spacer
home > epc > Summer 2011
PUBLICATIONS

European Pharmaceutical Contractor

epc
Summer 2011

   
Text
PDF
bullet
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.


 
view
download pdf

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.

 
view
download pdf
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.  
view
download pdf
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.
 
view
download pdf
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.
 
view
download pdf

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.

 
view
download pdf
bullet
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.
 
view
download pdf
Onesmo Mpanju, Stephen Dodds and Henrietta Ukwu of PPD, Inc elucidate the regulatory forces influencing the delicate balance between sustainable innovation and competitive pricing.
 
view
download pdf
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.
 
view
download pdf
bullet
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.
 
view
download pdf
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.
 
view
download pdf
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.
 
view
download pdf
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.
 
view
download pdf
bullet
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.


 
view
download pdf
bullet
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.
 
view
download pdf
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.
 
view
download pdf
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.
 
view
download pdf
bullet
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.
 
view
download pdf
   
spacer



Published quarterly in
February, May,
August and November

News and Press Releases

Strategic Alliance to support efficient, ethical practices in biopharma industry

Hayward, CA and Stockholm, Sweden (07-12-2017) Two leading drug development and regulatory consultancies announced today that they have formed a new strategic collaboration to help life science companies navigate an increasingly complex global environment. Ethiprax Associates LLC, a leading Compliance and Ethics solutions consultancy based in the US, and NDA Group, a world-leading integrated regulatory/drug development consultancy, are now collaborating to provide the life science industry with truly integrated, trans-Atlantic Compliance-and Risk Management strategies.
More info >>

White Papers

Cartridge Based Drug Delivery System

Weibel CDS AG

Cartridge based drug delivery systems small and easy to use? This question is discussed in this article by Ludwig Weibel, CEO and Hans Peter Manser, Business Director of Weibel CDS AG. A novel and innovative approach is presented offering patients numerous advantages making their life easier, saving time and avoiding needle stick injuries. Safer, easier and faster drug delivery Weibel CDS AG, Switzerland develops and produces innovative, user friendly, application oriented injection systems and devices.
More info >>

Industry Events

3rd Annual Inhalation & Respiratory Drug Delivery Congress

8-9 May 2018, London, UK

Oxford Global are proud to present our hugely popular 3rd Annual Inhalation & Respiratory Drug Delivery Congress, 8th 9th May 2018, London, UK. Over 300 delegates representing global pharmaceutical organisations, leading biotech companies and internationally renowned academic institutions will gather for over 20 presentations and case studies focused on the key issues in inhalation and respiratory drug delivery.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement