samedan logo
 
 
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

2019 Pharmapack Awards

Pharmapack Europe have announced entries for the 2019 Pharmapack Awards are now open across both the ‘Exhibitor Innovation’ and ‘Health Products’ categories with a closing date of 30th November 2018. The Health Products category will include two winners with one for Patient-Centric Design – which is launched in partnership with HCPC Europe (Healthcare Compliance Packaging Council of Europe) – and a second introduced alongside Adelphe for Eco-design in health packaging and drug delivery devices. Pharmapack Europe have also announced that they’re accepting applications for the start-up hub which provides young start-up companies servicing the pharma industry with the benefit of valuable networking and learning opportunities at half the price of a regular stand.
More info >>

White Papers

Preparation of Pharmaceutical Samples for Metals Analysis

RSSL

There has been a lot of discussion regarding the methods of analysis for pharmaceutical products as we await the upcoming changes to both the EP and USP, relating to the analysis of metal impurities.
More info >>

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.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement