This week, Clinical Trials Arena will be shining a spotlight on data management as part of May’s ‘Data Week’. Running throughout the week of June 27th, 2016, CTA will post articles uncovering the most pressing issues facing industry today.
Experts, such as, Abhijit Vaidya (Cipla, Ltd., India) writes about the development of medical devices in India, whereas Wagner Souza (AstraZeneca, Brazil), describes the pharmaceutical industry landscape in South America.
Be sure to visit CTA later today when Rakesh Shah (Merck Serono, India) assesses the supply chain market in India in a compelling article.
In the meantime, catch up on some CTA’s most recent stories delving into the challenges of running trials in emerging markets…
A journey through the clinical trial supply chain in Korea
Many Korean pharmaceutical companies have internal facilities to manufacture their drugs. However these facilities for manufacture cater to the full pipeline of drug development. From a business perspective, commercial drugs are produced on a larger scale and have significant value to the company, and as a result are often prioritized on the production line within the manufacturing facility. Clinical drugs (IPs) are generally produced in much smaller amounts, and despite the consequence of prolonged manufacturing time to clinical teams, the importance of speedy IP manufacture is not always appreciated on the manufacturing line. To finish this compelling article, read Gwong-Cheung Hur’s article here…
Best Practices for Conducting Multi-Regional Trials in Emerging Regions
If you have been pondering whether to employ a multi-regional strategy in your clinical development program, you are not alone. Despite the growing prevalence of global clinical trials and global registration strategies in the past two decades and the increase in the number of firms who specialize in conducting these trials, there are still a depressingly large number of ways that the unsuspecting sponsor can get it wrong and see their clinical development plans spin hopelessly off the rails. Here are a few points to consider in planning your next multi-regional project…
Clinical Trials in Asia, Part I: Tale of the Tiger or Tiger by the Tail?
Say you are a proto-typical biotech company with one lead clinical drug candidate and several others in either pre-clinical or discovery. Chances are high that your development strategy will be to out-license your lead program to a big pharma company or be acquired. Given the exponentially rising costs of late-stage development through commercialization, this is not an unreasonable expectation on the part of your investors, particularly venture capitalists. And it’s certainly justifiable, if your plan to get to your next clinical development milestone is based on getting it done in the US or Europe.
Would your investors’ exit strategy be different if you could add value to your enterprise by achieving your clinical milestone faster and at less cost? Enter Asia.