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European Biopharmaceutical Review

Adapt to Survive

No market is immune to change, and life sciences continues to face its fair share of upheaval as the industry accommodates emerging innovation in healthcare and a raft of other challenges to the status quo. Below are five of the most prominent trends and what they mean in practice.

Strategic Acquisitions

As a shortcut to attractive new product lines, when development and testing cycles can be frustratingly long, companies are increasingly sizing up strategic purchases. 2016 saw high levels of merger and acquisition (M&A) activity and more of the same had been forecast for 2017 (1,2). Though this has not quite materialised so far, it is expected to pick up in the second half of the year.

However, profiting from these deals means the acquiring company must be able to align its branding, content and labelling quickly, reliably and efficiently. This is essential in upholding brand image, stabilising compliance efforts and maximising process efficiency, as well as market opportunity.

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Peter Muller is Managing Director for Schlafender Hase, Americas. For the last 20 years, he has worked on software and process improvement projects with Fortune 500 companies from various industries including pharma, consumer goods, food, aerospace and defence. Peter has a wealth of experience working with international clients to define their organisations’ goals and help them leverage new technologies to achieve productivity gains, process improvements and cost savings.
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Peter Muller
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News and Press Releases

BioGenes Establishes Scientific Advisory Board

Berlin, Germany, December 12, 2017 / B3C newswire / -- BioGenes GmbH, specializing in ELISA development and production and a global leader in host cell protein (HCP) assay development, today announces the establishment of a Scientific Advisory Board which includes the following four renowned experts:
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White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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Industry Events

BioTrinity 2018

23-25 April 2018, Novotel London West in Hammersmith

BioTrinity 2018 is taking place from 23-25 April at the Novotel London West in Hammersmith. Now in its 12th year, BioTrinity remains the leading life sciences biopartnering and investment conference in Europe, and is a must attend event for R&D companies, TTO’s and academia who are looking to meet, collaborate, partner and seek funding from Big Pharma, Investors and Associated Industry companies.
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