clinical Trials Regulation has been drafted over and over again and now it would appear that another facet of it will be rethought. Proposals which would have allowed secondary researchers to download, save and print clinical trial data will now not be formally adopted until October. This is because the European Medicines Agency (EMA) would like to clarify …

clinical trials briefing - another u turn for clinical trials regulation

It’s another U-Turn for Clinical Trials Regulation!

In May the EMA announced plans that clinical trial study reports could only be accessed via a ‘view on screen only’ mode, as per the new Clinical Trials Regulation. This was a seeming u-turn on their previous plans for transparency  and aiding researchers in accessing information, thus giving rise to the European Ombudsmen and the IQWiG to attack the plans. …

Clinical Trials Briefing - U-turn on transparency

Has the EMA made a U-turn on Transparency?

Many researchers are worried that the EMA will not honor its pledge to allow public scrutiny and access to clinical trial data. Draft documents, sent to certain institutions and individuals last week, detailed how the EMA was to move forward in regards to transparency, instigating a new ‘look, but don’t touch’ policy. As reported by the Institute for Quality and …

Clinical Trials Briefing, transparency in trials

EU Ombudsmen concerned over clinical trial data transparency backtracking

EU Ombudsmen Emily O’Reilly wrote an open letter to the EMA on 13th May, concerned about it’s policy on clinical trial transparency. The policy would appear to backtrack on its original format of access to and publication of clinical trial information. The Clinical Trials Regulation aims to make any clinical trials conducted in the EU subject to public scrutiny, through …

Stem Cells Live: Japan’s New Legislation – will companies benefit from it?

“It is not a phase I clinical trial”, said Dr Hasakazu Hirata, during a keynote interview with Prof Chris Mason. Dr Hirata is Review Director at the Office of Cellular and Tissue-Based Products for the Pharmaceutical and Medical Device Agency (PMDA), the FDA and EMA equivalent in Japan.  He talked about the new legislation being promoted by the Japanese government. …