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| home > ebr > Winter 2015 |
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 PUBLICATIONS |
European Biopharmaceutical Review |
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Editor’s Letter
In light of the Ebola outbreak, Deborah O’Neil reminds us just what our industry is capable of, as well as reflecting on a number of this edition’s features.
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Human Airway Epithelium
Hold Your Breath
Air-liquid interface culture models can provide a powerful platform in preclinical drug development for various respiratory diseases. Samuel Constant, Song Huang and Ludovic Wiszniewski at Epithelix and Christophe Mas at OncoTheis explore further.
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Fluorinated Pharmaceuticals
Synthesis and Opportunity
As fluorinated active pharmaceutical ingredients continue to be introduced into the marketplace, Graham Sandford at Durham University and Cormac Murphy at University College Dublin examine the technology.
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Molecular Biomarkers
Mental Change
Efforts in the field of mental illness could lead to novel therapeutic targets and the individualisation of patient strategies. Paul C Guest at Cambridge University reflects on how considering schizophrenia as a whole body disease may result in better treatment approaches.
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Biomanufacturing Strategies
Keep it Flexible
Accinov’s Sylvain Peyrache and Agnes Nagy contemplate the effect biologics are having on the biopharmaceutical industry. With the recent progression of technology, new solutions are allowing companies to implement biomanufacturing strategies far more easily according to regulation requirements and project timelines.
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Cell-Based Therapeutics
Heading For Market
Stefanos Theoharis from apceth GmbH maintains that it is imperative to keep in mind the various end-goals when developing cell-based therapeutics. This will position the final product well in the marketplace of tomorrow, and deliver real benefit to patients in need.
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Biopharmaceutical Manufacturing
Synthetic Biology
Dominik Schelshorn, Sanda Ljubicic, Imre Berger and Daniel Fitzgerald of Geneva Biotech contemplate the new era of synthetic biology, and how the rapid advance of tools and technologies is changing the way we produce biopharmaceuticals.
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Case Study: Schistosomiasis
Positive Action
Schistosomiasis is one of the most prevalent – yet often neglected – parasitic diseases. Elly Kourany-Lefoll, Jennifer Keiser and Remco de Vrueh at the Pediatric Praziquantel Consortium explain how a recent collaboration hopes to formulate readily administrable treatments.
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Q&A: Vaccine Insight
Developing Immunity
Frost & Sullivan’s Aish Vivekanandan guides EBR through the hurdles of vaccine development and the impact of Ebola, before discussing what we can expect from the next decade of research.
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Active Immunotherapy
Fighting Fit
Research has shown the potential for targeted immunotherapy in non-infectious diseases, specifi cally in the prevention and management of non-small-cell lung cancer. Bioven’s Erik D’Hondt and Pangaea Biotech’s Jordi Bertran-Alamillo and Jordi Codony-Servat comment on recent clinical trial results.
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Radioimmunotherapy
Alpha, Better
Treating cancer is not a one-size-fits-all proposition. Kaushik Dave and Dragan Cicic from Actinium Pharmaceuticals Inc run through the latest developments in radioimmunotherapy and the promising effects of alpha-emitters in reducing cancerous cells.
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Oncology Studies
Put to the Test
SMS-oncology’s Lindy Bosch and Raymond Hoffmans look at the components typically comprising a Phase 1 oncology study, describing characteristics such as sponsor types, drugs used, dose levels and patient stratification, as well as overall trial objectives.
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Event Review: Crystallography
Crystal Clear
Following on from 2014 – the Year of Crystallography –EBR’s Emma Naks reviews photographer Max Alexander’s exhibition, Illuminating Atoms, which captured crystallography experiments in action, as well as displaying portraits of modern day crystallographers
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Funding Models
Destination Europe
Poul Sørensen and Emil Pot of European Biopharmaceutical Enterprises comment on Europe’s sluggish R&D output, and recommend mobilising investment to encourage innovative entrepreneurship as a means of boosting economic growth.
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In Brief
Crouching Tiger
Emile Bellott casts his mind east and asks: will China have multinational pharma companies of its own? And how will they compare to those in Europe and America?
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Intellectual Property Act
Right of Way
Jasnoop Cheema at Greenaway Scott assesses the UK’s Intellectual Property Act, outlining how the latest changes hope to simplify the current patenting process and encourage growth in the life sciences sector.
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News and Press Releases |
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SHIONOGI’S NOVEL ANTIBIOTIC, FETCROJA® (CEFIDEROCOL), HAS BEEN SELECTED BY UK’S NICE / NHSE&I AS PART OF AN ANTIMICROBIAL SUBSCRIPTION STYLE REIMBURSEMENT MODEL
The National Institute for Clinical and Health Excellence (NICE) and the National Health Service England and Improvement (NHSE&I) have recognised the potential of Shionogi’s innovative antibiotic, cefiderocol, and selected it for inclusion in this pilot reimbursement model which ‘de-links’ payment from volume of use
Shionogi recognises the UK’s leadership role in introducing this first fully ‘delinked’ pilot reimbursement model, which is an important step in making the market for novel antibiotics more predictable and sustainable; we strongly believe in the introduction of further suitable pull incentives in order to help stimulate the antimicrobial development pipeline
Fetcroja® (cefiderocol) is indicated for the treatment of infections due to aerobic Gram-negative bacteria in adults with limited treatment options1
Antimicrobial resistance (AMR) is a major health burden which results in over 700,000 deaths globally2 and 5,000 deaths per year in the UK3 from an infection with multidrug-resistant bacteria and this is predicted to kill 10 million people every year globally by 2050, unless action is taken2
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White Papers |
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Challenges of Analytical Method Transfer in the Pharmaceutical Industry
RSSL
The development and validation of suitable analytical methods is a critical part of the overall drug-development life-cycle. For the majority of products, particularly those that are clinically successful, the transfer of the analytical method between laboratories will be required. This process is designed to verify that a given laboratory is capable of performing a test method for its intended purpose. This can be performed either internally (at the same company), or, with the on-going increasing trend in outsourcing, to an external Contract Research or Development organisation (CRO or CDO).
More info >> |
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Industry Events |
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Bio Integrates 2021
20 May 2021, VIRTUAL CONFERENCE
Following the continued success of last year’s inaugural digital event,
Life Science Integrates is delighted to announce the 3rd Bio Integrates
conference. Addressing the needs of innovative companies developing the
therapies of tomorrow, this one-day conference provides a unique forum
to discuss the major challenges impacting the sector.
More info >> |
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