Category: Medical Writing in China


Chinese Biopharmaceutical Startups and Global Medical Communications

Posted on by Yanni Wang

Chinese biopharmaceutical startupsChinese biopharmaceutical startups are on the rise, and now is a great time for new drug development in China. That’s a comment I hear a lot recently from people who work in the Chinese pharmaceutical industry.

Why? They say it’s because of the following.

  • Continued support for new drug development from the central and local Chinese governments,
  • Improved drug approval process in China,
  • Increased interest in investing in biopharmaceutical products in China, and
  • Growing entrepreneurial spirit among overseas Chinese returnees

The sunny environment is fueling the growth of Chinese biopharmaceutical startups. Some experts predict that in the next 5 to 10 years some of these Chinese biopharmaceutical startups will play a great role not only in the Chinese pharmaceutical industry but also the global pharmaceutical industry.

As a bilingual medical communications professional who works closely with global clients in China, the US, and Europe, I am watching the rise of the Chinese biopharmaceutical startups with great interest. I am especially interested in learning the strategies the Chinese biopharmaceutical startups use to communicate with the rest of the world. Meanwhile, I wonder if the rise of the Chinese pharmaceutical startups will affect the global medical communications strategy of foreign pharmaceutical companies. If so, how?

Here are my observations regarding how Chinese biopharmaceutical startups communicate with regulatory agencies outside of China, and their common global medical communications strategy.

Global regulatory submissions for Chinese biopharmaceutical startups

Many of Chinese biopharmaceutical startups choose to conduct clinical trials simultaneously in China and other countries, with popular locations including the US and Australia. While some of the larger companies have decided to form their own medical writing teams, others seem to be working with local CROs. Because certain regulatory documents (eg, clinical study reports, investigators brochures, and protocols) need to be written in both Chinese and English, I believe that bilingual Chinese and English medical writers will become increasingly more desirable to these companies as well as CROs. The rise of the Chinese regulatory medical writing profession is a great sign.

Global scientific and medical communications strategy

Presenting at international conferences is a great way for Chinese biopharmaceutical startups to share data and increase visibility. Many of these companies tend to carefully choose and attend a few international symposia pertaining to their products. Most of the founders and top management team members of Chinese biopharmaceutical startups have global research as well as management experience. When time permits, they prefer preparing and delivering presentations themselves, sometimes with help from their highly capable assistants or in-house writing team.

Publishing in high-impact English journals are also very important to Chinese biopharmaceutical startups, because English publications in prestigious journals can enhance their credibility and strength in investors’ as well as potential collaborators’ eyes.

Many of the leaders of Chinese biopharmaceutical startups are scientists, and they read and breath in science. But when it’s time to write, they tend to let their academic collaborators take the lead. These academic researchers often choose to draft manuscripts themselves. Some of them may choose to have editorial providers to help edit and proofread their manuscripts before submission, but others may choose to work with editorial service providers from the beginning to speed up the process.

Long-term global medical communications strategy

Do all the Chinese biopharmaceutical startups have a long-term global medical communications strategy? The short answer is, some do but most don’t. Due to the inherent high risks and high costs associated with drug development, survival unfortunately is often the number one objective of many Chinese biopharmaceutical startups. Even with the government’ and investors’ support, Chinese biopharmaceutical startups can still quickly run out of money. Promoting their brand and communicating their progress effectively with investors and peers are highly critical to their survival. Companies that already have marketable products tend to  have a long-term global medical communications strategy. Startups without a marketable product tend to develop and revise short-term global medical communications strategies from time to time depending on the progress of the drug development.

With the recent changes in the Chinese regulatory policies and the rise of the Chinese biopharmaceutical startups, foreign pharmaceutical companies interested in the Chinese market will need to modify their global medical communications strategy as well.


The Evolving Landscape of Scientific Publishing in China

Posted on by Yanni Wang

Scientific publishing in ChinaScientific publishing is thriving in China. The recently exposed misconduct may have caused concerns regarding the quality of scientific research conducted in China. But with enhanced regulation and extensive education, the situation will improve. And with the Chinese government’s continued support for scientific research, scientific publishing will continue to evolve in China.

Publication boom and misconduct

The past decade has witnessed an astonishing increase in the number of scientific papers published by Chinese scholars. The publication boom is an expected result of the Chinese government’s enhanced support for science and research. Universities and research institutions’ encouragement for publishing in English journals also fueled the growth. In addition to funding, many universities and research institutes offer various types of scientific publishing-related incentives, including name recognition, career advancement, as well as monetary awards known as “cash-per-publication” policies.

