Two Steps Forward

If I were to believe my Chinese zodiac horoscope for 2019, then in the area of career, I’m to expect a “medley of obstacles and conflicts” along my path. First up may be the choice of China as the focus for this issue. It seemed a fine selection based on all the positive press around biotechs in the country, as well as notable regulatory developments. But then came a couple of manufacturing scandals, including improperly prepared

Lisa Henderson

DTaP vaccines, followed by substandard manufacturing processes in generic valsartan manufactured in China and distributed in the US, followed by Trump’s increased rules around investments in China or by China-based entities in the US, followed by … CRISPR babies. 

CRISPR babies almost sealed the deal for not moving forward with this February topic, but the other editors talked me off the ledge and here we are with a well-rounded issue on the state of biopharma in China. And what I’ve learned interviewing China’s pharma industry watchers and participants, is what looks like a negative setback is actually part and parcel for the country as it grows its innovative medicines and increases quality standards in a very remarkable upward curve. 

One of those industry watchers, Bill Trombetta, PhD, professor of healthcare strategy and marketing at St. Joseph’s University’s Haub School of Business in Philadelphia, last visited China in 2013 with a group of graduate students. The first such tour was in 2002 to learn and observe in Hong Kong at the time of the transition from UK affiliation to China’s authority and control. The 2013 grad study tour in Beijing included visits to a number of stakeholders, including a “small mom and pop drug” manufacturer, Bayer and Novo Nordisk, a CRO, a medical school, and hospital. 

With every visit, Trombetta said China changed immensely. From developing large industrial parks-what used to be rural areas to developed and easily accessible suburbs, as well as advances in the drug channel, Trombetta continues to watch the country evolve its pharmaceutical capacity. My discussions with him frame this article in our coverage. 

Similar observations are borne out in our reporting. Strikingly, are the advances in the Chinese regulatory process for drug development and manufacturing. Though the bad apples in manufacturing are still clearly a concern, the court of public opinion is pressuring the government to act not just through prosecutorial means, but through a regulatory process that should weed out the bad actors and improve the overall quality of the supply chain. 

IP concerns have been reduced, mostly through stronger legal contracts and understanding. If you check out these videos with our Senior Editor Michelle Maskaly at a ChinaBio event during JPM in early January, you’ll see that these executives don’t view IP as the barrier it once was. 

According to reporting by our European Editor Julian Upton, Christian Hogg, CEO of Hong Kong-based biopharma company Chi-Med, observed that protectionism has melted away over the last 10 years, as the country has listened to multinational companies. 

In addition to China’s government changes and growing middle-class, a major influencer is the educated, skilled, and entrepreneurial individuals who have returned from their ex-China experiences with the desire to improve and invest in the legitimacy of China’s science. Quality in development, IP, manufacturing, processes is very important to them because they truly want to be viewed as an equal player on the world biopharma stage. 

But even as we were putting our coverage together, yet another scandal occurred-the reports that approximately 145 children had received an expired polio vaccine in the Jinhu province. Not necessarily a manufacturing problem, but it marks the fifth vaccine-related issue in the country in the past seven years. Enough for parents and citizens to gather publicly and voice concerns to their government. Enough of an incident for the media here and there to cover it and wonder if China can get its policies in order. In general, another knock against the overall ability of the country to take it to the next level. 

In comparison, the FDA regularly investigates and fines entities and individuals for manufacturing problems, GCP violations, labeling and advertising inconsistencies, and government-influenced issues outside of regulatory, such as pricing. These also make the headlines in the US and lead to an overall picture painted for the public and for policy development. It’s not just in China, governments all over struggle with their own cultural norms, practices, and public pressures. 

I’m still a bit wary about my career obstacles for 2019, but my horoscope also said that if I persevere, I will overcome these challenges. So no smooth sailing for me this year, but also for biopharma in China. What looks like two steps forward, takes one step back. But patiently persevering, even with one step back, or climbing over another high step, eventually you are still moving forward.

Lisa Henderson is Editor-in-Chief of Pharm Exec. She can be reached at lisa.henderson@ubm.com. Follow Lisa on Twitter: @trialsonline