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European Biopharmaceutical Review

Editor’s Letter

Biotechnology companies at the sharp end of the drug discovery process are in a rather unique commercial position of an initial, protracted pre-revenue phase, where best practice in forecasting future value is essential for setting out strategy and for securing investment and commercial partners, as Mirador Analytics’ Jamie Blackport and Chris Watson remind us (page 14). Fast-forward to having, not one, but multiple products launched in various regions, each with distinct and increasingly complex regulatory information requirements, Romuald Braun at AMPLEXOR extols the virtues of pan-project global digitisation for a next-generation approach to regulatory information management (page 86).

The importance of geography, and not underestimating country-specific regulation territories where one might assume all constituent countries were on a level regulatory playing field, is reiterated in Tórben Thers Nřrgaard at PharmaLex Nordics (page 50). Tórben takes a fascinating look at the Scandinavian contrasts between systems and cultures across Norway, Sweden, and Denmark. Expand into the wider Nordic region to include Finland and Iceland, and the complexities and contrasts broaden further. Scandinavia is a recognised hotbed of highly innovative biotech companies. Stephen McNeeney PhD at Potter Clarkson discusses the criticality of these companies ensuring appropriate protection of what is likely to be their only or main significant asset: intellectual property (page 37).

The importance of vaccines as essential weapons in the war against antimicrobial resistance and in preventing difficult-totreat bacterial infections is a topic covered by the team at PnuVax (page 10). Thomas Lingelbach at Valneva explores this deeper in an article focussing on the utility of vaccination against Lyme disease and other preventable illnesses (page 62). Otherwise, advances in spray drying and electron-beam sterilisation techniques could provide solutions to current stability-associated formulation challenges in critical vaccine development, according to Dr Jens Altrichter, Dr Kristina Kemter, Rebekka Ströver, and Professor Dr Martin Scholz at LEUKOCARE (page 28).

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