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European Biopharmaceutical Review

ebr
Autumn 2003
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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In her Editor's Letter, Dr Helen Abbott reviews the articles in this quarter's issue of EBR  
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STRATEGY AND FINANCE
Dr Stephen Parker, Director of sp2 Consulting Limited, tells A Tale of Two Countries: Speculating the Fortunes of the UK and US Pharma Markets  
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In Investor-Exec Relations: A Biotech Investor Perspective, Dr Alex Pasteur, Investment Manager at Cambridge Gateway Fund, discusses the use of 'best practice' when resolving conflicts between management teams of small biotech companies and their financial colleagues  
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Lisa Mynheer, DiagnOx Manager at Oxford Innovation Ltd, considers Funding and Mentoring Support for Medical Diagnostic Start-ups  
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The recently published Burrill & Company Biotech 2003 report contains significant cause for optimism across the biotechnology sector, argues Dr Adam Stoten, Research Analyst and Associate Consultant at Technomark, in Burrill & Company Report - An Overview  
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Science and Innovation
Gerben Moolhuizen MBA and Leo GJ de Leede PhD at Octoplus, and Giulio F Paciotti PhD and Lawrence Tamarkin PhD of Cytimmune Sciences Inc, present Colloidal Gold Nanoparticles as a New Approach to Target Tumour Necrosis Factor to Solid Cancers  
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Are we are gaining on cancer at last? G Steven Burrill, CEO of Burrill & Company investigates, in Battling Cancer  
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Burkhard Ziebolz PhD, Science Communications Manager for Roche Diagnostics, discusses bone breakdown products as markers for disease management, in Early Detection of Osteoporosis with b-Crosslaps  
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In Osteoporosis - A Field Posing Challenges and Rewards, Enrico Bastianelli, Vice-President Corporate Development and Philippe Ballero, Chief Executive Officer at ProSkelia Pharmaceuticals, follow the progress of research for more effective agents  
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Aimee Dingwell, News Editor at BioCentury Publications Inc, talks to Spiros Jamas, President and CEO of Enanta, in Upping the Anti - Keeping Ahead of Antibiotic Resistance  
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BioDevelopment
Reliable protocols are available for the inclusion of a genetic component into a clinical trial. Dr Stephen Little, CEO of DxS Ltd, investigates in Sample Collection and Transport for Genetic Analysis in Clinical Trials  
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With preparation and good management, the risks associated with conducting a clinical trial can be mitigated, says Chris Tait, Life Science Underwriting Manager at Chubb Insurance Company, Europe, in Clinical Trials: Managing 21st Century Risks  
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Roger Bullock, Principal Investigator and Director, and Charlotte Rose, Business Manager at the Kingshill Research Centre examine the Emerging Changes in the Management of Clinical Trials in NHS Organisations  
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In the first of a two-part article, Sharon Grimster, Director of Westerly Projects Ltd, looks at Biopharmaceutical Manufacturing: Past, Present and Future  
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In A Concept for the Improvement of Biopharmaceutical Process Development - The Austrian Center of Biopharmaceutical Technology, Dr Friedmann Hesse PhD, Co-ordinator of the Austrian Center of Biopharmaceutical Technology (ACBT), discusses the centre's work  
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Sean Flanagan, Commercial Director at Kryotrans Ltd and Sue Lee, Manager of Biopharm Systems at World Courier, look at The Cold Chain, Distribution Challenges and Strategic Partnerships  
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Dr Keith Chidwick, Consultant at Technomark Consulting Services Ltd, presents a Review of the Second Annual Biological Forum, 2nd-3rd June 2003, Palais des Congress in Lyon  
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Increasingly, biopharmaceutical organisations and companies are looking for global collaborators. In Meeting Requirements: Choosing Your Specialist Logistics Company, Jamie French, Operations Manager at Biocair, discusses how to select the right company  
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Legal, Regulatory and Public Policy
In Regulating Home Genetic Testing: Might Protecting the Public do more Harm than Good? Sarah Carter BA (Hons), MSc and Professor David Taylor, Professor of Pharmaceutical and Public Health Policy, University of London, explore the development of UK regulation of home genetic testing and consider the public interests at stake  
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As some companies start to offer genetic tests outside the context of a medical consultation, Philip Webb, Chair of the HGC Working Group on Genetic Testing Services Supplied Direct to the Public, considers regulating testing, in Genes Direct - A Report from the Human Genetics Commission  