However, with the push for more publications, especially high-impact English publications, came along research and publication misconduct. The recently exposed scandals have unfortunately tarnished the integrity and reputation of Chinese research. The incidents also triggered investigations and crackdowns from the Chinese government agencies, including the China Association for Science and Technology (CAST). The investigations exposed various types of misconducts, including plagiarism, data falsification, as well as authorship purchasing and review manipulation.

Determined to improve the integrity and reputation of Chinese research and scientific publishing, the CAST has developed and is implementing a series of programs to prevent future frauds.

Challenges of scientific publishing

The truth is, many researchers (Chinese-speaking and English-speaking researchers alike), do not like to write. Writing is simply not something they like to do. If you ask, some of them will jokingly tell you that it’s why they are pursuing science, not writing! Writing in English adds another layer of challenges to many Chinese researchers.

To increase their chance of publishing in English journals, many Chinese researchers seek editorial assistance either from individual editors or editorial agencies. The need fueled the increase in the number of editorial service providers in China.

Continued need for publication guidance and assistance

Despite the setback caused by the publication misconduct, the need for legitimate scientific writing and editing services in China is still high. The main challenge, however, is how to uphold the ethical standards.

The good news is the Chinese government is making great efforts to enhance the research integrity in China. Many Chinese researchers and government officials fully understand the importance of research and publication integrity and they deeply care about their reputation. Through carefully planned educational programs, updated publication guidelines, and enhanced government regulations, the quality of scientific publishing in China will improve.

What legitimate editorial service providers need to do

The research misconducts unfortunately have negatively affected the image and reputation of all editorial service providers. In the future, companies that provide legitimate editorial services will need to try hard to distance themselves from the so-called “paper brokers,” and to hold high ethical standards. When necessary, they may also need to educate the researchers they serve and encourage them to follow the guidelines of international journals such as the ICMJE guidelines.  Building a transparent, ethical, and trustworthy relationship between legitimate editorial service providers and researchers will benefit every party involved.

 


Trends and Opportunities of Scientific Medical Writing in China Part II: The Emerging Profession of Chinese Regulatory Medical Writing

Posted on by Yanni Wang

  (Photo credit: Lin Qiang)

A hidden field

Regulatory medical writing is a relatively new profession in China. It’s not that the need for regulatory medical writing didn’t exist in China a decade ago. It’s just that regulatory medical writing itself was not considered a profession until recent years. In the past, most Chinese pharmaceutical companies did not have their own medical writing or regulatory writing departments. Regulatory-related medical writing was often managed by functional unites such as medical affairs.

A new concept

The idea of using professional medical writers to develop regulatory documents was probably first introduced by global pharmaceutical companies striving to enter the Chinese market. Even though these companies had their headquarters-based medical writers to develop documents for global submissions, they still needed local medical writers to generate Chinese regulatory documents and work with the Chinese regulatory agencies. The need for regulatory medical writers who could write in Chinese and understand the local regulations was urgent.

In the beginning, the global biopharmaceutical companies turned to China-based contract research organization (CROs) to help with medical writing-related work. But gradually, these companies, especially those that had set up R&D centers in China, started to build their own medical writing teams in China. As they started to hire and train Chinese medical writers, they introduced the concept of professional medical writing to China. And the profession of Chinese regulatory medical writing emerged as a result.

A growing field

A decade ago, professional regulatory medical writers were few in China, and majority of them worked for global pharmaceutical companies. Today there are hundreds of Chinese regulatory medical writers working for foreign and domestic companies alike. And the number is expected to continue to grow.

In addition to global pharmaceutical companies, CROs and Chinese biopharmaceutical companies including many biotech startups also contributed to the rapid growth of Chinese regulatory medical writing.

Many of these Chinese CROs and biotech startups were founded and are managed by Chinese overseas returnees. Before returning to China, the owners and the management teams of these companies often had worked at global pharmaceutical giants for many years. Many of them have decades of research as well as management experience, and they know the importance of high-quality medical writing documents. When they need to have their clinical study reports written, they look for professional medical writers who can produce high-quality results.

The need for professional medical writers fueled the growth of the medical writing field in China. As more and more Chinese returnees start their own companies in China, the field of Chinese regulatory medical writing will continue to grow.

Currently most of the Chinese medical writers work for biopharmaceutical companies, medical device companies, and CROs. As the field continues to grow and as the first group of medical writers gain more experience, some may choose to freelance or work as contractors. The idea of becoming a freelance medical writer may sound foreign or even scary to many Chinese medical writers right now, but it won’t be so in few years.

A mature profession

The evolving regulatory landscape in China, especially the recent approval of the CFDA as an ICH member, will no doubt help the Chinese regulatory medial writing grow into a mature profession.