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

SKYCELL ANNOUNCES GLOBAL COLLABORATION WITH AIR FRANCE KLM MARTINAIR CARGO

Zurich, Switzerland / Schiphol, Netherlands / Roissy Charles de Gaulle, France, April 2, 2019 – SkyCell, the Swiss-based manufacturer of the world’s safest temperature-controlled containers for pharmaceuticals, and Air France KLM Martinair Cargo will expand their existing collaboration. Therefore, both companies have announced a global collaboration to work more closely together on existing and future business in logistics of pharmaceuticals.
More info >>

White Papers

Working Towards a Standardised Identification Solution

PCI Pharma Services

The security of the pharmaceutical supply chain is an issue of growing concern, with recent reports addressing its vulnerability to counterfeiting. The complexity of the European supply chain is one of the key factors of this counterfeiting pandemic, with millions of medicine packs being moved around the EU, annually. Aside from this, fragmentation has resulted in decreased transparency in the supply chain and increased difficulties to track and trace medicines, leading to significant threat from counterfeiting. As a key source of income for the European economy, it is essential that the supply chain remains safe and free of counterfeits. A significant stumbling block within the industry remains to be the lack of a unified, single‐source pan‐European or indeed global database where scanned bar codes on drug packaging can be verified at point of dispense. At some point in the future the pharmaceutical industry, regulatory bodies, clinicians and retailers will need to join forces to overcome this.
More info >>

 
Industry Events

9th Annual Outsourcing in Clinical Trials Europe 2019

14-15 May 2019, Milan, Italy

Now in its 9th year, the Outsourcing in Clinical Trials Europe event is firmly established as the leading platform for the biopharmaceutical industry to collaborate to improve clinical trial partnerships, accelerate development timelines and leverage new technologies. Over 500 clinical professionals from biopharmaceutical and solution-provider companies attended the 2018 conference in Barcelona to develop new partnerships and find answers to their most pressing clinical trial challenges.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement