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PUBLICATIONS

European Biopharmaceutical Review

ebr
Summer 2014

   
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Editor’s Letter

Deborah O'Neil contemplates the industry's changing climate and reflects on some of this edition's focus features.
 
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STRATEGY AND FINANCE
Dry Shipping

The Physics of Failure


Dan O’Donnell at Fisher BioServices urges companies to pay closer attention to the basic principles of physics when distributing cell-based products. This will allow the focus to stay on the patients and clinical trials, and not on delivery.
 
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BioResearch and Innovation
gmMSC Technology

Mesenchymal Stem Cells 2.0


Technological breakthroughs in the development of next generation mesenchymal stem cells are leading to increasing patient benefits, as well as clinical and commercial success, thinks apceth’s Stefanos Theoharis.
 
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Oral Diseases

Mouth to Mouth


Pierre Attali at BioAlliance Pharma considers why systemic and topical treatments for oral diseases are not always the best option, and recommends the use of mucoadhesive buccal formulations as an alternative.
 
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Iminosugars
 
A Rare Approach


The successful development of iminosugar-based chaperone compounds could be the answer to treating lysosomal storage diseases and many other orphan pathologies. Julie Charollais-Thoenig and Stéphane Demotz at Dorphan SA explain.
 
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Placenta-Derived Therapeutics

Great Expectations


With preeclampsia still a leading killer of pregnant women and a major contributor to foetal morbidity, Pluristem Therapeutics’ Karine Kleinhaus talks about the need to invest research into placenta-derived cell therapies.
 
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Genetic Toxicology

Genotox Support


Andrew Eaton and Matthew Tate at Gentronix muse on how an understanding of genetic toxicology can help chemists to formulate and improve compounds in an effective way.


 
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Discovery Technology
Column Technology

HPLC’s Golden Jubilee


In the first of a two-part series, Ronald Majors from Agilent Technologies looks back at the origins of high-performance liquid chromatography, and reflects on how far this technology has come on the eve of its 50th anniversary.
 
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Novel Therapeutics

Lease of Life


Novozymes Biopharma’s Dermot Pearson suggests how extending the therapeutic half-life of drugs can offer pharma companies new prospects to improve the
profile of their products.
 
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Hypoxia Replication

Prime Conditions


Investigators are embracing new hypoxia workstations which push the boundaries of research capabilities by enabling the capture of real-time dissolved oxygen directly from cell-culture media. Michael Rau at Oxford Optronix reports.
 
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BioDevelopment and Regulatory
Regulatory Update

New Twists for Orphans


Fresh changes at the FDA have had important implications for the orphan drug development process. Timothy Coté at Coté Orphan Consulting guides companies and sponsors through the regulatory minefield.
 
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Cell-BasedPotency Assays

Quality Assurance

When developing a cell-based potency assay intended for product release and quality control, careful considerations need to be taken. Weihong Wang at Eurofins Lancaster Laboratories investigates.


 
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Biosimilars

Making Progress


There has been increasing recognition of the value of biosimilars as a cost-effective answer to the problem of patent expiry and demands for lower priced alternatives. NDA Group’s Dr Gopalan Narayanan provides some thoughts.


 
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Patent Protection

The Secret of Success


Bioproduction processes can offer companies the chance to exploit new subject matter to extend the patent life of a drug. This rise in second-generation copyrights is prompting legal moves, says Paul Calvo at Sterne, Kessler, Goldstein and Fox.
 
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BIOINFORMATICS
Whole Genome Sequencing

Applied Information


Rodrigo Barnes at Aridhia Informatics believes that annotation services are the solution to delivering research data concerning genome sequencing to both clinicians and patients.
 
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INTERVIEW
Industry Interview

Radiation Response

Xstrahl’s Adrian Treverton talks to EBR about the future direction of radiation oncology, and how it can provide more patient-centred healthcare.
 
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INDUSTRY DYNAMICS
Clinical Research Outsourcing

Merging Markets


Vijaya Vulapalli at GBI Research explores how clinical research outsourcing partners are set to cash in on the opportunities presented by pharma’s tough times.
 
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News and Press Releases

Blood Tests May Prevent Relapse in Breast Cancer Patients

The Royal Marsden NHS Foundation Trust is leading an international research collaboration to offer blood tests that can identify risk of relapse in breast cancer patients. The trial will assess whether personalised blood tests can show which patients will relapse, years before it’s shown on a scan - treatment can then be altered to try and prevent relapse from happening. There are currently no effective tests to establish which patients are at risk of relapse after previous treatment for breast cancer.
More info >>

White Papers

Clinical Trial Site Contracting: The Conservative, Progressive and Hybrid Models

DrugDev

For the last 20 years, pharmaceutical companies have turned to a variety of clinical outsourcing solutions to reduce costs and improve timelines, enabling them to focus on their core value of research and development. In today’s tightly competitive market, companies are constantly striving for ways to further cut costs and reduce study startup cycle times, while maintaining quality. One of the key cost factors in global R&D spending, estimated at around $102 billion per Kalorama market research, is the cost of conducting clinical trials. CRO’s, which account for about 30% of the total R&D spending, have risen to the challenge of the clinical, technical and administrative management of these trials. But some pharmaceutical companies question how much control to relinquish to vendor partners, especially in the legal arena, due to potential ramifications.
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