Europe

Report: Clinical research benefits the U.K. economy

Friday, December 2, 2016

An independent report, commissioned by the National Institute for Health Research (NIHR) Clinical Research Network and produced by KPMG’s Economics team, provides an assessment of the economic impact of the NIHR Clinical Research Network’s activities to support clinical research in the U.K. The report includes assessment of the economic contribution made to the U.K. economy through clinical research activity supported by the network; analysis to quantify the value of payments made to NHS Trusts for commercial studies, and the value to the NHS of pharmaceuticals used as part of industry-sponsored studies.

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Three Questions: Dr. Stella Blackburn, QuintilesIMS

Monday, November 28, 2016

CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Suz Redfearn spoke with Dr. Stella Blackburn, vice president and global head of risk management for real-world evidence solutions at QuintilesIMS. As part of her efforts, Blackburn has been focused on the EMA’s adaptive pathways pilot program.

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The European Commission launches a public consultation on the Pediatric Regulation

Friday, November 18, 2016

The European Commission (EC) has launched a public consultation to get views and feedback from stakeholders, to support the Commission in drafting its second report on the Pediatric Regulation after nearly 10 years of implementation. The consultation is open until February 20, 2017. Stakeholders should send their comments directly to the EC by accessing the consultation page.

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EMA to revise first-in-human clinical trials guideline

Friday, November 18, 2016

The EMA, in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants. The revised guideline is open for public consultation until 28 February 2017. Comments should be sent to FIH-rev@ema.europa.eu using the template provided.

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Envigo launches hepatotoxicity testing for drug development de-risking program

Monday, November 7, 2016

Envigo has launched an integrated program of in vitro technologies that help predict the likelihood of compounds causing drug induced livery injury (DILI)—one of the major causes of drugs being withdrawn from the market. Since 1980, over 30 drugs have been withdrawn because of hepatotoxicity with many others having severe restrictions placed upon their use. As a consequence, and to help minimize any risks to patients taking their medicines, the pharma industry is concerned not to progress compounds that show any potential DILI liability.

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OncoDNA signs agreement with SOLTI to provide tumor molecular profile analysis to breast cancer patients

Thursday, October 27, 2016

Belgium-based OncoDNA SA, The Cancer Theranostic Company, which supplies the only comprehensive solution from cancer profiling (OncoDEEP&TRACE), combining solid and liquid biopsies analysis to help oncologists with drug treatment options and efficacy monitoring, has signed a partnership agreement, through its Spanish distributor BioSequence, with SOLTI, a non-profit organization dedicated to clinical research in breast cancer with a broad network of leading hospital centers in Spain, Portugal, France and Italy to supply tumor molecular profiling analysis for SOLTI’s AGATA breast cancer screening program.

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Kite Pharma appoints Chris Nowers head of Europe Commercial Operations

Monday, October 24, 2016

Kite Pharma has announced the appointment of Chris Nowers as its head of Europe. Nowers will be based in London. In his new role, Nowers will oversee European commercial operations to build awareness in the region of Kite’s growing pipeline portfolio of chimeric antigen receptor (CAR) and T-cell receptor (TCR) therapy product candidates and prepare for the potential launch of the company’s lead product candidate, KTE-C19.

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NNIT partners with SAP to collaborate on IDMP

Tuesday, October 18, 2016

NNIT, a global provider of IT services and consultancy, has announced a worldwide partnership with SAP SE, the market leader in enterprise application software, to market leading solutions supporting regulatory compliance for Identification of Medicinal Products (IDMP) within the pharmaceutical industry. 

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