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| home > ebr > Winter 2016 |
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 PUBLICATIONS |
European Biopharmaceutical Review |
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Editor's Letter
EBR’s Editor, Deborah O’Neil, summarises January’s main themes, and draws on articles that reference the latest industry news and discoveries.
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Feature
Q&A: eHealth
Mukhtar Ahmed at BioClinica talks to EBR about the thriving popularity of eHealth technologies, and how paperless systems can help to drive better research and patient engagement.
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Features
Spotlight
In an industry increasingly reliant on internet-based collaborations, new EMA guidelines requiring digital signatures on most electronic submissions are the way forward for the pharma industry, suggests SAFE-Biopharma’s Jon Weisberg.
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Features
Microindentation Testing
Markus Fabich at Olympus discusses microindentation analysis – a method for investigating the mechanical characteristics of bone – and how digital light microscopy can streamline this highly intricate process.
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Drug Development
Biopharma Outsourcing
Richard Hucker, Ian James, Scott Vincent and Carl Watson at A4P Consulting report a considerable rise in outsourcing activities within drug development among large biopharma and niche companies alike, and share their predictions on future trends.
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Regular Feature
Orphan Drugs
Industry advisor Emile Bellott reflects in depth on the recent boom in orphan drug approvals by the FDA, as well as what the next decade holds for this rapidly expanding sector.
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Regular Feature
In Brief
Antimicrobial resistance is an increasingly serious concern, and one which is a very real possibility in the 21st century – threatening the achievements of modern medicine and putting patients at risk. EBR Editor Deborah O’Neil looks at what pharma is doing to address a growing crisis
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Research Hubs
Leading Edge
With a £200 million funding boost and five newly established research hubs, the UK is taking its place as a world leader in the regenerative medicine market, says David Pan at the UKRMP.
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Drug Development
Implementing Automation
With the average cost of developing a new medicine estimated at $2.6 billion, cost reduction and reducing time to market have become an increasing focus. Implementing an automated quality management system can streamline processes, states MasterControl’s Lane Hirning.
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Drug Development
Time to Market
The rush to get a new drug approved does not have to mean a trade-off between cost and safety, believes Clinovo’s Glenn Keet, who reveals how current tech innovations can bolster safety while accelerating time to market.
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Drug Development
Early-Stage Development
The EMA's new Adaptive Pathways Network – designed to support early patient access to new medicines in areas of high unmet medical need – could significantly lower drug development costs, claims Karine Kleinhaus at Pluristem Therapeutics.
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Feature
Preclinical Safety Assessment
John Carter and Robert Guest at Envigo consider how in vitro assays are helping to steer the development of alternatives to animal-based toxicity testing.
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Therapeutic Advances
Q&A: Stem Cell Lines
Takara Bio Europe’s Kristina Runeberg describes iPS – a new technology that is able to derive hepatocytes from multiple induced pluripotent cells, and which subsequently shortens the drug development process.
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Features
Genetic Modification
2015 was a breakthrough year for biomedicine, thanks to the discovery of a new gene-editing tool, CRISPR/Cas9. Regina Au from BioMarketing Insight discovers how this revolutionary system could potentially wipe out numerous diseases.
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Cell Therapy
World View
Cecilia Van Cauwenberghe at Frost & Sullivan explores the potential of regenerative medicine in combatting major diseases, and finds that each market region approaches this lucrative sector very differently.
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Therapeutic Advances
Antibody Engineering
From
CDR grafting and phage display to transgenic mice approaches, the past
two decades have seen rapid advances in humanisation techniques to
reduce immunogenicity. So why are humanised murine antibodies still
being used in today’s labs? Andrew Glover at Fusion Antibodies
investigates.
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Therapeutic Advances
Viral Vector Techniques
Recent innovations in viral vector technologies are helping to tackle the challenges of traditional vaccination systems – including complex manufacturing processes. But certain obstacles need to be addressed before these methods can go to market, explains Carl Christel at Sirion Biotech.
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Regenerative Medicine
Lab Technology
From generating organs using 3D printing to lab-grown tissues, regenerative medicine has progressed significantly in recent years. BioMarketing Insight's Regna Au examines the key developments in a field that has contributed hugely to the fight against life-threatening diseases.
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News and Press Releases |
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Significant improvement in overall survival with ERLEADA®▼ (apalutamide) for patients with non-metastatic castration-resistant prostate cancer
BEERSE, BELGIUM, May 14, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the final analysis of the pivotal Phase 3 SPARTAN study demonstrating ERLEADA®▼ (apalutamide) in combination with androgen deprivation therapy (ADT) significantly improved overall survival (OS), compared to ADT alone, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high risk of developing metastases.1 Results will be presented at the American Society of Clinical Oncology (ASCO) Virtual Scientific Programme (Abstract #5516) beginning on Friday 29th May.
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White Papers |
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Case Study: Cmed’s Mobile Data Management Solution
Cmed Clinical Services
The trial presented to Cmed was a randomized, double blinded, placebo
and active controlled study to evaluate the cardiac safety of multiple
doses of [study drug] in health volunteers.
The pharmaceutical
company, who were into the second year of development of a potential
blockbuster compound for the treatment of chronic myelogenous leukaemia
(CML), were requested by the FDA to design a trial to provide
information on the cardiac safety of different dose levels of the study
drug in healthy adult volunteers. The primary objective of the study was
specifically to find the maximum tolerated dose before QTc levels
became unsafe. All development of the compound was put on hold until the
results of this study were submitted to the FDA and approval granted
for the compound to progress into full development.
More info >> |
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Industry Events |
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12th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology
8-11 February 2021, Vienna, Austria
In continuation of the very successful scientific meetings in Budapest, Paris, Berlin, Florence, Geneva, Barcelona, Malta, Istanbul, Lisbon, Glasgow and Granada, the 12th PBP World will be held in Vienna from 8-11 Feb 2021. This every two year held conference has gained an ever increasing impact among the pharmaceutical scientists: With up to 1000 submitted abstracts and about 1300 participants it has become a well-established major meeting, attracting scientists from all over the world.
More info >> |
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