spacer
home > ebr > winter 2019 > editor’s letter
PUBLICATIONS
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).

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer

Print this page
Send to a friend
Privacy statement
News and Press Releases

Are you keeping up to date with changes to pharmaceutical laws and guidance?

The legal and regulatory environment affecting the pharmaceutical industry is in a period of unprecedented change. Are you keeping up with all these changes?
More info >>

White Papers

The EC Definition of a Nanomaterial - Potential Measurement Methodologies

NanoSight

In October 2011 the European Commission published a definition of Nanomaterials. This move followed more than six years of scientific consideration of the potential toxicological and environmental challenges posed by engineered nanomaterials.
More info >>

 
Industry Events

Clinical Trial Supply Europe 2019

13-14 March 2019, Milan, Italy

Following on from our largest and most engaging meeting to date, Clinical Trial Supply Europe will be returning to Milan for its 20th year in 2019! The 19th annual edition welcomed pharmaceutical companies across Europe who got together to share knowledge and issues regarding clinical trial supplies, both with regards to operational and technological challenges. Over the two days, delegates discussed issues which affected their business in our dedicated operational and technological streams.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement