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European BioPharmaceutical Review

ebr
Summer 2006
At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. EBR provides a unique platform of communication for the market across Europe, North America and the rest of the developed world. To find out what's hot in the world of of biopharmaceuticals, take a look below at the range of articles featured in this issue of EBR
   
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An introduction to the themes of EBR Summer from Editor Helen Tayton-Martin  
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BioFinance and Management
In Markets Reloaded, Christian Tidona of Tidona Consulting GmbH and Peter Liepolt of trio-financial relations AG review current trends in the capital markets  
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In The Business Alchemist, Nigel Wild at Nigel Wild Associates looks at the formative years of a biotech start-up and the conditions conducive to longevity  
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From increased access to capital to losses in management time, Keith White at Critchleys considers the potential perils and pay-offs of flotation, in The Buoyancy of Floating  
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BioBusiness Development
In The Spin-Out Life Cycle, Mark Lomas at Ashfords and Michael Roberts of Greaves Brewster LLP explore the legal and IP minefields of founding and developing a biotech enterprise  
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Tim Jinks of BTG discusses the merits of Tapping New Pipelines, and forming partnerships and licensing agreements early on in the development process  
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With a particular focus on the Bolar exemptions, Aura Soininen and Ben Rapinoja at Borenius & Kemppinen Ltd assess the latest moves in European implementation of pharmaceutical legislation, in Enacting Exemption  
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In the context of an industry where collaboration is evermore important, Dr Duncan Curley at McDermott Will & Emery UK LLP takes up A Matter of Possession - the critical issue of intellectual property  
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BioResearch and Innovation
With significant international variations in legal and ethical attitudes towards stem cell research, the prospect of therapies making it to market is uncertain. In Roots and Shoots - The Future of Stem Cells, Himanshu Parmar at Frost & Sullivan considers both the potential and the problems of this field  
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Dr James Miskin, Professor Susan Kingsman and Dr Kyriacos Mitrophanous at Oxford Biomedica provide an overview of developments in the use of integrating vectors to introduce genes to target cells, in Ingenious Therapy  
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Dr Ansgar Santel of SR Pharma plc/Atugen AG investigates a valuable technology, both in vivo and in vitro, in RNAi: The Secrets of Silence Uncovered  
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With greater affinity and biostability, third generation compounds based on LNA chemistry are a promising therapeutic avenue. In RNAi Antagonism: The New Meaning of Antisense, Keith McCullagh of Santaris Pharma looks at this development in switching-off disease-causing genes  
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BioDiscovery Technology
Gunilla Hššg at Recip AB illustrates the successful implementation of a new laboratory information management system, in LIMS Lifts Confidence  
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In Reaping the Benefits of New Microarray Technology, Jordan Stockton at Agilent Technologies delves into the expanding uses of this technique  
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Steven Reynolds and Damir Blazina at Oxford Instruments Molecular Biotools explain how nuclear magnetic resonance spectroscopy is providing solutions to the need to isolate higher quality leads in a target-rich environment, in One Small Acronym for Man, One Giant Leap for NMR  
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John Favier at DEM Solutions ventures into A Virtual Reality in his discussion of computer aided design and its cost- and time-saving possibilities  
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BioDevelopment and Regulatory
The intricacies of the 2004 act on human tissue use and storage continue to unfold in a second article by Neil Sullivan at Cord8 Ltd - The Human Factor: Part II  
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It makes good sense to investigate possible harmful effects on the heart at the earliest stages of drug development. Dr Simon Bryant and Dr Derek Terrar at Oxford Cardiac Pharmacology Ltd (OCP) address Matters of the Heart: Assessing Cardiac Side Effects  
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With a host of patents on the verge of expiration, biogenerics are receiving increasing attention; Dr Conrad Savoy of Biopartners weighs the issues In a Biosimilar Vein  
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In our second article on biogenerics - Tackling the Brand Nation - Dr Faiz Kermani at Chiltern details the hurdles to be overcome in order to maximise the potential of this new class of drug  
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BioFormulation and Manufacturing
Gerald Adams of Lyosolutions elucidates the complexities of freeze-drying and investigates its increasing range of applications, in A New Ice Age  
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In Making Vaccines Safer: Progress Toward Animal-Free Production, David Mead, Dermot Pearson and Maree Devine at Delta Biotechnology Limited review the problems attending animal-derived protein products and the solutions offered by alternative sources  
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BIORegional: France
With a focus on financial incentives and policies to promote skills development and research, such as the Research Tax Credit, Geraldine Filippi at Invest in France uncovers Europe's third largest market, in Boosting Biotech the French Way  
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BIORegional: Sweden 
In Goteborg: In the Realm of Research, Olivia Lindau-Jonsson and Anders Linnard at Business Region Goteborg review the biomedical history of the region and consider how this supports continuing innovation in fields such as cardiovascular therapy, biomaterials and metabolic diseases  
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With over 200 biotech companies and 130 products in late preclinical or clinical trials, Sweden has the fourth largest biotech industry in Europe. Ylva Williams at Invest in Sweden Agency illuminates the national biotech scene in terms of finance, centres of academic excellence, traditions in drug development and more, in Northern Lights  
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Edited by
Dr Helen Tayton-Martin,
Corporate & Business
Development Specialist,
Life Science
Published quarterly in
February, May,
August and November

Industry Events

4th Annual Patient Recruitment and Retention in Clinical Trials

13-15 October 2008, Amsterdam

Patient recruitment is now consuming thirty percent of clinical trial time - more time than any other clinical trial activity - and almost half of all trial delays result from patient recruitment problems. As the recruiting culture becomes more sophisticated and the forces affecting patient enrollment grow more numerous and complex, pharmaceutical companies are striving to discover new strategies to facilitate enrollment in clinical trials. With increasing industry pressure to develop, test and market greater numbers of new drugs faster, pharmaceutical companies need to perform clinical trials as quickly as possible. Inefficient patient recruitment processes is a formidable barrier to pharmaceutical companies' success in launching new products. Improving the patient recruitment process is imperative to avoid wasted investments and eliminate costly delays in bringing new drugs to market -- today and even more so in the not-so-distant future. Improved patient recruitment presents one of the largest opportunities for pharmaceutical companies to eliminate delays in clinical trials, thereby making it possible to reduce time to market.  With patent time limits and large overheads meaning that any delays in the development timeline can be disastrous, a good understanding of how to successfully recruit patients for trials is vital for any company looking to succeed.
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News and Press Releases

Azopharma Product Development Group, Inc

HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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