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European Biopharmaceutical Review

Editor’s Letter

Our summer 2014 edition comes to you at the end of what has been a rollercoaster period of pharma megamergers – asset swapping between Novartis and GSK, Valeant pursuing Allergan, and the mother of all deals that never was: Pfizer’s aborted acquisition of AstraZeneca.

The industry remains in a period of transition, and Vijaya Vulapalli of GBI Research covers a related topic: the reduction in internal R&D in favour of outsourcing (page 62). As more preclinical development activities are outsourced, the CRO market will continue to grow steadily and expand beyond Europe and the US to other territories. That said, in an interesting parallel to the current pharma mergers trend, this growth has also led to mergers within the contract research sector – and the creation of even larger multinational players that continue to dominate the CRO market.

Paul Calvo at SKGF discusses the intellectual property risk posed by biosimilars and how the protection of the processes used to generate biopharmaceuticals may become more necessary for the industry (page 68). NDA Group's Gopalan Narayanan views the biosimilars theme from a very different perspective, calling for a smoother regulatory path for products that are “not biological generics” (page 66).

Continuing our excellent series of cell therapy focused articles, novel uses of biologicals and challenges in their clinical application are assessed in this edition. Stefanos Theoharis from apceth examines genetically modifi ed mesenchymal stem cells (page 18); placenta-derived pluripotent stem cells for tackling preeclampisa are highlighted by Pluristem Therapeutics' Karine Kleinhaus (page 36); and ensuring cell therapies reach target patients in trials is taken up by Dan O’Donnell at Fisher BioServices (page 54).

In addition, two articles address the importance of cell-based effi cacy and safety/toxicology assays. Andrew Eaton and Matthew Tate at Gentronix look at genetic toxicology assays (page 44), and Eurofins Lancaster Laboratories'Weihong Wang focuses on cell-based potency assays (page 50).

Finally, the impact of hypoxia workstations on this type of important preclinical cell-based work is an interesting area of cell-based assays explored by Michael Rau of Oxford Optronix (page 58).

This edition features a host of other articles on different aspects of biopharma discovery and development. For example, iminosugar-based chaperones are presented as a potential solution to lysosomal storage diseases by Dorphan's Julie Charollais-Thoenig and Stéphane Demotz (page 30).

Orphan conditions is a theme we have covered in detail of late, and this continues with Timothy Coté of Coté Orphan Consulting’s advice on regulatory changes in this area (page 22), as well as Pierre Attali at BioAlliance Pharma's introduction to oral orphan diseases and the suitability of buccally administered treatments (page 26).

I doubt the current climate of change in the sector will have completely settled by the time our next edition of EBR comes out in October. But I hope that whatever further corporate shifts lie on the horizon are benefi cial for you and yours – and our industry as a whole in the long term.

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