Michael Varrone回答:

with the impact on IND submission for gene therapy products. So it's interesting because the agency, it wants to see more cell and gene therapy products on the market，and they're trying to facilitate that by quicker reviews and working with companies.

关于基因治疗产品的IND申报会受到什么影响。这很有趣，因为FDA希望看到更多的细胞和基因治疗产品上市，他们正试图通过更快的审评和与公司合作来促进这一点。

But at the same time for IND submissions in particular, I think going forward, there's going to be more focus on safety, on safety issues.

但与此同时，特别是对于IND申报来说，我认为未来会更加关注安全性问题。

And in particular with Chinese enterprises, just because some of the comments that Dr. Makary and Dr. Prasad, the head of the Center for Biologics, some of the statements they have said recently，where they've expressed some, I don't want to say skepticism, but they've specifically pointed to CAR T products as a national security threat when being manufactured in China.

尤其是针对中国企业，因为Makary博士和生物制品中心负责人Prasad博士最近的一些评论，以及他们最近发表的一些声明，表达了一些——我不想说是怀疑——但他们明确指出，CAR T产品在中国生产会构成国家安全威胁。

So there's definitely a focus on manufacturing issues with CAR T products，and a skepticism with foreign manufacturing. Now that said, they still have to operate within the parameters of the law. So they can't have any biases toward a foreign company over a domestic company.

因此，FDA现在明显在特别关注CAR T 产品的生产问题，并对外国生产持怀疑态度。话虽如此，他们仍然必须在法律的框架内运作。所以，他们不能对外国公司比对国内公司有任何偏见。

So what I expect is them to again be more, actually scrutinize more in IND submission from Chinese companies，to make sure that they strictly comply with all of the requirements going forward.

所以我预计他们会对来自中国公司的IND申报进行更严格的审评，以确保他们严格遵守未来所有要求。

And to do that again, I think that the best thing that Chinese companies can do， is to make sure that they have all of the boxes checked on what they need for the IND，and to make sure they have a robust data to the extent they need data to support that IND submission, data to support it, to show that the clinical trial will be safe going forward.

要做到这一点，我认为中国公司能做的最好的事情就是，确保他们在IND所需的所有方面都已准备妥当，并确保有稳健的数据来支持IND申报，证明临床试验是安全的。

So I think that that's one of the ways to prepare in advance, make sure that the informed consent is appropriate，and all of those requirements for the IND in particular, because FDA is going to highly scrutinize that submission.

所以我认为这是提前准备的一种方式，确保知情同意是适当的，并满足IND的所有这些要求，因为FDA将会严格审评申报资料。