Pharmaceutical Executive Europe - March 2007 - (Page 12)

Finding Success in Asia Dr Nadina C. Jose looks at the issues companies should consider before outsourcing their clinical trials to Asia. Dr Nadina C. Jose rug development has an average length of 12 years with an average cost of $802 million,1 yet only one out of every 15 drugs in development typically makes it through to approval. For the most par t, the reasons to do global clinical trials rest in our current environment: business drivers such as development costs, key business and regulatory needs, timely product launch and the growing relevance of emerging markets such as China, India, Singapore, South Africa, Africa and Latin America play significant roles in influencing the decisions being made. Scientific drivers — such as access to treatmentnaïve patients, earlier delivery of innovative new products because of shortened development time, developing more opinion leaders and generation of rich data to address ethnic diversity2 — provide bridging trials and push forward targeted therapy for endemic populations. Drug development really begins with a good idea; that is, an idea that a certain molecule may show promise of efficacy and safety in a specific disease indication, not to mention the potential that this molecule may actually be a cure for the disease for which it is intended. Thus, in ascertaining the unique potential such a product may bring, creating a roadmap towards executing an otherwise complex process is of the utmost importance. This becomes D highly significant when clinical trials are set to be launched in non-EU regions such as Asia, where pharmaceutical and biotech companies have vigorously established their presence in countries including China, Singapore, India, Thailand, the Philippines, Indonesia, Malaysia and Taiwan. The elements to consider before embarking on a non-EU trial are featured below. Identify the issues These issues start with the decision to go global or not. If so, which region, and which country in the region? What are the regulatory hurdles? Is a reliable research infrastructure available? Are the investigative sites trained? How many resources are allocated and available for the project to succeed? Then there’s the allimportant composition of the project team; how much of the work will remain in-house and how much will be outsourced? What guidelines are used to identify which region of the world would best be suited for the project? Is cost the major determining factor other than the availability of untapped population? Are there ‘landmines’4 to be identified and detonated? Prioritize the level of importance Project management is an art. Efficient project management begins with a well thought-out plan, MARCH 2007 CLINICAL TRIALS MANAGEMENT 12

Table of Contents for the Digital Edition of Pharmaceutical Executive Europe - March 2007

Content
Linking People, Process and Technology
Building Alliances
Finding Success in Asia
Selecting South Africa
Advance from Europe
EDC: Are We Missing the Boat?
The Right Equipment
Next Stop: Vienna

Pharmaceutical Executive Europe - March 2007

http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201302
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201301
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201212
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201211
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201210
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201209
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201208
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201207
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201206
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201205
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201204
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201203
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201202
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201201
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201112
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201111
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201110
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201109
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110823
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110809
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110728_v2
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110728
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110711
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110624
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110609
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110526
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110512
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_oracle_201105
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110426
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110412
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110324
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110310
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110224
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110208
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110128
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_mediakit2011
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20101216
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20101124
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20101111
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20101027
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20101013
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100930
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100915_supp
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100915
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100825
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100811
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100727
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100713
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100623
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100609
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100526
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100512
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_ims_201005
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100427
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100414
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100324
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100310
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100224
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100210
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100126
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100112
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20091222
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20091208
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20091124
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20091110
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20091027
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20091013
http://digital.findpharma.com/nxtbooks/advanstaruk/PEE_DIGEST_20090930
http://digital.findpharma.com/nxtbooks/advanstaruk/PEE_digest_20090916
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090902
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090825
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090819
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090812
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090805
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090729
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090721
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090715
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090708
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090701
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090624
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090617
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090610
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090602
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090526
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090519
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090512
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090505
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_southafrica
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090429
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090422
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090415
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090408
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090401_v2
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090401
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090325
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090318
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090311
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090304
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090224
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090218
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090211
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090203
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090128
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090121
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090114
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope1208
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope1108
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope1008
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope-ims1008
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0908
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0808
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0708
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0608
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope-imssales0508
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0508
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0408
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0308
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0208
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope-imssales0208
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0108
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope-ims1207
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope1107
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope1007
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope-imsoncology0907
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0407
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0307
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope1206
https://www.nxtbookmedia.com