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

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