2 years ago
April 4, 2017
Takeaways: Slator’s Roundtable on Compliance and Vendor Management in Clinical Trials
If you ask the World Health Organization (WHO), the global response to public health emergencies isn’t fast enough. This is not only about pandemics like the zika or ebola virus which can spread like wildfire across national borders with devastating consequences. Diseases also develop and spread faster today and require faster response from governments and health organizations.
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.
“There needs to be a good systems in place,” Burtmanis affirmed, emphasizing that the risk universe is large. Beyond the language issues, there have been developments in recent years around regulations and compliance, especially in China, that are also throwing a curved ball on multinational as well as local organizations.
The recent move of the Chinese government, for example, to kickstart the health sector by subsidizing domestic R&D, strengthening IP rules and enforcement, establishing biotech parks, and encouraging big pharma to invest and set up R&D facilities (with tax breaks), appear to be good news at face value. However, it is forcing a rethink among global companies, and even local firms.
With the incentives in place, is it a good time to partner now with local CROs? Maya said the whole point is that China wants to create a dynamic innovation hub within this region and it is leading way in appealing to industries, particularly the tech and life sciences and automation sectors, to encourage them to have the confidence in putting their money in China. But can the locals keep up with international standards?
“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” — Maija Burtmanis, Senior Legal/Compliance Life Sciences Professional
And when the China Food and Drug Administration (CFDA) introduced in July 2015 a circular mandating the self-inspection of clinical trial data to encourage multinational and even local companies to self-inspect their own trials, warning of surprise audits and harsh consequences for those who fail to comply with standards, it has also led many multinational companies in the US or Europe to question their confidence in their own CROs.
“Companies are taking it seriously. So the world of clinical development, regulatory compliance has become extremely important,” Burtmanis said. “Many companies have initiated their own self-inspections.”
However, as many participants have shared, this development has also triggered voluntary withdrawals from projects from local CROs, knowing that they wouldn’t be able to comply with the standards. “So the situation now is that you lack qualified CROs to do the job,” one participant said.
The point is, big and small players must do due diligence. “A lot of it comes down to selecting the providers with the track record and the experience,” Burtmanis concluded.
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