The life sciences sector is in a bind. While there is an adequate pipeline of medicines under development (over 240,000 clinical studies across countries are listed on Clinicaltrials.gov), major challenges affect the speed of bringing these drugs into full development, starting off with bottlenecks in doing clinical trials.
A recent study conducted by Lionbridge identified the top issues in clinical trials – delays in patient recruitment, increased regulatory guidelines, compliance and vendor management issues, and global language challenges, particularly in culturally sensitive regions like the Asia-Pacific.
Slator gathered industry experts in Singapore on March 30, 2017 to discuss these issues in greater detail and foster a better understanding of the challenges ahead. Participants included senior executives from leading life sciences companies such as Anidan Group, Alcon, Astellas, Elsai, EPS International, Gsk, INC Research, Johnson and Johnson, Lundbeck Singapore, Novartis Asia-Pacific, PRA, PRAHS, Sandoz, Sanofi, Takeda Development Center Asia and Vifor Pharma.
The roundtable was sponsored by Lionbridge, one of the largest global providers of language translation and localization services for the life sciences industry. Maija Burtmanis, an Australian qualified senior Legal/Compliance Life Sciences Professional, who led the discussions, emphasized at the beginning of the presentation that only four countries in Asia-Pacific have English as a first language. This makes bilingual translation, interpretation of key data, and compliance to regulatory guidance absolutely critical.
Burtmanis has worked as a senior lawyer and compliance professional for Pfizer, Novartis and Johnson & Johnson and has covered jurisdictions including Russia, Japan, China, India and the breadth of Asia-Pacific.
“From a legal perspective, if there is one thing we must be concerned about, it is how to get the interpretation of the language right,” she said.
As conducting clinical trials across different locations often include working with third parties such as contract research organizations (CROs), the process requires a robust structure for success. A participant highlighted the fact that a global company working in the local China market may be constrained to work with local companies working in local Chinese protocols only and have to use English translation services.