Per Tanner Greer, China is all-in on leading the new industrial revolution, which will of course first be a revolution in science and technology. My only insight into the tech part is that Chinese companies now make the most innovative earphones and the most electric cars, and from reading Apple in China I have a vague sense that they were contract manufacturers in those fields first, then perfected the craft and outdid their former employers.
Most relevant to the world is what they But who are “they”? CCP leadership which sets the tone, startups and conglomerates which do the actual legwork, or the provincial bosses who act as intermediaries? I won’t even pretend to know. have done and will do with renewable energy, batteries, quantum computing and the like. The most relevant to me is what they are doing with biomedical research, particularly in cell & gene therapy. And as the field progresses from discovery to manufacturing — both research-grade and commercial — to clinical trials and actual practice so does the extent of their involvement.
On the discovery side, Chinese authors have already overtaken their American counterparts in the number of papers in top scientific journals. A crude metric for sure — and let’s not get into the whole peer review debate — but it is a measure of general lab activity. Determining whether China overtaking the US is a direct or indirect result of American sinophobia or evidence that the sinophobia was justified I will leave as an exercise for the reader.
In manufacturing, China is in the “let us do your work for you” stage. Not a week goes by that I don’t get an email from a China-based CDMO Contract Development and Manufacturing Organization, which just to make things confusing is often shortened even further to Contract Manufacturing Organization, or CMO, which means so many different things within the same field (Chief Medical/Manufacturing/Marketing Officer, anyone?) that it has become ridiculous. and WuXi Biologics — headquarters in Shanghai — is among the top 5 companies of that type in the world. These companies specialize in being taught how to do things and then doing them at scale, picking up a few things about process development and optimization on the way. Why the US would not want CDMOs from China was so obvious that the bill forbidding federally funded entities from contracting with them sped through Congress, though not after being revised to not explicitly mention WuXi by name.
“They” are not taking the same approach with clinical trials: a wise decision on their part, since the only thing they could have possibly learned from American trialists was inefficiency and bloat. No, the big push is for investigator-initiated trials which can speed up approvals — they only require local oversight, not a national FDA-equivalent to give their blessing — and get cell & gene treatments to patients within weeks, provided of course that they are manufactured in China.
An eternity ago I wrote about two different types of trials, ones meant to introduce new treatments and others meant to establish guidelines and prune less effective therapies. I argued that the regulatory burden for the two should be different, since the latter — Set 2 as I called them — are clearly less risky and carry less uncertainty. We have of course already experienced the world of unregulated trials of new therapies, and it was not pretty. With its IIT push, China is speeding them up further. The risks are clear, but who benefits?
Top of mind are the patients who will get effective treatments sooner. The invisible graveyard will shrink! But of course most treatments won’t work and most patients who take part in IITs and their family members will have spent much time, some even money, to get false hope. A much larger proportion of the beneficiaries will be companies that hit a false positive, and in single-center IITs of small sample size there will be many of those. They will of course be willfully ignorant of the fact that their high response rate in a 10-patient single-arm open-label trial was spurious, but will instead get just enough conviction to pass on the asset to the greater fool. And so will the roulette wheel keep spinning, fueled by financialization that somehow ends up being the root cause of most of the world’s current ills.
I fully expect the American biotech establishment to learn the wrong lesson from Chinese IITs and instead of feeling relief that someone else is taking on the foolish risk be pressured into copying them. Here is to the steadfast box-checkers and blank faces whom I trust to put on the brakes.