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European Pharmaceutical Contractor

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Summer 2011

   
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Marketplace & Business

Dave Roberts at Selcia provides a breakdown of the uses, benefits and custom synthesis of carbon-14 radiolabelled compounds by tackling the key issues affecting their use within drug development.


 
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If sites do not perform as sponsors envisage, the results will invariably be hampered. Diana L Anderson of DAC Patient Recruitment Services advocates the use of aggressive education, which can ensure suitable performance levels are reached.

 
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As increased budgetary pressures have led payers to demand more evidence of the therapeutic value of a new drug, the application of personalised medicine principles has shown its worth, purports Robert Hollamby of United BioSource Corporation.  
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India continues to be a popular destination for global pharma multinational corporations, but in order to take the market to the next level a number of challenges need to be resolved, explains Sujay Shetty at PricewaterhouseCoopers.
 
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Stephen Dean of CRO Communication Services illustrates that it is important for contract research organisations to find new ways to develop exceptional customer service in order to differentiate themselves from their competitors.
 
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As innovation and the application of new technology are increasingly being driven by CROs rather than the pharmaceutical industry, it is vital that CROs adapt and invest in people, equipment and knowledge, argues Mohammed Abrar of Unilabs York Bioanalytical Solutions.

 
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Legal & Regulatory
Although patenting a new chemical entity can provide substantial protection from competition, protecting only this form may prove costly in the long run, suggest Raymond R Mandra and Kimberley A Gavin of Fitzpatrick, Cella, Harper & Scinto.
 
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Onesmo Mpanju, Stephen Dodds and Henrietta Ukwu of PPD, Inc elucidate the regulatory forces influencing the delicate balance between sustainable innovation and competitive pricing.
 
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Haydn Evans of CPA Global explains that as patent protections expire, the industry will see an increase in collaborations between established pharmaceutical and generics companies and stresses the role that intellectual property can play in informing business decisions.
 
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Clinical Development
As yet, a clear approval route for many biosimilar products is yet to be defined; therefore, efficient pathways will become even more critical as pharma expands into the biosimilar market, asserts Hans-Peter Guler of INC Research.
 
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Alan Copa and Shaheen Limbada of Cetero Research describe the importance of robust recruitment strategies in accelerated studies to attract study participants in a more efficient manner, citing social media and patient-centric advertising as ways to connect with participants.
 
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When implementing a simplified strategic model for succeeding in personalised healthcare, three drivers should be factored in biological/science, information management, and healthcare collaboration suggests Mats Sundgren of AstraZeneca.
 
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Before the FDA approves any new drug applications for weight management products, it considers the overall safety profile of the product. As Regina M Ballinger of Thomson Reuters shows, this is where some applications in 2010 have fallen short.
 
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DRUG DISCOVERY, DELIVERY & THERAPEUTICS

David Bunton of Biopta Ltd makes a case for using fresh, functional human tissue in drug development as part of the drive towards truly personalised medicine.


 
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Data Management & IT Solutions
As a major buzzword of the new decade, social media is a platform that can improve patient communication and facilitate recruitment efforts, explains Matt Kibby at BBK Worldwide.
 
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To get the most out of electronic data capture, companies should reconsider how their internal processes operate in order to guarantee that the infrastructure is present to support the benefits of digital data capture, reports Joshua Pines of Medidata Solutions.
 
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M Jason Brooke and Leah R Kendall of Epstein, Becker & Green, PC, and Dane Stout of the Anson Group look at mobile health and its implications for pharmaceutical companies, along with the progress that needs to be made to regulate this relatively new aspect of healthcare.
 
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Regional Focus
In recent years, more clinical trials are being conducted in emerging regions such as Latin America. Eduardo Gotuzzo, Melissa Brosset, Camila Masias,Natalia Freundt and Maria Jose Inurritegui at Gotuzzo Asociados set out the many benefits on offer.
 
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