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PUBLICATIONS

Spring 2006
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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introduction
Dr Graham Hughes reviews this issue's tasty submissions in his Editor's Letter  
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Keynote
Established in 1958, the UK Code of Practice is one of the oldest in the global pharmaceutical sector, and provides a 'gold standard' for other industry codes throughout the world. Dr Richard Barker of the ABPI reports on the recent revisions and their implications, in Code Known  
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The symbiotic relationship that exists between the medical profession and the pharmaceutical industry is a fragile one. In Critical Concerns & Social Responsibility, Dr Otmar Kloiber of the World Medical Association reminds us that when communication breaks down, patients, physicians and the industry all suffer  
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In Time for Transparency, Dr Beat Widler of F. Hoffmann-La Roche Ltd considers the ethical obligation to disclose comprehensive information on clinical trial results - both positive and negative  
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Marketplace & Business
Cross-border compliance concerns continue to exercise the experts, as pharma outsources its operations and distributes to an ever-widening base of customers. Craig Wylie of BearingPoint ponders what's in store, in 2006: The Year of Compliance  
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To Outsource or Not - Is that Still the Question? Dr R Graham Hughes peers into his crystal ball to catch a glimpse of the prospects for contract research organisations  
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Times are changing fast. The focus of pharmaceutical research and development on finding new drugs is on the wane; today, the emphasis is put on innovation that extends the life cycle of a product. Guenther Illert at Capgemini reflects on the situation, in Pharma Feels the Strain  
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R&D Tax
Paul Harris of Ernst & Young looks at both the short-term and long-term trends playing out through R&D tax schemes in the UK, in Getting Back More Than Comic Relief  
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It is widely recognised that countries in which significant levels of R&D are conducted enjoy enhanced economic growth. David Cobb of Deloitte reports on the countries willing to reinvent themselves in order to make themselves more appealing to investors, in Competitive Regimes - R&D Global Scene  
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Legal & Regulatory
Regulatory requirements are being enforced more strongly than ever in order to protect the consumer: a fact evident with the recent expansion of the EU, where companies operating out of the former Eastern Bloc have to address these matters - and quickly. Carl Turner of Compliance Control weighs up Eastern Promise  
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Addicted to blockbusters? As the supply of big patents continues to shrink, Julian Hitchcock of Mills & Reeve wonders where pharma's new fix can come from, in Making Designer Drugs Pay  
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World's Health on High Alert - as the need for collective defences against infectious disease risks becomes greater, Linda Horton of Hogan & Hartson examines how the new international health regulations will affect global companies and governments alike  
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Clinical Research
In The Clinical Trial Hub, Dr Georg A Mathis of Appletree Ltd argues that the high quality of data and the cost effectiveness of trials make it well worth considering the inclusion of sites in CEE in any worldwide development plan  
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Today, pharma companies face the challenge of reaching an increasingly sophisticated customer - and in every country across the globe. It is, however, worth remembering the value of country-specific information notes Gary Muddyman of Conversis, in Back in the USSR  
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In order to remain competitive, service providers need to develop strategies suited to the sponsor's most pressing needs. In Staffing by Contract? Umakanta Sahoo and Rakesh Lalchandani at Chiltern International reveal that the key to the Indian approach is mutual benefit  
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Biomarkers & Drug Development
In The Rise of the Little 'Omics', Chris Beecher of Metabolon, Inc, explores how to get the most out of metabolomics for biomarker discovery - a young science with great potential 88 The use of biomarkers in clinical trials for documenting population changes is intended to support - indeed, eventually replace - other clinical observations. Dr Lawrence K Oliver at Mayo Clinical Trial Services discovers direct patient care can transform drug development, in Meet Your Marker  
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Faced with the possibility of a new breed of therapeutic abuse, sports testing laboratories may need to dramatically alter their working practices. The Intricacies of Detecting Gene Doping are asking serious questions of sport, concludes Phil Teale at HFL Ltd  
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Therapeutic Innovation
Each year 10.9 million people worldwide are diagnosed with cancer and 6.7 million die from it. In The Life & Times of Cancer (Research UK), Harpal S Kumar of Cancer Research UK discusses how the public sector must work more closely with the pharmaceutical industry to accelerate the development of new treatments from the lab to the clinic  
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Breathe Easy, Datamonitor's Shaun Falkingbridge assures us - developments are afoot to tackle the unmet need for adjustable dosing regimes that permit a temporary increase in drug dose during an asthma attack  
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Clinical Laboratories & Logistics
Dr Nick Crabb and Dr John Conti-Ramsden of Intertek reflect on an industry trend towards the practice of a more collaborative 'open innovation' approach to development at all stages of the drug pipeline, using analytical service organisations with advanced technical resources, in From Mission to Market  
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The drug development industry lags behind other high-tech segments that use tools such as product life cycle management to integrate their value-chains and partnerships with their suppliers and vendors. Dr Agostino Fede of PPD talks Central Labs and Sponsors: A Perfect Partnership?  
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Lost in Translation? As industry becomes increasingly global and good channels of communication prove ever more vital, Ted Marshall of Translution Limited gives computer-assisted solutions to translation issues a comprehension test  
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Reviews & Previews
With over 350 sessions and more than 1,000 speakers, the 42nd DIA Annual Meeting in Philadelphia, starting on the 18th June, provides the perfect opportunity for the global pharmaceutical community to talk shop  
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Data Management & IT Solutions
IT Today Transforms Clinical Trials' Tomorrow - Dr Max Horneck of clinIT AG believes that setting up a trial with IT provides the infrastructure required to answer the increasing challenges posed by changes in regulations  
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The average cost of developing new drugs and bringing them to market is now 350 million. Faced with this expense, pharmaceutical companies are increasing their efforts to contain development costs, argues Steve Beats of DRS Data Services Limited, in Hybrids Hit the Big Time  
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As the age of paper in clinical research comes to an end, Phil Lee of PHT Corporation asks whether the heir apparent is up to the job, in Why Go ePRO?  
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The way in which pharmaceutical companies choose to implement electronic document management can determine how effective their business becomes. Chris Dewey of Active Navigation considers the best way of Dealing with Documentation  
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News and Press Releases

Janssen Announces Phase 1 Results for Bispecific Antibody Amivantamab in the Treatment of Patients with Advanced Non-Small Cell Lung Cancer Harbouring Exon 20 Insertion Mutations

BEERSE, BELGIUM, May 18, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the Phase 1 CHRYSALIS study evaluating amivantamab (JNJ-6372) in the treatment of patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations.[i] Amivantamab is an EGFR and MET-targeted bispecific antibody, which targets activating and resistance EGFR mutations, and MET pathway activation.[ii],[iii] Investigators assessed efficacy using overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), duration of response, as well as the safety profile of amivantamab,1 which were the basis of the U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation granted earlier this year.[iv]
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White Papers

Another Successful Visit Against the Odds

Medical Research Network (MRN) Limited

Our dedicated team of nurses, couriers and project managers deliver, come rain or shine. Making sure a Clinical Trial visit can go ahead in the home can be a complex process, and last month bad weather nearly stopped play on an important Home Trial Support visit. Thanks to the commitment and dedication from the entire team it went ahead against the odds.
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Industry Events

World Vaccine Congress Europe

18-21 October 2020, Barcelona, Spain

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
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