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European Pharmaceutical Contractor

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Autumn 2016

   
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Legal & Regulatory
ICH E6 (R2) Addendum

Game Changer


The new ICH guidance will be implemented in November 2016, which will have a profound effect on the management of clinical trials. Nick Neri at ERT outlines some of the steps that pharma companies need to take in order to remain compliant.
 
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Data De-Identification

Protecting Patient Identities


As organisations are required to become more transparent in their studies, the identities of patients are being put at risk. d-Wise’s Chris Olinger comments on new guidelines trying to alleviate this problem.
 
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Spotlight

The Path to Easier Product Lifecycle Maintenance

TRAC Services
reveals the importance of the regulatory affairs function within pharma, and how good document management is critical in the successful production of drugs.
 
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Regulatory Update

On Duty

Viktoriya Angelova
at Rephine gives an overview of the most significant changes the new ICH Addendum brings, particularly with regards to sponsor and investigator responsibilities.


 
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Reviews & Previews
Event Review

Up to Standard?


A central theme of this year’s DIA annual meeting in Philadelphia, US, was cyber identity and the issues associated with it. Jon Weisberg at SAFE-BioPharma reports.
 
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Data Management & IT Solutions
Biostatistics

SAS and R Team in Clinical Research


To either prove or disprove stated hypotheses, it is necessary to carry out statistical analyses and collect data. KCR’s Adrian Olszewski introduces two reliable packages to support evidencebased research on drugs.


 
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News and Press Releases

Oxford Genetics licenses SnapFast™ expression vectors to Twist Bioscience

November 16, 2017, Oxford, England and San Francisco, US. – Oxford Genetics, a leader in innovative synthetic biology-based technologies for biologics discovery, development and delivery, announced today a new licensing agreement with Twist Bioscience Corporation, a company enabling customers to succeed through its offering of rapid, high-quality synthetic DNA. Oxford Genetics will supply Twist Bioscience with its SnapFast™ technology platform to provide a broad range of application-specific expression vectors which Twist Bioscience will use to clone synthesized DNA for its diverse customer base.
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White Papers

Orthogonal Approaches for the Analysis of Protein Sequence

Ludger Ltd

One of the most important classes of biopharmaceuticals is monoclonal antibodies. They are expressed from living cells, and are consequently subject to complex biochemical pathways. Not all of these routes are fully understood, and many are sensitive to the subtlest of environmental changes. Changes such as these can affect the final biopharmaceutical sequence, structure and post-translational modifications, not to mention any changes that may occur during further purification. This often means that the final product from one batch may be different from the last in another batch. Each batch is a complicated mix of similar molecules, and analysis of the degree of batch-to-batch variation is therefore very important to the establishment of the drug's safety for medicinal use and patient administration.
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Industry Events

14th Annual Biomarkers & Immuno-Oncology World Congress

11-13 June 2018, Westin Boston Waterfront, Boston, Massachusetts

The Biomarkers and Immuno-Oncology World Congress brings together a unique and international mix of large and medium pharmaceutical, biotech and diagnostics companies, leading universities and clinical research institutions, government and national labs, CROs, emerging companies and tool providers—making the Congress a perfect meeting-place to share experience, foster collaborations across industry and academia, and evaluate emerging technologies.
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