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| home > epc > Spring 2002 |
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 PUBLICATIONS |
European Pharmaceutical Contractor |
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| At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. EPC 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 pharmaceuticals, take a look below at the range of articles featured in this issue of EPC |
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| In his Editor's Letter, Dr Graham Hughes reviews the articles in this Spring issue of EPC |
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| Wayne Griffin, Managing Director of Acumen Pharmaceutical Services Ltd, predicts the effects that the implementation of the EU Clinical Trials Directive will have across member states in UK Phase I/IIa CROs - The Challenges Ahead |
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| All too often, British biotechs look to America for partnership in drug discovery and development. Philip Oliver, International Technology Promoter, Life Sciences - Europe, explains that partnering opportunities exist closer to home in UK and European Biotechs - Partnering for Profit |
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| In their Annual Review of Contract Research Organisations, Dr Graham Hughes, Scientific Director of Technomark Consulting Services Ltd, and Marianne O'Neill, Manager of Technomark Research, conclude that in spite of the tough times, the CRO industry is alive and well |
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| In recent years the pharmaceutical industry has become ever more competitive and it faces several major challenges in the 21st Century. Dr Faiz Kermani and Dr Gordon Findlay of CMR International offer some guidelines for Understanding Recent Trends in Pharmaceutical R&D |
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| Analysts believe that the Internet will transform clinical trials into an efficient exchange of electronic communication and data analysis. Paul Webb, Commercial and Operations Director, and Nigel Trim, Managing Director of MATRIX Contract Research Limited, consider the Transformation from Paper to Electronic Clinical Trials - The Site Perspective |
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| Marcin Dudek, Director of Clinical Operations and Dr Aneta Sitarska-Haber, Clinical Research Manager at Kiecana Clinical Research in Poland, examine the growth of registered trials in CEE countries and explain Why it is Worth Conducting Clinical Trials in Poland |
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| In Clinical Trials and New Drug Applications in Japan, Tony Mitchell, Director of Regulatory Affairs at Origin Pharmaceutical Services Limited, discusses the changes in the Japanese regulatory framework which have led to more effective, transparent and manageable approval processes |
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| Parallel trade is a relatively young yet highly controversial industry sector that is breaking free from the confines of the EU and taking a foothold in non-EU countries. Tim Atkinson, an Independent Biopharmaceutical Analyst, explores Global Parallel Trade - A Growing Concern |
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| In Medical Devices Exposed, David Wright, Managing Director/Director of Clinical and Regulatory, and Richard Wyse, Medical Director, at Celsus Ltd., highlight the European regulations for medical devices that companies must now meet before placing their products on the EC market |
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| Professor Chris Atterwill, Director of the Biosciences Group at Huntingdon Life Sciences looks at In Vitro Preclinical Lead Optimisation Technologies (PLOTs) in Pharmaceutical Development and explains that there is a need for early, rapid and robust screening assays which will allow a lead series of compounds to be ranked for desirable or undesirable characteristics |
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| In Peptide Pharmaceuticals Manufacturing - Making Fmoc Solid Phase Synthesis The Preferred Route, Kevin Price, Business Manager of the Peptide Pharmaceutical Business within Avecia Biotechnology, predicts that the Human Genome Project coupled with proteomics will lead to large numbers of new peptide and protein drug candidates |
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| In recent years there have been a number of developments indicating that testing in the future may not rely so heavily on animals. C. Deegan and M. Thomas of SafePharm Laboratories suggest some Alternatives to Animals for Toxicity Testing |
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In The Importance of Market Research in Patient Recruitment, Dr Diana Anderson, President & Chief Executive Officer at Rheumatology Research International, explains that when developing a campaign it is crucial to understand what motivates patients to participate in a clinical trial
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| Richard Barrett of Pfizer Global Research and Development, UK, previews the Drug Information Association's 14th Annual EuroMeeting - Basel, Switzerland, 5th-8th March 2002 |
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| There is a poor appreciation of the importance of adult tissue stem cells in normal tissue homeostasis and how drugs can affect their behaviour. In Stem Cells - The Clinician's 'Philosopher's Stone', Professor Christopher Potten, Founder of EpiStem Ltd, emphasises that to ignore stem cell effects is akin to treating the symptoms rather than the cause of disease |
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| Thomas Vorre-Grшntved MSc, Business Development Manager, Pharma and Diagnostic Production at Nunc A/S in Denmark, looks at Implementing New and Old Technologies - A Dedicated Strategy in Developing a Microarray Technology |
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| In anticipation of future regulations, pharmaceutical companies are reviewing their 'cold chain' and temperature controlled processes. Mario Johnson, Pharmaceutical Industry Development Manager for DHL UK offers some advice on Ensuring Adequate Temperature Controlled Distribution - Regulations, Recommendations and Technology |
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| Andre Grigjanis, Managing Director, Global Competence Centre for IBS Pharma, and John O'Connor, Vice President Global Sales, the IBS Group highlight the benefits of integrated software that cover the full spectrum of the pharmaceutical industry's requirements, in Industry-Specific Supply Chain Software - The Sugar that Helps the Medicine Go Down |
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| User acceptance is among the greatest concerns a study sponsor has when implementing EDC. Thomas Haskell, Director of Product Management at CB Technologies offers some tips on What You Should Expect from a User-Friendly EDC Solution |
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| In Convergent Technologies - Opportunities in Clinical Trials, Kris Gustafson, Director of Interactive Technologies, and Joanna Williams, IVRS Project Director for ICON Clinical Research, advise clinical trials managers to take advantage of the convergence of various user interface management technologies |
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| David Gingell, Marketing Director, EMEA of Documentum Inc. explains how a late arrival to the e-business world will in fact provide the pharmaceutical industry with significant advantages, in Content Management - The Competitive Edge for e-Business Winners in the Pharmaceutical Industry |
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| Simon Crowe, Senior Business Development Manager, Informatics & Technology Services, PPD Development, UK emphasises the importance of planning, time considerations, process change, education and training in Maintaining Validation Control Over EDC Systems During a Clinical Study |
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Industry Events |
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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.
More info >> |
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News and Press Releases |
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PFIZER PRESENTS OVERALL SURVIVAL DATA FOR SUTENT™ VERSUS INTERFERON-ALFA
Chicago, 31 May 2008- Results from a landmark study have shown that sunitinib (SUTENT™)
has demonstrated overall survival greater than two years in patients with
metastatic renal cell carcinoma (mRCC), also known as advanced kidney cancer.
This is the first time overall survival data representing more than two years
has been achieved in the first line setting of mRCC, which is clinically
meaningful and reflective of major advances in the treatment of kidney
cancer.
More info >> |
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