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Dr Helen Abbott, Senior Consultant at Technomark Consulting Services Ltd and Editor of EBR, gives an overview of EuropaBio Emerging Enterprises Board in EuropaBio - Europe's Biotechnology Industry Association in Action, and then further discusses the board in the follow-up article, In Conversation with Dr Philippe Pouletty, Chairman of the EuropaBio Emerging Enterprises Board  
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EuropaBio's Emerging Enterprises Sub-Board - In Conversation with Dr Philippe Pouletty, Chairman of the EuropaBio Emerging Enterprises Board  
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Drug Discovery
Dr Leming Shi, Principal Investigator and Dr Weida Tong, Director at the Center for Toxicoinfomratics, National Center for Toxicological Research (NCTR) and the Food and Drug Administration, USA, and Dr Xian-Ping Lu, Chief Scientific Officer at Chipscreen Biosciences Ltd, China, consider Biochemoinformatics: Integrating Bioinformatics and Chemoinformatics for Drug Discovery and Development  
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Dr Leming Shi, Principal Investigator and Dr Weida Tong, Director at the Center for Toxicoinfomratics, National Center for Toxicological Research (NCTR) and the Food and Drug Administration, USA, and Dr Xian-Ping Lu, Chief Scientific Officer at Chipscreen Biosciences Ltd, China, consider Biochemoinformatics: Integrating Bioinformatics and Chemoinformatics for Drug Discovery and Development  
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Christine Wilde and Georg Schmidt of Tosoh Bioscience; Eva Moellenhoff at the German Institute for High Blood Pressure Research; Bimal Chatterjee at the GSF-National Research Center for Environment and Health, Institute of Development Genetics; and S Nakatani, T Tsuda, Y Yamasaki, H Moriyama, H Watanabe and Y Kato of Tosoh Corporation, discuss Quantification of Gene Expression by Combining Competitive RT-PCR with HPLC Analysis  
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Hans Peter Fischer, Project Manager at Genedata AG, considers Turning Quantity into Quality: Novel Quality Assurance Strategies for Data Produced by High-Throughput Genomics Technologies  
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SPECIAL FOCUS: AGRICULTURAL BIOTECH AND BOTANICALS
The Future of Agricultural Biotechnology is considered by William Martineau, Senior Research Analyst at The Freedonia Group, Inc  
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In The Need for Convergence and Co-operation: Regulation, Public-Private Partnerships and the Future of Agricultural Biotech, Helena Robin Bordie, Consultant for Croplife International, asks why agricultural biotechnology has failed to deliver food security to the poorest nations  
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Dr Detlef Wilke, Partner at Biotech Consulting GmbH and Jens A Katzek, Managing Director of BIO-Mitteldeutschland GmbH, consider plants as alternative eukaryotic expression systems, in Primary Production of Biopharmaceuticals in Plants - An Economically Attractive Choice?  
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In the near future Britain should become the first country to license a cannabis-based pharmaceutical. David Potter at GW Pharmaceuticals offers his expertise, in Medicinal Cannabis Production - The Botanist's View  
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Edited by
Dr Deborah O'Neil,
Chief Executive and Scientific Officer,
NovaBiotics Ltd
Published quarterly in
January, April,
July, and October

News and Press Releases

Clinical and Regulatory Operational Excellence Forum

1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment? Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?
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White Papers

PhlexEarchive: The Right Solution for Electronic Archiving of TMF Content

Phlexglobal Ltd

Many sponsor organizations have already recognized the value of moving from paper to electronic Trial Master Files (eTMFs). But few sponsors have taken a more holistic approach to the TMF lifecycle and looked at the entire process from study start-up through archiving of the TMF in electronic format, also known as e-archiving. The recurring value of managing, tracking, maintaining and accessing electronic files should not stop at the point of archiving. All of the challenges of managing an active paper TMF carry through to a paper archive. All of the benefits of an electronic TMF also carry through to the electronic archive. As companies look to move their compliance assets to secure, long-term storage, it is important to consider ongoing compliance requirements, security, accessibility, efficiency and costs of archiving TMF content in a digital format.
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Industry Events

ASGCT 22nd Annual Meeting

29 April - 2 May 2019, Washington Hilton, Washington, D.C

The 2019 ASGCT Annual Meeting is expected to be the largest in Society history, eclipsing the mark set by the 2018 meeting just last year. Join more than 3,500 researchers, clinicians, advocates, and industry leaders in discovering the latest science and technology surrounding gene and cell therapy.
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